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cochrane-simplification-train-1400 | cochrane-simplification-train-1400 | The systematic review currently includes 63 randomised trials with 3675 participants. Bromperidol (n = 9), loxapine (n = 7), and trifluoperazine (n = 6) were the most frequently administered antipsychotics comparator to haloperidol. The included studies were published between 1962 and 1993, were characterised by small sample sizes (mean: 58 participants, range from 18 to 206) and the predefined outcomes were often incompletely reported. All results for the main outcomes were based on very low or low quality data. In many trials the mechanism of randomisation, allocation, and blinding was frequently not reported. In short-term studies (up to 12 weeks), there was no clear evidence of a difference between haloperidol and the pooled group of the other first-generation antipsychotic agents in terms of the primary outcome "clinically important response to treatment" (40 RCTs, n = 2132, RR 0.93 CI 0.87 to 1.00). In the medium-term trials, haloperidol may be less effective than the other first-generation antipsychotic group but this evidence is based on only one trial (1 RCT, n = 80, RR 0.51 CI 0.37 to 0.69). Based on limited evidence, haloperidol alleviated more positive symptoms of schizophrenia than the other antipsychotic drugs. There were no statistically significant between-group differences in global state, other mental state outcomes, behaviour, leaving the study early due to any reason, due to inefficacy, as well as due to adverse effects. The only statistically significant difference in specific side effects was that haloperidol produced less akathisia in the medium term. The findings of the meta-analytic calculations support the statements of previous narrative, unsystematic reviews suggesting comparable efficacy of first-generation antipsychotics. In efficacy-related outcomes, there was no clear evidence of a difference between the prototypal drug haloperidol and other, mainly high-potency first-generation antipsychotics. Additionally, we demonstrated that haloperidol is characterised by a similar risk profile compared to the other first-generation antipsychotic compounds. The only statistically significant difference in specific side effects was that haloperidol produced less akathisia in the medium term. The results were limited by the low methodological quality in many of the included original studies. Data for the main results were low or very low quality. Therefore, future clinical trials with high methodological quality are required. | Previous small studies and unsystematic reviews have found no difference between the various first- generation antipsychotic drugs. This has led to the assumption that these drugs are similar in effectiveness (despite observations by psychiatrists and health professionals that these drugs do sometimes differ in their effectiveness and side effects). Because of high prescription-rates, research on haloperidol is very important. A search for randomised trials was run in 2012. This review includes 63 trials with 3675 participants. Haloperidol was compared with a large number of other first-generation antipsychotic drugs (including bromperidol, loxapine and trifluoperazine) to assess its effectiveness, acceptability and tolerability. The findings of the review support the evidence of previous small, narrative studies and unsystematic reviews. There was no difference between haloperidol and other mainly high-potency first-generation antipsychotic drugs. In addition, haloperidol was characterised by a similar risk profile and side effects to other first-generation antipsychotic drugs. People receiving haloperidol were less likely to experience akathisia in the medium term. Occurrence of other specific side effect such as tremor, dystonia, dyskinesia and rigor were all similar between treatment groups. Psychiatrists and people with schizophrenia should know that haloperidol and other first-generation antipsychotic drugs are similar in their effectiveness and risk of side effects. These drugs should also be similar in their acceptability for people with schizophrenia. However, results were limited due to the low quality of many of the included studies and low quality of evidence provided. Future studies of higher quality are required. This plain language summary has been written by a consumer Ben Gray: Senior Peer Researcher www.mcpin.org. | 10.1002/14651858.CD009831.pub2 | [
"Previous small studies and unsystematic reviews have found no difference between the various first- generation antipsychotic drugs. This has led to the assumption that these drugs are similar in effectiveness (despite observations by psychiatrists and health professionals that these drugs do sometimes differ in their effectiveness and side effects). Because of high prescription-rates, research on haloperidol is very important. A search for randomised trials was run in 2012. This review includes 63 trials with 3675 participants. Haloperidol was compared with a large number of other first-generation antipsychotic drugs (including bromperidol, loxapine and trifluoperazine) to assess its effectiveness, acceptability and tolerability. The findings of the review support the evidence of previous small, narrative studies and unsystematic reviews. There was no difference between haloperidol and other mainly high-potency first-generation antipsychotic drugs. In addition, haloperidol was characterised by a similar risk profile and side effects to other first-generation antipsychotic drugs. People receiving haloperidol were less likely to experience akathisia in the medium term. Occurrence of other specific side effect such as tremor, dystonia, dyskinesia and rigor were all similar between treatment groups. Psychiatrists and people with schizophrenia should know that haloperidol and other first-generation antipsychotic drugs are similar in their effectiveness and risk of side effects. These drugs should also be similar in their acceptability for people with schizophrenia. However, results were limited due to the low quality of many of the included studies and low quality of evidence provided. Future studies of higher quality are required. This plain language summary has been written by a consumer Ben Gray: Senior Peer Researcher www.mcpin.org."
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cochrane-simplification-train-1401 | cochrane-simplification-train-1401 | Four studies at unclear to high risk of bias comprising 463 participants were included. The mean study duration was 7.5 months (range 3 to 18 months). One of our primary outcomes－'change from baseline in health related quality of life'－and two of our secondary outcomes－'change from baseline in LT4 replacement dosage at end of the study' and 'economic costs'－were not assessed in any of the studies. One study at high risk of bias showed statistically significant improvement in subjective well-being with sodium selenite 200 μg plus titrated LT4 compared with placebo plus titrated LT4 (relative risk (RR) 4.67, 95% confidence interval (CI) 1.61 to 13.50; P = 0.004; 36 participants; number needed to treat (NNT) = 2 (95% CI 2 to 3)). Selenomethionine 200 μg reduced the serum levels of anti-thyroid peroxidase antibodies compared with placebo in two studies (mean difference (MD) -917 U/mL, 95% CI -1056 to -778; P < 0.001; 85 participants) and (MD -345 IU/mL, 95% CI -359 to -331; P < 0.001; 169 participants). Pooling of the studies was not feasible due to marked clinical heterogeneity (I2 = 99%). In a further comparison within the first study where selenomethionine was combined with LT4 the reduction in TPO antibodies was even more noticeable (MD -1508 U/mL, 95% CI -1671 to -1345; P < 0.001; 86 participants). In a third study, where LT4 was added to both intervention arms, a reduction in serum levels of anti-thyroid peroxidase antibodies favoured the selenomethionine arm as well (MD -235 IU/mL, 95% CI -374 to -95; P = 0.001; 88 participants). Although the changes from baseline were statistically significant in these three studies, their clinical relevance is unclear. Serum antibodies were not statistically significantly affected in the study comparing sodium selenite 200 μg plus titrated LT4 with placebo plus titrated LT4 (MD -25, 95% CI -181 to 131; P = 0.75; 36 participants). Adverse events were reported in two studies (1 of 85 and 1 of 88 participants, respectively). Selenium supplementation did not appear to have a statistically significant impact on the incidence of adverse events (RR 2.93, 95% CI 0.12 to 70.00; and RR 2.63, 95% CI 0.11 to 62.95). Results of these four studies show that evidence to support or refute the efficacy of selenium supplementation in people with Hashimoto's thyroiditis is incomplete. The current level of evidence for the efficacy of selenium supplementation in the management of people with Hashimoto's thyroiditis is based on four randomised controlled trials assessed at unclear to high risk of bias; this does not at present allow confident decision making about the use of selenium supplementation for Hashimoto's thyroiditis. This review highlights the need for randomised placebo-controlled trials to evaluate the effects of selenium in people with Hashimoto's thyroiditis and can ultimately provide reliable evidence to help inform clinical decision making. | Four studies at unclear to high risk of bias comprising 463 participants were included. The mean study duration was 7.5 months (range 3 to 18 months). None of the studies addressed our key primary outcome－'health-related quality of life'. Two of our secondary outcomes－'change from baseline in levothyroxine (i.e. thyroid hormone) replacement dosage at end of the study' and 'economic costs'－were not assessed either. One study at high risk of bias showed a statistically significant improvement in subjective well-being with sodium selenite 200 μg plus levothyroxine compared with placebo plus levothyroxine (14/18 compared with 3/18, respectively). Selenomethionine 200 μg reduced the serum levels of anti-thyroid peroxidase antibodies in three studies, and although the changes from baseline were statistically significant, their clinical relevance is unclear. Adverse events were reported in two studies, and selenium supplementation did not lead to more adverse events than were seen with placebo. One adverse event was reported in both studies in the selenomethionine 200 μg plus LT4 arm versus none in the control arm. In conclusion, the results of these four studies do not provide enough evidence to support the use of selenium in the treatment of Hashimoto's thyroiditis. | 10.1002/14651858.CD010223.pub2 | [
"Four studies at unclear to high risk of bias comprising 463 participants were included. The mean study duration was 7.5 months (range 3 to 18 months). None of the studies addressed our key primary outcome－'health-related quality of life'. Two of our secondary outcomes－'change from baseline in levothyroxine (i.e. thyroid hormone) replacement dosage at end of the study' and 'economic costs'－were not assessed either. One study at high risk of bias showed a statistically significant improvement in subjective well-being with sodium selenite 200 μg plus levothyroxine compared with placebo plus levothyroxine (14/18 compared with 3/18, respectively). Selenomethionine 200 μg reduced the serum levels of anti-thyroid peroxidase antibodies in three studies, and although the changes from baseline were statistically significant, their clinical relevance is unclear. Adverse events were reported in two studies, and selenium supplementation did not lead to more adverse events than were seen with placebo. One adverse event was reported in both studies in the selenomethionine 200 μg plus LT4 arm versus none in the control arm. In conclusion, the results of these four studies do not provide enough evidence to support the use of selenium in the treatment of Hashimoto's thyroiditis."
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cochrane-simplification-train-1402 | cochrane-simplification-train-1402 | We did not identify any randomised controlled trials that evaluated the effectiveness of sleep positioning systems on hip migration. We did find two randomised cross-over trials that met the inclusion criteria in respect of secondary objectives relating to sleep quality and pain. Neither study reported any important difference between sleeping in sleep positioning systems and not for sleep patterns or sleep quality (two studies, 21 children, very low quality evidence) and pain (one study, 11 children, very low quality evidence). These were small studies with established users of sleep positioning systems and were judged to have high risk of bias. We found no eligible trials that explored the other secondary objectives (number or frequency of hip problems, quality of life of the child and family, physical functioning, and adverse effects). We found no randomised trials that evaluated the effectiveness of sleep positioning systems to reduce or prevent hip migration in children with cerebral palsy. Nor did we find any randomised trials that evaluated the effect of sleep positioning systems on the number or frequency of hip problems, quality of life of the child and family or on physical functioning. Limited data from two randomised trials, which evaluated the effectiveness of sleep positioning systems on sleep quality and pain for children with cerebral palsy, showed no significant differences in these aspects of health when children were using and not using a sleep positioning system. In order to inform clinical decision-making and the prescription of sleep positioning systems, more rigorous research is needed to determine effectiveness, cost-effectiveness, and the likelihood of adverse effects. | We carried out a comprehensive search for studies. The evidence is current to December 2014. No randomised controlled trials were found that evaluated the effectiveness of sleep positioning systems to reduce or prevent hip migration. Two small randomised controlled trials compared children's quality of sleep when they were using and not using their sleep positioning system. One of these studies also examined pain when sleeping in and out of a sleep positioning system. These were cross-over trials (see Cochrane Glossary). The children in these studies spent a few nights using their sleep positioning system and then a few nights not using it, or the other way round. The order in which they either used or did not use the equipment was randomised. Twenty-one children with cerebral palsy, aged between 5 and 16 years, who were used to sleeping in sleep positioning systems took part in the studies. One of the studies took place in a sleep laboratory and the other study took place in the children's homes. Neither study reported any differences in quality of sleep or pain whether using or not using their sleep positioning system. These results need to be interpreted cautiously due to the small numbers of children involved and the fact that the children who participated were already accustomed users of the equipment. There were also various weaknesses in the way the research was designed and reported. The quality of the current evidence regarding the effectiveness of sleep positioning systems for children with cerebral palsy is very low and more robust research is needed to help families and professionals make informed decisions about whether to use this intervention. | 10.1002/14651858.CD009257.pub2 | [
"We carried out a comprehensive search for studies. The evidence is current to December 2014. No randomised controlled trials were found that evaluated the effectiveness of sleep positioning systems to reduce or prevent hip migration. Two small randomised controlled trials compared children's quality of sleep when they were using and not using their sleep positioning system. One of these studies also examined pain when sleeping in and out of a sleep positioning system. These were cross-over trials (see Cochrane Glossary). The children in these studies spent a few nights using their sleep positioning system and then a few nights not using it, or the other way round. The order in which they either used or did not use the equipment was randomised. Twenty-one children with cerebral palsy, aged between 5 and 16 years, who were used to sleeping in sleep positioning systems took part in the studies. One of the studies took place in a sleep laboratory and the other study took place in the children's homes. Neither study reported any differences in quality of sleep or pain whether using or not using their sleep positioning system. These results need to be interpreted cautiously due to the small numbers of children involved and the fact that the children who participated were already accustomed users of the equipment. There were also various weaknesses in the way the research was designed and reported. The quality of the current evidence regarding the effectiveness of sleep positioning systems for children with cerebral palsy is very low and more robust research is needed to help families and professionals make informed decisions about whether to use this intervention."
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cochrane-simplification-train-1403 | cochrane-simplification-train-1403 | We included 33 trials with a total of 2293 participants from 0.9 to 12 (mean or median) years of age. Most trials were at low risk of selection, detection, attrition, and reporting bias, however the lack of blinding of participants and personnel caring for participants resulted in 25 trials being judged as at high or unclear risk of bias. We identified five ongoing trials. Ultrasound guidance probably reduces the risk of failed block (risk difference (RD) −0.16, 95% confidence interval (CI) −0.25 to −0.07; 22 trials; 1789 participants; moderate-quality evidence). When ultrasound guidance was used, there was a small to moderate reduction in pain one hour after surgery, equivalent to a reduction of 1.3 points on the revised Bieri FACES pain scale (scale; 0 = no pain, 10 = maximal pain) (standardized mean difference (SMD) −0.41, 95% CI −0.74 to −0.07 (medium effect size); 15 trials; 982 participants; moderate-quality evidence). Ultrasound guidance increases block duration by the equivalent of 42 minutes (SMD 1.24, 95% CI 0.72 to 1.75; 10 trials; 460 participants; high-quality evidence). There is probably little or no difference in the time taken to perform the block (SMD −0.46, 95% CI −1.06 to 0.13; 9 trials; 680 participants; moderate-quality evidence). It is uncertain whether the number of needle passes required is reduced with the use of ultrasound guidance (SMD −0.63, 95% CI −1.08 to −0.18; 3 trials; 256 participants; very low-quality evidence). There were no occurrences of major complications in either the intervention or control arms of the trials (cardiac arrest from local anaesthetic toxicity (22 trials; 1576 participants; moderate-quality evidence); lasting neurological injury (19 trials; 1250 participants; low-quality evidence)). There may be little of no difference in the risk of bloody puncture (RD −0.02, 95% CI −0.05 to 0.00; 13 trials; 896 participants; low-quality evidence) or transient neurological injury (RD −0.00, 95% CI −0.01 to 0.01; 18 trials; 1230 participants; low-quality evidence). There were no occurrences of seizure from local anaesthetic toxicity (22 trials; 1576 participants; moderate-quality evidence) or block infections without neurological injury (18 trials; 1238 participants; low-quality evidence). Ultrasound guidance for regional blockade in children probably decreases the risk of failed block. It increases the duration of the block and probably decreases pain scores at one hour after surgery. There may be little or no difference in the risks of some minor complications. The five ongoing studies may alter the conclusions of the review once published and assessed. | We included 33 well-designed studies with a total of 2293 children in which ultrasound guidance was compared with another method of nerve localization (traditional landmarks techniques or nerve stimulator) for regional blockade in children. Sources of funding included a government organization (two studies), a charitable organization (two studies), and an institutional department (13 studies). Two studies declared that they received industry help (equipment loan). The source of funding was unclear for 14 studies. Ultrasound guidance for regional blockade in children may decrease the occurrence of failed block. It may also increase duration of the block and reduce pain at one hour after surgery. Ultrasound guidance may decrease the number of needle passes required to perform the block. However, because the vast majority of blocks in children are performed with the child under deep sedation or general anaesthesia, the true value of this finding might be arguable. There were no major complications in the included trials. There may be little or no difference between study groups in risks of minor complications. Altogether, whether or not these findings justify the extra cost of ultrasound guidance should probably also take into account the anaesthesiologist's expertise and local resources. The five ongoing studies may alter the conclusions of the review once published and assessed. We assessed the quality of the evidence as moderate for decreased occurrence of a failed block and improved pain scores at one hour; high for prolonged block duration; and very low for decreased number of needle passes. | 10.1002/14651858.CD011436.pub3 | [
"We included 33 well-designed studies with a total of 2293 children in which ultrasound guidance was compared with another method of nerve localization (traditional landmarks techniques or nerve stimulator) for regional blockade in children. Sources of funding included a government organization (two studies), a charitable organization (two studies), and an institutional department (13 studies). Two studies declared that they received industry help (equipment loan). The source of funding was unclear for 14 studies. Ultrasound guidance for regional blockade in children may decrease the occurrence of failed block. It may also increase duration of the block and reduce pain at one hour after surgery. Ultrasound guidance may decrease the number of needle passes required to perform the block. However, because the vast majority of blocks in children are performed with the child under deep sedation or general anaesthesia, the true value of this finding might be arguable. There were no major complications in the included trials. There may be little or no difference between study groups in risks of minor complications. Altogether, whether or not these findings justify the extra cost of ultrasound guidance should probably also take into account the anaesthesiologist's expertise and local resources. The five ongoing studies may alter the conclusions of the review once published and assessed. We assessed the quality of the evidence as moderate for decreased occurrence of a failed block and improved pain scores at one hour; high for prolonged block duration; and very low for decreased number of needle passes."
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cochrane-simplification-train-1404 | cochrane-simplification-train-1404 | Six trials met the inclusion criteria. We have not found any new studies since the initial review. In the trial comparing the desogestrel versus levonorgestrel progestin-only pill, desogestrel was not associated with a significantly lower risk of accidental pregnancy; the rate ratio was 0.27 (95% CI 0.06 to 1.19). However, the desogestrel progestin-only pill caused more bleeding problems, although this difference was not statistically significant. The trial comparing low-dose mifepristone versus a levonorgestrel progestin-only pill found similar pregnancy rates. In the trial comparing ethynodiol diacetate versus a combined oral contraceptive, irregular cycles occurred in all women assigned to the progestin-only pill (odds ratio 135.96; 95% CI 7.61 to 2421.02). In a trial comparing two progestin-only and two combined oral contraceptives, the progestin-only pill containing levonorgestrel 30 μg had higher efficacy than did the pill containing norethisterone 350 μg. An early trial found megestrol acetate inferior to other progestin-only pills in terms of efficacy. A study of the timing of pill initiation after birth found no important differences, but high losses to follow up undermined the trial. Evidence is insufficient to compare progestin-only pills to each other or to combined oral contraceptives. | We found six trials for the initial review. We have not found any more studies since then. Some studies are several decades old and not very relevant to pills available today. A newer pill containing the progestin desogestrel may work better to prevent pregnancy than an older pill with levonorgestrel. The newer pill caused more bleeding problems. Pills with levonorgestrel may be more effective than pills with other progestins that are no longer used. These studies are not adequate to tell how progestin-only pills compare to each other or to combined (two-hormone) pills. Larger studies with currently used pills are needed to answer these questions. | 10.1002/14651858.CD007541.pub3 | [
"We found six trials for the initial review. We have not found any more studies since then. Some studies are several decades old and not very relevant to pills available today. A newer pill containing the progestin desogestrel may work better to prevent pregnancy than an older pill with levonorgestrel. The newer pill caused more bleeding problems. Pills with levonorgestrel may be more effective than pills with other progestins that are no longer used. These studies are not adequate to tell how progestin-only pills compare to each other or to combined (two-hormone) pills. Larger studies with currently used pills are needed to answer these questions."
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cochrane-simplification-train-1405 | cochrane-simplification-train-1405 | We included 38 studies (15,903 participants) in this review, 18 of which were cluster-randomised trials (11,995 participants) and two were quasi-randomised trials (399 participants). We included 33 studies in the meta-analyses. We included eight studies (3405 participants) in the meta-analysis assessing episodes of relationship violence. There was substantial heterogeneity (I2 = 57%) for this outcome. The risk ratio was 0.77 (95% confidence interval (CI) 0.53 to 1.13). We included 22 studies (5256 participants) in the meta-analysis assessing attitudes towards relationship violence. The standardised mean difference (SMD) was 0.06 (95% CI -0.01 to 0.15). We included four studies (887 participants) in the meta-analysis assessing behaviour related to relationship violence; the SMD was -0.07 (95% CI -0.31 to 0.16). We included 10 studies (6206 participants) in the meta-analysis assessing knowledge related to relationship violence; the results showed an increase in knowledge in favour of the intervention (SMD 0.44, 95% CI 0.28 to 0.60) but there was substantial heterogeneity (I2 = 52%). We included seven studies (1369 participants) in the meta-analysis assessing skills related to relationship violence. The SMD was 0.03 (95% CI -0.11 to 0.17). None of the included studies assessed physical health, psychosocial health or adverse outcomes. Subgroup analyses showed no statistically significant differences by intervention setting or type of participants. The quality of evidence for all outcomes included in our meta-analysis was moderate due to an unclear risk of selection and detection bias and a high risk of performance bias in most studies. Studies included in this review showed no evidence of effectiveness of interventions on episodes of relationship violence or on attitudes, behaviours and skills related to relationship violence. We found a small increase in knowledge but there was evidence of substantial heterogeneity among studies. Further studies with longer-term follow-up are required, and study authors should use standardised and validated measurement instruments to maximise comparability of results. | This review looked at the results of 38 studies. The results showed no convincing evidence that the programmes decreased relationship violence, or that they improved participants' attitudes, behaviours and skills related to relationship violence. The results showed that participants' knowledge about relationships improved slightly following the programmes. These results should be interpreted with caution, as individual studies differed in the types of participants and interventions that they used and the ways in which changes were measured. None of the studies looked at the effect of the programmes on physical and mental health. Further studies, which follow participants for a longer period of time and which look at the relationship between attitudes, knowledge, behaviour, skills and the number of times relationship violence occurs, are required to improve our understanding of how well these programmes work. | 10.1002/14651858.CD004534.pub3 | [
"This review looked at the results of 38 studies. The results showed no convincing evidence that the programmes decreased relationship violence, or that they improved participants' attitudes, behaviours and skills related to relationship violence. The results showed that participants' knowledge about relationships improved slightly following the programmes. These results should be interpreted with caution, as individual studies differed in the types of participants and interventions that they used and the ways in which changes were measured. None of the studies looked at the effect of the programmes on physical and mental health. Further studies, which follow participants for a longer period of time and which look at the relationship between attitudes, knowledge, behaviour, skills and the number of times relationship violence occurs, are required to improve our understanding of how well these programmes work."
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cochrane-simplification-train-1406 | cochrane-simplification-train-1406 | We included 83 RCTs with 14,967 participants; we found no quasi-randomized studies. All participants were undergoing non-cardiac surgery, and types of surgery ranged from low to high risk. Types of beta-blockers were: propranolol, metoprolol, esmolol, landiolol, nadolol, atenolol, labetalol, oxprenolol, and pindolol. In nine studies, beta-blockers were titrated according to heart rate or blood pressure. Duration of administration varied between studies, as did the time at which drugs were administered; in most studies, it was intraoperatively, but in 18 studies it was before surgery, in six postoperatively, one multi-arm study included groups of different timings, and one study did not report timing of drug administration. Overall, we found that more than half of the studies did not sufficiently report methods used for randomization. All studies in which the control was standard care were at high risk of performance bias because of the open-label study design. Only two studies were prospectively registered with clinical trials registers, which limited the assessment of reporting bias. In six studies, participants in the control group were given beta-blockers as rescue therapy during the study period. The evidence for all-cause mortality at 30 days was uncertain; based on the risk of death in the control group of 25 per 1000, the effect with beta-blockers was between two fewer and 13 more per 1000 (risk ratio (RR) 1.17, 95% confidence interval (CI) 0.89 to 1.54; 16 studies, 11,446 participants; low-certainty evidence). Beta-blockers may reduce the incidence of myocardial infarction by 13 fewer incidences per 1000 (RR 0.72, 95% CI 0.60 to 0.87; 12 studies, 10,520 participants; low-certainty evidence). We found no evidence of a difference in cerebrovascular events (RR 1.65, 95% CI 0.97 to 2.81; 6 studies, 9460 participants; low-certainty evidence), or in ventricular arrhythmias (RR 0.72, 95% CI 0.35 to 1.47; 5 studies, 476 participants; very low-certainty evidence). Beta-blockers may reduce atrial fibrillation or flutter by 26 fewer incidences per 1000 (RR 0.41, 95% CI 0.21 to 0.79; 9 studies, 9080 participants; low-certainty evidence). However, beta-blockers may increase bradycardia by 55 more incidences per 1000 (RR 2.49, 95% CI 1.74 to 3.56; 49 studies, 12,239 participants; low-certainty evidence), and hypotension by 44 more per 1000 (RR 1.40, 95% CI 1.29 to 1.51; 49 studies, 12,304 participants; moderate-certainty evidence). We downgraded the certainty of the evidence owing to study limitations; some studies had high risks of bias, and the effects were sometimes altered when we excluded studies with a standard care control group (including only placebo-controlled trials showed an increase in early mortality and cerebrovascular events with beta-blockers). We also downgraded for inconsistency; one large, well-conducted, international study found a reduction in myocardial infarction, and an increase in cerebrovascular events and all-cause mortality, when beta-blockers were used, but other studies showed no evidence of a difference. We could not explain the reason for the inconsistency in the evidence for ventricular arrhythmias, and we also downgraded this outcome for imprecision because we found few studies with few participants. The evidence for early all-cause mortality with perioperative beta-blockers was uncertain. We found no evidence of a difference in cerebrovascular events or ventricular arrhythmias, and the certainty of the evidence for these outcomes was low and very low. We found low-certainty evidence that beta-blockers may reduce atrial fibrillation and myocardial infarctions. However, beta-blockers may increase bradycardia (low-certainty evidence) and probably increase hypotension (moderate-certainty evidence). Further evidence from large placebo-controlled trials is likely to increase the certainty of these findings, and we recommend the assessment of impact on quality of life. We found 18 studies awaiting classification; inclusion of these studies in future updates may also increase the certainty of the evidence. | This review assessed evidence from randomized controlled trials (RCTs) on whether beta-blockers reduce deaths or other serious events when given to people undergoing surgery other than heart surgery. The findings for heart surgery are covered in another review. Background Surgery increases stress in the body, which responds by releasing the hormones adrenaline and noradrenaline. Stress from surgery can lead to death or other serious events such as heart attacks, stroke, or an irregular heartbeat. For surgery that does not involve the heart, an estimated 8% of people may have injury to their heart around the time of surgery. Beta-blockers are drugs that block the action of adrenaline and noradrenaline on the heart. Beta-blockers can slow down the heart, and reduce blood pressure, and this may reduce the risk of serious events. However, beta-blockers may lead to a very low heart rate or very low blood pressure which could increase the risk of death or a stroke. Prevention of early complications after surgery is important, but using beta-blockers to prevent these complications is controversial. Study characteristics The evidence is current to 28 June 2019. We included 83 RCTs with 14,967 adults who were undergoing different types of surgery other than heart surgery. Eighteen studies are awaiting classification (because we did not have enough details to assess them), and three studies are ongoing. The types of beta-blockers used in the studies were: propranolol, metoprolol, esmolol, landiolol, nadolol, atenolol, labetalol, oxprenolol, and pindolol. Studies compared these beta-blockers with either a placebo (disguised to look like a beta-blocker but containing no medicine) or with standard care. Key results Beta-blockers may make little or no difference to the number of people who die within 30 days of surgery (16 studies, 11,446 participants; low-certainty evidence), have a stroke (6 studies, 9460 participants; low-certainty evidence), or experience ventricular arrhythmias (irregular heartbeat rhythms, starting in the main chambers of the heart, that are potentially life-threatening and may need immediate medical treatment; 5 studies, 476 participants; very low-certainty evidence). We found that beta-blockers may reduce atrial fibrillation (an irregular heartbeat, starting in the atrial chambers of the heart, that increases the risk of stroke if untreated; 9 studies, 9080 participants; low certainty-evidence), and the number of people who have a heart attack (12 studies, 10,520 participants; low-certainty evidence). However, taking beta-blockers may increase the number of people who experience a very low heart rate (49 studies, 12,239 participants; low-certainty evidence), or very low blood pressure (49 studies, 12,304 participants; moderate-certainty evidence), around the time of surgery. In a few studies, we also found little or no difference in the number of people who died after 30 days, who died because of a heart problem, or had heart failure. We found no evidence of whether beta-blockers alter the length of time in hospital. No studies assessed whether people who were given beta-blockers had a better quality of life after heart surgery. Certainty of the evidence The certainty of the evidence in this review was limited by including some studies that were at high risk of bias, and we noticed that some of our findings were different if we only included placebo-controlled studies or studies that reported how participants were randomized. We also found one large, well-conducted, international study that had different findings to the smaller studies. It showed a reduction in heart attacks and an increase in stroke and all-cause mortality when beta-blockers were used, whilst the other studies did not show a clear effect. We were also less certain of the findings for outcomes with few studies, such as for ventricular arrhythmias. Conclusion Although beta-blockers may make little or no difference to the number of people who die within 30 days, have a stroke, or have ventricular arrhythmias, they may reduce atrial fibrillation and heart attacks. Taking beta-blockers may increase the number of people with a very low heart rate or very low blood pressure around the time of surgery. Further evidence from large, placebo-controlled trials is likely to increase the certainty of these findings, and we recommend the assessment of impact on quality of life. | 10.1002/14651858.CD013438 | [
"This review assessed evidence from randomized controlled trials (RCTs) on whether beta-blockers reduce deaths or other serious events when given to people undergoing surgery other than heart surgery. The findings for heart surgery are covered in another review. Background Surgery increases stress in the body, which responds by releasing the hormones adrenaline and noradrenaline. Stress from surgery can lead to death or other serious events such as heart attacks, stroke, or an irregular heartbeat. For surgery that does not involve the heart, an estimated 8% of people may have injury to their heart around the time of surgery. Beta-blockers are drugs that block the action of adrenaline and noradrenaline on the heart. Beta-blockers can slow down the heart, and reduce blood pressure, and this may reduce the risk of serious events. However, beta-blockers may lead to a very low heart rate or very low blood pressure which could increase the risk of death or a stroke. Prevention of early complications after surgery is important, but using beta-blockers to prevent these complications is controversial. Study characteristics The evidence is current to 28 June 2019. We included 83 RCTs with 14,967 adults who were undergoing different types of surgery other than heart surgery. Eighteen studies are awaiting classification (because we did not have enough details to assess them), and three studies are ongoing. The types of beta-blockers used in the studies were: propranolol, metoprolol, esmolol, landiolol, nadolol, atenolol, labetalol, oxprenolol, and pindolol. Studies compared these beta-blockers with either a placebo (disguised to look like a beta-blocker but containing no medicine) or with standard care. Key results Beta-blockers may make little or no difference to the number of people who die within 30 days of surgery (16 studies, 11,446 participants; low-certainty evidence), have a stroke (6 studies, 9460 participants; low-certainty evidence), or experience ventricular arrhythmias (irregular heartbeat rhythms, starting in the main chambers of the heart, that are potentially life-threatening and may need immediate medical treatment; 5 studies, 476 participants; very low-certainty evidence). We found that beta-blockers may reduce atrial fibrillation (an irregular heartbeat, starting in the atrial chambers of the heart, that increases the risk of stroke if untreated; 9 studies, 9080 participants; low certainty-evidence), and the number of people who have a heart attack (12 studies, 10,520 participants; low-certainty evidence). However, taking beta-blockers may increase the number of people who experience a very low heart rate (49 studies, 12,239 participants; low-certainty evidence), or very low blood pressure (49 studies, 12,304 participants; moderate-certainty evidence), around the time of surgery. In a few studies, we also found little or no difference in the number of people who died after 30 days, who died because of a heart problem, or had heart failure. We found no evidence of whether beta-blockers alter the length of time in hospital. No studies assessed whether people who were given beta-blockers had a better quality of life after heart surgery. Certainty of the evidence The certainty of the evidence in this review was limited by including some studies that were at high risk of bias, and we noticed that some of our findings were different if we only included placebo-controlled studies or studies that reported how participants were randomized. We also found one large, well-conducted, international study that had different findings to the smaller studies. It showed a reduction in heart attacks and an increase in stroke and all-cause mortality when beta-blockers were used, whilst the other studies did not show a clear effect. We were also less certain of the findings for outcomes with few studies, such as for ventricular arrhythmias. Conclusion Although beta-blockers may make little or no difference to the number of people who die within 30 days, have a stroke, or have ventricular arrhythmias, they may reduce atrial fibrillation and heart attacks. Taking beta-blockers may increase the number of people with a very low heart rate or very low blood pressure around the time of surgery. Further evidence from large, placebo-controlled trials is likely to increase the certainty of these findings, and we recommend the assessment of impact on quality of life."
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cochrane-simplification-train-1407 | cochrane-simplification-train-1407 | The one study included in this review is a small (n=30) randomised controlled trial lasting 24 weeks. It was followed-up by an open label study with a crossover design. No significant differences were found on any four validated outcomes including global functioning and three measures of cognitive abilities and behavioural problems. 6 out of 16 carers (37%) of participants on donepezil and 2 out of 15 (13%) on placebo reported improvement. No data were available for day to day skills, institutionalisation, reduction in carers' stress or economic outcomes. Half the intervention group and 20% of the placebo group reported adverse events; two participants left because of adverse events. To date there is only one small randomised controlled study on the effect of donepezil. This shows, at best, a modest, non statistically significant trend in favour of people with Down syndrome and Alzheimer's dementia who are able to tolerate donepezil (this drug is currently only dispensed in relatively large doses and is contraindicated for those with cardiac and respiratory problems).This study does not provide good evidence on which to base practice. Findings in an open-label follow up to this study suggest possible benefit in some individuals. Further, larger randomised controlled studies with longer-term follow up are required. | This review identified one randomised controlled trial of donepezil in people with Down syndrome. This shows, at best, a modest, non statistically significant trend in favour of people with Down syndrome and Alzheimer's dementia who are able to tolerate donepezil. The trial was of good quality, but small. It is important to note that people with Down syndrome may often have other conditions which mean that the drug is not suitable for all. Further research is needed. | 10.1002/14651858.CD007178.pub2 | [
"This review identified one randomised controlled trial of donepezil in people with Down syndrome. This shows, at best, a modest, non statistically significant trend in favour of people with Down syndrome and Alzheimer's dementia who are able to tolerate donepezil. The trial was of good quality, but small. It is important to note that people with Down syndrome may often have other conditions which mean that the drug is not suitable for all. Further research is needed."
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cochrane-simplification-train-1408 | cochrane-simplification-train-1408 | Updating the previous review through December 2009 identified 41 additional papers, for a grand total of 278 references. Two-hundred and fourty-two of them were excluded because they analyzed survival (n=27), were repetitive (n=29), letters/reviews (n=71) or had no data (n=115). Thirty-six studies on 12,127 patients remained included: 23 showed a detrimental effect of PBT; 22 used multivariable analyses, and 14 found an independent PBT effect. Pooled estimates of PBT effect on recurrence in randomised studies yielded an OR of 1.42 (95% CI, 1.20 to 1.67) against transfused patients. Stratified meta-analyses confirmed these findings also by site and stage of disease, regardless of timing, type, and in a dose-related fashion, although heterogeneity was detected. Data on surgical techniques was not available for further analysis. This updated meta-analysis confirms the previous findings and supports the association of PBT on the recurrence of curable colorectal cancers. However, since heterogeneity was detected and the effect of surgical technique could not be assessed, a causal relationship cannot still be claimed. Carefully restricted indications for PBT seems necessary. | This review include 36 studies, identified from 278 references retrieved until December 2009, and report a moderate association between colorectal cancer recurrence and perioperative transfusions, with an OR of 1.42 (95% CI, 1.20 to 1.67). Similar estimates are present in several subgroup meta-analyses, as well as in meta-analyses stratified for known risk factors. These findings support carefully restricted indications for perioperative blood transfusions in colorectal cancer patients operated for cure, and continue to await the results of studies addressing the role of surgeon-related risk factors on the need for transfusion and disease recurrence. | 10.1002/14651858.CD005033.pub2 | [
"This review include 36 studies, identified from 278 references retrieved until December 2009, and report a moderate association between colorectal cancer recurrence and perioperative transfusions, with an OR of 1.42 (95% CI, 1.20 to 1.67). Similar estimates are present in several subgroup meta-analyses, as well as in meta-analyses stratified for known risk factors. These findings support carefully restricted indications for perioperative blood transfusions in colorectal cancer patients operated for cure, and continue to await the results of studies addressing the role of surgeon-related risk factors on the need for transfusion and disease recurrence."
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cochrane-simplification-train-1409 | cochrane-simplification-train-1409 | We included four studies with 151 randomized participants. Two studies included participants who were mechanically ventilated, one study included a mix of ventilated and non-ventilated participants and in one study participants were being weaned from mechanical ventilation. Three studies reported admission diagnoses, which varied: these included sepsis, pneumonia and cardiac or cardiorespiratory arrest. All studies compared melatonin against no agent; three were placebo-controlled trials; and one compared melatonin with usual care. All studies administered melatonin in the evening. All studies reported adequate methods for randomization and placebo-controlled trials were blinded at the participant and personnel level. We noted high risk of attrition bias in one study and were unclear about potential bias introduced in two studies with differences between participants at baseline. It was not appropriate to combine data owing to differences in measurement tools, or methods used to report data. The effects of melatonin on subjectively rated quantity and quality of sleep are uncertain (very low certainty evidence). Three studies (139 participants) reported quantity and quality of sleep as measured through reports of participants or family members or by personnel assessments. Study authors in one study reported no difference in sleep efficiency index scores between groups for participant assessment (using Richards-Campbell Sleep Questionnaire) and nurse assessment. Two studies reported no difference in duration of sleep observed by nurses. The effects of melatonin on objectively measured quantity and quality of sleep are uncertain (very low certainty evidence). Two studies (37 participants) reported quantity and quality of sleep as measured by polysomnography (PSG), actigraphy, bispectral index (BIS) or electroencephalogram (EEG). Study authors in one study reported no difference in sleep efficiency index scores between groups using BIS and actigraphy. These authors also reported longer sleep in participants given melatonin which was not statistically significant, and improved sleep (described as "better sleep") in participants given melatonin from analysis of area under the curve (AUC) of BIS data. One study used PSG but authors were unable to report data because of a large loss of participant data. One study (82 participants) reported no evidence of a difference in anxiety scores (very low certainty evidence). Two studies (94 participants) reported data for mortality: one study reported that overall one-third of participants died; and one study reported no evidence of difference between groups in hospital mortality (very low certainty). One study (82 participants) reported no evidence of a difference in length of ICU stay (very low certainty evidence). Effects of melatonin on adverse events were reported in two studies (107 participants), and are uncertain (very low certainty evidence): one study reported headache in one participant given melatonin, and one study reported excessive sleepiness in one participant given melatonin and two events in the control group (skin reaction in one participant, and excessive sleepiness in another participant). The certainty of the evidence for each outcome was limited by sparse data with few participants. We noted study limitations in some studies due to high attrition and differences between groups in baseline data; and doses of melatonin varied between studies. Methods used to measure data were not consistent for outcomes, and use of some measurement tools may not be effective for use on the ICU patient. All studies included participants in the ICU but we noted differences in ICU protocols, and one included study used a non-standard sedation protocol with participants which introduced indirectness to the evidence. We found insufficient evidence to determine whether administration of melatonin would improve the quality and quantity of sleep in ICU patients. We identified sparse data, and noted differences in study methodology, in ICU sedation protocols, and in methods used to measure and report sleep. We identified five ongoing studies from database and clinical trial register searches. Inclusion of data from these studies in future review updates would provide more certainty for the review outcomes. | The evidence is current to September 2017. We included four studies with 151 participants in the review. All participants were critically ill and were in the ICU. All studies compared melatonin with no agent (an inactive substance called a placebo), or with usual care. We did not combine data from the four included studies. Three studies used nurses and participants to assess sleep and reported no difference in quality and quantity of sleep. Two studies used equipment to measure quality and quantity of sleep, and one of these studies reported no difference in sleep efficiency (how well the person sleeps during night-time hours) according to melatonin use and, according to some analysis, evidence of "better sleep" for those given melatonin. One study reported problems with equipment which led to a loss of data. One study reported no difference in anxiety, and there was no difference in mortality, or length of stay in the ICU. We noted few potential side effects of melatonin (headache in one participant, and excessive sleepiness in another participant). We noted differences between groups in doses of melatonin and two studies reported differences between groups in participant characteristics which could have affected the results. One study had a large loss of data and another study did not use standard anaesthetic drugs to sedate patients. Few studies used appropriate equipment to measure quantity of sleep. We found few studies with few participants that assessed our review outcomes. We judged all evidence to be very low quality, and we could not be certain whether melatonin given to adults in the ICU improves quantity and quality of sleep. We found five ongoing studies in database and clinical trial register searches. Inclusion of these studies in future review updates would provide more certainty for the review outcomes. | 10.1002/14651858.CD012455.pub2 | [
"The evidence is current to September 2017. We included four studies with 151 participants in the review. All participants were critically ill and were in the ICU. All studies compared melatonin with no agent (an inactive substance called a placebo), or with usual care. We did not combine data from the four included studies. Three studies used nurses and participants to assess sleep and reported no difference in quality and quantity of sleep. Two studies used equipment to measure quality and quantity of sleep, and one of these studies reported no difference in sleep efficiency (how well the person sleeps during night-time hours) according to melatonin use and, according to some analysis, evidence of \"better sleep\" for those given melatonin. One study reported problems with equipment which led to a loss of data. One study reported no difference in anxiety, and there was no difference in mortality, or length of stay in the ICU. We noted few potential side effects of melatonin (headache in one participant, and excessive sleepiness in another participant). We noted differences between groups in doses of melatonin and two studies reported differences between groups in participant characteristics which could have affected the results. One study had a large loss of data and another study did not use standard anaesthetic drugs to sedate patients. Few studies used appropriate equipment to measure quantity of sleep. We found few studies with few participants that assessed our review outcomes. We judged all evidence to be very low quality, and we could not be certain whether melatonin given to adults in the ICU improves quantity and quality of sleep. We found five ongoing studies in database and clinical trial register searches. Inclusion of these studies in future review updates would provide more certainty for the review outcomes."
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cochrane-simplification-train-1410 | cochrane-simplification-train-1410 | We identified 16 randomised controlled trials with 3578 participants that fitted our inclusion criteria. These studies included a wide spectrum of interventions covering clinic-based brief interventions, Internet-based interventions that could be used from home and mobile phone-based interventions. The mean age of participants was between 46 to 67 years old and mean time since diagnosis was 6 to 13 years. The duration of the interventions varied between 1 to 12 months. There were three reported deaths out of 3578 participants. Computer-based diabetes self-management interventions currently have limited effectiveness. They appear to have small benefits on glycaemic control (pooled effect on glycosylated haemoglobin A1c (HbA1c): -2.3 mmol/mol or -0.2% (95% confidence interval (CI) -0.4 to -0.1; P = 0.009; 2637 participants; 11 trials). The effect size on HbA1c was larger in the mobile phone subgroup (subgroup analysis: mean difference in HbA1c -5.5 mmol/mol or -0.5% (95% CI -0.7 to -0.3); P < 0.00001; 280 participants; three trials). Current interventions do not show adequate evidence for improving depression, health-related quality of life or weight. Four (out of 10) interventions showed beneficial effects on lipid profile. One participant withdrew because of anxiety but there were no other documented adverse effects. Two studies provided limited cost-effectiveness data - with one study suggesting costs per patient of less than $140 (in 1997) or 105 EURO and another study showed no change in health behaviour and resource utilisation. Computer-based diabetes self-management interventions to manage type 2 diabetes appear to have a small beneficial effect on blood glucose control and the effect was larger in the mobile phone subgroup. There is no evidence to show benefits in other biological outcomes or any cognitive, behavioural or emotional outcomes. | We identified 16 trials involving 3578 adults that met our criteria. These studies included different types of interventions used in different places like touch screen computers in hospital clinics, computers connected to the Internet at home and programmes that communicated with mobile phones. The average age of people taking part was between 46 to 67 years old and most of those people had lived with diabetes for 6 to 13 years. Participants were given access to the interventions for 1 to 12 months, depending on the intervention. Three out of the 3578 participants died but these deaths did not appear to be linked to the trials. Overall, there is evidence that computer programmes have a small beneficial effect on blood sugar control - the estimated improvement in glycosylated haemoglobin A1c (HbA1c - a long-term measurement of metabolic control) was 2.3 mmol/mol or 0.2%. This was slightly higher when we looked at studies that used mobile phones to deliver their intervention - the estimated improvement in HbA1c was 5.5 mmol/mol or 0.5% in the studies that used mobile phones. Some of the programmes lowered cholesterol slightly. None of the programmes helped with weight loss or coping with depression. One participant withdrew because of anxiety but there were no obvious side effects and hypoglycaemic episodes were not reported in any of the studies. There was very little information about costs or value for money. In summary, existing computer programmes to help adults self-manage type 2 diabetes appear to have a small positive effect on blood sugar control and the mobile phone interventions appeared to have larger effects. There is no evidence to show that current programmes can help with weight loss, depression or improving health-related quality of life but they do appear to be safe. | 10.1002/14651858.CD008776.pub2 | [
"We identified 16 trials involving 3578 adults that met our criteria. These studies included different types of interventions used in different places like touch screen computers in hospital clinics, computers connected to the Internet at home and programmes that communicated with mobile phones. The average age of people taking part was between 46 to 67 years old and most of those people had lived with diabetes for 6 to 13 years. Participants were given access to the interventions for 1 to 12 months, depending on the intervention. Three out of the 3578 participants died but these deaths did not appear to be linked to the trials. Overall, there is evidence that computer programmes have a small beneficial effect on blood sugar control - the estimated improvement in glycosylated haemoglobin A1c (HbA1c - a long-term measurement of metabolic control) was 2.3 mmol/mol or 0.2%. This was slightly higher when we looked at studies that used mobile phones to deliver their intervention - the estimated improvement in HbA1c was 5.5 mmol/mol or 0.5% in the studies that used mobile phones. Some of the programmes lowered cholesterol slightly. None of the programmes helped with weight loss or coping with depression. One participant withdrew because of anxiety but there were no obvious side effects and hypoglycaemic episodes were not reported in any of the studies. There was very little information about costs or value for money. In summary, existing computer programmes to help adults self-manage type 2 diabetes appear to have a small positive effect on blood sugar control and the mobile phone interventions appeared to have larger effects. There is no evidence to show that current programmes can help with weight loss, depression or improving health-related quality of life but they do appear to be safe."
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cochrane-simplification-train-1411 | cochrane-simplification-train-1411 | We included two small trials involving 79 patients. One trial (20 patients) examined the efficacy of intravenous, adjusted dose unfractionated heparin. The other trial (59 patients) examined high dose, body weight adjusted, subcutaneous, low-molecular weight heparin (nadroparin). Anticoagulant therapy was associated with a pooled relative risk of death of 0.33 (95% confidence interval (CI) 0.08 to 1.21) and of death or dependency of 0.46 (95% CI 0.16 to 1.31). The absolute reduction in the risk of death or dependency was 13% (95% CI 30% to -3%). No new symptomatic intracerebral haemorrhages were observed. One major gastro-intestinal haemorrhage occurred after anticoagulant treatment. Two control patients (placebo) had a diagnosis of probable pulmonary embolism (one fatal). Based upon the limited evidence available, anticoagulant treatment for cerebral venous sinus thrombosis appeared to be safe and was associated with a potentially important reduction in the risk of death or dependency which did not reach statistical significance. | We only found two small trials involving 79 patients; the results of the review suggested that anticoagulant drugs are probably safe and may be beneficial for people with sinus thrombosis but these results are not conclusive. | 10.1002/14651858.CD002005.pub2 | [
"We only found two small trials involving 79 patients; the results of the review suggested that anticoagulant drugs are probably safe and may be beneficial for people with sinus thrombosis but these results are not conclusive."
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cochrane-simplification-train-1412 | cochrane-simplification-train-1412 | We included six studies with 350 participants followed for at least three months. All of these studies enrolled participants undergoing total knee replacement. Studies were at least partially blinded. Three studies had a high risk of performance bias and one a high risk of attrition bias, but the risk of bias was otherwise unclear or low. Only one study assessed joint function using a global score. Due to heterogeneity in outcome and reporting, we could only pool three out of six RCTs, with range of motion assessed at three months after surgery used as a surrogate for joint function. All studies had a high risk of detection bias. Using the random-effects model, there was no statistically significant difference between the experimental and control groups (mean difference 3.99 degrees, 95% confidence interval (CI) − 2.23 to 10.21; P value = 0.21, 3 studies, 140 participants, very low quality evidence). We did not perform further analyses because immediate adverse effects were not part of the explicit outcomes of any of these typically small studies, and long-term adverse events after regional anaesthesia are rare. None of the included studies elicited or reported long-term adverse effects like persistent nerve damage. More high-quality studies are needed to establish the effects of regional analgesia on function after major joint replacement, as well as on the risk of adverse events (falls). | We searched electronic databases and abstracts for relevant studies. The search was last updated in June 2015. We found six studies, with 350 participants followed-up for at least three months. All of these studies enrolled participants undergoing knee replacement. Because the studies did not report the same outcomes, it was difficult to pool the results. We could only pool three out of six randomized controlled trials studying regional anaesthesia for better function after total knee replacement. Pooling data from 140 participants, with range of motion assessed at three months after surgery, there was no statistically significant difference between the use of regional analgesia and conventional pain control with intravenous medications. None of the included studies examined long-term adverse effects like persistent nerve damage. We deemed the quality of the evidence to be very low, as the included studies were not considered to be of high calibre and included few participants. We do not have enough information to determine if regional anaesthesia improves function after major joint replacement or not. We need more and better clinical trials to decide whether there is an effect of regional analgesia on the surgical results after total shoulder, hip or knee replacement surgery. We need more research to understand if regional analgesia increases the risk of falls after joint replacement. | 10.1002/14651858.CD010278.pub2 | [
"We searched electronic databases and abstracts for relevant studies. The search was last updated in June 2015. We found six studies, with 350 participants followed-up for at least three months. All of these studies enrolled participants undergoing knee replacement. Because the studies did not report the same outcomes, it was difficult to pool the results. We could only pool three out of six randomized controlled trials studying regional anaesthesia for better function after total knee replacement. Pooling data from 140 participants, with range of motion assessed at three months after surgery, there was no statistically significant difference between the use of regional analgesia and conventional pain control with intravenous medications. None of the included studies examined long-term adverse effects like persistent nerve damage. We deemed the quality of the evidence to be very low, as the included studies were not considered to be of high calibre and included few participants. We do not have enough information to determine if regional anaesthesia improves function after major joint replacement or not. We need more and better clinical trials to decide whether there is an effect of regional analgesia on the surgical results after total shoulder, hip or knee replacement surgery. We need more research to understand if regional analgesia increases the risk of falls after joint replacement."
