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cochrane-simplification-train-1700 | cochrane-simplification-train-1700 | Thirteen trials involving 269 people were included. All trials compared EMG-BFB plus standard physiotherapy to standard physiotherapy either alone or with sham EMG-BFB. Only one study used a motor strength assessment scale for evaluation of patients, which indicated benefit from EMG-BFB (WMD 1.09, 95% CI 0.48 to 1.70). EMG-BFB did not have a significant benefit in improving range of motion (ROM) through the ankle (SMD 0.05, 95% CI -0.36 to 0.46), knee or wrist joints. However, one trial suggested a benefit in ROM at the shoulder (SMD 0.88, 95% CI 0.07 to 1.70). Change in stride length or gait speed was not improved by EMG-BFB. Two studies used different assessment scores to quantify gait quality. One of these suggested a beneficial effect of EMG-BFB (SMD 0.90, 95% CI 0.01 to 1.78). Most of the studies examining functional outcomes used different assessment scales, which made meta-analysis impossible. Two studies that used the same scale did show a beneficial effect (SMD 0.69, 95% CI 0.15 to 1.23). Despite evidence from a small number of individual studies to suggest that EMG-BFB plus standard physiotherapy produces improvements in motor power, functional recovery and gait quality when compared to standard physiotherapy alone, combination of all the identified studies did not find a treatment benefit. Overall the results are limited because the trials were small, generally poorly designed and utilised varying outcome measures. | Amongst the 13 studies identified, there was a small amount of evidence to suggest that EMG-BFB had a beneficial effect when used with standard physiotherapy techniques. However EMG-BFB cannot currently be recommended as an effective routine treatment because other studies found no effect, and the positive trials were small. | 10.1002/14651858.CD004585.pub2 | [
"Amongst the 13 studies identified, there was a small amount of evidence to suggest that EMG-BFB had a beneficial effect when used with standard physiotherapy techniques. However EMG-BFB cannot currently be recommended as an effective routine treatment because other studies found no effect, and the positive trials were small."
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cochrane-simplification-train-1701 | cochrane-simplification-train-1701 | In this third update, we identified three new randomised controlled trials, for a total of 15 randomised controlled trials involving 71,422 participants. Nine trials (60%) had low risk of bias, length of follow-up ranged from one to 7.3 years. Compared with placebo, there were no differences in effects of homocysteine-lowering interventions on myocardial infarction (homocysteine-lowering = 7.1% versus placebo = 6.0%; RR 1.02, 95% confidence interval (CI) 0.95 to 1.10, I2 = 0%, 12 trials; N = 46,699; Bayes factor 1.04, high-quality evidence), death from any cause (homocysteine-lowering = 11.7% versus placebo = 12.3%, RR 1.01, 95% CI 0.96 to 1.06, I2 = 0%, 11 trials, N = 44,817; Bayes factor = 1.05, high-quality evidence), or serious adverse events (homocysteine-lowering = 8.3% versus comparator = 8.5%, RR 1.07, 95% CI 1.00 to 1.14, I2 = 0%, eight trials, N = 35,788; high-quality evidence). Compared with placebo, homocysteine-lowering interventions were associated with reduced stroke outcome (homocysteine-lowering = 4.3% versus comparator = 5.1%, RR 0.90, 95% CI 0.82 to 0.99, I2 = 8%, 10 trials, N = 44,224; high-quality evidence). Compared with low doses, there were uncertain effects of high doses of homocysteine-lowering interventions on stroke (high = 10.8% versus low = 11.2%, RR 0.90, 95% CI 0.66 to 1.22, I2 = 72%, two trials, N = 3929; very low-quality evidence). We found no evidence of publication bias. In this third update of the Cochrane review, there were no differences in effects of homocysteine-lowering interventions in the form of supplements of vitamins B6, B9 or B12 given alone or in combination comparing with placebo on myocardial infarction, death from any cause or adverse events. In terms of stroke, this review found a small difference in effect favouring to homocysteine-lowering interventions in the form of supplements of vitamins B6, B9 or B12 given alone or in combination comparing with placebo. There were uncertain effects of enalapril plus folic acid compared with enalapril on stroke; approximately 143 (95% CI 85 to 428) people would need to be treated for 5.4 years to prevent 1 stroke, this evidence emerged from one mega-trial. Trial sequential analyses showed that additional trials are unlikely to increase the certainty about the findings of this issue regarding homocysteine-lowering interventions versus placebo. There is a need for additional trials comparing homocysteine-lowering interventions combined with antihypertensive medication versus antihypertensive medication, and homocysteine-lowering interventions at high doses versus homocysteine-lowering interventions at low doses. Potential trials should be large and co-operative. | The evidence is current to June 2017. We included 15 studies involving 71,422 participants living in countries with or without mandatory supplementation of foods with vitamins. These studies compared different regimens of B vitamins (cyanocobalamin (B12), folic acid (B9) and pyridoxine (B6)) with a control or any other comparison group. The studies were published between 2002 and 2015. We found no evidence that homocysteine-lowering interventions, in the form of supplements of vitamins B6, B9 or B12 given alone or in combination, at any dosage compared with placebo, or standard care, prevented heart attack or reduced death rates in participants at risk of, or living with cardiovascular disease. Homocysteine-lowering interventions combined with antihypertensive medication had uncertain effects on stroke, approximately 143 people would need to be treated for 5.4 years to prevent 1 stroke. Homocysteine-lowering interventions compared with placebo or any other comparison did not affect serious adverse events (cancer). The quality of evidence from these studies was generally high. | 10.1002/14651858.CD006612.pub5 | [
"The evidence is current to June 2017. We included 15 studies involving 71,422 participants living in countries with or without mandatory supplementation of foods with vitamins. These studies compared different regimens of B vitamins (cyanocobalamin (B12), folic acid (B9) and pyridoxine (B6)) with a control or any other comparison group. The studies were published between 2002 and 2015. We found no evidence that homocysteine-lowering interventions, in the form of supplements of vitamins B6, B9 or B12 given alone or in combination, at any dosage compared with placebo, or standard care, prevented heart attack or reduced death rates in participants at risk of, or living with cardiovascular disease. Homocysteine-lowering interventions combined with antihypertensive medication had uncertain effects on stroke, approximately 143 people would need to be treated for 5.4 years to prevent 1 stroke. Homocysteine-lowering interventions compared with placebo or any other comparison did not affect serious adverse events (cancer). The quality of evidence from these studies was generally high."
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cochrane-simplification-train-1702 | cochrane-simplification-train-1702 | We included five RCTs in the review, with a total of 2392 participants. We assessed one trial to be at low risk of bias; two at unclear risk of bias (in one multicentred trial the possibility of centre effects was unclear, whilst the other trial was stopped early), and two at high risk of bias, due to issues with blinding and selective reporting of outcome data. All included studies reported the effects of progesterone on mortality and disability. Low quality evidence revealed no evidence of a difference in overall mortality between the progesterone group and placebo group (RR 0.91, 95% CI 0.65 to 1.28, I² = 62%; 5 studies, 2392 participants, 2376 pooled for analysis). Using the GRADE criteria, we assessed the quality of the evidence as low, due to the substantial inconsistency across studies. There was also no evidence of a difference in disability (unfavourable outcomes as assessed by the Glasgow Outcome Score) between the progesterone group and placebo group (RR 0.98, 95% CI 0.89 to 1.06, I² = 37%; 4 studies; 2336 participants, 2260 pooled for analysis). We assessed the quality of this evidence to be moderate, due to inconsistency across studies. Data were not available for meta-analysis for the outcomes of mean intracranial pressure, blood pressure, body temperature or adverse events. However, data from three studies showed no difference in mean intracranial pressure between the groups. Data from another study showed no evidence of a difference in blood pressure or body temperature between the progesterone and placebo groups, although there was evidence that intravenous progesterone infusion increased the frequency of phlebitis (882 participants). There was no evidence of a difference in the rate of other adverse events between progesterone treatment and placebo in the other three studies that reported on adverse events. This updated review did not find evidence that progesterone could reduce mortality or disability in patients with TBI. However, concerns regarding inconsistency (heterogeneity among participants and the intervention used) across included studies reduce our confidence in these results. There is no evidence from the available data that progesterone therapy results in more adverse events than placebo, aside from evidence from a single study of an increase in phlebitis (in the case of intravascular progesterone). There were not enough data on the effects of progesterone therapy for our other outcomes of interest (intracranial pressure, blood pressure, body temperature) for us to be able to draw firm conclusions. Future trials would benefit from a more precise classification of TBI and attempts to optimise progesterone dosage and scheduling. | We searched the medical literature widely for randomised controlled trials that investigated the effects of progesterone in people with TBI up to 30 September 2016. Randomised controlled trials provide the most robust medical evidence. . We included five studies with a total of 2392 participants, and identified three ongoing studies. The studies all compared a group of participants who received progesterone within 24 hours of TBI against a group who received a pretend - or dummy - medicine (known as a placebo) that looked the same as the progesterone. The results of our review did not find evidence that, when compared to placebo, progesterone could reduce death and disability in people with TBI. There were too few data available on the other outcomes that we were interested in (pressure inside the skull (intracranial pressure), blood pressure, body temperature and adverse events (harms)), for us to be able to analyse these in detail. However, although the information available shows no evidence of a difference in effect between the progesterone and control groups for intracranial pressure, blood pressure or body temperature, one study showed an increased level of an adverse event called phlebitis (inflammation in the vein) in the progesterone group, possibly because the progestreone was given into the vein through an intravascular infusion ('drip'). We judged the quality of the evidence to be low for the data on risk of death, and moderate for the data on risk of disability. These judgements resulted from differences across studies, including different doses of progesterone and different time points for assessment of participants in the included studies. This means that we have limited confidence in the conclusions of this review. | 10.1002/14651858.CD008409.pub4 | [
"We searched the medical literature widely for randomised controlled trials that investigated the effects of progesterone in people with TBI up to 30 September 2016. Randomised controlled trials provide the most robust medical evidence. . We included five studies with a total of 2392 participants, and identified three ongoing studies. The studies all compared a group of participants who received progesterone within 24 hours of TBI against a group who received a pretend - or dummy - medicine (known as a placebo) that looked the same as the progesterone. The results of our review did not find evidence that, when compared to placebo, progesterone could reduce death and disability in people with TBI. There were too few data available on the other outcomes that we were interested in (pressure inside the skull (intracranial pressure), blood pressure, body temperature and adverse events (harms)), for us to be able to analyse these in detail. However, although the information available shows no evidence of a difference in effect between the progesterone and control groups for intracranial pressure, blood pressure or body temperature, one study showed an increased level of an adverse event called phlebitis (inflammation in the vein) in the progesterone group, possibly because the progestreone was given into the vein through an intravascular infusion ('drip'). We judged the quality of the evidence to be low for the data on risk of death, and moderate for the data on risk of disability. These judgements resulted from differences across studies, including different doses of progesterone and different time points for assessment of participants in the included studies. This means that we have limited confidence in the conclusions of this review."
]
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cochrane-simplification-train-1703 | cochrane-simplification-train-1703 | We identified 11 trials for inclusion in the review. All trials were small (total participants 665) and had various methodological limitations including uncertainty about methods to ensure allocation concealment and blinding. Most participants were clinically stable preterm infants of less than about 34 weeks' gestational age or with birth weight less than about 1750 g. Fewer participants were extremely preterm, extremely low birth weight, or growth restricted. Most trials found no effects on feed intolerance, assessed variously as mean pre-feed gastric residual volume, incidence of abdominal distension or other gastrointestinal signs of concern, or time taken to achieve full enteral feeds (meta-analysis was limited because studies used different measures). Meta-analysis showed no effect on the risk of necrotising enterocolitis (typical risk ratio 1.10, 95% CI 0.36 to 3.34; risk difference 0.00, 95% CI -0.03 to 0.04; 5 trials, 385 infants) (low-certainty evidence; downgraded for imprecision and design weaknesses). The identified trials provide only low-certainty evidence about the effects of feeding preterm infants protein hydrolysate versus standard formula. Existing data do not support conclusions that feeding protein hydrolysate affects the risk of feed intolerance or necrotising enterocolitis. Additional large, pragmatic trials are needed to provide more reliable and precise estimates of effectiveness and cost-effectiveness. | In searches of medical databases up to 28 January 2019, we found 11 relevant trials; most were small (involving 665 infants in total) and had methodological weaknesses. Currently available evidence suggests that feeding preterm infants hydrolysed formula (rather than standard formula) during their initial hospital admission has no important benefits or harms. However, this finding is not yet conclusive, and larger trials of better quality are needed to provide evidence to help clinicians and families make informed choices about this issue. Data from these trials provide no strong or consistent evidence that feeding preterm infants hydrolysed formula rather than standard formula improved or worsened digestion or changed the risk of severe bowel problems. | 10.1002/14651858.CD012412.pub3 | [
"In searches of medical databases up to 28 January 2019, we found 11 relevant trials; most were small (involving 665 infants in total) and had methodological weaknesses. Currently available evidence suggests that feeding preterm infants hydrolysed formula (rather than standard formula) during their initial hospital admission has no important benefits or harms. However, this finding is not yet conclusive, and larger trials of better quality are needed to provide evidence to help clinicians and families make informed choices about this issue. Data from these trials provide no strong or consistent evidence that feeding preterm infants hydrolysed formula rather than standard formula improved or worsened digestion or changed the risk of severe bowel problems."
]
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cochrane-simplification-train-1704 | cochrane-simplification-train-1704 | No new trials were identified for inclusion in this update. We identified 12 trials for inclusion, 10 of which contributed outcomes data. There were a total of 6820 participants. In trials of healthy children living in low-income communities, two trials did not demonstrate a significant difference between the zinc-supplemented and placebo groups in the numbers of participants experiencing an episode of definite otitis media during follow-up (3191 participants); another trial showed a significantly lower incidence rate of otitis media in the zinc group (rate ratio 0.69, 95% confidence interval (CI) 0.61 to 0.79, n = 1621). A small trial of 39 infants undergoing treatment for severe malnutrition suggested a benefit of zinc for the mean number of episodes of otitis media (mean difference (MD) -1.12 episodes, 95% CI -2.21 to -0.03). Zinc supplements did not seem to cause any serious adverse events but a small minority of children were reported to have vomited shortly after ingestion of the supplements. The trial evidence included is generally of good quality, with a low risk of bias. Evidence on whether zinc supplementation can reduce the incidence of otitis media in healthy children under the age of five years living in low- and middle-income countries is mixed. There is some evidence of benefit in children being treated for marasmus (severe malnutrition), but this is based on one small trial and should therefore be treated with caution. | The review authors searched the medical literature for studies up to March 2014. We searched for trials which compared middle ear infections in people randomly selected to receive zinc supplements or who did not receive supplements. We found 10 eligible studies, all conducted amongst young children. The total number of participants was 6820. Nine trials were conducted in low- and middle-income countries. Seven trials were conducted on healthy children. Participants included both males and females. The results of the trials provided no convincing evidence that zinc supplements reduce the occurrence of middle ear infections in healthy children. However, in one small study of severely malnourished children, those receiving zinc supplements had fewer middle ear infections. The only adverse effect was vomiting. The trial evidence included is generally of good quality, with a low risk of bias. All the included trials included otitis media only as a secondary outcome. Therefore, there was a potential to miss trials which were less publicised or less well indexed within the electronic databases. | 10.1002/14651858.CD006639.pub4 | [
"The review authors searched the medical literature for studies up to March 2014. We searched for trials which compared middle ear infections in people randomly selected to receive zinc supplements or who did not receive supplements. We found 10 eligible studies, all conducted amongst young children. The total number of participants was 6820. Nine trials were conducted in low- and middle-income countries. Seven trials were conducted on healthy children. Participants included both males and females. The results of the trials provided no convincing evidence that zinc supplements reduce the occurrence of middle ear infections in healthy children. However, in one small study of severely malnourished children, those receiving zinc supplements had fewer middle ear infections. The only adverse effect was vomiting. The trial evidence included is generally of good quality, with a low risk of bias. All the included trials included otitis media only as a secondary outcome. Therefore, there was a potential to miss trials which were less publicised or less well indexed within the electronic databases."
]
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cochrane-simplification-train-1705 | cochrane-simplification-train-1705 | We included eight trials covering 109 surgical trainees with limited laparoscopic experience. Of the eight trials, six compared virtual reality versus no supplementary training. One trial compared virtual reality training versus box-trainer training and versus no supplementary training, and one trial compared virtual reality training versus box-trainer training. There were no trials that compared different forms of virtual reality training. All the trials were at high risk of bias. Operating time and operative performance were the only outcomes reported in the trials. The remaining outcomes such as mortality, morbidity, quality of life (the primary outcomes of this review) and hospital stay (a secondary outcome) were not reported. Virtual reality training versus no supplementary training: The operating time was significantly shorter in the virtual reality group than in the no supplementary training group (3 trials; 49 participants; MD -11.76 minutes; 95% CI -15.23 to -8.30). Two trials that could not be included in the meta-analysis also showed a reduction in operating time (statistically significant in one trial). The numerical values for operating time were not reported in these two trials. The operative performance was significantly better in the virtual reality group than the no supplementary training group using the fixed-effect model (2 trials; 33 participants; SMD 1.65; 95% CI 0.72 to 2.58). The results became non-significant when the random-effects model was used (2 trials; 33 participants; SMD 2.14; 95% CI -1.29 to 5.57). One trial could not be included in the meta-analysis as it did not report the numerical values. The authors stated that the operative performance of virtual reality group was significantly better than the control group. Virtual reality training versus box-trainer training: The only trial that reported operating time did not report the numerical values. In this trial, the operating time in the virtual reality group was significantly shorter than in the box-trainer group. Of the two trials that reported operative performance, only one trial reported the numerical values. The operative performance was significantly better in the virtual reality group than in the box-trainer group (1 trial; 19 participants; SMD 1.46; 95% CI 0.42 to 2.50). In the other trial that did not report the numerical values, the authors stated that the operative performance in the virtual reality group was significantly better than the box-trainer group. Virtual reality training appears to decrease the operating time and improve the operative performance of surgical trainees with limited laparoscopic experience when compared with no training or with box-trainer training. However, the impact of this decreased operating time and improvement in operative performance on patients and healthcare funders in terms of improved outcomes or decreased costs is not known. Further well-designed trials at low risk of bias and random errors are necessary. Such trials should assess the impact of virtual reality training on clinical outcomes. | Two authors searched the medical literature available until July 2012 and obtained the information from the identified trials. The use of two authors to identify studies and obtain information decreases the errors in obtaining the information. We identified and included eight trials covering 109 surgical trainees in this review. The trials compared virtual reality with no supplementary training or with box-trainer training (physical simulator using a camera to display the inside of the box and instruments). There were no trials that compared different forms of virtual reality training. All the trials were at high risk of bias (defects in study design that can lead to arriving at wrong conclusions with overestimation of benefits and underestimation of harms of virtual reality training or standard training). Operating time and operative performance were the only outcomes reported in the trials. The remaining outcomes such as death, complications, quality of life, and hospital stay after the operation were not reported in any of the trials. Overall virtual reality training appears to decrease the operating time (by about 10 minutes) and improve the operative performance of surgical trainees (difficult to quantify from the available reports) with limited laparoscopic experience when compared with no supplementary training or with box-trainer training. However, the impact of this decreased operating time and improvement in operative performance on patients or healthcare funders in terms of improved health or decreased costs is not known. Further well-designed trials are necessary, with less risk of arriving at wrong conclusions because of poor study design or because of chance. Such trials should assess the impact of virtual reality training on patients and healthcare funders. | 10.1002/14651858.CD006575.pub3 | [
"Two authors searched the medical literature available until July 2012 and obtained the information from the identified trials. The use of two authors to identify studies and obtain information decreases the errors in obtaining the information. We identified and included eight trials covering 109 surgical trainees in this review. The trials compared virtual reality with no supplementary training or with box-trainer training (physical simulator using a camera to display the inside of the box and instruments). There were no trials that compared different forms of virtual reality training. All the trials were at high risk of bias (defects in study design that can lead to arriving at wrong conclusions with overestimation of benefits and underestimation of harms of virtual reality training or standard training). Operating time and operative performance were the only outcomes reported in the trials. The remaining outcomes such as death, complications, quality of life, and hospital stay after the operation were not reported in any of the trials. Overall virtual reality training appears to decrease the operating time (by about 10 minutes) and improve the operative performance of surgical trainees (difficult to quantify from the available reports) with limited laparoscopic experience when compared with no supplementary training or with box-trainer training. However, the impact of this decreased operating time and improvement in operative performance on patients or healthcare funders in terms of improved health or decreased costs is not known. Further well-designed trials are necessary, with less risk of arriving at wrong conclusions because of poor study design or because of chance. Such trials should assess the impact of virtual reality training on patients and healthcare funders."