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cochrane-simplification-train-1413 | cochrane-simplification-train-1413 | When pipotiazine palmitate was compared with 'standard' oral antipsychotic no differences were found for outcomes of global impression (n=53, 1 RCT, RR 2.57, CI 0.8 to 8.6), relapse (n=124, 1 RCT, RR 1.55 CI 0.76 to 3.2), study attrition (n=219, 3 RCTs, RR 1.37 CI 0.8 to 2.4) and behaviour (n=124, 1 RCT, WMD 4.65, CI -1.1 to 10.4). There was also no reported difference in adverse effects such as tardive dyskinesia or the need for anticholinergic drugs. Sixteen studies compared pipotiazine palmitate with other depot preparations (n=1123). Pipotiazine palmitate was consistently equivalent to other depots in terms of a range of outcomes, including global impression (n=217, 4 RCTs, RR not improved 0.99 CI 0.91 to 1.07), relapse (n=239, 5 RCTs, RR relapse by 1 year 0.98 CI 0.55 to 1.75), and adverse effects (n=337, 5 RCTs, RR needing anticholinergic medication 0.98 CI 0.84 to 1.15). Although well-conducted and reported randomised trials are still needed to fully inform practice (no trial data exists reporting hospital and services outcomes, satisfaction with care and economics) pipotiazine palmitate is a viable choice for both clinician and recipient of care. | We undertook this review to determine the effects of pipotiazine palmitate for schizophrenia in comparison to placebo, other oral antipsychotics and other depot antipsychotics. We included results of 12 medium term trials, two long term trials, three short term trials and one trial that looked at immediate effects. We found that depot pipotiazine is effective for the treatment of schizophrenia, but overall was similar in effect to other depots and oral typical antipsychotic drugs. | 10.1002/14651858.CD001720.pub2 | [
"We undertook this review to determine the effects of pipotiazine palmitate for schizophrenia in comparison to placebo, other oral antipsychotics and other depot antipsychotics. We included results of 12 medium term trials, two long term trials, three short term trials and one trial that looked at immediate effects. We found that depot pipotiazine is effective for the treatment of schizophrenia, but overall was similar in effect to other depots and oral typical antipsychotic drugs."
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cochrane-simplification-train-1414 | cochrane-simplification-train-1414 | Three trials involving 247 people were included. Two studies involving 151 people assessed the use of folate in addition to other treatment, and found that adding folate reduced Hamilton Depression Rating Scale scores on average by a further 2.65 points (95% confidence interval 0.38 to 4.93). Fewer patients treated with folate experienced a reduction in their HDRS score of less than 50% at ten weeks (relative risk (RR) 0.47, 95% CI 0.24 to 0.92) The number needed to treat with folate for one additional person to experience a 50% reduction on this scale was 5 (95% confidence interval 4 to 33). One study involving 96 people assessed the use of folate instead of the antidepressant trazodone and did not find a significant benefit from the use of folate. The trials identified did not find evidence of any problems with the acceptability or safety of folate. The limited available evidence suggests folate may have a potential role as a supplement to other treatment for depression. It is currently unclear if this is the case both for people with normal folate levels, and for those with folate deficiency. | This systematic review was undertaken to see if giving folate to people with depressive disorders reduced their depressive symptoms. Three randomized trials were identified, involving a total of 247 people. In all three trials, folate was well tolerated. In two of these trials, folate was added to other antidepressant drug treatment and there was limited evidence that folate helped. In the third trial, folate was compared to trazodone, an antidepressant drug. No difference was found. There is therefore limited evidence that adding folate to other antidepressant may be helpful, but larger trials are needed before patients and clinicians can be confident that it will be helpful. | 10.1002/14651858.CD003390 | [
"This systematic review was undertaken to see if giving folate to people with depressive disorders reduced their depressive symptoms. Three randomized trials were identified, involving a total of 247 people. In all three trials, folate was well tolerated. In two of these trials, folate was added to other antidepressant drug treatment and there was limited evidence that folate helped. In the third trial, folate was compared to trazodone, an antidepressant drug. No difference was found. There is therefore limited evidence that adding folate to other antidepressant may be helpful, but larger trials are needed before patients and clinicians can be confident that it will be helpful."
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cochrane-simplification-train-1415 | cochrane-simplification-train-1415 | The review included nine studies; these studies differed in a variety of ways including definition of asthma exacerbations, FeNO cut-off levels used (12 parts per billion (ppb) to 30 ppb), the way in which FeNO was used to adjust therapy and duration of study (6 to 12 months). Of 1426 children randomised, 1329 completed the studies. The inclusion criteria for the participants in each study varied but all had a diagnosis of asthma. There was a significant difference in the number of children having one or more asthma exacerbations over the study period, they were significantly lower in the FeNO group in comparison to the control group (odds ratio (OR) 0.62, 95% confidence interval (CI) 0.49 to 0.80; 1279 participants; 8 studies). The number needed to treat for an additional beneficial outcome (NNTB) over 52 weeks was 10 (95% CI 7 to 20). There was no difference between the groups when comparing exacerbation rates (mean difference (MD) -0.37, 95% CI -0.8 to 0.06; 736 participants; 4 studies; I2 = 67%). The number of children in the FeNO group requiring oral corticosteroid courses was lower in comparison to the children in the control group (OR 0.63, 95% CI 0.48 to 0.83; 1169 participants; 7 studies; I2 = 0%). There was no statistically significant difference between the groups for exacerbations requiring hospitalisation (OR 0.75, 95% CI 0.41 to 1.36; 1110 participants; 6 studies; I2 = 0%). There were no significant differences between the groups for any of the secondary outcomes (forced expiratory volume in one second (FEV1), FeNO levels, symptom scores or inhaled corticosteroid doses at final visit). The included studies recorded no adverse events. Three studies had inadequate blinding and were thus considered to have a high risk of bias. However, when these studies were removed in subgroup analysis, the difference between the groups for the primary outcome (exacerbations) remained statistically significant. The GRADE quality of the evidence ranged from moderate (for the outcome 'Number of participants who had one or more exacerbations over the study period') to very low (for the outcome 'Exacerbation rates'), based on lack of blinding, statistical heterogeneity and imprecision. In this updated review with five new included studies, tailoring asthma medications based on FeNO levels (in comparison with primarily guideline management) significantly decreased the number of children who had one or more exacerbations over the study period but did not impact on the day-to-day clinical symptoms or inhaled corticosteroid doses. Therefore, the use of FeNO to guide asthma therapy in children may be beneficial in a subset of children, it cannot be universally recommended for all children with asthma. Further RCTs need to be conducted and these should encompass different asthma severities, different settings including primary care and less affluent settings, and consider different FeNO cut-offs. | We included all randomised controlled trials that compared adjustment of asthma medications by either usual clinical care (control group) versus using exhaled nitric oxide. The participants included in the trials had asthma diagnosed as per relevant asthma guidelines. The evidence is current to June 2016 when the searches were last completed. The review included nine studies (involving 1426 children) that varied in a several ways including length of the study, exhaled nitric oxide cut-off levels used for altering medicines and the way each study defined flare-ups or attacks (called exacerbations). The studies ranged from 6 to 12 months in length. The exhaled nitric oxide cut-off values used by the different studies as a basis for decreasing or increasing medicines also varied. The mean age of the participants ranged from 10 to 14 years old. In this review, we found that guiding asthma medicines based on exhaled nitric oxide (compared to a control group) was beneficial in reducing the number of children who had at least one exacerbation during the study. In the control group where therapy was guided according to clinical symptoms, 40 children out of 100 had at least one exacerbation over 48.5 weeks, compared to 28 out of 100 children where treatment was guided by exhaled nitric oxide. However, we found no difference between groups in other measures of asthma severity that impact on day-to-day clinical symptoms or inhaled corticosteroid dose (medications used to control asthma). Therefore, using exhaled nitric oxide levels to adjust asthma therapy may reduce the number of attacks that children with asthma have but does not impact on the day-to-day symptoms. The level of evidence found ranged from moderate, when comparing the two groups for the number of children who had one or more exacerbations, to very low when comparing the number of exacerbations. | 10.1002/14651858.CD011439.pub2 | [
"We included all randomised controlled trials that compared adjustment of asthma medications by either usual clinical care (control group) versus using exhaled nitric oxide. The participants included in the trials had asthma diagnosed as per relevant asthma guidelines. The evidence is current to June 2016 when the searches were last completed. The review included nine studies (involving 1426 children) that varied in a several ways including length of the study, exhaled nitric oxide cut-off levels used for altering medicines and the way each study defined flare-ups or attacks (called exacerbations). The studies ranged from 6 to 12 months in length. The exhaled nitric oxide cut-off values used by the different studies as a basis for decreasing or increasing medicines also varied. The mean age of the participants ranged from 10 to 14 years old. In this review, we found that guiding asthma medicines based on exhaled nitric oxide (compared to a control group) was beneficial in reducing the number of children who had at least one exacerbation during the study. In the control group where therapy was guided according to clinical symptoms, 40 children out of 100 had at least one exacerbation over 48.5 weeks, compared to 28 out of 100 children where treatment was guided by exhaled nitric oxide. However, we found no difference between groups in other measures of asthma severity that impact on day-to-day clinical symptoms or inhaled corticosteroid dose (medications used to control asthma). Therefore, using exhaled nitric oxide levels to adjust asthma therapy may reduce the number of attacks that children with asthma have but does not impact on the day-to-day symptoms. The level of evidence found ranged from moderate, when comparing the two groups for the number of children who had one or more exacerbations, to very low when comparing the number of exacerbations."
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cochrane-simplification-train-1416 | cochrane-simplification-train-1416 | Twelve trials met the inclusion criteria. One trial is still ongoing, leaving a total of 11 trials eligible involving 653 participants. These trials were conducted between 1978 and 2006 and enrolled participants from fairly comparable patient populations. None of the studies included people with neutrophil dysfunction. Ten studies included only adults, and two studies included children and adults. Ten of these studies contained separate data for each arm and were able to be critically appraised. One study re-randomised people and therefore quantitative analysis was unable to be performed. Overall, the quality of the evidence was very low to low across different outcomes according to GRADE methodology. This was due to many of the studies being at high risk of bias, and many of the outcome estimates being imprecise. All-cause mortality was reported for nine studies (609 participants). There was no difference in all-cause mortality over 30 days between people receiving prophylactic granulocyte transfusions and those that did not (seven studies; 437 participants; RR 0.92, 95% CI 0.63 to 1.36, very low-quality evidence). Mortality due to infection was reported for seven studies (398 participants). There was no difference in mortality due to infection over 30 days between people receiving prophylactic granulocyte transfusions and those that did not (six studies; 286 participants; RR 0.69, 95% CI 0.33 to 1.44, very low-quality evidence). The number of people with localised or systemic bacterial or fungal infections was reported for nine studies (609 participants). There were differences between the granulocyte dose subgroups (test for subgroup differences P = 0.01). There was no difference in the number of people with infections over 30 days between people receiving prophylactic granulocyte transfusions and those that did not in the low-dose granulocyte group (< 1.0 x 1010 granulocytes per day) (four studies, 204 participants; RR 0.84, 95% CI 0.58 to 1.20; very low-quality evidence). There was a decreased number of people with infections over 30 days in the people receiving prophylactic granulocyte transfusions in the intermediate-dose granulocyte group (1.0 x 1010 to 4.0 x 1010 granulocytes per day) (4 studies; 293 participants; RR 0.40, 95% CI 0.26 to 0.63, low-quality evidence). There was a decreased number of participants with bacteraemia and fungaemia in the participants receiving prophylactic granulocyte transfusions (nine studies; 609 participants; RR 0.45, 95% CI 0.30 to 0.65, low-quality evidence). There was no difference in the number of participants with localised bacterial or fungal infection in the participants receiving prophylactic granulocyte transfusions (six studies; 296 participants; RR 0.75, 95% CI 0.50 to 1.14; very low-quality evidence). Serious adverse events were only reported for participants receiving granulocyte transfusions and donors of granulocyte transfusions. In people who are neutropenic due to myelosuppressive chemotherapy or a haematopoietic stem cell transplant, there is low-grade evidence that prophylactic granulocyte transfusions decrease the risk of bacteraemia or fungaemia. There is low-grade evidence that the effect of prophylactic granulocyte transfusions may be dose-dependent, a dose of at least 1.0 x 1010 per day being more effective at decreasing the risk of infection. There is insufficient evidence to determine any difference in mortality rates due to infection, all-cause mortality, or serious adverse events. | The evidence is current to April 2015. In this update, 12 trials were identified that compared giving granulocyte transfusions to prevent infections compared to not giving granulocytes to prevent infection. One trial has not yet been completed. Eleven trials containing a total of 653 participants were reviewed. These trials were conducted between 1978 and 2006. Data from one trial were not included in the analyses because patients were included within the trial more than once. Ten studies included only adults, and two studies included children and adults. Six studies reported their funding sources, and all were funded by charities or governments. Giving granulocyte transfusions to prevent infections did not affect the risk of death due to infection, or the risk of death due to any cause. Giving granulocyte transfusions to prevent infections decreased the number of people who had a bacterial or fungal infection in the blood, but did not decrease the number of people having a localised bacterial or fungal infection. It is unknown whether granulocyte transfusions increased the risk of having a serious adverse event because adverse events were only reported in people receiving granulocyte transfusions. The evidence for most of the findings was of very low or low quality. This was because patients and their doctors knew which study arm the patient had been allocated to and two of the studies were not true randomised studies (patients were allocated to the granulocyte transfusion arm if they had a suitable granulocyte donor). | 10.1002/14651858.CD005341.pub3 | [
"The evidence is current to April 2015. In this update, 12 trials were identified that compared giving granulocyte transfusions to prevent infections compared to not giving granulocytes to prevent infection. One trial has not yet been completed. Eleven trials containing a total of 653 participants were reviewed. These trials were conducted between 1978 and 2006. Data from one trial were not included in the analyses because patients were included within the trial more than once. Ten studies included only adults, and two studies included children and adults. Six studies reported their funding sources, and all were funded by charities or governments. Giving granulocyte transfusions to prevent infections did not affect the risk of death due to infection, or the risk of death due to any cause. Giving granulocyte transfusions to prevent infections decreased the number of people who had a bacterial or fungal infection in the blood, but did not decrease the number of people having a localised bacterial or fungal infection. It is unknown whether granulocyte transfusions increased the risk of having a serious adverse event because adverse events were only reported in people receiving granulocyte transfusions. The evidence for most of the findings was of very low or low quality. This was because patients and their doctors knew which study arm the patient had been allocated to and two of the studies were not true randomised studies (patients were allocated to the granulocyte transfusion arm if they had a suitable granulocyte donor)."
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cochrane-simplification-train-1417 | cochrane-simplification-train-1417 | Five randomised trials involving 664 participants were analysed. Five different herbal medicines were tested in these trials, including Huo-Xue-Tong-Fu decoction, Xiao-Cheng-Qi-Tang decoction, a combination of Xiao-Cheng-Qi-Tang and Si-Jun-Zi-Tang decoctions, Chang-Nian-Lian-Song-Jie-Tang decoction, and Fufang-Da-Cheng-Qi-Tang decoction. There were variations in the tested herbal compositions and methods of medicine administration. The main outcomes reported in the trials were effects on abdominal pain, abdominal distension, constipation defection, time of first defecation after treatment, and reoperation rate during the course of the disease. Secondary outcomes selected for this review were not available, including complications such as small bowel perfusion (bowel resection, system complications, and other possible complications), length of hospital stay, cost of hospitalisation, and time from admission to surgical intervention. The results of five trials showed that patients receiving TCM combined with conventional therapy seemed to have improved outcomes compared with patients receiving conventional treatment alone (OR 4.24, 95% CI 2.83 to 6.36). However, we cannot conclusively determine the efficacy of TCM in this review due to inadequate reporting, low methodological quality, and the prevalence of various biases in the reviewed studies. Furthermore, because none of the reviewed trials discussed adverse events, we could not evaluate the safety of TCM for adhesive SBO patients. All trials were conducted and published in China. Although many studies have assessed the use of TCM products for adhesive SBO, most were excluded from this review due to their methodological limitations. This systematic review did not find sufficient evidence to support the objective efficacy and safety of TCM for patients with adhesive SBO. The positive evidence should be interpreted with caution given the insufficient number of studies with large sample sizes, the absence of well-designed, high-quality trials, and the lack of safety information. Therefore, further studies with larger sample sizes and high-quality, randomised, and controlled trials are necessary to produce more accurate and meaningful data on the efficacy of Chinese herbal medicines for adhesive SBO. | This review examined five randomised trials with five different Chinese herbal medicines, involving a total of 664 participants. All trials were conducted and published in China. None of the trials mentioned adverse effects. The methodological limitations in these studies are quite obvious, and any conclusions based on their results should be made with caution. This systematic review did not find sufficient evidence to support the objective efficacy and safety of TCM for adhesive SBO patients. Further high-quality trials evaluating oral TCM for adhesive SBO are urgently needed. | 10.1002/14651858.CD008836.pub2 | [
"This review examined five randomised trials with five different Chinese herbal medicines, involving a total of 664 participants. All trials were conducted and published in China. None of the trials mentioned adverse effects. The methodological limitations in these studies are quite obvious, and any conclusions based on their results should be made with caution. This systematic review did not find sufficient evidence to support the objective efficacy and safety of TCM for adhesive SBO patients. Further high-quality trials evaluating oral TCM for adhesive SBO are urgently needed."
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cochrane-simplification-train-1418 | cochrane-simplification-train-1418 | We found 22 eligible studies that included a total of 11,450 women. With 6 NRS added to this update, the review includes 17 NRS and 5 RCTs. By contraceptive method, the review has 16 studies of depot medroxyprogesterone acetate (DMPA), 4 of levonorgestrel-releasing intrauterine contraception (LNG-IUC), 5 for implants, and 2 for progestin-only pills. Comparison groups did not differ significantly for weight change or other body composition measure in 15 studies. Five studies with moderate or low quality evidence showed differences between study arms. Two studies of a six-rod implant also indicated some differences, but the evidence was low quality. Three studies showed differences for DMPA users compared with women not using a hormonal method. In a retrospective study, weight gain (kg) was greater for DMPA versus copper (Cu) IUC in years one (MD 2.28, 95% CI 1.79 to 2.77), two (MD 2.71, 95% CI 2.12 to 3.30), and three (MD 3.17, 95% CI 2.51 to 3.83). A prospective study showed adolescents using DMPA had a greater increase in body fat (%) compared with a group not using a hormonal method (MD 11.00, 95% CI 2.64 to 19.36). The DMPA group also had a greater decrease in lean body mass (%) (MD -4.00, 95% CI -6.93 to -1.07). A more recent retrospective study reported greater mean increases with use of DMPA versus Cu IUC for weight (kg) at years 1 (1.3 vs 0.2), 4 (3.5 vs 1.9), and 10 (6.6 vs 4.9). Two studies reported a greater mean increase in body fat mass (%) for POC users versus women not using a hormonal method. The method was LNG-IUC in two studies (reported means 2.5 versus -1.3; P = 0.029); (MD 1.60, 95% CI 0.45 to 2.75). One also studied a desogestrel-containing pill (MD 3.30, 95% CI 2.08 to 4.52). Both studies showed a greater decrease in lean body mass among POC users. We considered the overall quality of evidence to be low; more than half of the studies had low quality evidence. The main reasons for downgrading were lack of randomizations (NRS) and high loss to follow-up or early discontinuation. These 22 studies showed limited evidence of change in weight or body composition with use of POCs. Mean weight gain at 6 or 12 months was less than 2 kg (4.4 lb) for most studies. Those with multiyear data showed mean weight change was approximately twice as much at two to four years than at one year, but generally the study groups did not differ significantly. Appropriate counseling about typical weight gain may help reduce discontinuation of contraceptives due to perceptions of weight gain. | Until 4 August 2016, we did computer searches for studies of a POC compared with another birth control method or no contraceptive. For the initial review, we wrote to investigators to find other trials. The focus was on change in body weight or other body measure of lean or fat mass. With six new studies in this update, we have 22 studies that included 11,450 women. The groups compared did not differ much for weight change or other body measures in 15 studies. Five studies with moderate or low quality results showed a difference between study groups. Three studies showed differences for users of the injectable ‘depo’ versus no hormonal method. Depo users had a greater weight gain in two studies. In the third study, adolescents had a greater increase in body fat (%) and decrease in lean body mass (%). Two studies showed a greater increase in body fat (%) for users of hormonal intrauterine contraception versus women not using a hormonal method. One also showed a similar difference with a progestin-only pill. Both studies showed a greater decrease in lean body mass with POC use. We found little evidence of weight gain when using POCs. Mean weight gain at 6 or 12 months was less than 2 kg (4.4 lb) for most studies. The groups using other birth control methods had about the same weight gain. Good counseling about typical weight gain may help women continue using birth control. | 10.1002/14651858.CD008815.pub4 | [
"Until 4 August 2016, we did computer searches for studies of a POC compared with another birth control method or no contraceptive. For the initial review, we wrote to investigators to find other trials. The focus was on change in body weight or other body measure of lean or fat mass. With six new studies in this update, we have 22 studies that included 11,450 women. The groups compared did not differ much for weight change or other body measures in 15 studies. Five studies with moderate or low quality results showed a difference between study groups. Three studies showed differences for users of the injectable ‘depo’ versus no hormonal method. Depo users had a greater weight gain in two studies. In the third study, adolescents had a greater increase in body fat (%) and decrease in lean body mass (%). Two studies showed a greater increase in body fat (%) for users of hormonal intrauterine contraception versus women not using a hormonal method. One also showed a similar difference with a progestin-only pill. Both studies showed a greater decrease in lean body mass with POC use. We found little evidence of weight gain when using POCs. Mean weight gain at 6 or 12 months was less than 2 kg (4.4 lb) for most studies. The groups using other birth control methods had about the same weight gain. Good counseling about typical weight gain may help women continue using birth control."
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cochrane-simplification-train-1419 | cochrane-simplification-train-1419 | We included 36 studies (33 RCTs) with a total of 3523 participants. Included studies were conducted in sub-Saharan Africa, the Middle East and North Africa, and Asia. Studies were implemented in response to armed conflicts; disasters triggered by natural hazards; and other types of humanitarian crises. Together, the 33 RCTs compared eight psychological treatments against a control comparator. Four studies included children and adolescents between 5 and 18 years of age. Three studies included mixed populations (two studies included participants between 12 and 25 years of age, and one study included participants between 16 and 65 years of age). Remaining studies included adult populations (18 years of age or older). Included trials compared a psychological therapy versus a control intervention (wait list in most studies; no treatment; treatment as usual). Psychological therapies were categorised mainly as cognitive-behavioural therapy (CBT) in 23 comparisons (including seven comparisons focused on narrative exposure therapy (NET), two focused on common elements treatment approach (CETA), and one focused on brief behavioural activation treatment (BA)); eye movement desensitisation and reprocessing (EMDR) in two comparisons; interpersonal psychotherapy (IPT) in three comparisons; thought field therapy (TFT) in three comparisons; and trauma or general supportive counselling in two comparisons. Although interventions were described under these categories, several psychotherapeutic elements were common to a range of therapies (i.e. psychoeducation, coping skills). In adults, psychological therapies may substantially reduce endpoint PTSD symptoms compared to control conditions (standardised mean difference (SMD) -1.07, 95% confidence interval (CI) -1.34 to -0.79; 1272 participants; 16 studies; low-quality evidence). The effect is smaller at one to four months (SMD -0.49, 95% CI -0.68 to -0.31; 1660 participants; 18 studies) and at six months (SMD -0.37, 95% CI -0.61 to -0.14; 400 participants; five studies). Psychological therapies may also substantially reduce endpoint depression symptoms compared to control conditions (SMD -0.86, 95% CI -1.06 to -0.67; 1254 participants; 14 studies; low-quality evidence). Similar to PTSD symptoms, follow-up data at one to four months showed a smaller effect on depression (SMD -0.42, 95% CI -0.63 to -0.21; 1386 participants; 16 studies). Psychological therapies may moderately reduce anxiety at endpoint (SMD -0.74, 95% CI -0.98 to -0.49; 694 participants; five studies; low-quality evidence) and at one to four months' follow-up after treatment (SMD -0.53, 95% CI -0.66 to -0.39; 969 participants; seven studies). Dropout rates are probably similar between study conditions (19.5% with control versus 19.1% with psychological therapy (RR 0.98 95% CI 0.82 to 1.16; 2930 participants; 23 studies, moderate quality evidence)). In children and adolescents, we found very low quality evidence for lower endpoint PTSD symptoms scores in psychotherapy conditions (CBT) compared to control conditions, although the confidence interval is wide (SMD -1.56, 95% CI -3.13 to 0.01; 130 participants; three studies;). No RCTs provided data on major depression or anxiety in children. The effect on withdrawal was uncertain (RR 1.87 95% CI 0.47 to 7.47; 138 participants; 3 studies, low quality evidence). We did not identify any studies that evaluated psychological treatments on (symptoms of) somatoform disorders or MUPS in LMIC humanitarian settings. There is low quality evidence that psychological therapies have large or moderate effects in reducing PTSD, depressive, and anxiety symptoms in adults living in humanitarian settings in LMICs. By one to four month and six month follow-up assessments treatment effects were smaller. Fewer trials were focused on children and adolescents and they provide very low quality evidence of a beneficial effect of psychological therapies in reducing PTSD symptoms at endpoint. Confidence in these findings is influenced by the risk of bias in the studies and by substantial levels of heterogeneity. More research evidence is needed, particularly for children and adolescents over longer periods of follow-up. | In adults, low-quality evidence shows greater benefit from psychological therapies than from control comparators in reducing (symptoms of) PTSD, major depression, and anxiety disorders. This evidence supports the approach of providing psychological therapies to populations affected by humanitarian crises, although we identified no studies that looked at the effectiveness or acceptability of psychological therapies for depressive and anxiety symptoms beyond six months. Only a small proportion of included trials reported data on children and adolescents, which provided very low-quality evidence of greater benefit derived from psychological treatments. With regard to acceptability, moderate- to low-quality evidence suggests no differences in dropout rates among adults and children and adolescents. Reviewers found no studies evaluating psychological treatments for (symptoms of) somatoform disorders or medically unexplained physical symptoms (MUPS) in adults, nor in children or adolescents, respectively. Researchers should conduct higher-quality trials to further evaluate the effectiveness of psychological therapies provided over longer periods to adults and to children and adolescents. Ideally, trials should be randomised, should use culturally appropriate and validated instruments to evaluate outcomes, and should assess correlates of reductions in treatment effects over time; in addition, researchers should make every effort to ensure high rates of follow-up beyond six months after completion of therapy. | 10.1002/14651858.CD011849.pub2 | [
"In adults, low-quality evidence shows greater benefit from psychological therapies than from control comparators in reducing (symptoms of) PTSD, major depression, and anxiety disorders. This evidence supports the approach of providing psychological therapies to populations affected by humanitarian crises, although we identified no studies that looked at the effectiveness or acceptability of psychological therapies for depressive and anxiety symptoms beyond six months. Only a small proportion of included trials reported data on children and adolescents, which provided very low-quality evidence of greater benefit derived from psychological treatments. With regard to acceptability, moderate- to low-quality evidence suggests no differences in dropout rates among adults and children and adolescents. Reviewers found no studies evaluating psychological treatments for (symptoms of) somatoform disorders or medically unexplained physical symptoms (MUPS) in adults, nor in children or adolescents, respectively. Researchers should conduct higher-quality trials to further evaluate the effectiveness of psychological therapies provided over longer periods to adults and to children and adolescents. Ideally, trials should be randomised, should use culturally appropriate and validated instruments to evaluate outcomes, and should assess correlates of reductions in treatment effects over time; in addition, researchers should make every effort to ensure high rates of follow-up beyond six months after completion of therapy."
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cochrane-simplification-train-1420 | cochrane-simplification-train-1420 | One study was included. It involved 44 adults aged 60 to 80 years and compared a glucose drink with a saccharin drink, given on only a single occasion. Those receiving the glucose drink were significantly faster in completing the switching condition of the modified Stroop test (F 1, 41 = 10.47; P < 0.01) compared to those receiving the saccharin drink. Participants in the glucose group also showed a significantly smaller dual-task cost in a computerised test of divided attention compared to the placebo group (F 1, 38 = 8.49; P < 0.01, ƞ2 = 0.18). As a glucose drink was administered only once, safety, global function, behaviour disturbance, and activities of daily living were not investigated in the study. With only one RCT included, there is insufficient evidence to base any recommendations about the use of any form of carbohydrate for enhancing cognitive performance in older adults with normal cognition or mild cognitive impairment. More studies of many different carbohydrates are needed to tease out complex nutritional issues and to further evaluate memory improvement. | Despite the evidence accumulated from biological and epidemiological (observational) studies and non-randomised clinical trials, only one randomised, controlled trial could be included in this review. This study had 44 participants. Participants who were given a single glucose drink showed possible momentary enhancement of cognitive performance compared to those given a saccharin drink. A safety assessment was not reported. We need more studies on different types of carbohydrates, particularly those from fruit, vegetable and whole grain sources, for older adults with normal cognition and mild cognitive impairment to understand the role of this nutrient type in the prevention or reduction of cognitive decline. | 10.1002/14651858.CD007220.pub2 | [
"Despite the evidence accumulated from biological and epidemiological (observational) studies and non-randomised clinical trials, only one randomised, controlled trial could be included in this review. This study had 44 participants. Participants who were given a single glucose drink showed possible momentary enhancement of cognitive performance compared to those given a saccharin drink. A safety assessment was not reported. We need more studies on different types of carbohydrates, particularly those from fruit, vegetable and whole grain sources, for older adults with normal cognition and mild cognitive impairment to understand the role of this nutrient type in the prevention or reduction of cognitive decline."
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cochrane-simplification-train-1421 | cochrane-simplification-train-1421 | We identified six relevant studies involving 1088 participants. This included two new studies published after the date of our previous review (2011). There was substantial variation in participants, in the diagnostic criteria used to define an episode of pneumonia, in the interventions and in the reported outcomes. We found no evidence relating to patients with a high probability of HAP who were not mechanically ventilated. For patients with VAP, overall a short seven- or eight-day course of antibiotics compared with a prolonged 10- to 15-day course increased 28-day antibiotic-free days (two studies; N = 431; mean difference (MD) 4.02 days; 95% confidence interval (CI) 2.26 to 5.78) and reduced recurrence of VAP due to multi-resistant organisms (one study; N = 110; odds ratio (OR) 0.44; 95% CI 0.21 to 0.95), without adversely affecting mortality and other recurrence outcomes. However, for cases of VAP specifically due to non-fermenting Gram-negative bacilli (NF-GNB), recurrence was greater after short-course therapy (two studies, N = 176; OR 2.18; 95% CI 1.14 to 4.16), though mortality outcomes were not significantly different. One study found that a three-day course of antibiotic therapy for patients with suspected HAP but a low Clinical Pulmonary Infection Score (CPIS) was associated with a significantly lower risk of superinfection or emergence of antimicrobial resistance, compared with standard (prolonged) course therapy. On the basis of a small number of studies and appreciating the lack of uniform definition of pneumonia, we conclude that for patients with VAP not due to NF-GNB a short, fixed course (seven or eight days) of antibiotic therapy appears not to increase the risk of adverse clinical outcomes, and may reduce the emergence of resistant organisms, compared with a prolonged course (10 to 15 days). However, for patients with VAP due to NF-GNB, there appears to be a higher risk of recurrence following short-course therapy. These findings do not differ from those of our previous review and are broadly consistent with current guidelines. There are few data from RCTs comparing durations of therapy in non-ventilated patients with HAP, but on the basis of a single study, short-course (three-day) therapy for HAP appears not to be associated with worse clinical outcome, and may reduce the risk of subsequent infection or the emergence of resistant organisms when there is low probability of pneumonia according to the CPIS. | The evidence was current as of June 2015. We identified six RCTs, which had enrolled 1088 patients. The studies took quite different approaches to their investigations, and we found only one study that had explored the duration of antibiotic therapy for ICU patients who had HAP, but were not mechanically ventilated. For patients with VAP, our main finding was that a course of seven or eight days of antibiotics was associated with an overall decrease in antibiotic administration and reduced the recurrence of pneumonia due to resistant organisms when compared with a 10- to 15-day course. Furthermore, this was achieved without any significant effect on mortality. Nevertheless, in cases when VAP was due to a particular type of organism ('non-fermenting Gram-negative bacillus'), which can be difficult to eradicate with antibiotics, the risk of pneumonia recurring appeared higher after a short course of treatment. One study found that for patients with possible (but low probability) HAP a short (three-day) course of therapy seemed to be associated with a lower chance of acquiring resistant organisms or of subsequent infections being due to a resistant organism. The quality of evidence for the main outcome measures was low to moderate. The main reasons that the quality was not high were that only a small number of studies were identified, and that there were differences in patient populations, in the nature of the interventions between studies and in the reported outcomes. | 10.1002/14651858.CD007577.pub3 | [
"The evidence was current as of June 2015. We identified six RCTs, which had enrolled 1088 patients. The studies took quite different approaches to their investigations, and we found only one study that had explored the duration of antibiotic therapy for ICU patients who had HAP, but were not mechanically ventilated. For patients with VAP, our main finding was that a course of seven or eight days of antibiotics was associated with an overall decrease in antibiotic administration and reduced the recurrence of pneumonia due to resistant organisms when compared with a 10- to 15-day course. Furthermore, this was achieved without any significant effect on mortality. Nevertheless, in cases when VAP was due to a particular type of organism ('non-fermenting Gram-negative bacillus'), which can be difficult to eradicate with antibiotics, the risk of pneumonia recurring appeared higher after a short course of treatment. One study found that for patients with possible (but low probability) HAP a short (three-day) course of therapy seemed to be associated with a lower chance of acquiring resistant organisms or of subsequent infections being due to a resistant organism. The quality of evidence for the main outcome measures was low to moderate. The main reasons that the quality was not high were that only a small number of studies were identified, and that there were differences in patient populations, in the nature of the interventions between studies and in the reported outcomes."
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cochrane-simplification-train-1422 | cochrane-simplification-train-1422 | We included five randomised controlled trials (RCTs), one controlled clinical trial (CCT), 27 cohort studies, 17 case-control studies, five time-series trials, one case cross-over trial, two ecological studies, six self controlled case series studies involving in all about 14,700,000 children and assessing effectiveness and safety of MMR vaccine. Based on the available evidence, one MMR vaccine dose is at least 95% effective in preventing clinical measles and 92% effective in preventing secondary cases among household contacts. Effectiveness of at least one dose of MMR in preventing clinical mumps in children is estimated to be between 69% and 81% for the vaccine prepared with Jeryl Lynn mumps strain and between 70% and 75% for the vaccine containing the Urabe strain. Vaccination with MMR containing the Urabe strain has demonstrated to be 73% effective in preventing secondary mumps cases. Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children and adolescents was estimated to be between 64% to 66% for one dose and 83% to 88% for two vaccine doses. We did not identify any studies assessing the effectiveness of MMR in preventing rubella. The highest risk of association with aseptic meningitis was observed within the third week after immunisation with Urabe-containing MMR (risk ratio (RR) 14.28; 95% confidence interval (CI) from 7.93 to 25.71) and within the third (RR 22.5; 95% CI 11.8 to 42.9) or fifth (RR 15.6; 95% CI 10.3 to 24.2) weeks after immunisation with the vaccine prepared with the Leningrad-Zagreb strain. A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 1.10; 95% CI 1.05 to 1.15) was assessed in one large person-time cohort study involving 537,171 children aged between three months and five year of age. Increased risk of febrile seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 4.09; 95% CI 3.1 to 5.33) and children aged 12 to 35 months (RI 5.68; 95% CI 2.31 to 13.97) within six to 11 days after exposure to MMR vaccine. An increased risk of thrombocytopenic purpura within six weeks after MMR immunisation in children aged 12 to 23 months was assessed in one case-control study (RR 6.3; 95% CI 1.3 to 30.1) and in one small self controlled case series (incidence rate ratio (IRR) 5.38; 95% CI 2.72 to 10.62). Increased risk of thrombocytopenic purpura within six weeks after MMR exposure was also assessed in one other case-control study involving 2311 children and adolescents between one month and 18 years (odds ratio (OR) 2.4; 95% CI 1.2 to 4.7). Exposure to the MMR vaccine was unlikely to be associated with autism, asthma, leukaemia, hay fever, type 1 diabetes, gait disturbance, Crohn's disease, demyelinating diseases, bacterial or viral infections. The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate. The evidence of adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases. | At least one dose of MMR vaccine is effective in preventing clinical mumps among children and adolescents when prepared with Jeryl Lynn strains (vaccine effectiveness = 69% to 81%, one cohort and one case-control study, 1656 participants), as well as when prepared with Urabe strain (vaccine effectiveness = 70% to 75%, one cohort and one case-control study, 1964 participants). Effectiveness against laboratory-confirmed mumps in children and adolescents was estimated to be between 64% to 66% for one and 83% to 88% for two doses of Jeryl Lynn MMR (two case-control studies, 1664 participants) and 87% for Urabe-containing MMR (one cohort study, 48 participants). Vaccination with Urabe MMR confers protection against secondary mumps infection (vaccine effectiveness = 73%, one cohort study, 147 participants). We identified no studies assessing the effectiveness of MMR vaccine against clinical or laboratory-confirmed rubella. Results from two very large case series studies involving about 1,500,000 children who were given the MMR vaccine containing Urabe or Leningrad-Zagreb strains show this vaccine to be associated with aseptic meningitis; whereas administration of the vaccine containing Moraten, Jeryl Lynn, Wistar RA, RIT 4385 strains is associated with febrile convulsion in children aged below five years (one person-time cohort study, 537,171 participants; two self controlled case series studies, 1001 participants). The MMR vaccine could also be associated with idiopathic thrombocytopaenic purpura (two case-controls, 2450 participants, one self controlled case series, 63 participants). We could assess no significant association between MMR immunisation and the following conditions: autism, asthma, leukaemia, hay fever, type 1 diabetes, gait disturbance, Crohn's disease, demyelinating diseases, or bacterial or viral infections. The methodological quality of many of the included studies made it difficult to generalise their results. The glossary of study designs is available in the full-text review. | 10.1002/14651858.CD004407.pub3 | [
"At least one dose of MMR vaccine is effective in preventing clinical mumps among children and adolescents when prepared with Jeryl Lynn strains (vaccine effectiveness = 69% to 81%, one cohort and one case-control study, 1656 participants), as well as when prepared with Urabe strain (vaccine effectiveness = 70% to 75%, one cohort and one case-control study, 1964 participants). Effectiveness against laboratory-confirmed mumps in children and adolescents was estimated to be between 64% to 66% for one and 83% to 88% for two doses of Jeryl Lynn MMR (two case-control studies, 1664 participants) and 87% for Urabe-containing MMR (one cohort study, 48 participants). Vaccination with Urabe MMR confers protection against secondary mumps infection (vaccine effectiveness = 73%, one cohort study, 147 participants). We identified no studies assessing the effectiveness of MMR vaccine against clinical or laboratory-confirmed rubella. Results from two very large case series studies involving about 1,500,000 children who were given the MMR vaccine containing Urabe or Leningrad-Zagreb strains show this vaccine to be associated with aseptic meningitis; whereas administration of the vaccine containing Moraten, Jeryl Lynn, Wistar RA, RIT 4385 strains is associated with febrile convulsion in children aged below five years (one person-time cohort study, 537,171 participants; two self controlled case series studies, 1001 participants). The MMR vaccine could also be associated with idiopathic thrombocytopaenic purpura (two case-controls, 2450 participants, one self controlled case series, 63 participants). We could assess no significant association between MMR immunisation and the following conditions: autism, asthma, leukaemia, hay fever, type 1 diabetes, gait disturbance, Crohn's disease, demyelinating diseases, or bacterial or viral infections. The methodological quality of many of the included studies made it difficult to generalise their results. The glossary of study designs is available in the full-text review."
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cochrane-simplification-train-1423 | cochrane-simplification-train-1423 | We identified seven completed trials (472 participants), and four ongoing trials (recruiting 837 participants) which are due to be completed by December 2020. Of the seven completed trials, five trials (456 participants) compared a TPO mimetic versus placebo (four romiplostim trials, and one eltrombopag trial), one trial (eight participants) compared DDAVP with placebo and one trial (eight participants) compared tranexamic acid with placebo. In the DDAVP trial, the only outcome reported was the bleeding time. In the tranexamic acid trial there were methodological flaws and bleeding definitions were subject to significant bias. Consequently, these trials could not be incorporated into the quantitative synthesis. No randomised trial of artificial platelet substitutes, platelet-poor plasma, fibrinogen concentrate, rFVIIa, rFXIII, rIL6 or rIL11 was identified. We assessed all five trials of TPO mimetics included in this review to be at high risk of bias because the trials were funded by the manufacturers of the TPO mimetics and the authors had financial stakes in the sponsoring companies. The GRADE quality of the evidence was very low to moderate across the different outcomes. There was insufficient evidence to detect a difference in the number of participants with at least one bleeding episode between TPO mimetics and placebo (RR 0.86, 95% CI 0.56 to 1.31, four trials, 206 participants, low-quality evidence). There was insufficient evidence to detect a difference in the risk of a life-threatening bleed between those treated with a TPO mimetic and placebo (RR 0.31, 95% CI 0.04 to 2.26, one trial, 39 participants, low-quality evidence). There was insufficient evidence to detect a difference in the risk of all-cause mortality between those treated with a TPO mimetic and placebo (RR 0.74, 95%CI 0.52 to 1.05, five trials, 456 participants, very low-quality evidence). There was a significant reduction in the number of participants receiving any platelet transfusion between those treated with TPO mimetics and placebo (RR 0.76, 95% CI 0.61 to 0.95, four trials, 206 participants, moderate-quality evidence). There was no evidence for a difference in the incidence of transfusion reactions between those treated with TPO mimetics and placebo (pOR 0.06, 95% CI 0.00 to 3.44, one trial, 98 participants, very low-quality evidence). There was no evidence for a difference in thromboembolic events between TPO mimetics and placebo (RR 1.41, 95%CI 0.39 to 5.01, five trials, 456 participants, very-low quality evidence). There was no evidence for a difference in drug reactions between TPO mimetics and placebo (RR 1.12, 95% CI 0.83 to 1.51, five trials, 455 participants, low-quality evidence). No trial reported the number of days of bleeding per participant, platelet transfusion episodes, mean red cell transfusions per participant, red cell transfusion episodes, transfusion-transmitted infections, formation of antiplatelet antibodies or platelet refractoriness. In order to demonstrate a reduction in bleeding events from 26 in 100 to 16 in 100 participants, a study would need to recruit 514 participants (80% power, 5% significance). There is insufficient evidence at present for thrombopoietin (TPO) mimetics for the prevention of bleeding for people with thrombocytopenia due to chronic bone marrow failure. There is no randomised controlled trial evidence for artificial platelet substitutes, platelet-poor plasma, fibrinogen concentrate, rFVIIa, rFXIII or rIL6 or rIL11, antifibrinolytics or DDAVP in this setting. | The evidence is current to April 2016. We identified 11 randomised controlled trials, of which seven had been completed. Of the seven completed trials, five trials (456 participants) assessed TPO mimetics, one trial (eight participants) assessed tranexamic acid and one trial (eight participants) assessed DDAVP. The trial of DDAVP only assessed the bleeding time: the time taken for bleeding to stop after a small cut is made in the participant's forearm. It did not assess any of the outcomes of interest to this review. The trial of tranexamic acid had significant methodological flaws in the way bleeding was reported. No randomised trial of artificial platelet substitutes, platelet-poor plasma, fibrinogen concentrate, rFVIIa, rFXIII, rIL6 or rIL11 was identified. Consequently, quantitative analysis was only performed on the five trials assessing TPO mimetics. Four of these trials included adults with myelodysplastic syndrome (MDS) and one trial assessed adults with MDS or acute myeloid leukaemia (AML). We assessed all five trials of TPO mimetics included in this review to be at high risk as the manufacturers if the TPO mimetics were directly involved in the design and publication of the trials. Differences in severity of disease and number of participants undergoing chemotherapy between trials meant that network meta-analysis could not be performed. A requirement of network meta-analysis is that participants in each trial should meet the eligibility criteria for each trial that is included. The four ongoing trials are all comparing TPO mimetics versus placebo; they are expected to recruit 837 participants in total and are due to be completed by December 2020. TPO mimetics may make little or no difference to the number of participants with any bleeding or severe/life-threatening bleeding. We are very uncertain whether TPO mimetics reduce the risk of mortality. TPO mimetics probably reduce the number of participants who need a platelet transfusion. We are very uncertain whether TPO mimetics reduce the risk of transfusion reactions or risk of thromboembolism. TPO mimetics may have little or no effect on the risk of drug reactions. No trial reported the number of days bleeding per participant, platelet transfusion episodes, mean red cell transfusions per participant, red cell transfusion episodes, transfusion-transmitted infections, formation of antiplatelet antibodies or platelet refractoriness. The quality of the evidence was low or very low for all outcomes except the number of participants receiving a platelet transfusion which was moderate-quality evidence. | 10.1002/14651858.CD012055.pub2 | [
"The evidence is current to April 2016. We identified 11 randomised controlled trials, of which seven had been completed. Of the seven completed trials, five trials (456 participants) assessed TPO mimetics, one trial (eight participants) assessed tranexamic acid and one trial (eight participants) assessed DDAVP. The trial of DDAVP only assessed the bleeding time: the time taken for bleeding to stop after a small cut is made in the participant's forearm. It did not assess any of the outcomes of interest to this review. The trial of tranexamic acid had significant methodological flaws in the way bleeding was reported. No randomised trial of artificial platelet substitutes, platelet-poor plasma, fibrinogen concentrate, rFVIIa, rFXIII, rIL6 or rIL11 was identified. Consequently, quantitative analysis was only performed on the five trials assessing TPO mimetics. Four of these trials included adults with myelodysplastic syndrome (MDS) and one trial assessed adults with MDS or acute myeloid leukaemia (AML). We assessed all five trials of TPO mimetics included in this review to be at high risk as the manufacturers if the TPO mimetics were directly involved in the design and publication of the trials. Differences in severity of disease and number of participants undergoing chemotherapy between trials meant that network meta-analysis could not be performed. A requirement of network meta-analysis is that participants in each trial should meet the eligibility criteria for each trial that is included. The four ongoing trials are all comparing TPO mimetics versus placebo; they are expected to recruit 837 participants in total and are due to be completed by December 2020. TPO mimetics may make little or no difference to the number of participants with any bleeding or severe/life-threatening bleeding. We are very uncertain whether TPO mimetics reduce the risk of mortality. TPO mimetics probably reduce the number of participants who need a platelet transfusion. We are very uncertain whether TPO mimetics reduce the risk of transfusion reactions or risk of thromboembolism. TPO mimetics may have little or no effect on the risk of drug reactions. No trial reported the number of days bleeding per participant, platelet transfusion episodes, mean red cell transfusions per participant, red cell transfusion episodes, transfusion-transmitted infections, formation of antiplatelet antibodies or platelet refractoriness. The quality of the evidence was low or very low for all outcomes except the number of participants receiving a platelet transfusion which was moderate-quality evidence."
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cochrane-simplification-train-1424 | cochrane-simplification-train-1424 | We included 57 trials in the first version of this review. For this update 1 of those trials was excluded and 12 new trials were added. The total number of included trials was, thus, 68, with 5578 participants, reporting on 50 different treatments, including placebo. Most trials were in primary impetigo or did not specify this. For many of the items that were assessed for risk of bias, most studies did not provide enough information. Fifteen studies reported blinding of participants and outcome assessors. Topical antibiotic treatment showed better cure rates than placebo (pooled risk ratio (RR) 2. 24, 95% confidence interval (CI) 1.61 to 3.13) in 6 studies with 575 participants. In 4 studies with 440 participants, there was no clear evidence that either of the most commonly studied topical antibiotics (mupirocin and fusidic acid) was more effective than the other (RR 1.03, 95% CI 0.95 to 1.11). In 10 studies with 581 participants, topical mupirocin was shown to be slightly superior to oral erythromycin (pooled RR 1.07, 95% CI 1.01 to 1.13). There were no significant differences in cure rates from treatment with topical versus other oral antibiotics. There were, however, differences in the outcome from treatment with different oral antibiotics: penicillin was inferior to erythromycin, in 2 studies with 79 participants (pooled RR 1.29, 95% CI 1.07 to 1.56), and cloxacillin, in 2 studies with 166 participants (pooled RR 1.59, 95% CI 1.21 to 2.08). There was a lack of evidence for the benefit of using disinfectant solutions. When 2 studies with 292 participants were pooled, topical antibiotics were significantly better than disinfecting treatments (RR 1.15, 95% CI 1.01 to 1.32). The reported number of side-effects was low, and most of these were mild. Side-effects were more common for oral antibiotic treatment compared to topical treatment. Gastrointestinal effects accounted for most of the difference. Worldwide, bacteria causing impetigo show growing resistance rates for commonly used antibiotics. For a newly developed topical treatment, retapamulin, no resistance has yet been reported. There is good evidence that topical mupirocin and topical fusidic acid are equally, or more, effective than oral treatment. Due to the lack of studies in people with extensive impetigo, it is unclear if oral antibiotics are superior to topical antibiotics in this group. Fusidic acid and mupirocin are of similar efficacy. Penicillin was not as effective as most other antibiotics. There is a lack of evidence to support disinfection measures to manage impetigo. | We identified 68 randomised controlled trials comparing various treatments for impetigo. Altogether, these studies evaluated 26 oral treatments and 24 topical treatments, including placebo, and results were described for 5708 participants. Overall, topical antibiotics showed better cure rates than topical placebo. Two antibiotic creams, mupirocin and fusidic acid, are at least as effective as oral antibiotics where the disease is not extensive. There was no clear evidence that either of these most commonly studied topical antibiotics was more effective than the other. Topical mupirocin was superior to the oral antibiotic, oral erythromycin. We found that the oral antibiotic, oral penicillin, is not effective for impetigo, while other oral antibiotics (e.g. erythromycin and cloxacillin) can help. It is unclear if oral antibiotics are superior to topical antibiotics for people with extensive impetigo. There is a lack of evidence to suggest that using disinfectant solutions improves impetigo. When 2 studies with 292 participants were pooled, topical antibiotics were significantly better than disinfecting treatments. Reported side-effects for topical treatments were mild and low in frequency; the treatments sometimes resulted in itching, burning, or staining. Oral antibiotics produced gastrointestinal complaints, such as nausea and diarrhoea, in 2% to 30% of participants, depending upon the specific antibiotic. Worldwide, bacteria causing impetigo show growing resistance rates for commonly used antibiotics. For a newly developed topical treatment, retapamulin, no resistance has yet been reported. | 10.1002/14651858.CD003261.pub3 | [
"We identified 68 randomised controlled trials comparing various treatments for impetigo. Altogether, these studies evaluated 26 oral treatments and 24 topical treatments, including placebo, and results were described for 5708 participants. Overall, topical antibiotics showed better cure rates than topical placebo. Two antibiotic creams, mupirocin and fusidic acid, are at least as effective as oral antibiotics where the disease is not extensive. There was no clear evidence that either of these most commonly studied topical antibiotics was more effective than the other. Topical mupirocin was superior to the oral antibiotic, oral erythromycin. We found that the oral antibiotic, oral penicillin, is not effective for impetigo, while other oral antibiotics (e.g. erythromycin and cloxacillin) can help. It is unclear if oral antibiotics are superior to topical antibiotics for people with extensive impetigo. There is a lack of evidence to suggest that using disinfectant solutions improves impetigo. When 2 studies with 292 participants were pooled, topical antibiotics were significantly better than disinfecting treatments. Reported side-effects for topical treatments were mild and low in frequency; the treatments sometimes resulted in itching, burning, or staining. Oral antibiotics produced gastrointestinal complaints, such as nausea and diarrhoea, in 2% to 30% of participants, depending upon the specific antibiotic. Worldwide, bacteria causing impetigo show growing resistance rates for commonly used antibiotics. For a newly developed topical treatment, retapamulin, no resistance has yet been reported."