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cochrane-simplification-train-1706 | cochrane-simplification-train-1706 | One study (45 participants) met the inclusion criteria. This double-blind, placebo-controlled, randomised, multinational study looked at laronidase at a dose of 0.58 mg/kg/week versus placebo in people with mucopolysaccharidosis type I. All primary outcomes listed in this review were studied in this study. The laronidase group achieved statistically significant improvements in per cent predicted forced vital capacity compared to placebo, MD 5.60 (95% confidence intervals 1.24 to 9.96) (low-quality evidence) and in the six-minute-walk test (mean improvement of 38.1 metres in the laronidase group; P = 0.039, when using a prospectively planned analysis of covariance) (low-quality evidence). The levels of urinary glycoaminoglycans were also significantly reduced (low-quality evidence). In addition, there were improvements in hepatomegaly, sleep apnoea and hypopnoea. Laronidase antibodies were detected in nearly all participants in the treatment group with no apparent clinical effect and titres were reducing by the end of the study (very low-quality evidence). Infusion-related adverse reactions occurred in both groups but all were mild and none necessitated medical intervention or infusion cessation (low-quality evidence). As assessed by questionnaires,changes in a 'Disability Index' after treatment were small and did not differ between groups (low-quality evidence). There were no deaths in either group (low-quality evidence). The current evidence demonstrates that laronidase is effective when compared to placebo in the treatment of mucopolysaccharidosis type I. The included study was comprehensive, with few participants and of low quality. The study included all of the key outcome measures we wished to look at. It demonstrated that laronidase is efficacious in relation to reducing biochemical parameters (reduced urine glycosaminoglycan excretion) and improved functional capacity as assessed by forced vital capacity and the six-minute-walk test. In addition glycosaminoglycan storage was reduced as ascertained by a reduction in liver volume. Laronidase appeared to be safe and, while antibodies were generated, these titres were reducing by the end of the study. More studies are required to determine long-term effectiveness and safety and to assess the impact upon quality of life. Enzyme replacement therapy with laronidase can be used pre- and peri-haemopoietic stem cell transplant, which is now the gold standard treatment in those individuals diagnosed under 2.5 years of age. We do not anticipate any further trials to be undertaken and therefore do not plan to update this review. | One 26-week randomised controlled study (45 participants) was included in the review. Participants were aged between six and 43 years old. The study was carried out in several centres around the world. Participants either received an intravenous infusion of laronidase 0.58 mg/kg or a placebo ('dummy' infusion). Current evidence is limited because we only found one randomised clinical trial in the medical literature, which did not include very many participants. Compared with placebo, enzyme replacement therapy improved lung function, the individuals’ ability to walk, reduced the excretion of abnormal glycosaminoglycans (a type of carbohydrate molecule) in the urine and also reduced the stopping of breathing related to sleep. Adverse reactions in relation to the infusions occurred in both groups but all were mild and none required medical intervention or for the infusions to be stopped. Enzyme replacement therapy can be used before and around the time of stem cell transplant, which is now the gold standard treatment for Hurler syndrome in individuals diagnosed before the age of two and a half years. More studies are needed to look at the long-term effects of this treatment and also to see the effects on the quality of life of these individuals. We do not anticipate any further trials to be undertaken and therefore do not plan to update this review. The included study was small and of low quality. | 10.1002/14651858.CD009354.pub5 | [
"One 26-week randomised controlled study (45 participants) was included in the review. Participants were aged between six and 43 years old. The study was carried out in several centres around the world. Participants either received an intravenous infusion of laronidase 0.58 mg/kg or a placebo ('dummy' infusion). Current evidence is limited because we only found one randomised clinical trial in the medical literature, which did not include very many participants. Compared with placebo, enzyme replacement therapy improved lung function, the individuals’ ability to walk, reduced the excretion of abnormal glycosaminoglycans (a type of carbohydrate molecule) in the urine and also reduced the stopping of breathing related to sleep. Adverse reactions in relation to the infusions occurred in both groups but all were mild and none required medical intervention or for the infusions to be stopped. Enzyme replacement therapy can be used before and around the time of stem cell transplant, which is now the gold standard treatment for Hurler syndrome in individuals diagnosed before the age of two and a half years. More studies are needed to look at the long-term effects of this treatment and also to see the effects on the quality of life of these individuals. We do not anticipate any further trials to be undertaken and therefore do not plan to update this review. The included study was small and of low quality."
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cochrane-simplification-train-1707 | cochrane-simplification-train-1707 | All nine identified trials compared different types of contraceptive implant. Eight, involving 1578 women, compared Implanon with Norplant , and one, involving 1198 women, compared Jadelle with Norplant. There was no difference between Implanon and Norplant for contraceptive effectiveness rates or continuation over 4 years. Both were highly effective methods of contraception with no pregnancies occurring in any of the trials during 26,972 and 28,108 women months of follow up respectively. The most common side-effect with Implanon and Norplant was changes in bleeding pattern. The pattern with Implanon was initially more variable, bleeding with both implants became less frequent with duration of use. After two years use the amenorrhoea rate was significantly higher with Implanon. The trials reported no significant difference in hormonal side-effects or adverse events. Implanon was significantly quicker to insert and remove than Norplant. There was no difference in contraceptive effectiveness and in continuation rates between Jadelle and Norplant. Jadelle was significantly quicker to remove than Norplant. Implanon, Norplant and Jadelle are highly effective contraceptive methods. No significant differences were found in contraceptive effectiveness or continuation. The most common side-effect with all implants was unpredictable vaginal bleeding. Time taken for removal of Implanon and Jadelle was less than that for Norplant. Although this systematic review was unable to provide a definitive answer on relative effectiveness, tolerability and acceptability of contraceptive implants in comparison to other contraceptive methods, it has raised issues around the conduct of contraceptive research. | All the trials identified compared different types of contraceptive implant. No trials were found that compared implants to other contraceptive methods. All the implants were highly effective methods of contraception in the selected women. The majority of women using contraceptive implants chose to continue with the method long term, over 80% of women were still using their implant at two years. Women in developed country studies were less likely to continue with these methods when compared to women in developing country studies. The most common reported side -effect was of irregular vaginal bleeding. Bleeding with all implants became less frequent with time. Removal was quicker for Implanon and Jadelle than for Norplant. Insertion problems were rare with any of the implants. Problems at removal were uncommon but were significantly more likely to occur in Norplant users than Implanon users. | 10.1002/14651858.CD001326.pub2 | [
"All the trials identified compared different types of contraceptive implant. No trials were found that compared implants to other contraceptive methods. All the implants were highly effective methods of contraception in the selected women. The majority of women using contraceptive implants chose to continue with the method long term, over 80% of women were still using their implant at two years. Women in developed country studies were less likely to continue with these methods when compared to women in developing country studies. The most common reported side -effect was of irregular vaginal bleeding. Bleeding with all implants became less frequent with time. Removal was quicker for Implanon and Jadelle than for Norplant. Insertion problems were rare with any of the implants. Problems at removal were uncommon but were significantly more likely to occur in Norplant users than Implanon users."
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cochrane-simplification-train-1708 | cochrane-simplification-train-1708 | We included four studies (2350 women). The overall risk of bias for the included studies was assessed as acceptable in two studies and good in two studies. No statistically significant differences were observed between women who received group antenatal care and those given standard individual antenatal care for the primary outcome of preterm birth (risk ratio (RR) 0.75, 95% confidence interval (CI) 0.57 to 1.00; three trials; N = 1888). The proportion of low-birthweight (less than 2500 g) babies was similar between groups (RR 0.92, 95% CI 0.68 to 1.23; three trials; N = 1935). No group differences were noted for the primary outcomes small-for-gestational age (RR 0.92, 95% CI 0.68 to 1.24; two trials; N = 1473) and perinatal mortality (RR 0.63, 95% CI 0.32 to 1.25; three trials; N = 1943). Satisfaction was rated marginally higher among women who were allocated to group antenatal care, but this 5 point difference is not clinically meaningful on the scale used (mean difference 4.90, 95% CI 3.10 to 6.70; one study; N = 993). No differences in neonatal intensive care admission, initiation of breastfeeding or spontaneous vaginal birth were observed between groups. Several outcomes related to stress and depression were reported in one trial. No differences between groups were observed for any of these outcomes. No data were available on the effects of group antenatal care on care provider satisfaction. We used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach to assess evidence for seven prespecified outcomes; results ranged from low quality (perinatal mortality) to moderate quality (preterm birth, low birthweight, neonatal intensive care unit admission, breastfeeding initiation) to high quality (satisfaction with antenatal care, spontaneous vaginal birth). Available evidence suggests that group antenatal care is acceptable to women and is associated with no adverse outcomes for them or for their babies. No differences in the rate of preterm birth were reported when women received group antenatal care. This review is limited because of the small numbers of studies and women, and because one study contributed 42% of the women. Most of the analyses are based on a single study. Additional research is required to determine whether group antenatal care is associated with significant benefit in terms of preterm birth or birthweight. | We undertook a systematic review of trials that compared the effects of group pregnancy care versus conventional individual pregnancy care on psychosocial, physiological, labour and birth outcomes for women and their babies as well as on care provider satisfaction. Four randomised controlled trials (involving 2350 women) were included: two were undertaken in the USA, one in Sweden and one in Iran. We found no differences between women who received group pregnancy care and those given one-to-one care in terms of important pregnancy outcomes such as preterm birth, infant birthweight or death of the baby. Women who attended group pregnancy care were no more likely to initiate breastfeeding than those receiving standard care. In one trial, women who attended group pregnancy care rated their satisfaction as similar to women receiving individual care. Major differences between trials were noted. One trial targeted young women 14 to 25 years of age in a setting with many African American women who had limited financial resources. The main purpose was to reduce human immunodeficiency virus (HIV) risk behaviour and sexually transmitted infections. Another trial was mainly looking at family readiness in a military setting, and another focused on women's satisfaction and emotional aspects of their care. This review is limited owing to the small numbers of studies and women, with one study contributing 42% of the women. More research is required to determine whether group pregnancy care is associated with significant benefits. | 10.1002/14651858.CD007622.pub3 | [
"We undertook a systematic review of trials that compared the effects of group pregnancy care versus conventional individual pregnancy care on psychosocial, physiological, labour and birth outcomes for women and their babies as well as on care provider satisfaction. Four randomised controlled trials (involving 2350 women) were included: two were undertaken in the USA, one in Sweden and one in Iran. We found no differences between women who received group pregnancy care and those given one-to-one care in terms of important pregnancy outcomes such as preterm birth, infant birthweight or death of the baby. Women who attended group pregnancy care were no more likely to initiate breastfeeding than those receiving standard care. In one trial, women who attended group pregnancy care rated their satisfaction as similar to women receiving individual care. Major differences between trials were noted. One trial targeted young women 14 to 25 years of age in a setting with many African American women who had limited financial resources. The main purpose was to reduce human immunodeficiency virus (HIV) risk behaviour and sexually transmitted infections. Another trial was mainly looking at family readiness in a military setting, and another focused on women's satisfaction and emotional aspects of their care. This review is limited owing to the small numbers of studies and women, with one study contributing 42% of the women. More research is required to determine whether group pregnancy care is associated with significant benefits."
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cochrane-simplification-train-1709 | cochrane-simplification-train-1709 | We included five trials, which were published between 1986 and 1992. Overall, they included 67 patients, all male, with ages ranging from one to 54 years. Intellectual disability in participants varied from borderline to severe and some studies included patients with an additional diagnosis of autism or autistic behaviour. Four of the studies were placebo-controlled cross-over trials and one study was a parallel design. The duration of follow-up ranged from two months to 12 months and the period on folic acid or placebo ranged from two to eight months. Doses of folic acid ranged from 10 mg to 250 mg per day, 10 mg per day being the most common. Most of the younger patients involved were also taking part in special education programmes (usually involving language and occupational therapy). We were not able to perform meta-analysis to combine results but none of the individual studies found evidence of clinical benefit with the use of folic acid medication in fragile X syndrome patients on any of the areas of interest, either psychological and learning capabilities or behaviour and social performance, as measured with standardised tools. Separate analysis of evidence for patients of different age groups, i.e. prepubertal children and postpubertal young people, found some statistically significant results, but did not show clear evidence of benefit for either group. Adverse effects of folic acid treatment were rare, not serious and transient. Studies were generally poorly reported and we classified only one study as being at low risk of bias. The quality of available evidence is low and not suitable for drawing conclusions about the effect of folic acid on fragile X syndrome patients. It consists of few studies with small samples of patients, all of them male, with little statistical power to detect anything other than huge effects. | This review asks whether folic acid helps improve symptoms in people with fragile X syndrome and whether it has any side effects. We found five randomised controlled trials, all of which were published between 1986 and 1992. These studies included 69 people, all male. One of the studies compared a folic acid group with a control group; the other four used a cross-over design (i.e. participants received first one treatment and then the other). The quality of reporting of the trials was generally poor, particularly the methods used, which made it difficult to assess the risk of bias in the studies. The results of the few published studies did not find significant differences in the effects of folic acid or placebo on psychological or learning capabilities, behaviour or social performance, as measured by standardised tools. There is therefore no evidence to support the recommendation of supplementing dietary intake with folic acid medication for people with fragile X syndrome. However, due to the number and quality of the studies, it is not possible to conclude with any certainty that folic acid does not help. Given that intellectual, behavioural, emotional and/or learning performance in people with fragile X syndrome are strongly influenced by different social factors, future studies should also pay attention to the evaluation of non-pharmacological interventions, such as modifications in the home environment, tailored behavioural interventions and classroom environments, or language and occupational therapy. | 10.1002/14651858.CD008476.pub2 | [
"This review asks whether folic acid helps improve symptoms in people with fragile X syndrome and whether it has any side effects. We found five randomised controlled trials, all of which were published between 1986 and 1992. These studies included 69 people, all male. One of the studies compared a folic acid group with a control group; the other four used a cross-over design (i.e. participants received first one treatment and then the other). The quality of reporting of the trials was generally poor, particularly the methods used, which made it difficult to assess the risk of bias in the studies. The results of the few published studies did not find significant differences in the effects of folic acid or placebo on psychological or learning capabilities, behaviour or social performance, as measured by standardised tools. There is therefore no evidence to support the recommendation of supplementing dietary intake with folic acid medication for people with fragile X syndrome. However, due to the number and quality of the studies, it is not possible to conclude with any certainty that folic acid does not help. Given that intellectual, behavioural, emotional and/or learning performance in people with fragile X syndrome are strongly influenced by different social factors, future studies should also pay attention to the evaluation of non-pharmacological interventions, such as modifications in the home environment, tailored behavioural interventions and classroom environments, or language and occupational therapy."
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cochrane-simplification-train-1710 | cochrane-simplification-train-1710 | We included 24 trials with 2996 participants in this updated review. The number of participants in each trial varied from 39 to 382. Most of the included studies compared bed rest versus immediate mobilization, and only two assessed the effects of supplementary fluids versus no supplementation. We judged the overall risk of bias of the included studies as low to unclear. The overall quality of evidence was low to moderate, downgraded because of the risk of bias assessment in most cases. The primary outcome in our review was the presence of PDPH. There was low quality evidence for an absence of benefits associated with bed rest compared with immediate mobilization on the incidence of severe PDPH (risk ratio (RR) 0.98; 95% confidence interval (CI) 0.68 to 1.41; participants = 1568; studies = 9) and moderate quality evidence on the incidence of any headache after lumbar puncture (RR 1.16; 95% CI 1.02 to 1.32; participants = 2477; studies = 18). Furthermore, bed rest probably increased PDPH (RR 1.24; 95% CI 1.04 to 1.48; participants = 1519; studies = 12) compared with immediate mobilization. An analysis restricted to the most methodologically rigorous trials (i.e. those with low risk of bias in allocation method, missing data and blinding of outcome assessment) gave similar results. There was low quality evidence for an absence of benefits associated with fluid supplementation on the incidence of severe PDPH (RR 0.67; 95% CI 0.26 to 1.73; participants = 100; studies = 1) and PDPH (RR 1; 95% CI 0.59 to 1.69; participants = 100; studies = 1), and moderate quality evidence on the incidence of any headache after lumbar puncture (RR 0.94; 95% CI 0.66 to 1.34; participants = 200; studies = 2). We did not expect other adverse events and did not assess them in this review. Since the previous version of this review, we found one new study for inclusion, but the conclusion remains unchanged. We considered the quality of the evidence for most of the outcomes assessed in this review to be low to moderate. As identified studies had shortcomings on aspects related to randomization and blinding of outcome assessment, we therefore downgraded the quality of the evidence. In general, there was no evidence suggesting that routine bed rest after dural puncture is beneficial for the prevention of PDPH onset. The role of fluid supplementation in the prevention of PDPH remains unclear. | This is an update of the original review published in 2013. We found one new study in a search of the published literature in February 2015. This review includes 24 studies with 2996 participants. We compared different types of bed rest and extra fluids to see if they prevented PDPH after a lumbar puncture. We found low to moderate quality evidence that bed rest does not prevent the onset of headaches after lumbar puncture, regardless of the duration of rest or the body or head positions assumed by the patient. Furthermore, bed rest probably increases the chances of having PDPH. We found few data on the usefulness of extra fluids, which did not seem to prevent PDPH. We believe that these practices should no longer be routinely recommended to patients for the prevention of headaches after lumbar puncture since there is no evidence supporting them. We considered the quality of the evidence for most of the outcomes assessed in this review to be low to moderate. | 10.1002/14651858.CD009199.pub3 | [
"This is an update of the original review published in 2013. We found one new study in a search of the published literature in February 2015. This review includes 24 studies with 2996 participants. We compared different types of bed rest and extra fluids to see if they prevented PDPH after a lumbar puncture. We found low to moderate quality evidence that bed rest does not prevent the onset of headaches after lumbar puncture, regardless of the duration of rest or the body or head positions assumed by the patient. Furthermore, bed rest probably increases the chances of having PDPH. We found few data on the usefulness of extra fluids, which did not seem to prevent PDPH. We believe that these practices should no longer be routinely recommended to patients for the prevention of headaches after lumbar puncture since there is no evidence supporting them. We considered the quality of the evidence for most of the outcomes assessed in this review to be low to moderate."
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cochrane-simplification-train-1711 | cochrane-simplification-train-1711 | We retrieved 2398 citations: 30 studies were eligible for further examination of their full text, and we found one registered clinical trial in progress. No studies could be included in the analysis or review. We assigned one study as awaiting classification, as it has not been accepted for publication. This systematic review failed to locate relevant published RCTs to support or refute the assertion that vascular access specialist teams are superior to the generalist model. A vascular access specialist team has advanced knowledge with regard to insertion techniques, clinical care, and management of vascular access devices, whereas a generalist model comprises nurses, doctors, or other designated healthcare professionals in the healthcare facility who may have less advanced insertion techniques and who care for vascular access devices amongst other competing clinical tasks. However, this conclusion may change once the one study awaiting classification and one ongoing study are published. There is a need for good-quality RCTs to evaluate the efficacy of a vascular access specialist team approach for vascular access device insertion and care for the prevention of failure. | We searched a wide range of medical databases on 7 February 2018. We identified 2398 potential studies, 30 of which we looked at in detail. We found one suitable study, however although the study is complete the manuscript has not yet been accepted for publication, and so we were unable to analyse the data. We have assigned the study as awaiting classification; once its results are published we will evaluate it again and decide if it is eligible for inclusion in the review. We found one registered trial that is investigating our review question, but it is still ongoing and not yet completed or published. We failed to locate any published randomized controlled trials (RCTs) to support or refute the assertion that vascular access specialist teams are superior to the generalist model for device insertion and prevention of failure. However, this conclusion may change once the one study awaiting classification and the one ongoing study are published. There is a need for good-quality RCTs to evaluate the efficacy of a VAST approach for VAD insertion and prevention of failure. An RCT is a study (or trial) that aims to reduce bias when testing a new treatment. The people taking part in the trial are randomly allocated to either the group receiving the treatment under investigation or to a group receiving standard treatment (or placebo treatment) as the control. We did not analyse the quality of the evidence as we did not find any suitable studies to include in our review. | 10.1002/14651858.CD011429.pub2 | [
"We searched a wide range of medical databases on 7 February 2018. We identified 2398 potential studies, 30 of which we looked at in detail. We found one suitable study, however although the study is complete the manuscript has not yet been accepted for publication, and so we were unable to analyse the data. We have assigned the study as awaiting classification; once its results are published we will evaluate it again and decide if it is eligible for inclusion in the review. We found one registered trial that is investigating our review question, but it is still ongoing and not yet completed or published. We failed to locate any published randomized controlled trials (RCTs) to support or refute the assertion that vascular access specialist teams are superior to the generalist model for device insertion and prevention of failure. However, this conclusion may change once the one study awaiting classification and the one ongoing study are published. There is a need for good-quality RCTs to evaluate the efficacy of a VAST approach for VAD insertion and prevention of failure. An RCT is a study (or trial) that aims to reduce bias when testing a new treatment. The people taking part in the trial are randomly allocated to either the group receiving the treatment under investigation or to a group receiving standard treatment (or placebo treatment) as the control. We did not analyse the quality of the evidence as we did not find any suitable studies to include in our review."
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cochrane-simplification-train-1712 | cochrane-simplification-train-1712 | A total of 13 studies (4495 participants) were included in this review. Agomelatine was compared to selective serotonin reuptake inhibitors (SSRIs), namely paroxetine, fluoxetine, sertraline, escitalopram, and to the serotonin–norepinephrine reuptake inhibitor (SNRI), venlafaxine. Participants were followed up for six to 12 weeks. Agomelatine did not show any advantage or disadvantage over the other antidepressants for our primary outcome, response to treatment (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.95 to 1.08, P value 0.75 compared to SSRIs, and RR 1.06; 95% CI 0.98 to 1.16, P value 0.16 compared to venlafaxine). Also, agomelatine showed no advantage or disadvantage over other antidepressants for remission (RR 0.83; 95% CI 0.68 to 1.01, P value 0.07 compared to SSRIs, and RR 1.08; 95% CI 0.94 to 1.24, P value 0.73 compared to venlafaxine). Overall, agomelatine appeared to be better tolerated than venlafaxine in terms of lower rates of drop outs (RR 0.40; 95% CI 0.24 to 0.67, P value 0.0005), and showed the same level of tolerability as SSRIs (RR 0.95; 95% CI 0.83 to 1.09, P value 0.44). Agomelatine induced a lower rate of dizziness than venlafaxine (RR 0.19, 95% CI 0.06 to 0.64, P value 0.007). With regard to the quality of the body of evidence, there was a moderate risk of bias for all outcomes, due to the number of included unpublished studies. There was some heterogeneity, particularly between published and unpublished studies. The included studies were conducted in inpatient and outpatient settings, thus limiting the generalisability of the results to primary care settings. With regard to precision, the efficacy outcomes were precise, but the tolerability outcomes were mostly imprecise. Publication bias was variable and depended on the outcome of the trial. Our review included unpublished studies, and we think that this reduced the impact of publication bias. The overall methodological quality of the studies was not very good. Almost all of the studies were sponsored by the pharmaceutical company that manufactures agomelatine (Servier), and some of these were unpublished. Attempts to contact the pharmaceutical company Servier for additional information on all unpublished studies were unsuccessful. Agomelatine did not seem to provide a significant advantage in efficacy over other antidepressive agents for the acute-phase treatment of major depression. Agomelatine was better tolerated than paroxetine and venlafaxine in terms of overall side effects, and fewer participants treated with agomelatine dropped out of the trials due to side effects compared to sertraline and venlafaxine, but data were limited because the number of included studies was small. We found evidence that compared agomelatine with only a small number of other active antidepressive agents, and there were only a few trials for each comparison, which limits the generalisability of the results. Moreover, the overall methodological quality of the studies was low, and, therefore, no firm conclusions can be drawn concerning the efficacy and tolerability of agomelatine. | The review included trials comparing agomelatine with a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs), and one antidepressant from the serotonin–norepinephrine reuptake inhibitor group, called venlafaxine. Participants in the studies were followed up for between six to 12 weeks. - Agomelatine was no more or less effective in reducing symptoms of depression than any of the other antidepressants. - Agomelatine was no more or less effective in preventing relapse of depression than any of the other antidepressants. - Agomelatine was tolerated better than venlafaxine (fewer people discontinued treatment), but the same as the SSRIs. - Agomelatine caused a lower rate of dizziness than venlafaxine. - Agomelatine caused a lower rate of vomiting, nausea and sexual side-effects than SSRIs. The reviewers conclude that agomelatine is not more effective than other antidepressants currently on the market. It did seem to be more tolerable to patients in terms of lower rates of some side-effects, however, the quality of trials was low and there were only a few trials that compared agomelatine with each medication. No firm conclusion on agomelatine can be made because of problems with reporting of data in the trials included. The authors recommend that further trials of agomelatine versus placebo (dummy pill), particularly in primary care settings (where the majority of patient/practitioner contact take place, e.g. GP surgeries), should be carried out to improve the quality of evidence. | 10.1002/14651858.CD008851.pub2 | [
"The review included trials comparing agomelatine with a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs), and one antidepressant from the serotonin–norepinephrine reuptake inhibitor group, called venlafaxine. Participants in the studies were followed up for between six to 12 weeks. - Agomelatine was no more or less effective in reducing symptoms of depression than any of the other antidepressants. - Agomelatine was no more or less effective in preventing relapse of depression than any of the other antidepressants. - Agomelatine was tolerated better than venlafaxine (fewer people discontinued treatment), but the same as the SSRIs. - Agomelatine caused a lower rate of dizziness than venlafaxine. - Agomelatine caused a lower rate of vomiting, nausea and sexual side-effects than SSRIs. The reviewers conclude that agomelatine is not more effective than other antidepressants currently on the market. It did seem to be more tolerable to patients in terms of lower rates of some side-effects, however, the quality of trials was low and there were only a few trials that compared agomelatine with each medication. No firm conclusion on agomelatine can be made because of problems with reporting of data in the trials included. The authors recommend that further trials of agomelatine versus placebo (dummy pill), particularly in primary care settings (where the majority of patient/practitioner contact take place, e.g. GP surgeries), should be carried out to improve the quality of evidence."
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cochrane-simplification-train-1713 | cochrane-simplification-train-1713 | Ten papers describing 10 unique trials met the inclusion criteria. Analysis of data from two trials (63 participants) showed that sodium valproate reduced headache frequency by approximately four headaches per 28 days as compared to placebo (MD -4.31; 95% confidence interval (CI) -8.32 to -0.30). Data from four trials (542 participants) showed that divalproex sodium (a stable combination of sodium valproate and valproic acid in a 1:1 molar ratio) more than doubled the proportion of responders relative to placebo (RR 2.18; 95% CI 1.28 to 3.72; NNT 4; 95% CI 2 to 11). One study of sodium valproate (34 participants) versus placebo supported the latter findings (RR for responders 2.83; 95% CI 1.27 to 6.31; NNT 3; 95% CI 2 to 9). There was no significant difference in the proportion of responders between sodium valproate versus flunarizine (one trial, 41 participants) or between divalproex sodium versus propranolol (one trial, 32 participants). Pooled analysis of post-treatment mean headache frequencies in two trials (88 participants) demonstrates a slight but significant advantage for topiramate 50 mg over valproate 400 mg (MD -0.90; 95% CI -1.58 to -0.22). For placebo-controlled trials of sodium valproate and divalproex sodium, NNHs for clinically important adverse events ranged from 7 to 14. Valproate is effective in reducing headache frequency and is reasonably well tolerated in adult patients with episodic migraine. | For the present review, researchers in The Cochrane Collaboration reviewed the evidence about the effects of valproate (valproic acid or sodium valproate or a combination of the two) in adult patients (≥ 16 years of age) with 'episodic' migraine (headache on < 15 days per month). They examined research published up to 15 January 2013 and found 10 relevant studies. Compared with placebo, valproate reduced the frequency of migraine headaches by approximately four per month (two studies, 63 participants). Patients were also more than twice as likely to reduce the number of their migraine headaches by 50% or more with valproate than with placebo (five studies, 576 participants). Side effects associated with valproate were common but generally mild; valproate can, however, cause birth defects and so should be used with caution in women of childbearing age. Further research is needed comparing valproate with other active drugs used for preventing migraine attacks. | 10.1002/14651858.CD010611 | [
"For the present review, researchers in The Cochrane Collaboration reviewed the evidence about the effects of valproate (valproic acid or sodium valproate or a combination of the two) in adult patients (≥ 16 years of age) with 'episodic' migraine (headache on < 15 days per month). They examined research published up to 15 January 2013 and found 10 relevant studies. Compared with placebo, valproate reduced the frequency of migraine headaches by approximately four per month (two studies, 63 participants). Patients were also more than twice as likely to reduce the number of their migraine headaches by 50% or more with valproate than with placebo (five studies, 576 participants). Side effects associated with valproate were common but generally mild; valproate can, however, cause birth defects and so should be used with caution in women of childbearing age. Further research is needed comparing valproate with other active drugs used for preventing migraine attacks."
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cochrane-simplification-train-1714 | cochrane-simplification-train-1714 | We included 12 studies (508 participants) in comparisons with placebo or an active control. Six studies enrolled participants with moderate or severe postherpetic neuralgia, and the remaining studies enrolled different, or mixed, neuropathic pain conditions, including trigeminal neuralgia and postsurgical or post-traumatic neuralgia. Four different formulations were used: 5% medicated patch, 5% cream, 5% gel, and 8% spray. Most studies used a cross-over design, and two used a parallel-group design. Two studies used enriched enrolment with randomised withdrawal. Seven studies used multiple doses, with one to four-week treatment periods, and five used single applications. We judged all of the studies at high risk of bias because of small size or incomplete outcome assessment, or both. There was no first or second tier evidence, and no pooling of data was possible for efficacy outcomes. Only one multiple-dose study reported our primary outcome of participants with ≥ 50% or ≥ 30% pain intensity reduction. Three single-dose studies reported participants who were pain-free at a particular time point, or had a 2-point (of 10) reduction in pain intensity. The two enriched enrolment, randomised withdrawal studies reported time to loss of efficacy. In all but one study, third tier (very low quality) evidence indicated that lidocaine was better than placebo for some measure of pain relief. Pooling multiple-dose studies across conditions demonstrated no clear evidence of an effect of lidocaine on the incidence of adverse events or withdrawals, but there were few events and the withdrawal phase of enriched enrolment designs is not suitable to assess the true impact of adverse events (very low quality evidence). This review found no evidence from good quality randomised controlled studies to support the use of topical lidocaine to treat neuropathic pain, although individual studies indicated that it was effective for relief of pain. Clinical experience also supports efficacy in some patients. Several large ongoing studies, of adequate duration, with clinically useful outcomes should provide more robust conclusions about both efficacy and harm. | In July 2014 we performed searches to look for clinical trials where topical lidocaine was used to treat neuropathic pain. We found 12 small studies of modest quality that tested topical lidocaine against topical placebo for a number of weeks. One study also tested a cream containing amitriptyline, which is an antidepressant. The 508 people in the studies had different types of neuropathic pain, with pain after herpes zoster infection the most common. There was some indication that topical lidocaine was beneficial in these studies (very low quality evidence). There was no clear evidence of an effect of lidocaine on the incidence of adverse events or withdrawals (very low quality evidence). A number of studies of topical lidocaine in neuropathic pain are ongoing. Several are large and of long duration. They will be of great help in working out the benefits of topical lidocaine when they are completed and results can be incorporated in this review. | 10.1002/14651858.CD010958.pub2 | [
"In July 2014 we performed searches to look for clinical trials where topical lidocaine was used to treat neuropathic pain. We found 12 small studies of modest quality that tested topical lidocaine against topical placebo for a number of weeks. One study also tested a cream containing amitriptyline, which is an antidepressant. The 508 people in the studies had different types of neuropathic pain, with pain after herpes zoster infection the most common. There was some indication that topical lidocaine was beneficial in these studies (very low quality evidence). There was no clear evidence of an effect of lidocaine on the incidence of adverse events or withdrawals (very low quality evidence). A number of studies of topical lidocaine in neuropathic pain are ongoing. Several are large and of long duration. They will be of great help in working out the benefits of topical lidocaine when they are completed and results can be incorporated in this review."
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cochrane-simplification-train-1715 | cochrane-simplification-train-1715 | We identified 29 randomised clinical trials, five of which were considered high quality. Only three trials reported inclusion of hepatitis B e-antigen negative mothers. Compared with placebo/no intervention, vaccine reduced hepatitis B occurrence (RR 0.28, 95% confidence interval (CI) 0.20 to 0.40, 4 trials). No significant differences of hepatitis B occurrence were found comparing recombinant vaccine (RV) versus plasma-derived vaccine (PDV) (RR 1.00, 95% CI 0.71 to 1.42, 4 trials) and high-dose versus low-dose vaccine (PDV: RR 0.97, 95% CI 0.55 to 1.68, 3 trials; RV: RR 0.78, 95% CI 0.31 to 1.94, 1 trial). Compared with placebo/no intervention, hepatitis B immunoglobulin or the combination of vaccine plus hepatitis B immunoglobulin reduced hepatitis B occurrence (hepatitis B immunoglobulin: RR 0.50, 95% CI 0.41 to 0.60, 1 trial; PDV plus hepatitis B immunoglobulin: RR 0.08, 95% CI 0.03 to 0.17, 3 trials). Compared with vaccine, vaccine plus hepatitis B immunoglobulin reduced hepatitis B occurrence (RR 0.54, 95% CI 0.41 to 0.73, 10 trials). Hepatitis B vaccine and hepatitis B immunoglobulin seem safe, but few trials reported on adverse events. Vaccine, hepatitis B immunoglobulin, and vaccine plus hepatitis B immunoglobulin prevent hepatitis B occurrence in newborn infants of HBsAg positive mothers. | When all the identified trials were combined, hepatitis B vaccine alone, hepatitis B immunoglobulin alone, and hepatitis B vaccine plus hepatitis B immunoglobulin reduced perinatal transmission of hepatitis B compared with placebo or no intervention. Hepatitis B vaccine plus hepatitis B immunoglobulin were superior to hepatitis B vaccination alone. Adverse events were rare and mostly non-serious. | 10.1002/14651858.CD004790.pub2 | [
"When all the identified trials were combined, hepatitis B vaccine alone, hepatitis B immunoglobulin alone, and hepatitis B vaccine plus hepatitis B immunoglobulin reduced perinatal transmission of hepatitis B compared with placebo or no intervention. Hepatitis B vaccine plus hepatitis B immunoglobulin were superior to hepatitis B vaccination alone. Adverse events were rare and mostly non-serious."
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cochrane-simplification-train-1716 | cochrane-simplification-train-1716 | Fourteen studies (involving 1879 couples) were included. Three studies reported live birth rate and these did not identify a significant difference after pooling the (preliminary) results (OR 1.21, 95% CI 0.67 to 2.19). With regard to pregnancy rates, there was also no evidence that glucocorticoids improved clinical outcome (13 RCTs; OR 1.16, 95% CI 0.94 to 1.44). However, a subgroup analysis of 650 women undergoing IVF (6 RCTs) revealed a significantly higher pregnancy rate for women using glucocorticoids (OR 1.50, 95% CI 1.05 to 2.13). There were no significant differences in adverse events, but these were poorly and inconsistently reported. Overall, there was no clear evidence that administration of peri-implantation glucocorticoids in ART cycles significantly improved the clinical outcome. The use of glucocorticoids in a subgroup of women undergoing IVF (rather than ICSI) was associated with an improvement in pregnancy rates of borderline statistical significance and should be interpreted with care. These findings were limited to the routine use of glucocorticoids and cannot be extrapolated to women with autoantibodies, unexplained infertility or recurrent implantation failure. Further well designed randomised studies are required to elucidate the possible role of this therapy in well defined patient groups. | This review investigated whether the administration of glucocorticoids around the time of implantation improved clinical outcomes in women undergoing IVF or ICSI when compared to no glucocorticoid administration. The review of trials found no evidence that glucocorticoids helped to improve live birth rates. However, there was some evidence of increased pregnancy rates, rather than live birth rates, among women undergoing IVF. This was not found in women undergoing ICSI. More research is needed to elucidate the possible role of this therapy in well defined patient groups. | 10.1002/14651858.CD005996.pub3 | [
"This review investigated whether the administration of glucocorticoids around the time of implantation improved clinical outcomes in women undergoing IVF or ICSI when compared to no glucocorticoid administration. The review of trials found no evidence that glucocorticoids helped to improve live birth rates. However, there was some evidence of increased pregnancy rates, rather than live birth rates, among women undergoing IVF. This was not found in women undergoing ICSI. More research is needed to elucidate the possible role of this therapy in well defined patient groups."
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cochrane-simplification-train-1717 | cochrane-simplification-train-1717 | Our search yielded 5073 references, but at the end of our selection process, only 16 studies fulfilled the review inclusion criteria. Nine of these provided individual participant data. We analysed only data concerning TSBA, cholic acid (CA), glycocholic acid (GCA), chenodeoxycholic acid (CDCA), and CA/CDCA because the remaining planned index tests were assessed in few studies. Only one study had low risk of bias in all four QUADAS-2 domains. The most biased domains were the patient sampling and the reference standard domains. When considering all studies with a cut-off of 10 μmol/L, TSBA overall sensitivity ranged from 0.72 to 0.98 and specificity ranged from 0.81 to 0.97. After a sensitivity analysis excluding case-control studies, TSBA sensitivity ranged from 0.48 to 0.66 and specificity from 0.52 to 0.99. After a sensitivity analysis excluding studies in which TSBA was part of the reference standard, TSBA sensitivity ranged from 0.49 to 0.65 and specificity from 0.53 to 0.99. We found the estimates of the overall accuracy for some serum bile acid components (CA, GCA, CDCA, and CA/CDCA) to be imprecise, with the CI for sensitivity and specificity very wide or impossible to calculate. Indirect comparisons between serum bile acid profile components and TSBA were not statistically significant. None of the heterogeneity analysis performed was statistically significant, except for the timing of assessment of TSBA (onset of symptoms, peak value among multiple assessments, delivery) but without clinically relevant results. We could not analyse the diagnostic accuracy of combinations of index tests because none of the included studies carried them out, and because of the small number of included studies. The overall high risk of bias, the existing concern regarding applicability of the results in clinical practice, and the great heterogeneity of the results in the included studies prevents us from making recommendations and reaching definitive conclusions at the present time. Thus, we do not find any compelling evidence to recommend or refute the routine use of any of these tests in clinical practice. So far, the diagnostic accuracy of TSBA for intrahepatic cholestasis of pregnancy might have been overestimated. There were too few studies to permit a precise estimate of the accuracy of serum bile acid profile components. Further primary clinical research is mandatory. We need both further phase II and phase III diagnostic studies. | This review considered all evidence provided by studies that assess the diagnostic accuracy of total serum bile acids (TSBA) and any component of serum bile acid profile for intrahepatic cholestasis of pregnancy in woman claiming onset of pruritus during pregnancy. We assessed all available reports from a wide, systematic search of databases of medical literature, irrespective of design, publication status, language, and study design. We finally included 16 studies, most of them assessing the accuracy (sensitivity and specificity) of TSBA with a cut-off of 10 μmol/L. Most studies had a case-control design, and these studies could have overestimated the diagnostic accuracy. When considering the studies with a cut-off of 10 μmol/L for TSBA serum concentration, TSBA overall sensitivity (the ability to correctly identify women with the disease) ranged from 72% to 98% and specificity (the ability to correctly identify women without the disease) ranged from 81% to 97%. However, after performing two different analyses excluding studies with probably less reliable results, the diagnostic accuracy seemed lower. We calculated the overall accuracy also of some components of serum bile acid profile, but the small number of studies and the high variability of the results led to very imprecise data. Only one of the 16 included studies was performed and reported well (low risk of bias). The remaining 15 studies had problems with study design or reporting (high risk of bias). Only five studies seemed to show low concern regarding applicability of the results in clinical practice. The overall high risk of bias, the existing concern regarding applicability of the results in clinical practice, and the poor uniformity of our results in the included studies prevents us from making recommendations and reaching definitive conclusions at present. Thus, we do not find any compelling evidence to recommend or refute the routine use of any of these tests in clinical practice. So far, the diagnostic accuracy of TSBA for intrahepatic cholestasis of pregnancy might have been overestimated. There were too few studies to permit a precise estimate of the accuracy of serum bile acid profile components. Further primary clinical research is mandatory. We need both further phase II and phase III diagnostic studies. | 10.1002/14651858.CD012546.pub2 | [
"This review considered all evidence provided by studies that assess the diagnostic accuracy of total serum bile acids (TSBA) and any component of serum bile acid profile for intrahepatic cholestasis of pregnancy in woman claiming onset of pruritus during pregnancy. We assessed all available reports from a wide, systematic search of databases of medical literature, irrespective of design, publication status, language, and study design. We finally included 16 studies, most of them assessing the accuracy (sensitivity and specificity) of TSBA with a cut-off of 10 μmol/L. Most studies had a case-control design, and these studies could have overestimated the diagnostic accuracy. When considering the studies with a cut-off of 10 μmol/L for TSBA serum concentration, TSBA overall sensitivity (the ability to correctly identify women with the disease) ranged from 72% to 98% and specificity (the ability to correctly identify women without the disease) ranged from 81% to 97%. However, after performing two different analyses excluding studies with probably less reliable results, the diagnostic accuracy seemed lower. We calculated the overall accuracy also of some components of serum bile acid profile, but the small number of studies and the high variability of the results led to very imprecise data. Only one of the 16 included studies was performed and reported well (low risk of bias). The remaining 15 studies had problems with study design or reporting (high risk of bias). Only five studies seemed to show low concern regarding applicability of the results in clinical practice. The overall high risk of bias, the existing concern regarding applicability of the results in clinical practice, and the poor uniformity of our results in the included studies prevents us from making recommendations and reaching definitive conclusions at present. Thus, we do not find any compelling evidence to recommend or refute the routine use of any of these tests in clinical practice. So far, the diagnostic accuracy of TSBA for intrahepatic cholestasis of pregnancy might have been overestimated. There were too few studies to permit a precise estimate of the accuracy of serum bile acid profile components. Further primary clinical research is mandatory. We need both further phase II and phase III diagnostic studies."
]
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cochrane-simplification-train-1718 | cochrane-simplification-train-1718 | We identified two eligible studies reporting 18 methodological filters. All methodological filters in these two studies were developed using terms from the reference standard records. The first study evaluated six filters for retrieving observational studies of surgical interventions. The study reported on six filters: one Precision Terms Filter (comprising terms with higher precision while maximum sensitivity was maintained) and one Specificity Terms Filter (comprising terms with higher specificity while maximum sensitivity was maintained), both of which were adapted for MEDLINE, for Embase, and for combined MEDLINE/Embase searches. The study reported one reference standard consisting of 217 articles from one systematic review of which 83.9% of the included studies were case series The second study reported on 12 filters for retrieving comparative non-randomised studies (cNRSs) including cohort, case-control, and cross-sectional studies. This study reported on 12 filters using four different approaches: Fixed method A (comprising of a fixed set of controlled vocabulary (CV) words), Fixed method B (comprising a fixed set of CV words and text words (TW)), Progressive method (CV) (a random choice of study design-related CV terms), and Progressive method (CV or TW) (a random choice of study design-related CV terms, and title and abstracts-based TWs). The study reported four reference standards consisting of 89 cNRSs from four systematic reviews. The six methodological filters developed from the first study reported sensitivity of 99.5% to 100% and precision of 16.7% to 21.1%. The Specificity Terms Filter for combined MEDLINE/Embase was preferred because it had higher precision and equal sensitivity to the Precision Terms Filter. The 12 filters from the second study reported lower sensitivity (48% to 100%) and much lower precision (0.09% to 4.47%). The Progressive method (CV or TW) had the highest sensitivity. There were methodological limitations in both included studies. The first study used one surgical intervention-focused systematic review thus limiting the generalizability of findings. The second study used four systematic reviews but with less than 100 studies. The external validation was performed only on Specificity Terms Filter from the first study Both studies were published 10 years ago and labelling and indexing of observational studies has changed since then. We found 18 methodological filters across two eligible studies. Search strategies from the first study had higher sensitivity and precision, underwent external validation and targeted observational studies. Search strategies from the second study had lower sensitivity and precision, focused on cNRSs, and were not validated externally. Given this limited and heterogeneous evidence, and its methodological limitations, further research and better indexation are needed. | We found two eligible studies reporting on 18 methodological filters, including six MEDLINE, six Embase and six combined MEDLINE/Embase filters. The firsts study focused on filters on observational studies of surgical interventions. The second study focused on filters for a specific subtype of observational studies: comparative non-randomised studies. Six filters from the first study showed sensitivity of 99.5% to 100% and precision of 16.7% to 21.1%. One type of filter was evaluated by two additional systematic reviews (i.e. externally validated) and found that this retrieved 85.2% to 100% of the articles in the reference standard. Twelve filters from the second study had lower sensitivity (48% to 100%) and much lower precision (0.09% to 4.47%). The included studies had several limitations. The first study used only one systematic review for search strategy development and focused on observational studies of surgical interventions, which might limit the generalizability of the findings to other literature searches. The reference standard in the second study, although encompassing four different systematic reviews, included a limited number of studies, which might affect the accuracy of the performance assessment. Both studies were published 10 years ago and labelling and indexing of observational studies has changed since then. | 10.1002/14651858.MR000041.pub2 | [
"We found two eligible studies reporting on 18 methodological filters, including six MEDLINE, six Embase and six combined MEDLINE/Embase filters. The firsts study focused on filters on observational studies of surgical interventions. The second study focused on filters for a specific subtype of observational studies: comparative non-randomised studies. Six filters from the first study showed sensitivity of 99.5% to 100% and precision of 16.7% to 21.1%. One type of filter was evaluated by two additional systematic reviews (i.e. externally validated) and found that this retrieved 85.2% to 100% of the articles in the reference standard. Twelve filters from the second study had lower sensitivity (48% to 100%) and much lower precision (0.09% to 4.47%). The included studies had several limitations. The first study used only one systematic review for search strategy development and focused on observational studies of surgical interventions, which might limit the generalizability of the findings to other literature searches. The reference standard in the second study, although encompassing four different systematic reviews, included a limited number of studies, which might affect the accuracy of the performance assessment. Both studies were published 10 years ago and labelling and indexing of observational studies has changed since then."