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cochrane-simplification-train-1425 | cochrane-simplification-train-1425 | Two studies met criteria for this review. One compared dilation and evacuation (D&E) to intra-amniotic instillation of prostaglandin F2 α. The second study compared D&E to induction with mifepristone and misoprostol. Compared with prostaglandin instillation, the combined incidence of minor complications was lower with D&E (OR 0.17, 95% CI 0.04-0.65) as was the total number of minor and major complications (OR 0.12, 95% CI 0.03-0.46). The number of women experiencing adverse events was also lower with D&E than with mifepristone and misoprostol (OR 0.06, 95% CI 0.01-0.76). Although women treated with mifepristone and misoprostol reported significantly more pain than those undergoing D&E, efficacy and acceptability were the same in both groups. In both trials, fewer subjects randomised to D&E required overnight hospitalisation. Dilation and evacuation is superior to instillation of prostaglandin F2 α. The current evidence also appears to favour D&E over mifepristone and misoprostol, however larger randomised trials are needed. | We did computer searches to find studies that compared any operation to any medicine used for abortion at this stage of pregnancy. We wrote to researchers and looked through book chapters and other articles to find more studies. We found two studies. The first compared dilation and evacuation (D&E) to injecting a drug into the pregnant womb. The second compared D&E to drugs taken by mouth and by vagina. The D&E operation was better than injecting medicines into the womb. Medicines taken by mouth and vagina worked as well and were as acceptable as a D&E, but caused more pain and side effects. More studies with modern medicines used for abortion after 3 months of pregnancy are needed. | 10.1002/14651858.CD006714.pub2 | [
"We did computer searches to find studies that compared any operation to any medicine used for abortion at this stage of pregnancy. We wrote to researchers and looked through book chapters and other articles to find more studies. We found two studies. The first compared dilation and evacuation (D&E) to injecting a drug into the pregnant womb. The second compared D&E to drugs taken by mouth and by vagina. The D&E operation was better than injecting medicines into the womb. Medicines taken by mouth and vagina worked as well and were as acceptable as a D&E, but caused more pain and side effects. More studies with modern medicines used for abortion after 3 months of pregnancy are needed."
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cochrane-simplification-train-1426 | cochrane-simplification-train-1426 | We included 11 RCTs (3215 women). The quality of the evidence ranged from very low to low. The main limitations were risk of bias (associated with poor reporting of allocation concealment and other methods) and imprecision for the primary outcome of live birth rate. Live birth rates: Seminal plasma application made little or no difference in live birth rates (RR 1.10, 95% CI 0.86 to 1.43; 948 participants; 3 studies; I2 = 0%). Low-quality evidence suggested that if the live birth rate following standard ART was 19%, it would be between 16% and 27% with seminal plasma application. Miscarriage rate: Seminal plasma application made little or no difference in miscarriage rates (RR 1.01, 95% CI 0.57 to 1.79; 1209 participants; 4 studies; I2 = 0%). Low-quality evidence suggested that if the miscarriage rate following standard ART was 3.7%, the miscarriage rate following seminal plasma application would be between 2.1% and 6.6%. Live birth or ongoing pregnancy rates: Seminal plasma application made little or no difference in live birth or ongoing pregnancy rates (RR 1.19, 95% CI 0.95 to 1.49; 1178 participants; 4 studies; I2 = 4%, low-quality evidence). The evidence suggested that if the live birth or ongoing pregnancy rate following standard ART was 19.5%, it would be between 18.5% and 29% with seminal plasma application. Clinical pregnancy rates: We are uncertain whether seminal plasma application increases clinical pregnancy rates (RR 1.15, 95% CI 1.01 to 1.31; 2768 participants; 10 studies; I2 = 0%). Very low-quality evidence suggested that if the clinical pregnancy rate following standard ART was 22.0%, it would be between 22.2% and 28.8% with seminal plasma application. This finding should be regarded with caution, as a post hoc sensitivity analysis restricted to studies at overall low risk of bias did not find a significant difference between the groups (RR 1.06, 95% CI 0.81 to 1.39; 547 participants; 3 studies; I2 = 0%). Multiple pregnancy rate: Seminal plasma application may make little or no difference to multiple pregnancy rates (RR 1.11, 95% CI 0.76 to 1.64; 1642 participants; 5 studies; I2 = 9%). Low-quality evidence suggested that if the multiple pregnancy rate following standard ART was 7%, the multiple pregnancy rate following seminal plasma application would be between 5% and 11.4%. Ectopic pregnancy: There was insufficient evidence to determine whether seminal plasma application influenced the risk of ectopic pregnancy (RR 1.59, 95% CI 0.20 to 12.78, 1521 participants; 5 studies; I2 = 0%) . Infectious complications or other adverse events: No data were available on these outcomes In women undergoing ART, there was insufficient evidence to determine whether there was a difference between the seminal plasma and the standard ART group in rates of live birth (low-quality evidence) or miscarriage (low-quality evidence). There was low-quality evidence suggesting little or no difference between the groups in rates of live birth or ongoing pregnancy (composite outcome). We found low-quality evidence that seminal plasma application may be associated with more clinical pregnancies than standard ART. There was low-quality evidence suggesting little or no difference between the groups in rates of multiple pregnancy. There was insufficient evidence to reach any conclusions about the risk of ectopic pregnancy, and no data were available on infectious complications or other adverse events. We conclude that seminal plasma application is worth further investigation, focusing on live birth and miscarriage rates. | This Cochrane review included 11 randomised controlled trials, in which women were randomly allocated to receive seminal plasma or not. These trials included a total of 3215 women undergoing ART. The evidence is current to October 2017. We found no clear evidence to suggest whether seminal plasma application influences rates of live birth or miscarriage in women undergoing ART. However, we found low-quality evidence suggesting that seminal plasma application may possibly lead to more clinical pregnancies than standard ART. There was low-quality evidence suggesting little or no difference between the groups in rates of multiple pregnancy. There was insufficient evidence to reach any conclusions about the risk of ectopic pregnancy (pregnancy in which the embryo attaches outside the womb), and no data were available on infectious complications or other adverse events. We conclude that seminal plasma application is worth further investigation focusing on live birth and miscarriage rates. The quality of evidence ranged from very low to low.The main limitations were risk of bias (associated with poor reporting of study methods) and lack of data for the primary outcome of live birth rate. | 10.1002/14651858.CD011809.pub2 | [
"This Cochrane review included 11 randomised controlled trials, in which women were randomly allocated to receive seminal plasma or not. These trials included a total of 3215 women undergoing ART. The evidence is current to October 2017. We found no clear evidence to suggest whether seminal plasma application influences rates of live birth or miscarriage in women undergoing ART. However, we found low-quality evidence suggesting that seminal plasma application may possibly lead to more clinical pregnancies than standard ART. There was low-quality evidence suggesting little or no difference between the groups in rates of multiple pregnancy. There was insufficient evidence to reach any conclusions about the risk of ectopic pregnancy (pregnancy in which the embryo attaches outside the womb), and no data were available on infectious complications or other adverse events. We conclude that seminal plasma application is worth further investigation focusing on live birth and miscarriage rates. The quality of evidence ranged from very low to low.The main limitations were risk of bias (associated with poor reporting of study methods) and lack of data for the primary outcome of live birth rate."
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cochrane-simplification-train-1427 | cochrane-simplification-train-1427 | We located reports from 14 trials for the initial review, but have not identified any new trials since then. In the largest trial to date, the gel (Advantage S) containing the lowest dose of nonoxynol-9 (52.5 mg) was significantly less effective in preventing pregnancy than were gels with higher doses of the same agent (100 mg and 150 mg). Probabilities of pregnancy by six months were 22% for the 52.5 mg gel, 16% for the 100 mg dose, and 14% for the 150 mg dose. In the same trial, the three different vehicles with 100 mg of nonoxynol-9 had similar efficacy. Interpretation of these figures is limited, since 39% of participants discontinued the method or were lost from the trial. Few important differences in efficacy emerged in other trials. The probability of pregnancy varied widely in reported trials. A gel containing nonoxynol-9 52.5 mg was inferior to two other products tested in the largest trial. Aside from this finding, personal characteristics and behavior of users may be more important than characteristics of the spermicide products in determining the probability of pregnancy. Gel was liked more than the film or vaginal suppository in the largest trial. Spermicide trials have the dual challenges of difficult recruitment and high discontinuation rates; the latter threatens trial validity. | Spermicides have been used as birth control for thousands of years. Studies have recently looked at how well they work to prevent pregnancy and whether women like them. Spermicides contain an active ingredient (usually nonoxynol-9) and something to disperse the product, such as foam or vaginal suppository (pessary). This review compared how well different spermicides worked for birth control when used alone. In August 2013, we did computer searches for randomized trials of spermicides used for birth control. We have not found any new trials since the initial review. For the initial review, we also wrote to researchers to find other trials. Trials had to focus on a spermicide used alone for birth control. The product could be compared to a different spermicide, the same spermicide used with a barrier method, another dose of the same spermicide, a different base for the same product, or another type of birth control. Each study must have had data on pregnancy. We located reports from 14 trials for the initial review. We have not found any new trials since then. The largest trial compared five different spermicides. The gel with the smallest amount of nonoxynol-9 did not prevent pregnancy as well as products with more of the same ingredient. Women liked the gel better than the film or suppository. Few differences were found in the other studies. These trials had problems recruiting women into the studies and then keeping them until the trial ended. Large losses to follow up can bias the results. | 10.1002/14651858.CD005218.pub4 | [
"Spermicides have been used as birth control for thousands of years. Studies have recently looked at how well they work to prevent pregnancy and whether women like them. Spermicides contain an active ingredient (usually nonoxynol-9) and something to disperse the product, such as foam or vaginal suppository (pessary). This review compared how well different spermicides worked for birth control when used alone. In August 2013, we did computer searches for randomized trials of spermicides used for birth control. We have not found any new trials since the initial review. For the initial review, we also wrote to researchers to find other trials. Trials had to focus on a spermicide used alone for birth control. The product could be compared to a different spermicide, the same spermicide used with a barrier method, another dose of the same spermicide, a different base for the same product, or another type of birth control. Each study must have had data on pregnancy. We located reports from 14 trials for the initial review. We have not found any new trials since then. The largest trial compared five different spermicides. The gel with the smallest amount of nonoxynol-9 did not prevent pregnancy as well as products with more of the same ingredient. Women liked the gel better than the film or suppository. Few differences were found in the other studies. These trials had problems recruiting women into the studies and then keeping them until the trial ended. Large losses to follow up can bias the results."
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cochrane-simplification-train-1428 | cochrane-simplification-train-1428 | We identified 28 randomised clinical trials involving 2365 participants. The cause of foot ulcer (neurologic, vascular, or combined) was poorly defined in all trials. The trials were conducted in ten countries. The trials assessed 11 growth factors in 30 comparisons: platelet-derived wound healing formula, autologous growth factor, allogeneic platelet-derived growth factor, transforming growth factor β2, arginine-glycine-aspartic acid peptide matrix, recombinant human platelet-derived growth factor (becaplermin), recombinant human epidermal growth factor, recombinant human basic fibroblast growth factor, recombinant human vascular endothelial growth factor, recombinant human lactoferrin, and recombinant human acidic fibroblast growth factor. Topical intervention was the most frequent route of administration. All the trials were underpowered and had a high risk of bias. Pharmaceutical industry sponsored 50% of the trials. Any growth factor compared with placebo or no growth factor increased the number of participants with complete wound healing (345/657 (52.51%) versus 167/482 (34.64%); RR 1.51, 95% CI 1.31 to 1.73; I2 = 51%, 12 trials; low quality evidence). The result is mainly based on platelet-derived wound healing formula (36/56 (64.28%) versus 7/27 (25.92%); RR 2.45, 95% 1.27 to 4.74; I2 = 0%, two trials), and recombinant human platelet-derived growth factor (becaplermin) (205/428 (47.89%) versus 109/335 (32.53%); RR 1.47, 95% CI 1.23 to 1.76, I2= 74%, five trials). In terms of lower limb amputation (minimum of one toe), there was no clear evidence of a difference between any growth factor and placebo or no growth factor (19/150 (12.66%) versus 12/69 (17.39%); RR 0.74, 95% CI 0.39 to 1.39; I2 = 0%, two trials; very low quality evidence). One trial involving 55 participants showed no clear evidence of a difference between recombinant human vascular endothelial growth factor and placebo in terms of ulcer-free days following treatment for diabetic foot ulcers (RR 0.64, 95% CI 0.14 to 2.94; P value 0.56, low quality of evidence) Although 11 trials reported time to complete healing of the foot ulcers in people with diabetes , meta-analysis was not possible for this outcome due to the unique comparisons within each trial, failure to report data, and high number of withdrawals. Data on quality of life were not reported. Growth factors showed an increasing risk of overall adverse event rate compared with compared with placebo or no growth factor (255/498 (51.20%) versus 169/332 (50.90%); RR 0.83; 95% CI 0.72 to 0.96; I2 = 48%; eight trials; low quality evidence). Overall, safety data were poorly reported and adverse events may have been underestimated. This Cochrane systematic review analysed a heterogeneous group of trials that assessed 11 different growth factors for diabetic foot ulcers. We found evidence suggesting that growth factors may increase the likelihood that people will have complete healing of foot ulcers in people with diabetes. However, this conclusion is based on randomised clinical trials with high risk of systematic errors (bias). Assessment of the quality of the available evidence (GRADE) showed that further trials investigating the effect of growth factors are needed before firm conclusions can be drawn. The safety profiles of the growth factors are unclear. Future trials should be conducted according to SPIRIT statement and reported according to the CONSORT statement by independent investigators and using the Foundation of Patient-Centered Outcomes Research recommendations. | The review authors searched the medical literature up to 3 March 2015, and identified 28 relevant medical trials, with a total of 2365 participants. The trials were performed in ten different countries, generally in out-patient settings. All the trials had low numbers of participants, which makes potential overestimation of benefits and underestimation of harms more likely. Half of the trials were sponsored by the pharmaceutical industry that produces these growth factors. The trials tested 11 different types of growth factor, usually by applying them to the ulcer surface. Growth factors had no effect on the risk of having one toe or more amputated when compared with either another growth factor, or placebo (inactive fake medicine), or standard care alone (evidence from four trials). However, when compared with placebo or no growth factor, growth factors seemed to make complete healing of ulcers (wound closure) more likely to occur (evidence from 12 trials). None of the trials reported data on participants’ quality of life. Harms caused by treatments were poorly reported, so the safety profile of growth factors remains unclear. It is clear that more trials are required to assess the benefits and harms of growth factors in the treatment of diabetic foot ulcers. These trials should be well-designed, conducted by independent researchers (not industry-sponsored), and have large numbers of participants. They should report outcomes that are of interest to patients, such as: how many of the participants’ ulcers healed, and how long the healing took; any level of amputation in the foot; quality of life; ulcer-free days following treatment; and harms caused by treatment, including whether there are any potential cancer risks. | 10.1002/14651858.CD008548.pub2 | [
"The review authors searched the medical literature up to 3 March 2015, and identified 28 relevant medical trials, with a total of 2365 participants. The trials were performed in ten different countries, generally in out-patient settings. All the trials had low numbers of participants, which makes potential overestimation of benefits and underestimation of harms more likely. Half of the trials were sponsored by the pharmaceutical industry that produces these growth factors. The trials tested 11 different types of growth factor, usually by applying them to the ulcer surface. Growth factors had no effect on the risk of having one toe or more amputated when compared with either another growth factor, or placebo (inactive fake medicine), or standard care alone (evidence from four trials). However, when compared with placebo or no growth factor, growth factors seemed to make complete healing of ulcers (wound closure) more likely to occur (evidence from 12 trials). None of the trials reported data on participants’ quality of life. Harms caused by treatments were poorly reported, so the safety profile of growth factors remains unclear. It is clear that more trials are required to assess the benefits and harms of growth factors in the treatment of diabetic foot ulcers. These trials should be well-designed, conducted by independent researchers (not industry-sponsored), and have large numbers of participants. They should report outcomes that are of interest to patients, such as: how many of the participants’ ulcers healed, and how long the healing took; any level of amputation in the foot; quality of life; ulcer-free days following treatment; and harms caused by treatment, including whether there are any potential cancer risks."
]
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cochrane-simplification-train-1429 | cochrane-simplification-train-1429 | Ten studies including 5056 participants met the inclusion criteria for this review and assessed the diagnostic accuracy of the index tests in people presenting to the emergency department with acute abdominal pain. The risk of bias was unclear or high for all of the included studies. The study that contributed approximately two-thirds of the participants included in this review was excluded from the results of the analysis presented below due to major concerns about the participants included in the study. We have presented only the results where at least two studies were included in the analysis. Serum amylase, serum lipase, and urinary trypsinogen-2 at the standard threshold levels of more than three times normal for serum amylase and serum lipase, and a threshold of 50 ng/mL for urinary trypsinogen-2 appear to have similar sensitivities (0.72 (95% CI 0.59 to 0.82); 0.79 (95% CI 0.54 to 0.92); and 0.72 (95% CI 0.56 to 0.84), respectively) and specificities (0.93 (95% CI 0.66 to 0.99); 0.89 (95% CI 0.46 to 0.99); and 0.90 (95% CI 0.85 to 0.93), respectively). At the median prevalence of 22.6% of acute pancreatitis in the studies, out of 100 people with positive test, serum amylase (more than three times normal), serum lipase (more than three times normal), and urinary trypsinogen (more than 50 ng/mL), 74 (95% CI 33 to 94); 68 (95% CI 21 to 94); and 67 (95% CI 57 to 76) people have acute pancreatitis, respectively; out of 100 people with negative test, serum amylase (more than three times normal), serum lipase (more than three times normal), and urinary trypsinogen (more than 50 ng/mL), 8 (95% CI 5 to 12); 7 (95% CI 3 to 15); and 8 (95% CI 5 to 13) people have acute pancreatitis, respectively. We were not able to compare these tests formally because of sparse data. As about a quarter of people with acute pancreatitis fail to be diagnosed as having acute pancreatitis with the evaluated tests, one should have a low threshold to admit the patient and treat them for acute pancreatitis if the symptoms are suggestive of acute pancreatitis, even if these tests are normal. About 1 in 10 patients without acute pancreatitis may be wrongly diagnosed as having acute pancreatitis with these tests, therefore it is important to consider other conditions that require urgent surgical intervention, such as perforated viscus, even if these tests are abnormal. The diagnostic performance of these tests decreases even further with the progression of time, and one should have an even lower threshold to perform additional investigations if the symptoms are suggestive of acute pancreatitis. | We identified 10 studies reporting information on 5056 people with abdominal pain that started suddenly. The studies included pancreatitis due to all causes. All of the studies were of unclear or low methodological quality, which may result in arriving at false conclusions. We excluded the study that contributed approximately two-thirds of the participants included in this review from the results of the analysis presented below due to concerns about whether the participants included in the study are typical of those seen in the emergency department. The accuracy of serum amylase, serum lipase, and urinary trypsinogen-2 in making the diagnosis of acute pancreatitis was similar. About a quarter of people with acute pancreatitis fail to be diagnosed as having acute pancreatitis with these tests. The patient should be admitted and treated as having acute pancreatitis, even if these tests are normal, if there is a suspicion of acute pancreatitis. As about 1 in 10 patients without acute pancreatitis may be wrongly diagnosed as having acute pancreatitis with these tests, it is important to consider other conditions that require urgent surgery, even if these tests are abnormal. The diagnostic performance of these tests decreases even further with the progression of time, and additional investigations should be performed if there is a suspicion of acute pancreatitis. | 10.1002/14651858.CD012010.pub2 | [
"We identified 10 studies reporting information on 5056 people with abdominal pain that started suddenly. The studies included pancreatitis due to all causes. All of the studies were of unclear or low methodological quality, which may result in arriving at false conclusions. We excluded the study that contributed approximately two-thirds of the participants included in this review from the results of the analysis presented below due to concerns about whether the participants included in the study are typical of those seen in the emergency department. The accuracy of serum amylase, serum lipase, and urinary trypsinogen-2 in making the diagnosis of acute pancreatitis was similar. About a quarter of people with acute pancreatitis fail to be diagnosed as having acute pancreatitis with these tests. The patient should be admitted and treated as having acute pancreatitis, even if these tests are normal, if there is a suspicion of acute pancreatitis. As about 1 in 10 patients without acute pancreatitis may be wrongly diagnosed as having acute pancreatitis with these tests, it is important to consider other conditions that require urgent surgery, even if these tests are abnormal. The diagnostic performance of these tests decreases even further with the progression of time, and additional investigations should be performed if there is a suspicion of acute pancreatitis."
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cochrane-simplification-train-1430 | cochrane-simplification-train-1430 | We identified seven new RCTs since publication of the original review in 2002. In total, we included 10 RCTs. Primary outcomes Early AST probably reduces the risk of death from any cause over time (hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.75 to 0.90; moderate-certainty evidence; 4767 participants). This corresponds to 57 fewer deaths (95% CI 80 fewer to 31 fewer) per 1000 participants at 5 years for the moderate risk group and 23 fewer deaths (95% CI 32 fewer to 13 fewer) per 1000 participants at 5 years in the low risk group. We downgraded for study limitations. Early versus deferred AST may have little or no effect on serious adverse events (risk ratio (RR) 1.05, 95% CI 0.95 to 1.16; low-certainty evidence; 10,575 participants) which corresponds to 6 more serious adverse events (6 fewer to 18 more) per 1000 participants. We downgraded the certainty of evidence for study limitations and selective reporting. Secondary outcomes Early AST probably reduces the risk of death from prostate cancer over time (HR 0.69, 95% CI 0.57 to 0.84; moderate-certainty evidence). This corresponds to 62 fewer prostate cancer deaths per 1000 (95% CI 87 fewer to 31 fewer) at 5 years for the moderate risk group and 24 fewer death from prostate cancer (95% CI 34 fewer to 12 fewer) per 1000 men at 5 years in the low risk group. We downgraded the certainty of evidence for study limitations. Early AST may decrease the rate of skeletal events (RR 0.37, 95% CI 0.17 to 0.80; low-certainty evidence) corresponding to 23 fewer skeletal events per 1000 (95% CI 31 fewer to 7 fewer). We downgraded for study limitations and imprecision. It may also increase fatigue (RR 1.41, 95% CI 1.23 to 1.62; low-certainty evidence), corresponding to 31 more men with this complaint per 1000 (95% CI 18 more to 48 more). We downgraded for study limitations and imprecision. It may increase the risk of heart failure (RR 1.90, 95% CI 1.09 to 3.33; low-certainty evidence) corresponding to 27 more events per 1000 (95% CI 3 more to 69 more). We downgraded the certainty of evidence for study limitations and imprecision. Global quality of life is probably similar after two years as assessed with the EORTC QLQ-C30 (version 3.0) questionnaire (mean difference −1.56, 95% CI −4.50 to 1.38; moderate-certainty evidence) with higher scores reflecting better quality of life. We downgraded the certainty of evidence for study limitations. Early AST probably extends time to death of any cause and time to death from prostate cancer. It may slightly decrease the rate of skeletal events. Rates of serious adverse events and quality of life may be similar. It may increase fatigue and may increase the risk of heart failure. Better quality trials would be particularly important to better understand the outcomes related to possible treatment-related harm, for which we only found low-certainty evidence. | We considered only studies in which chance decided whether men with prostate cancer got early or late hormonal treatment. We found 10 studies that matched our question. We found that early hormonal treatment probably lowers the risk of dying from any cause. The risk of serious unwanted effects may be similar to that of late treatment. Early hormonal treatment probably lowers the risk of dying from prostate cancer and slightly lowers the risk of problems related to cancer spreading to the bones. Men getting early treatment may be more likely to feel tired and develop heart weakness. Overall quality of life is probably unaffected (or only slightly affected) by early treatment. The certainty of evidence was either moderate, which means that the true results are likely close to what we found; or low, in which case our concern is that the true results could be quite different to what we found. | 10.1002/14651858.CD003506.pub2 | [
"We considered only studies in which chance decided whether men with prostate cancer got early or late hormonal treatment. We found 10 studies that matched our question. We found that early hormonal treatment probably lowers the risk of dying from any cause. The risk of serious unwanted effects may be similar to that of late treatment. Early hormonal treatment probably lowers the risk of dying from prostate cancer and slightly lowers the risk of problems related to cancer spreading to the bones. Men getting early treatment may be more likely to feel tired and develop heart weakness. Overall quality of life is probably unaffected (or only slightly affected) by early treatment. The certainty of evidence was either moderate, which means that the true results are likely close to what we found; or low, in which case our concern is that the true results could be quite different to what we found."
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cochrane-simplification-train-1431 | cochrane-simplification-train-1431 | Five parallel and 26 crossover randomised controlled trials were identified. The quality of reporting was found to be poor. Pooled data from parallel studies shows a statistically non-significant preference for physiologic pacing (primarily dual chamber pacing) for the prevention of stroke, heart failure and mortality, and a statistically significant beneficial effect regarding the prevention of atrial fibrillation (odds ratio (OR) 0.79, 95% CI 0.68 to 0.93). Both parallel and crossover studies favour dual chamber pacing with regard to pacemaker syndrome (parallel: Peto OR 0.11, 95% CI 0.08 to 0.14; crossover: standardised mean difference (SMD) -0.74, 95% CI - 0.95 to -0.52). Pooled data from crossover studies shows a statistically significant trend towards dual chamber pacing being more favourable in terms of exercise capacity (SMD -0.24, 95% CI -0.03 to -0.45). No individual studies reported a significantly more favourable outcome with single chamber ventricular pacing. This review shows a trend towards greater effectiveness with dual chamber pacing compared to single chamber ventricular pacing, which supports the current British Pacing and Electrophysiology Group's Guidelines regarding atrioventricular block. Additional randomised controlled trial evidence from ongoing trials in this area will further inform the debate. | The review of trials found that dual chamber pacemakers tended to prevent more subsequent heart problems than single chamber ventricular pacemakers. The impact on people's overall quality of life is uncertain. The review did not investigate the relative benefits or risks of surgery to upgrade to a dual chamber pacemaker. | 10.1002/14651858.CD003710.pub2 | [
"The review of trials found that dual chamber pacemakers tended to prevent more subsequent heart problems than single chamber ventricular pacemakers. The impact on people's overall quality of life is uncertain. The review did not investigate the relative benefits or risks of surgery to upgrade to a dual chamber pacemaker."
]
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cochrane-simplification-train-1432 | cochrane-simplification-train-1432 | It was not possible to aggregate the five included studies (214 participants). Four studies (206 participants) addressed the question of whether differences in outcomes were seen when vitamin C and E supplementation versus placebo was provided for participants with asthma, and only one of those studies (160 children) included a paediatric population; the remaining three studies included a combined total of just 46 adults. An additional study considered the question of whether differences in outcomes were noted when vitamin C and E supplementation was compared with placebo for exercise-induced asthma; this trial included only eight participants. The randomisation process of the trials were unclear leading us to downgrade the quality of the evidence. Four of the studies were double blind while the other study was single blind. None of these studies provided data on our two prespecified primary outcome measures: exacerbations and HRQL. Lung function data obtained from the studies were inconclusive. The only studies that provided any suggestion of an effect, and only with some outcomes, were the paediatric study, especially for children with moderate to severe asthma, and the small study on exercise-induced asthma. Even so, this evidence was judged to be at moderate/low quality. Only one study contributed data on asthma symptoms and adverse events, reporting no evidence of an effect of the intervention for symptoms and that one participant in the treatment group dropped out due to cystitis. It is not possible to draw firm conclusions from this review with respect to the comparison of vitamin C and E supplementation versus placebo in the management of asthma or exercise-induced bronchoconstriction. We found only one study relevant to exercise-induced bronchoconstriction; most included participants came from studies designed to assess the effect of vitamin supplementation on the impact of atmospheric pollutants (such as ozone). Evidence is lacking on the comparison of vitamin C and E supplementation versus placebo for asthma with respect to outcomes such as HRQL and exacerbations, which were not addressed by any of the included studies. When compared with lung function tests alone, HRQL scores and exacerbation frequency are better indicators of the severity of asthma, its impact on daily activities and its response to treatment in a patient population. These end points are well recognised in good quality studies of asthma management. However, clinical studies of vitamins C and E in the management of asthma using these important end points of exacerbations and effects on quality of life are not available, and evidence is insufficient to support robust conclusions on the role of vitamin C and E supplementation in asthma and exercise-induced breathlessness. | Five studies comparing vitamins C and E versus placebo (no vitamins C and E) in 214 people with asthma or exercise-induced breathlessness were included in this review. Four studies included adults, and one included children. The very limited number of studies available for review and their different designs meant that we were only able to describe individual studies, rather than pooling their results to determine an average result. In most study reports, the design was not well described; therefore it was impossible to assess the risk of bias for most of the studies. In terms of our key outcomes, very few relevant data were provided by the trial authors. We found no indication of benefit in the studies that considered vitamins C and E in relation to asthma. However, at this stage, it is not possible to form any clear conclusions based on these findings, as available evidence is insufficient to allow proper assessment of the use of vitamins C and E as treatment for patients with asthma. Additional well-designed research is required to answer this question. How patients were allocated to receive either vitamins C and E or placebo was not clearly described in any of the five included studies. This may mean that the studies were not well randomised, which can affect the results. A second concern is that the designs of the studies were different, which means that we cannot be certain that the studies were measuring the same thing. By taking this into account, we judged the evidence in this review overall to be of low to moderate quality. | 10.1002/14651858.CD010749.pub2 | [
"Five studies comparing vitamins C and E versus placebo (no vitamins C and E) in 214 people with asthma or exercise-induced breathlessness were included in this review. Four studies included adults, and one included children. The very limited number of studies available for review and their different designs meant that we were only able to describe individual studies, rather than pooling their results to determine an average result. In most study reports, the design was not well described; therefore it was impossible to assess the risk of bias for most of the studies. In terms of our key outcomes, very few relevant data were provided by the trial authors. We found no indication of benefit in the studies that considered vitamins C and E in relation to asthma. However, at this stage, it is not possible to form any clear conclusions based on these findings, as available evidence is insufficient to allow proper assessment of the use of vitamins C and E as treatment for patients with asthma. Additional well-designed research is required to answer this question. How patients were allocated to receive either vitamins C and E or placebo was not clearly described in any of the five included studies. This may mean that the studies were not well randomised, which can affect the results. A second concern is that the designs of the studies were different, which means that we cannot be certain that the studies were measuring the same thing. By taking this into account, we judged the evidence in this review overall to be of low to moderate quality."
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cochrane-simplification-train-1433 | cochrane-simplification-train-1433 | Ten trials involving 1205 participants were included. The duration of patient follow-up ranged from 2 days to 2 years after the intervention. Overall, the quality of the evidence generated by these trials was low, due to risk of bias in the included trials and inconsistency in the results. Manual lymph drainage In total, four studies used manual lymph drainage (MLD) in combination with usual care or other interventions. In one study, lymphoedema incidence was lower in patients receiving MLD and usual care (consisting of standard education or exercise, or both) compared to usual care alone. A second study reported no difference in lymphoedema incidence when MLD was combined with physiotherapy and education compared to physiotherapy alone. Two other studies combining MLD with compression and scar massage or exercise observed a reduction in lymphoedema incidence compared to education only, although this was not significant in one of the studies. Two out of the four studies reported on shoulder mobility where MLD combined with exercise gave better shoulder mobility for lateral arm movement (shoulder abduction) and forward flexion in the first weeks after breast cancer surgery, compared to education only (mean difference for abduction 22°; 95% confidence interval (CI) 14 to 30; mean difference for forward flexion 14°; 95% CI 7 to 22). Two of the studies on MLD reported on pain, with inconsistent results. Results on HRQoL in two studies on MLD were also contradictory. Exercise: early versus delayed start of shoulder mobilising exercises Three studies examined early versus late start of postoperative shoulder exercises. The pooled relative risk of lymphoedema after an early start of exercises was 1.69 (95% CI 0.94 to 3.01, 3 studies, 378 participants). Shoulder forward flexion was better at one and six months follow-up for participants who started early with mobilisation exercises compared to a delayed start (two studies), but no meta-analysis could be performed due to statistical heterogeneity. There was no difference in shoulder mobility or self-reported shoulder disability at 12 months follow-up (one study). One study evaluated HRQoL and reported difference at one year follow-up (mean difference 1.6 points, 95% CI -2.14 to 5.34, on the Trial Outcome Index of the FACT-B). Two studies collected data on wound drainage volumes and only one study reported higher wound drainage volumes in the early exercise group. Exercise: resistance training Two studies compared progressive resistance training to restricted activity. Resistance training after breast cancer treatment did not increase the risk of developing lymphoedema (RR 0.58; 95% CI 0.30 to 1.13, two studies, 358 participants) provided that symptoms are monitored and treated immediately if they occur. One out of the two studies measured pain where participants in the resistance training group reported pain more often at three months and six months compared to the control group. One study reported HRQoL and found no significant difference between the groups. Patient education, monitoring and early intervention One study investigated the effects of a comprehensive outpatient follow-up programme, consisting of patient education, exercise, monitoring of lymphoedema symptoms and early intervention for lymphoedema, compared to education alone. Lymphoedema incidence was lower in the comprehensive outpatient follow-up programme (at any time point) compared to education alone (65 people). Participants in the outpatient follow-up programme had a significantly faster recovery of shoulder abduction compared to the education alone group. Based on the current available evidence, we cannot draw firm conclusions about the effectiveness of interventions containing MLD. The evidence does not indicate a higher risk of lymphoedema when starting shoulder-mobilising exercises early after surgery compared to a delayed start (i.e. seven days after surgery). Shoulder mobility (that is, lateral arm movements and forward flexion) is better in the short term when starting shoulder exercises earlier compared to later. The evidence suggests that progressive resistance exercise therapy does not increase the risk of developing lymphoedema, provided that symptoms are closely monitored and adequately treated if they occur. Given the degree of heterogeneity encountered, limited precision, and the risk of bias across the included studies, the results of this review should be interpreted with caution. | The evidence is current to May 2013. Ten studies were included: four studies used manual lymph drainage with usual care, or combined with exercise or compression versus usual care or education alone (395 participants); three studies examined early versus late start of postoperative shoulder exercises (378 people); two studies used either progressive resistance exercise or restricted activity (358 people); and one study investigated a physiotherapy care plan versus no physiotherapy (65 people). The duration of patient follow-up ranged from two days to two years after the intervention. No firm conclusion can be drawn about the effect of manual lymph drainage in addition to exercise and education on preventing the incidence of lymphoedema. This is because the two included studies found contradicting results. In addition, no firm conclusion can be drawn about manual lymph drainage in combination with other interventions, because only two studies were found that each tested different combinations. One of these studies found that manual lymph drainage combined with exercise lowered the risk of lymphoedema. The other study combined manual lymph drainage with compression, but this study was too small to draw conclusions. Arm mobility (i.e. reaching upwards over the head) was better after manual lymph drainage than without it, but this improvement lasted only for the first few weeks after breast cancer surgery. When assessing whether early or late shoulder exercises reduced the likelihood of developing lymphoedema, the studies did not provide a clear result. The likely incidence of lymphoedema ranged from 5% to 27% (early start) compared to 4% to 20% (for delayed start) during the first 6 to 12 months after surgery. Starting shoulder exercises immediately after surgery may improve shoulder mobility in the first month, compared to starting after the first week but no firm conclusions can be drawn and mobility is comparable later on. Progressive resistance training did not increase the risk of developing lymphoedema compared to restricted activity, on the basis that symptoms were monitored and treated immediately if they occurred. For all investigated interventions, no firm conclusion can be drawn about their effectiveness in reducing pain or improving quality of life. The evidence was considered to be low quality, except for the evidence on resistance training, which was of moderate quality. This was because many studies had shortcomings in how they were conducted; there were only a small number of studies for each intervention; the results differed between comparable studies; and the groups studied were relatively small. | 10.1002/14651858.CD009765.pub2 | [
"The evidence is current to May 2013. Ten studies were included: four studies used manual lymph drainage with usual care, or combined with exercise or compression versus usual care or education alone (395 participants); three studies examined early versus late start of postoperative shoulder exercises (378 people); two studies used either progressive resistance exercise or restricted activity (358 people); and one study investigated a physiotherapy care plan versus no physiotherapy (65 people). The duration of patient follow-up ranged from two days to two years after the intervention. No firm conclusion can be drawn about the effect of manual lymph drainage in addition to exercise and education on preventing the incidence of lymphoedema. This is because the two included studies found contradicting results. In addition, no firm conclusion can be drawn about manual lymph drainage in combination with other interventions, because only two studies were found that each tested different combinations. One of these studies found that manual lymph drainage combined with exercise lowered the risk of lymphoedema. The other study combined manual lymph drainage with compression, but this study was too small to draw conclusions. Arm mobility (i.e. reaching upwards over the head) was better after manual lymph drainage than without it, but this improvement lasted only for the first few weeks after breast cancer surgery. When assessing whether early or late shoulder exercises reduced the likelihood of developing lymphoedema, the studies did not provide a clear result. The likely incidence of lymphoedema ranged from 5% to 27% (early start) compared to 4% to 20% (for delayed start) during the first 6 to 12 months after surgery. Starting shoulder exercises immediately after surgery may improve shoulder mobility in the first month, compared to starting after the first week but no firm conclusions can be drawn and mobility is comparable later on. Progressive resistance training did not increase the risk of developing lymphoedema compared to restricted activity, on the basis that symptoms were monitored and treated immediately if they occurred. For all investigated interventions, no firm conclusion can be drawn about their effectiveness in reducing pain or improving quality of life. The evidence was considered to be low quality, except for the evidence on resistance training, which was of moderate quality. This was because many studies had shortcomings in how they were conducted; there were only a small number of studies for each intervention; the results differed between comparable studies; and the groups studied were relatively small."
]
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cochrane-simplification-train-1434 | cochrane-simplification-train-1434 | Eighteen RCTs (14 dihydropyridines, 4 non-dihydropyridines) with a total of 141,807 participants were included. All-cause mortality was not different between first-line CCBs and any other first-line antihypertensive classes. CCBs reduced the following outcomes as compared to β-blockers: total cardiovascular events (RR 0.84, 95% CI [0.77, 0.92]), stroke (RR 0.77, 95% CI [0.67, 0.88]) and cardiovascular mortality (RR 0.90, 95% CI [0.81, 0.99]). CCBs increased total cardiovascular events (RR 1.05 , 95% CI [1.00, 1.09], p = 0.03) and congestive heart failure events (RR 1.37, 95% CI [1.25, 1.51]) as compared to diuretics. CCBs reduced stroke (RR 0.89, 95% CI [0.80, 0.98]) as compared to ACE inhibitors and reduced stroke (RR 0.85, 95% CI [0.73, 0.99]) and MI (RR 0.83, 95% CI [0.72, 0.96]) as compared to ARBs. CCBs also increased congestive heart failure events as compared to ACE inhibitors (RR 1.16, 95% CI [1.06, 1.27]) and ARBs (RR 1.20, 95% CI [1.06, 1.36]). The other evaluated outcomes were not significantly different. Diuretics are preferred first-line over CCBs to optimize reduction of cardiovascular events. The review does not distinguish between CCBs, ACE inhibitors or ARBs, but does provide evidence supporting the use of CCBs over β-blockers. Many of the differences found in the current review are not robust and further trials might change the conclusions. More well-designed RCTs studying the mortality and morbidity of patients taking CCBs as compared with other antihypertensive drug classes are needed for patients with different stages of hypertension, different ages, and with different co-morbidities such as diabetes. | We found 18 trials in 141,807 participants to answer the question. All-cause mortality was not different between CCBs and any other antihypertensive drug classes. Diuretics were found to be better at reducing total cardiovascular events than CCBs and CCBs were found to be better at reducing total cardiovascular events than β-blockers. This information will be helpful for health professionals and patients to assist them in choosing the best drug for initial treatment of hypertension. | 10.1002/14651858.CD003654.pub4 | [
"We found 18 trials in 141,807 participants to answer the question. All-cause mortality was not different between CCBs and any other antihypertensive drug classes. Diuretics were found to be better at reducing total cardiovascular events than CCBs and CCBs were found to be better at reducing total cardiovascular events than β-blockers. This information will be helpful for health professionals and patients to assist them in choosing the best drug for initial treatment of hypertension."
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cochrane-simplification-train-1435 | cochrane-simplification-train-1435 | One-hundred and eight trials (18 placebo-controlled and 90 before-and-after) evaluated the dose-related efficacy of rosuvastatin in 19,596 participants. Rosuvastatin 10 to 40 mg/day caused LDL-cholesterol decreases of 46% to 55%, when all the trials were combined using the generic inverse variance method. The quality of evidence for these effects is high. Log dose-response data over doses of 1 to 80 mg, revealed strong linear dose-related effects on blood total cholesterol, LDL-cholesterol and non-HDL-cholesterol. When compared to atorvastatin, rosuvastatin was about three-fold more potent at reducing LDL-cholesterol. There was no dose-related effect of rosuvastatin on blood HDL-cholesterol, but overall, rosuvastatin increased HDL by 7%. There is a high risk of bias for the trials in this review, which would affect WDAEs, but unlikely to affect the lipid measurements. WDAEs were not statistically different between rosuvastatin and placebo in 10 of 18 of these short-term trials (risk ratio 0.84; 95% confidence interval 0.48 to 1.47). The total blood total cholesterol, LDL-cholesterol and non-HDL-cholesterol-lowering effect of rosuvastatin was linearly dependent on dose. Rosuvastatin log dose-response data were linear over the commonly prescribed dose range. Based on an informal comparison with atorvastatin, this represents a three-fold greater potency. This review did not provide a good estimate of the incidence of harms associated with rosuvastatin because of the short duration of the trials and the lack of reporting of adverse effects in 44% of the placebo-controlled trials. | We searched for all the trial evidence from trials of three to 12 week duration reporting the effect of rosuvastatin on cholesterol. We found 108 trials involving 19,596 participants. Based on an informal comparison with atorvastatin three-fold lower doses of rosuvastatin are needed to lower cholesterol by the same amount. This review cannot be used to assess harms of rosuvastatin, because of the short duration of these trials and the high risk of bias for this outcome; adverse effects were only reported in 10 of the 18 trials that could be used to assess harms. | 10.1002/14651858.CD010254.pub2 | [
"We searched for all the trial evidence from trials of three to 12 week duration reporting the effect of rosuvastatin on cholesterol. We found 108 trials involving 19,596 participants. Based on an informal comparison with atorvastatin three-fold lower doses of rosuvastatin are needed to lower cholesterol by the same amount. This review cannot be used to assess harms of rosuvastatin, because of the short duration of these trials and the high risk of bias for this outcome; adverse effects were only reported in 10 of the 18 trials that could be used to assess harms."
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cochrane-simplification-train-1436 | cochrane-simplification-train-1436 | We included four studies involving 644 pregnant women. Three studies were randomised controlled trials and one trial was a quasi-randomised study. A higher dose of oxytocin was associated with a significant reduction in length of labour reported from one trial (mean difference (MD) -3.50 hours; 95% confidence interval (CI) -6.38 to -0.62; one trial, 40 women). There was a decrease in the rate of caesarean section (risk ratio (RR) 0.62; 95% CI 0.44 to 0.86 four trials, 644 women) and an increase in the rate of spontaneous vaginal birth in the high-dose group (RR 1.35; 95% CI 1.13 to 1.62, three trials, 444 women), although for both of these outcomes there were inconsistencies between studies in the size of effect. When we carried out sensitivity analysis (temporarily removing a study at high risk of bias) the differences between groups were no longer statistically significant There were no significant differences between high- and low-dose regimens for instrumental vaginal birth, epidural analgesia, hyperstimulation, postpartum haemorrhage, chorioamnionitis or women's perceptions of experiences. For neonatal outcomes, there was no significant difference between groups for Apgar scores, umbilical cord pH, admission to special care baby unit, or neonatal mortality. The following outcomes were not evaluated in the included studies: perinatal mortality, uterine rupture, abnormal cardiotocography, women's pyrexia, dystocia and neonatal neurological morbidity. Higher-dose regimens of oxytocin (4 mU per minute or more) were associated with a reduction in the length of labour and in caesarean section, and an increase in spontaneous vaginal birth. However, there is insufficient evidence to recommend that high-dose regimens are advised routinely for women with delay in the first stage of labour. Further research should evaluate the effect of high-dose regimens of oxytocin for women delayed in labour and should include maternal and neonatal outcomes as well as the effects on women. | From the four randomised controlled trials involving 644 pregnant women that we included in this review, results indicate that a higher dose of oxytocin (4-7 mU per minute, compared with 1-2 mU per minute) reduced the length of labour and the rate of caesarean sections with increased spontaneous vaginal births, but the studies did not provide enough evidence on possible differences between the high- and low-dose regimens on adverse events including hyperstimulation of the uterus, and outcomes for the newborn infant. Only one trial reported on the possible effect on women. The overall quality of the included trials was mixed, but this might reflect how clinical trials were reported in the past. While the current evidence is promising and suggests that the high-dose regimens reduce the length of labour and the rate of caesarean sections, this evidence is not strong enough to recommend that high-dose regimens are used routinely for women delayed in labour. We recommend that further research is carried out. | 10.1002/14651858.CD007201.pub3 | [
"From the four randomised controlled trials involving 644 pregnant women that we included in this review, results indicate that a higher dose of oxytocin (4-7 mU per minute, compared with 1-2 mU per minute) reduced the length of labour and the rate of caesarean sections with increased spontaneous vaginal births, but the studies did not provide enough evidence on possible differences between the high- and low-dose regimens on adverse events including hyperstimulation of the uterus, and outcomes for the newborn infant. Only one trial reported on the possible effect on women. The overall quality of the included trials was mixed, but this might reflect how clinical trials were reported in the past. While the current evidence is promising and suggests that the high-dose regimens reduce the length of labour and the rate of caesarean sections, this evidence is not strong enough to recommend that high-dose regimens are used routinely for women delayed in labour. We recommend that further research is carried out."
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cochrane-simplification-train-1437 | cochrane-simplification-train-1437 | Despite extensive searching we found no randomised trials suitable for inclusion. Based on the available evidence a meaningful conclusion cannot be reached. The term "single brain metastasis" is used to describe a brain metastasis found in patients presenting with an inoperable lung cancer or from an uncontrolled primary tumour some time after diagnosis, and the term "solitary brain metastasis" is used when the brain metastasis is diagnosed some time after radical, potentially curative treatment. In the evaluated studies, we found that the criteria for the definition of solitary brain metastasis were not consistent. Some series combined patients with single and solitary brain metastasis. Some of the single arm or cohort studies came from single institutions where the availability of both techniques (radiosurgery and surgery) was not described. Therefore, it is possible that the most accessible technique might be used preferentially, reinforced by a general belief that the techniques are equivalent. This has prevented an appropriate treatment comparison, which should be made through a well designed phase III clinical trial. | This review set out to compare both techniques. Our literature search has shown that a well-designed randomised trial comparing surgery and radiosurgery for patients with solitary brain metastasis has never been performed. Therefore, this review has been unable to show any advantage of one treatment over the other for this group of patients. | 10.1002/14651858.CD004840.pub2 | [
"This review set out to compare both techniques. Our literature search has shown that a well-designed randomised trial comparing surgery and radiosurgery for patients with solitary brain metastasis has never been performed. Therefore, this review has been unable to show any advantage of one treatment over the other for this group of patients."
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cochrane-simplification-train-1438 | cochrane-simplification-train-1438 | We included five studies with 1601 children in the review. Pooled analysis demonstrated that the following outcomes were comparable between the two groups: clinical cure at the end of therapy (RR 1.03, 95% CI 0.99 to 1.07); during therapy (RR 1.06, 95% CI 0.85 to 1.33) and at follow-up (RR 1.02, 95% CI 0.95 to 1.09); recurrent AOM (RR 1.21, 95% CI 0.52 to 2.81); compliance rate (RR 1.04, 95% CI 0.98 to 1.10) and overall adverse events (RR 0.92, 95% CI 0.52 to 1.63). When we performed subgroup analysis separately for trials with amoxicillin only and amoxicillin/clavulanate only, it showed that all important outcomes were comparable between once or twice daily groups and the three times daily group. The risk of bias amongst the five included studies was as follows: for random sequence generation we graded two studies as low and three unclear risk of bias; for allocation concealment all studies were at unclear risk of bias; for blinding (performance and detection bias) we graded four as high and one as unclear risk of bias; for incomplete outcome data (attrition bias) we graded two low, two high and one as unclear risk of bias; for reporting bias four were at low and one at high risk; and for ‘other’ bias four were at low and one at unclear risk of bias. This review showed that the results of using once or twice daily doses of amoxicillin, with or without clavulanate, were comparable with three doses for the treatment of AOM. | We identified five randomised clinical studies with 1601 children comparing two dosing schedules. Participants were aged 12 years or younger with AOM. The primary outcome was clinical cure rate in terms of resolution of otalgia and fever at the end of antibiotic therapy (days seven to 15). The secondary outcomes were clinical cure rate in terms of middle ear effusion during therapy, clinical cure rate post-treatment (one to three months) in terms of resolution of middle ear infection, AOM complications and adverse events to medication. The results showed that treating acute middle ear infection with either once/twice daily or three times daily amoxicillin, with or without clavulanate, has the same results using our outcome measures, including adverse events such as diarrhoea and skin reactions. The evidence is current to March 2013. | 10.1002/14651858.CD004975.pub3 | [
"We identified five randomised clinical studies with 1601 children comparing two dosing schedules. Participants were aged 12 years or younger with AOM. The primary outcome was clinical cure rate in terms of resolution of otalgia and fever at the end of antibiotic therapy (days seven to 15). The secondary outcomes were clinical cure rate in terms of middle ear effusion during therapy, clinical cure rate post-treatment (one to three months) in terms of resolution of middle ear infection, AOM complications and adverse events to medication. The results showed that treating acute middle ear infection with either once/twice daily or three times daily amoxicillin, with or without clavulanate, has the same results using our outcome measures, including adverse events such as diarrhoea and skin reactions. The evidence is current to March 2013."
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cochrane-simplification-train-1439 | cochrane-simplification-train-1439 | We included 15 trials involving a total of 3911 women and infant pairs. We judged the trials to have an overall moderate risk of bias. Maternal outcomes: No studies in this review reported on maternal death or on severe maternal morbidity. There were no significant differences between early versus late cord clamping groups for the primary outcome of severe postpartum haemorrhage (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.65 to 1.65; five trials with data for 2066 women with a late clamping event rate (LCER) of ˜3.5%, I2 0%) or for postpartum haemorrhage of 500 mL or more (RR 1.17 95% CI 0.94 to 1.44; five trials, 2260 women with a LCER of ˜12%, I2 0%). There were no significant differences between subgroups depending on the use of uterotonic drugs. Mean blood loss was reported in only two trials with data for 1345 women, with no significant differences seen between groups; or for maternal haemoglobin values (mean difference (MD) -0.12 g/dL; 95% CI -0.30 to 0.06, I2 0%) at 24 to 72 hours after the birth in three trials. Neonatal outcomes: There were no significant differences between early and late clamping for the primary outcome of neonatal mortality (RR 0.37, 95% CI 0.04 to 3.41, two trials, 381 infants with a LCER of ˜1%), or for most other neonatal morbidity outcomes, such as Apgar score less than seven at five minutes or admission to the special care nursery or neonatal intensive care unit. Mean birthweight was significantly higher in the late, compared with early, cord clamping (101 g increase 95% CI 45 to 157, random-effects model, 12 trials, 3139 infants, I2 62%). Fewer infants in the early cord clamping group required phototherapy for jaundice than in the late cord clamping group (RR 0.62, 95% CI 0.41 to 0.96, data from seven trials, 2324 infants with a LCER of 4.36%, I2 0%). Haemoglobin concentration in infants at 24 to 48 hours was significantly lower in the early cord clamping group (MD -1.49 g/dL, 95% CI -1.78 to -1.21; 884 infants, I2 59%). This difference in haemoglobin concentration was not seen at subsequent assessments. However, improvement in iron stores appeared to persist, with infants in the early cord clamping over twice as likely to be iron deficient at three to six months compared with infants whose cord clamping was delayed (RR 2.65 95% CI 1.04 to 6.73, five trials, 1152 infants, I2 82%). In the only trial to report longer-term neurodevelopmental outcomes so far, no overall differences between early and late clamping were seen for Ages and Stages Questionnaire scores. A more liberal approach to delaying clamping of the umbilical cord in healthy term infants appears to be warranted, particularly in light of growing evidence that delayed cord clamping increases early haemoglobin concentrations and iron stores in infants. Delayed cord clamping is likely to be beneficial as long as access to treatment for jaundice requiring phototherapy is available. | Although early cord clamping has been thought to reduce the risk of bleeding after birth (postpartum haemorrhage), this review of 15 randomised trials involving a total of 3911 women and infant pairs showed no significant difference in postpartum haemorrhage rates when early and late cord clamping (generally between one and three minutes) were compared. There were, however, some potentially important advantages of delayed cord clamping in healthy term infants, such as higher birthweight, early haemoglobin concentration, and increased iron reserves up to six months after birth. These need to be balanced against a small additional risk of jaundice in newborns that requires phototherapy. | 10.1002/14651858.CD004074.pub3 | [
"Although early cord clamping has been thought to reduce the risk of bleeding after birth (postpartum haemorrhage), this review of 15 randomised trials involving a total of 3911 women and infant pairs showed no significant difference in postpartum haemorrhage rates when early and late cord clamping (generally between one and three minutes) were compared. There were, however, some potentially important advantages of delayed cord clamping in healthy term infants, such as higher birthweight, early haemoglobin concentration, and increased iron reserves up to six months after birth. These need to be balanced against a small additional risk of jaundice in newborns that requires phototherapy."
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cochrane-simplification-train-1440 | cochrane-simplification-train-1440 | We included nine RCTs involving 3253 nursing home residents in this review; seven of these trials used cluster randomisation. The mean resident age ranged from 78 to 86 years across studies, and most participants were women (more than 66% in all studies). The proportion of residents with dental protheses ranged from 62% to 87%, and the proportion of edentulous residents ranged from 32% to 90% across studies. Eight studies compared educational interventions with information and practical components versus (optimised) usual care, while the ninth study compared educational interventions with information only versus usual care. All interventions included educational sessions on oral health for nursing staff (five trials) or for both staff and residents (four trials), and used more than one active component. Follow-up of included studies ranged from three months to five years. No study showed overall low risk of bias. Four studies had a high risk of bias, and the other five studies were at unclear risk of bias. None of the trials assessed our predefined primary outcomes 'oral health' and 'oral health-related quality of life'. All trials assessed our third primary outcome, 'dental or denture plaque'. Meta-analyses showed no evidence of a difference between interventions and usual care for dental plaque (mean difference -0.04, 95% confidence interval (CI) -0.26 to 0.17; six trials; 437 participants; low quality evidence) or denture plaque (standardised mean difference -0.60, 95% CI -1.25 to 0.05; five trials; 816 participants; low quality evidence). None of the studies assessed adverse events of the intervention. We found insufficient evidence to draw robust conclusions about the effects of oral health educational interventions for nursing home staff and residents. We did not find evidence of meaningful effects of educational interventions on any measure of residents' oral health; however, the quality of the available evidence is low. More adequately powered and high-quality studies using relevant outcome measures are needed. | We searched for relevant studies that had been conducted up until January 2016 and identified nine trials involving a total of 3253 nursing home residents. The average age of residents across the studies ranged from 78 to 86 years. In all of the studies most of the people taking part had dentures (between 62% and 87%). The trials evaluated a variety of approaches including educational programmes, skills training, and written information material. Topics included dental issues that were particularly relevant for older people such as care of dentures and covered dental and oral diseases, prevention of oral diseases, dental hygiene tools, and oral health care guidelines. The length of the trials ranged from three months to five years. We could not identify a clear benefit of training of nurses and/or residents on residents' dental health as assessed by dental and denture plaque. No study assessed oral health, oral health-related quality of life or adverse events. As education programmes were not fully described, results do not allow for clear conclusions about the effectiveness or potential harm of specific oral health education interventions in nursing homes. Overall, there was a low quality of information from the studies regarding all of the results. We conclude that there is a need for clinical trials to investigate the advantages and harms of oral health educational programmes in nursing homes. | 10.1002/14651858.CD010535.pub2 | [
"We searched for relevant studies that had been conducted up until January 2016 and identified nine trials involving a total of 3253 nursing home residents. The average age of residents across the studies ranged from 78 to 86 years. In all of the studies most of the people taking part had dentures (between 62% and 87%). The trials evaluated a variety of approaches including educational programmes, skills training, and written information material. Topics included dental issues that were particularly relevant for older people such as care of dentures and covered dental and oral diseases, prevention of oral diseases, dental hygiene tools, and oral health care guidelines. The length of the trials ranged from three months to five years. We could not identify a clear benefit of training of nurses and/or residents on residents' dental health as assessed by dental and denture plaque. No study assessed oral health, oral health-related quality of life or adverse events. As education programmes were not fully described, results do not allow for clear conclusions about the effectiveness or potential harm of specific oral health education interventions in nursing homes. Overall, there was a low quality of information from the studies regarding all of the results. We conclude that there is a need for clinical trials to investigate the advantages and harms of oral health educational programmes in nursing homes."
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cochrane-simplification-train-1441 | cochrane-simplification-train-1441 | Five studies met the criteria for inclusion in the review. Two of these were multi-intervention studies where the dietary intervention was one component of a wider programme of prevention, but where data on dietary behaviour change were reported. One of the single intervention studies was concerned with dental caries prevention. The other two concerned general health outcomes. There were no studies concerned with dietary change aimed at preventing tooth erosion. In four out of the five included studies a significant change in dietary behaviour was found for at least one of the primary outcome variables. There is some evidence that one-to-one dietary interventions in the dental setting can change behaviour, although the evidence is greater for interventions aiming to change fruit/vegetable and alcohol consumption than for those aiming to change dietary sugar consumption. There is a need for more studies, particularly in the dental practice setting, as well as greater methodological rigour in the design, statistical analysis and reporting of such studies. | We identified five studies. Two of these were concerned with diet advice given concerning general health (one was about alcohol and one was about fruit and vegetable consumption). In both these studies there was a change to healthier behaviour following the advice. We also identified three studies which attempted to change sugar consumption habits in order to reduce dental decay. However, in two out of these three studies there were also other types and forms of advice given at the same time, for example about toothbrushing. It was therefore impossible to say whether changes in diet came about because of the diet advice given or because they were subtly influenced by the other messages. For example: advice on toothbrushing might make patients more aware of their oral health resulting in changes to their diet. Most of the studies concerning sugar consumption are of relatively weak quality. The evidence for dietary advice aiming to change sugar consumption is poor. Further studies in this area should be considered. | 10.1002/14651858.CD006540.pub2 | [
"We identified five studies. Two of these were concerned with diet advice given concerning general health (one was about alcohol and one was about fruit and vegetable consumption). In both these studies there was a change to healthier behaviour following the advice. We also identified three studies which attempted to change sugar consumption habits in order to reduce dental decay. However, in two out of these three studies there were also other types and forms of advice given at the same time, for example about toothbrushing. It was therefore impossible to say whether changes in diet came about because of the diet advice given or because they were subtly influenced by the other messages. For example: advice on toothbrushing might make patients more aware of their oral health resulting in changes to their diet. Most of the studies concerning sugar consumption are of relatively weak quality. The evidence for dietary advice aiming to change sugar consumption is poor. Further studies in this area should be considered."
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cochrane-simplification-train-1442 | cochrane-simplification-train-1442 | Two trials randomised in total 106 patients to piggy-back method (n = 53) versus conventional method with veno-venous bypass (n = 53). Both trials were at high risk of bias. There was no significant difference in post-operative mortality, primary graft non-function, vascular complications, renal failure, transfusion requirements, intensive therapy unit (ITU) stay, or hospital stay between the two groups. The warm ischaemic time was significantly shorter in the piggy-back method than the conventional method (MD -11.50 minutes; 95% CI -19.35 to -3.65; P < 0.01). The proportion of patients who developed chest complications were significantly higher in the the piggy-back method than the conventional method (75.8% versus 44.1%; P = 0.01). One trial randomised 80 patients to piggy-back with porto-caval bypass (n = 40) versus piggy-back without porto-caval bypass (n = 40). This trial was at high risk of bias. There was no significant difference in post-operative mortality, re-transplantation due to primary graft non-function, vascular complications, renal failure, or hospital stay between the two groups. Fewer patients required blood transfusion in the piggy-back with porto-caval bypass group (55%) than the piggy-back without porto-caval bypass group (75%) (P = 0.02). There was no significant difference in the mean amount of blood transfused between the groups (MD -1.00 unit; 95% CI -2.19 to 0.19; P = 0.10). The ITU stay was significantly shorter in the piggy-back with porto-caval bypass group (2.9 days) than the piggy-back without porto-caval bypass group (4.9 days; MD -2.00 days; 95% CI -3.82 to -0.18; P = 0.03). There were no trials comparing piggy-back method with conventional method without veno-venous bypass or different techniques of piggy-back method. There is currently no evidence to recommend or refute the use of piggy-back method of liver transplantation. | We systematically searched various medical databases to determine how the piggy-back method compares with the standard method of liver transplantation or with different piggy-back techniques. Two clinical trials randomised 106 patients to the piggy-back method (53 patients) versus the standard method (53 patients). Both trials were at high risk of systematic errors. There was no significant difference in post-operative death, primary graft non-function (the liver graft does not start functioning at all), complications related to the blood vessels, kidney failure, blood transfusion requirements, intensive therapy unit (ITU) stay, or hospital stay between the two groups. The proportion of patients who developed chest complications were significantly higher with the piggy-back method than with the conventional method (76% in piggy-back method versus 44% in conventional method; statistically significant). One trial randomised 80 patients to a variant of piggy-back (in which blood from the intestines is temporarily diverted; 40 patients) versus standard piggy-back method (in which blood from the intestines is blocked; 40 patients). This trial was at high risk of systematic error. There was no significant difference in post-operative death, re-transplantation due to primary graft non-function (liver graft does not start functioning at all), vascular complications, kidney failure, or hospital stay between the two groups. Significantly fewer patients required blood transfusion with the variant piggy-back method (55%) than with the standard piggy-back method (75%). The ITU stay was significantly shorter in the variant (2.9 days) than with the standard piggy-back method (4.9 days). There were no trials comparing piggy-back method and standard method of liver transplantation without diversion of venous blood or different techniques of piggy-back method. We conclude that there is currently no evidence to recommend or refute the use of piggy-back method of liver transplantation. | 10.1002/14651858.CD008258.pub2 | [
"We systematically searched various medical databases to determine how the piggy-back method compares with the standard method of liver transplantation or with different piggy-back techniques. Two clinical trials randomised 106 patients to the piggy-back method (53 patients) versus the standard method (53 patients). Both trials were at high risk of systematic errors. There was no significant difference in post-operative death, primary graft non-function (the liver graft does not start functioning at all), complications related to the blood vessels, kidney failure, blood transfusion requirements, intensive therapy unit (ITU) stay, or hospital stay between the two groups. The proportion of patients who developed chest complications were significantly higher with the piggy-back method than with the conventional method (76% in piggy-back method versus 44% in conventional method; statistically significant). One trial randomised 80 patients to a variant of piggy-back (in which blood from the intestines is temporarily diverted; 40 patients) versus standard piggy-back method (in which blood from the intestines is blocked; 40 patients). This trial was at high risk of systematic error. There was no significant difference in post-operative death, re-transplantation due to primary graft non-function (liver graft does not start functioning at all), vascular complications, kidney failure, or hospital stay between the two groups. Significantly fewer patients required blood transfusion with the variant piggy-back method (55%) than with the standard piggy-back method (75%). The ITU stay was significantly shorter in the variant (2.9 days) than with the standard piggy-back method (4.9 days). There were no trials comparing piggy-back method and standard method of liver transplantation without diversion of venous blood or different techniques of piggy-back method. We conclude that there is currently no evidence to recommend or refute the use of piggy-back method of liver transplantation."
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cochrane-simplification-train-1443 | cochrane-simplification-train-1443 | Eleven suitable trials that tested vigabatrin doses between 1000 mg and 6000 mg were identified and included in the analysis. There were 982 observations on 747 patients in the primary ITT analysis of treatment efficacy. Patients treated with vigabatrin were significantly more likely to obtain a 50% or greater reduction in seizure frequency compared with those treated with placebo (RR 2.58, 95% CI 1.87 to 3.57). Those treated with vigabatrin were also significantly more likely to have treatment withdrawn (RR 2.49, 95% CI 1.05 to 5.88), and were more likely to experience a number of side effects, significantly so for fatigue or drowsiness. There was some evidence of small study effect bias, with smaller studies tending to report greater estimates of RR than larger studies. It is possible, therefore, that the actual RR of obtaining 50% reduction in seizure frequency is less than that obtained by a meta-analysis of fully published studies. This review of randomised controlled trials showed that vigabatrin can reduce seizure frequency in people with drug-resistant partial epilepsy. Short-term follow-up of patients showed that some side effects were associated with its use. Further analysis of longer-term observational studies is required to evaluate how likely patients are to develop visual field defects and whether such side effects are associated with dose and duration of drug use. | These results were obtained from short-term randomised controlled trials. However, it should be noted that information that is not reported in this review, from longer-term follow-up studies of people using vigabatrin, has shown that its use is frequently associated with visual field defects which may go undetected. | 10.1002/14651858.CD007302.pub2 | [
"These results were obtained from short-term randomised controlled trials. However, it should be noted that information that is not reported in this review, from longer-term follow-up studies of people using vigabatrin, has shown that its use is frequently associated with visual field defects which may go undetected."
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cochrane-simplification-train-1444 | cochrane-simplification-train-1444 | Ten studies (440 subfertile couples) were included. Results of the meta-analysis demonstrated no difference in outcome measures and adverse events in the routine use of adjuvant growth hormone in in-vitro fertilisation protocols. However, meta-analysis demonstrated a statistically significant difference in both live birth rates and pregnancy rates favouring the use of adjuvant growth hormone in in-vitro fertilisation protocols in women who are considered poor responders without increasing adverse events, OR 5.39, 95% CI 1.89 to 15.35 and OR 3.28, 95% CI 1.74 to 6.20 respectively. Although the use of growth hormone in poor responders has been found to show a significant improvement in live birth rates, we were unable to identify which sub-group of poor responders would benefit the most from adjuvant growth hormone. The result needs to be interpreted with caution, the included trials were few in number and small sample size. Therefore, before recommending growth hormone adjuvant in in-vitro fertilisation further research is necessary to fully define its role. | The review of trials found no evidence that growth hormone helps improve birth rates in women who are undergoing ovulation induction prior to in-vitro fertilisation. However there is some evidence of increased pregnancy and birth rates in women who are considered 'poor responders' to in-vitro fertilisation. More research is needed. | 10.1002/14651858.CD000099.pub3 | [
"The review of trials found no evidence that growth hormone helps improve birth rates in women who are undergoing ovulation induction prior to in-vitro fertilisation. However there is some evidence of increased pregnancy and birth rates in women who are considered 'poor responders' to in-vitro fertilisation. More research is needed."
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cochrane-simplification-train-1445 | cochrane-simplification-train-1445 | A total of 55 trials were included for one or more outcomes for this review. In duodenal ulcer healing, eradication therapy was superior to ulcer healing drug (UHD) (34 trials, 3910 participants, RR of ulcer persisting = 0.66, 95% confidence interval (CI) 0.58 to 0.76; 381/2286 (adjusted proportion: 12.4%) in eradication therapy plus UHD versus 304/1624 (18.7%) in UHD; low quality evidence) and no treatment (two trials, 207 participants, RR 0.37, 95% CI 0.26 to 0.53; 30/125 (adjusted proportion: 21.7%) in eradication therapy versus 48/82 (58.5%) in no treatment; low quality evidence). In gastric ulcer healing, the differences were imprecise between eradication therapy and UHD (15 trials, 1974 participants, RR 1.23, 95% CI 0.90 to 1.68; 220/1192 (adjusted proportion: 16.0%) in eradication therapy plus UHD versus 102/782 (13.0%) in UHD; very low quality evidence). In preventing duodenal ulcer recurrence the differences were imprecise between maintenance therapy with H.pylori eradication therapy and maintenance therapy with UHD (four trials, 319 participants, RR of ulcer recurring 0.73; 95% CI 0.42 to 1.25; 19/159 (adjusted proportion: 11.9%) in eradication therapy versus 26/160 (16.3%) in UHD; very low quality evidence), but eradication therapy was superior to no treatment (27 trials 2509 participants, RR 0.20, 95% CI 0.15 to 0.26; 215/1501 (adjusted proportion: 12.9%) in eradication therapy versus 649/1008 (64.4%) in no treatment; very low quality evidence). In preventing gastric ulcer recurrence, eradication therapy was superior to no treatment (12 trials, 1476 participants, RR 0.31, 95% CI 0.22 to 0.45; 116/697 (adjusted proportion: 16.3%) in eradication therapy versus 356/679 (52.4%) in no treatment; very low quality evidence). None of the trials reported proportion of people with gastric ulcer not healed after initial therapy between H.pylori eradication therapy and no active treatment or the proportion of people with recurrent gastric ulcer or peptic ulcers during maintenance therapy between H.pylori eradication therapy and ulcer healing drug therapy. Adding a one to two-week course of H. pylori eradication therapy is an effective treatment for people with H. pylori-positive duodenal ulcer when compared to ulcer healing drugs alone and no treatment. H. pylori eradication therapy is also effective in preventing recurrence of duodenal and gastric ulcer compared to no treatment. There is currently no evidence that H. pylori eradication therapy is an effective treatment in people with gastric ulcer or that it is effective in preventing recurrence of duodenal ulcer compared to ulcer healing drug. However, confidence intervals were wide and significant benefits or harms of H. pylori eradication therapy in acute ulcer healing of gastric ulcers compared to no treatment, and in preventing recurrence of duodenal ulcers compared to ulcer healing drugs cannot be ruled out. | Fifty-five studies provided information for the review. Thirty-four studies compared H. pylori eradication therapy plus ulcer-healing drug against ulcer-healing drug alone in the healing of duodenal ulcer. Two studies compared H. pylori eradication therapy against no treatment in the healing of duodenal ulcer. Fifteen studies compared H. pylori eradication therapy plus ulcer-healing drug against ulcer-healing drug alone in the healing of gastric ulcer. Three studies compared H. pylori eradication therapy plus ulcer-healing drug against ulcer-healing drug alone in the healing of peptic ulcer (gastric or duodenal ulcer). One study compared H. pylori eradication therapy against no treatment in the healing of peptic ulcer (gastric or duodenal ulcer). Four studies compared H. pylori eradication therapy against ulcer-healing drug in preventing the recurrence of duodenal ulcer after initial ulcer had been healed. Twenty-seven studies compared H. pylori eradication therapy against no treatment in preventing the recurrence of duodenal ulcer after initial ulcer had been healed. Twelve studies compared H. pylori eradication therapy against no treatment in preventing the recurrence of gastric ulcer after initial ulcer had been healed, while one study compared H. pylori eradication therapy against no treatment in preventing the recurrence of peptic ulcer (gastric or duodenal ulcer) after initial ulcer had been healed. Four studies compared H. pylori eradication therapy plus ulcer-healing drug versus comparison regimen in the relief of symptoms from peptic ulcer (gastric or duodenal ulcer). There were no studies comparing H. pylori eradication therapy against no treatment in the healing of gastric ulcer, H. pylori eradication therapy against ulcer-healing drug as maintenance therapy in preventing the recurrence of gastric ulcer after initial ulcer had been healed, or H. pylori eradication therapy plus ulcer-healing drug against no treatment or ulcer-healing drug in the relief of symptoms in people with peptic ulcer. Some trials provided information for more than one comparison. The evidence is current until March 2016. Adding a one to two-week course of H. pylori eradication therapy speeds up ulcer healing for people with H. pylori-positive duodenal ulcer when compared to ulcer-healing drugs alone and no treatment. H. pylori eradication therapy is also effective in preventing recurrence of duodenal and gastric ulcer (ulcer returning after initial healing) compared to no treatment. There is currently no evidence that H. pylori eradication therapy is an effective treatment in people with gastric ulcer or that it is effective in preventing recurrence of duodenal ulcer compared to ulcer-healing drugs. However, because of the small number of studies included for the last two comparisons, significant benefits or harms of H. pylori eradication therapy in acute ulcer healing of gastric ulcers compared to no treatment and in preventing recurrence of duodenal ulcers compared to ulcer healing drugs cannot be ruled out. The quality of evidence was low or very low because most of the studies had errors in study design. As a result, there is a lot of uncertainty regarding the results. | 10.1002/14651858.CD003840.pub5 | [
"Fifty-five studies provided information for the review. Thirty-four studies compared H. pylori eradication therapy plus ulcer-healing drug against ulcer-healing drug alone in the healing of duodenal ulcer. Two studies compared H. pylori eradication therapy against no treatment in the healing of duodenal ulcer. Fifteen studies compared H. pylori eradication therapy plus ulcer-healing drug against ulcer-healing drug alone in the healing of gastric ulcer. Three studies compared H. pylori eradication therapy plus ulcer-healing drug against ulcer-healing drug alone in the healing of peptic ulcer (gastric or duodenal ulcer). One study compared H. pylori eradication therapy against no treatment in the healing of peptic ulcer (gastric or duodenal ulcer). Four studies compared H. pylori eradication therapy against ulcer-healing drug in preventing the recurrence of duodenal ulcer after initial ulcer had been healed. Twenty-seven studies compared H. pylori eradication therapy against no treatment in preventing the recurrence of duodenal ulcer after initial ulcer had been healed. Twelve studies compared H. pylori eradication therapy against no treatment in preventing the recurrence of gastric ulcer after initial ulcer had been healed, while one study compared H. pylori eradication therapy against no treatment in preventing the recurrence of peptic ulcer (gastric or duodenal ulcer) after initial ulcer had been healed. Four studies compared H. pylori eradication therapy plus ulcer-healing drug versus comparison regimen in the relief of symptoms from peptic ulcer (gastric or duodenal ulcer). There were no studies comparing H. pylori eradication therapy against no treatment in the healing of gastric ulcer, H. pylori eradication therapy against ulcer-healing drug as maintenance therapy in preventing the recurrence of gastric ulcer after initial ulcer had been healed, or H. pylori eradication therapy plus ulcer-healing drug against no treatment or ulcer-healing drug in the relief of symptoms in people with peptic ulcer. Some trials provided information for more than one comparison. The evidence is current until March 2016. Adding a one to two-week course of H. pylori eradication therapy speeds up ulcer healing for people with H. pylori-positive duodenal ulcer when compared to ulcer-healing drugs alone and no treatment. H. pylori eradication therapy is also effective in preventing recurrence of duodenal and gastric ulcer (ulcer returning after initial healing) compared to no treatment. There is currently no evidence that H. pylori eradication therapy is an effective treatment in people with gastric ulcer or that it is effective in preventing recurrence of duodenal ulcer compared to ulcer-healing drugs. However, because of the small number of studies included for the last two comparisons, significant benefits or harms of H. pylori eradication therapy in acute ulcer healing of gastric ulcers compared to no treatment and in preventing recurrence of duodenal ulcers compared to ulcer healing drugs cannot be ruled out. The quality of evidence was low or very low because most of the studies had errors in study design. As a result, there is a lot of uncertainty regarding the results."
]
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cochrane-simplification-train-1446 | cochrane-simplification-train-1446 | We included six RCTs, with a total of 449 patients. In four studies (267 patients) the CL intervention resulted in reduced medical costs (in two studies the outcomes could be pooled: MD -352.55 US Dollars (95% CI -522.32 to -182.78)) and improved physical functioning (three studies, MD 5.71 (95% CI 4.11 to 7.31)). In two studies (182 patients) the intervention was a joint consultation with a psychiatrist in presence of the physician, and resulted in reduced severity of somatization symptoms, reduced medical consumption and improved social functioning. There is limited evidence that a CL is effective in terms of medical costs and improvement of physical functioning for patients with MUPS in primary care. The results are even less pronounced in patients with clinically less severe, but more meaningful, forms of MUPS and the results vary for other patient-related outcomes. All studies, except one, were performed in the United States and therefore the results can not be generalized directly to countries with other healthcare systems. Furthermore all studies were small and of only moderate quality. There is very limited evidence that a joint consultation with the patient by a psychiatrist in the presence of the physician, together with the provision of a CL, reduces severity of somatization symptoms and medical consumption. | In our review we found six studies, with a total of 449 patients, in which one of two interventions were applied. One intervention (four studies, 267 patients) was a CL following a consultation between the patient and the psychiatrist; the other (two studies, 182 patients) was a CL following a joint consultation between patient, psychiatrist and primary care physician. In each case comparison was against care as usual, provided by the primary care physician. The first intervention resulted in reduced medical costs (three studies) and improved physical functioning (three studies). We found evidence for a slight reduction in the severity of the MUPS, reduced medical consumption and improved social functioning following the second intervention, although in only one of two studies assessed. There are serious limitations in generalizability of the results to modern healthcare: most trials reported doctor-related outcomes with patient-related outcomes varying in results; the intervention appears to be far more effective for the most serious but rare disorders, and less so in the more common forms of MUPS; five of the six studies were performed in the United States and four studies before 1995. Furthermore the studied populations were small and five of the six studies were of moderate quality. Our final conclusion is that CLs may be helpful for physicians who treat patients with MUPS (based on the provider-related outcomes). However, until further studies are conducted to find out if the intervention results in improved patient-related outcomes, the overall effectiveness of CLs cannot be demonstrated. | 10.1002/14651858.CD006524.pub2 | [
"In our review we found six studies, with a total of 449 patients, in which one of two interventions were applied. One intervention (four studies, 267 patients) was a CL following a consultation between the patient and the psychiatrist; the other (two studies, 182 patients) was a CL following a joint consultation between patient, psychiatrist and primary care physician. In each case comparison was against care as usual, provided by the primary care physician. The first intervention resulted in reduced medical costs (three studies) and improved physical functioning (three studies). We found evidence for a slight reduction in the severity of the MUPS, reduced medical consumption and improved social functioning following the second intervention, although in only one of two studies assessed. There are serious limitations in generalizability of the results to modern healthcare: most trials reported doctor-related outcomes with patient-related outcomes varying in results; the intervention appears to be far more effective for the most serious but rare disorders, and less so in the more common forms of MUPS; five of the six studies were performed in the United States and four studies before 1995. Furthermore the studied populations were small and five of the six studies were of moderate quality. Our final conclusion is that CLs may be helpful for physicians who treat patients with MUPS (based on the provider-related outcomes). However, until further studies are conducted to find out if the intervention results in improved patient-related outcomes, the overall effectiveness of CLs cannot be demonstrated."
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cochrane-simplification-train-1447 | cochrane-simplification-train-1447 | We included reports for six studies of 656 participants that compared high- and low-intensity exercise programs; five studies exclusively recruited people with symptomatic knee osteoarthritis (620 participants), and one study exclusively recruited people with hip or knee osteoarthritis (36 participants). The majority of the participants were females (70%). No studies evaluated physical activity programs. We found the overall quality of evidence to be low to very low due to concerns about study limitations and imprecision (small number of studies, large confidence intervals) for the major outcomes using the GRADE approach. Most of the studies had an unclear or high risk of bias for several domains, and we judged five of the six studies to be at high risk for performance, detection, and attrition bias. Low-quality evidence indicated reduced pain on a 20-point Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale (mean difference (MD) -0.84, 95% confidence interval (CI) -1.63 to -0.04; 4% absolute reduction, 95% CI -8% to 0%; number needed to treat for an additional beneficial outcome (NNTB) 11, 95% CI 14 to 22) and improved physical function on the 68-point WOMAC disability subscale (MD -2.65, 95% CI -5.29 to -0.01; 4% absolute reduction; NNTB 10, 95% CI 8 to 13) immediately at the end of the exercise programs (from 8 to 24 weeks). However, these results are unlikely to be of clinical importance. These small improvements did not continue at longer-term follow-up (up to 40 weeks after the end of the intervention). We are uncertain of the effect on quality of life, as only one study reported this outcome (0 to 200 scale; MD 4.3, 95% CI -6.5 to 15.2; 2% absolute reduction; very low level of evidence). Our subgroup analyses provided uncertain evidence as to whether increased exercise time (duration, number of sessions) and level of resistance (strength or effort) have an impact on the exercise program effects. Three studies reported withdrawals due to adverse events. The number of dropouts was small. Only one study systematically monitored adverse effects, but four studies reported some adverse effects related to knee pain associated with an exercise program. We are uncertain as to whether high intensity increases the number of adverse effects (Peto odds ratio 1.72, 95% CI 0.51 to 5.81; - 2% absolute risk reduction; very low level of evidence). None of the included studies reported serious adverse events. We found very low-quality to low-quality evidence for no important clinical benefit of high-intensity compared to low-intensity exercise programs in improving pain and physical function in the short term. There was insufficient evidence to determine the effect of different types of intensity of exercise programs. We are uncertain as to whether higher-intensity exercise programs may induce more harmful effects than those of lower intensity; this must be evaluated by further studies. Withdrawals due to adverse events were poorly monitored and not reported systematically in each group. We downgraded the evidence to low or very low because of the risk of bias, inconsistency, and imprecision. The small number of studies comparing high- and low-intensity exercise programs in osteoarthritis underscores the need for more studies investigating the dose–response relationship in exercise programs. In particular, further studies are needed to establish the minimal intensity of exercise programs needed for clinical effect and the highest intensity patients can tolerate. Larger studies should comply with the Consolidated Standards of Reporting Trials (CONSORT) checklist and systematically report harms data to evaluate the potential impact of highest intensities of exercise programs in people with joint damage. | We identified six randomized controlled trails with 656 participants. Five studies (620 participants) enrolled people with knee osteoarthritis, and one study (36 participants) enrolled people with knee or hip osteoarthritis. The studies included more women (70%) than men. On a scale of 0 to 20 points (lower scores mean reduced pain), people who completed a high-intensity exercise program rated their pain 0.84 points lower (4% absolute improvement) than people who completed a low-intensity exercise program. People who performed a low-intensity exercise program rated their pain at 6.6 points. On a scale of 0 to 68 points (lower scores mean better function), people who completed a high-intensity exercise program rated their physical function 2.65 points lower (4% absolute improvement) than people who completed a low-intensity exercise program. People who performed a low-intensity exercise program rated their pain at 20.4 points. On a scale of 0 to 200 mm visual analog scale (higher score means better function), people who completed a high-intensity exercise program rated their quality of life 4.3 mm higher (6.5 mm lower to 15.2 mm higher) (2% absolute improvement) than people who performed a low-intensity exercise program. People who performed a low-intensity exercise program rated their quality of life at 66.7 mm. Two per cent more people had adverse effects with high-intensity exercise, or 17 more people out of 1000. • 39 out of 1000 people reported an adverse effect related to high-intensity exercise program • 22 out of 1000 people reported an adverse effect related to low-intensity exercise program Adverse events were not systematically monitored and and were incompletely reported by group. None of the included studies reported serious adverse events. Based on the evidence, people with knee osteoarthritis who perform high-intensity exercise may experience slight improvements in knee pain and function at the end of the exercise program (8 to 24 weeks) when compared with a low-intensity exercise program. We are uncertain as to whether high-intensity exercise improves quality of life or increases the number of people who experience adverse events. We graded the quality of evidence as low for pain and function and very low for quality of life. The small number of studies and participants included in some analyses reduced the robustness and precision of these findings. Adverse effects were poorly recorded. Very low quality evidence shows we are uncertain whether higher-intensity exercise programs may result in more side effects than lower-intensity exercise programs. Further research may change the result. | 10.1002/14651858.CD010203.pub2 | [
"We identified six randomized controlled trails with 656 participants. Five studies (620 participants) enrolled people with knee osteoarthritis, and one study (36 participants) enrolled people with knee or hip osteoarthritis. The studies included more women (70%) than men. On a scale of 0 to 20 points (lower scores mean reduced pain), people who completed a high-intensity exercise program rated their pain 0.84 points lower (4% absolute improvement) than people who completed a low-intensity exercise program. People who performed a low-intensity exercise program rated their pain at 6.6 points. On a scale of 0 to 68 points (lower scores mean better function), people who completed a high-intensity exercise program rated their physical function 2.65 points lower (4% absolute improvement) than people who completed a low-intensity exercise program. People who performed a low-intensity exercise program rated their pain at 20.4 points. On a scale of 0 to 200 mm visual analog scale (higher score means better function), people who completed a high-intensity exercise program rated their quality of life 4.3 mm higher (6.5 mm lower to 15.2 mm higher) (2% absolute improvement) than people who performed a low-intensity exercise program. People who performed a low-intensity exercise program rated their quality of life at 66.7 mm. Two per cent more people had adverse effects with high-intensity exercise, or 17 more people out of 1000. • 39 out of 1000 people reported an adverse effect related to high-intensity exercise program • 22 out of 1000 people reported an adverse effect related to low-intensity exercise program Adverse events were not systematically monitored and and were incompletely reported by group. None of the included studies reported serious adverse events. Based on the evidence, people with knee osteoarthritis who perform high-intensity exercise may experience slight improvements in knee pain and function at the end of the exercise program (8 to 24 weeks) when compared with a low-intensity exercise program. We are uncertain as to whether high-intensity exercise improves quality of life or increases the number of people who experience adverse events. We graded the quality of evidence as low for pain and function and very low for quality of life. The small number of studies and participants included in some analyses reduced the robustness and precision of these findings. Adverse effects were poorly recorded. Very low quality evidence shows we are uncertain whether higher-intensity exercise programs may result in more side effects than lower-intensity exercise programs. Further research may change the result."
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cochrane-simplification-train-1448 | cochrane-simplification-train-1448 | Compared with the previous review, which was published in 2011, we included 14 additional studies (493 participants), excluded one study and included data for meta-analysis of HRQOL. In total, we included in this review 44 studies including 1195 participants, and we included 33 of these (901 participants)in the meta-analysis. We found that breathlessness during exercise or daily activities was reduced by oxygen compared with air (32 studies; 865 participants; SMD -0.31, 95% CI -0.43 to -0.20; I2 = 29%; low-quality evidence). This translates to a decrease in breathlessness of about 0.7 points on a 0 to 10 numerical rating scale. In contrast, we found no effect of short-burst oxygen given before exercise (four studies; 90 participants; SMD -0.03, 95% CI -0.28 to 0.22; I2 = 0%; low-quality evidence). Oxygen reduced breathlessness measured during exercise tests (30 studies; 591 participants; SMD -0.34, 95% CI -0.46 to -0.22; I2 = 29%; moderate-quality evidence), whereas evidence of an effect on breathlessness measured in daily life was limited (two studies; 274 participants; SMD -0.13, 95% CI, -0.37 to 0.11; I2 = 0%; low-quality evidence). Oxygen did not clearly affect HRQOL (five studies; 267 participants; SMD 0.12, 95% CI -0.04 to 0.28; I2 = 0%; low-quality evidence). Patient preference and adverse events could not be analysed owing to insufficient data. We are moderately confident that oxygen can relieve breathlessness when given during exercise to mildly hypoxaemic and non-hypoxaemic people with chronic obstructive pulmonary disease who would not otherwise qualify for home oxygen therapy. Most evidence pertains to acute effects during exercise tests, and no evidence indicates that oxygen decreases breathlessness in the daily life setting. Findings show that oxygen does not affect health-related quality of life. | We examined the research published to 12 July 2016. We included studies of oxygen therapy versus air delivered through nasal prongs or mask during exertion, continuously, 'as needed' over a defined period or as short-burst oxygen before exertion. Study participants were 18 years of age or older, had received a diagnosis of COPD, had low oxygen levels in the blood and did not receive long-term oxygen therapy. We included a total of 44 studies (1195 participants) in this review. Compared with the previous review, which was published in 2011, we have added 14 studies (493 participants) to this review. We found that oxygen can modestly reduce breathlessness. To be effective, oxygen has to be given during exercise. Most studies evaluated oxygen given during exercise testing in the laboratory. Oxygen therapy during daily life had uncertain effects on breathlessness and did not clearly change patient quality of life. We rated the quality of evidence using one of the following grades: very low, low, moderate or high. For very low-quality evidence, we were uncertain about the results. With high-quality evidence, we were very certain about the results. We found that evidence for oxygen given for breathlessness was moderate to low. We are moderately confident that oxygen can relieve breathlessness when given during exercise to people with COPD with mildly or moderately decreased blood oxygen levels. However, most studies reported acute effects during an exercise test, and no evidence suggests that oxygen decreases breathlessness during daily life. Findings indicate that oxygen does not affect health-related quality of life. | 10.1002/14651858.CD006429.pub3 | [
"We examined the research published to 12 July 2016. We included studies of oxygen therapy versus air delivered through nasal prongs or mask during exertion, continuously, 'as needed' over a defined period or as short-burst oxygen before exertion. Study participants were 18 years of age or older, had received a diagnosis of COPD, had low oxygen levels in the blood and did not receive long-term oxygen therapy. We included a total of 44 studies (1195 participants) in this review. Compared with the previous review, which was published in 2011, we have added 14 studies (493 participants) to this review. We found that oxygen can modestly reduce breathlessness. To be effective, oxygen has to be given during exercise. Most studies evaluated oxygen given during exercise testing in the laboratory. Oxygen therapy during daily life had uncertain effects on breathlessness and did not clearly change patient quality of life. We rated the quality of evidence using one of the following grades: very low, low, moderate or high. For very low-quality evidence, we were uncertain about the results. With high-quality evidence, we were very certain about the results. We found that evidence for oxygen given for breathlessness was moderate to low. We are moderately confident that oxygen can relieve breathlessness when given during exercise to people with COPD with mildly or moderately decreased blood oxygen levels. However, most studies reported acute effects during an exercise test, and no evidence suggests that oxygen decreases breathlessness during daily life. Findings indicate that oxygen does not affect health-related quality of life."
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cochrane-simplification-train-1449 | cochrane-simplification-train-1449 | We included two studies with 57 smokers with a diagnosis of rheumatoid arthritis (RA). We identified no studies including other IJDs. One pilot study compared a smoking cessation intervention specifically for people with RA with a less intensive, generic smoking cessation intervention. People included in the study had a mean age of 56.5 years and a disease duration of 7.7 years (mean). The second study tested effects of an eight-week cognitive-behavioural patient education intervention on cardiovascular disease (CVD) risk for people with RA and compared this with information on CVD risk only. The intervention encouraged participants to address multiple behaviours impacting CVD risk, including smoking cessation, but did not target smoking cessation alone. People included in the study had a mean age of 62.2 years (intervention group) and 60.8 years (control group), and disease duration of 11.6 years (intervention group) and 14.1 years (control group). It was not appropriate to perform a meta-analysis of abstinence data from the two studies due to clinical heterogeneity between interventions. Neither of the studies individually provided evidence to show benefit of the interventions tested. Only one study reported on adverse effects. These effects were non-serious, and numbers were comparable between trial arms. Neither of the studies assessed or reported disease activity or any of the predefined secondary outcomes. We assessed the overall certainty of evidence as very low due to indirectness, imprecision, and high risk of detection bias based on GRADE. We found very little research investigating the efficacy of smoking cessation intervention specifically in people with IJD. Included studies are limited by imprecision, risk of bias, and indirectness. Neither of the included studies investigated whether smoking cessation intervention reduced disease activity among people with IJD. High-quality, adequately powered studies are warranted. In particular, researchers should ensure that they measure disease markers and quality of life, in addition to long-term smoking cessation. | We searched the literature in October 2018. We included two studies with a total of 57 adult smokers - both men and women - with rheumatoid arthritis. One of the studies tested an intervention to help people with rheumatoid arthritis to quit smoking. This study recruited only smokers and compared this specialist, stop smoking programme with a standard, less intensive stop smoking programme. The other study tested an intervention to reduce the risk of heart disease and stroke in people with rheumatoid arthritis. Researchers recruited non-smokers and smokers and compared this programme to a brief factual information leaflet about risks of heart disease. Both studies followed study participants for six months. These studies were funded by Arthritis Research UK Educational Research Fellowship, Arthritis Research UK, the New Zealand Health Research Council, Arthritis New Zealand, and the University of Otago Research Fund. Neither of the two included studies found that the more intensive, specialist interventions aimed at people with rheumatoid arthritis helped more people with rheumatoid arthritis to quit smoking than the less intensive, generic interventions. Only one of the studies reported on the safety of the stop smoking programme used. Very few side effects related to use of nicotine replacement therapy were reported, and none of these were serious. As a result, we do not know whether helping people with inflammatory arthritis improves their disease. We rated the overall quality of the included studies as very low because studies were very few and included few participants; only one of the studies tested an intervention that specifically tried to help people to quit smoking, and there is a chance that people who received the intensive intervention were more likely to incorrectly report that they had stopped smoking when in fact they had not. As a result, further large studies should be carried out to test stop smoking programmes for people with IJD. Researchers should ensure that they measure whether people's IJD symptoms improve, and should confirm whether people have stopped smoking. | 10.1002/14651858.CD012958.pub2 | [
"We searched the literature in October 2018. We included two studies with a total of 57 adult smokers - both men and women - with rheumatoid arthritis. One of the studies tested an intervention to help people with rheumatoid arthritis to quit smoking. This study recruited only smokers and compared this specialist, stop smoking programme with a standard, less intensive stop smoking programme. The other study tested an intervention to reduce the risk of heart disease and stroke in people with rheumatoid arthritis. Researchers recruited non-smokers and smokers and compared this programme to a brief factual information leaflet about risks of heart disease. Both studies followed study participants for six months. These studies were funded by Arthritis Research UK Educational Research Fellowship, Arthritis Research UK, the New Zealand Health Research Council, Arthritis New Zealand, and the University of Otago Research Fund. Neither of the two included studies found that the more intensive, specialist interventions aimed at people with rheumatoid arthritis helped more people with rheumatoid arthritis to quit smoking than the less intensive, generic interventions. Only one of the studies reported on the safety of the stop smoking programme used. Very few side effects related to use of nicotine replacement therapy were reported, and none of these were serious. As a result, we do not know whether helping people with inflammatory arthritis improves their disease. We rated the overall quality of the included studies as very low because studies were very few and included few participants; only one of the studies tested an intervention that specifically tried to help people to quit smoking, and there is a chance that people who received the intensive intervention were more likely to incorrectly report that they had stopped smoking when in fact they had not. As a result, further large studies should be carried out to test stop smoking programmes for people with IJD. Researchers should ensure that they measure whether people's IJD symptoms improve, and should confirm whether people have stopped smoking."
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cochrane-simplification-train-1450 | cochrane-simplification-train-1450 | We included 14 trials with 1863 participants. Evidence from six studies showed that self management programmes improved quality of life in people with stroke (standardised mean difference (SMD) random effects 0.20, 95% confidence interval (CI) 0.00 to 0.41, P = 0.05; low quality evidence) and improved self efficacy (SMD, random effects 0.33, 95% CI 0.04 to 0.61, P = 0.03; low quality evidence) compared with usual care. Individual studies reported benefits for health-related behaviours such as reduced use of health services, smoking, and alcohol intake, as well as improved diet and attitude. However, there was no superior effect for such programmes in the domains of locus of control, activities of daily living, medication adherence, participation, or mood. Statistical heterogeneity was mostly low; however, there was much variation in the types and delivery of programmes. Risk of bias was relatively low for complex intervention clinical trials where participants and personnel could not be blinded. The current evidence indicates that self management programmes may benefit people with stroke who are living in the community. The benefits of such programmes lie in improved quality of life and self efficacy. These are all well-recognised goals for people after stroke. There is evidence for many modes of delivery and examples of tailoring content to the target group. Leaders were usually professionals but peers (stroke survivors and carers) were also reported - the commonality is being trained and expert in stroke and its consequences. It would be beneficial for further research to be focused on identifying key features of effective self management programmes and assessing their cost-effectiveness. | We found 14 studies up to April 2016 involving 1863 participants that looked at the benefits of these programmes for people with stroke. They were conducted in a variety of countries in a variety of formats - sometimes in groups, sometimes individually, and for varying time periods. We found that such programmes may improve the quality of life after stroke. People with stroke reported improvements in their ability to live the way they wanted and that they felt more empowered to take charge of their lives, rather than be dependent on other people for their happiness and satisfaction with life. There were no reports of any risks or negative effects. The majority of the studies were well conducted and represent credible evidence that self management programmes may benefit people with stroke who are living in the community. | 10.1002/14651858.CD010442.pub2 | [
"We found 14 studies up to April 2016 involving 1863 participants that looked at the benefits of these programmes for people with stroke. They were conducted in a variety of countries in a variety of formats - sometimes in groups, sometimes individually, and for varying time periods. We found that such programmes may improve the quality of life after stroke. People with stroke reported improvements in their ability to live the way they wanted and that they felt more empowered to take charge of their lives, rather than be dependent on other people for their happiness and satisfaction with life. There were no reports of any risks or negative effects. The majority of the studies were well conducted and represent credible evidence that self management programmes may benefit people with stroke who are living in the community."
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cochrane-simplification-train-1451 | cochrane-simplification-train-1451 | We have included nine trials, involving 2391 women and their babies in this review. Trials were at a moderate to high risk of bias overall. Results of primary outcomes revealed no significant differences in rates of vaginal delivery not achieved within 24 hours (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.78 to 1.14, two trials, 1339 women) or caesarean section (RR 0.96, 95% CI 0.81 to 1.14, eight trials, 2023 women). There was no difference in serious maternal morbidity or death (RR 1.24, 95% CI 0.55 to 2.82, one trial, 523 women), and no difference in serious neonatal morbidity or perinatal death (RR 0.84, 95% CI 0.23 to 3.12, one trial, 781 infants). Finally, no trials reported on the number of women who had uterine hyperstimulation with fetal heart rate changes. Results of secondary outcomes revealed no difference between time from induction to delivery (mean difference (MD) -0.90 hours, 95% CI -2.28 to +0.49 hours; five studies), uterine rupture (RR 3.10, 95% CI 0.50 to 19.33; three trials), epidural analgesia (RR 1.03, 95% CI 0.89 to 1.18; two trials), instrumental birth (RR 1.22, 95% CI 0.88 to 1.66; three trials), Apgar less than seven at five minutes (RR 1.25, 95% CI 0.77 to 2.01, five trials), perinatal death (RR 0.84, 95% CI 0.23 to 3.12; two trials), postpartum haemorrhage (RR 1.08, 95% CI 0.87 to 1.34; five trials), or endometritis (RR 1.35, 95% CI 0.53 to 3.43; three trials). Removal of high bias studies reveals a significant reduction of induction to delivery interval (MD -1.94 hours, 95% CI -0.99 to -2.89 hours, 489 women). A significant increase in hyperstimulation without specifying fetal heart rate changes was found in the high-dose group (RR 1.86, 95% CI 1.55 to 2.25). No other secondary outcomes were reported: unchanged/unfavourable cervix after 12 to 24 hours, meconium-stained liquor, neonatal intensive care unit admission, neonatal encephalopathy, disability in childhood, other maternal side-effects (nausea, vomiting, diarrhoea), maternal antibiotic use, maternal satisfaction, neonatal infection and neonatal antibiotic use. The findings of our review do not provide evidence that high-dose oxytocin increases either vaginal delivery within 24 hours or the caesarean section rate. There is no significant decrease in induction to delivery time at meta-analysis but these results may be confounded by poor quality trials. High-dose oxytocin was shown to increase the rate of uterine hyperstimulation but the effects of this are not clear. The conclusions here are specific to the definitions used in this review. Further trials evaluating the effects of high-dose regimens of oxytocin for induction of labour should consider all important maternal and infant outcomes. | We included nine randomised controlled trials involving 2391 women and their babies in this review. The trials were of moderate quality overall. All trials compared giving women a high dose versus a low dose of oxytocin for induction of labour. We found that women who had a high dose of oxytocin were not more likely to have a shorter induction to delivery interval or have a vaginal birth within 24 hours of receiving the treatment than women receiving a low dose of oxytocin. When poor-quality trials are removed from analysis however, the induction to delivery interval was significantly shorter with high-dose oxytocin compared to low-dose oxytocin. The likelihood of having a caesarean was similar with the different doses of oxytocin for induction of labour. No differences were shown between the two groups of women in terms of serious complications, including death of the mother or her baby but women receiving the high-dose oxytocin did have an increased risk of excessive uterine contractions (known as uterine hyperstimulation). No trials provided any information about the number of women with uterine hyperstimulation with changes in the babies' heart rate. Similarly, no trials assessed satisfaction of the mother or her caregivers. The trials were at moderate to high risk of bias overall. The definition of high- and low-dose protocols and the outcomes measured varied considerably across the trials. The current evidence is not strong enough to recommend high-dose over low-dose regimens for routine induction of labour. We recommend that further research is carried out. | 10.1002/14651858.CD009701.pub2 | [
"We included nine randomised controlled trials involving 2391 women and their babies in this review. The trials were of moderate quality overall. All trials compared giving women a high dose versus a low dose of oxytocin for induction of labour. We found that women who had a high dose of oxytocin were not more likely to have a shorter induction to delivery interval or have a vaginal birth within 24 hours of receiving the treatment than women receiving a low dose of oxytocin. When poor-quality trials are removed from analysis however, the induction to delivery interval was significantly shorter with high-dose oxytocin compared to low-dose oxytocin. The likelihood of having a caesarean was similar with the different doses of oxytocin for induction of labour. No differences were shown between the two groups of women in terms of serious complications, including death of the mother or her baby but women receiving the high-dose oxytocin did have an increased risk of excessive uterine contractions (known as uterine hyperstimulation). No trials provided any information about the number of women with uterine hyperstimulation with changes in the babies' heart rate. Similarly, no trials assessed satisfaction of the mother or her caregivers. The trials were at moderate to high risk of bias overall. The definition of high- and low-dose protocols and the outcomes measured varied considerably across the trials. The current evidence is not strong enough to recommend high-dose over low-dose regimens for routine induction of labour. We recommend that further research is carried out."