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cochrane-simplification-train-1719 | cochrane-simplification-train-1719 | After screening 1808 abstracts, and the references of 65 reviews, we found only seven relevant studies (1050 patients) that met our inclusion criteria. None of these were considered, methodologically, a high quality randomized controlled trial. Four of the included RCTs on fibromyalgia were graded low quality and suggest no quantifiable benefits. The three included RCTs on widespread musculoskeletal pain showed that based on limited evidence, overall, no evidence of efficacy was observed. However, behavioral treatment and stress management appear to be important components. Education combined with physical training showed some positive effects in long term follow up. We conclude that there appears to be little scientific evidence for the effectiveness of multidisciplinary rehabilitation for these musculoskeletal disorders. However, multidisciplinary rehabilitation is a commonly used intervention for chronic musculoskeletal disorders, which cause much personal suffering and substantial economic loss to the society. There is a need for high quality trials in this field. | The main purpose of this systematic review was to determine the effectiveness of multidisciplinary rehabilitation for fibromyalgia and wide spread musculoskeletal pain among working age adults. Patients included in the controlled trials in this review ranged in age from 18-65 years. Seven studies, with 1050 patients were included. The effectiveness of multidisciplinary rehabilitation was graded limited, showing no quantifiable benefit for both fibromyalgia and widespread musculoskeletal pain. | 10.1002/14651858.CD001984 | [
"The main purpose of this systematic review was to determine the effectiveness of multidisciplinary rehabilitation for fibromyalgia and wide spread musculoskeletal pain among working age adults. Patients included in the controlled trials in this review ranged in age from 18-65 years. Seven studies, with 1050 patients were included. The effectiveness of multidisciplinary rehabilitation was graded limited, showing no quantifiable benefit for both fibromyalgia and widespread musculoskeletal pain."
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cochrane-simplification-train-1720 | cochrane-simplification-train-1720 | Five RCTs involving 895 sporadic and 52 familial ALS/MND participants were included. There was no statistical evidence for a differential response to treatment in participants with familial ALS/MND compared to those with sporadic ALS/MND. The pooled estimate of the hazard ratio for the interaction term (treatment x familial ALS) suggested a more beneficial response with respect to survival among participants with familial ALS/MND, but the result was not statistically significant. Pooled estimates of the rate of decline on the ALSFRS suggested a slightly better overall response to treatment among those with familial ALS/MND, but the result was not statistically significant. Based on the available data, there is little evidence for a differential response to treatment among people with familial and sporadic ALS/MND. Future randomized controlled trials should document whether people with familial ALS/MND are included and the presence or absence of a mutation in an ALS susceptibility gene amongst those with familial ALS/MND. | We identified all randomized controlled trials in ALS/MND and wrote to the authors to request the data needed to complete this review. Although many more studies were eligible for inclusion, only five authors were willing and able to share the data from their individual randomized controlled trials. Based on the analyses of these data, we find no evidence to support a statistically significant difference in the response to treatment between people with the familial and sporadic forms of ALS/MND. | 10.1002/14651858.CD006153.pub2 | [
"We identified all randomized controlled trials in ALS/MND and wrote to the authors to request the data needed to complete this review. Although many more studies were eligible for inclusion, only five authors were willing and able to share the data from their individual randomized controlled trials. Based on the analyses of these data, we find no evidence to support a statistically significant difference in the response to treatment between people with the familial and sporadic forms of ALS/MND."
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cochrane-simplification-train-1721 | cochrane-simplification-train-1721 | Four randomised controlled trials involving 543 women were identified and are included in this review. In the included studies, the active treatment arm was the 20 μg/day levonorgestrel-releasing intrauterine system (LNG-IUS) plus endometrial surveillance; the control arm was endometrial surveillance alone. In tamoxifen users, the LNG-IUS led to a reduction in the incidence of endometrial polyps over both a 12-month period (Peto OR 0.22, 95% CI 0.08 to 0.64, 2 studies, n = 212, I² = 0%) and over a long-term follow-up period (24 to 60 months) (Peto OR 0.22, 95% CI 0.13 to 0.39, 4 studies, n = 417, I² = 0%, moderate quality evidence). Also the LNG-IUS led to a reduction in the incidence of endometrial hyperplasia over a long-term follow-up period (24 to 60 months) (Peto OR 0.13, 95% CI 0.03 to 0.67, four studies, n = 417, I² = 0%, moderate quality evidence). However, it should be noted that the number of events of endometrial hyperplasia was low (n = 6). None of the trials were sufficiently powered to detect whether LNG-IUS leads to significant changes in the incidence of endometrial cancer in tamoxifen users. At 12 months of follow-up abnormal vaginal bleeding or spotting was more common in the LNG-IUS treatment group (Peto OR 7.26, 95% CI 3.37 to 15.66, 3 studies, n = 376, I² = 0%, moderate quality evidence). By 24 months of follow-up, abnormal vaginal bleeding or spotting occurred less frequently compared to 12 months of follow-up in the LNG-IUS treatment group but was still more common than the control group (Peto OR 2.72, 95% CI 1.04 to 7.10, 2 studies, n = 233, I² = 0%, moderate quality evidence). By 60 months of follow-up, no cases of abnormal vaginal bleeding or spotting were reported in either group. The numbers of events for the following outcomes were low: fibroids (n = 13), breast cancer recurrence (n = 18), and breast cancer-related deaths (n = 16). There was no evidence of a difference between the LNG-IUS treatment group and controls for these outcomes. The quality of the evidence was judged as moderate, due to limited sample sizes and low event rates for the outcome comparisons. The LNG-IUS reduces the incidence of benign endometrial polyps and endometrial hyperplasia in women with breast cancer taking tamoxifen. At 12 and 24 months of follow-up, the LNG-IUS increased abnormal vaginal bleeding or spotting among women in the treatment group compared to those in the control. There is no clear evidence from the available randomised controlled trials that the LNG-IUS prevents endometrial cancer in these women. There is no clear evidence from the available randomised controlled trials that the LNG-IUS affects the risk of breast cancer recurrence or breast cancer-related deaths. Larger studies are necessary to assess the effects of the LNG-IUS on the incidence of endometrial cancer, and to determine whether the LNG-IUS might have an impact on the risk of secondary breast cancer events. | We included four randomised controlled trials involving 543 women. The studies took place in the United Kingdom, Turkey, Egypt and Hong Kong, and the primary outcome in all studies was abnormal changes in the lining of the uterus. Three studies reported on the outcome of fibroids. Three studies reported on abnormal vaginal bleeding or spotting. Two studies reported on the outcomes of breast cancer recurrence, and three studies reported on the outcomes of breast cancer-related death. The evidence is current to October 2015. This review suggests that the LNG-IUS can reduce the risk of endometrial polyps and endometrial hyperplasia over a long-term follow-up period (24 to 60 months) in women taking tamoxifen following breast cancer. At 12 and 24 months of follow-up, more women in the LNG-IUS group experienced abnormal vaginal bleeding or spotting. However by 60 months of follow-up, no abnormal vaginal bleeding or spotting was reported in either group. There were insufficient data to show whether there is any effect on incidence of endometrial cancer (a cancer originating in glandular tissue), fibroids, breast cancer recurrence, or breast cancer-related death. The quality of the evidence was judged as moderate, due to limited sample sizes and low event rates for the outcome comparisons. Larger studies are necessary to assess the effects of the LNG-IUS on the incidence of endometrial cancer, and the impact of the LNG-IUS on the risk of secondary breast cancer events. | 10.1002/14651858.CD007245.pub3 | [
"We included four randomised controlled trials involving 543 women. The studies took place in the United Kingdom, Turkey, Egypt and Hong Kong, and the primary outcome in all studies was abnormal changes in the lining of the uterus. Three studies reported on the outcome of fibroids. Three studies reported on abnormal vaginal bleeding or spotting. Two studies reported on the outcomes of breast cancer recurrence, and three studies reported on the outcomes of breast cancer-related death. The evidence is current to October 2015. This review suggests that the LNG-IUS can reduce the risk of endometrial polyps and endometrial hyperplasia over a long-term follow-up period (24 to 60 months) in women taking tamoxifen following breast cancer. At 12 and 24 months of follow-up, more women in the LNG-IUS group experienced abnormal vaginal bleeding or spotting. However by 60 months of follow-up, no abnormal vaginal bleeding or spotting was reported in either group. There were insufficient data to show whether there is any effect on incidence of endometrial cancer (a cancer originating in glandular tissue), fibroids, breast cancer recurrence, or breast cancer-related death. The quality of the evidence was judged as moderate, due to limited sample sizes and low event rates for the outcome comparisons. Larger studies are necessary to assess the effects of the LNG-IUS on the incidence of endometrial cancer, and the impact of the LNG-IUS on the risk of secondary breast cancer events."
]
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cochrane-simplification-train-1722 | cochrane-simplification-train-1722 | For the first comparison, five studies met the inclusion criteria. Community-based antibiotic delivery for neonatal PSBI reduced neonatal mortality when compared to hospital referral only (typical risk ratio (RR) 0.82, 95% confidence interval (CI) 0.68 to 0.99; 5 studies, n = 125,134; low-quality evidence). There was, however, a high level of statistical heterogeneity (I² = 87%) likely, due to the heterogenous nature of the study settings as well as the fact that four of the studies provided various co-interventions in conjunction with community-based antibiotics. Community-based antibiotic delivery for neonatal PSBI showed a possible effect on reducing sepsis-specific neonatal mortality (typical RR 0.78, 95% CI 0.60 to 1.00; 2 studies, n = 40,233; low-quality evidence). For the second comparison, five studies met the inclusion criteria. Using a simplified antibiotic approach resulted in similar rates of neonatal mortality when compared to the standard regimen of seven days of injectable procaine benzylpenicillin and injectable procaine benzylpenicillin and injectable gentamicin delivered in community-settings for neonatal PSBI (typical RR 0.81, 95% CI 0.44 to 1.50; 3 studies, n = 3476; moderate-quality evidence). In subgroup analysis, the simplified antibiotic regimen of seven days of oral amoxicillin and injectable gentamicin showed no difference in neonatal mortality (typical RR 0.84, 95% CI 0.47 to 1.51; 3 studies, n = 2001; moderate-quality evidence). Two days of injectable benzylpenicillin and injectable gentamicin followed by five days of oral amoxicillin showed no difference in neonatal mortality (typical RR 0.88, 95% CI 0.29 to 2.65; 3 studies, n = 2036; low-quality evidence). Two days of injectable gentamicin and oral amoxicillin followed by five days of oral amoxicillin showed no difference in neonatal mortality (RR 0.67, 95% CI 0.24 to 1.85; 1 study, n = 893; moderate-quality evidence). For fast breathing alone, seven days of oral amoxicillin resulted in no difference in neonatal mortality (RR 0.99, 95% CI 0.20 to 4.91; 1 study, n = 1406; low-quality evidence). None of the studies in the second comparison reported the effect of a simplified antibiotic regimen on sepsis-specific neonatal mortality. Low-quality data demonstrated that community-based antibiotics reduced neonatal mortality when compared to the standard hospital referral for neonatal PSBI in resource-limited settings. The use of co-interventions, however, prevent disentanglement of the contribution from community-based antibiotics. Moderate-quality evidence showed that simplified, community-based treatment of PSBI using regimens which rely on the combination of oral and injectable antibiotics did not result in increased neonatal mortality when compared to the standard treatment of using only injectable antibiotics. Overall, the evidence suggests that simplified, community-based antibiotics may be efficacious to treat neonatal PSBI when hospitalisation is not feasible. However, implementation research is recommended to study the effectiveness and scale-up of simplified, community-based antibiotics in resource-limited settings. | We searched medical databases and found two types of studies that addressed our review question. One group of five trials studied communities in which sick newborns were offered antibiotics in the home or ambulatory clinics and compared them to communities in which sick newborns received only the standard referral to a hospital. The second group of five trials treated sick newborns in the home or clinic with either the intravenous antibiotics that are typically administered in the hospital or with simpler antibiotic regimens that relied more on oral antibiotics. The trials were conducted in a variety of countries within sub-Saharan Africa and South Asia. The evidence is up to date as of 16 April 2018. There is reduced risk of newborn death when sick newborns are given antibiotics in the home or clinic compared to sick newborns who are only referred to a hospital, but this result is based on low-quality evidence. In addition, the majority of the studies that examined home- or clinic-based antibiotics included other interventions, such as improved care at birth, that may have influenced the findings. Moderate-quality evidence showed that antibiotic regimens that involve fewer injections and can be administered in the home or clinic do not result in more newborn deaths when compared to the typically administered antibiotic regimens that rely solely on injections. Based on this result, simpler antibiotic regimens delivered in the home or clinic may be considered as an alternative treatment for sick newborns that cannot access a hospital. However, it is important to remember that the studies were conducted under ideal conditions with a high level of patient monitoring. Additional research in real-world settings with limited resources are recommended to determine if the results hold true. The quality of evidence ranged from low to moderate quality. | 10.1002/14651858.CD007646.pub3 | [
"We searched medical databases and found two types of studies that addressed our review question. One group of five trials studied communities in which sick newborns were offered antibiotics in the home or ambulatory clinics and compared them to communities in which sick newborns received only the standard referral to a hospital. The second group of five trials treated sick newborns in the home or clinic with either the intravenous antibiotics that are typically administered in the hospital or with simpler antibiotic regimens that relied more on oral antibiotics. The trials were conducted in a variety of countries within sub-Saharan Africa and South Asia. The evidence is up to date as of 16 April 2018. There is reduced risk of newborn death when sick newborns are given antibiotics in the home or clinic compared to sick newborns who are only referred to a hospital, but this result is based on low-quality evidence. In addition, the majority of the studies that examined home- or clinic-based antibiotics included other interventions, such as improved care at birth, that may have influenced the findings. Moderate-quality evidence showed that antibiotic regimens that involve fewer injections and can be administered in the home or clinic do not result in more newborn deaths when compared to the typically administered antibiotic regimens that rely solely on injections. Based on this result, simpler antibiotic regimens delivered in the home or clinic may be considered as an alternative treatment for sick newborns that cannot access a hospital. However, it is important to remember that the studies were conducted under ideal conditions with a high level of patient monitoring. Additional research in real-world settings with limited resources are recommended to determine if the results hold true. The quality of evidence ranged from low to moderate quality."
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cochrane-simplification-train-1723 | cochrane-simplification-train-1723 | We identified 22 RCTs and two quasi-RCTs evaluating the effectiveness of group-based parenting programmes in improving the emotional and behavioural adjustment of children aged up to three years and 11 months (maximum mean age three years 11 months). The total number of participants in the studies were 3161 parents and their young children. Eight studies were conducted in the USA, five in the UK, four in Canada, five in Australia, one in Mexico, and one in Peru. All of the included studies were of behavioural, cognitive-behavioural or videotape modelling parenting programmes. We judged 50% (or more) of the included studies to be at low risk for selection bias, detection bias (observer-reported outcomes), attrition bias, selective reporting bias, and other bias. As it is not possible to blind participants and personnel to the type of intervention in these trials, we judged all studies to have high risk of performance bias. Also, there was a high risk of detection bias in the 20 studies that included parent-reported outcomes. The results provide evidence that group-based parenting programmes reduce overall emotional and behavioural problems (SMD -0.81, 95% CI -1.37 to -0.25; 5 studies, 280 participants, low quality evidence) based on total parent-reported data assessed at postintervention. This result was not, however, maintained when two quasi-RCTs were removed as part of a sensitivity analysis (SMD -0.67, 95% CI -1.43 to 0.09; 3 studies, 221 participants). The results of data from subscales show evidence of reduced total externalising problems (SMD -0.23, 95% CI -0.46 to -0.01; 8 studies, 989 participants, moderate quality evidence). Single study results show very low quality evidence of reductions in externalising problems hyperactivity-inattention subscale (SMD -1.34; 95% CI -2.37 to -0.31; 19 participants), low quality evidence of no effect on total internalising problems (SMD 0.34; 95% CI -0.12 to 0.81; 73 participants), and very low quality evidence of an increase in social skills (SMD 3.59; 95% CI 2.42 to 4.76; 32 participants), based on parent-reported data assessed at postintervention. Results for secondary outcomes, which were also measured using subscales, show an impact on parent-child interaction in terms of reduced negative behaviour (SMD -0.22, 95% CI -0.39 to -0.06; 7 studies, 941 participants, moderate quality evidence), and improved positive behaviour (SMD 0.48, 95% CI 0.17 to 0.79; 4 studies, 173 participants, moderate quality evidence) as rated by independent observers postintervention. No further meta-analyses were possible. Results of subgroup analyses show no evidence for treatment duration (seven weeks or less versus more than eight weeks) and inconclusive evidence for prevention versus treatment interventions. The findings of this review, which relate to the broad group of universal and at-risk (targeted) children and parents, provide tentative support for the use of group-based parenting programmes to improve the overall emotional and behavioural adjustment of children with a maximum mean age of three years and 11 months, in the short-term. There is, however, a need for more research regarding the role that these programmes might play in the primary prevention of both emotional and behavioural problems, and their long-term effectiveness. | We searched the scientific literature for all randomised controlled trials (RCTs) and quasi-RCTs published up to July 2015. RCTs are studies in which people are randomly allocated to treatment groups. Quasi-RCTs are studies in which people receive treatment based on methods that are not strictly random such as date of birth, or their hospital record number, and the results of quasi-RCTs are generally considered less trustworthy than those of RCTs. We found 24 trials (22 RCTs and two quasi-RCTs) to include in our review. These studies included, in total, information from 3161 parents and their young children. Eight studies had been carried out in the USA, five in the UK, four in Canada, five in Australia, one in Mexico, and one in Peru. All of the studies looked at behavioural, cognitive-behavioural or videotape modelling parenting programmes. Behavioural programmes are aimed at helping parents develop methods that will reduce bad behaviour, usually with the use of techniques such as praise or rewards. It also aims to help parents set limits that make sense. Cognitive-behavioral skills allow parents think about behaviour patterns and focus on solutions. Programmes can use a variety of techniques; for example, videotape modelling programmes enable parents to learn by watching videotaped films of other parents implementing some of the techniques described above. Some of the studies we found included people chosen specially because they were ‘at risk’ of behavioural problems, while others included parents and children without any specific risks. When we put all of the studies together, overall, we found that group-based parenting programmes can improve the emotional and behavioural development of young children, although the quality of the evidence was, on the whole, low. Furthermore, our findings were not convincing when we removed two studies that used quasi-randomised methods. Our findings also showed evidence of an improvement in externalising problems (these might include negative behaviours in children or young people that are directed towards the external environment such as anger, aggression or conflict with the law). However, the evidence for this, once again, came from studies that we rated as being of only moderate quality, and was only found for some parts of the outcome measure (known as a subscale). Results from single studies that could not be combined with other studies and that were of poor quality, on the whole, showed no impact on children’s internalising problems (e.g. depression and anxiety). However, there was some improvement on one subscale of a measure that focused on children’s hyperactivity-inattention and another subscale that focused on social skills. There was moderate-quality evidence that group-based parenting programmes also improve the way in which parents and children interact, as measured by fewer negative behaviours. Our reasons for rating the quality of the evidence as low or moderate included: inconsistency in the findings from different studies (different studies yielded different results); unclear risk of bias (where it was not possible for us to assess the ways in which the included studies might be biased due to inadequate information); and small numbers of parents in the included studies. We believe more research is needed to be able to reach a firm conclusion about whether the effects we have found are short term only or whether they continue over time and therefore may be able to prevent future behavioural problems. | 10.1002/14651858.CD003680.pub3 | [
"We searched the scientific literature for all randomised controlled trials (RCTs) and quasi-RCTs published up to July 2015. RCTs are studies in which people are randomly allocated to treatment groups. Quasi-RCTs are studies in which people receive treatment based on methods that are not strictly random such as date of birth, or their hospital record number, and the results of quasi-RCTs are generally considered less trustworthy than those of RCTs. We found 24 trials (22 RCTs and two quasi-RCTs) to include in our review. These studies included, in total, information from 3161 parents and their young children. Eight studies had been carried out in the USA, five in the UK, four in Canada, five in Australia, one in Mexico, and one in Peru. All of the studies looked at behavioural, cognitive-behavioural or videotape modelling parenting programmes. Behavioural programmes are aimed at helping parents develop methods that will reduce bad behaviour, usually with the use of techniques such as praise or rewards. It also aims to help parents set limits that make sense. Cognitive-behavioral skills allow parents think about behaviour patterns and focus on solutions. Programmes can use a variety of techniques; for example, videotape modelling programmes enable parents to learn by watching videotaped films of other parents implementing some of the techniques described above. Some of the studies we found included people chosen specially because they were ‘at risk’ of behavioural problems, while others included parents and children without any specific risks. When we put all of the studies together, overall, we found that group-based parenting programmes can improve the emotional and behavioural development of young children, although the quality of the evidence was, on the whole, low. Furthermore, our findings were not convincing when we removed two studies that used quasi-randomised methods. Our findings also showed evidence of an improvement in externalising problems (these might include negative behaviours in children or young people that are directed towards the external environment such as anger, aggression or conflict with the law). However, the evidence for this, once again, came from studies that we rated as being of only moderate quality, and was only found for some parts of the outcome measure (known as a subscale). Results from single studies that could not be combined with other studies and that were of poor quality, on the whole, showed no impact on children’s internalising problems (e.g. depression and anxiety). However, there was some improvement on one subscale of a measure that focused on children’s hyperactivity-inattention and another subscale that focused on social skills. There was moderate-quality evidence that group-based parenting programmes also improve the way in which parents and children interact, as measured by fewer negative behaviours. Our reasons for rating the quality of the evidence as low or moderate included: inconsistency in the findings from different studies (different studies yielded different results); unclear risk of bias (where it was not possible for us to assess the ways in which the included studies might be biased due to inadequate information); and small numbers of parents in the included studies. We believe more research is needed to be able to reach a firm conclusion about whether the effects we have found are short term only or whether they continue over time and therefore may be able to prevent future behavioural problems."