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cochrane-simplification-train-1452 | cochrane-simplification-train-1452 | In this updated review, we included no new randomised controlled trials. We included two trials in the review, one with 40 breast cancer patients receiving high-dose chemotherapy and G-CSF compared to antibiotics, a second one evaluating 155 patients with small-cell lung cancer receiving GM-CSF or antibiotics. We judge the overall risk of bias as high in the G-CSF trial, as neither patients nor physicians were blinded and not all included patients were analysed as randomised (7 out of 40 patients). We considered the overall risk of bias in the GM-CSF to be moderate, because of the risk of performance bias (neither patients nor personnel were blinded), but low risk of selection and attrition bias. For the trial comparing G-CSF to antibiotics, all cause mortality was not reported. There was no evidence of a difference for infection-related mortality, with zero events in each arm. Microbiologically or clinically documented infections, severe infections, quality of life, and adverse events were not reported. There was no evidence of a difference in frequency of febrile neutropenia (risk ratio (RR) 1.22; 95% confidence interval (CI) 0.53 to 2.84). The quality of the evidence for the two reported outcomes, infection-related mortality and frequency of febrile neutropenia, was very low, due to the low number of patients evaluated (high imprecision) and the high risk of bias. There was no evidence of a difference in terms of median survival time in the trial comparing GM-CSF and antibiotics. Two-year survival times were 6% (0 to 12%) in both arms (high imprecision, low quality of evidence). There were four toxic deaths in the GM-CSF arm and three in the antibiotics arm (3.8%), without evidence of a difference (RR 1.32; 95% CI 0.30 to 5.69; P = 0.71; low quality of evidence). There were 28% grade III or IV infections in the GM-CSF arm and 18% in the antibiotics arm, without any evidence of a difference (RR 1.55; 95% CI 0.86 to 2.80; P = 0.15, low quality of evidence). There were 5 episodes out of 360 cycles of grade IV infections in the GM-CSF arm and 3 episodes out of 334 cycles in the cotrimoxazole arm (0.8%), with no evidence of a difference (RR 1.55; 95% CI 0.37 to 6.42; P = 0.55; low quality of evidence). There was no significant difference between the two arms for non-haematological toxicities like diarrhoea, stomatitis, infections, neurologic, respiratory, or cardiac adverse events. Grade III and IV thrombopenia occurred significantly more frequently in the GM-CSF arm (60.8%) compared to the antibiotics arm (28.9%); (RR 2.10; 95% CI 1.41 to 3.12; P = 0.0002; low quality of evidence). Neither infection-related mortality, incidence of febrile neutropenia, nor quality of life were reported in this trial. As we only found two small trials with 195 patients altogether, no conclusion for clinical practice is possible. More trials are necessary to assess the benefits and harms of G(M)-CSF compared to antibiotics for infection prevention in cancer patients receiving chemotherapy. | We searched several medical databases and identified two randomised controlled trials (RCT) that met our inclusion criteria; no new trials were identified for this review update. One trial included 40 breast cancer patients receiving high-dose chemotherapy. Eighteen patients received G-CSF and 22 got antibiotics (ciprofloxacin and amphotericin) to prevent infection. Another trial evaluated GM-CSF versus antibiotics in patients with small-cell lung cancer, with 78 patients in the GM-CSF arm and 77 patients in the antibiotics arm. The study that analysed G-CSF versus antibiotics did not report all cause mortality, microbiologically or clinically documented infections, severe infections, quality of life, or adverse events. We found no evidence of a difference between the two prophylactic options for the outcomes of infection-related mortality (no patient died because of infection), or febrile neutropenia. The trial that assessed GM-CSF versus antibiotics did not found any evidence of a difference in all cause mortality, trial mortality, infections, or severe infections. The only difference between the two arms was found for the adverse event thrombocytopenia, favouring patients receiving antibiotics. Quality of life was not reported in this trial. More research is needed to determine the best prevention against infection in cancer patients. The quality of the evidence for infection-related mortality and frequency of febrile neutropenia in the G-CSF trial was very low, because of the small number of patients that were evaluated, and the study design (high risk of bias). The trial that analysed GM-CSF versus antibiotics reported overall survival, toxic deaths, infections, severe infections, and adverse events. Because of the very small number of patients included, we judged that the overall quality for all these outcomes was low. The evidence is current to December 2015. | 10.1002/14651858.CD007107.pub3 | [
"We searched several medical databases and identified two randomised controlled trials (RCT) that met our inclusion criteria; no new trials were identified for this review update. One trial included 40 breast cancer patients receiving high-dose chemotherapy. Eighteen patients received G-CSF and 22 got antibiotics (ciprofloxacin and amphotericin) to prevent infection. Another trial evaluated GM-CSF versus antibiotics in patients with small-cell lung cancer, with 78 patients in the GM-CSF arm and 77 patients in the antibiotics arm. The study that analysed G-CSF versus antibiotics did not report all cause mortality, microbiologically or clinically documented infections, severe infections, quality of life, or adverse events. We found no evidence of a difference between the two prophylactic options for the outcomes of infection-related mortality (no patient died because of infection), or febrile neutropenia. The trial that assessed GM-CSF versus antibiotics did not found any evidence of a difference in all cause mortality, trial mortality, infections, or severe infections. The only difference between the two arms was found for the adverse event thrombocytopenia, favouring patients receiving antibiotics. Quality of life was not reported in this trial. More research is needed to determine the best prevention against infection in cancer patients. The quality of the evidence for infection-related mortality and frequency of febrile neutropenia in the G-CSF trial was very low, because of the small number of patients that were evaluated, and the study design (high risk of bias). The trial that analysed GM-CSF versus antibiotics reported overall survival, toxic deaths, infections, severe infections, and adverse events. Because of the very small number of patients included, we judged that the overall quality for all these outcomes was low. The evidence is current to December 2015."
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cochrane-simplification-train-1453 | cochrane-simplification-train-1453 | Searching identified 113 records. We obtained the full text of 48 of these records for closer inspection. Sixteen trials, randomising a total of 919 participants are included. The majority of trials included adults with schizophrenia or similar illness who were inpatients, and while they were poorly characterised, most appeared to include patients with a chronic presentation. The intervention NRI in nine of the 16 trials was reboxetine, with atomoxetine and viloxazine used in the remaining trials. 14 trials compared NRIs with placebo. Only two trials provided data to compare NRIs against an active control and both compared reboxetine to citalopram but at 4 weeks and 24 weeks respectively so they could not be combined in a meta-analysis. One trial was described as 'open' and we considered it to be at high risk of bias for randomisation and blinding, three trials were at high risk of bias for attrition, six for reporting, and two for other sources of bias. Our main outcomes of interest were significant response or improvement in positive/negative mental state, global state and cognitive functioning, average cognitive functioning scores, significant response or improvement in quality of life and incidence of nausea. All data for main outcomes were short term. NRIs versus placebo Mental state results showed significantly greater rates of improvement in negative symptoms scores (1 RCT, n = 50; RR 3.17, 95% CI 1.52 to 6.58; very low quality evidence) with NRIs on the PANSS negative. No data were reported for significant response or improvement in positive symptoms, but average endpoint PANSS positive scores were available and showed no difference between NRIs and placebo (5 RCTs, n = 294; MD −0.16, 95% CI −0.96 to 0.63; low-quality evidence). Improvement in clinical global status was similar between groups (1 RCT, n = 28; RR 0.99, 95% CI 0.45 to 2.20; very low quality evidence). Significant response or improvement in cognitive functioning data were not reported. Average composite cognitive scores showed no difference between NRIs and placebo (4 RCTs, n = 180; SMD 0.04, 95% CI −0.28 to 0.36; low-quality evidence). Significant response or improvement in quality of life data were not reported, however average endpoint scores from the GQOLI-74 were reported. Those receiving NRIs had better quality of life scores compared to placebo (1 RCT, n = 114; MD 9.36, 95% CI 7.89 to 10.83; very low quality evidence). All-cause withdrawals did not differ between the treatment groups (8 RCTs, n = 401, RR 0.94 95% CI 0.63 to 1.39; moderate-quality evidence). Rates of nausea were not greater with NRIs (3 RCTs, n = 176; RR 0.49, 95% CI 0.10 to 2.41; low-quality evidence). Our results provide tentative very low quality evidence that compared to placebo, NRIs (specifically reboxetine) may have a benefit on the negative symptoms of schizophrenia. Limited evidence also suggests that NRIs have no effect on the positive symptoms of schizophrenia or cognitive functioning. NRIs appear generally well tolerated with no real differences in adverse effects such as nausea noted between NRIs and placebo. However, these results are based on short-term follow-up and are poor quality — there is need for more good-quality evidence. A large RCT of reboxetine over a longer period of time, focusing specifically on negative and cognitive symptoms as well as more detailed and comprehensive reporting of outcomes, including adverse events, is required. | The Information Specialist of Cochrane Schizophrenia searched their specialised register for relevant trials up to February 2017. We found sixteen trials that could be included. These trials randomised 919 adults with schizophrenia to receive either an NRI, a placebo (dummy treatment), or an antidepressant. All participants continued to receive the antipsychotic medications they were already taking. Most trials included participants who were in hospital and who had had symptoms of schizophrenia for a long time. Our main areas of interest were the effect NRIs have on improving mental and global state, cognitive functioning and quality of life for people with schizophrenia; and if NRIs cause unpleasant side-effects such as nausea. We found that compared to placebo treatment, NRIs (reboxetine in particular) have an effect on improving negative symptoms. However, we did not find evidence that NRIs have an effect on improving positive symptoms, cognitive functioning or incidence of nausea. One trial reported a benefit of reboxetine on quality of life scores. The results of our review should be viewed with caution as the quality of evidence available is very low due to the small size of studies and poor quality of the trials. In order to make firm conclusions regarding the effectiveness of NRIs for people with schizophrenia we need larger and better quality trials of NRIs. These should be long term and look particularly at negative and cognitive symptoms as well as side-effects. | 10.1002/14651858.CD010219.pub2 | [
"The Information Specialist of Cochrane Schizophrenia searched their specialised register for relevant trials up to February 2017. We found sixteen trials that could be included. These trials randomised 919 adults with schizophrenia to receive either an NRI, a placebo (dummy treatment), or an antidepressant. All participants continued to receive the antipsychotic medications they were already taking. Most trials included participants who were in hospital and who had had symptoms of schizophrenia for a long time. Our main areas of interest were the effect NRIs have on improving mental and global state, cognitive functioning and quality of life for people with schizophrenia; and if NRIs cause unpleasant side-effects such as nausea. We found that compared to placebo treatment, NRIs (reboxetine in particular) have an effect on improving negative symptoms. However, we did not find evidence that NRIs have an effect on improving positive symptoms, cognitive functioning or incidence of nausea. One trial reported a benefit of reboxetine on quality of life scores. The results of our review should be viewed with caution as the quality of evidence available is very low due to the small size of studies and poor quality of the trials. In order to make firm conclusions regarding the effectiveness of NRIs for people with schizophrenia we need larger and better quality trials of NRIs. These should be long term and look particularly at negative and cognitive symptoms as well as side-effects."
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cochrane-simplification-train-1454 | cochrane-simplification-train-1454 | Eleven studies met the criteria for inclusion in this review, all were randomised clinical trials, two were double-blind. There were a total number of 1969 participants. The sequence generation was inadequate in one study, adequate in five studies and unclear in the remaining studies. The allocation of concealment was adequate in three studies and unclear in the remaining studies. Methadone appeared statistically significantly more effective than non-pharmacological approaches in retaining patients in treatment and in the suppression of heroin use as measured by self report and urine/hair analysis (6 RCTs, RR = 0.66 95% CI 0.56-0.78), but not statistically different in criminal activity (3 RCTs, RR=0.39; 95%CI: 0.12-1.25) or mortality (4 RCTs, RR=0.48; 95%CI: 0.10-2.39). Methadone is an effective maintenance therapy intervention for the treatment of heroin dependence as it retains patients in treatment and decreases heroin use better than treatments that do not utilise opioid replacement therapy. It does not show a statistically significant superior effect on criminal activity or mortality. | However the review found that people have withdrawn from trials when they are assigned to a drug-free program. Consequently, there are no trials comparing methadone maintenance treatment with drug-free methods other than methadone placebo trials, or comparing methadone maintenance with methadone for detoxification only. These trials show that methadone can reduce the use of heroin in dependent people, and keep them in treatment programs. | 10.1002/14651858.CD002209.pub2 | [
"However the review found that people have withdrawn from trials when they are assigned to a drug-free program. Consequently, there are no trials comparing methadone maintenance treatment with drug-free methods other than methadone placebo trials, or comparing methadone maintenance with methadone for detoxification only. These trials show that methadone can reduce the use of heroin in dependent people, and keep them in treatment programs."
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cochrane-simplification-train-1455 | cochrane-simplification-train-1455 | We included eight RCTs (746 participants) in the review. The risk of bias in the studies was generally low. Five studies did not demonstrate any advantage in using a topical treatment prior to endoscopy. One study suggested that a vasoconstrictor alone should be used to reduce the general level of unpleasantness. Two studies did not compare treatment against placebo or no treatment, so it was not possible to draw meaningful conclusions from them. There may be some unpleasant side effects from the use of topical preparations, such as unpleasant taste. There was variation in the format of the outcome data and a lack of complete data; none of the included studies reported their results in a way that would allow pooling and we could not therefore perform meta-analysis. The included studies do not demonstrate any evidence to support the use of topical treatments prior to the use of a fibre-optic nasal endoscope. Some go as far as to suggest that these agents should not be used due to cost and unpleasant side effects. Five studies did not demonstrate any advantage in terms of reducing pain or discomfort when using a topical treatment prior to endoscopy. The absence of demonstrable effect may be due to relatively small patient groups. It is therefore possible that there is a small effect of using these sprays. Further research using standardised reporting methods is needed. | We looked for randomised controlled trials comparing any of these topical treatments with placebo, no treatment or another topical treatment in adult patients undergoing nasal pharyngolaryngoscopy (NPL). We included eight studies in the review (with a total of 746 patients). It was not possible to combine data from any of the studies, therefore we assessed the individual study results. Five of the studies did not demonstrate any advantage, in terms of reducing pain or discomfort, of using a topical treatment prior to endoscopy. One of these suggested that a vasoconstrictor (xylometazoline) alone reduced the level of "general unpleasantness". Two studies did not compare the treatment against placebo or no treatment. A final study actually suggested an increase in pain with the use of topical agents. There may be some unpleasant side effects from the use of topical preparations, such as unpleasant taste. Further standardised research is required. | 10.1002/14651858.CD005606.pub2 | [
"We looked for randomised controlled trials comparing any of these topical treatments with placebo, no treatment or another topical treatment in adult patients undergoing nasal pharyngolaryngoscopy (NPL). We included eight studies in the review (with a total of 746 patients). It was not possible to combine data from any of the studies, therefore we assessed the individual study results. Five of the studies did not demonstrate any advantage, in terms of reducing pain or discomfort, of using a topical treatment prior to endoscopy. One of these suggested that a vasoconstrictor (xylometazoline) alone reduced the level of \"general unpleasantness\". Two studies did not compare the treatment against placebo or no treatment. A final study actually suggested an increase in pain with the use of topical agents. There may be some unpleasant side effects from the use of topical preparations, such as unpleasant taste. Further standardised research is required."
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cochrane-simplification-train-1456 | cochrane-simplification-train-1456 | We pooled summary estimates from 10 trials evaluating SmartCare™ involving 654 participants. Overall, eight trials were judged to be at low or unclear risk of bias, and two trials were judged to be at high risk of bias. Compared with non-automated strategies, SmartCare™ decreased weaning time (mean difference (MD) -2.68 days, 95% confidence interval (CI) -3.99 to -1.37; P value < 0.0001, seven trials, 495 participants, moderate-quality evidence), time to successful extubation (MD -0.99 days, 95% CI -1.89 to -0.09; P value 0.03, seven trials, 516 participants, low-quality evidence), length of ICU stay (MD -5.70 days, 95% CI -10.54 to -0.85; P value 0.02, six trials, 499 participants, moderate-quality evidence) and proportions of participants receiving ventilation for longer than seven and 21 days (risk ratio (RR) 0.44, 95% CI 0.23 to 0.85; P value 0.01 and RR 0.39, 95% CI 0.18 to 0.86; P value 0.02). SmartCare™ reduced the total duration of ventilation (MD -1.68 days, 95% CI -3.33 to -0.03; P value 0.05, seven trials, 521 participants, low-quality evidence) and the number of participants receiving ventilation for longer than 14 days (RR 0.61, 95% CI 0.37 to 1.00; P value 0.05); however the estimated effects were imprecise. SmartCare™ had no effect on time to first successful SBT, mortality or adverse events, specifically reintubation. Subgroup analysis suggested that trials with protocolized (versus non-protocolized) control weaning strategies reported significantly shorter ICU stays. Sensitivity analysis excluded two trials with high risk of bias and supported a trend toward significant reductions in weaning time favouring SmartCare™. Compared with non-automated weaning strategies, weaning with SmartCare™ significantly decreased weaning time, time to successful extubation, ICU stay and proportions of patients receiving ventilation for longer than seven days and 21 days. It also showed a favourable trend toward fewer patients receiving ventilation for longer than 14 days; however the estimated effect was imprecise. Summary estimates from our review suggest that these benefits may be achieved without increasing the risk of adverse events, especially reintubation; however, the quality of the evidence ranged from low to moderate, and evidence was derived from 10 small randomized controlled trials. | We identified 10 trials of moderate quality involving 654 participants and comparing SmartCare™ versus non-automated weaning strategies. Compared with non-automated strategies, SmartCare™ significantly decreased weaning time, time to successful removal from breathing machines and time spent in the ICU, with fewer patients receiving breathing machine support for longer than seven days and 21 days, and no increase in adverse events. SmartCare™ also showed a favourable trend toward fewer patients receiving ventilation for longer than 14 days, with no increase in adverse events. Subgroup analyses suggested more beneficial effects on weaning time in trials comparing SmartCare™ to a protocolized weaning strategy versus a non-protocolized control strategy. Sensitivity analyses, which excluded two trials with high risk of bias, supported significant reductions in weaning time with SmartCare™. | 10.1002/14651858.CD008638.pub2 | [
"We identified 10 trials of moderate quality involving 654 participants and comparing SmartCare™ versus non-automated weaning strategies. Compared with non-automated strategies, SmartCare™ significantly decreased weaning time, time to successful removal from breathing machines and time spent in the ICU, with fewer patients receiving breathing machine support for longer than seven days and 21 days, and no increase in adverse events. SmartCare™ also showed a favourable trend toward fewer patients receiving ventilation for longer than 14 days, with no increase in adverse events. Subgroup analyses suggested more beneficial effects on weaning time in trials comparing SmartCare™ to a protocolized weaning strategy versus a non-protocolized control strategy. Sensitivity analyses, which excluded two trials with high risk of bias, supported significant reductions in weaning time with SmartCare™."
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cochrane-simplification-train-1457 | cochrane-simplification-train-1457 | We included eight RCTs with 1546 women. Five RCTs were included in our previous review and three new RCTs were added in this update of the review. They compared true acupuncture versus sham acupuncture (three RCTs), true acupuncture versus relaxation (one RCT), true acupuncture versus clomiphene (one RCT), low-frequency electroacupuncture versus physical exercise or no intervention (one RCT) and true acupuncture versus Diane-35 (two RCTs). Studies that compared true acupuncture versus Diane-35 did not measure fertility outcomes as they were focused on symptom control. Seven of the studies were at high risk of bias in at least one domain. For true acupuncture versus sham acupuncture, we could not exclude clinically relevant differences in live birth (RR 0.97, 95% CI 0.76 to 1.24; 1 RCT, 926 women; low-quality evidence); multiple pregnancy rate (RR 0.89, 95% CI 0.33 to 2.45; 1 RCT, 926 women; low-quality evidence); ovulation rate (SMD 0.02, 95% CI –0.15 to 0.19, I2 = 0%; 2 RCTs, 1010 women; low-quality evidence); clinical pregnancy rate (RR 1.03, 95% CI 0.82 to 1.29; I2 = 0%; 3 RCTs, 1117 women; low-quality evidence) and miscarriage rate (RR 1.10, 95% CI 0.77 to 1.56; 1 RCT, 926 women; low-quality evidence). Number of intermenstrual days may have improved in participants receiving true acupuncture compared to sham acupuncture (MD –312.09 days, 95% CI –344.59 to –279.59; 1 RCT, 141 women; low-quality evidence). True acupuncture probably worsens adverse events compared to sham acupuncture (RR 1.16, 95% CI 1.02 to 1.31; I2 = 0%; 3 RCTs, 1230 women; moderate-quality evidence). No studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane-35 did not measure fertility outcomes. We were uncertain whether acupuncture improved ovulation rate (measured by ultrasound three months post treatment) compared to relaxation (MD 0.35, 95% CI 0.14 to 0.56; 1 RCT, 28 women; very low-quality evidence) or Diane-35 (RR 1.45, 95% CI 0.87 to 2.42; 1 RCT, 58 women; very low-quality evidence). Overall evidence ranged from very low quality to moderate quality. The main limitations were failure to report important clinical outcomes and very serious imprecision. For true acupuncture versus sham acupuncture we cannot exclude clinically relevant differences in live birth rate, multiple pregnancy rate, ovulation rate, clinical pregnancy rate or miscarriage. Number of intermenstrual days may improve in participants receiving true acupuncture compared to sham acupuncture. True acupuncture probably worsens adverse events compared to sham acupuncture. No studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane-35 did not measure fertility outcomes as the women in these trials did not seek fertility. We are uncertain whether acupuncture improves ovulation rate (measured by ultrasound three months post treatment) compared to relaxation or Diane-35. The other comparisons did not report on this outcome. Adverse events were recorded in the acupuncture group for the comparisons physical exercise or no intervention, clomiphene and Diane-35. These included dizziness, nausea and subcutaneous haematoma. Evidence was very low quality with very wide CIs and very low event rates. There are only a limited number of RCTs in this area, limiting our ability to determine effectiveness of acupuncture for PCOS. | We searched medical databases for clinical studies where people were randomly put into one of two or more treatment groups including acupuncture treatment for women with PCOS who were infrequently or never ovulating. Acupuncture was compared with pretend acupuncture (sham), no treatment, lifestyle changes (e.g. relaxation) and conventional treatment. We included eight studies with 1546 women in this review. The studies compared true acupuncture versus sham acupuncture, clomiphene (medicines to induce ovulation), relaxation and Diane-35 (combined oral contraceptive pill); and low-frequency electroacupuncture (where small electrical currents are passed through the acupuncture needles) versus physical exercise. We included women who wanted to get pregnant and women who wanted regular ovulation and symptom control as our two main populations of interest. Our main interests were live birth rate, multiple pregnancy rate (for women who wanted to get pregnant) and ovulation rate (for women who wanted regular ovulation/symptom control). Due to the very low quality of the evidence and imprecise results, we were uncertain of the effect of acupuncture on live birth rate, multiple pregnancy rate and ovulation rate compared to sham acupuncture. For the same reasons, we were also uncertain of the effect of acupuncture on clinical pregnancy and miscarriage rate. Acupuncture may have improved restoration of regular menstrual periods. Acupuncture probably worsened side effects when compared to sham acupuncture. No studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane-35 did not measure fertility outcomes as women were only interested in symptom control. We were uncertain whether acupuncture improved ovulation rate compared to relaxation or Diane-35 (measured by ultrasound, which uses high-frequency sound waves to create an image, three months after treatment). The other comparisons did not report on ovulation rate. Side effects were recorded in the acupuncture group for the comparisons physical exercise or no intervention, clomiphene and Diane-35. These included dizziness, nausea (feeling sick) and bruising. The overall evidence was low or very low quality. There is currently insufficient evidence to support the use of acupuncture for treatment of ovulation disorders in women with PCOS. The evidence ranged from very low to moderate quality, the main limitations were not reporting important clinical results and not enough data. | 10.1002/14651858.CD007689.pub4 | [
"We searched medical databases for clinical studies where people were randomly put into one of two or more treatment groups including acupuncture treatment for women with PCOS who were infrequently or never ovulating. Acupuncture was compared with pretend acupuncture (sham), no treatment, lifestyle changes (e.g. relaxation) and conventional treatment. We included eight studies with 1546 women in this review. The studies compared true acupuncture versus sham acupuncture, clomiphene (medicines to induce ovulation), relaxation and Diane-35 (combined oral contraceptive pill); and low-frequency electroacupuncture (where small electrical currents are passed through the acupuncture needles) versus physical exercise. We included women who wanted to get pregnant and women who wanted regular ovulation and symptom control as our two main populations of interest. Our main interests were live birth rate, multiple pregnancy rate (for women who wanted to get pregnant) and ovulation rate (for women who wanted regular ovulation/symptom control). Due to the very low quality of the evidence and imprecise results, we were uncertain of the effect of acupuncture on live birth rate, multiple pregnancy rate and ovulation rate compared to sham acupuncture. For the same reasons, we were also uncertain of the effect of acupuncture on clinical pregnancy and miscarriage rate. Acupuncture may have improved restoration of regular menstrual periods. Acupuncture probably worsened side effects when compared to sham acupuncture. No studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane-35 did not measure fertility outcomes as women were only interested in symptom control. We were uncertain whether acupuncture improved ovulation rate compared to relaxation or Diane-35 (measured by ultrasound, which uses high-frequency sound waves to create an image, three months after treatment). The other comparisons did not report on ovulation rate. Side effects were recorded in the acupuncture group for the comparisons physical exercise or no intervention, clomiphene and Diane-35. These included dizziness, nausea (feeling sick) and bruising. The overall evidence was low or very low quality. There is currently insufficient evidence to support the use of acupuncture for treatment of ovulation disorders in women with PCOS. The evidence ranged from very low to moderate quality, the main limitations were not reporting important clinical results and not enough data."
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cochrane-simplification-train-1458 | cochrane-simplification-train-1458 | We included 28 trials (2681 children) investigating 17 interventions of interest; all trials were conducted in high-income countries. Overall we judged the trials to be at high risk of bias. Except for parental acupuncture (graded low), all other GRADE assessments of the primary outcomes of comparisons were very low, indicating a high degree of uncertainty about the overall findings. Parental presence: In five trials (557 children), parental presence at induction of anaesthesia did not reduce child anxiety compared with not having a parent present (standardized mean difference (SMD) 0.03, 95% confidence interval (CI) -0.14 to 0.20). In a further three trials (267 children) where we were unable to pool results, we found no clear differences in child anxiety, whether a parent was present or not. In a single trial, child anxiety showed no significant difference whether one or two parents were present, although parental anxiety was significantly reduced when both parents were present at the induction. Parental presence was significantly less effective than sedative premedication in reducing children's anxiety at induction in three trials with 254 children (we could not pool results). Child interventions (passive): When a video of the child's choice was played during induction, children were significantly less anxious than controls (median difference modified Yale Preoperative Anxiety Scale (mYPAS) 31.2, 95% CI 27.1 to 33.3) in a trial of 91 children. In another trial of 120 children, co-operation at induction did not differ significantly when a video fairytale was played before induction. Children exposed to low sensory stimulation were significantly less anxious than control children on introduction of the anaesthesia mask and more likely to be co-operative during induction in one trial of 70 children. Music therapy did not show a significant effect on children's anxiety in another trial of 51 children. Child interventions (mask introduction): We found no significant differences between a mask exposure intervention and control in a single trial of 103 children for child anxiety (risk ratio (RR) 0.59, 95% CI 0.31 to 1.11) although children did demonstrate significantly better co-operation in the mask exposure group (RR 1.27, 95% CI 1.06 to 1.51). Child interventions (interactive): In a three-arm trial of 168 children, preparation with interactive computer packages (in addition to parental presence) was more effective than verbal preparation, although differences between computer and cartoon preparation were not significant, and neither was cartoon preparation when compared with verbal preparation. Children given video games before induction were significantly less anxious at induction than those in the control group (mYPAS mean difference (MD) -9.80, 95% CI -19.42 to -0.18) and also when compared with children who were sedated with midazolam (mYPAS MD -12.20, 95% CI -21.82 to -2.58) in a trial of 112 children. When compared with parental presence only, clowns or clown doctors significantly lessened children's anxiety in the operating/induction room (mYPAS MD -24.41, 95% CI -38.43 to -10.48; random-effects, I² 75%) in three trials with a total of 133 children. However, we saw no significant differences in child anxiety in the operating room between clowns/clown doctors and sedative premedication (mYPAS MD -9.67, 95% CI -21.14 to 1.80, random-effects, I² 66%; 2 trials of 93 children). In a trial of hypnotherapy versus sedative premedication in 50 children, there were no significant differences in children's anxiety at induction (RR 0.59, 95% CI 0.33 to 1.04). Parental interventions: Children of parents having acupuncture compared with parental sham acupuncture were less anxious during induction (mYPAS MD -17, 95% CI -30.51 to -3.49) and were more co-operative (RR 1.59, 95% CI 1.01 to 2.53) in a single trial of 67 children. Two trials with 191 parents assessed the effects of parental video viewing but did not report any of the review's prespecified primary outcomes. This review shows that the presence of parents during induction of general anaesthesia does not diminish their child's anxiety. Potentially promising non-pharmacological interventions such as parental acupuncture; clowns/clown doctors; playing videos of the child's choice during induction; low sensory stimulation; and hand-held video games need further investigation in larger studies. | We included 28 trials (2681 children under the age of 18 years and or their parents) with a large number of interventions (17) assessed. The presence of parents at induction of the child's anaesthesia has been the most commonly investigated intervention (eight trials), but has not been shown to reduce anxiety or distress in children, or increase their co-operation during induction of anaesthesia. Although parents should not be actively discouraged from being present if they prefer to do so, equally parents should not be encouraged to be present at their child's induction if they prefer not to do so. Most commonly other interventions are given to the child (e.g. video games or hypnosis) but sometimes the intervention is given to the parent. One study of acupuncture for parents found that the parent was less anxious, and the child was more co-operative, at induction of anaesthesia. Another study of giving parents information, in the form of pamphlets or videos, failed to show an effect. In other studies looking at interventions for children, clowns or clown doctors, a quiet environment, video games and computer packages (but not music therapy) each showed benefits such as improved co-operation in the children. Many of the studies were of poor quality and too small to provide clear answers to the study question. However potentially promising non-pharmacological interventions such as parental acupuncture; clowns/clown doctors; playing videos of the child's choice during induction, pre-operative hypnosis and hand-held video games require further testing in future studies. Non-drug interventions that might help parents relax need further study, as there is some evidence that more relaxed parents may improve their child's anaesthesia induction experience. | 10.1002/14651858.CD006447.pub3 | [
"We included 28 trials (2681 children under the age of 18 years and or their parents) with a large number of interventions (17) assessed. The presence of parents at induction of the child's anaesthesia has been the most commonly investigated intervention (eight trials), but has not been shown to reduce anxiety or distress in children, or increase their co-operation during induction of anaesthesia. Although parents should not be actively discouraged from being present if they prefer to do so, equally parents should not be encouraged to be present at their child's induction if they prefer not to do so. Most commonly other interventions are given to the child (e.g. video games or hypnosis) but sometimes the intervention is given to the parent. One study of acupuncture for parents found that the parent was less anxious, and the child was more co-operative, at induction of anaesthesia. Another study of giving parents information, in the form of pamphlets or videos, failed to show an effect. In other studies looking at interventions for children, clowns or clown doctors, a quiet environment, video games and computer packages (but not music therapy) each showed benefits such as improved co-operation in the children. Many of the studies were of poor quality and too small to provide clear answers to the study question. However potentially promising non-pharmacological interventions such as parental acupuncture; clowns/clown doctors; playing videos of the child's choice during induction, pre-operative hypnosis and hand-held video games require further testing in future studies. Non-drug interventions that might help parents relax need further study, as there is some evidence that more relaxed parents may improve their child's anaesthesia induction experience."
]
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cochrane-simplification-train-1459 | cochrane-simplification-train-1459 | Five RCTs (295 participants) were included in this review. All were identified during the original review. The overall risk of bias was high for two RCTs and unclear for three. One RCT compared different proprietary alginate dressings (20 participants), three compared alginate and hydrocolloid dressings (215 participants), and one compared alginate and plain non-adherent dressings (60 participants). Follow-up periods were six weeks in three RCTs and 12 weeks in two. No statistically significant between-group differences were detected for any comparison, for any healing outcome. Meta-analysis was feasible for one comparison (alginate and hydrocolloid dressings), with data from two RCTs (84 participants) pooled for complete healing at six weeks: risk ratio 0.42 (95% confidence interval 0.14 to 1.21). Adverse event profiles were generally similar between groups (not assessed for alginate versus plain non-adherent dressings). The current evidence base does not suggest that alginate dressings are more or less effective in the healing of venous leg ulcers than hydrocolloid or plain non-adherent dressings, and there is no evidence to indicate a difference between different proprietary alginate dressings. However, the RCTs in this area are considered to be of low or unclear methodological quality. Further, good quality evidence is required from well designed and rigorously conducted RCTs that employ - and clearly report on - methods to minimise bias, prior to any definitive conclusions being made regarding the efficacy of alginate dressings in the management of venous leg ulcers. | We evaluated the evidence from five randomised controlled trials that compared either different brands of alginate dressings, or alginate dressings with other types of dressings. In terms of wound healing, we found no good evidence to suggest that there is any difference between different brands of alginate dressings, nor between alginate dressings and hydrocolloid or plain non-adherent dressings. Adverse events were generally similar between treatment groups (but not assessed for alginate versus plain non-adherent dressings). Overall, the current evidence is of low quality. Further, good quality evidence is required before any definitive conclusions can be made regarding the use of alginate dressings in the management of venous leg ulcers. | 10.1002/14651858.CD010182.pub3 | [
"We evaluated the evidence from five randomised controlled trials that compared either different brands of alginate dressings, or alginate dressings with other types of dressings. In terms of wound healing, we found no good evidence to suggest that there is any difference between different brands of alginate dressings, nor between alginate dressings and hydrocolloid or plain non-adherent dressings. Adverse events were generally similar between treatment groups (but not assessed for alginate versus plain non-adherent dressings). Overall, the current evidence is of low quality. Further, good quality evidence is required before any definitive conclusions can be made regarding the use of alginate dressings in the management of venous leg ulcers."
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cochrane-simplification-train-1460 | cochrane-simplification-train-1460 | We included two RCTs, both published in 2015 involving a total of 391 participants with treatment duration of 12 to 13 weeks. One RCT compared a quinolone (moxifloxacin pulsed, for 5 days every 4 weeks), with a tetracycline (doxycycline continuous) or a macrolide (azithromycin intermittent). The second RCT compared a tetracycline (doxycycline continuous) plus a macrolide (roxithromycin continuous), with roxithromycin (continuous) alone. The trials recruited participants with a mean age of 68 years, with moderate-severity COPD. Both trials included participants who had between two and five exacerbations in the previous one to two years. In one trial, 17% of patients had previously been using inhaled corticosteroids. In the other study, all patients were positive for Chlamydophila pneumoniae (C pneumoniae). Overall, we judged the evidence presented to be of very low-certainty, mainly due to imprecision, but we also had concerns about indirectness and methodological quality of the included studies. The primary outcome measures for this review included exacerbations, quality of life, drug resistance and serious adverse events. Macrolide + tetracycline versus macrolide There was no clear difference between treatments in improvement in quality of life as assessed by the Chronic Respiratory Questionnaire (CRQ). The CRQ scale ranges from 0 to 10 and higher scores on the scale indicate better quality of life. CRQ sub-scales for dyspnoea (mean difference (MD) 0.58, 95% confidence interval (CI) -0.84 to 2.00; 187 participants; very low-certainty evidence), fatigue (MD 0.02, 95% CI -1.08 to 1.12; 187 participants; very low-certainty evidence), emotional function (MD -0.37, 95% CI -1.74 to 1.00; 187 participants; very low-certainty evidence), or mastery (MD -0.79, 95% CI -1.86 to 0.28; 187 participants; very low-certainty evidence) at 12 weeks. For serious adverse events, it was uncertain if there was a difference between combined roxithromycin and doxycycline versus roxithromycin alone at 48 weeks follow-up after active treatment of 12 weeks (odds ratio (OR) 1.00, 95% CI 0.52 to 1.93; 198 participants; very low-certainty evidence). There were five deaths reported in the combined treatment arm, versus three in the single treatment arm at 48 weeks follow-up after active treatment of 12 weeks (OR 1.63, 95% CI 0.38 to 7.02; 198 participants; very low-certainty evidence). Quinolone versus tetracycline There was no clear difference between moxifloxacin and doxycycline for the number of participants experiencing one or more exacerbations (OR 0.44, 95% CI 0.14 to 1.38; 50 participants, very low-certainty evidence) at 13 weeks. There were no serious adverse events or deaths reported in either treatment groups. We did not identify any evidence for our other primary outcomes. Quinolone versus macrolide There was no clear difference between moxifloxacin and azithromycin for the number of participants experiencing one or more exacerbations (OR 1.00, 95% CI 0.32 to 3.10; 50 participants; very low-certainty evidence) at 13 weeks. There were no serious adverse events or deaths reported in either treatment groups. We did not identify any evidence for our other primary outcomes. Marcolide versus tetracycline There was no clear difference between azithromycin and doxycycline for the number of participants experiencing one or more exacerbations (OR 0.44, 95% CI 0.14 to 1.38; 50 participants; very low-certainty evidence) at 13 weeks. There were no serious adverse events or deaths reported in either treatment groups. We did not identify any evidence for our other primary outcomes. We did not find head-to-head evidence for impact of antibiotics on drug resistance. It is not clear from the evidence included in this review whether there is a difference in efficacy or safety between different classes or regimens of prophylactic antibiotic, given for 12 to 13 weeks to people with COPD. Whilst no head-to-head comparisons of antibiotic resistance were identified, concerns about this continue. The sample size in this review is small and both included studies are of short duration. Thus, there is considerable uncertainty in effects observed and the effects of different prophylactic antibiotics requires further research. | We found two randomised trials, including 391 people with COPD. The participants had an average age of 68 years. The first study included three groups of COPD patients taking either moxifloxacin (daily for 5 days every 4 weeks), doxycycline (daily for 13 weeks) or azithromycin (3 times per week for 13 weeks). The second study investigated the use of doxycycline (daily) in addition to roxithromycin (daily) for 12 weeks in COPD. Our main outcomes were number of exacerbations, quality of life, serious side effects (known as 'adverse events') and antibiotic resistance. Overall, we were unable to determine any difference between one antibiotic compared with each other in improving the main outcomes we measured. We were unclear whether one antibiotic was better or worse than another in terms of reducing exacerbations or improving quality of life. Neither of the studies reported a comparison between antibiotics for drug resistance. In one study lasting 13 weeks we found no serious side effects of taking moxifloxacin, azithromycin or doxycycline, and no deaths were reported. In the other study, very similar numbers of people experienced serious side effects in both the combined antibiotic and single antibiotic treatment groups after 12 weeks of treatment and 48 weeks of follow-up. However, the numbers were small so we are not sure if one treatment option may cause more side effects than the other. In the same study, five people in the combined treatment group died, compared to three people in the single treatment group. Again, these numbers are too small to draw any conclusions. We were very uncertain about the results due to finding only two small studies that gave people with COPD antibiotics for only 12 or 13 weeks. The studies only looked at four different antibiotics and did not measure all the things we were interested in. | 10.1002/14651858.CD013024.pub2 | [
"We found two randomised trials, including 391 people with COPD. The participants had an average age of 68 years. The first study included three groups of COPD patients taking either moxifloxacin (daily for 5 days every 4 weeks), doxycycline (daily for 13 weeks) or azithromycin (3 times per week for 13 weeks). The second study investigated the use of doxycycline (daily) in addition to roxithromycin (daily) for 12 weeks in COPD. Our main outcomes were number of exacerbations, quality of life, serious side effects (known as 'adverse events') and antibiotic resistance. Overall, we were unable to determine any difference between one antibiotic compared with each other in improving the main outcomes we measured. We were unclear whether one antibiotic was better or worse than another in terms of reducing exacerbations or improving quality of life. Neither of the studies reported a comparison between antibiotics for drug resistance. In one study lasting 13 weeks we found no serious side effects of taking moxifloxacin, azithromycin or doxycycline, and no deaths were reported. In the other study, very similar numbers of people experienced serious side effects in both the combined antibiotic and single antibiotic treatment groups after 12 weeks of treatment and 48 weeks of follow-up. However, the numbers were small so we are not sure if one treatment option may cause more side effects than the other. In the same study, five people in the combined treatment group died, compared to three people in the single treatment group. Again, these numbers are too small to draw any conclusions. We were very uncertain about the results due to finding only two small studies that gave people with COPD antibiotics for only 12 or 13 weeks. The studies only looked at four different antibiotics and did not measure all the things we were interested in."
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cochrane-simplification-train-1461 | cochrane-simplification-train-1461 | We included 16 trials, which all compared either vaginal or intramuscular (IM) progesterone with a placebo or no treatment, and involved a total of 4548 women. The risk of bias for the majority of included studies was low, with the exception of three studies that had inadequate blinding, or significant loss to follow-up or both, or were not reported well enough for us to make a judgement. We graded the evidence low to high quality, with downgrading for statistical heterogeneity, design limitations in some of the studies contributing data, and imprecision of the effect estimate. 1 IM progesterone versus no treatment or placebo More women delivered at less than 34 weeks' gestation in the IM progesterone group compared with placebo (risk ratio (RR) 1.54, 95% confidence interval (CI) 1.06 to 2.26; women = 399; studies = 2; low-quality evidence). Although the incidence of perinatal death in the progesterone group was higher, there was considerable uncertainty around the effect estimate and high heterogeneity between studies (average RR 1.45, 95% CI 0.60 to 3.51; infants = 3089; studies = 6; I2 = 71%; low-quality evidence). No studies reported maternal mortality or major neurodevelopmental disability at childhood follow-up. There were no clear group differences found in any of the other maternal or infant outcomes (preterm birth less than 37 weeks (RR 1.05, 95% CI 0.98 to 1.13; women = 2010; studies = 5; high-quality evidence); preterm birth less than 28 weeks (RR 1.08, 95% CI 0.75 to 1.55; women = 1920; studies = 5; moderate-quality evidence); infant birthweight less than 2500 g (RR 0.99, 95% CI 0.90 to 1.08; infants = 4071; studies = 5; I2 = 76%, moderate-quality evidence)). No childhood outcomes were reported in the trials. 2 Vaginal progesterone versus no treatment or placebo by dose There were no clear group differences in incidence of preterm birth before 34 weeks (average RR 0.90, 95% CI 0.66 to 1.23; women = 1503; studies = 5; I2 = 36%; low-quality evidence). Although fewer births before 34 weeks appeared to occur in the progesterone group, the CIs crossed the line of no effect. Incidence of perinatal death was higher in the progesterone group, although there was considerable uncertainty in the effect estimate and the quality of the evidence was low for this outcome (RR 1.23, 95% CI 0.74 to 2.06; infants = 2287; studies = 3; low-quality evidence). No studies reported maternal mortality or major neurodevelopmental disability at childhood follow-up. There were no clear group differences found in any of the other maternal or infant outcomes (preterm birth less than 37 weeks (average RR 0.97, 95% CI 0.89 to 1.06; women = 1597; studies = 6; moderate-quality evidence); preterm birth less than 28 weeks (RR 1.53, 95% CI 0.79 to 2.97; women = 1345; studies = 3; low-quality evidence); infant birthweight less than 2500 g (average RR 0.95, 95% CI 0.84 to 1.07; infants = 2640; studies = 3; I2 = 66%, moderate-quality evidence)). No childhood outcomes were reported in the trials. For secondary outcomes, there were no clear group differences found in any of the other maternal outcomes except for caesarean section, where women who received vaginal progesterone did not have as many caesarean sections as those in the placebo group, although the difference between groups was not large (8%) (RR 0.92, 95% CI 0.86 to 0.98; women = 1919; studies = 5; I2 = 0%). There were no clear group differences found in any of the infant outcomes except for mechanical ventilation, which was required by fewer infants whose mothers had received the vaginal progesterone (RR 0.70, 95% CI 0.52 to 0.94; infants = 2695; studies = 4). Overall, for women with a multiple pregnancy, the administration of progesterone (either IM or vaginal) does not appear to be associated with a reduction in risk of preterm birth or improved neonatal outcomes. Future research could focus on a comprehensive individual participant data meta-analysis including all of the available data relating to both IM and vaginal progesterone administration in women with a multiple pregnancy, before considering the need to conduct trials in subgroups of high-risk women (for example, women with a multiple pregnancy and a short cervical length identified on ultrasound). | We searched for evidence on 1 November 2016 and identified 16 randomised controlled trials involving 4548 women for inclusion in the review. In studies where women received progesterone by injection into the muscle compared with placebo (dummy treatment) more women gave birth before the 34th week of pregnancy in the progesterone group (low-quality evidence). There was no clear difference between the groups in the likelihood of the baby dying before or soon after the birth (low-quality evidence). No studies reported whether any women died or whether any babies had longer-term developmental problems or disability. There seems to be little or no difference between women receiving progesterone or placebo for other important outcomes, such as preterm birth before 37 weeks (high-quality evidence); preterm birth before 28 weeks (moderate-quality evidence) or infant birthweight less than 2500 grams (moderate-quality evidence). No childhood outcomes were reported in the trials. In studies where women received vaginal progesterone there may be little or no difference between women receiving progesterone or placebo in preterm birth before 34 weeks (low-quality evidence); although fewer births before 34 weeks occurred in the progesterone group, this finding may have occurred by chance. The number of infant deaths before or soon after birth was similar in both groups (low-quality evidence). No studies reported maternal death or longer-term outcomes for babies. There may be little or no difference between groups receiving vaginal progesterone versus placebo in any other important outcomes (preterm birth before 37 weeks (moderate-quality evidence); preterm birth before 28 weeks (low-quality evidence); or infant birthweight less than 2500 grams (moderate-quality evidence)). No childhood outcomes were reported in the trials. For other outcomes, we found no clear group differences, except for caesarean section where women who received vaginal progesterone did not have as many caesarean sections as those in the placebo group (although the difference between groups was not large (8%)). Fewer infants whose mothers had received the vaginal progesterone needed mechanical help with breathing. We did not find any studies looking at progesterone taken by mouth. Overall, for women with a multiple pregnancy, treatment with progesterone (either intramuscular or vaginal) does not appear to reduce the likelihood of preterm birth or improve outcomes for babies. Future research could focus on looking at information about individual women taking part in studies, so that everything available about both intramuscular and vaginal progesterone treatments in women with a multiple pregnancy can be considered together. | 10.1002/14651858.CD012024.pub3 | [
"We searched for evidence on 1 November 2016 and identified 16 randomised controlled trials involving 4548 women for inclusion in the review. In studies where women received progesterone by injection into the muscle compared with placebo (dummy treatment) more women gave birth before the 34th week of pregnancy in the progesterone group (low-quality evidence). There was no clear difference between the groups in the likelihood of the baby dying before or soon after the birth (low-quality evidence). No studies reported whether any women died or whether any babies had longer-term developmental problems or disability. There seems to be little or no difference between women receiving progesterone or placebo for other important outcomes, such as preterm birth before 37 weeks (high-quality evidence); preterm birth before 28 weeks (moderate-quality evidence) or infant birthweight less than 2500 grams (moderate-quality evidence). No childhood outcomes were reported in the trials. In studies where women received vaginal progesterone there may be little or no difference between women receiving progesterone or placebo in preterm birth before 34 weeks (low-quality evidence); although fewer births before 34 weeks occurred in the progesterone group, this finding may have occurred by chance. The number of infant deaths before or soon after birth was similar in both groups (low-quality evidence). No studies reported maternal death or longer-term outcomes for babies. There may be little or no difference between groups receiving vaginal progesterone versus placebo in any other important outcomes (preterm birth before 37 weeks (moderate-quality evidence); preterm birth before 28 weeks (low-quality evidence); or infant birthweight less than 2500 grams (moderate-quality evidence)). No childhood outcomes were reported in the trials. For other outcomes, we found no clear group differences, except for caesarean section where women who received vaginal progesterone did not have as many caesarean sections as those in the placebo group (although the difference between groups was not large (8%)). Fewer infants whose mothers had received the vaginal progesterone needed mechanical help with breathing. We did not find any studies looking at progesterone taken by mouth. Overall, for women with a multiple pregnancy, treatment with progesterone (either intramuscular or vaginal) does not appear to reduce the likelihood of preterm birth or improve outcomes for babies. Future research could focus on looking at information about individual women taking part in studies, so that everything available about both intramuscular and vaginal progesterone treatments in women with a multiple pregnancy can be considered together."
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cochrane-simplification-train-1462 | cochrane-simplification-train-1462 | Four randomised controlled trials were included. No unintended pregnancies were reported during the study periods. Only one trial was of good methodological quality. It compared the influence of a levonorgestrel-releasing intrauterine device (IUD) versus a copper IUD on carbohydrate metabolism in women with type 1 diabetes mellitus. No significant difference was found between the two groups. The other three trials were of limited methodological quality. Two compared progestogen-only pills with different estrogen and progestogen combinations, and one also included the levonorgestrel-releasing IUD and copper IUD. The trials reported that blood glucose levels remained stable during treatment with most regimens. Only high-dose combined oral contraceptives and 30 µg ethinylestradiol + 75 µg gestodene were identified as slightly impairing glucose homeostasis. The three studies found conflicting results regarding lipid metabolism. Some combined oral contraceptives appeared to have a minor adverse effect while others appeared to slightly improve lipid metabolism. The copper IUD and progestogen-only oral contraceptives also slightly improved lipid metabolism and no influence was seen while using the levonorgestel-releasing IUD. Only one study reported on micro- and macrovascular complications. It observed no signs or symptoms of thromboembolic incidents or visual disturbances, however study duration was short. Only minor adverse effects were reported in two studies. The four included randomised controlled trials in this systematic review provided insufficient evidence to assess whether progestogen-only and combined contraceptives differ from non-hormonal contraceptives in diabetes control, lipid metabolism and complications. Three of the four studies were of limited methodological quality, sponsored by pharmaceutical companies and described surrogate outcomes. Ideally, an adequately reported, high-quality randomised controlled trial analysing both intermediate outcomes (that is glucose and lipid metabolism) and true clinical endpoints (micro- and macrovascular disease) in users of combined, progestogen-only and non-hormonal contraceptives should be conducted. However, due to the low incidence of micro- and macrovascular disease and accordingly the large sample size and long follow-up period needed to observe differences in risk, a randomised controlled trial might not be the ideal design. | In this review, both progestogen-only methods (pills and an intrauterine device) and low-dose combined oral contraceptives appeared to have only minor influences on glucose and fat metabolism. However only four studies, most of limited quality, examining a small number of women were included in this review. Only one of the studies reported on true clinical endpoints that is micro- and macrovascular disease. It found no signs or symptoms of thromboembolic incidents or visual disturbances. However this trial was performed over a short period of time. Therefore no definite conclusions can be made based on this review. Future trials analysing glucose and fat metabolism as well as long-term complications for all available contraceptive methods are needed. | 10.1002/14651858.CD003990.pub4 | [
"In this review, both progestogen-only methods (pills and an intrauterine device) and low-dose combined oral contraceptives appeared to have only minor influences on glucose and fat metabolism. However only four studies, most of limited quality, examining a small number of women were included in this review. Only one of the studies reported on true clinical endpoints that is micro- and macrovascular disease. It found no signs or symptoms of thromboembolic incidents or visual disturbances. However this trial was performed over a short period of time. Therefore no definite conclusions can be made based on this review. Future trials analysing glucose and fat metabolism as well as long-term complications for all available contraceptive methods are needed."
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cochrane-simplification-train-1463 | cochrane-simplification-train-1463 | We included 24 studies (5577 women). There were no trials specifically of miscarriage treatment after 13 weeks' gestation. Three trials involving 335 women compared misoprostol treatment (all vaginally administered) with expectant care. There was no difference in complete miscarriage (average risk ratio (RR) 1.23, 95% confidence interval (CI) 0.72 to 2.10; 2 studies, 150 women, random-effects; very low-quality evidence), or in the need for surgical evacuation (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, 308 women, random-effects; low-quality evidence). There were few data on 'deaths or serious complications'. For unplanned surgical intervention, we did not identify any difference between misoprostol and expectant care (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, 308 women, random-effects; low-quality evidence). Sixteen trials involving 4044 women addressed the comparison of misoprostol (7 studies used oral administration, 6 studies used vaginal, 2 studies sublingual, 1 study combined vaginal + oral) with surgical evacuation. There was a slightly lower incidence of complete miscarriage with misoprostol (average RR 0.96, 95% CI 0.94 to 0.98; 15 studies, 3862 women, random-effects; very low-quality evidence) but with success rate high for both methods. Overall, there were fewer surgical evacuations with misoprostol (average RR 0.05, 95% CI 0.02 to 0.11; 13 studies, 3070 women, random-effects; very low-quality evidence) but more unplanned procedures (average RR 5.03, 95% CI 2.71 to 9.35; 11 studies, 2690 women, random-effects; low-quality evidence). There were few data on 'deaths or serious complications'. Nausea was more common with misoprostol (average RR 2.50, 95% CI 1.53 to 4.09; 11 studies, 3015 women, random-effects; low-quality evidence). We did not identify any difference in women's satisfaction between misoprostol and surgery (average RR 1.00, 95% CI 0.99 to 1.00; 9 studies, 3349 women, random-effects; moderate-quality evidence). More women had vomiting and diarrhoea with misoprostol compared with surgery (vomiting: average RR 1.97, 95% CI 1.36 to 2.85; 10 studies, 2977 women, random-effects; moderate-quality evidence; diarrhoea: average RR 4.82, 95% CI 1.09 to 21.32; 4 studies, 757 women, random-effects; moderate-quality evidence). Five trials compared different routes of administration, or doses, or both, of misoprostol. There was no clear evidence of one regimen being superior to another. Limited evidence suggests that women generally seem satisfied with their care. Long-term follow-up from one included study identified no difference in subsequent fertility between the three approaches. The available evidence suggests that medical treatment, with misoprostol, and expectant care are both acceptable alternatives to routine surgical evacuation given the availability of health service resources to support all three approaches. Further studies, including long-term follow-up, are clearly needed to confirm these findings. There is an urgent need for studies on women who miscarry at more than 13 weeks' gestation. | We searched for evidence on 13 May 2016 and identified 24 studies involving 5577 women, and all these studies were of women at less than 13 weeks' gestation. There were a number of different ways of giving the drugs and so there are limited data for each comparison. Overall, the review found no real difference in the success between misoprostol and waiting for spontaneous miscarriage (expectant care), nor between misoprostol and surgery. The overall success rate of treatment (misoprostol and surgery) was over 80% and sometimes as high as 99%, and one study identified no difference in subsequent fertility between methods of medication, surgery or expectant management. Vaginal misoprostol was compared with oral misoprostol in one study which found no difference in success, but there was an increase in the incidence of diarrhoea with oral misoprostol. However, women on the whole seemed happy with their care, whichever treatment they were given. The review suggests that misoprostol or waiting for spontaneous expulsion of fragments are important alternatives to surgery, but women should be offered an informed choice. Further studies are clearly needed to confirm these findings and should include long-term follow-up. There is an urgent need for studies on women who miscarry at more than 13 weeks' gestation. | 10.1002/14651858.CD007223.pub4 | [
"We searched for evidence on 13 May 2016 and identified 24 studies involving 5577 women, and all these studies were of women at less than 13 weeks' gestation. There were a number of different ways of giving the drugs and so there are limited data for each comparison. Overall, the review found no real difference in the success between misoprostol and waiting for spontaneous miscarriage (expectant care), nor between misoprostol and surgery. The overall success rate of treatment (misoprostol and surgery) was over 80% and sometimes as high as 99%, and one study identified no difference in subsequent fertility between methods of medication, surgery or expectant management. Vaginal misoprostol was compared with oral misoprostol in one study which found no difference in success, but there was an increase in the incidence of diarrhoea with oral misoprostol. However, women on the whole seemed happy with their care, whichever treatment they were given. The review suggests that misoprostol or waiting for spontaneous expulsion of fragments are important alternatives to surgery, but women should be offered an informed choice. Further studies are clearly needed to confirm these findings and should include long-term follow-up. There is an urgent need for studies on women who miscarry at more than 13 weeks' gestation."
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cochrane-simplification-train-1464 | cochrane-simplification-train-1464 | We included 20 trials using a variety of biomedical tests interventions; one trial included two interventions, for a total of 21 interventions. We included a total of 9262 participants, all of whom were adult smokers. All studies included both men and women adult smokers at different stages of change and motivation for smoking cessation. We judged all but three studies to be at high or unclear risk of bias in at least one domain. We pooled trials in three categories according to the type of biofeedback provided: feedback on risk exposure (five studies); feedback on smoking-related disease risk (five studies); and feedback on smoking-related harm (11 studies). There was no evidence of increased cessation rates from feedback on risk exposure, consisting mainly of feedback on CO measurement, in five pooled trials (RR 1.00, 95% CI 0.83 to 1.21; I2 = 0%; n = 2368). Feedback on smoking-related disease risk, including four studies testing feedback on genetic markers for cancer risk and one study with feedback on genetic markers for risk of Crohn's disease, did not show a benefit in smoking cessation (RR 0.80, 95% CI 0.63 to 1.01; I2 = 0%; n = 2064). Feedback on smoking-related harm, including nine studies testing spirometry with or without feedback on lung age and two studies on feedback on carotid ultrasound, also did not show a benefit (RR 1.26, 95% CI 0.99 to 1.61; I2 = 34%; n = 3314). Only one study directly compared multiple forms of measurement with a single form of measurement, and did not detect a significant difference in effect between measurement of CO plus genetic susceptibility to lung cancer and measurement of CO only (RR 0.82, 95% CI 0.43 to 1.56; n = 189). There is little evidence about the effects of biomedical risk assessment as an aid for smoking cessation. The most promising results relate to spirometry and carotid ultrasound, where moderate-certainty evidence, limited by imprecision and risk of bias, did not detect a statistically significant benefit, but confidence intervals very narrowly missed one, and the point estimate favoured the intervention. A sensitivity analysis removing those studies at high risk of bias did detect a benefit. Moderate-certainty evidence limited by risk of bias did not detect an effect of feedback on smoking exposure by CO monitoring. Low-certainty evidence, limited by risk of bias and imprecision, did not detect a benefit from feedback on smoking-related risk by genetic marker testing. There is insufficient evidence with which to evaluate the hypothesis that multiple types of assessment are more effective than single forms of assessment. | This review includes 20 studies using a variety of measurements. One study included two measurements, for a total of 21 measurements assessed. The main feedback measurements we assessed were the level of carbon monoxide in people's breath (a sign of current smoking), measures of lung function (a sign of lung damage from smoking), genetic tests to provide individual risk of cancer, and ultrasound of major arteries in the neck to measure the amount of plaque (a risk factor for stroke). We grouped studies into three categories according to the type of feedback people were given: feedback on exposure to smoking (five studies); feedback on a person's risk for smoking-related diseases (five studies); and feedback on the harms of smoking (11 studies). The studies included a total of 9262 people. All participants were adult smokers, and both men and women were included (although one study performed in a clinic for army veterans included only 4% women). Most studies were conducted in general practices or ambulatory clinics. All of the studies lasted at least six months. The reported evidence is current as of March 2018. We did not find evidence that giving smokers feedback on their smoking exposure, their genetic risk of smoking-related disease, or the effects of smoking on their body helps them quit smoking. The most promising results were for giving people feedback on the harm smoking does to their bodies. The studies did not report on harms or side effects of providing feedback. However, given the nature of the measurements (lung or blood tests), we would expect the risk of harms to be low. Because of problems with the way some of the studies were conducted, we think that further research is likely to change our conclusions. | 10.1002/14651858.CD004705.pub5 | [
"This review includes 20 studies using a variety of measurements. One study included two measurements, for a total of 21 measurements assessed. The main feedback measurements we assessed were the level of carbon monoxide in people's breath (a sign of current smoking), measures of lung function (a sign of lung damage from smoking), genetic tests to provide individual risk of cancer, and ultrasound of major arteries in the neck to measure the amount of plaque (a risk factor for stroke). We grouped studies into three categories according to the type of feedback people were given: feedback on exposure to smoking (five studies); feedback on a person's risk for smoking-related diseases (five studies); and feedback on the harms of smoking (11 studies). The studies included a total of 9262 people. All participants were adult smokers, and both men and women were included (although one study performed in a clinic for army veterans included only 4% women). Most studies were conducted in general practices or ambulatory clinics. All of the studies lasted at least six months. The reported evidence is current as of March 2018. We did not find evidence that giving smokers feedback on their smoking exposure, their genetic risk of smoking-related disease, or the effects of smoking on their body helps them quit smoking. The most promising results were for giving people feedback on the harm smoking does to their bodies. The studies did not report on harms or side effects of providing feedback. However, given the nature of the measurements (lung or blood tests), we would expect the risk of harms to be low. Because of problems with the way some of the studies were conducted, we think that further research is likely to change our conclusions."
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cochrane-simplification-train-1465 | cochrane-simplification-train-1465 | Thirty-seven trials were identified; only one was at low risk of bias. Most of the analyses failed to find any significant differences. The significant findings that were found were the following: 1) icteric medical patients receiving parenteral nutrition had a reduced serum bilirubin (mean difference (MD) -2.86 mg%, 95% CI -3.82 mg% to -1.89 mg%, 3 trials) and better nitrogen balance (MD 3.60 g/day, 95% CI 0.86 g/day to 6.34 g/day, 1 trial); 2) surgical patients receiving parenteral nutrition had a reduced incidence of postoperative ascites only in the fixed-effect model (RR 0.65, 95% CI 0.48 to 0.87, 2 trials, I2 = 70%) and one trial demonstrated a reduction in postoperative complications, especially infections (pneumonia in particular); 3) enteral nutrition may have improved nitrogen balance in medical patients (although a combination of the three trials was not possible); 4) one surgical trial of enteral nutrition found a reduction in postoperative complications; and 5) oral nutritional supplements had several effects in medical patients (reduced occurrence of ascites (RR 0.57, 95% CI 0.37 to 0.88, 3 trials), possibly (significant differences only seen in the fixed-effect model) reduced rates of infection (RR 0.49, 95% CI 0.24 to 0.99, 3 trials, I2 = 14%), and improved resolution of hepatic encephalopathy (RR 3.75, 95% CI 1.15 to 12.18, 2 trials, I2 = 79%). While there was no overall effect of the supplements on mortality in medical patients, the one low risk of bias trial found an increased risk of death in the recipients of the supplements. Three trials of supplements in surgical patients failed to show any significant differences. No new information was derived from the various subgroup or sensitivity analyses. The exploratory analyses were also unrevealing except for a logical conundrum. There was no difference in mortality when all of the trials were combined, but the trials of parenteral nutrition found that those recipients had better survival (RR 0.53, 95% CI 0.29 to 0.98, 10 trials). Either the former observation represents a type II error or the latter one a type I error. The data do not compellingly justify the routine use of parenteral nutrition, enteral nutrition, or oral nutritional supplements in patients with liver disease. The fact that all but one of these trials were at high risks of bias even casts doubt on the few benefits that were demonstrated. Data from well-designed and executed randomised trials that include an untreated control group are needed before any such recommendation can be made. Future trials have to be powered adequately to see small, but clinically important, differences. | Since the best way to make such a determination is to undertake randomised trials, in which patients are assigned by chance to receive, or not receive, one or another of these treatments, this systematic review was undertaken to identify and summarise this information. Randomised trials comparing patients with liver diseases who were assigned to receive parenteral nutrition, enteral nutrition, or oral nutritional supplements to similar patients assigned not to receive any nutritional intervention were collected. The three nutritional interventions were considered separately. In addition, within each category of nutritional intervention, patients with medical conditions were compared separately from patients with surgical conditions. Thus there were six primary analyses, medical patients receiving or not receiving parenteral nutrition, surgical patients receiving or not receiving parenteral nutrition, medical patients receiving or not receiving enteral nutrition, surgical patients receiving or not receiving enteral nutrition, medical patients receiving or not receiving supplements by mouth, and surgical patients receiving or not receiving supplements by mouth. The outcomes of interest were mortality, hepatic morbidity (ascites, gastrointestinal bleeding, encephalopathy), quality of life, adverse events, infections, cost, duration of hospitalisation, jaundice, postoperative complications (only for the surgical trials), and nutritional outcomes (for example, body weight). A total of 37 randomised trials were identified. All but one had a high risk of systematic error (bias, that is overestimation of benefits and underestimation of harms). When the data were combined, most of the analyses failed to demonstrate a difference. There were some significant differences observed. These were that 1) parenteral nutrition reduced serum bilirubin more rapidly and improved one type of nutritional outcome (nitrogen balance) in medical patients with jaundice, and may have reduced some postoperative complications; 2) enteral nutrition may have improved nitrogen balance in medical patients, and reduced postoperative complications in surgical patients; and 3) supplements reduced the occurrence of ascites and also may have decreased the number of infections. Furthermore, the receipt of supplements (especially ones containing branched-chain amino acids) may have been helpful in the treatment of patients with hepatic encephalopathy. No significant effects were seen from the use of supplements in surgical patients. None of these observed benefits can be said to be definitively present because of the presence of methodologic flaws in the trials, which may have produced an overestimation of the observed effect. Moreover, due to too few patients included in the trials with two few outcome measures, both spurious significant findings and spurious insignificant findings cannot be excluded. The data are not strong enough to justify a recommendation to use these nutritional interventions routinely. We need well-designed and well-conducted randomised trials to prove that such therapy is indeed efficacious. | 10.1002/14651858.CD008344.pub2 | [
"Since the best way to make such a determination is to undertake randomised trials, in which patients are assigned by chance to receive, or not receive, one or another of these treatments, this systematic review was undertaken to identify and summarise this information. Randomised trials comparing patients with liver diseases who were assigned to receive parenteral nutrition, enteral nutrition, or oral nutritional supplements to similar patients assigned not to receive any nutritional intervention were collected. The three nutritional interventions were considered separately. In addition, within each category of nutritional intervention, patients with medical conditions were compared separately from patients with surgical conditions. Thus there were six primary analyses, medical patients receiving or not receiving parenteral nutrition, surgical patients receiving or not receiving parenteral nutrition, medical patients receiving or not receiving enteral nutrition, surgical patients receiving or not receiving enteral nutrition, medical patients receiving or not receiving supplements by mouth, and surgical patients receiving or not receiving supplements by mouth. The outcomes of interest were mortality, hepatic morbidity (ascites, gastrointestinal bleeding, encephalopathy), quality of life, adverse events, infections, cost, duration of hospitalisation, jaundice, postoperative complications (only for the surgical trials), and nutritional outcomes (for example, body weight). A total of 37 randomised trials were identified. All but one had a high risk of systematic error (bias, that is overestimation of benefits and underestimation of harms). When the data were combined, most of the analyses failed to demonstrate a difference. There were some significant differences observed. These were that 1) parenteral nutrition reduced serum bilirubin more rapidly and improved one type of nutritional outcome (nitrogen balance) in medical patients with jaundice, and may have reduced some postoperative complications; 2) enteral nutrition may have improved nitrogen balance in medical patients, and reduced postoperative complications in surgical patients; and 3) supplements reduced the occurrence of ascites and also may have decreased the number of infections. Furthermore, the receipt of supplements (especially ones containing branched-chain amino acids) may have been helpful in the treatment of patients with hepatic encephalopathy. No significant effects were seen from the use of supplements in surgical patients. None of these observed benefits can be said to be definitively present because of the presence of methodologic flaws in the trials, which may have produced an overestimation of the observed effect. Moreover, due to too few patients included in the trials with two few outcome measures, both spurious significant findings and spurious insignificant findings cannot be excluded. The data are not strong enough to justify a recommendation to use these nutritional interventions routinely. We need well-designed and well-conducted randomised trials to prove that such therapy is indeed efficacious."
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cochrane-simplification-train-1466 | cochrane-simplification-train-1466 | Heparinization of the infusate decreases the incidence of catheter occlusion but does not affect the frequency of aortic thrombosis. Heparinization of the flush solution is not an adequate alternative. There does not appear to be an effect on frequency of intraventricular hemorrhage, death or clinical ischemic phenomena. Heparinization of the fluid infused through an umbilical arterial catheter decreases the likelihood of umbilical arterial catheters occluding. The lowest concentration tested so far (0.25 units/mL) has been shown to be effective. Heparinization of flushes without heparinizing the infusate is ineffective. The frequency of aortic thrombosis has not been shown to be affected; however, the confidence intervals for this effect are very wide. The frequency of intraventricular hemorrhage has not been shown to be affected by heparinization of the infusate, but again the confidence intervals are very wide and even a major increase in the incidence of grade 3 and 4 intraventricular hemorrhage would not have been detected. | This review found that low heparin doses are effective in preventing catheters becoming blocked and needing to be re-inserted. There is not enough evidence to rule out the possibility of adverse effects. Heparin does not seem to lower the rate of blood clots in the major artery. | 10.1002/14651858.CD000507 | [
"This review found that low heparin doses are effective in preventing catheters becoming blocked and needing to be re-inserted. There is not enough evidence to rule out the possibility of adverse effects. Heparin does not seem to lower the rate of blood clots in the major artery."
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cochrane-simplification-train-1467 | cochrane-simplification-train-1467 | The initial search identified 1014 records which identified 13 publications for further examination. After screening the full text of the 13 selected papers, only one study evaluating 47 babies finally met the inclusion criteria. Using the same cohort at two different time periods, the study investigated the effects of high versus low dose thyroid hormone replacement in relation to (1) time taken to achieve euthyroid status and (2) neurodevelopmental outcome. The study reported that a high dose is more effective in rising serum thyroxine and free thyroxine concentrations to the target range and earlier normalisation of thyroid stimulating hormone compared to a lower dose. Similarly, full scale intelligence quotient was noted to be significantly higher in children who received the high dose compared to the lower dose. However, the verbal intelligence quotient and performance intelligence quotient were similar in both groups. Growth and adverse effects were not reported in the included trial. There is currently only one randomised controlled trial evaluating the effects of high versus low dose of initial thyroid hormone replacement for CHT. There is inadequate evidence to suggest that a high dose is more beneficial compared to a low dose initial thyroid hormone replacement in the treatment of CHT. | There is currently only one study reporting on 47 babies that fulfils our review criteria and compares different high dose versus low dose of initial replacement thyroxine for the treatment of congenital hypothyroidism. There is not enough evidence to suggest that a high dose is more beneficial than a low dose therapy. Growth and adverse effects were not reported in the included study. There should be more randomised controlled trials to assess the effects of high versus low dose of initial thyroid hormone replacement for congenital hypothyroidism. | 10.1002/14651858.CD006972.pub2 | [
"There is currently only one study reporting on 47 babies that fulfils our review criteria and compares different high dose versus low dose of initial replacement thyroxine for the treatment of congenital hypothyroidism. There is not enough evidence to suggest that a high dose is more beneficial than a low dose therapy. Growth and adverse effects were not reported in the included study. There should be more randomised controlled trials to assess the effects of high versus low dose of initial thyroid hormone replacement for congenital hypothyroidism."
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cochrane-simplification-train-1468 | cochrane-simplification-train-1468 | Seven studies enrolling 385 patients were included. There were substantial methodological concerns for most studies including the use of quasi-random allocation methods and sizeable, largely unexplained differences in reported numbers allocated to each group. One study reported phenobarbitone compared to supportive care alone did not reduce treatment failure or time to regain birthweight, but resulted in a significant reduction in duration of supportive care (MD -162.1 min/day, 95% CI -249.2, -75.1). Comparing phenobarbitone to diazepam, meta-analysis of two studies found phenobarbitone resulted in a significant reduction in treatment failure (typical RR 0.39, 95% CI 0.24, 0.62). Comparing phenobarbitone with chlorpromazine, one study reported no significant difference in treatment failure. In infants treated with an opiate, one study reported addition of clonidine resulted in no significant difference in treatment failure, seizures or mortality. In infants treated with an opiate, one study reported addition of phenobarbitone significantly reduced the proportion of time infants had a high abstinence severity score, duration of hospitalisation and maximal daily dose of opiate. Infants with NAS due to opiate withdrawal should receive initial treatment with an opiate. Where a sedative is used, phenobarbitone should be used in preference to diazepam. In infants treated with an opiate, the addition of phenobarbitone or clonidine may reduce withdrawal severity. Further studies are needed to determine the role of sedatives in infants with NAS due to opiate withdrawal and the safety and efficacy of adding phenobarbitone or clonidine in infants treated with an opiate for NAS. | Trials of sedatives have generally been of poor quality. Individual studies have reported that use of phenobarbitone compared to supportive care alone reduces the amount time an infant needs supportive care, is better than diazepam at preventing treatment failure and reduces the severity of withdrawal in infants treated with a opiate. In infants treated with an opiate, the addition of a sedative (phenobarbitone or clonidine) may reduce withdrawal severity, although safety and efficacy need confirming. The long term effects of use of phenobarbitone on an infant's development have not been determined. | 10.1002/14651858.CD002053.pub3 | [
"Trials of sedatives have generally been of poor quality. Individual studies have reported that use of phenobarbitone compared to supportive care alone reduces the amount time an infant needs supportive care, is better than diazepam at preventing treatment failure and reduces the severity of withdrawal in infants treated with a opiate. In infants treated with an opiate, the addition of a sedative (phenobarbitone or clonidine) may reduce withdrawal severity, although safety and efficacy need confirming. The long term effects of use of phenobarbitone on an infant's development have not been determined."
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cochrane-simplification-train-1469 | cochrane-simplification-train-1469 | We found one eligible trial that included 72 preterm infants. This trial was not blinded. We are uncertain as to the effect of re-feeding gastric residual on efficacy outcomes such as time to regain birth weight (mean difference (MD) 0.40 days, 95% confidence interval (CI) -2.89 to 3.69 days; very low quality evidence), time to reach enteral feeds ≥ 120 mL/kg/d (MD -1.30 days, 95% CI -2.93 to 0.33 days; very low quality evidence), number of infants with extrauterine growth restriction at discharge (risk ratio (RR) 1.29, 95% CI 0.38 to 4.34; very low quality evidence), duration of total parenteral nutrition (MD -0.30 days, 95% CI -2.07 to 1.47 days; very low quality evidence), and length of hospital stay (MD -1.90 days, 95% CI -25.27 to 21.47 days; very low quality evidence). Similarly, we are uncertain as to the effect of re-feeding gastric residual on safety outcomes such as incidence of stage 2 or 3 necrotising enterocolitis and/or spontaneous intestinal perforation (RR 0.71, 95% CI 0.25 to 2.04; very low quality evidence), number of episodes of feed interruption lasting ≥ 12 hours (RR 0.80, 95% CI 0.42 to 1.52; very low quality evidence), or mortality before discharge (RR 0.50, 95% CI 0.14 to 1.85; low-quality evidence). We are uncertain as to the effect of re-feeding gastric residual in the subgroups of human milk-fed and formula-fed infants. We found no data on other outcomes such as linear and head growth during hospital stay, postdischarge growth, number of infants with parenteral nutrition-associated liver disease, and neurodevelopmental outcomes. We found only limited data from one small unblinded trial on the efficacy and safety of re-feeding gastric residuals in preterm infants. The quality of evidence was low to very low. Hence, available evidence is insufficient to support or refute re-feeding of gastric residuals in preterm infants. A large, randomised controlled trial is needed to provide data of sufficient quality and precision to inform policy and practice. | The thorough literature search is up-to-date as of Febraury 2018. We found only one small randomised controlled trial (with 72 preterm infant participants) that addressed this question. We are uncertain as to whether re-feeding stomach aspirates has an effect on important outcomes such as incidence of necrotising enterocolitis, mortality before discharge, time to regain birth weight, time to reach full enteral feeds, duration of parenteral nutrition and duration of hospital stay. Available evidence is insufficient to support or refute re-feeding of stomach aspirates in preterm infants. More trials are needed to examine whether re-feeding the stomach aspirates is beneficial or harmful in preterm infants. | 10.1002/14651858.CD012940.pub2 | [
"The thorough literature search is up-to-date as of Febraury 2018. We found only one small randomised controlled trial (with 72 preterm infant participants) that addressed this question. We are uncertain as to whether re-feeding stomach aspirates has an effect on important outcomes such as incidence of necrotising enterocolitis, mortality before discharge, time to regain birth weight, time to reach full enteral feeds, duration of parenteral nutrition and duration of hospital stay. Available evidence is insufficient to support or refute re-feeding of stomach aspirates in preterm infants. More trials are needed to examine whether re-feeding the stomach aspirates is beneficial or harmful in preterm infants."
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cochrane-simplification-train-1470 | cochrane-simplification-train-1470 | We included four new studies (530 participants), and excluded three previously included studies (126 participants). In all, 37 studies provided information on 5914 participants. Most studies used oral gabapentin or gabapentin encarbil at doses of 1200 mg or more daily in different neuropathic pain conditions, predominantly postherpetic neuralgia and painful diabetic neuropathy. Study duration was typically four to 12 weeks. Not all studies reported important outcomes of interest. High risk of bias occurred mainly due to small size (especially in cross-over studies), and handling of data after study withdrawal. In postherpetic neuralgia, more participants (32%) had substantial benefit (at least 50% pain relief or PGIC very much improved) with gabapentin at 1200 mg daily or greater than with placebo (17%) (RR 1.8 (95% CI 1.5 to 2.1); NNT 6.7 (5.4 to 8.7); 8 studies, 2260 participants, moderate-quality evidence). More participants (46%) had moderate benefit (at least 30% pain relief or PGIC much or very much improved) with gabapentin at 1200 mg daily or greater than with placebo (25%) (RR 1.8 (95% CI 1.6 to 2.0); NNT 4.8 (4.1 to 6.0); 8 studies, 2260 participants, moderate-quality evidence). In painful diabetic neuropathy, more participants (38%) had substantial benefit (at least 50% pain relief or PGIC very much improved) with gabapentin at 1200 mg daily or greater than with placebo (23%) (RR 1.7 (95% CI 1.4 to 2.0); NNT 6.6 (5.0 to 10); 6 studies, 1331 participants, moderate-quality evidence). More participants (52%) had moderate benefit (at least 30% pain relief or PGIC much or very much improved) with gabapentin at 1200 mg daily or greater than with placebo (37%) (RR 1.4 (95% CI 1.3 to 1.6); NNT 6.6 (4.9 to 9.9); 7 studies, 1439 participants, moderate-quality evidence). For all conditions combined, adverse event withdrawals were more common with gabapentin (11%) than with placebo (8.2%) (RR 1.4 (95% CI 1.1 to 1.7); NNH 30 (20 to 65); 22 studies, 4346 participants, high-quality evidence). Serious adverse events were no more common with gabapentin (3.2%) than with placebo (2.8%) (RR 1.2 (95% CI 0.8 to 1.7); 19 studies, 3948 participants, moderate-quality evidence); there were eight deaths (very low-quality evidence). Participants experiencing at least one adverse event were more common with gabapentin (63%) than with placebo (49%) (RR 1.3 (95% CI 1.2 to 1.4); NNH 7.5 (6.1 to 9.6); 18 studies, 4279 participants, moderate-quality evidence). Individual adverse events occurred significantly more often with gabapentin. Participants taking gabapentin experienced dizziness (19%), somnolence (14%), peripheral oedema (7%), and gait disturbance (14%). Gabapentin at doses of 1800 mg to 3600 mg daily (1200 mg to 3600 mg gabapentin encarbil) can provide good levels of pain relief to some people with postherpetic neuralgia and peripheral diabetic neuropathy. Evidence for other types of neuropathic pain is very limited. The outcome of at least 50% pain intensity reduction is regarded as a useful outcome of treatment by patients, and the achievement of this degree of pain relief is associated with important beneficial effects on sleep interference, fatigue, and depression, as well as quality of life, function, and work. Around 3 or 4 out of 10 participants achieved this degree of pain relief with gabapentin, compared with 1 or 2 out of 10 for placebo. Over half of those treated with gabapentin will not have worthwhile pain relief but may experience adverse events. Conclusions have not changed since the previous update of this review. | In January 2017 we searched for clinical trials in which gabapentin was used to treat neuropathic pain in adults. We found 37 studies that satisfied the inclusion criteria, randomising 5914 participants to treatment with gabapentin, placebo, or other drugs. Studies lasted 4 to 12 weeks. Most studies reported beneficial outcomes that people with neuropathic pain think are important. Results were mainly in pain after shingles and pain resulting from nerve damage in diabetes. In pain after shingles, 3 in 10 people had pain reduced by half or more with gabapentin and 2 in 10 with placebo. Pain was reduced by a third or more for 5 in 10 with gabapentin and 3 in 10 with placebo. In pain caused by diabetes, 4 in 10 people had pain reduced by half or more with gabapentin and 2 in 10 with placebo. Pain was reduced by a third or more for 5 in 10 with gabapentin and 4 in 10 with placebo. There was no reliable evidence for any other type of neuropathic pain. Side effects were more common with gabapentin (6 in 10) than with placebo (5 in 10). Dizziness, sleepiness, water retention, and problems with walking each occurred in about 1 in 10 people who took gabapentin. Serious side effects were uncommon, and not different between gabapentin and placebo. Slightly more people taking gabapentin stopped taking it because of side effects. Gabapentin is helpful for some people with chronic neuropathic pain. It is not possible to know beforehand who will benefit and who will not. Current knowledge suggests that a short trial is the best way of telling. The evidence was mostly of moderate quality. This means that the research provides a good indication of the likely effect. The likelihood that the effect will be substantially different is moderate. | 10.1002/14651858.CD007938.pub4 | [
"In January 2017 we searched for clinical trials in which gabapentin was used to treat neuropathic pain in adults. We found 37 studies that satisfied the inclusion criteria, randomising 5914 participants to treatment with gabapentin, placebo, or other drugs. Studies lasted 4 to 12 weeks. Most studies reported beneficial outcomes that people with neuropathic pain think are important. Results were mainly in pain after shingles and pain resulting from nerve damage in diabetes. In pain after shingles, 3 in 10 people had pain reduced by half or more with gabapentin and 2 in 10 with placebo. Pain was reduced by a third or more for 5 in 10 with gabapentin and 3 in 10 with placebo. In pain caused by diabetes, 4 in 10 people had pain reduced by half or more with gabapentin and 2 in 10 with placebo. Pain was reduced by a third or more for 5 in 10 with gabapentin and 4 in 10 with placebo. There was no reliable evidence for any other type of neuropathic pain. Side effects were more common with gabapentin (6 in 10) than with placebo (5 in 10). Dizziness, sleepiness, water retention, and problems with walking each occurred in about 1 in 10 people who took gabapentin. Serious side effects were uncommon, and not different between gabapentin and placebo. Slightly more people taking gabapentin stopped taking it because of side effects. Gabapentin is helpful for some people with chronic neuropathic pain. It is not possible to know beforehand who will benefit and who will not. Current knowledge suggests that a short trial is the best way of telling. The evidence was mostly of moderate quality. This means that the research provides a good indication of the likely effect. The likelihood that the effect will be substantially different is moderate."
]
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cochrane-simplification-train-1471 | cochrane-simplification-train-1471 | Two RCTs including 172 patients with moderate to severe UC who failed conventional therapy met the inclusion criteria. Both studies were rated as low risk of bias. We did not pool efficacy data from the two included studies due to differences in dose and route of administration. The small phase I study found no statistically significant differences between etrolizumab and placebo in the proportion of patients who failed to enter remission (RR 1.04, 95% CI 1.04 to 1.69; participants = 23) or respond at week 10 (RR 1.67, 95% CI 0.26 to 10.82; participants = 23). The phase II study reported on failure to enter clinical remission at weeks 6 and 10. In the etrolizumab group 91% (71/78) of patients failed to enter remission at week 6 compared to 95% (39/41) of placebo patients (RR 0.96, 95% CI 0.87 to 1.06). Subgroup analysis revealed no statistically significant differences by dose. At week 10, there was a statistically significant difference in clinical remission rates favouring etrolizumab over placebo. Of the patients who received etrolizumab, 85% (66/78) failed to enter remission at week 10 compared to 100% (41/41) patients in the placebo group (RR 0.86, 95% CI 0.77 to 0.95). A subgroup analysis by dose found a statistically significant difference in clinical remission rates favoring 100 mg etrolizumab over placebo (RR 0.81 CI 95% 0.68 to 0.96), but not 300 mg etrolizumab over placebo (RR 0.91, 95% CI 0.80 to 1.03). No significant heterogeneity was detected for this comparison (P = 0.28, I2 = 13.5%). GRADE analyses indicated that the overall quality of evidence for the clinical remission outcomes was moderate due to sparse data. Both of the included studies reported on safety. The outcome adverse events was initially pooled, however this analysis was removed due to high heterogeneity (I2 = 88%). The phase I study found no statistically significant difference between etrolizumab and placebo in the proportion of patients who had at least one adverse event. Ninety-five per cent (36/38) of etrolizumab patients had at least one adverse event compared to 100% (10/10) of placebo patients (RR 0.98, 95% CI 0.84 to 1.14). Common adverse events reported in the phase I study included exacerbation of UC, headache, fatigue, abdominal pain, dizziness, nasopharyngitis, nausea, arthralgia and urinary tract infection. There was a statistically significant difference between etrolizumab and placebo in the proportion of patients who had at least one adverse event. Fifty-six per cent (44/78) of etrolizumab patients had at least one adverse event compared to 79% of placebo patients (RR 0.71, 95% CI 0.55 to 0.91). A GRADE analysis indicates that the overall quality of the evidence for this outcome was moderate due to sparse data. Common adverse events reported in the phase II study included worsening UC, nasopharyngitis, nervous system disorders, headache and arthralgia . A pooled analysis of two studies indicates that there was no statistically significant difference in the proportion of patients who had a serious adverse event. Twelve per cent (14/116) of etrolizumab patients had a serious adverse event compared to 12% of placebo patients (6/49) (RR 0.92, 95% CI 0.36 to 2.34). A GRADE analysis indicated that the overall quality of the evidence for this outcome was low due to very sparse data (20 events). Common serious adverse events included worsening of UC, impaired wound healing and bacterial peritonitis. Moderate quality evidence suggests that etrolizumab may be an effective induction therapy for some patients with moderate to severe ulcerative colitis who have failed conventional therapy. Due to small numbers of patients in dose subgroups the optimal dosage of etrolizumab is unclear. Due to sparse data we are uncertain regarding the risk of adverse events and serious adverse events. Further studies are needed to determine the efficacy and safety of etrolizumab in this patient population. There are five ongoing phase III etrolizumab trials and two ongoing open-label extension studies that will provide important new information on the efficacy, safety and optimal dose of this drug for the treatment of UC. | The researchers identified two studies that included a total of 172 participants with moderate to severe ulcerative colitis who have failed treatment with immunosuppressives (e.g. steroids) or another biologic drug. Both studies compared etrolizumab to placebo (a fake medicine). Both studies were of high quality. The smaller study (48 participants) found no difference in remission rates between etrolizumab and placebo at week 10. The larger study (124 participants) found no difference between etrolizumab and placebo in the proportion of participants who achieved remission at week 6. However, there was a statistically meaningful difference in remission rates at week 10 favoring etrolizumab over placebo. In the larger study (124 participants) placebo participants were significantly more likely to have at least one side effect compared to those who took etrolizumab. Common side effects in this study included worsening ulcerative colitis, nasopharyngitis (common cold), nervous system disorders, headache and arthralgia (joint pain). In the other study (48 participants) there was no difference in the side effect rates between the placebo and etrolizumab groups. Common side effects in this study included worsening of ulcerative colitis, headache, fatigue (tiredness), abdominal pain, dizziness, nasopharyngitis (common cold), nausea, arthralgia (joint pain) and urinary tract infection. There was no meaningful difference between etrolizumab and placebo in the proportion of patients who experienced serious side effects. Serious side effects included worsening of ulcerative colitis and infection. Etrolizumab may be better than placebo for producing remission in people with moderate to severe ulcerative colitis who have failed other treatments. Different doses of etrolizumab were investigated but it is unclear what dose is most effective. More studies are required to determine the effectiveness and safety of etrolizumab in patients with moderate to severe ulcerative colitis. Currently there are seven ongoing studies investigating etrolizumab treatment for ulcerative colitis. These studies will provide important new information on the effectiveness, safety and ideal dose of etrolizumab for the treatment of people with moderate to severe ulcerative colitis. | 10.1002/14651858.CD011661.pub2 | [
"The researchers identified two studies that included a total of 172 participants with moderate to severe ulcerative colitis who have failed treatment with immunosuppressives (e.g. steroids) or another biologic drug. Both studies compared etrolizumab to placebo (a fake medicine). Both studies were of high quality. The smaller study (48 participants) found no difference in remission rates between etrolizumab and placebo at week 10. The larger study (124 participants) found no difference between etrolizumab and placebo in the proportion of participants who achieved remission at week 6. However, there was a statistically meaningful difference in remission rates at week 10 favoring etrolizumab over placebo. In the larger study (124 participants) placebo participants were significantly more likely to have at least one side effect compared to those who took etrolizumab. Common side effects in this study included worsening ulcerative colitis, nasopharyngitis (common cold), nervous system disorders, headache and arthralgia (joint pain). In the other study (48 participants) there was no difference in the side effect rates between the placebo and etrolizumab groups. Common side effects in this study included worsening of ulcerative colitis, headache, fatigue (tiredness), abdominal pain, dizziness, nasopharyngitis (common cold), nausea, arthralgia (joint pain) and urinary tract infection. There was no meaningful difference between etrolizumab and placebo in the proportion of patients who experienced serious side effects. Serious side effects included worsening of ulcerative colitis and infection. Etrolizumab may be better than placebo for producing remission in people with moderate to severe ulcerative colitis who have failed other treatments. Different doses of etrolizumab were investigated but it is unclear what dose is most effective. More studies are required to determine the effectiveness and safety of etrolizumab in patients with moderate to severe ulcerative colitis. Currently there are seven ongoing studies investigating etrolizumab treatment for ulcerative colitis. These studies will provide important new information on the effectiveness, safety and ideal dose of etrolizumab for the treatment of people with moderate to severe ulcerative colitis."
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cochrane-simplification-train-1472 | cochrane-simplification-train-1472 | We identified 136 studies; 133 with 64,640 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The majority of studies were conducted in adults and had similar numbers of men and women. People enrolled in the studies typically smoked at least 15 cigarettes a day at the start of the studies. We judged the evidence to be of high quality; we judged most studies to be at high or unclear risk of bias but restricting the analysis to only those studies at low risk of bias did not significantly alter the result. The RR of abstinence for any form of NRT relative to control was 1.55 (95% confidence interval (CI) 1.49 to 1.61). The pooled RRs for each type were 1.49 (95% CI 1.40 to 1.60, 56 trials, 22,581 participants) for nicotine gum; 1.64 (95% CI 1.53 to 1.75, 51 trials, 25,754 participants) for nicotine patch; 1.52 (95% CI 1.32 to 1.74, 8 trials, 4439 participants) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials, 976 participants) for nicotine inhalator; and 2.02 (95% CI 1.49 to 2.73, 4 trials, 887 participants) for nicotine nasal spray. The effects were largely independent of the definition of abstinence, the intensity of additional support provided or the setting in which the NRT was offered. Adverse events from using NRT were related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. Attempts to quantitatively synthesize the incidence of various adverse effects were hindered by extensive variation in reporting the nature, timing and duration of symptoms. The odds ratio (OR) of chest pains or palpitations for any form of NRT relative to control was 1.88 (95% CI 1.37 to 2.57, 15 included and excluded trials, 11,074 participants). However, chest pains and palpitations were rare in both groups and serious adverse events were extremely rare. There is high-quality evidence that all of the licensed forms of NRT (gum, transdermal patch, nasal spray, inhalator and sublingual tablets/lozenges) can help people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50% to 60%, regardless of setting, and further research is very unlikely to change our confidence in the estimate of the effect. The relative effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT. NRT often causes minor irritation of the site through which it is administered, and in rare cases can cause non-ischaemic chest pain and palpitations. | This review includes 136 trials of NRT, with 64,640 people in the main analysis. All studies were conducted in people who wanted to quit smoking. Most studies were conducted in adults and had similar numbers of men and women. People enrolled in the studies typically smoked at least 15 cigarettes a day at the start of the studies. The evidence is current to July 2017. Trials lasted for at least six months. We found evidence that all forms of NRT made it more likely that a person's attempt to quit smoking would succeed. The chances of stopping smoking were increased by 50% to 60%. NRT works with or without additional counselling, and does not need to be prescribed by a doctor. Side effects from using NRT are related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. There is no evidence that NRT increases the risk of heart attacks. The overall quality of the evidence is high, meaning that further research is very unlikely to change our conclusions. | 10.1002/14651858.CD000146.pub5 | [
"This review includes 136 trials of NRT, with 64,640 people in the main analysis. All studies were conducted in people who wanted to quit smoking. Most studies were conducted in adults and had similar numbers of men and women. People enrolled in the studies typically smoked at least 15 cigarettes a day at the start of the studies. The evidence is current to July 2017. Trials lasted for at least six months. We found evidence that all forms of NRT made it more likely that a person's attempt to quit smoking would succeed. The chances of stopping smoking were increased by 50% to 60%. NRT works with or without additional counselling, and does not need to be prescribed by a doctor. Side effects from using NRT are related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. There is no evidence that NRT increases the risk of heart attacks. The overall quality of the evidence is high, meaning that further research is very unlikely to change our conclusions."
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cochrane-simplification-train-1473 | cochrane-simplification-train-1473 | We identified 12 RCTs and one quasi-RCT (6923 participants), six for cardiac surgery (3359 participants) and seven for thoracic surgery (3564 participants). No study evaluated fondaparinux, the new oral direct thrombin, direct factor Xa inhibitors, or caval filters. All studies had major study design flaws and most lacked a placebo or no treatment control group. We typically graded the quality of the overall body of evidence for the various outcomes and comparisons as low, due to imprecise estimates of effect and risk of bias. We could not pool data because of the different comparisons and the lack of data. In cardiac surgery, 71 symptomatic VTEs occurred in 3040 participants from four studies. In a study of 2551 participants, representing 85% of the review population in cardiac surgery, the combination of unfractionated heparin with pneumatic compression stockings was associated with a 61% reduction of symptomatic VTE compared to unfractionated heparin alone (1.5% versus 4.0%; risk ratio (RR) 0.39; 95% confidence interval (CI) 0.23 to 0.64). Major bleeding was only reported in one study, which found a higher incidence with vitamin K antagonists compared to platelet inhibitors (11.3% versus 1.6%, RR 7.06; 95% CI 1.64 to 30.40). In thoracic surgery, 15 symptomatic VTEs occurred in 2890 participants from six studies. In the largest study evaluating unfractionated heparin versus an inactive control the rates of symptomatic VTE were 0.7% versus 0%, respectively, giving a RR of 6.71 (95% CI 0.40 to 112.65). There was insufficient evidence to determine if there was a difference in the risk of major bleeding from two studies evaluating fixed-dose versus weight-adjusted low molecular weight heparin (2.7% versus 8.1%, RR 0.33; 95% CI 0.07 to 1.60) and unfractionated heparin versus low molecular weight heparin (6% and 4%, RR 1.50; 95% CI 0.26 to 8.60). The evidence regarding the efficacy and safety of thromboprophylaxis in cardiac and thoracic surgery is limited. Data for important outcomes such as pulmonary embolism or major bleeding were often lacking. Given the uncertainties around the benefit-to-risk balance, no conclusions can be drawn and a case-by-case risk evaluation of VTE and bleeding remains preferable. | We identified 13 randomised controlled trials (6923 participants), six for cardiac surgery (3359 participants) and seven for thoracic surgery (3564 participants). The evidence is current to May 2014. No study evaluated fondaparinux, the new oral direct thrombin or direct factor Xa inhibitors, or caval filters. Data could not be combined because of the different comparisons and the lack of data. Data for clinically relevant outcomes such as pulmonary embolism (blockage of one or more arteries of the lung) or major bleeding were often lacking. In cardiac surgery, symptomatic venous thromboembolism occurred in 71 out of 3040 participants from three studies. In a study of 2551 participants, representing 85% of the review population in cardiac surgery, the combination of unfractionated heparin with intermittent pneumatic compression was associated with an important reduction of symptomatic venous thromboembolism compared to unfractionated heparin alone. Major (important) bleeding was reported in one study only, and the best estimate was that bleedings occurred seven times more often in participants on vitamin K antagonists compared to participants on platelet inhibitors, but the true estimate may lay between one and a half to 30. In thoracic surgery, symptomatic venous thromboembolism occurred in 15 out of 2890 participants from six studies. Combined analysis could not be performed, but the largest study evaluating unfractionated heparin versus an inactive control did not show a benefit in terms of reduced occurrence of symptomatic venous thromboembolism. Major bleeding was reported in two studies that did not find significantly different rates between fixed-dose and weight-adjusted low molecular weight heparin (2.7% versus 8.1%) and between unfractionated heparin and low molecular weight heparin (6% and 4%). Overall, the evidence on the use of thromboprophylaxis in cardiac and thoracic surgery appeared to be scarce, so we are very uncertain about the benefit-to-risk balance. All studies had major study design flaws and most lacked a placebo or no treatment control group. We typically graded the quality of the overall body of evidence for the various outcomes and comparisons as low, due to imprecise estimates of effect and risk of bias. Our data suggest that thromboprophylaxis cannot be suggested for all patients undergoing these types of surgery, but should rather be considered case-by-case based on the individual risk of venous thromboembolism and bleeding. | 10.1002/14651858.CD009658.pub2 | [
"We identified 13 randomised controlled trials (6923 participants), six for cardiac surgery (3359 participants) and seven for thoracic surgery (3564 participants). The evidence is current to May 2014. No study evaluated fondaparinux, the new oral direct thrombin or direct factor Xa inhibitors, or caval filters. Data could not be combined because of the different comparisons and the lack of data. Data for clinically relevant outcomes such as pulmonary embolism (blockage of one or more arteries of the lung) or major bleeding were often lacking. In cardiac surgery, symptomatic venous thromboembolism occurred in 71 out of 3040 participants from three studies. In a study of 2551 participants, representing 85% of the review population in cardiac surgery, the combination of unfractionated heparin with intermittent pneumatic compression was associated with an important reduction of symptomatic venous thromboembolism compared to unfractionated heparin alone. Major (important) bleeding was reported in one study only, and the best estimate was that bleedings occurred seven times more often in participants on vitamin K antagonists compared to participants on platelet inhibitors, but the true estimate may lay between one and a half to 30. In thoracic surgery, symptomatic venous thromboembolism occurred in 15 out of 2890 participants from six studies. Combined analysis could not be performed, but the largest study evaluating unfractionated heparin versus an inactive control did not show a benefit in terms of reduced occurrence of symptomatic venous thromboembolism. Major bleeding was reported in two studies that did not find significantly different rates between fixed-dose and weight-adjusted low molecular weight heparin (2.7% versus 8.1%) and between unfractionated heparin and low molecular weight heparin (6% and 4%). Overall, the evidence on the use of thromboprophylaxis in cardiac and thoracic surgery appeared to be scarce, so we are very uncertain about the benefit-to-risk balance. All studies had major study design flaws and most lacked a placebo or no treatment control group. We typically graded the quality of the overall body of evidence for the various outcomes and comparisons as low, due to imprecise estimates of effect and risk of bias. Our data suggest that thromboprophylaxis cannot be suggested for all patients undergoing these types of surgery, but should rather be considered case-by-case based on the individual risk of venous thromboembolism and bleeding."
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cochrane-simplification-train-1474 | cochrane-simplification-train-1474 | Fifteen studies (N= 2012) were included in analyses. We assessed the risk of bias for included studies as low overall. We identified nine high 'risk of bias' assessments, 22 unclear, and 59 low 'risk of bias' assessments. Most judgements of a high risk of bias were due to inadequate reporting. Analyses revealed seven effects. Participants with headache conditions receiving psychological therapies delivered via the Internet had reduced pain (number needed to treat to benefit = 2.72, risk ratio 7.28, 95% confidence interval (CI) 2.67 to 19.84, p < 0.01) and a moderate effect was found for disability post-treatment (standardised mean difference (SMD) ‒0.65, 95% CI ‒0.91 to ‒0.39, p < 0.01). However, only two studies could be entered into each analysis; hence, findings should be interpreted with caution. There was no clear evidence that psychological therapies improved depression or anxiety post-treatment (SMD −0.26, 95% CI −0.87 to 0.36, p > 0.05; SMD −0.48, 95% CI −1.22 to 0.27, p > 0.05), respectively. In participants with non-headache conditions, psychological therapies improved pain post-treatment (p < 0.01) with a small effect size (SMD −0.37, 95% CI −0.59 to −0.15), disability post-treatment (p < 0.01) with a moderate effect size (SMD −0.50, 95% CI −0.79 to −0.20), and disability at follow-up (p < 0.05) with a small effect size (SMD −0.15, 95% CI −0.28 to −0.01). However, the follow-up analysis included only two studies and should be interpreted with caution. A small effect was found for depression and anxiety post-treatment (SMD −0.19, 95% CI −0.35 to −0.04, p < 0.05; SMD −0.28, 95% CI −0.49 to −0.06, p < 0.01), respectively. No clear evidence of benefit was found for other follow-up analyses. Analyses of adverse effects were not possible. No data were presented on satisfaction/acceptability. Only one study could be included in an analysis of the effect of psychological therapies on quality of life in participants with headache conditions; hence, no analysis could be undertaken. Three studies presented quality of life data for participants with non-headache conditions; however, no clear evidence of benefit was found (SMD −0.27, 95% CI −0.54 to 0.01, p > 0.05). There is insufficient evidence to make conclusions regarding the efficacy of psychological therapies delivered via the Internet in participants with headache conditions. Psychological therapies reduced pain and disability post-treatment; however, no clear evidence of benefit was found for depression and anxiety. For participants with non-headache conditions, psychological therapies delivered via the Internet reduced pain, disability, depression, and anxiety post-treatment. The positive effects on disability were maintained at follow-up. These effects are promising, but considerable uncertainty remains around the estimates of effect. These results come from a small number of trials, with mostly wait-list controls, no reports of adverse events, and non-clinical recruitment methods. Due to the novel method of delivery, the satisfaction and acceptability of these therapies should be explored in this population. These results are similar to those of reviews of traditional face-to-face therapies for chronic pain. | Four databases were searched up to November 2013. We found 15 trials that met our inclusion criteria. Four trials included individuals with headache pain, 10 trials included individuals with non-headache pain, and one trial included individuals with both headache and non-headache pain. We looked at data about pain, disability, depression, and anxiety immediately after the end of treatment and between 3 to 12 months follow-up. We also looked at how satisfied people were with the treatments, and its effects on their quality of life. We found that for people with headache pain, pain symptoms and disability scores improved immediately following the end of treatment. However, only two trials could be entered into each of these analyses and so findings should be treated with caution. For people with non-headache pain, pain, disability, depression, and anxiety improved immediately after the end of treatment. Disability was also improved at follow-up. Only one study recorded quality of life scores in individuals with headache pain, so we were unable to analyse the results. Three studies presented quality of life scores for individuals with non-headache pain immediately following treatment. We did not find that quality of life improved after receiving the therapy. No data could be analysed on treatment satisfaction/acceptability. We conclude that these findings are promising for psychological treatments delivered via the Internet for the management of chronic pain in adults, but more trials are needed to determine the efficacy of such therapies. | 10.1002/14651858.CD010152.pub2 | [
"Four databases were searched up to November 2013. We found 15 trials that met our inclusion criteria. Four trials included individuals with headache pain, 10 trials included individuals with non-headache pain, and one trial included individuals with both headache and non-headache pain. We looked at data about pain, disability, depression, and anxiety immediately after the end of treatment and between 3 to 12 months follow-up. We also looked at how satisfied people were with the treatments, and its effects on their quality of life. We found that for people with headache pain, pain symptoms and disability scores improved immediately following the end of treatment. However, only two trials could be entered into each of these analyses and so findings should be treated with caution. For people with non-headache pain, pain, disability, depression, and anxiety improved immediately after the end of treatment. Disability was also improved at follow-up. Only one study recorded quality of life scores in individuals with headache pain, so we were unable to analyse the results. Three studies presented quality of life scores for individuals with non-headache pain immediately following treatment. We did not find that quality of life improved after receiving the therapy. No data could be analysed on treatment satisfaction/acceptability. We conclude that these findings are promising for psychological treatments delivered via the Internet for the management of chronic pain in adults, but more trials are needed to determine the efficacy of such therapies."