]
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cochrane-simplification-train-1724 | cochrane-simplification-train-1724 | For this update, four trials with a combined total of 3314 participants fulfilled the inclusion criteria. Two trials compared surveillance with immediate open repair; two trials compared surveillance with immediate endovascular repair. Overall, the risk of bias within the included studies was low and the quality of the evidence high. The four trials showed an early survival benefit in the surveillance group (due to 30-day operative mortality with surgery) but no significant differences in long-term survival (adjusted HR 0.88, 95% confidence interval (CI) 0.75 to 1.02, mean follow-up 10 years; HR 1.21, 95% CI 0.95 to 1.54, mean follow-up 4.9 years; HR 0.76, 95% CI 0.30 to 1.93, median follow-up 32.4 months; HR 1.01, 95% CI 0.49 to 2.07, mean follow-up 20 months). A pooled analysis of participant-level data from two trials (with a maximum follow-up of seven to eight years) showed no statistically significant difference in survival between immediate open repair and surveillance (propensity score-adjusted HR 0.99; 95% CI 0.83 to 1.18), and that this lack of treatment effect did not vary by AAA diameter (P = 0.39) or participant age (P = 0.61). The meta-analysis of mortality at one year for the endovascular trials likewise showed no significant association (RR at one year 1.15, 95% CI 0.60 to 2.17). Quality-of-life results among trials were conflicting. The results from the four trials to date demonstrate no advantage to immediate repair for small AAA (4.0 cm to 5.5 cm), regardless of whether open or endovascular repair is used and, at least for open repair, regardless of patient age and AAA diameter. Thus, neither immediate open nor immediate endovascular repair of small AAAs is supported by currently available evidence. | Small asymptomatic AAAs are at low risk of rupture and are monitored through regular imaging so they can be surgically repaired if they subsequently enlarge. This review identified four well-conducted, controlled trials that randomised 3314 participants with small (diameter 4.0 cm to 5.5 cm) asymptomatic AAAs to immediate repair or regular, routine ultrasounds to check for aneurysm growth (surveillance). Among the patients randomised to surveillance, the aneurysm was repaired if it was enlarging, reached 5.5 cm in diameter, or became symptomatic. The four trials showed an early survival benefit in the surveillance group because of the number of deaths within 30 days of surgery (operative mortality). The trials did not show a meaningful difference in long-term survival between immediate repair and selective surveillance over the three to eight years of follow-up. Some 31% to 75% of the participants randomised to surveillance eventually had the aneurysm repaired. Overall, the risk of bias within the included studies was low and the quality of the evidence high. The results from the four trials conducted to date suggest no overall advantage to immediate surgery for small AAAs (4.0 cm to 5.5 cm). A pooled analysis of the two trials comparing immediate open surgical repair to surveillance demonstrated that this result holds true regardless of patient age or aneurysm size (within the range of 4.0 cm to 5.5 cm diameter). Furthermore, the more recent trials, which focused on the efficacy of endovascular repair, also failed to show a benefit over surveillance. Quality-of-life results among trials were conflicting. Thus, neither immediate open nor immediate endovascular repair of small AAAs is supported by the current evidence. | 10.1002/14651858.CD001835.pub4 | [
"Small asymptomatic AAAs are at low risk of rupture and are monitored through regular imaging so they can be surgically repaired if they subsequently enlarge. This review identified four well-conducted, controlled trials that randomised 3314 participants with small (diameter 4.0 cm to 5.5 cm) asymptomatic AAAs to immediate repair or regular, routine ultrasounds to check for aneurysm growth (surveillance). Among the patients randomised to surveillance, the aneurysm was repaired if it was enlarging, reached 5.5 cm in diameter, or became symptomatic. The four trials showed an early survival benefit in the surveillance group because of the number of deaths within 30 days of surgery (operative mortality). The trials did not show a meaningful difference in long-term survival between immediate repair and selective surveillance over the three to eight years of follow-up. Some 31% to 75% of the participants randomised to surveillance eventually had the aneurysm repaired. Overall, the risk of bias within the included studies was low and the quality of the evidence high. The results from the four trials conducted to date suggest no overall advantage to immediate surgery for small AAAs (4.0 cm to 5.5 cm). A pooled analysis of the two trials comparing immediate open surgical repair to surveillance demonstrated that this result holds true regardless of patient age or aneurysm size (within the range of 4.0 cm to 5.5 cm diameter). Furthermore, the more recent trials, which focused on the efficacy of endovascular repair, also failed to show a benefit over surveillance. Quality-of-life results among trials were conflicting. Thus, neither immediate open nor immediate endovascular repair of small AAAs is supported by the current evidence."
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cochrane-simplification-train-1725 | cochrane-simplification-train-1725 | Four studies randomly assigning 9130 people with asthma were included; two were six-month double-blind studies, and two were 12-month open-label studies. No trials included children younger than age 12. Trials included more women than men, with mean age ranging from 38 to 45, and mean baseline steroid dose (inhaled beclomethasone (BDP) equivalent) from 636 to 888 μg. Mean baseline forced expiratory volume in one second (FEV1) percentage predicted was between 70% and 73% in three of the trials, and 96% in another. All studies were funded by AstraZeneca and were generally free from methodological biases, although the two open-label studies were rated as having high risk for blinding, and some evidence of selective outcome reporting was found. These possible sources of bias did not lead us to downgrade the quality of the evidence. The quantity of inhaled steroids, including puffs taken for relief from symptoms, was consistently lower for SiT than for the comparison groups. Separate data for exacerbations leading to hospitalisations, to emergency room (ER) visits or to a course of oral steroids could not be obtained. Compared with higher fixed-dose combination inhalers, fewer people using SiT had exacerbations requiring hospitalisation or a visit to the ER (odds ratio (OR) 0.72, 95% confidence interval (CI) 0.57 to 0.90; I2 = 0%, P = 0.66), and fewer had exacerbations requiring a course of oral corticosteroids (OR 0.75, 95% CI 0.65 to 0.87; I2 = 0%, P = 0.82). This translates to one less person admitted to hospital or visiting the ER (95% CI 0 to 2 fewer) and two fewer people needing oral steroids (95% CI 1 to 3 fewer) compared with fixed-dose combination treatment with a short-acting beta-agonist (SABA) reliever (per 100 treated over eight months). No statistical heterogeneity was observed in either outcome, and the evidence was rated of high quality. Although issues with blinding were evident in two of the studies, and one study recruited a less severe population, sensitivity analyses did not change the main results, so quality was not downgraded. We could not rule out the possibility that SiT increased rates of serious adverse events (OR 0.92, 95% CI 0.74 to 1.13; I2 = 0%, P = 0.98; moderate-quality evidence, downgraded owing to imprecision). We were unable to say whether SiT improved results for several secondary outcomes (morning and evening peak expiratory flow (PEF), rescue medication use, symptoms scales), and in cases where results were significant, the effect sizes were not considered clinically meaningful (predose FEV1, nocturnal awakenings and quality of life). SiT reduces the number of people having asthma exacerbations requiring oral steroids and the number requiring hospitalisation or an ER visit compared with fixed-dose combination inhalers. Evidence for serious adverse events was unclear. The mean daily dose of inhaled corticosteroids (ICS) in SiT, including the total dose administered with reliever use, was always lower than that of the other combination groups. This suggests that the flexibility in steroid administration that is possible with SiT might be more effective than a standard fixed-dose combination by increasing the dose only when needed and keeping it low during stable stages of the disease. Data for hospitalisations alone could not be obtained, and no studies have yet addressed this question in children younger than age 12. | Four studies including 9130 adults and adolescents were included. None of the studies included children younger than age 12. The studies lasted for six months to a year, and all were funded by one drug company. Studies included more women than men, with average age of about 40. Three studies recruited people with quite similar symptoms, but one study included people with less severe asthma. The studies were well conducted, although two did not hide which treatments were being taken (known as blinding), which might have affected the results. The amount of inhaled steroids, including puffs taken for relief from symptoms, was consistently lower for SiT than for the comparison groups using two types of inhalers. Overall, we believe that the quality of the evidence was high to moderate. Fewer people taking SiT had flare-ups that needed a hospital stay or a visit to the ER (one fewer per 100 treated than in the control group, 95% CI 0 to 2 fewer) or a course of oral steroids (two fewer per 100 treated, 95% CI one to three fewer). If more studies are published, it is unlikely that our opinions on these main findings will change. However, we could not tell whether one treatment caused more serious adverse events than the other. SiT had a small benefit on one measure of lung function (predose forced expiratory volume in one second (FEV1)). However, for several other measures, not enough information was available to show which treatment was better (amount of medication taken on an 'as needed' basis, various symptom measures and quality of life). In conclusion, SiT reduces the need for a hospital stay or an ER visit and for courses of oral steroids for asthma flare-ups. SiT did not increase the quantity of inhaled steroids taken overall, and it was unclear whether it increases or decreases serious side effects. Currently no data are available for the use of SiT in children younger than age 12. | 10.1002/14651858.CD009019.pub2 | [
"Four studies including 9130 adults and adolescents were included. None of the studies included children younger than age 12. The studies lasted for six months to a year, and all were funded by one drug company. Studies included more women than men, with average age of about 40. Three studies recruited people with quite similar symptoms, but one study included people with less severe asthma. The studies were well conducted, although two did not hide which treatments were being taken (known as blinding), which might have affected the results. The amount of inhaled steroids, including puffs taken for relief from symptoms, was consistently lower for SiT than for the comparison groups using two types of inhalers. Overall, we believe that the quality of the evidence was high to moderate. Fewer people taking SiT had flare-ups that needed a hospital stay or a visit to the ER (one fewer per 100 treated than in the control group, 95% CI 0 to 2 fewer) or a course of oral steroids (two fewer per 100 treated, 95% CI one to three fewer). If more studies are published, it is unlikely that our opinions on these main findings will change. However, we could not tell whether one treatment caused more serious adverse events than the other. SiT had a small benefit on one measure of lung function (predose forced expiratory volume in one second (FEV1)). However, for several other measures, not enough information was available to show which treatment was better (amount of medication taken on an 'as needed' basis, various symptom measures and quality of life). In conclusion, SiT reduces the need for a hospital stay or an ER visit and for courses of oral steroids for asthma flare-ups. SiT did not increase the quantity of inhaled steroids taken overall, and it was unclear whether it increases or decreases serious side effects. Currently no data are available for the use of SiT in children younger than age 12."
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cochrane-simplification-train-1726 | cochrane-simplification-train-1726 | No RCTs or quasi-RCTs were identified. There were 40 longitudinal cohort studies providing data on 63,887 participants; 43,209 (68%) who were referred early and 20,678 (32%) referred late. Comparative mortality was higher in patients referred to specialist services late versus those referred early. Risk ratios (RR) for mortality reductions in patients referred early were evident at three months (RR 0.61, 95% CI 0.55 to 0.67; I² = 84%) and remained at five years (RR 0.66, 95% CI 0.60 to 0.71; I² = 87%). Initial hospitalisation was 9.12 days shorter with early referral (95% CI -10.92 to -7.32 days; I² = 82%) compared to late referral. Pooled analysis showed patients referred early were more likely than late referrals to initiate RRT with peritoneal dialysis (RR 1.74, 95% CI 1.64 to 1.84; I² = 92%). Patients referred early were less likely to receive temporary vascular access (RR 0.47, 95% CL 0.45 to 0.50; I² = 97%) than those referred late. Patients referred early were more likely to receive permanent vascular access (RR 3.22, 95% CI 2.92 to 3.55; I² = 97%). Systolic blood pressure (BP) was significantly lower in early versus late referrals (MD -3.09 mm Hg, 95% CI -5.23 to -0.95; I² = 85%); diastolic BP was significantly lower in early versus late referrals (MD -1.64 mm Hg, 95% CI -2.77 to -0.51; I² = 82%). EPO use was significantly higher in those referred early (RR 2.92, 95% CI 2.42 to 3.52; I² = 0%). eGFR was higher in early referrals (MD 0.42 mL/min/1.73 m², 95% CI 0.28 to 0.56; I² = 95%). Diabetes prevalence was similar in patients referred early and late (RR 1.05, 95% CI 0.96 to 1.15; I² = 87%) as was ischaemic heart disease (RR 1.05, 95% CI 0.97 to 1.13; I² = 74%), peripheral vascular disease (RR 0.99, 95% CI 0.84 to 1.17; I² = 90%), and congestive heart failure (RR 1.00, 95% CI 0.86 to 1.15; I² = 92%). Inability to walk was less prevalent in early referrals (RR 0.66, 95% CI 0.51 to 0.86). Prevalence of chronic obstructive pulmonary disease was similar in those referred early and late (RR 0.89, 95% CI 0.70 to 1.14; I² = 94%) as was cerebrovascular disease (RR 0.90, 95% CI 0.74 to 1.11; I² = 83%). The quality of the included studies was assessed as being low to moderate based on the Newcastle-Ottawa Scale. Slight differences in the definition of early versus late referral infer some risk of bias. Generally, heterogeneity in most of the analyses was high. Our analysis showed reduced mortality and mortality and hospitalisation, better uptake of peritoneal dialysis and earlier placement of arteriovenous fistulae for patients with chronic kidney disease who were referred early to a nephrologist. Differences in mortality and hospitalisation data between the two groups were not explained by differences in prevalence of comorbid disease or serum phosphate. However, early referral was associated with better preparation and placement of dialysis access. | Our analyses of 40 studies of people with chronic kidney disease shows that people referred earlier to a specialist kidney doctor lived longer. Death rates in people referred early were about half of those referred late and these benefits were seen as early as three months and lasted for at least five years. People referred early also spent less time in hospital and were better prepared for dialysis. Dialysis first requires surgical placement of a fistula and early referral to specialist services often means better preparation, a lower risk of infection and other complications. We did not discover any adverse effects from early specialist referral. Randomised controlled trials provide the most reliable information of all study designs, so it should be noted that all 40 studies analysed for this review used a cohort design. Cohort studies are the next best level of evidence and the only available evidence. For ethical reasons it is unlikely that a randomised controlled trial that deliberately assigns patients to late specialist referral will ever be conducted. | 10.1002/14651858.CD007333.pub2 | [
"Our analyses of 40 studies of people with chronic kidney disease shows that people referred earlier to a specialist kidney doctor lived longer. Death rates in people referred early were about half of those referred late and these benefits were seen as early as three months and lasted for at least five years. People referred early also spent less time in hospital and were better prepared for dialysis. Dialysis first requires surgical placement of a fistula and early referral to specialist services often means better preparation, a lower risk of infection and other complications. We did not discover any adverse effects from early specialist referral. Randomised controlled trials provide the most reliable information of all study designs, so it should be noted that all 40 studies analysed for this review used a cohort design. Cohort studies are the next best level of evidence and the only available evidence. For ethical reasons it is unlikely that a randomised controlled trial that deliberately assigns patients to late specialist referral will ever be conducted."
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cochrane-simplification-train-1727 | cochrane-simplification-train-1727 | Nine studies involving 751 participants were included. Two of them produced effect sizes which showed a consistent and statistically significant difference in favour of the active drug. Combining all studies produced a pooled estimate of effect of 0.39 standard deviations (confidence interval, 0.24 to 0.54) in favour of the antidepressant measured by improvement in mood. There was high heterogeneity due to one strongly positive trial. Sensitivity analysis omitting this trial reduced the pooled effect to 0.17 (0.00 to 0.34). The pooled effect for inpatient and outpatient trials was highly sensitive to decisions about which combination of data was included but inpatient trials produced the lowest effects. The more conservative estimates from the present analysis found that differences between antidepressants and active placebos were small. This suggests that unblinding effects may inflate the efficacy of antidepressants in trials using inert placebos. Further research into unblinding is warranted. | This review examined trials which compared antidepressants with 'active' placebos, that is placebos containing active substances which mimic side effects of antidepressants. Small differences were found in favour of antidepressants in terms of improvements in mood. This suggests that the effects of antidepressants may generally be overestimated and their placebo effects may be underestimated. | 10.1002/14651858.CD003012.pub2 | [
"This review examined trials which compared antidepressants with 'active' placebos, that is placebos containing active substances which mimic side effects of antidepressants. Small differences were found in favour of antidepressants in terms of improvements in mood. This suggests that the effects of antidepressants may generally be overestimated and their placebo effects may be underestimated."
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cochrane-simplification-train-1728 | cochrane-simplification-train-1728 | Five trials including 391 children aged three to 18 years met our criteria. Two studies (117 children) compared anaesthetic ear drops versus placebo immediately at diagnosis. All children received some form of oral pain relief. In all five studies it was clear that ear pain diminishes rapidly for most sufferers. Nevertheless there was a statistically significant difference in the proportion of children achieving a 50% reduction in pain in favour of anaesthetic drops 10 minutes after instillation (risk ratio (RR) 2.13, 95% confidence interval (CI) 1.19 to 3.80) and 30 minutes after instillation (RR 1.43, 95% CI 1.12 to 1.81) on the day AOM was diagnosed but not at 20 minutes (RR 1.24, 95% CI 0.88 to 1.74). Three trials (274 children) compared anaesthetic ear drops with naturopathic herbal ear drops. Naturopathic drops were favoured 15 and 30 minutes after instillation, one to three days after diagnosis, but the differences were not statistically significant. Only one trial looked at adverse reactions and found none. Overall the findings of this review are based on trial evidence that is at low or unclear risk of bias. Evidence from five RCTs, only two of which addressed the most relevant question of primary effectiveness, provides limited evidence that ear drops are effective 30 minutes after administration in older children with AOM. Uncertainty exists as to the magnitude of this effect and more high-quality studies are needed. | Children in all the trials experienced a rapid, short-term reduction in pain after using ear drops. It is hard to know if this was the result of the natural course of the illness; the placebo effect of receiving treatment; the soothing effect of any liquid in the ear or the pharmacological effects of the ear drops themselves. Nevertheless, there is some evidence that when combined with oral pain medication, anaesthetic ear drops may help to relieve pain more rapidly in children aged three to 18 years. More good-quality trials are needed. | 10.1002/14651858.CD005657.pub2 | [
"Children in all the trials experienced a rapid, short-term reduction in pain after using ear drops. It is hard to know if this was the result of the natural course of the illness; the placebo effect of receiving treatment; the soothing effect of any liquid in the ear or the pharmacological effects of the ear drops themselves. Nevertheless, there is some evidence that when combined with oral pain medication, anaesthetic ear drops may help to relieve pain more rapidly in children aged three to 18 years. More good-quality trials are needed."
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cochrane-simplification-train-1729 | cochrane-simplification-train-1729 | We included two studies in this review, which were both assessed as being at high risk of bias. The two studies, involving a total of 111 participants, compared the use of Tooth Masseuse and OrthoAccel with conventional treatment mechanics during orthodontic alignment and canine retraction phases, respectively. Both studies included objective assessment of the amount or rate of tooth movement, but we were not able to meta-analyse this data as they used different outcome measurements at different stages of the orthodontic treatment process. One study measured subjective evaluation of pain and discomfort and the other evaluated adverse effects. The studies did not directly report either the duration of orthodontic treatment or the number of visits during active treatment. Using the Tooth Masseuse with 111 Hz at 0.06 Newtons (N) for 20 minutes daily resulted in greater reduction in irregularity in the lower incisor region over 10 weeks, assessed using Little's Irregularity Index (LII) with a mean difference (MD) of 0.6 mm (95% confidence interval (CI) -0.94 to 2.34) when compared to the control group. Pain and discomfort increased at six to eight hours after arch wire placement and after seven days, with minimal difference between the intervention and control groups. No statistical tests were provided for either variable and the differences between the two groups were not clinically important. Using OrthoAccel with 30 Hz at 0.25 N for 20 minutes daily produced a higher rate of maxillary canine distalisation in comparison to the control group (MD 0.37 mm/month; 95% CI -0.07 to 0.81; P = 0.05). Whilst this difference suggested 50% faster tooth movement using the vibrational appliance, the absolute differences were marginal and deemed clinically unimportant. Similar levels of non-serious adverse effects were reported in the intervention and control groups with a risk ratio of 0.96 (95% CI 0.32 to 2.85). Overall, the quality of the evidence was very low and therefore we cannot rely on the findings. There is very little clinical research concerning the effectiveness of non-surgical interventions to accelerate orthodontic treatment. The available evidence is of very low quality and so it is not possible to determine if there is a positive effect of non-surgical adjunctive interventions to accelerate tooth movement. Although there have been claims that there may be a positive effect of light vibrational forces, results of the current studies do not reach either statistical or clinical significance. Further well-designed and rigorous RCTs with longer follow-up periods are required to determine whether non-surgical interventions may result in a clinically important reduction in the duration of orthodontic treatment, without any adverse effects. | Authors for the Cochrane Oral Health Group carried out this review of existing studies. The evidence on which it is based is current up to 26 November 2014. We included two studies involving a total of 111 participants in this review. A single orthodontic specialist in a private practice in Australia carried out one study, while the other study was conducted on patients treated by orthodontic residents in a university hospital seating in the United States of America. In one study, the age of participants ranged from 11 to 15 years old, and in the second, the average age of participants was 21 years. The studies evaluated the additional use of two devices that use light vibrational forces - Tooth Masseuse in people receiving conventional fixed appliance treatment during the tooth alignment stage and OrthoAccel for those receiving conventional fixed appliance treatment for the space closure stage in orthodontic treatment. Participants receiving additional treatment with the devices were compared to those receiving only the conventional treatment. The trials evaluated different aspects of orthodontic tooth movement and side effects. The studies evaluated three outcomes: rate of tooth movement; patient perception of pain and discomfort, and unwanted side effects. There were substantial differences between the studies, which meant that we were unable to combine the results. From the limited evidence available, it is not possible to establish if the use of vibrational forces during treatment with fixed orthodontic appliances has a significant beneficial or harmful effect on either the rate of orthodontic tooth movement or the duration of treatment. The quality of evidence was very low. | 10.1002/14651858.CD010887.pub2 | [
"Authors for the Cochrane Oral Health Group carried out this review of existing studies. The evidence on which it is based is current up to 26 November 2014. We included two studies involving a total of 111 participants in this review. A single orthodontic specialist in a private practice in Australia carried out one study, while the other study was conducted on patients treated by orthodontic residents in a university hospital seating in the United States of America. In one study, the age of participants ranged from 11 to 15 years old, and in the second, the average age of participants was 21 years. The studies evaluated the additional use of two devices that use light vibrational forces - Tooth Masseuse in people receiving conventional fixed appliance treatment during the tooth alignment stage and OrthoAccel for those receiving conventional fixed appliance treatment for the space closure stage in orthodontic treatment. Participants receiving additional treatment with the devices were compared to those receiving only the conventional treatment. The trials evaluated different aspects of orthodontic tooth movement and side effects. The studies evaluated three outcomes: rate of tooth movement; patient perception of pain and discomfort, and unwanted side effects. There were substantial differences between the studies, which meant that we were unable to combine the results. From the limited evidence available, it is not possible to establish if the use of vibrational forces during treatment with fixed orthodontic appliances has a significant beneficial or harmful effect on either the rate of orthodontic tooth movement or the duration of treatment. The quality of evidence was very low."
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cochrane-simplification-train-1730 | cochrane-simplification-train-1730 | No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow-up, in general there is little information on the longer-term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well-tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review. | We first searched the literature in 2004 and most recently in September 2014, finding 6 studies in total. All studies included patients with heart attack and some also included patients with severe angina. The dose of hyperbaric oxygen was similar in most studies. Overall, we found some evidence that people with ACS are less likely to die or to have major adverse events, and to have more rapid relief from their pain if they receive hyperbaric oxygen therapy as part of their treatment. However, our conclusions are based on relatively small randomised trials. Our confidence in these findings is further reduced because in most of these studies both the patients and researchers were aware of who was receiving HBOT and it is possible a 'placebo effect' has biased the result in favour of HBOT. HBOT was generally well-tolerated. Some patients complained of claustrophobia when treated in small (single person) chambers and there was no evidence of important toxicity from oxygen breathing in any subject. One individual suffered damage to the eardrum from pressurisation. While HBOT may reduce the risk of dying, time to pain relief and the chance of adverse heart events in people with heart attack and unstable angina, more work is needed to be sure that HBOT should be recommended. | 10.1002/14651858.CD004818.pub4 | [
"We first searched the literature in 2004 and most recently in September 2014, finding 6 studies in total. All studies included patients with heart attack and some also included patients with severe angina. The dose of hyperbaric oxygen was similar in most studies. Overall, we found some evidence that people with ACS are less likely to die or to have major adverse events, and to have more rapid relief from their pain if they receive hyperbaric oxygen therapy as part of their treatment. However, our conclusions are based on relatively small randomised trials. Our confidence in these findings is further reduced because in most of these studies both the patients and researchers were aware of who was receiving HBOT and it is possible a 'placebo effect' has biased the result in favour of HBOT. HBOT was generally well-tolerated. Some patients complained of claustrophobia when treated in small (single person) chambers and there was no evidence of important toxicity from oxygen breathing in any subject. One individual suffered damage to the eardrum from pressurisation. While HBOT may reduce the risk of dying, time to pain relief and the chance of adverse heart events in people with heart attack and unstable angina, more work is needed to be sure that HBOT should be recommended."
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cochrane-simplification-train-1731 | cochrane-simplification-train-1731 | We included 77 studies with 5619 randomised participants. There was potential bias in most studies, with small size being the most common; individual treatment groups had fewer than 50 participants in 60 studies. Participants were relatively young, with mean age in the studies typically between 50 and 70 years. Multiple major problems with adverse event reporting were found, including failing to report adverse events in all participants who received medication, all adverse events experienced, how adverse events were collected, and not defining adverse event terminology or whether a reporting system was used. Direct measures of patient consciousness, patient appetite, or thirst were not apparent. For opioids used to treat cancer pain adverse event incidence rates were 25% for constipation, 23% for somnolence, 21% for nausea, 17% for dry mouth, and 13% for vomiting, anorexia, and dizziness. Asthenia, diarrhoea, insomnia, mood change, hallucinations and dehydration occurred at incidence rates of 5% and below. We found no direct evidence that opioids affected patient consciousness, appetite or thirst when used to treat cancer pain. However, somnolence, dry mouth, and anorexia were common adverse events in people with cancer pain treated with morphine, fentanyl, oxycodone, or codeine. We are aware that there is an important literature concerning the problems that exist with adverse event measurement, reporting, and attribution. Together with the known complications concerning concomitant medication, data collection and reporting, and nomenclature, this means that these adverse events cannot always be attributed unequivocally to the use of opioids, and so they provide only a broad picture of adverse events with opioids in cancer pain. The research agenda includes developing definitions for adverse events that have a spectrum of severity or importance, and the development of appropriate measurement tools for recording such events to aid clinical practice and clinical research. | This review identified 77 studies with over 5,000 people who received various treatments. The population in these trials was mainly aged between 50 and 70 years. Trial quality was generally poor; particular problems included small study size, and not reporting adverse events in all patients, or all recorded adverse events. Known problems with adverse event measurement, recording, and reporting made assessment even more difficult. For all four opioids together, 1 in 4 people experienced constipation and somnolence (sleepiness, drowsiness), 1 in 5 experienced nausea and dry mouth, and 1 in 8 experienced vomiting, loss of appetite, and dizziness. Weakness, diarrhoea, insomnia (difficulty in sleeping), mood change, hallucinations and dehydration occurred at rates of 1 in 20 people and below. These results may contribute to understanding the effects of opioids on consciousness, appetite, and thirst in end-of-life care in all patients deemed to be people who are dying. | 10.1002/14651858.CD011056.pub2 | [
"This review identified 77 studies with over 5,000 people who received various treatments. The population in these trials was mainly aged between 50 and 70 years. Trial quality was generally poor; particular problems included small study size, and not reporting adverse events in all patients, or all recorded adverse events. Known problems with adverse event measurement, recording, and reporting made assessment even more difficult. For all four opioids together, 1 in 4 people experienced constipation and somnolence (sleepiness, drowsiness), 1 in 5 experienced nausea and dry mouth, and 1 in 8 experienced vomiting, loss of appetite, and dizziness. Weakness, diarrhoea, insomnia (difficulty in sleeping), mood change, hallucinations and dehydration occurred at rates of 1 in 20 people and below. These results may contribute to understanding the effects of opioids on consciousness, appetite, and thirst in end-of-life care in all patients deemed to be people who are dying."
]
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cochrane-simplification-train-1732 | cochrane-simplification-train-1732 | One RCT and two non-randomised studies that allowed for multivariate analyses met the inclusion criteria and included a total of 141 women. One RCT found that neoadjuvant chemoradiation did not appear to offer longer survival compared to primary surgery in advanced vulval tumours (RR = 1.29, 95% confidence interval (CI) 0.87 to 1.91). There was also no statistically significant difference in survival between primary chemoradiation and primary surgery in a study that included 63 women (pooled adjusted HR= 1.09, 95% CI 0.37 to 3.17) and in another study that only included 12 eligible women and compared the same interventions (HR was non-informative when statistical adjustment was made). Adverse events were extensively reported in only one study, which found no statistically significant difference in risk of adverse events between primary chemoradiation and primary surgery due to the very small numbers in each group. In the RCT there was no observed statistically significant difference between neoadjuvant chemoradiation and primary surgery. Adverse events were not reported in the largest study of 63 women. Quality of life (QoL) was not reported in any of the included studies. All studies were at high risk of bias. Women with advanced vulval tumours showed no significant difference in overall survival or treatment-related adverse events when chemoradiation (primary or neoadjuvant) was compared with primary surgery. The retrospective studies had a high risk of bias as the entry criteria for primary chemoradiation was based on inoperability or tumour requiring exenteration.The radiochemotherapy regimens varied widely. There was no data on QoL. There is no standard terminology for 'operable and inoperable vulval cancer', and for 'primary and neoadjuvant chemoradiation'. Stratification according to unresectability of the primary tumour and/or lymph nodes is needed, for good quality comparison. | Women requiring extensive surgery (urinary and or feacal stoma formation) or with inoperable tumour were predominantly given primary chemoradiation in the two retrospective studies identified, making the available evidence weak (although we only included studies that used statistical adjustment). There was no data on quality of life. There is a great need for good quality studies comparing various primary treatments in locally advanced vulval cancer which are either inoperable at presentation or operable but would require extensive surgery. | 10.1002/14651858.CD003752.pub3 | [
"Women requiring extensive surgery (urinary and or feacal stoma formation) or with inoperable tumour were predominantly given primary chemoradiation in the two retrospective studies identified, making the available evidence weak (although we only included studies that used statistical adjustment). There was no data on quality of life. There is a great need for good quality studies comparing various primary treatments in locally advanced vulval cancer which are either inoperable at presentation or operable but would require extensive surgery."
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cochrane-simplification-train-1733 | cochrane-simplification-train-1733 | We included 18 RCTs (7208 participants), of which 16 recruited adults and adolescents (6872) and two recruited children six to 17 years of age (336) with asthma and significant reversibility to bronchodilator at baseline. Fourteen (79%) trials were of high methodological quality. The risk of exacerbations requiring systemic corticosteroids (primary outcome of the review) was significantly lower with the combination of LABA + ICS compared with LTRA + ICS—from 13% to 11% (eight studies, 5923 adults and 334 children; risk ratio (RR) 0.87, 95% confidence interval (CI) 0.76 to 0.99; high-quality evidence). The number needed to treat for an additional beneficial outcome (NNTB) with LABA compared with LTRA to prevent one additional exacerbation over four to 102 weeks was 62 (95% CI 34 to 794). The choice of LTRA, the dose of ICS and the participants' age group did not significantly influence the magnitude of effect. Although results were inconclusive, the effect appeared stronger in trials that used a single device rather than two devices to administer ICS and LABA and in trials of less than 12 weeks' duration. The addition of LABA to ICS was associated with a statistically greater improvement from baseline in lung function, as well as in symptoms, rescue medication use and quality of life, although the latter effects were modest. LTRA was superior in the prevention of exercise-induced bronchospasm. More participants were satisfied with the combination of LABA + ICS than LTRA + ICS (three studies, 1625 adults; RR 1.12, 95% CI 1.04 to 1.20; moderate-quality evidence). The overall risk of withdrawal was significantly lower with LABA + ICS than with LTRA + ICS (13 studies, 6652 adults and 308 children; RR 0.84, 95% CI 0.74 to 0.96; moderate-quality evidence). Although the risk of overall adverse events was equivalent between the two groups, the risk of serious adverse events (SAE) approached statistical significance in disfavour of LABA compared with LTRA (nine studies, 5658 adults and 630 children; RR 1.33, 95% CI 0.99 to 1.79; P value 0.06; moderate-quality evidence), with no apparent impact of participants' age group. The following adverse events were reported, but no significant differences were demonstrated between groups: headache (11 studies, N = 6538); cardiovascular events (five studies, N = 5163), osteopenia and osteoporosis (two studies, N = 2963), adverse events (10 studies, N = 5977 adults and 300 children). A significant difference in the risk of oral moniliasis was noted, but this represents a low occurrence rate. In adults with asthma that is inadequately controlled by predominantly low-dose ICS with significant bronchodilator reversibility, the addition of LABA to ICS is modestly superior to the addition of LTRA in reducing oral corticosteroid–treated exacerbations, with an absolute reduction of two percentage points. Differences favouring LABA over LTRA as adjunct therapy were observed in lung function and, to a lesser extend, in rescue medication use, symptoms and quality of life. The lower overall withdrawal rate and the higher proportion of participants satisfied with their therapy indirectly favour the combination of LABA + ICS over LTRA + ICS. Evidence showed a slightly increased risk of SAE with LABA compared with LTRA, with an absolute increase of one percentage point. Our findings modestly support the use of a single inhaler for the delivery of both LABA and low- or medium-dose ICS. Because of the paucity of paediatric trials, we are unable to draw firm conclusions about the best adjunct therapy in children. | From available evidence until December 2012, we found 16 trials involving 6872 adults and two trials involving 336 children contributing to the review. The risk of asthma exacerbations requiring the use of corticosteroids was lower with the combination of LABA + ICS compared with LTRA + ICS—from 13% to 11%. The choice of LTRA (montelukast or zafirlukast), the dose of ICS and the age of patients did not significantly affect the results. The effect appeared stronger in trials of short duration and in those using a single device to administer both ICS and LABA. Serious adverse events were more common with LABA than with LTRA, particularly in adults. The combination of LABA + ICS was superior to LTRA + ICS in terms of lung function and was modestly superior in other indicators of the control of asthma and quality of life. LTRA was found superior in preventing deterioration during exercise. The risk of withdrawal from a trial for any reason was significantly lower with LABA than with LTRA. More patients were satisfied with the combination of LABA + ICS, and fewer changed therapy if they started with LABA instead of LTRA. In adults whose asthma is inadequately controlled with ICS, the addition of LABA to ICS was found to be modestly superior to LTRA + ICS. Although both options appeared safe, evidence suggests that slightly more serious adverse events (SAE) may be seen with LABA than with LTRA, particularly when separate devices are used to administer LABA + ICS. Because only two paediatric trials contributed data to the review, the best adjunct strategy to ICS remains uncertain for children. Our confidence in the quality of evidence is high in the primary efficacy outcome (i.e. patients with exacerbation requiring systemic corticosteroids and high to moderate efficacy and safety measures). One open-label study of adult patients with asthma contributed to certain outcomes that led to downgrading of the quality of evidence from high to moderate. Of note, only two paediatric trials contributed to this review. | 10.1002/14651858.CD003137.pub5 | [
"From available evidence until December 2012, we found 16 trials involving 6872 adults and two trials involving 336 children contributing to the review. The risk of asthma exacerbations requiring the use of corticosteroids was lower with the combination of LABA + ICS compared with LTRA + ICS—from 13% to 11%. The choice of LTRA (montelukast or zafirlukast), the dose of ICS and the age of patients did not significantly affect the results. The effect appeared stronger in trials of short duration and in those using a single device to administer both ICS and LABA. Serious adverse events were more common with LABA than with LTRA, particularly in adults. The combination of LABA + ICS was superior to LTRA + ICS in terms of lung function and was modestly superior in other indicators of the control of asthma and quality of life. LTRA was found superior in preventing deterioration during exercise. The risk of withdrawal from a trial for any reason was significantly lower with LABA than with LTRA. More patients were satisfied with the combination of LABA + ICS, and fewer changed therapy if they started with LABA instead of LTRA. In adults whose asthma is inadequately controlled with ICS, the addition of LABA to ICS was found to be modestly superior to LTRA + ICS. Although both options appeared safe, evidence suggests that slightly more serious adverse events (SAE) may be seen with LABA than with LTRA, particularly when separate devices are used to administer LABA + ICS. Because only two paediatric trials contributed data to the review, the best adjunct strategy to ICS remains uncertain for children. Our confidence in the quality of evidence is high in the primary efficacy outcome (i.e. patients with exacerbation requiring systemic corticosteroids and high to moderate efficacy and safety measures). One open-label study of adult patients with asthma contributed to certain outcomes that led to downgrading of the quality of evidence from high to moderate. Of note, only two paediatric trials contributed to this review."
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cochrane-simplification-train-1734 | cochrane-simplification-train-1734 | We identified and included a single eligible trial comparing SLNB with observation which was published in eight different reports (from 2005 to 2014) with 2001 participants. This trial did not report on our first primary outcome of overall survival (which was also the planned primary outcome of this trial). When contacted for this important data, the trial authors stated "there are numerous additional analyses that have yet to be reported for the trial". We were able however to estimate overall survival from data included in the appendix of the published report and found no evidence of benefit for SLNB for overall survival. The overall survival hazard ratio (HR) using ITT (intention-to-treat) analysis was 0.99 95% confidence interval [CI] 0.82 to 1.19, 1661 participants). The overall survival using ITT for intermediate thickness melanomas was (HR 0.92, 95% CI 0.73 to 1.16) and for thick melanomas it was (HR 1.15, 95% CI 0.82 to 1.61). The study did report on our second primary outcome of rate of treatment complications: short-term surgical morbidity (30 days) in 1735 participants showed no difference between SLNB and observation (risk ratio [RR] 1.11, 955 CI 0.9 to 1.37) for wide excision of the tumour site but favoured observation for complications related to the regional nodal basin (RR 14.36, 95% CI 6.74 to 30.59). Our secondary outcomes of disease-specific and disease-free survival, local recurrence and distant metastases were reported. There were 1347 participants in the intermediate-thickness melanoma group and 314 in the thick melanoma group.The study did not report the actual 10-year melanoma-specific survival rate for all included participants. Instead, melanoma-specific survival rates for each group of participants: intermediate-thickness melanoma (defined as 1.2 to 3.5 mm) and thick melanomas (defined as 3.50 mm or more) was reported. In the intermediate-thickness melanoma group there was no statistically significant difference in disease-specific survival between study groups at 10 years (81.4 ± 1.5% versus 78.3 ± 2.0%, HR 0.84, 95% CI 0.65 to 1.09). In the thick melanoma group, again there was no statistically significant difference in disease-specific survival between study groups at 10 years (58.9.3 ± 4.1% versus 64.4 ± 4.6%, HR 1.12, 95% CI 0.77 to 1.64). Combining these groups there was some heterogeneity (I² = 34%) but the total HR was not statistically significant (HR 0.92, 95% CI 0.74 to 1.14). The summary estimate for disease-free survival at 10 years favoured SLNB over observation in participants with intermediate-thickness and thick melanomas (HR 0.75, 95% CI 0.63 to 0.89). With regard to the rate of local and regional recurrence as the site of first recurrence, a benefit of SLNB uniformly existed in both groups of participants with intermediate-thickness and thick melanomas (RR 0.56, 95% CI 0.45 to 0.69). This is in contrast with a uniformly unfavourable effect of SLNB with regard to the rate of distant metastases as site of first recurrence, in both groups of participants with intermediate-thickness and thick melanomas (HR 1.33, 95% CI 1.03 to 1.72). We found no evidence of improved overall survival or melanoma-specific survival rates for participants with intermediate or thick melanomas who underwent SLNB compared with observation alone. Disease-free survival and rate of local and regional recurrence favoured SLNB in both groups of participants with intermediate-thickness and thick melanomas but short-term surgical morbidity was higher in the SLNB group, especially with regard to complications in the nodal basin. The evidence for the outcomes of interest in this review is of low quality due to the risk of bias and imprecision of the estimated effects. Further research may have an important impact on our estimate of the effectiveness of SLNB in managing primary localised cutaneous melanoma. Currently this evidence is not sufficient to document a benefit of SLNB when compared to observation in individuals with primary localised cutaneous melanoma. | We found one published randomised controlled trial with 2001 participants with localised skin cancer who had undergone removal of the primary tumour and were then randomised to receive SLNB or observation. Participants testing positive for cancer cells in the sentinel lymph node then underwent CLND. Participants in the observation group underwent removal of the lymph nodes only on disease recurrence. The study did not report on our primary outcome of interest (overall survival), but it did report on our secondary outcomes of disease-specific survival (time to death only from melanoma), disease-free survival (time to first melanoma recurrence at any site), and recurrence. Although the authors of the one included study did not report the primary outcome of overall survival, we were able to calculate it from data they included in their report appendix which showed no benefit of SLNB for people with intermediate or thick melanomas. Our one included study also did not report any difference in disease-specific survival for participants who underwent SLNB or observation. Disease-free survival was better in the SLNB treatment group. However, recurrence of the melanoma at a distant site in the body occurred more frequently in participants in the SLNB group than in those in the observation group. We assessed the quality of the evidence for this trial as low for the above outcomes. As indicated by the results of this one included study, there is no clear evidence at present to recommend that SLNB, followed by CLND. is a better means of improving overall or melanoma-specific survival than observation. | 10.1002/14651858.CD010307.pub2 | [
"We found one published randomised controlled trial with 2001 participants with localised skin cancer who had undergone removal of the primary tumour and were then randomised to receive SLNB or observation. Participants testing positive for cancer cells in the sentinel lymph node then underwent CLND. Participants in the observation group underwent removal of the lymph nodes only on disease recurrence. The study did not report on our primary outcome of interest (overall survival), but it did report on our secondary outcomes of disease-specific survival (time to death only from melanoma), disease-free survival (time to first melanoma recurrence at any site), and recurrence. Although the authors of the one included study did not report the primary outcome of overall survival, we were able to calculate it from data they included in their report appendix which showed no benefit of SLNB for people with intermediate or thick melanomas. Our one included study also did not report any difference in disease-specific survival for participants who underwent SLNB or observation. Disease-free survival was better in the SLNB treatment group. However, recurrence of the melanoma at a distant site in the body occurred more frequently in participants in the SLNB group than in those in the observation group. We assessed the quality of the evidence for this trial as low for the above outcomes. As indicated by the results of this one included study, there is no clear evidence at present to recommend that SLNB, followed by CLND. is a better means of improving overall or melanoma-specific survival than observation."