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cochrane-simplification-train-1475 | cochrane-simplification-train-1475 | Twenty six trials met inclusion criteria. Methodological quality was variable and trial populations were generally small (median sample size = 48, range 14 to 180). Exercise was demonstrated to be effective in terms of short term recovery in rotator cuff disease (RR 7.74 (1.97, 30.32), and longer term benefit with respect to function (RR 2.45 (1.24, 4.86). Combining mobilisation with exercise resulted in additional benefit when compared to exercise alone for rotator cuff disease. Laser therapy was demonstrated to be more effective than placebo for adhesive capsulitis (RR 8, 95%CI 2.11 to 30.34) but not for supraspinatus tendinitis (RR 2, 95%CI 0.98 to 4.09). Both ultrasound and pulsed electromagnetic field therapy resulted in improvement compared to placebo in pain in calcific tendinitis (RR 1.81 (1.26, 2.60) and RR 19 (1.16, 12.43) respectively). There is no evidence of the effect of ultrasound in shoulder pain (mixed diagnosis), adhesive capsulitis or rotator cuff tendinitis. When compared to exercises, ultrasound is of no additional benefit over and above exercise alone. There is some evidence that for rotator cuff disease, corticosteroid injections are superior to physiotherapy and no evidence that physiotherapy alone is of benefit for adhesive capsulitis The small sample sizes, variable methodological quality and heterogeneity in terms of population studied, physiotherapy intervention employed and length of follow up of randomised controlled trials of physiotherapy interventions results in little overall evidence to guide treatment. There is evidence to support the use of some interventions in specific and circumscribed cases. There is a need for trials of physiotherapy interventions for specific clinical conditions associated with shoulder pain, for shoulder pain where combinations of physiotherapy interventions, as well as, physiotherapy interventions as an adjunct to other, non physiotherapy interventions are compared. This is more reflective of current clinical practice. Trials should be adequately powered and address key methodological criteria such as allocation concealment and blinding of outcome assessor. | Twenty-six trials presented sufficient data to be included in meta-analysis. There is some evidence from methodologically weak trials to indicate that some physiotherapy interventions are effective for some specific shoulder disorders. The results overall provide little evidence to guide treatment. There is a clear need for further high quality trials of physiotherapy interventions, including trials using combinations of modalities, in the treatment of shoulder disorders. | 10.1002/14651858.CD004258 | [
"Twenty-six trials presented sufficient data to be included in meta-analysis. There is some evidence from methodologically weak trials to indicate that some physiotherapy interventions are effective for some specific shoulder disorders. The results overall provide little evidence to guide treatment. There is a clear need for further high quality trials of physiotherapy interventions, including trials using combinations of modalities, in the treatment of shoulder disorders."
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cochrane-simplification-train-1476 | cochrane-simplification-train-1476 | We include three new studies in this update, making a total of 11 included trials with 1387 participants. The average age was 69 years and all trials included men and women. Participants were followed for up to two years. There was an improvement in primary duplex patency at six and 12 months in participants treated with PTA plus stent over lesions treated with PTA alone (six months: odds ratio (OR) 2.90, 95% confidence interval (CI) 1.17 to 7.18, P = 0.02, six studies, 578 participants; 12 months: OR 1.78, 95% CI 1.02 to 3.10, P = 0.04, nine studies, 858 participants). This was lost by 24 months (P = 0.06). There was a significant angiographic patency benefit at six months (OR 2.49, 95% CI 1.49 to 4.17, P = 0.0005, four studies, 329 participants) which was lost by 12 months (OR 1.30, 95% CI 0.84 to 2.00, P = 0.24, five studies, 384 participants). Ankle brachial index (ABI) and treadmill walking distance showed no improvement at 12 months (P = 0.49 and P = 0.57 respectively) between participants treated with PTA alone or PTA with stent insertion. Three trials (660 participants) reported quality of life, which showed no significant difference between participants treated with PTA alone or PTA with stent insertion at any time interval. Antiplatelet therapy protocols and inclusion criteria regarding affected arteries between trials showed marked heterogeneity. Although there was a short-term gain in primary patency there was no sustained benefit from primary stenting of lesions of the superficial femoral artery in addition to angioplasty. Future trials should focus on quality of life for claudication and limb salvage for critical ischaemia. | We identified 11 randomised controlled trials with a total of 1387 participants. Their average age was 69 years and all trials included men and women. The participants were randomised to have either balloon angioplasty alone or balloon angioplasty with stent placement. At two years, blood flowing through the narrowing in the arteries was no greater in participants with a stent inserted than in those without. There was a small improvement in the distance that the participants with a stent could walk up to one year later. However, when asked about their quality of life there was no improvement, whether a stent was placed or not, up to one year later. There were differences in the included trials; in some trials people with narrowings in other leg arteries were included. There were also differences between trials in the blood thinning drugs given after stent placement, which may change results, as these agents are important in keeping stents working in other parts of the body. These factors led us to the conclusion that there is a small benefit to adding a stent when performing balloon angioplasty for people in whom balloon angioplasty fails. However, there is insufficient evidence to support this approach as routine practice for everyone and future trials should examine whether subgroups of patients may benefit from stenting. | 10.1002/14651858.CD006767.pub3 | [
"We identified 11 randomised controlled trials with a total of 1387 participants. Their average age was 69 years and all trials included men and women. The participants were randomised to have either balloon angioplasty alone or balloon angioplasty with stent placement. At two years, blood flowing through the narrowing in the arteries was no greater in participants with a stent inserted than in those without. There was a small improvement in the distance that the participants with a stent could walk up to one year later. However, when asked about their quality of life there was no improvement, whether a stent was placed or not, up to one year later. There were differences in the included trials; in some trials people with narrowings in other leg arteries were included. There were also differences between trials in the blood thinning drugs given after stent placement, which may change results, as these agents are important in keeping stents working in other parts of the body. These factors led us to the conclusion that there is a small benefit to adding a stent when performing balloon angioplasty for people in whom balloon angioplasty fails. However, there is insufficient evidence to support this approach as routine practice for everyone and future trials should examine whether subgroups of patients may benefit from stenting."
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cochrane-simplification-train-1477 | cochrane-simplification-train-1477 | We included 44 trials (5783 participants with HF) with a median of six months' follow-up. For this latest update, we identified 11 new trials (N = 1040), in addition to the previously identified 33 trials. Although the evidence base includes predominantly patients with HFrEF with New York Heart Association classes II and III receiving centre-based exercise-based CR programmes, a growing body of studies include patients with HFpEF and are undertaken in a home-based setting. All included studies included a no formal exercise training intervention comparator. However, a wide range of comparators were seen across studies that included active intervention (i.e. education, psychological intervention) or usual medical care alone. The overall risk of bias of included trials was low or unclear, and we downgraded results using the GRADE tool for all but one outcome. Cardiac rehabilitation may make little or no difference in all-cause mortality over the short term (≤ one year of follow-up) (27 trials, 28 comparisons (2596 participants): intervention 67/1302 (5.1%) vs control 75/1294 (5.8%); risk ratio (RR) 0.89, 95% confidence interval (CI) 0.66 to 1.21; low-quality GRADE evidence) but may improve all-cause mortality in the long term (> 12 months follow up) (6 trials/comparisons (2845 participants): intervention 244/1418 (17.2%) vs control 280/1427 (19.6%) events): RR 0.88, 95% CI 0.75 to 1.02; high-quality evidence). Researchers provided no data on deaths due to HF. CR probably reduces overall hospital admissions in the short term (up to one year of follow-up) (21 trials, 21 comparisons (2182 participants): (intervention 180/1093 (16.5%) vs control 258/1089 (23.7%); RR 0.70, 95% CI 0.60 to 0.83; moderate-quality evidence, number needed to treat: 14) and may reduce HF-specific hospitalisation (14 trials, 15 comparisons (1114 participants): (intervention 40/562 (7.1%) vs control 61/552 (11.1%) RR 0.59, 95% CI 0.42 to 0.84; low-quality evidence, number needed to treat: 25). After CR, a clinically important improvement in short-term disease-specific health-related quality of life may be evident (Minnesota Living With Heart Failure questionnaire - 17 trials, 18 comparisons (1995 participants): mean difference (MD) -7.11 points, 95% CI -10.49 to -3.73; low-quality evidence). Pooling across all studies, regardless of the HRQoL measure used, shows there may be clinically important improvement with exercise (26 trials, 29 comparisons (3833 participants); standardised mean difference (SMD) -0.60, 95% CI -0.82 to -0.39; I² = 87%; Chi² = 215.03; low-quality evidence). ExCR effects appeared to be consistent different models of ExCR delivery: centre vs. home-based, exercise dose, exercise only vs. comprehensive programmes, and aerobic training alone vs aerobic plus resistance programmes. This updated Cochrane Review provides additional randomised evidence (11 trials) to support the conclusions of the previous version (2014) of this Cochane Review. Compared to no exercise control, CR appears to have no impact on mortality in the short term (< 12 months' follow-up). Low- to moderate-quality evidence shows that CR probably reduces the risk of all-cause hospital admissions and may reduce HF-specific hospital admissions in the short term (up to 12 months). CR may confer a clinically important improvement in health-related quality of life, although we remain uncertain about this because the evidence is of low quality. Future ExCR trials need to continue to consider the recruitment of traditionally less represented HF patient groups including older, female, and HFpEF patients, and alternative CR delivery settings including home- and using technology-based programmes. | We searched the scientific literature for randomised controlled trials (experiments in which two or more interventions, possibly including a control intervention or no intervention, are compared by randomly allocating participants to study groups). We looked at the effectiveness of exercise-based rehabilitation compared with no exercise in adults (over 18 years of age) with heart failure. We considered HF due to reduced ejection fraction (HFrEF) (i.e. the chambers of the heart contract poorly, and, as a result, a smaller volume of blood is pumped around the body). We also considered HF due to preserved ejection fraction (HFpEF) (i.e. the chambers of the heart contract normally but do not relax efficiently, resulting in a smaller volume of blood pumped around the body). Our search is current to January 2018. We found 44 studies that included 5783 people with HF, mainly HFrEF. The findings of this update are broadly consistent with those of the previous (2014) version of this Cochrane Review. They show important benefits of exercise-based rehabilitation that include a probable reduction in the risk of overall hospital admissions in the short term, as well as the potential for reduction in heart failure admissions. The effect of exercise-based rehabilitation on health-related quality of life is uncertain due to very low-quality evidence. Exercise-based rehabilitation may make little or no difference in all-cause mortality in trials with follow-up less than 12 months. Further evidence is needed to better show the effects of exercise rehabilitation among people with HFpEF and the impact of alternative models of delivery, such as home-based programmes. Generally, recent trials have been better reported and are at low to moderate risk of bias. Using the GRADE method, we assessed the quality of evidence to range from high to very low across measured outcomes. Common reasons for downgrading outcomes include that results were inconsistent and/or imprecise. | 10.1002/14651858.CD003331.pub5 | [
"We searched the scientific literature for randomised controlled trials (experiments in which two or more interventions, possibly including a control intervention or no intervention, are compared by randomly allocating participants to study groups). We looked at the effectiveness of exercise-based rehabilitation compared with no exercise in adults (over 18 years of age) with heart failure. We considered HF due to reduced ejection fraction (HFrEF) (i.e. the chambers of the heart contract poorly, and, as a result, a smaller volume of blood is pumped around the body). We also considered HF due to preserved ejection fraction (HFpEF) (i.e. the chambers of the heart contract normally but do not relax efficiently, resulting in a smaller volume of blood pumped around the body). Our search is current to January 2018. We found 44 studies that included 5783 people with HF, mainly HFrEF. The findings of this update are broadly consistent with those of the previous (2014) version of this Cochrane Review. They show important benefits of exercise-based rehabilitation that include a probable reduction in the risk of overall hospital admissions in the short term, as well as the potential for reduction in heart failure admissions. The effect of exercise-based rehabilitation on health-related quality of life is uncertain due to very low-quality evidence. Exercise-based rehabilitation may make little or no difference in all-cause mortality in trials with follow-up less than 12 months. Further evidence is needed to better show the effects of exercise rehabilitation among people with HFpEF and the impact of alternative models of delivery, such as home-based programmes. Generally, recent trials have been better reported and are at low to moderate risk of bias. Using the GRADE method, we assessed the quality of evidence to range from high to very low across measured outcomes. Common reasons for downgrading outcomes include that results were inconsistent and/or imprecise."
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cochrane-simplification-train-1478 | cochrane-simplification-train-1478 | We included seven trials with 1521 participants in this review. The expectant-care group was more likely to have an incomplete miscarriage by two weeks (RR 3.98; 95% CI 2.94 to 5.38) or by six to eight weeks (RR 2.56; 95% CI 1.15 to 5.69). The need for unplanned surgical treatment was greater for the expectant-care group (RR 7.35; 95% CI 5.04 to 10.72). The mean percentage needing surgical management in the expectant-care group was 28%, while 4% of the surgical-treatment group needed additional surgery. The expectant-care group had more days of bleeding (MD 1.59; 95% CI 0.74 to 2.45). Further, more of the expectant-care group needed transfusion (RR 6.45; 95% CI 1.21 to 34.42). The mean percentage needing blood transfusion was 1.4% for expectant care compared with none for surgical management. Results were mixed for pain. Diagnosis of infection was similar for the two groups (RR 0.63; 95% CI 0.36 to 1.12), as were results for various psychological outcomes. Pregnancy data were limited. Costs were lower for the expectant-care group (MD -499.10; 95% CI -613.04 to -385.16; in UK pounds sterling). Expectant management led to a higher risk of incomplete miscarriage, need for unplanned (or additional) surgical emptying of the uterus, bleeding and need for transfusion. Risk of infection and psychological outcomes were similar for both groups. Costs were lower for expectant management. Given the lack of clear superiority of either approach, the woman's preference should be important in decision making. Pharmacological ('medical') management has added choices for women and their clinicians and has been examined in other reviews. | We searched for randomized trials that compared waiting versus surgery for miscarriage. In addition, we looked at reference lists to find trials. We also wrote to researchers to find more studies. Seven trials with 1521 women looked at waiting versus surgery for miscarriage. More women who waited for the miscarriage to complete on its own had tissue left in the womb. This was studied at two weeks and at six to eight weeks. More of these women needed surgery to complete the process. These women also had more days of bleeding. Some needed to be given blood, compared with none in the surgery group. Both groups had about the same numbers of infections. Results were mixed for pain. Mental health also seemed about the same for both treatment groups. Costs were lower for waiting than for surgery. Overall, no strong medical results argue for either approach. Information was limited on future pregnancy. One trial was large, while the others had small numbers of women. What the woman prefers should be the major concern. Drug treatment (such as with misoprostol and mifepristone) has added choices for women and their clinicians, and has been studied in other reviews. | 10.1002/14651858.CD003518.pub3 | [
"We searched for randomized trials that compared waiting versus surgery for miscarriage. In addition, we looked at reference lists to find trials. We also wrote to researchers to find more studies. Seven trials with 1521 women looked at waiting versus surgery for miscarriage. More women who waited for the miscarriage to complete on its own had tissue left in the womb. This was studied at two weeks and at six to eight weeks. More of these women needed surgery to complete the process. These women also had more days of bleeding. Some needed to be given blood, compared with none in the surgery group. Both groups had about the same numbers of infections. Results were mixed for pain. Mental health also seemed about the same for both treatment groups. Costs were lower for waiting than for surgery. Overall, no strong medical results argue for either approach. Information was limited on future pregnancy. One trial was large, while the others had small numbers of women. What the woman prefers should be the major concern. Drug treatment (such as with misoprostol and mifepristone) has added choices for women and their clinicians, and has been studied in other reviews."
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cochrane-simplification-train-1479 | cochrane-simplification-train-1479 | The review included three studies involving 112 participants. All the included studies performed the comparison breathing exercises as part of a more complex intervention versus control. There were no trials comparing breathing exercises alone with control. Asthma severity of participants from the included studies varied. The studies measured: quality of life, asthma symptoms, reduction in medication usage, number of acute exacerbations and lung function. Breathing exercise techniques used by the included studies consisted of lateral costal breathing, diaphragmatic breathing, inspiratory patterns and pursed lips. One study included in the review did not specify the type of breathing exercise used. The control groups received different interventions: one received placebo treatment, one an educational programme and doctor appointments, and one was not described. There were no reported between-group comparisons for any of the primary outcomes. We judged the included studies as having an unclear risk of bias. We could draw no reliable conclusions concerning the use of breathing exercises for children with asthma in clinical practice. The breathing exercises were part of a more comprehensive package of care, and could not be assessed on their own. Moreover, there were methodological differences among the three small included studies and poor reporting of methodological aspects and results in most of the included studies. | The included studies had an overall small number of participants and sessions. No included study compared breathing exercises alone versus a control. Instead, breathing exercises were part of a package of treatments and were compared to a control. The methods used to conduct the studies were not as well reported as we would like and so were unclear about the quality of the trials. Overall, we judged the included studies as being at an unclear risk of bias and the quality of the evidence included in the review was low. We could draw no reliable conclusions concerning the use of breathing exercises for children with asthma in clinical practice. | 10.1002/14651858.CD011017.pub2 | [
"The included studies had an overall small number of participants and sessions. No included study compared breathing exercises alone versus a control. Instead, breathing exercises were part of a package of treatments and were compared to a control. The methods used to conduct the studies were not as well reported as we would like and so were unclear about the quality of the trials. Overall, we judged the included studies as being at an unclear risk of bias and the quality of the evidence included in the review was low. We could draw no reliable conclusions concerning the use of breathing exercises for children with asthma in clinical practice."
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cochrane-simplification-train-1480 | cochrane-simplification-train-1480 | In total, 31 heterogeneous trials including 1690 participants with patellofemoral pain are included in this review. There was considerable between-study variation in patient characteristics (e.g. activity level) and diagnostic criteria for study inclusion (e.g. minimum duration of symptoms) and exercise therapy. Eight trials, six of which were quasi-randomised, were at high risk of selection bias. We assessed most trials as being at high risk of performance bias and detection bias, which resulted from lack of blinding. The included studies, some of which contributed to more than one comparison, provided evidence for the following comparisons: exercise therapy versus control (10 trials); exercise therapy versus other conservative interventions (e.g. taping; eight trials evaluating different interventions); and different exercises or exercise programmes. The latter group comprised: supervised versus home exercises (two trials); closed kinetic chain (KC) versus open KC exercises (four trials); variants of closed KC exercises (two trials making different comparisons); other comparisons of other types of KC or miscellaneous exercises (five trials evaluating different interventions); hip and knee versus knee exercises (seven trials); hip versus knee exercises (two studies); and high- versus low-intensity exercises (one study). There were no trials testing exercise medium (land versus water) or duration of exercises. Where available, the evidence for each of seven main outcomes for all comparisons was of very low quality, generally due to serious flaws in design and small numbers of participants. This means that we are very unsure about the estimates. The evidence for the two largest comparisons is summarised here. Exercise versus control. Pooled data from five studies (375 participants) for pain during activity (short-term) favoured exercise therapy: mean difference (MD) -1.46, 95% confidence interval (CI) -2.39 to -0.54. The CI included the minimal clinically important difference (MCID) of 1.3 (scale 0 to 10), indicating the possibility of a clinically important reduction in pain. The same finding applied for usual pain (short-term; two studies, 41 participants), pain during activity (long-term; two studies, 180 participants) and usual pain (long-term; one study, 94 participants). Pooled data from seven studies (483 participants) for functional ability (short-term) also favoured exercise therapy; standardised mean difference (SMD) 1.10, 95% CI 0.58 to 1.63. Re-expressed in terms of the Anterior Knee Pain Score (AKPS; 0 to 100), this result (estimated MD 12.21 higher, 95% CI 6.44 to 18.09 higher) included the MCID of 10.0, indicating the possibility of a clinically important improvement in function. The same finding applied for functional ability (long-term; three studies, 274 participants). Pooled data (two studies, 166 participants) indicated that, based on the 'recovery' of 250 per 1000 in the control group, 88 more (95% CI 2 fewer to 210 more) participants per 1000 recovered in the long term (12 months) as a result of exercise therapy. Hip plus knee versus knee exercises. Pooled data from three studies (104 participants) for pain during activity (short-term) favoured hip and knee exercise: MD -2.20, 95% CI -3.80 to -0.60; the CI included a clinically important effect. The same applied for usual pain (short-term; two studies, 46 participants). One study (49 participants) found a clinically important reduction in pain during activity (long-term) for hip and knee exercise. Although tending to favour hip and knee exercises, the evidence for functional ability (short-term; four studies, 174 participants; and long-term; two studies, 78 participants) and recovery (one study, 29 participants) did not show that either approach was superior. This review has found very low quality but consistent evidence that exercise therapy for PFPS may result in clinically important reduction in pain and improvement in functional ability, as well as enhancing long-term recovery. However, there is insufficient evidence to determine the best form of exercise therapy and it is unknown whether this result would apply to all people with PFPS. There is some very low quality evidence that hip plus knee exercises may be more effective in reducing pain than knee exercise alone. Further randomised trials are warranted but in order to optimise research effort and engender the large multicentre randomised trials that are required to inform practice, these should be preceded by research that aims to identify priority questions and attain agreement and, where practical, standardisation regarding diagnostic criteria and measurement of outcome. | The evidence, where available, for each of seven main outcomes for all comparisons was of very low quality. This means that we are very unsure about the reliability of these results. The evidence for the comparison of exercise therapy versus control (e.g. no treatment) showed that exercise therapy may provide a clinically important reduction in pain during activity and usual pain in the short term (three months or less) and in the long term (more than three months). The review also found evidence that exercise therapy may provide a clinically important improvement in functional ability in both the short and long term, as well as resulting in greater numbers reporting recovery from their symptoms in the long term. The review found evidence that hip plus knee exercises may provide a clinically important reduction in pain during activity and usual pain in the short term and pain during activity in the long term, when compared with knee exercises only. There was inconclusive evidence to say whether functional ability or recovery was better in either group. This review has found very low quality but consistent evidence that exercise therapy for PFPS may result in clinically important reduction in pain and improvement in functional ability, as well as enhancing long-term recovery. However, we cannot say what is the best form of exercise therapy nor whether this result would apply to all people with patellofemoral pain. There is some very low quality evidence that hip plus knee exercises may be more effective in reducing pain than knee exercise alone. Before further studies are done, research is needed to identify priority questions and achieve better consensus on diagnostic criteria and measurement of outcome. | 10.1002/14651858.CD010387.pub2 | [
"The evidence, where available, for each of seven main outcomes for all comparisons was of very low quality. This means that we are very unsure about the reliability of these results. The evidence for the comparison of exercise therapy versus control (e.g. no treatment) showed that exercise therapy may provide a clinically important reduction in pain during activity and usual pain in the short term (three months or less) and in the long term (more than three months). The review also found evidence that exercise therapy may provide a clinically important improvement in functional ability in both the short and long term, as well as resulting in greater numbers reporting recovery from their symptoms in the long term. The review found evidence that hip plus knee exercises may provide a clinically important reduction in pain during activity and usual pain in the short term and pain during activity in the long term, when compared with knee exercises only. There was inconclusive evidence to say whether functional ability or recovery was better in either group. This review has found very low quality but consistent evidence that exercise therapy for PFPS may result in clinically important reduction in pain and improvement in functional ability, as well as enhancing long-term recovery. However, we cannot say what is the best form of exercise therapy nor whether this result would apply to all people with patellofemoral pain. There is some very low quality evidence that hip plus knee exercises may be more effective in reducing pain than knee exercise alone. Before further studies are done, research is needed to identify priority questions and achieve better consensus on diagnostic criteria and measurement of outcome."
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cochrane-simplification-train-1481 | cochrane-simplification-train-1481 | We obtained and scrutinised 41 potentially relevant records, and from these we could include only six trials (n = 1835). Five of the six trials had high risk of attrition bias and all trials were sponsored by pharmaceutical companies. Results showed a clinically important change in global state (1 RCT, n = 336, RR 0.81, 95% CI 0.68 to 0.97, low-quality evidence) and mental state (1 RCT, n = 336, RR 0.72, 95% CI 0.59 to 0.86, very low-quality evidence) at short-term amongst people receiving asenapine. People receiving asenapine demonstrated significant reductions in negative symptoms (1 RCT, n = 336, MD -1.10, 95% CI -2.29 to 0.09, very low-quality evidence) at short-term. Individuals receiving asenapine demonstrated significantly fewer incidents of serious adverse effects (1 RCT, n = 386, RR 0.29, 95% CI 0.14 to 0.63, very low-quality evidence) at medium-term. There was no clear difference in people discontinuing the study for any reason between asenapine and placebo at short-term (5 RCTs, n = 1046, RR 0.91, 95% CI 0.80 to 1.04, very low-quality evidence). No trial reported data for extrapyramidal symptoms or costs. There is some, albeit preliminary, evidence that asenapine provides an improvement in positive, negative, and depressive symptoms, whilst minimising the risk of adverse effects. However due to the low-quality and limited quantity of evidence, it remains difficult to recommend the use of asenapine for people with schizophrenia. We identify a need for large-scale, longer-term, better-designed and conducted randomised controlled trials investigating the clinical effects and safety of asenapine. | The review includes six trials with 1835 people. The trials randomised people with schizophrenia to receive either asenapine or placebo. Five of these trials had high rates of people leaving early and were sponsored by pharmaceutical companies. There is some evidence that asenapine, when compared to placebo, improves the positive, negative and depressive symptoms of schizophrenia while having less risk of debilitating side effects. However, due to the low quantity and limited quality of evidence currently available, it remains difficult to recommend the use of asenapine for schizophrenia. There is a need for large-scale, longer-term follow up, and bias-free randomised controlled trials investigating the effects and safety of asenapine. Ben Gray, Senior Peer Researcher, McPin Foundation. http://mcpin.org/ | 10.1002/14651858.CD011458.pub2 | [
"The review includes six trials with 1835 people. The trials randomised people with schizophrenia to receive either asenapine or placebo. Five of these trials had high rates of people leaving early and were sponsored by pharmaceutical companies. There is some evidence that asenapine, when compared to placebo, improves the positive, negative and depressive symptoms of schizophrenia while having less risk of debilitating side effects. However, due to the low quantity and limited quality of evidence currently available, it remains difficult to recommend the use of asenapine for schizophrenia. There is a need for large-scale, longer-term follow up, and bias-free randomised controlled trials investigating the effects and safety of asenapine. Ben Gray, Senior Peer Researcher, McPin Foundation. http://mcpin.org/"
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cochrane-simplification-train-1482 | cochrane-simplification-train-1482 | Sixteen placebo controlled trials have been completed with atypical antipsychotics although only nine had sufficient data to contribute to a meta-analysis and only five have been published in full in peer reviewed journals. No trials of amisulpiride, sertindole or zotepine were identified which met the criteria for inclusion. The included trials led to the following results: 1. There was a significant improvement in aggression with risperidone and olanzapine treatment compared to placebo. 2. There was a significant improvement in psychosis amongst risperidone treated patients. 3. Risperidone and olanzapine treated patients had a significantly higher incidence of serious adverse cerebrovascular events (including stroke), extrapyramidal side effects and other important adverse outcomes. 4. There was a significant increase in drop-outs in risperidone (2 mg) and olanzapine (5-10 mg) treated patients. 5. The data were insufficient to examine impact upon cognitive function. Evidence suggests that risperidone and olanzapine are useful in reducing aggression and risperidone reduces psychosis, but both are associated with serious adverse cerebrovascular events and extrapyramidal symptoms. Despite the modest efficacy, the significant increase in adverse events confirms that neither risperidone nor olanzapine should be used routinely to treat dementia patients with aggression or psychosis unless there is severe distress or risk of physical harm to those living and working with the patient. Although insufficient data were available from the considered trials, a meta-analysis of seventeen placebo controlled trials of atypical neuroleptics for the treatment of behavioural symptoms in people with dementia conducted by the Food and Drug Administration suggested a significant increase in mortality (OR 1.7). A peer-reviewed meta-analysis (Schneider 2005) of 15 placebo controlled studies (nine unpublished) found similarly increased risk in mortality (OR=1.54, 95% CI 0.004 to 0.02, p=0.01) for the atypical neuroleptics. | Atypical antipsychotics have become the pharmacological treatment of choice for many clinicians in the treatment of behavioural and psychiatric symptoms in people with dementia, and the largest evidence base for double blind placebo controlled trials in this area is for risperidone. Particularly in view of recent safety concerns, a meta-analysis of efficacy and adverse events to inform clinical practice is timely. Modest efficacy is evident, but the elevated risk of cerebrovascular adverse events, mortality, upper respiratory infections, oedema and extrapyramidal symptoms is a concern, particularly as selective reporting makes interpretation of other potential adverse outcomes impossible. | 10.1002/14651858.CD003476.pub2 | [
"Atypical antipsychotics have become the pharmacological treatment of choice for many clinicians in the treatment of behavioural and psychiatric symptoms in people with dementia, and the largest evidence base for double blind placebo controlled trials in this area is for risperidone. Particularly in view of recent safety concerns, a meta-analysis of efficacy and adverse events to inform clinical practice is timely. Modest efficacy is evident, but the elevated risk of cerebrovascular adverse events, mortality, upper respiratory infections, oedema and extrapyramidal symptoms is a concern, particularly as selective reporting makes interpretation of other potential adverse outcomes impossible."
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cochrane-simplification-train-1483 | cochrane-simplification-train-1483 | We identified 17 trials and included 12 RCTs (11 completed and one trial protocol - this trial was terminated early) (464 participants). Eight trials included only children, whilst four trials included both children and adults. Trial duration ranged from one to 12 months. Nine trials compared a probiotic (seven single strain and three multistrain preparations) with a placebo preparation, two trials compared a synbiotic (multistrain) with a placebo preparation and one trial compared two probiotic preparations. Overall we judged the risk of bias in the 12 trials to be low. Three trials had a high risk of performance bias, two trials a high risk of attrition bias and six trials a high risk of reporting bias. Only two trials were judged to have low or unclear risk of bias for all domains. Four trials were sponsored by grants only, two trials by industry only, two trials by both grants and industry and three trials had an unknown funding source. Combined data from four trials (225 participants) suggested probiotics may reduce the number of pulmonary exacerbations during a four to 12 month time-frame, mean difference (MD) -0.32 episodes per participant (95% confidence interval (CI) -0.68 to 0.03; P = 0.07) (low-certainty evidence); however, the 95% CI includes the possibility of both an increased and a reduced number of exacerbations. Additionally, two trials (127 participants) found no evidence of an effect on the duration of antibiotic therapy during the same time period. Combined data from four trials (177 participants) demonstrated probiotics may reduce faecal calprotectin, MD -47.4 µg/g (95% CI -93.28 to -1.54; P = 0.04) (low-certainty evidence), but the results for other biomarkers mainly did not show any difference between probiotics and placebo. Two trials (91 participants) found no evidence of effect on height, weight or body mass index (low-certainty evidence). Combined data from five trials (284 participants) suggested there was no difference in lung function (forced expiratory volume at one second (FEV1) % predicted) during a three- to 12-month time frame, MD 1.36% (95% CI -1.20 to 3.91; P = 0.30) (low-certainty evidence). Combined data from two trials (115 participants) suggested there was no difference in hospitalisation rates during a three- to 12-month time frame, MD -0.44 admissions per participant (95% CI -1.41 to 0.54; P = 0.38) (low-certainty evidence). One trial (37 participants) reported health-related quality of life and while the parent report favoured probiotics, SMD 0.87 (95% CI 0.19 to 1.55) the child self-report did not identify any effect, SMD 0.59 (95% CI -0.07 to 1.26) (low-certainty evidence). There were limited results for gastrointestinal symptoms and intestinal microbial profile which were not analysable. Only four trials and one trial protocol (298 participants) reported adverse events as a priori hypotheses. No trials reported any deaths. One terminated trial (12 participants and available as a protocol only) reported a severe allergic reaction (severe urticaria) for one participant in the probiotic group. Two trials reported a single adverse event each (vomiting in one child and diarrhoea in one child). The estimated number needed to harm for any adverse reaction (serious or not) is 52 people (low-certainty evidence). Probiotics significantly reduce faecal calprotectin (a marker of intestinal inflammation) in children and adults with CF, however the clinical implications of this require further investigation. Probiotics may make little or no difference to pulmonary exacerbation rates, however, further evidence is required before firm conclusions can be made. Probiotics are associated with a small number of adverse events including vomiting, diarrhoea and allergic reactions. In children and adults with CF, probiotics may be considered by patients and their healthcare providers. Given the variability of probiotic composition and dosage, further adequately-powered multicentre RCTs of at least 12 months duration are required to best assess the efficacy and safety of probiotics for children and adults with CF. | The review included 12 randomised controlled trials (11 completed and one trial protocol (plan) - this trial was terminated early but reported some results on side effects) with 464 people with cystic fibrosis. Eight trials included only children, whilst four trials included both children and adults. The trials lasted between one and 12 months. Eight trials used a probiotic with a single type of bacteria and four trials used a probiotic with two or more types of bacteria. Only one trial compared different bacteria and the others compared probiotics to a placebo (dummy treatment with no active medication). Probiotics may reduce the rate of pulmonary exacerbations, however, this is not definite; pulmonary exacerbations are events where breathing symptoms are worsened (e.g. increased cough, sputum or shortness of breath) and lung function declines. Probiotics may reduce a marker of gut inflammation called calprotectin, however, the benefit of this to an individual is unknown. There were no differences between probiotics and placebo for height, weight or body mass index (BMI). Results did not show that probiotics affect lung function, need for admission to hospital or abdominal symptoms. One small trial measured quality of life and the parents questionnaire favoured probiotics, but the children's self report did not show a difference between probiotics and placebo. Probiotics may cause vomiting, diarrhoea and allergic reactions. We estimate 52 people need to take probiotics for one person to have an adverse event. We could not analyse the results of the trial comparing different probiotics because of its design. Future trials should look into the use of probiotics for at least 12 months and assess measures of lung and gut health, growth, abdominal symptoms, quality of life and adverse events. Given the wide range or probiotics (single and multi-strain combinations), doses used and degree of effectiveness, determining the best regimen(s) to investigate further will be challenging. There were several issues with the overall certainty of the evidence which affects our confidence in the results from these trials. We think the fact that some participants did not complete their treatment or were not included in the reports may affect the results on weight. We think the fact that not all planned outcomes were reported in four trials may affect the results of intestinal inflammation, growth and abdominal symptoms. We think the fact that the pharmaceutical industry sponsored at least four of the trials should be considered when looking at the results of this review. As most trials only included children we are not certain that the results would also apply to adults and there were also some issues related to whether people taking part in the trial knew which treatment they were receiving. We judged the certainty of evidence for changes in pulmonary exacerbations, intestinal inflammation, lung function, hospital admissions, weight and health-related quality of life to be low. Adverse events were only recorded by four trials and the protocol for the terminated trial and the certainty of the evidence was also judged to be low. | 10.1002/14651858.CD012949.pub2 | [
"The review included 12 randomised controlled trials (11 completed and one trial protocol (plan) - this trial was terminated early but reported some results on side effects) with 464 people with cystic fibrosis. Eight trials included only children, whilst four trials included both children and adults. The trials lasted between one and 12 months. Eight trials used a probiotic with a single type of bacteria and four trials used a probiotic with two or more types of bacteria. Only one trial compared different bacteria and the others compared probiotics to a placebo (dummy treatment with no active medication). Probiotics may reduce the rate of pulmonary exacerbations, however, this is not definite; pulmonary exacerbations are events where breathing symptoms are worsened (e.g. increased cough, sputum or shortness of breath) and lung function declines. Probiotics may reduce a marker of gut inflammation called calprotectin, however, the benefit of this to an individual is unknown. There were no differences between probiotics and placebo for height, weight or body mass index (BMI). Results did not show that probiotics affect lung function, need for admission to hospital or abdominal symptoms. One small trial measured quality of life and the parents questionnaire favoured probiotics, but the children's self report did not show a difference between probiotics and placebo. Probiotics may cause vomiting, diarrhoea and allergic reactions. We estimate 52 people need to take probiotics for one person to have an adverse event. We could not analyse the results of the trial comparing different probiotics because of its design. Future trials should look into the use of probiotics for at least 12 months and assess measures of lung and gut health, growth, abdominal symptoms, quality of life and adverse events. Given the wide range or probiotics (single and multi-strain combinations), doses used and degree of effectiveness, determining the best regimen(s) to investigate further will be challenging. There were several issues with the overall certainty of the evidence which affects our confidence in the results from these trials. We think the fact that some participants did not complete their treatment or were not included in the reports may affect the results on weight. We think the fact that not all planned outcomes were reported in four trials may affect the results of intestinal inflammation, growth and abdominal symptoms. We think the fact that the pharmaceutical industry sponsored at least four of the trials should be considered when looking at the results of this review. As most trials only included children we are not certain that the results would also apply to adults and there were also some issues related to whether people taking part in the trial knew which treatment they were receiving. We judged the certainty of evidence for changes in pulmonary exacerbations, intestinal inflammation, lung function, hospital admissions, weight and health-related quality of life to be low. Adverse events were only recorded by four trials and the protocol for the terminated trial and the certainty of the evidence was also judged to be low."
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cochrane-simplification-train-1484 | cochrane-simplification-train-1484 | We included two studies with 362 pregnant women. Both studies compared ampicillin-sulbactam (N = 183) versus normal saline (N = 179) in pregnant women with MSAF. Prophylactic antibiotics appeared to have no statistically significant reduction in the incidence of neonatal sepsis (risk ratio (RR) 1.00, 95% CI 0.21 to 4.76), neonatal intensive care unit (NICU) admission (RR 0.83, 95% CI 0.39 to 1.78) and postpartum endometritis (RR 0.50, 95% CI 0.18 to 1.38). However, there was a significant decrease in the risk of chorioamnionitis (RR 0.36, 95% CI 0.21 to 0.62). No serious adverse effects were reported. Drug resistance, duration of mechanical ventilation and duration of admission to NICU/hospital were not reported. Most of the domains for risk of bias were at low risk of bias for one study and at unclear risk of bias for the other study. The quality of the evidence using GRADE was low for neonatal sepsis, postpartum endometritis, and neonatal mortality and morbidity prior to discharge (Neonatal intensive care admissions) and of moderate quality for chorioamnionitis. Current evidence indicates that compared to placebo, antibiotics for MSAF in labour may reduce chorioamnionitis. There was no evidence that antibiotics could reduce postpartum endometritis, neonatal sepsis and NICU admission. This systematic review identifies the need for more well-designed, adequately powered RCTs to assess the effect of prophylactic antibiotics in the incidence of maternal and neonatal complications. | Our review was based on two identified randomised controlled study (involving 362 women) and found that prophylactic antibiotics may reduce the risk of intra-amniotic infection in women with MSAF (moderate quality evidence). Antibiotics use did not clearly reduce neonatal sepsis (low quality evidence), NICU admission (low quality evidence) or postpartum endometritis (low quality evidence). Studies with much larger numbers of pregnant women with MSAF would be needed to examine these issues. | 10.1002/14651858.CD007772.pub3 | [
"Our review was based on two identified randomised controlled study (involving 362 women) and found that prophylactic antibiotics may reduce the risk of intra-amniotic infection in women with MSAF (moderate quality evidence). Antibiotics use did not clearly reduce neonatal sepsis (low quality evidence), NICU admission (low quality evidence) or postpartum endometritis (low quality evidence). Studies with much larger numbers of pregnant women with MSAF would be needed to examine these issues."
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cochrane-simplification-train-1485 | cochrane-simplification-train-1485 | One RCT and nine observational studies were included in the review. These ten studies identified 2,112 episodes of HIV transmission, 1,016 among treated couples and 1,096 among untreated couples. The rate ratio for the single randomised controlled trial was 0.04 [95% CI 0.00, 0.27]. All index partners in this study had CD4 cell counts at baseline of 350-550 cells/µL. Similarly, the summary rate ratio for the nine observational studies was 0.58 [95% CI 0.35, 0.96], with substantial heterogeneity (I2=64%). After excluding two studies with inadequate person-time data, we estimated a summary rate ratio of 0.36 [95% CI 0.17, 0.75] with substantial heterogeneity (I2=62%). We also performed subgroup analyses among the observational studies to see if the effect of ART on prevention of HIV differed by the index partner's CD4 cell count. Among couples in which the infected partner had ≥350 CD4 cells/µL, we estimated a rate ratio of 0.12 [95% CI 0.01, 1.99]. In this subgroup, there were 247 transmissions in untreated couples and 30 in treated couples. ART is a potent intervention for prevention of HIV in discordant couples in which the index partner has ≤550 CD4 cells/µL. A recent multicentre RCT confirms the suspected benefit seen in earlier observational studies and reported in more recent ones. Questions remain about durability of protection, the balance of benefits and adverse events associated with earlier therapy, long-term adherence and transmission of ART-resistant strains to partners. Resource limitations and implementation challenges must also be addressed. Counselling, support, and follow up, as well as mutual disclosure, may have a role in supporting adherence, so programmes should be designed with these components. In addition to ART provision, the operational aspects of delivering such programmes must be considered. | We found one randomised controlled trial and nine observational studies that examined this question. Overall we found that in couples in which the infected partner was being treated with antiretroviral drugs the uninfected partners had, at worst, more than 40% lower risk of being infected than in couples where the infected partner was not receiving treatment. Since the World Health Organization (WHO) already recommends antiretroviral treatment for all persons with ≤350 CD4 cells/µL, we also examined studies that had studied couples in which the infected partners had CD4 counts higher than this level. We found that there is strong evidence from the randomised controlled trial that in this group HIV was less likely to be transmitted to uninfected partners from treated infected partners than from untreated infected partners. | 10.1002/14651858.CD009153.pub3 | [
"We found one randomised controlled trial and nine observational studies that examined this question. Overall we found that in couples in which the infected partner was being treated with antiretroviral drugs the uninfected partners had, at worst, more than 40% lower risk of being infected than in couples where the infected partner was not receiving treatment. Since the World Health Organization (WHO) already recommends antiretroviral treatment for all persons with ≤350 CD4 cells/µL, we also examined studies that had studied couples in which the infected partners had CD4 counts higher than this level. We found that there is strong evidence from the randomised controlled trial that in this group HIV was less likely to be transmitted to uninfected partners from treated infected partners than from untreated infected partners."
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cochrane-simplification-train-1486 | cochrane-simplification-train-1486 | Four cluster-randomised controlled studies met the inclusion criteria. All of them investigated complex interventions comprising educational approaches. Three studies offered education and training for nursing staff, one study offered multidisciplinary team meetings as main component of the intervention. There was one high-quality study, but overall the methodological quality of studies was moderate. The studies revealed consistent results for the primary end point. All studies documented a decrease of the proportion of residents with antipsychotic drug use or a reduction in days with antipsychotic use per 100 days per resident, respectively. In summary, the reviewed evidence on psychosocial interventions targeting professionals is consistent with a reduction of antipsychotic medication prescription in care home residents. However, owing to heterogeneous approaches, summary effect sizes cannot be determined. There is evidence to support the effectiveness of psychosocial interventions for reducing antipsychotic medication in care home residents. However, the review was based on a small number of heterogeneous studies with important methodological shortcomings. The most recent and methodologically most rigorous study showed the most pronounced effect. | This review investigates whether psychosocial interventions aimed at reducing antipsychotic medication in care homes are effective. By psychosocial interventions, we mean programmes that consist of different non-pharmacological components including talking to the staff, residents, or both. We identified four randomised controlled trials for inclusion in the review. All studies examined, among other components, education targeted at nursing staff in care homes. The methodological quality of three studies was limited, one study showed high quality. In all studies the interventions led to a reduction of antipsychotic medication use, but the overall magnitude of the effect remains unclear. | 10.1002/14651858.CD008634.pub2 | [
"This review investigates whether psychosocial interventions aimed at reducing antipsychotic medication in care homes are effective. By psychosocial interventions, we mean programmes that consist of different non-pharmacological components including talking to the staff, residents, or both. We identified four randomised controlled trials for inclusion in the review. All studies examined, among other components, education targeted at nursing staff in care homes. The methodological quality of three studies was limited, one study showed high quality. In all studies the interventions led to a reduction of antipsychotic medication use, but the overall magnitude of the effect remains unclear."
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cochrane-simplification-train-1487 | cochrane-simplification-train-1487 | We included 10 trials involving 26,865 high vascular risk patients. The trials were generally of high quality. Aspirin was compared with ticlopidine in nine trials (7633 patients) and with clopidogrel in one trial (19,185 patients). Compared with aspirin, allocation to a thienopyridine produced a modest, just statistically significant, reduction in the odds of a serious vascular event (11.6% versus 12.5%; odds ratio (OR) 0.92, 95% confidence interval (CI) 0.85 to 0.99), corresponding to the avoidance of 10 (95% CI 0 to 20) serious vascular events per 1000 patients treated for about two years. However, the wide confidence interval includes the possibility of negligible additional benefit. Compared with aspirin, thienopyridines significantly reduced gastrointestinal adverse effects. However, thienopyridines increased the odds of skin rash and diarrhoea, ticlopidine more than clopidogrel. Allocation to ticlopidine, but not clopidogrel, significantly increased the odds of neutropenia. In patients with TIA/ischaemic stroke, the results were similar to those for all patients combined. The thienopyridine derivatives are at least as effective as aspirin in preventing serious vascular events in patients at high risk, and possibly somewhat more so. However, the size of any additional benefit is uncertain and could be negligible. Clopidogrel has a more favourable adverse effects profile than ticlopidine and so is the thienopyridine of choice. It should be used as an alternative to aspirin in patients genuinely intolerant of or allergic to aspirin. | This review of 10 trials comparing either clopidogrel or ticlopidine with aspirin in about 27,000 people found that clopidogrel and ticlopidine were at least as effective as aspirin for the prevention of stroke and heart attacks, and might be slightly more effective. In terms of adverse effects, compared with aspirin, clopidogrel and ticlopidine caused less stomach upset and less bleeding from the gut, but more diarrhoea and skin rash. Ticlopidine produced more of these last two adverse effects than clopidogrel when compared with aspirin. Ticlopidine can also cause suppression of the bone marrow production of blood cells, which can be a serious complication. Clopidogrel is therefore the thienopyridine of choice since it is safer and better tolerated. However, since it is substantially more expensive than aspirin and not clearly more effective, it should generally only be used instead of aspirin in patients who are unable to take aspirin. | 10.1002/14651858.CD001246.pub2 | [
"This review of 10 trials comparing either clopidogrel or ticlopidine with aspirin in about 27,000 people found that clopidogrel and ticlopidine were at least as effective as aspirin for the prevention of stroke and heart attacks, and might be slightly more effective. In terms of adverse effects, compared with aspirin, clopidogrel and ticlopidine caused less stomach upset and less bleeding from the gut, but more diarrhoea and skin rash. Ticlopidine produced more of these last two adverse effects than clopidogrel when compared with aspirin. Ticlopidine can also cause suppression of the bone marrow production of blood cells, which can be a serious complication. Clopidogrel is therefore the thienopyridine of choice since it is safer and better tolerated. However, since it is substantially more expensive than aspirin and not clearly more effective, it should generally only be used instead of aspirin in patients who are unable to take aspirin."