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cochrane-simplification-train-1735 | cochrane-simplification-train-1735 | Eighteen trials which randomised 3888 people to rosiglitazone treatment were identified. Longest duration of therapy was four years with a median of 26 weeks. Published studies of at least 24 weeks rosiglitazone treatment in people with type 2 diabetes mellitus did not provide evidence that patient-oriented outcomes like mortality, morbidity, adverse effects, costs and health-related quality of life are positively influenced by this compound. Metabolic control measured by glycosylated haemoglobin A1c (HbA1c) as a surrogate endpoint did not demonstrate clinically relevant differences to other oral antidiabetic drugs. Occurrence of oedema was significantly raised (OR 2.27, 95% confidence interval (CI) 1.83 to 2.81). The single large RCT (ADOPT - A Diabetes Outcomes Progression Trial) indicated increased cardiovascular risk. New data on raised fracture rates in women reveal extensive action of rosiglitazone in various body tissues. New studies should focus on patient-oriented outcomes to clarify the benefit-risk ratio of rosiglitazone therapy. Safety data and adverse events of all investigations (published and unpublished) should be made available to the public. | Eighteen trials randomised 3888 people to rosiglitazone therapy. The longest duration of rosiglitazone treatment was four years, most trials lasted around half a year. Unfortunately, the published studies of at least 24 weeks rosiglitazone treatment in people with type 2 diabetes mellitus did not provide relevant evidence that patient-oriented outcomes are positively influenced by this agent. The chance of developing oedema was approximately doubled, the risk of cardiovascular diseases increased. The single large randomised controlled trial showed evidence of raised cardiovascular risk after rosiglitazone treatment. Moreover, new safety data show increased numbers of broken bones in women. This finding was published years after approval of this agent by drug regulatory authorities. New ways of exploring drug effects, for example by early long-term studies in many people, as well as public access to all safety data of published and unpublished investigations have to be established. | 10.1002/14651858.CD006063.pub2 | [
"Eighteen trials randomised 3888 people to rosiglitazone therapy. The longest duration of rosiglitazone treatment was four years, most trials lasted around half a year. Unfortunately, the published studies of at least 24 weeks rosiglitazone treatment in people with type 2 diabetes mellitus did not provide relevant evidence that patient-oriented outcomes are positively influenced by this agent. The chance of developing oedema was approximately doubled, the risk of cardiovascular diseases increased. The single large randomised controlled trial showed evidence of raised cardiovascular risk after rosiglitazone treatment. Moreover, new safety data show increased numbers of broken bones in women. This finding was published years after approval of this agent by drug regulatory authorities. New ways of exploring drug effects, for example by early long-term studies in many people, as well as public access to all safety data of published and unpublished investigations have to be established."
]
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cochrane-simplification-train-1736 | cochrane-simplification-train-1736 | We found two studies involving 4993 participants. The methodological quality of the trials was good. Both studies included women at low risk for hypertensive disorders, with Doppler ultrasound of the uterine arteries performed in the second trimester of pregnancy. In both studies, pathological finding of uterine arteries was followed by low-dose aspirin administration. We identified no difference in short-term maternal and fetal clinical outcomes. We identified no randomised studies assessing the utero-placental vessels in the first trimester or in women at high risk for hypertensive disorders. Present evidence failed to show any benefit to either the baby or the mother when utero-placental Doppler ultrasound was used in the second trimester of pregnancy in women at low risk for hypertensive disorders. Nevertheless, this evidence cannot be considered conclusive with only two studies included. There were no randomised studies in the first trimester, or in women at high risk. More research is needed to investigate whether the use of utero-placental Doppler ultrasound may improve pregnancy outcome. | It is used in pregnancy to study blood circulation in the baby, the mother's uterus and the placenta. If abnormal blood circulation is identified, then it is possible that medical interventions might improve outcomes. We set out to assess the value of using Doppler ultrasound of the mother's uterus or placenta (utero-placental Doppler ultrasound) as a screening tool. Other reviews have looked at the use of Doppler ultrasound on the babies' vessels (fetal and umbilical Doppler ultrasound). We also choose to look at women with low-risk and high-risk pregnancies, and in their first or second trimesters. This screening offers a potential for benefit, but also a possibility of unnecessary interventions and adverse effects. The review of randomised controlled trials of routine Doppler ultrasound of the uterus or placenta identified two studies involving 4993 women. All the women were in the second trimester of pregnancy and at low risk for hypertensive disorders. The studies were of good quality but small in size. We identified no improvements for the baby or the mother. However, more data would be needed to show whether maternal Doppler is effective, or not, for improving outcomes. We did not find any studies in the first trimester of pregnancy or in women at risk of high blood pressure disorders. More research is needed on this important aspect of care. | 10.1002/14651858.CD008363.pub2 | [
"It is used in pregnancy to study blood circulation in the baby, the mother's uterus and the placenta. If abnormal blood circulation is identified, then it is possible that medical interventions might improve outcomes. We set out to assess the value of using Doppler ultrasound of the mother's uterus or placenta (utero-placental Doppler ultrasound) as a screening tool. Other reviews have looked at the use of Doppler ultrasound on the babies' vessels (fetal and umbilical Doppler ultrasound). We also choose to look at women with low-risk and high-risk pregnancies, and in their first or second trimesters. This screening offers a potential for benefit, but also a possibility of unnecessary interventions and adverse effects. The review of randomised controlled trials of routine Doppler ultrasound of the uterus or placenta identified two studies involving 4993 women. All the women were in the second trimester of pregnancy and at low risk for hypertensive disorders. The studies were of good quality but small in size. We identified no improvements for the baby or the mother. However, more data would be needed to show whether maternal Doppler is effective, or not, for improving outcomes. We did not find any studies in the first trimester of pregnancy or in women at risk of high blood pressure disorders. More research is needed on this important aspect of care."
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cochrane-simplification-train-1737 | cochrane-simplification-train-1737 | Twelve studies comparing pharmacist-provided services versus usual care were included in this review. Of the 12 studies, seven were from lower middle income countries and five were from upper middle income countries. Eleven studies examined pharmacist-provided services targeted at patients and one study evaluated pharmacist interventions targeted at healthcare professionals. Pharmacist-provided services targeting patients resulted in a small improvement of clinical outcomes such as blood pressure (-25 mm Hg/-6 mm Hg and -4.56 mm Hg/-2.45 mm Hg), blood glucose (-39.84 mg/dl and -16.16 mg/dl), blood cholesterol (-25.7 mg/dl)/ triglyceride levels (-80.1 mg/dl) and asthma outcomes (peak expiratory flow rate 1.76 l/min). Moreover, there was a small improvement in the quality of life, although four studies did not report the effect size explicitly. Health service utilisation, such as rate of hospitalisation and general practice and emergency room visits, was also found to be reduced by the patient targeted pharmacist-provided services. A single study examined the effect of patient targeted pharmacist interventions on medical expenses and the cost was found to be reduced. A single study that examined pharmacist services that targeted healthcare professionals demonstrated a very small impact on asthma symptom scores. No studies assessing the impact of pharmacist-provided non-dispensing services that targeted healthcare professionals reported health service utilisation and cost outcomes. Overall, five studies did not adequately report the numerical data for outcomes but instead reported qualitative statements about results, which prevented an estimation of the effect size. Studies for the comparison of patient targeted services provided by pharmacists versus the same services provided by other healthcare professionals or untrained healthcare workers were not found. Similarly, studies for the comparison of healthcare professional targeted services provided by pharmacists versus the same services provided by other healthcare professionals or untrained healthcare workers were not found. Pharmacist-provided services that target patients may improve clinical outcomes such as management of high glucose levels among diabetic patients, management of blood pressure and cholesterol levels and may improve the quality of life of patients with chronic conditions such as diabetes, hypertension and asthma. Pharmacist services may reduce health service utilisation such as visits to general practitioners and hospitalisation rates. We are uncertain about the effect of educational sessions by pharmacists for healthcare professionals due to the imprecision of a single study included in this review. Similarly, conclusions could not be drawn for health service utilisation and costs due to lack of evidence on interventions delivered by pharmacists to healthcare professionals. These results were heterogenous in the types of outcomes measured, clinical conditions and approaches to measurement of outcomes, and require cautious interpretation. All eligible studies were from middle income countries and the results may not be applicable to low income countries. | In 11 of the studies, pharmacists gave education and counselling to patients with chronic illnesses such as asthma and diabetes. Pharmacists gave the patients information about how to use their medicines properly and about possible side effects of the medicines, and helped them to identify and solve problems with their medicines. They also gave the patients information about the disease and advice about self-management and the importance of a healthy lifestyle. The patients who were given these services were compared to patients who were given the usual pharmacist services without education or counselling. In one study, pharmacists gave education to general practitioners (GPs) about care of children with asthma. These GPs were compared to GPs who were given usual pharmacist services. No studies were found where pharmacist-provided services were compared to the services provided by other health workers. What happens when pharmacists provide services other than dispensing medication? When pharmacists give education and counselling to patients with chronic illnesses: · patients may experience small improvements in health outcomes such as blood pressure levels and glucose levels (low quality evidence), · patients may use health services less (for instance fewer visits to the doctor, fewer stays in hospital) (low quality evidence), · patients probably experience small improvements in quality of life (moderate quality evidence), · patients’ medication costs may be lower (low quality evidence). When pharmacists give education and counselling about asthma care to GPs: · their patients may experience slightly fewer asthma symptoms (low quality evidence). | 10.1002/14651858.CD010398 | [
"In 11 of the studies, pharmacists gave education and counselling to patients with chronic illnesses such as asthma and diabetes. Pharmacists gave the patients information about how to use their medicines properly and about possible side effects of the medicines, and helped them to identify and solve problems with their medicines. They also gave the patients information about the disease and advice about self-management and the importance of a healthy lifestyle. The patients who were given these services were compared to patients who were given the usual pharmacist services without education or counselling. In one study, pharmacists gave education to general practitioners (GPs) about care of children with asthma. These GPs were compared to GPs who were given usual pharmacist services. No studies were found where pharmacist-provided services were compared to the services provided by other health workers. What happens when pharmacists provide services other than dispensing medication? When pharmacists give education and counselling to patients with chronic illnesses: · patients may experience small improvements in health outcomes such as blood pressure levels and glucose levels (low quality evidence), · patients may use health services less (for instance fewer visits to the doctor, fewer stays in hospital) (low quality evidence), · patients probably experience small improvements in quality of life (moderate quality evidence), · patients’ medication costs may be lower (low quality evidence). When pharmacists give education and counselling about asthma care to GPs: · their patients may experience slightly fewer asthma symptoms (low quality evidence)."
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cochrane-simplification-train-1738 | cochrane-simplification-train-1738 | A total of four studies (one randomized controlled trial, three non- randomized studies) involving 8488 people living with HIV/AIDS were included. The main findings of this review demonstrated a trend to improved outcomes when treated by a provider with more training/expertise in HIV/AIDS care in the outpatient (clinic) setting. Due to the heterogeneity of the included studies, we could not perform a meta-analysis. We present a descriptive review of the results. The results demonstrate improved medical outcomes when treated by a provider with more training/expertise in HIV/AIDS care in the outpatient (clinic) setting. Since all of these studies were conducted in North America, this does not address any issues regarding the level of training/expertise required by providers working in countries with more limited resources. Practitioners who do not consider themselves 'experts' in HIV/AIDS care and care for few of these patients need to seriously consider this review which demonstrates a trend towards worse patient outcomes when receiving care by those with low caseloads/training in HIV/AIDS care. | This systematic review examined studies from 1980-2009 that identified both provider experience/qualifications as well as a volumes indicator (number of HIV/AIDS patients). Only four studies met the inclusion criteria for the final review. Given the varied methods of each study, a meta-analysis was not possible. | 10.1002/14651858.CD003938.pub2 | [
"This systematic review examined studies from 1980-2009 that identified both provider experience/qualifications as well as a volumes indicator (number of HIV/AIDS patients). Only four studies met the inclusion criteria for the final review. Given the varied methods of each study, a meta-analysis was not possible."
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cochrane-simplification-train-1739 | cochrane-simplification-train-1739 | We identified nine studies. We excluded eight of these as they did not restrict participation to people with high fatigue. The single eligible trial investigated the use of modafinil compared to placebo. Although this study found a significant improvement over time in the primary outcome of fatigue, the improvement occurred after both modafinil and placebo with no significant difference in response between the two groups. The included trial did not reach its planned recruitment target and therefore may not, in practice, have been adequately powered to detect a difference. The trial was at a low risk of bias across most areas. There was an unclear risk of bias related to the use of mean imputation because the investigators did not analyse the impact of imputation on the results. There was insufficient evidence to draw reliable and generalisable conclusions regarding potential effectiveness or harm of any pharmacological or non-pharmacological treatments for fatigue in people with PBT. More research is needed on how best to treat people with brain tumours with high fatigue. | In March 2016, we searched five medical databases. We found one clinical trial that was eligible for inclusion; the trial investigated the medicine modafinil in 37 adults with PBT and high levels of fatigue. People in the study received six weeks of modafinil followed by a one-week washout period and six further weeks of placebo, or vice versa. The washout period aims to allow time for any effects of the first treatment to wear off before the new one gets started. The one included trial found no evidence of a difference between modafinil and placebo in treating fatigue. It is possible that this could be due to the trial not reaching its planned number of participants. Several other studies investigated the management of fatigue too, but in these studies high fatigue was not essential for participation. We do not currently know whether any treatments are effective in the management of people with PBT and high fatigue. With only one included trial, the overall quality of evidence was low. More high-quality studies are needed that enrol adults with BPT and high fatigue. | 10.1002/14651858.CD011376.pub2 | [
"In March 2016, we searched five medical databases. We found one clinical trial that was eligible for inclusion; the trial investigated the medicine modafinil in 37 adults with PBT and high levels of fatigue. People in the study received six weeks of modafinil followed by a one-week washout period and six further weeks of placebo, or vice versa. The washout period aims to allow time for any effects of the first treatment to wear off before the new one gets started. The one included trial found no evidence of a difference between modafinil and placebo in treating fatigue. It is possible that this could be due to the trial not reaching its planned number of participants. Several other studies investigated the management of fatigue too, but in these studies high fatigue was not essential for participation. We do not currently know whether any treatments are effective in the management of people with PBT and high fatigue. With only one included trial, the overall quality of evidence was low. More high-quality studies are needed that enrol adults with BPT and high fatigue."
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cochrane-simplification-train-1740 | cochrane-simplification-train-1740 | We included 12 trials, which recruited 389 participants. No studies assessed the primary outcome tooth loss. Ten trials compared FMS and control; three of these were assessed as being at high risk of bias, three as unclear risk and four as low risk. There was no evidence for a benefit for FMS over the control for change in probing pocket depth (PPD), gain in probing attachment (i.e. clinical attachment level; CAL) or bleeding on probing (BOP). The difference in changes between FMS and control for whole mouth PPD at three to four months was 0.01 mm higher (95% CI -0.17 to 0.19, three trials, 82 participants). There was no evidence of heterogeneity. The difference in changes for CAL was 0.02 mm lower (95% CI -0.26 to 0.22, three trials, 82 participants), and the difference in change in BOP was 2.86 per cent of sites lower (95% CI -7.65 to 1.93, four trials, 120 participants). We included six trials in the meta-analyses comparing FMD and control, with two trials assessed as being at high risk of bias, one as low and three as unclear. The analyses did not indicate a benefit for FMD over the control for PPD, CAL or BOP. The difference in changes for whole-mouth PPD between FMD and control at three to four months was 0.13 mm higher (95% CI -0.09 to 0.34, two trials, 44 participants). There was no evidence of heterogeneity. The difference in changes for CAL was 0.04mm higher (95% CI -0.25 to 0.33, two trials, 44 participants) and the difference in change in BOP being 12.59 higher for FMD (95% CI -8.58 to 33.77, three trials, 68 participants). Three trials were included in the analyses comparing FMS and FMD. The mean difference in PPD change at three to four months was 0.11 mm lower (-0.34 to 0.12, two trials, 45 participants) indicating no evidence of a difference between the two interventions. There was a difference in the gain in CAL at three to four months (-0.25 mm, 95% CI -0.42 to -0.07, two trials, 45 participants), favouring FMD but this was not found at six to eight months. There was no evidence for a difference between FMS and FMD for BOP (-1.59, 95% CI -9.97 to 6.80, two trials, 45 participants). Analyses were conducted for different teeth types (single- or multi-rooted) and for teeth with different levels of probing depth at baseline, for PPD, CAL and BOP. There was insufficient evidence of a benefit for either FMS or FMD. Harms and adverse events were reported in eight studies. The most important harm identified was an increased body temperature after FMS or FMD treatments. We assessed the quality of the evidence for each comparison and outcome as 'low' because of design limitations leading to risk of bias and because of the small number of trials and participants, which led to imprecision in the effect estimates. The inclusion of five additional RCTs in this updated review comparing the clinical effects of conventional mechanical treatment with FMS and FMD approaches for the treatment of chronic periodontitis has not changed the conclusions of the original review. From the twelve included trials there is no clear evidence that FMS or FMD provide additional benefit compared to conventional scaling and root planing. In practice, the decision to select one approach to non-surgical periodontal therapy over another should include patient preference and the convenience of the treatment schedule. | This review, carried out within the Cochrane Oral Health Group, is an update of one we published in 2008 and the evidence is current up to March 2015. We identified another five relevant studies for inclusion in this review and therefore this review includes 12 studies, which involved 389 participants. There is one Chinese study awaiting classification. Participants in the included studies were aged between 27 and 78 years, and there were roughly the same number of men and women involved. The studies we included had to be randomised controlled trials with at least three months of follow-up that evaluated full-mouth scaling and root planing within 24 hours. Both FMS and FMD were compared to conventional quadrant scaling and root planing, which was the control group. Participants had to have a clinical diagnosis of chronic periodontitis according to the International Classification of Periodontal Diseases. We excluded studies of people with aggressive periodontitis, systemic disorders or who were taking antibiotics. Treatment effects of FMS and FMD compared to conventional scaling and root planing (SRP) are modest and there are no clear implications for periodontal care. Harms and adverse events were reported in eight studies. The most important harm identified was an increased body temperature after FMS or FMD treatments. In practice, the decision to select one approach to non-surgical periodontal therapy over another can include patient preference and the convenience of the treatment schedule. The quality of the evidence is low for all treatment comparisons and outcomes. This is due to the small number of studies and participants involved and limitations in the study designs. Future research is likely to change findings. | 10.1002/14651858.CD004622.pub3 | [
"This review, carried out within the Cochrane Oral Health Group, is an update of one we published in 2008 and the evidence is current up to March 2015. We identified another five relevant studies for inclusion in this review and therefore this review includes 12 studies, which involved 389 participants. There is one Chinese study awaiting classification. Participants in the included studies were aged between 27 and 78 years, and there were roughly the same number of men and women involved. The studies we included had to be randomised controlled trials with at least three months of follow-up that evaluated full-mouth scaling and root planing within 24 hours. Both FMS and FMD were compared to conventional quadrant scaling and root planing, which was the control group. Participants had to have a clinical diagnosis of chronic periodontitis according to the International Classification of Periodontal Diseases. We excluded studies of people with aggressive periodontitis, systemic disorders or who were taking antibiotics. Treatment effects of FMS and FMD compared to conventional scaling and root planing (SRP) are modest and there are no clear implications for periodontal care. Harms and adverse events were reported in eight studies. The most important harm identified was an increased body temperature after FMS or FMD treatments. In practice, the decision to select one approach to non-surgical periodontal therapy over another can include patient preference and the convenience of the treatment schedule. The quality of the evidence is low for all treatment comparisons and outcomes. This is due to the small number of studies and participants involved and limitations in the study designs. Future research is likely to change findings."
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cochrane-simplification-train-1741 | cochrane-simplification-train-1741 | We included 56 studies (2838 participants). Antihypertensive agents were the most beneficial non-immunosuppressive intervention for IgAN. The antihypertensives examined were predominantly angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB) or combinations of both, versus other antihypertensives and other agents. The benefits of antihypertensive agents, particularly inhibitors of the renin angiotensin system, appear to potentially outweigh the harms in patients with IgAN. The benefits are largely manifest as a reduction in proteinuria, a surrogate outcome. There is no evidence that treatment with any of the antihypertensive agents evaluated affect major renal and/or cardiovascular endpoints or long-term mortality risk beyond the benefit that arises from controlling hypertension in patients with IgAN. The RCT evidence is insufficiently robust to demonstrate efficacy for any of the other non-immunosuppressive therapies evaluated here. IgAN remains a disease in search of adequately powered RCTs to reliably inform clinical practice. More and better evidence is needed to understand the magnitude of benefit and the possible risks of anti-hypertensive or more specifically of ACEi/ARB therapy alone or in combination and which specific types of patients with the IgAN might have the greatest potential for benefit. For other non-immunosuppressive therapies, where neither benefit nor significant harm has yet to be demonstrated, there remains some justification for further exploration of the potential benefits. | We included 56 studies enrolling 2838 participants. Antihypertensive agents were the most beneficial non-immunosuppressive intervention for IgAN. The antihypertensives examined here were predominantly angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB) or combinations of both, compared with other antihypertensives and other agents. The benefits of antihypertensive agents appear to potentially outweigh the harms in patients with IgAN. The benefits were mostly reported as a reduction in 24 hour proteinuria. There is no evidence that treatment with any of the antihypertensive agents evaluated to date affect major renal and/or cardiovascular endpoints or long-term mortality risk beyond the benefit that arises from controlling hypertension in patients with IgAN. The RCT evidence is insufficiently robust to demonstrate efficacy for any of the other non-immunosuppressive therapies evaluated here. IgAN remains a disease in search of adequately powered RCTs to reliably inform clinical practice. More and better evidence is needed to understand the magnitude of benefit and the possible risks of anti-hypertensive or more specifically of ACEi/ARB therapy alone or in combination and which specific types of patients with the IgAN might have the greatest potential for benefit. For other non-immunosuppressive therapies, where benefit nor significant harm has yet to be demonstrated, there remains some justification for further exploration of the potential benefits. | 10.1002/14651858.CD003962.pub2 | [
"We included 56 studies enrolling 2838 participants. Antihypertensive agents were the most beneficial non-immunosuppressive intervention for IgAN. The antihypertensives examined here were predominantly angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB) or combinations of both, compared with other antihypertensives and other agents. The benefits of antihypertensive agents appear to potentially outweigh the harms in patients with IgAN. The benefits were mostly reported as a reduction in 24 hour proteinuria. There is no evidence that treatment with any of the antihypertensive agents evaluated to date affect major renal and/or cardiovascular endpoints or long-term mortality risk beyond the benefit that arises from controlling hypertension in patients with IgAN. The RCT evidence is insufficiently robust to demonstrate efficacy for any of the other non-immunosuppressive therapies evaluated here. IgAN remains a disease in search of adequately powered RCTs to reliably inform clinical practice. More and better evidence is needed to understand the magnitude of benefit and the possible risks of anti-hypertensive or more specifically of ACEi/ARB therapy alone or in combination and which specific types of patients with the IgAN might have the greatest potential for benefit. For other non-immunosuppressive therapies, where benefit nor significant harm has yet to be demonstrated, there remains some justification for further exploration of the potential benefits."