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cochrane-simplification-train-1488 | cochrane-simplification-train-1488 | Three short-term RCTs, which enrolled 277 randomised participants with acute phase GBS, were included. Risk of bias in the included studies was generally unclear due to insufficient information. None of the included studies reported the primary outcome selected for this review, which was number of patients with self reported pain relief of 50% or greater. One small study investigated seven-day regimens of gabapentin versus placebo. Pain was rated on a scale from 0 (no pain) to 10 (maximum pain). Amongst the 18 participants, significantly lower mean pain scores were found at the endpoint (day 7) in the gabapentin phase compared to the endpoint of the placebo phase (mean difference -3.61, 95% CI -4.12 to -3.10) (very low quality evidence). For adverse events, no significant differences were found in the incidence of nausea (risk ratio (RR) 0.50, 95% CI 0.05 to 5.04) or constipation (RR 0.14, 95% CI 0.01 to 2.54). A second study enrolling 36 participants compared gabapentin, carbamazepine and placebo, all administered over seven days. Participants in the gabapentin group had significantly lower median pain scores on all treatment days in comparison to the placebo and carbamazepine groups (P < 0.05). There were no statistically significant differences in the median pain scores between the carbamazepine and placebo groups from day 1 to day 3, but from day 4 until the end of the study significantly lower median pain scores were noted in the carbamazepine group (P < 0.05) (very low quality evidence). There were no adverse effects of gabapentin or carbamazepine reported, other than sedation. One large RCT (223 participants, all also treated with intravenous immunoglobulin), compared a five-day course of methylprednisolone with placebo and found no statistically significant differences in number of participants developing pain (RR 0.89, 95% CI 0.68 to 1.16), number of participants with decreased pain (RR 0.95, 95% CI 0.63 to 1.42) or number of participants with increased pain (RR 0.85, 95% CI 0.52 to 1.41) (low quality evidence). The study did not report whether there were any adverse events. Since the last version of this review we found no new studies. While management of pain in GBS is essential and pharmacotherapy is widely accepted as being an important component of treatment, this review does not provide sufficient evidence to support the use of any pharmacological intervention in people with pain in GBS. Although reductions in pain severity were found when comparing gabapentin and carbamazepine with placebo, the evidence was limited and its quality very low. Larger, well-designed RCTs are required to further investigate the efficacy and safety of potential interventions for patients with pain in GBS. Additionally, interventions for pain in the convalescent phase of GBS should be investigated. | We first carried out a wide search of medical databases to find studies that met the requirements for this review. We identified three studies, which involved 277 participants who were randomly assigned to different treatments for pain in GBS. Two studies compared a pain medicine (gabapentin or carbamazepine) with placebo (inactive treatment). The other study compared a steroid medicine with placebo. Two medicines, gabapentin and carbamazepine, reduced pain severity compared to placebo (inactive) treatment and they had few side effects. One study found that people taking gabapentin had less pain, sleepiness or need for additional pain killers than those given carbamazepine. However, these studies were small and the treatment period was short. One trial, with 223 participants, found that methylprednisolone, which is a steroid medicine, did not affect the numbers of people who developed pain or change the numbers with more pain or less pain compared with placebo. This study did not report whether there were any side effects. This review does not provide enough evidence to say whether or not treatments for pain in people with GBS work. Although both gabapentin and carbamazepine reduced the severity of pain compared to placebo, and few side effects were reported, the studies were small and the quality of the evidence was very low. Much larger, well-designed studies are needed to confirm that drug treatments are safe and effective for people with pain in the period soon after onset of GBS. Long-term studies of pain treatments at the stage when people with GBS are recovering should also be conducted and these should include assessment of effects of pain treatments on quality of life. This review was first published in 2013 and an updated search in 2014 revealed no additional studies. The evidence is current to November 2014. | 10.1002/14651858.CD009950.pub3 | [
"We first carried out a wide search of medical databases to find studies that met the requirements for this review. We identified three studies, which involved 277 participants who were randomly assigned to different treatments for pain in GBS. Two studies compared a pain medicine (gabapentin or carbamazepine) with placebo (inactive treatment). The other study compared a steroid medicine with placebo. Two medicines, gabapentin and carbamazepine, reduced pain severity compared to placebo (inactive) treatment and they had few side effects. One study found that people taking gabapentin had less pain, sleepiness or need for additional pain killers than those given carbamazepine. However, these studies were small and the treatment period was short. One trial, with 223 participants, found that methylprednisolone, which is a steroid medicine, did not affect the numbers of people who developed pain or change the numbers with more pain or less pain compared with placebo. This study did not report whether there were any side effects. This review does not provide enough evidence to say whether or not treatments for pain in people with GBS work. Although both gabapentin and carbamazepine reduced the severity of pain compared to placebo, and few side effects were reported, the studies were small and the quality of the evidence was very low. Much larger, well-designed studies are needed to confirm that drug treatments are safe and effective for people with pain in the period soon after onset of GBS. Long-term studies of pain treatments at the stage when people with GBS are recovering should also be conducted and these should include assessment of effects of pain treatments on quality of life. This review was first published in 2013 and an updated search in 2014 revealed no additional studies. The evidence is current to November 2014."
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cochrane-simplification-train-1489 | cochrane-simplification-train-1489 | Seven studies, 482 participants, met the inclusion criteria. - Comparing antidepressant with placebo, no statistically significant results for dropouts. Selecting studies with low risk of bias, 325 participants, results favour placebo, RR 1.40 (Cl 95% 1.00 to 1.96). For severity of depression, results from two studies, 183 participants, favour antidepressants utilising Clinical Global Impression Scale RR 1.92 (CI 95% 1.26 to 2.94), while another study, 95 participants, utilising the Hamilton Depression Rating Scale, did not find a statistically significant difference RR 0.96 (CI 95% 0.54 to 1.71). For adverse events, result favour placebo, four studies, 311 participants, RR 2.90 (Cl 95% 1.23 to 6.86). For drug use, three studies, 211 participants, it was not possible to pool data because outcomes' measures were not comparable. Looking at singular studies, no statistically significant difference was seen. - Comparing different classes of antidepressants, the results favour tricyclics for severity of depression, two studies, 183 participants, RR 1.92 (Cl 95% 1.26 to 2.94) and favour placebo for adverse events, two studies, 172 participants, RR 3.11 (Cl 95% 1.06 to 9.12). There is low evidence, at the present, supporting the clinical use of antidepressants for the treatment of depressed opioid addicts in treatment with opioid agonists. There is a need of larger randomised studies investigating relevant outcomes, safety issues and reporting data to allow comparison of results. | Authors included seven randomised controlled studies that involved 482 participants in our review. The studies were conducted in outpatient settings over four to 16 weeks; six were in USA and one in Australia. The mean age of participants was 34 years and 62% were males. No clear difference was found in the number of dropouts from an opioid agonist maintenance program between people receiving antidepressants and those in the placebo groups. Neither was drug use different (two studies). Severity of depression was reduced with the use of antidepressants (two studies), including tricyclic antidepressants. Adverse events were important as more of the participants who received antidepressants withdrew from the studies for medical reasons compared with those participants on placebo (four studies). The differences between studies in clinical (participant characteristics, the medications used, services and treatments delivered) and methodological characteristics (study design and quality) made it difficult to draw confident conclusions about the efficacy and safety of antidepressants for the treatment of depression in people who are dependent on opioids. | 10.1002/14651858.CD008373.pub2 | [
"Authors included seven randomised controlled studies that involved 482 participants in our review. The studies were conducted in outpatient settings over four to 16 weeks; six were in USA and one in Australia. The mean age of participants was 34 years and 62% were males. No clear difference was found in the number of dropouts from an opioid agonist maintenance program between people receiving antidepressants and those in the placebo groups. Neither was drug use different (two studies). Severity of depression was reduced with the use of antidepressants (two studies), including tricyclic antidepressants. Adverse events were important as more of the participants who received antidepressants withdrew from the studies for medical reasons compared with those participants on placebo (four studies). The differences between studies in clinical (participant characteristics, the medications used, services and treatments delivered) and methodological characteristics (study design and quality) made it difficult to draw confident conclusions about the efficacy and safety of antidepressants for the treatment of depression in people who are dependent on opioids."
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cochrane-simplification-train-1490 | cochrane-simplification-train-1490 | We identified eight trials published from 2004 to 2017 randomising a total of 1730 participants, with mean intervention duration of 12 weeks. All eight trials were judged to be at overall high risk of bias and effect estimates are reported at the end of the intervention with a follow-up range of eight to 24 weeks. Seven trials reported all-cause mortality, but deaths only occurred in one trial with no evidence of a difference between exercise-based cardiac rehabilitation and control (risk ratio (RR) 1.96, 95% confidence interval (CI) 0.18 to 21.26; participants = 196; trials = 1; quality of evidence: low). There was also no evidence of a difference in serious adverse events between exercise-based cardiac rehabilitation and control (RR 1.05, 95% CI 0.77 to 1.44; participants = 356; trials = 2; quality of evidence: low). Due to the variation in reporting of health-related quality of life outcomes, it was not possible to pool data. However, the five trials reporting health-related quality of life at the end of the intervention, each showed little or no evidence of a difference between exercise-based cardiac rehabilitation and control. For secondary outcomes, there was evidence of a higher pooled exercise capacity (peak VO2) at the end of the intervention (mean difference (MD) 0.91 mL/kg/min, 95% CI 0.60 to 1.21; participants = 1485; trials = 7; quality of evidence: very low) favouring exercise-based cardiac rehabilitation, albeit there was evidence of substantial statistical heterogeneity (I2 = 78%). There was no evidence of a difference in the risk of requiring antitachycardia pacing (RR 1.26, 95% CI 0.84 to 1.90; participants = 356; trials = 2; quality of evidence: moderate), appropriate shock (RR 0.56, 95% CI 0.20 to 1.58; participants = 428; studies = 3; quality of evidence: low) or inappropriate shock (RR 0.60, 95% CI 0.10 to 3.51; participants = 160; studies = 1; quality of evidence: moderate). Due to a lack of evidence, we were unable to definitively assess the impact of exercise-based cardiac rehabilitation on all-cause mortality, serious adverse events and health-related quality of life in adults with an ICD. However, our findings do provide very low-quality evidence that patients following exercise-based cardiac rehabilitation experience a higher exercise capacity compared with the no exercise control. Further high-quality randomised trials are needed in order to assess the impact of exercise-based cardiac rehabilitation in this population on all-cause mortality, serious adverse events, health-related quality of life, antitachycardia pacing and shock. | We searched for randomised controlled trials (experiments in which participants are randomly allocated to an experimental intervention compared with a control intervention) that investigated exercise-based interventions compared with no exercise intervention control. We found eight trials published from 2004 to 2017 with a total of 1730 participants. Two trials did not report on funding and one trial reported funding from industry. The evidence is current to 30 August 2018. The review showed no evidence of an impact on the risk of death, harmful side effects or having antitachycardia pacing or shock therapy when comparing the exercise intervention to the control. There was also little or no evidence of a difference on health-related quality of life. However, there was an improvement in exercise capacity in favour of the exercise group. The quality of the evidence ranged from moderate to very low for all outcomes. The number of events was low, it was possible for people in the trials to know to which intervention group they were randomised, the reporting of the results was not complete in some trials, and for some outcomes, the results varied across trials. These considerations limited our confidence in the overall results of the review. Further adequately powered and well-conducted randomised trials are needed to assess the impact of exercise-based cardiac rehabilitation in adults with an implantable cardioverter defibrillator. | 10.1002/14651858.CD011828.pub2 | [
"We searched for randomised controlled trials (experiments in which participants are randomly allocated to an experimental intervention compared with a control intervention) that investigated exercise-based interventions compared with no exercise intervention control. We found eight trials published from 2004 to 2017 with a total of 1730 participants. Two trials did not report on funding and one trial reported funding from industry. The evidence is current to 30 August 2018. The review showed no evidence of an impact on the risk of death, harmful side effects or having antitachycardia pacing or shock therapy when comparing the exercise intervention to the control. There was also little or no evidence of a difference on health-related quality of life. However, there was an improvement in exercise capacity in favour of the exercise group. The quality of the evidence ranged from moderate to very low for all outcomes. The number of events was low, it was possible for people in the trials to know to which intervention group they were randomised, the reporting of the results was not complete in some trials, and for some outcomes, the results varied across trials. These considerations limited our confidence in the overall results of the review. Further adequately powered and well-conducted randomised trials are needed to assess the impact of exercise-based cardiac rehabilitation in adults with an implantable cardioverter defibrillator."
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cochrane-simplification-train-1491 | cochrane-simplification-train-1491 | We extracted data from 53 studies. We included 24 studies with a total of 581 participants. Three studies used a parallel-group, randomised design which compared prone and supine positions only. The remaining 21 studies used a randomised cross-over design. These studies compared prone, supine, lateral, elevated and flat positions. Prone positioning was significantly more beneficial than supine positioning in terms of oxygen saturation (mean difference (MD) 1.97%, 95% CI 1.18 to 2.77), arterial oxygen (MD 6.24 mm Hg, 95% confidence interval (CI) 2.20 to 10.28), episodes of hypoxaemia (MD -3.46, 95% CI -4.60 to -2.33) and thoracoabdominal synchrony (MD -30.76, 95% CI -41.39 to -20.14). No adverse effects were identified. There were no statistically significant differences between any other positions. As the majority of studies did not describe how possible biases were addressed, the potential for bias in these findings is unclear. The prone position was significantly superior to the supine position in terms of oxygenation. However, as most participants were ventilated preterm infants, the benefits of prone positioning may be most relevant to these infants. In addition, although placing infants and children in the prone position may improve respiratory function, the association of SIDS with prone positioning means that infants should only be placed in this position while under continuous cardiorespiratory monitoring. | We included 24 studies with a total of 581 participants. Lying on the front (the prone position) was better than lying on the back (the supine position) for oxygenating the blood but the difference was small. The increase in oxygen saturation on average increased by 2%. This finding was based on data from nine studies (195 children, 165 preterm and 95 ventilated) measuring this outcome. The rapid rate of breathing with respiratory distress was slightly lower in the prone position (on average four breaths/minute lower) based on six studies (100 infants aged up to one month, 59 ventilated). No adverse effects were identified. There were no obvious differences with other positions. As most of the 581 children in these studies were preterm babies (60%) and (70%) ventilated by machine, the benefits of prone positioning may be most relevant to these infants. ***It is important to remember that these children were hospitalised. Therefore, given the association of the prone position with sudden infant death syndrome (SIDS), the prone position should not be used for children unless they are in hospital and their breathing is constantly monitored. As the majority of studies did not describe how possible biases in the design of the study were addressed, the potential for bias in these findings is unclear. Also the findings of this review are limited by the small number of participants in studies, changes in infants and children were only measured for short time periods and the small changes in oxygenation which were seen in this review are not as meaningful as other measures of illness and recovery. Only five studies looked at children older than one year and few studies compared positions other than prone and supine. | 10.1002/14651858.CD003645.pub3 | [
"We included 24 studies with a total of 581 participants. Lying on the front (the prone position) was better than lying on the back (the supine position) for oxygenating the blood but the difference was small. The increase in oxygen saturation on average increased by 2%. This finding was based on data from nine studies (195 children, 165 preterm and 95 ventilated) measuring this outcome. The rapid rate of breathing with respiratory distress was slightly lower in the prone position (on average four breaths/minute lower) based on six studies (100 infants aged up to one month, 59 ventilated). No adverse effects were identified. There were no obvious differences with other positions. As most of the 581 children in these studies were preterm babies (60%) and (70%) ventilated by machine, the benefits of prone positioning may be most relevant to these infants. ***It is important to remember that these children were hospitalised. Therefore, given the association of the prone position with sudden infant death syndrome (SIDS), the prone position should not be used for children unless they are in hospital and their breathing is constantly monitored. As the majority of studies did not describe how possible biases in the design of the study were addressed, the potential for bias in these findings is unclear. Also the findings of this review are limited by the small number of participants in studies, changes in infants and children were only measured for short time periods and the small changes in oxygenation which were seen in this review are not as meaningful as other measures of illness and recovery. Only five studies looked at children older than one year and few studies compared positions other than prone and supine."
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cochrane-simplification-train-1492 | cochrane-simplification-train-1492 | We included nine studies with data for 638 VOC events and 594 participants aged 17 to 42 years with SCD presenting to a hospital emergency department in a painful VOC. Three studies investigated a non-steroidal anti-inflammatory drug (NSAID) compared to placebo. One study compared an opioid with a placebo, two studies compared an opioid with an active comparator, two studies compared an anticoagulant with a placebo, and one study compared a combination of three drugs with a combination of four drugs. Risk of bias across the nine studies varied. Studies were primarily at an unclear risk of selection, performance, and detection bias. Studies were primarily at a high risk of bias for size with fewer than 50 participants per treatment arm; two studies had 50 to 199 participants per treatment arm (unclear risk). Non-steroidal anti-inflammatory drugs (NSAID) compared with placebo No data were reported regarding participant-reported pain relief of 50% or 30% or greater. The efficacy was uncertain regarding PGIC very much improved, and PGIC much or very much improved (no difference; 1 study, 21 participants; very low-quality evidence). Very low-quality, uncertain results suggested similar rates of adverse events across both the NSAIDs group (16/45 adverse events, 1/56 serious adverse events, and 1/56 withdrawal due to adverse events) and the placebo group (19/45 adverse events, 2/56 serious adverse events, and 1/56 withdrawal due to adverse events). Opioids compared with placebo No data were reported regarding participant-reported pain relief of 50% or 30%, PGIC, or adverse events (any adverse event, serious adverse events, and withdrawals due to adverse events). Opioids compared with active comparator No data were reported regarding participant-reported pain relief of 50% or 30% or greater. The results were uncertain regarding PGIC very much improved (33% of the opioids group versus 19% of the placebo group). No data were reported regarding PGIC much or very much improved. Very low-quality, uncertain results suggested similar rates of adverse events across both the opioids group (9/66 adverse events, and 0/66 serious adverse events) and the placebo group (7/64 adverse events, 0/66 serious adverse events). No data were reported regarding withdrawal due to adverse events. Quality of the evidence We downgraded the quality of the evidence by three levels to very low-quality because there are too few data to have confidence in results (e.g. too few participants per treatment arm). Where no data were reported for an outcome, we had no evidence to support or refute (quality of the evidence is unknown). This review identified only nine studies, with insufficient data for all pharmacological interventions for analysis. The available evidence is very uncertain regarding the efficacy or harm from pharmacological interventions used to treat pain related to sickle cell VOC in adults. This area could benefit most from more high quality, certain evidence, as well as the establishment of suitable registries which record interventions and outcomes for this group of people. | In September 2019, we searched for clinical trials that used medicines in any setting to treat painful sickle cell crises. We found nine trials, with 594 adults (aged 17 to 42 years) who had sickle cell disease, experiencing a combined total of 638 painful episodes. The studies looked at different comparisons of the medicines butorphanol, cetiedil, fentanyl, ketoprofen, ketorolac, metoclopramide, morphine, paracetamol, placebo, tinzaparin, and tramadol. Only three studies compared the same two drugs (non-steroidal anti-inflammatory drugs such as ibuprofen, aspirin, or naproxen, with a placebo (pretend treatment)) and we had very limited data to be able to investigate the effects on pain scores from these medicines. Side effects were rare and were generally mild. We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. Very low-quality evidence means that we are very uncertain about the results. High-quality evidence means that we are very confident in the results. For pain relief and side effects, we rated the quality of evidence as very low. We downgraded the quality of the evidence to very low because there were not enough data (e.g. too few participants). For some outcomes the quality of the evidence is unknown because there was no evidence available. | 10.1002/14651858.CD012187.pub2 | [
"In September 2019, we searched for clinical trials that used medicines in any setting to treat painful sickle cell crises. We found nine trials, with 594 adults (aged 17 to 42 years) who had sickle cell disease, experiencing a combined total of 638 painful episodes. The studies looked at different comparisons of the medicines butorphanol, cetiedil, fentanyl, ketoprofen, ketorolac, metoclopramide, morphine, paracetamol, placebo, tinzaparin, and tramadol. Only three studies compared the same two drugs (non-steroidal anti-inflammatory drugs such as ibuprofen, aspirin, or naproxen, with a placebo (pretend treatment)) and we had very limited data to be able to investigate the effects on pain scores from these medicines. Side effects were rare and were generally mild. We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. Very low-quality evidence means that we are very uncertain about the results. High-quality evidence means that we are very confident in the results. For pain relief and side effects, we rated the quality of evidence as very low. We downgraded the quality of the evidence to very low because there were not enough data (e.g. too few participants). For some outcomes the quality of the evidence is unknown because there was no evidence available."
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cochrane-simplification-train-1493 | cochrane-simplification-train-1493 | Twelve trials, with 615 participants, met our inclusion criteria. The median number of participants in each trial was 27, and median trial duration was 16 weeks. The included studies were conducted over a 32-year time period, from 1983 to 2015. A single RCT that was underpowered to detect clinically meaningful differences investigated most interventions. There were four trials of anti-TNF-α (tumour necrosis factor-alpha) therapies, which included etanercept, infliximab, and adalimumab. Adalimumab 40 mg weekly improved the Dermatology Life Quality Index (DLQI) score in participants with moderate to severe HS by 4.0 points relative to placebo (95% confidence interval (CI) -6.5 to -1.5 points), an effect size approximately equal to the DLQI minimal clinically important difference. We reduced the evidence quality to 'moderate' because the effect size was based on the results of only one study. In a meta-analysis of two studies with 124 participants, standard dose adalimumab 40 mg every other week was ineffective compared with placebo (moderate quality evidence). In a smaller study of 38 participants, of whom only 33 provided efficacy data, infliximab 5 mg/kg treatment improved DLQI by 8.4 DLQI points after eight weeks. Etanercept 50 mg twice weekly was well tolerated but ineffective. In a RCT of 200 participants, no difference was found in surgical complications (week one: risk ratio (RR) 0.78, 95% CI 0.58 to 1.05, moderate quality evidence) or risk of recurrence (after three months: RR 0.96, 95% CI 0.68 to 1.34, moderate quality evidence) in those randomised to receive a gentamicin-collagen sponge prior to primary closure compared with primary closure alone. RCTs of other interventions, including topical clindamycin 1% solution; oral tetracycline; oral ethinylestradiol 50 mcg with either cyproterone acetate 50 mg or norgestrel 500 mcg; intense pulsed light; neodymium-doped yttrium aluminium garnet (Nd:YAG) laser; methylene blue gel photodynamic therapy; and staphage lysate, were relatively small studies, preventing firm conclusions due to imprecision. Many knowledge gaps exist in RCT evidence for HS. Moderate quality evidence exists for adalimumab, which improves DLQI score when 40 mg is given weekly, twice the standard psoriasis dose. However, the 95% confidence interval includes an effect size of only 1.5 DLQI points, which may not be clinically relevant, and the safety profile of weekly dosing has not been fully established. Infliximab also improves quality of life, based on moderate quality evidence. More RCTs are needed in most areas of HS care, particularly oral treatments and the type and timing of surgical procedures. Outcomes should be validated, ideally, including a minimal clinically important difference for HS. | Our review included only randomised controlled trials (RCTs); we included 12 trials, containing a total of 615 people. In most cases, only a single trial that was too small to provide meaningful results investigated the treatments. There was no RCT evidence to support several quite commonly used treatments. The average duration of the trials was four months, long enough to check whether a treatment works initially but not long enough to show the duration of disease control or to detect delayed side effects. The evidence from two trials for clindamycin lotion applied to the skin and oral tetracyclines was relatively weak, despite these antibiotics being standard treatments for mild to moderate HS. There were four pharmaceutical industry-sponsored trials of anti-TNF-α (tumour necrosis factor-alpha) therapies, which included etanercept, infliximab, and adalimumab. Of these, a trial of etanercept did not find benefit, whereas a small trial of infliximab reported an improvement in quality of life after eight weeks. A larger trial, including 154 participants, investigated adalimumab. There was no benefit for moderate to severe HS at standard psoriasis doses of 40 mg every other week, but 40 mg weekly did improve quality of life. The estimate of quality of life improvement ranged from a level that probably would help people with HS to a level that might not be enough to justify use of adalimumab. The trial found no increase in serious side effects, including infections, but it was not large enough to detect rare effects. There were no trials investigating when to perform surgery or what surgical procedure to consider. One trial looked at inserting an antibiotic sponge into wounds after removal of HS lesions, but found no benefit compared with surgery without the antibiotic sponge. There were three trials of laser-type treatments, but the trial quality was too low to recommend these therapies. Our review has highlighted a need for more clinical trials to give better evidence to guide treatment choices in HS. More trials of oral treatments are required as well as surgical studies. Future trials should include patient-reported outcomes, such as quality of life and pain. | 10.1002/14651858.CD010081.pub2 | [
"Our review included only randomised controlled trials (RCTs); we included 12 trials, containing a total of 615 people. In most cases, only a single trial that was too small to provide meaningful results investigated the treatments. There was no RCT evidence to support several quite commonly used treatments. The average duration of the trials was four months, long enough to check whether a treatment works initially but not long enough to show the duration of disease control or to detect delayed side effects. The evidence from two trials for clindamycin lotion applied to the skin and oral tetracyclines was relatively weak, despite these antibiotics being standard treatments for mild to moderate HS. There were four pharmaceutical industry-sponsored trials of anti-TNF-α (tumour necrosis factor-alpha) therapies, which included etanercept, infliximab, and adalimumab. Of these, a trial of etanercept did not find benefit, whereas a small trial of infliximab reported an improvement in quality of life after eight weeks. A larger trial, including 154 participants, investigated adalimumab. There was no benefit for moderate to severe HS at standard psoriasis doses of 40 mg every other week, but 40 mg weekly did improve quality of life. The estimate of quality of life improvement ranged from a level that probably would help people with HS to a level that might not be enough to justify use of adalimumab. The trial found no increase in serious side effects, including infections, but it was not large enough to detect rare effects. There were no trials investigating when to perform surgery or what surgical procedure to consider. One trial looked at inserting an antibiotic sponge into wounds after removal of HS lesions, but found no benefit compared with surgery without the antibiotic sponge. There were three trials of laser-type treatments, but the trial quality was too low to recommend these therapies. Our review has highlighted a need for more clinical trials to give better evidence to guide treatment choices in HS. More trials of oral treatments are required as well as surgical studies. Future trials should include patient-reported outcomes, such as quality of life and pain."
]
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cochrane-simplification-train-1494 | cochrane-simplification-train-1494 | We included seven RCTs (1217 women) of varying methodological quality in the review; most trials were at moderate or high risk of bias. Three were multi-centre trials, two were single-centre trials, and in two trials it was unclear if they were single or multi-centre. These trials compared the following interventions for women with locally advanced cervical cancer (stages IB2 to III): hysterectomy (simple or radical) with radiotherapy (N = 194) versus radiotherapy alone (N = 180); hysterectomy (simple or radical) with chemoradiotherapy (N = 31) versus chemoradiotherapy alone (N = 30); hysterectomy (radical) with chemoradiotherapy (N = 111) versus internal radiotherapy with chemoradiotherapy (N = 100); hysterectomy (simple or radical) with upfront (neoadjuvant) chemotherapy (N = 298) versus radiotherapy alone (N = 273). One trial (N = 256) found no difference in the risk of death or disease progression between women who received attenuated radiotherapy followed by hysterectomy and those who received radiotherapy (external and internal) alone (hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.61 to 1.29). This trial also reported no difference between the two groups in terms of adverse effects (18/129 grade 3 or 4 adverse effects in the hysterectomy and radiation group and 19 cases in 18/121 women in the radiotherapy alone group). There was no difference in 5-year tumour-free actuarial survival (representation of the probable years of survivorship of a defined population of participants) or severe complications (grade 3) in another trial (N = 118) which reported the same comparison (6/62 versus 6/56 in the radiation with surgery group versus the radiotherapy alone group, respectively). The quality of the evidence was low for all these outcomes. One trial (N = 61) reported no difference (P value > 0.10) in overall and recurrence-free survival at 3 years between chemoradiotherapy and hysterectomy versus chemoradiotherapy alone (low quality evidence). Adverse events and morbidity data were not reported. Similarly, another trial (N = 211) found no difference in the risk of death (HR 0.65, 95% CI 0.35 to 1.21, P value = 0.19, low quality evidence), disease progression (HR 0.70, 95% CI 0.31 to 1.34, P value = 0.24, low quality evidence) or severe late complications (P value = 0.53, low quality evidence) between women who received internal radiotherapy versus hysterectomy after both groups had received external-beam chemoradiotherapy. Meta analysis of three trials of neoadjuvant chemotherapy and hysterectomy versus radiotherapy alone, assessing 571 participants, found that women who received neoadjuvant chemotherapy plus hysterectomy had less risk of death than those who received radiotherapy alone (HR 0.71, 95% CI 0.55 to 0.93, I2 = 0%, moderate quality evidence). However, a significant number of the participants that received neoadjuvant chemotherapy plus hysterectomy had radiotherapy as well. There was no difference in the proportion of women with disease progression or recurrence between the two groups (RR 0.75, 95% CI 0.53 to 1.05, I2 = 20%, moderate quality evidence). Results of single trials reported no apparent (P value > 0.05) difference in long-term severe complications, grade 3 acute toxicity and severe late toxicity between the two groups (low quality evidence). Quality of life outcomes were not reported in any of the trials. From the available RCTs, we found insufficient evidence that hysterectomy with radiotherapy, with or without chemotherapy, improves the survival of women with locally advanced cervical cancer who are treated with radiotherapy or chemoradiotherapy alone. The overall quality of the evidence was variable across the different outcomes and was universally downgraded due to concerns about risk of bias. The quality of the evidence for neoadjuvant chemotherapy and radical hysterectomy versus radiotherapy alone for survival outcomes was moderate, with evidence from other comparisons of low quality. This was mainly based on poor reporting and sparseness of data where results were based on single trials. More trials that assess medical management with and without hysterectomy may test the robustness of the findings of this review as further research is likely to have an important impact on our confidence in the estimate of effect. | Two studies, including 374 women, compared preoperative radiotherapy and hysterectomy versus radiotherapy alone, but only one trial reported overall survival, with no difference between the groups. These studies found no difference in the risk of disease progression (or death) or five-year tumour-free survival. One study, including 61 women, reported no difference in overall and recurrence-free survival between chemotherapy and hysterectomy versus chemoradiotherapy alone. Another study comparing internal radiotherapy (brachytherapy) versus hysterectomy in 211 women who received chemoradiotherapy found no difference in the risk of death or disease progression. By combining results from three of the independent studies that assessed 571 women, we found that fewer women who received neoadjuvant chemotherapy plus hysterectomy died than those who received radiotherapy alone. However, many women in the first group also had radiotherapy. There was no difference in the number of women who were disease-free after treatment. Adverse events were incompletely reported. Results of single trials showed no differences in severe adverse events between the two groups in any comparison. Limited data suggested that the interventions appeared to be reasonably well tolerated, although more evidence is needed. Quality of life measures were not reported. We found insufficient evidence that hysterectomy added to radiation and chemoradiation improved survival, quality of life or adverse events in locally advanced cervical cancer compared with medical treatment alone. Overall, the quality of the evidence was variable and was universally downgraded due to concerns about risk of bias. The quality of the evidence for neoadjuvant chemotherapy and radical hysterectomy versus radiotherapy alone for survival outcomes was moderate, with evidence from other comparisons being of low quality. Further data from carefully planned trials assessing medical management with and without hysterectomy are likely to impact on how confident we are about these findings. | 10.1002/14651858.CD010260.pub2 | [
"Two studies, including 374 women, compared preoperative radiotherapy and hysterectomy versus radiotherapy alone, but only one trial reported overall survival, with no difference between the groups. These studies found no difference in the risk of disease progression (or death) or five-year tumour-free survival. One study, including 61 women, reported no difference in overall and recurrence-free survival between chemotherapy and hysterectomy versus chemoradiotherapy alone. Another study comparing internal radiotherapy (brachytherapy) versus hysterectomy in 211 women who received chemoradiotherapy found no difference in the risk of death or disease progression. By combining results from three of the independent studies that assessed 571 women, we found that fewer women who received neoadjuvant chemotherapy plus hysterectomy died than those who received radiotherapy alone. However, many women in the first group also had radiotherapy. There was no difference in the number of women who were disease-free after treatment. Adverse events were incompletely reported. Results of single trials showed no differences in severe adverse events between the two groups in any comparison. Limited data suggested that the interventions appeared to be reasonably well tolerated, although more evidence is needed. Quality of life measures were not reported. We found insufficient evidence that hysterectomy added to radiation and chemoradiation improved survival, quality of life or adverse events in locally advanced cervical cancer compared with medical treatment alone. Overall, the quality of the evidence was variable and was universally downgraded due to concerns about risk of bias. The quality of the evidence for neoadjuvant chemotherapy and radical hysterectomy versus radiotherapy alone for survival outcomes was moderate, with evidence from other comparisons being of low quality. Further data from carefully planned trials assessing medical management with and without hysterectomy are likely to impact on how confident we are about these findings."
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cochrane-simplification-train-1495 | cochrane-simplification-train-1495 | We identified 37 eligible studies involving over 15,000 participants who smoked tobacco. The majority of studies recruited participants with particular characteristics, often from groups of people who are less likely to seek support to stop smoking than the general population. Although a few studies recruited participants who intended to stop smoking soon or had no intentions to quit, most recruited a population without regard to their intention to quit. MI was conducted in one to 12 sessions, with the total duration of MI ranging from five to 315 minutes across studies. We judged four of the 37 studies to be at low risk of bias, and 11 to be at high risk, but restricting the analysis only to those studies at low or unclear risk did not significantly alter results, apart from in one case - our analysis comparing higher to lower intensity MI. We found low-certainty evidence, limited by risk of bias and imprecision, comparing the effect of MI to no treatment for smoking cessation (RR = 0.84, 95% CI 0.63 to 1.12; I2 = 0%; adjusted N = 684). One study was excluded from this analysis as the participants recruited (incarcerated men) were not comparable to the other participants included in the analysis, resulting in substantial statistical heterogeneity when all studies were pooled (I2 = 87%). Enhancing existing smoking cessation support with additional MI, compared with existing support alone, gave an RR of 1.07 (95% CI 0.85 to 1.36; adjusted N = 4167; I2 = 47%), and MI compared with other forms of smoking cessation support gave an RR of 1.24 (95% CI 0.91 to 1.69; I2 = 54%; N = 5192). We judged both of these estimates to be of low certainty due to heterogeneity and imprecision. Low-certainty evidence detected a benefit of higher intensity MI when compared with lower intensity MI (RR 1.23, 95% CI 1.11 to 1.37; adjusted N = 5620; I2 = 0%). The evidence was limited because three of the five studies in this comparison were at risk of bias. Excluding them gave an RR of 1.00 (95% CI 0.65 to 1.54; I2 = n/a; N = 482), changing the interpretation of the results. Mental health and quality of life outcomes were reported in only one study, providing little evidence on whether MI improves mental well-being. There is insufficient evidence to show whether or not MI helps people to stop smoking compared with no intervention, as an addition to other types of behavioural support for smoking cessation, or compared with other types of behavioural support for smoking cessation. It is also unclear whether more intensive MI is more effective than less intensive MI. All estimates of treatment effect were of low certainty because of concerns about bias in the trials, imprecision and inconsistency. Consequently, future trials are likely to change these conclusions. There is almost no evidence on whether MI for smoking cessation improves mental well-being. | This review included 37 trials covering over 15,000 people who smoked tobacco. Studies were conducted in a lot of different types of people, including people with health problems or drug use problems, young people, homeless people, and people who had been arrested or were in prison. Some people felt ready to quit smoking and others did not. Motivational interviewing was provided in one to 12 sessions and took from as little as five minutes, to as much as eight hours, to deliver. Studies lasted for at least six months. The evidence is up to date to August 2018. There was not enough information available to decide whether motivational interviewing helped more people to stop smoking than no stop smoking treatment. People were slightly more likely to stop smoking if they were provided with motivational interviewing rather than another type of treatment to stop smoking, but our findings suggest that there is still a chance that motivational interviewing could also reduce a person's chances of quitting compared with other stop smoking treatments. This means more research is needed to decide whether motivational interviewing can help more people to quit than other types of treatment. Using longer motivational interviewing with more treatment sessions may help more people to give up smoking than shorter motivational interviewing with fewer sessions, however more research is needed to be sure that this is the case. We also looked at whether being provided with motivational interviewing to quit smoking increased people's well-being. Most studies did not provide any information about this, and so more studies are needed to answer this question. There is low-quality evidence looking at whether motivational interviewing helps more people to quit smoking than no treatment. This means it is difficult to know whether motivational interviewing helps people to quit smoking or not, and more studies are needed. The quality of the evidence was also low for all of the other questions we asked about quitting smoking, which means that our findings may change when new research is carried out. The quality of the research is rated as low because there were problems with the design of studies, findings of studies were very different to one another, and there were not enough data, making it difficult to determine whether motivational interviewing or more intense motivational interviewing helped people to quit smoking or not. | 10.1002/14651858.CD006936.pub4 | [
"This review included 37 trials covering over 15,000 people who smoked tobacco. Studies were conducted in a lot of different types of people, including people with health problems or drug use problems, young people, homeless people, and people who had been arrested or were in prison. Some people felt ready to quit smoking and others did not. Motivational interviewing was provided in one to 12 sessions and took from as little as five minutes, to as much as eight hours, to deliver. Studies lasted for at least six months. The evidence is up to date to August 2018. There was not enough information available to decide whether motivational interviewing helped more people to stop smoking than no stop smoking treatment. People were slightly more likely to stop smoking if they were provided with motivational interviewing rather than another type of treatment to stop smoking, but our findings suggest that there is still a chance that motivational interviewing could also reduce a person's chances of quitting compared with other stop smoking treatments. This means more research is needed to decide whether motivational interviewing can help more people to quit than other types of treatment. Using longer motivational interviewing with more treatment sessions may help more people to give up smoking than shorter motivational interviewing with fewer sessions, however more research is needed to be sure that this is the case. We also looked at whether being provided with motivational interviewing to quit smoking increased people's well-being. Most studies did not provide any information about this, and so more studies are needed to answer this question. There is low-quality evidence looking at whether motivational interviewing helps more people to quit smoking than no treatment. This means it is difficult to know whether motivational interviewing helps people to quit smoking or not, and more studies are needed. The quality of the evidence was also low for all of the other questions we asked about quitting smoking, which means that our findings may change when new research is carried out. The quality of the research is rated as low because there were problems with the design of studies, findings of studies were very different to one another, and there were not enough data, making it difficult to determine whether motivational interviewing or more intense motivational interviewing helped people to quit smoking or not."
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cochrane-simplification-train-1496 | cochrane-simplification-train-1496 | Seven treatment studies of 257 infants with suspected systemic bacterial infection and three prophylaxis studies comprising 359 neonates are analysed. Treatment studies: There is no evidence that the addition of G-CSF or GM-CSF to antibiotic therapy in preterm infants with suspected systemic infection reduces immediate all cause mortality. No significant survival advantage was seen at 14 days from the start of therapy [typical RR 0.71 (95% CI 0.38,1.33); typical RD -0.05 (95% CI -0.14, 0.04)]. However all seven of the treatment studies were small, the largest recruiting only 60 infants. The subgroup analysis of 97 infants from three treatment studies who, in addition to systemic infection, had clinically significant neutropenia (< 1.7 x 109/l) at trial entry, does show a significant reduction in mortality by day 14 [RR 0.34 (95% CI 0.12, 0.92); RD -0.18 (95% CI -0.33, -0.03); NNT 6 (95% CI 3-33)]. Prophylaxis studies have not demonstrated a significant reduction in mortality in neonates receiving GM-CSF [RR 0.59 (95% CI 0.24,1.44); RD -0.03 (95% CI -0.08,0.02)]. The identification of sepsis as the primary outcome of prophylaxis studies has been hampered by inadequately stringent definitions of systemic infection. However, data from one study suggest that prophylactic GM-CSF may provide protection against infection when given to preterm infants who are neutropenic or at high risk of developing postnatal neutropenia. There is currently insufficient evidence to support the introduction of either G-CSF or GM-CSF into neonatal practice, either as treatment of established systemic infection to reduce resulting mortality, or as prophylaxis to prevent systemic infection in high risk neonates. No toxicity of CSF use was reported in any study included in this review. The limited data suggesting that CSF treatment may reduce mortality when systemic infection is accompanied by severe neutropenia should be investigated further in adequately powered trials which recruit sufficient infants infected with organisms associated with a significant mortality risk. | The haemopoietic colony stimulating factors (CSFs), granulocyte-macrophage colony stimulating factor (GM-CSF) and granulocyte colony stimulating factor (G-CSF) are naturally occurring substances (cytokines) that can increase circulating white blood cells (neutrophils) and their ability to destroy bacteria. Common minor side effects are low grade fever and skeletal pain. The review authors identified seven treatment studies of 257 premature infants with suspected systemic bacterial infection. Adding G-CSF or GM-CSF to antibiotic therapy did not improve survival, overall. It may be, however, that infants who had clinically low neutrophils at the start of treatment did show some reduction in number of deaths by day 14 (taken from three studies). In three studies in which 359 low birthweight or premature neonates were treated preventatively (prophylaxis) no reduction in deaths was evident in those neonates receiving GM-CSF. GM-CSF was well tolerated with no adverse reactions in these small studies. | 10.1002/14651858.CD003066 | [
"The haemopoietic colony stimulating factors (CSFs), granulocyte-macrophage colony stimulating factor (GM-CSF) and granulocyte colony stimulating factor (G-CSF) are naturally occurring substances (cytokines) that can increase circulating white blood cells (neutrophils) and their ability to destroy bacteria. Common minor side effects are low grade fever and skeletal pain. The review authors identified seven treatment studies of 257 premature infants with suspected systemic bacterial infection. Adding G-CSF or GM-CSF to antibiotic therapy did not improve survival, overall. It may be, however, that infants who had clinically low neutrophils at the start of treatment did show some reduction in number of deaths by day 14 (taken from three studies). In three studies in which 359 low birthweight or premature neonates were treated preventatively (prophylaxis) no reduction in deaths was evident in those neonates receiving GM-CSF. GM-CSF was well tolerated with no adverse reactions in these small studies."
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cochrane-simplification-train-1497 | cochrane-simplification-train-1497 | Only one additional RCT met the eligibility criteria (24 participants) for this updated review. Although this was a feasibility study, not designed to investigate intervention effect, it suggested that TENS may improve bone pain on movement in a cancer population. The initial review identified two RCTs (64 participants) therefore this review now includes a total of three RCTs (88 participants). These studies were heterogenous with respect to study population, sample size, study design, methodological quality, mode of TENS, treatment duration, method of administration and outcome measures used. In one RCT, there were no significant differences between TENS and placebo in women with chronic pain secondary to breast cancer treatment. In the other RCT, there were no significant differences between acupuncture-type TENS and sham in palliative care patients; this study was underpowered. Despite the one additional RCT, the results of this updated systematic review remain inconclusive due to a lack of suitable RCTs. Large multi-centre RCTs are required to assess the value of TENS in the management of cancer-related pain in adults. | Only one new study met eligibility criteria for this review update, making at total of three included studies. TENS was given to 15 participants in one study, 41 participants in the other and 24 participants in the most recently included study. The newly included study suggested TENS might improve cancer bone pain on movement, but as a pilot study it was not designed to determine the impact of TENS on pain. The two studies in the previous review did not show that TENS significantly improved cancer pain. One study did not have sufficient participants to determine whether or not TENS had an effect. TENS was well tolerated in all three studies. There were significant differences in participants, treatments, procedures and symptom measurement tools used in the studies. In two of the studies some participants were able to identify when they received active TENS and when they received placebo. Consequently, there is insufficient evidence to judge whether TENS should be used in adults with cancer-related pain. Further research using well designed clinical trials is needed to improve knowledge in this field. | 10.1002/14651858.CD006276.pub3 | [
"Only one new study met eligibility criteria for this review update, making at total of three included studies. TENS was given to 15 participants in one study, 41 participants in the other and 24 participants in the most recently included study. The newly included study suggested TENS might improve cancer bone pain on movement, but as a pilot study it was not designed to determine the impact of TENS on pain. The two studies in the previous review did not show that TENS significantly improved cancer pain. One study did not have sufficient participants to determine whether or not TENS had an effect. TENS was well tolerated in all three studies. There were significant differences in participants, treatments, procedures and symptom measurement tools used in the studies. In two of the studies some participants were able to identify when they received active TENS and when they received placebo. Consequently, there is insufficient evidence to judge whether TENS should be used in adults with cancer-related pain. Further research using well designed clinical trials is needed to improve knowledge in this field."
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cochrane-simplification-train-1498 | cochrane-simplification-train-1498 | We identified 15 studies for possible inclusion in the review. Five studies reporting results from a total of 354 participants (aged 5 to 50 years) were included in this review. All studies compared once-daily dosing with thrice-daily dosing. One cross-over trial had 26 participants who received the first-arm treatment but only 15 received the second arm. One study had a low risk of bias for all criteria assessed; the remaining included studies had a high risk of bias from blinding, but for other criteria were judged to have either an unclear or a low risk of bias. There was little or no difference between treatment groups in: forced expiratory volume in one second, mean difference (MD) 0.33 (95% confidence interval (CI) -2.81 to 3.48, moderate-quality evidence); forced vital capacity, MD 0.29 (95% CI -6.58 to 7.16, low-quality evidence); % weight for height, MD -0.82 (95% CI -3.77 to 2.13, low-quality evidence); body mass index, MD 0.00 (95% CI -0.42 to 0.42, low-quality evidence); or in the incidence of ototoxicity, relative risk 0.56 (95% CI 0.04 to 7.96, moderate-quality evidence). Once-daily treatment in children probably improved the percentage change in creatinine, MD -8.20 (95% CI -15.32 to -1.08, moderate-quality evidence), but showed no difference in adults, MD 3.25 (95% CI -1.82 to 8.33, moderate-quality evidence). The included trials did not report antibiotic resistance patterns or quality of life. Once- and three-times daily aminoglycoside antibiotics appear to be equally effective in the treatment of pulmonary exacerbations of cystic fibrosis. There is evidence of less nephrotoxicity in children. | This review includes five studies with a total of 354 children and adults. All the trials compared once-a-day dosing with three times-a-day dosing. The review found that when treating people with cystic fibrosis for pulmonary exacerbations, giving the antibiotics once per day was just as good at as giving them more frequently in terms of lung function and body mass index. The review also found that giving the antibiotics once per day appeared to be less toxic to the kidneys in children. There were no differences between the different treatment schedules for other outcomes that the studies measured. While once-daily treatment can be just as effective and more convenient than three-times daily treatment, we recommend further studies to look at the long-term safety of this treatment schedule. We judged that just one of the five studies carried a low risk that any design factors might affect the outcome results. In the remaining four studies, we thought that the fact that it was obvious whether the antibiotics were given once or three times a day could affect some outcome measures (e.g. lung function). Other risk factors were unclear or at low risk of bias. We assessed the evidence for lung function, body mass index and the evidence for side effects (e.g. toxicity) to be moderate to low quality. | 10.1002/14651858.CD002009.pub7 | [
"This review includes five studies with a total of 354 children and adults. All the trials compared once-a-day dosing with three times-a-day dosing. The review found that when treating people with cystic fibrosis for pulmonary exacerbations, giving the antibiotics once per day was just as good at as giving them more frequently in terms of lung function and body mass index. The review also found that giving the antibiotics once per day appeared to be less toxic to the kidneys in children. There were no differences between the different treatment schedules for other outcomes that the studies measured. While once-daily treatment can be just as effective and more convenient than three-times daily treatment, we recommend further studies to look at the long-term safety of this treatment schedule. We judged that just one of the five studies carried a low risk that any design factors might affect the outcome results. In the remaining four studies, we thought that the fact that it was obvious whether the antibiotics were given once or three times a day could affect some outcome measures (e.g. lung function). Other risk factors were unclear or at low risk of bias. We assessed the evidence for lung function, body mass index and the evidence for side effects (e.g. toxicity) to be moderate to low quality."
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cochrane-simplification-train-1499 | cochrane-simplification-train-1499 | We identified 74 trials including 5902 participants that met the inclusion criteria of this review. A total of 46 trials (4274 participants) provided information for one or more outcomes. All the trials were at high risk of bias in one or more domains. Overall, all the evidence was low or very low quality. The proportion of participants with symptoms varied from 19.9% to 100% in the trials that reported this information. The proportion of participants who were antimitochondrial antibody (AMA) positive ranged from 80.8% to 100% in the trials that reported this information. It appeared that most trials included participants who had not received previous treatments or included participants regardless of the previous treatments received. The follow-up in the trials ranged from 1 to 96 months. The proportion of people with mortality (maximal follow-up) was higher in the methotrexate group versus the no intervention group (OR 8.83, 95% CI 1.01 to 76.96; 60 participants; 1 trial; low quality evidence). The proportion of people with mortality (maximal follow-up) was lower in the azathioprine group versus the no intervention group (OR 0.56, 95% CI 0.32 to 0.98; 224 participants; 2 trials; I2 = 0%; low quality evidence). However, it has to be noted that a large proportion of participants (25%) was excluded from the trial that contributed most participants to this analysis and the results were not reliable. There was no evidence of a difference in any of the remaining comparisons. The proportion of people with serious adverse events was higher in the D-penicillamine versus no intervention group (OR 28.77, 95% CI 1.57 to 526.67; 52 participants; 1 trial; low quality evidence). The proportion of people with serious adverse events was higher in the obeticholic acid plus ursodeoxycholic acid (UDCA) group versus the UDCA group (OR 3.58, 95% CI 1.02 to 12.51; 216 participants; 1 trial; low quality evidence). There was no evidence of a difference in any of the remaining comparisons for serious adverse events (proportion) or serious adverse events (number of events). None of the trials reported health-related quality of life at any time point. Funding: nine trials had no special funding or were funded by hospital or charities; 31 trials were funded by pharmaceutical companies; and 34 trials provided no information on source of funding. Based on very low quality evidence, there is currently no evidence that any intervention is beneficial for primary biliary cholangitis. However, the follow-up periods in the trials were short and there is significant uncertainty in this issue. Further well-designed randomised clinical trials are necessary. Future randomised clinical trials ought to be adequately powered; performed in people who are generally seen in the clinic rather than in highly selected participants; employ blinding; avoid post-randomisation dropouts or planned cross-overs; should have sufficient follow-up period (e.g. five or 10 years or more); and use clinically important outcomes such as mortality, health-related quality of life, cirrhosis, decompensated cirrhosis, and liver transplantation. Alternatively, very large groups of participants should be randomised to facilitate shorter trial duration. | We identified 74 randomised clinical trials (5902 participants). Of these, 46 randomised clinical trials (4274 participants) provided information for one or more measures (outcomes). The trials included people with primary biliary cholangitis with and without symptoms; with and without antimitochondrial antibody (AMA) (an indicator of primary biliary cholangitis) regardless of whether they received previous treatments. The average follow-up period in the trials ranged from one month to eight years in the trials that reported this information. Funding: nine trials receive no additional funding or were funded by parties with no vested interest in the results. Thirty-one trials were partially or fully funded by the pharmaceutical companies that would benefit based on the results of the trial. The source of funding was not available from the remaining trials. The overall quality of evidence was very low and all the trials were at high risk of bias, which means that there is possibility of making wrong conclusions overestimating benefits or underestimating harms of one treatment or the other because of the way that the trials were conducted. There was no reliable evidence of decrease in the deaths between any of the interventions versus no intervention. There was no evidence of decrease in serious complications or complications of any severity between any of the treatments and no treatment. None of the trials reported health-related quality of life (a measure of a person's satisfaction with their life and health) at any time point. Overall, there is currently no evidence of benefit of any intervention in primary biliary cholangitis. There is significant uncertainty in this issue and further high-quality randomised clinical trials are required. | 10.1002/14651858.CD011648.pub2 | [
"We identified 74 randomised clinical trials (5902 participants). Of these, 46 randomised clinical trials (4274 participants) provided information for one or more measures (outcomes). The trials included people with primary biliary cholangitis with and without symptoms; with and without antimitochondrial antibody (AMA) (an indicator of primary biliary cholangitis) regardless of whether they received previous treatments. The average follow-up period in the trials ranged from one month to eight years in the trials that reported this information. Funding: nine trials receive no additional funding or were funded by parties with no vested interest in the results. Thirty-one trials were partially or fully funded by the pharmaceutical companies that would benefit based on the results of the trial. The source of funding was not available from the remaining trials. The overall quality of evidence was very low and all the trials were at high risk of bias, which means that there is possibility of making wrong conclusions overestimating benefits or underestimating harms of one treatment or the other because of the way that the trials were conducted. There was no reliable evidence of decrease in the deaths between any of the interventions versus no intervention. There was no evidence of decrease in serious complications or complications of any severity between any of the treatments and no treatment. None of the trials reported health-related quality of life (a measure of a person's satisfaction with their life and health) at any time point. Overall, there is currently no evidence of benefit of any intervention in primary biliary cholangitis. There is significant uncertainty in this issue and further high-quality randomised clinical trials are required."
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