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cochrane-simplification-train-1742 | cochrane-simplification-train-1742 | We included 14 RCTs that evaluated PLD alone or in combination with other drugs. Four RCTs contributed no data to the meta-analyses. Two studies compared PLD plus carboplatin (carbo) to paclitaxel (PAC)/carbo in women with platinum-sensitive relapsed EOC. Overall survival (OS) was similar for these treatments, however progression-free survival (PFS) was longer with PLD/carbo (1164 participants; hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.74 to 0.97; I² = 7%; P value 0.01). PLD/carbo was associated with significantly more anaemia and thrombocytopenia than PAC/carbo, whereas PAC/carbo was associated with significantly more alopecia, neuropathies, hypersensitivity reactions and arthralgias/myalgias. PLD/carbo was well-tolerated and women receiving this treatment were significantly less likely to discontinue treatment than those receiving PAC/carbo (two studies, 1150 participants; risk ratio (RR) 0.38, 95% CI 0.26 to 0.57; I² = 0%; P < 0.00001). Five studies compared other agents to PLD alone. None of these agents were associated with significantly better survival or severe adverse-event profiles than PLD. Topotecan and gemcitabine were associated with significantly more haematological severe adverse events than PLD, and patupilone was associated with significantly more severe neuropathies and diarrhoea. Severe hand-foot syndrome (HFS) occurred consistently more frequently with PLD than the other drugs. Three studies compared PLD combination treatment to PLD alone. Two combinations resulted in a significantly longer PFS compared with PLD alone: trabectedin (TBD)/PLD (one study, 672 women; HR 0.79, 95% CI 0.65 to 0.96; P value 0.02) and vintafolide (EC145)/PLD (one study, 149 women; HR 0.63, 95% CI 0.41 to 0.97; P value 0.04). TBD/PLD appeared to benefit the partially platinum-sensitive subgroup only. Further studies are likely to have an important impact on our confidence in these estimates. TBD/PLD was associated with significantly more haematological and gastrointestinal severe adverse events than PLD alone, whereas EC145/PLD appeared to be well-tolerated. For platinum-resistant relapsed EOC, the median PFS and OS for single-agent PLD across seven included studies was 15 weeks and 54 weeks, respectively. Severe HFS occurred significantly more frequently in women receiving a 50 mg/m² dose of PLD than those receiving less than 50 mg/m² (17% versus 2%, respectively; P value 0.01). In platinum-sensitive relapsed epithelial ovarian cancer, PLD/carbo is more effective than PAC/carbo and is better tolerated; PLD/carbo should therefore be considered as first-line treatment in women with platinum-sensitive relapsed EOC. PLD alone is a useful agent for platinum-resistant relapsed EOC, however it remains unclear how it compares with other single agents for this subgroup and in what order these agents should be used. There is insufficient evidence to support the use of PLD in combination with other agents in platinum-resistant relapsed EOC. | We searched electronic databases and other resources for studies of PLD for relapsed ovarian cancerEOC, and included 14 studies up to October 2012. Most of these studies (12/14) were funded by drug manufacturers with a commercial interest in PLD (two studies) or the comparator drugs (10 studies). For women with platinum-sensitive relapsed EOC, we pooled data from two studies (1164 participants) that compared carboplatin plus PLD (PLD/carbo) with standard treatment (paclitaxel plus carbo (PAC/carbo)). Women survived for a similar length of time overall on these two treatments but the cancer took longer to progress in those receiving PLD/carbo. Women who received PLD experienced more severe low blood cell counts than the standard treatment. By comparison, women in the standard treatment group experienced more severe hair loss, nerve damage, allergic reactions, and joint and muscle pain. More women in the standard treatment group stopped treatment early suggesting that PLD/carbo was better tolerated than standard treatment. We concluded that PLD/carbo was a better treatment option than PAC/carbo for platinum-sensitive relapsed EOC. Five studies compared PLD to five other chemotherapy drugs. The numbers of participants in these studies ranged from 97 to 829 women and we did not pool these data. PLD worked as least as well as the other agents and was comparatively well-tolerated. In all studies, hand-foot syndrome (HFS: swollen, painful, red, cracked and peeled soles and palms) occurred more frequently in the PLD group. Three studies compared PLD plus another drug (canfosfamide (CAN), vintafolide (EC145) or trabectedin (TBD)) to PLD alone. The final results of the CAN study were not reported. The numbers of participants in the other studies ranged from 149 to 672 women and we did not pool these data. Women receiving the PLD/TBD combination treatment progressed six weeks later than those getting PLD only, however they did not live longer overall, and the combination treatment was associated with additional harmful effects. EC145 may improve survival in women with platinum-resistant relapsed ovarian cancer when combined with PLD; this combination is currently under investigation in a large trial. Although HFS can be severely disabling, we noted that it occurred much less frequently when lower doses of PLD were used. We consider the evidence related to the longer time to cancer progression with PLD/carbo for platinum-sensitive relapsed ovarian cancer to be of a high quality. There is currently insufficient evidence to support the use of other PLD combination treatments in relapsed EOC. | 10.1002/14651858.CD006910.pub2 | [
"We searched electronic databases and other resources for studies of PLD for relapsed ovarian cancerEOC, and included 14 studies up to October 2012. Most of these studies (12/14) were funded by drug manufacturers with a commercial interest in PLD (two studies) or the comparator drugs (10 studies). For women with platinum-sensitive relapsed EOC, we pooled data from two studies (1164 participants) that compared carboplatin plus PLD (PLD/carbo) with standard treatment (paclitaxel plus carbo (PAC/carbo)). Women survived for a similar length of time overall on these two treatments but the cancer took longer to progress in those receiving PLD/carbo. Women who received PLD experienced more severe low blood cell counts than the standard treatment. By comparison, women in the standard treatment group experienced more severe hair loss, nerve damage, allergic reactions, and joint and muscle pain. More women in the standard treatment group stopped treatment early suggesting that PLD/carbo was better tolerated than standard treatment. We concluded that PLD/carbo was a better treatment option than PAC/carbo for platinum-sensitive relapsed EOC. Five studies compared PLD to five other chemotherapy drugs. The numbers of participants in these studies ranged from 97 to 829 women and we did not pool these data. PLD worked as least as well as the other agents and was comparatively well-tolerated. In all studies, hand-foot syndrome (HFS: swollen, painful, red, cracked and peeled soles and palms) occurred more frequently in the PLD group. Three studies compared PLD plus another drug (canfosfamide (CAN), vintafolide (EC145) or trabectedin (TBD)) to PLD alone. The final results of the CAN study were not reported. The numbers of participants in the other studies ranged from 149 to 672 women and we did not pool these data. Women receiving the PLD/TBD combination treatment progressed six weeks later than those getting PLD only, however they did not live longer overall, and the combination treatment was associated with additional harmful effects. EC145 may improve survival in women with platinum-resistant relapsed ovarian cancer when combined with PLD; this combination is currently under investigation in a large trial. Although HFS can be severely disabling, we noted that it occurred much less frequently when lower doses of PLD were used. We consider the evidence related to the longer time to cancer progression with PLD/carbo for platinum-sensitive relapsed ovarian cancer to be of a high quality. There is currently insufficient evidence to support the use of other PLD combination treatments in relapsed EOC."
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cochrane-simplification-train-1743 | cochrane-simplification-train-1743 | Four studies randomising a total of 202 people with schizophrenia are included. Oral fluphenazine was compared with oral amisulpride, risperidone, quetiapine and olanzapine. Comparing oral fluphenazine with amisulpride, there was no difference between groups for mental state using the Brief Psychiatric Rating Scale (BPRS) (1 RCT, n = 57, MD 5.10 95% CI -2.35 to 12.55, very low-quality evidence), nor was there any difference in numbers leaving the study early for any reason (2 RCTs, n = 98, RR 1.19 95% CI 0.63 to 2.28, very low-quality evidence). More people required concomitant anticholinergic medication in the fluphenazine group compared to amisulpride (1 RCT, n = 36, RR 7.82 95% CI 1.07 to 57.26, very low-quality evidence). No data were reported for important outcomes including relapse, changes in life skills, quality of life or cost-effectiveness. Comparing oral fluphenazine with risperidone, data showed no difference between groups for 'clinically important response' (1 RCT, n = 26, RR 0.67 95% CI 0.13 to 3.35, very low-quality evidence) nor leaving the study early due to inefficacy (1 RCT, n = 25, RR 1.08 95% CI 0.08 to 15.46, very low-quality evidence). No data were reported data for relapse; change in life skills; quality of life; extrapyramidal adverse effects; or cost-effectiveness. Once again there was no difference when oral fluphenazine was compared with quetiapine for clinically important response (1 RCT, n = 25, RR 0.62 95% CI 0.12 to 3.07, very low-quality evidence), nor leaving the study early for any reason (1 RCT, n = 25, RR 0.46 95% CI 0.05 to 4.46, very low-quality evidence). No data were reported for relapse; clinically important change in life skills; quality of life; extrapyramidal adverse effects; or cost-effectiveness. Compared to olanzapine, fluphenazine showed no superiority for clinically important response (1 RCT, n = 60, RR 1.33 95% CI 0.86 to 2.07, very low-quality evidence), in incidence of akathisia (1 RCT, n = 60, RR 3.00 95% CI 0.90 to 10.01, very low-quality evidence) or in people leaving the study early (1 RCT, n = 60, RR 3.00 95% CI 0.33 to 27.23, very low-quality evidence). No data were reported for relapse; change in life skills; quality of life; or cost-effectiveness. Measures of clinical response and mental state do not highlight differences between fluphenazine and amisulpride, risperidone, quetiapine or olanzapine. Largely measures of adverse effects are also unconvincing for substantive differences between fluphenazine and the newer drugs. All included trials carry a substantial risk of bias regarding reporting of adverse effects and this bias would have favoured the newer drugs. The four small short included studies do not provide much clear information about the relative merits or disadvantages of oral fluphenazine compared with newer atypical antipsychotics. | An electronic search of Cochrane Schizophrenia's register of studies was carried out in 2013. Review authors looked for trials that randomised people with schizophrenia to receive either oral fluphenazine or an atypical antipsychotic. Four studies with a total of 202 people with schizophrenia could be included. The trials compared fluphenazine with either amisulpride, risperidone, quetiapine or olanzapine. Results Data showed oral fluphenazine is no better or worse in improving mental state than amisulpride but more people receiving oral fluphenazine did need to take additional anticholinergic medication (drugs used to help relieve a range of symptoms such as involuntary movements of the muscles, high blood pressure and insomnia). Data from the trials comparing oral fluphenazine with either risperidone, quetiapine or olanzapine also showed no superiority between the treatment groups for clinical improvement. Only the trial comparing oral fluphenazine with olanzapine provided adverse-effects data. Again, incidence of akathisia, a movement disorder, was similar between treatment groups. Quality of evidence Evidence from these few trials is poor, of low quality and involves a small number of participants. It does not provide clear overall information about whether oral fluphenazine is better or worse than atypical antipsychotic drugs for treating people with schizophrenia. Data were not available for important outcomes such as such, relapse, hospital admission, satisfaction, costs and quality of life. Adverse-effects data were poorly reported. Future large-scale research should report on these important outcomes. Conclusions Fluphenazine is low cost and widely available, so is likely to remain one of the most widely used treatments for schizophrenia worldwide. However, evidence currently available from randomised controlled trials about its effectiveness compared to atypical antipsychotics is unclear. | 10.1002/14651858.CD010832.pub2 | [
"An electronic search of Cochrane Schizophrenia's register of studies was carried out in 2013. Review authors looked for trials that randomised people with schizophrenia to receive either oral fluphenazine or an atypical antipsychotic. Four studies with a total of 202 people with schizophrenia could be included. The trials compared fluphenazine with either amisulpride, risperidone, quetiapine or olanzapine. Results Data showed oral fluphenazine is no better or worse in improving mental state than amisulpride but more people receiving oral fluphenazine did need to take additional anticholinergic medication (drugs used to help relieve a range of symptoms such as involuntary movements of the muscles, high blood pressure and insomnia). Data from the trials comparing oral fluphenazine with either risperidone, quetiapine or olanzapine also showed no superiority between the treatment groups for clinical improvement. Only the trial comparing oral fluphenazine with olanzapine provided adverse-effects data. Again, incidence of akathisia, a movement disorder, was similar between treatment groups. Quality of evidence Evidence from these few trials is poor, of low quality and involves a small number of participants. It does not provide clear overall information about whether oral fluphenazine is better or worse than atypical antipsychotic drugs for treating people with schizophrenia. Data were not available for important outcomes such as such, relapse, hospital admission, satisfaction, costs and quality of life. Adverse-effects data were poorly reported. Future large-scale research should report on these important outcomes. Conclusions Fluphenazine is low cost and widely available, so is likely to remain one of the most widely used treatments for schizophrenia worldwide. However, evidence currently available from randomised controlled trials about its effectiveness compared to atypical antipsychotics is unclear."
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cochrane-simplification-train-1744 | cochrane-simplification-train-1744 | We included 38 studies. Based on three studies, acupuncture was not shown to be more effective than a waiting list control for long-term abstinence, with wide confidence intervals and evidence of heterogeneity (n = 393, risk ratio [RR] 1.79, 95% confidence interval [CI] 0.98 to 3.28, I² = 57%). Compared with sham acupuncture, the RR for the short-term effect of acupuncture was 1.22 (95% CI 1.08 to 1.38), and for the long-term effect was 1.10 (95% CI 0.86 to 1.40). The studies were not judged to be free from bias, and there was evidence of funnel plot asymmetry with larger studies showing smaller effects. The heterogeneity between studies was not explained by the technique used. Acupuncture was less effective than nicotine replacement therapy (NRT). There was no evidence that acupuncture is superior to psychological interventions in the short- or long-term. There is limited evidence that acupressure is superior to sham acupressure for short-term outcomes (3 trials, n = 325, RR 2.54, 95% CI 1.27 to 5.08), but no trials reported long-term effects, The pooled estimate for studies testing an intervention that included continuous auricular stimulation suggested a short-term benefit compared to sham stimulation (14 trials, n = 1155, RR 1.69, 95% CI 1.32 to 2.16); subgroup analysis showed an effect for continuous acupressure (7 studies, n = 496, RR 2.73, 95% CI 1.78 to 4.18) but not acupuncture with indwelling needles (6 studies, n = 659, RR 1.24, 95% CI 0.91 to 1.69). At longer follow-up the CIs did not exclude no effect (5 trials, n = 570, RR 1.47, 95% CI 0.79 to 2.74). The evidence from two trials using laser stimulation was inconsistent and could not be combined. The combined evidence on electrostimulation suggests it is not superior to sham electrostimulation (short-term abstinence: 6 trials, n = 634, RR 1.13, 95% CI 0.87 to 1.46; long-term abstinence: 2 trials, n = 405, RR 0.87, 95% CI 0.61 to 1.23). Although pooled estimates suggest possible short-term effects there is no consistent, bias-free evidence that acupuncture, acupressure, or laser therapy have a sustained benefit on smoking cessation for six months or more. However, lack of evidence and methodological problems mean that no firm conclusions can be drawn. Electrostimulation is not effective for smoking cessation. Well-designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence-based interventions. | We included 38 randomised studies published up to October 2013. Trials tested a variety of different interventions and controls. The specific points used, the number of sessions and whether there was continuous stimulation varied. Three studies (393 people) compared acupuncture to a waiting list control. Nineteen studies (1,588 people) compared active acupuncture to sham acupuncture, but only 11 of these studies included long-term follow-up of six months or more. Three studies (253 people) compared acupressure to sham acupressure but none had long-term follow-up. Two trials used laser stimulation and six (634 people) used electrostimulation. The overall quality of the evidence was moderate. Key findings Three studies comparing acupuncture to a waiting list control and reporting long-term abstinence did not show clear evidence of benefit. For acupuncture compared with sham acupuncture, there was weak evidence of a small short-term benefit but not of any long-term benefit. Acupuncture was less effective than nicotine replacement therapy (NRT) and not shown to be better than counselling. There was limited evidence that acupressure is superior to sham acupressure in the short term but no evidence about long-term effects. In an analysis of the subgroup of trials where the treatment included continuous stimulation, those trials which used continuous acupressure to points on the ear had the largest short-term effect. The evidence from two trials using laser stimulation was inconsistent. The seven trials of electrostimulation do not suggest evidence of benefit compared to sham electrostimulation. The review did not find consistent evidence that active acupuncture or related techniques increased the number of people who could successfully quit smoking. However, some techniques may be better than doing nothing, at least in the short term, and there is not enough evidence to dismiss the possibility that they might have an effect greater than placebo. They are likely to be less effective than current evidence-based interventions. They are safe when correctly applied. | 10.1002/14651858.CD000009.pub4 | [
"We included 38 randomised studies published up to October 2013. Trials tested a variety of different interventions and controls. The specific points used, the number of sessions and whether there was continuous stimulation varied. Three studies (393 people) compared acupuncture to a waiting list control. Nineteen studies (1,588 people) compared active acupuncture to sham acupuncture, but only 11 of these studies included long-term follow-up of six months or more. Three studies (253 people) compared acupressure to sham acupressure but none had long-term follow-up. Two trials used laser stimulation and six (634 people) used electrostimulation. The overall quality of the evidence was moderate. Key findings Three studies comparing acupuncture to a waiting list control and reporting long-term abstinence did not show clear evidence of benefit. For acupuncture compared with sham acupuncture, there was weak evidence of a small short-term benefit but not of any long-term benefit. Acupuncture was less effective than nicotine replacement therapy (NRT) and not shown to be better than counselling. There was limited evidence that acupressure is superior to sham acupressure in the short term but no evidence about long-term effects. In an analysis of the subgroup of trials where the treatment included continuous stimulation, those trials which used continuous acupressure to points on the ear had the largest short-term effect. The evidence from two trials using laser stimulation was inconsistent. The seven trials of electrostimulation do not suggest evidence of benefit compared to sham electrostimulation. The review did not find consistent evidence that active acupuncture or related techniques increased the number of people who could successfully quit smoking. However, some techniques may be better than doing nothing, at least in the short term, and there is not enough evidence to dismiss the possibility that they might have an effect greater than placebo. They are likely to be less effective than current evidence-based interventions. They are safe when correctly applied."
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cochrane-simplification-train-1745 | cochrane-simplification-train-1745 | A total of 18 studies (systematic reviews or meta-analyses) met our inclusion criteria. Ten compared random allocation versus non-random allocation and nine compared adequate versus inadequate or unclear concealment of allocation within controlled trials. All studies were at high risk of bias. For the comparison of randomised versus non-randomised studies, four comparisons yielded inconclusive results (differed between outcomes or different modes of analysis); three comparisons showed similar results for random and non-random allocation; two comparisons had larger estimates of effect in non-randomised studies than in randomised trials; and two comparisons had larger estimates of effect in randomised than in non-randomised studies. Five studies found larger estimates of effect in trials with inadequate concealment of allocation than in trials with adequate concealment. The four other studies did not find statistically significant differences. The results of randomised and non-randomised studies sometimes differed. In some instances non-randomised studies yielded larger estimates of effect and in other instances randomised trials yielded larger estimates of effect. The results of controlled trials with adequate and inadequate/unclear concealment of allocation sometimes differed. When differences occurred, most often trials with inadequate or unclear allocation concealment yielded larger estimates of effects relative to controlled trials with adequate allocation concealment. However, it is not generally possible to predict the magnitude, or even the direction, of possible selection biases and consequent distortions of treatment effects from studies with non-random allocation or controlled trials with inadequate or unclear allocation concealment. | Randomised controlled trials (RCTs) use the play of chance to allocate participants to comparison groups to prevent selection bias. Other means of treatment allocation are more prone to bias because decisions about which treatment to use can be influenced by the preferences of the physician or patient. This review compares random allocation (allocated to treatment using a random method) versus non-random allocation (allocated to treatment using a non-random method, such as alternation or external, uncontrollable factors, with no clinical judgement involved) and controlled trials with adequate versus inadequate/unclear concealment of allocation. Concealed treatment allocation is best described in general terms as the process used to prevent foreknowledge of group assignment in a controlled trial (such as the use of sequentially numbered opaque, sealed envelopes). The results of randomised and non-randomised studies sometimes differed. Sometimes non-randomised studies yielded larger estimates of effect, and sometimes randomised trials yielded larger estimates of effect. On the other hand, not using concealed random allocation resulted in larger estimates of effect, but sometimes it resulted in similar estimates of effect (from harmful to beneficial or vice versa). It is a paradox that the unpredictability of random allocation is the best protection against the unpredictability of the extent to which non-randomised studies may be biased. | 10.1002/14651858.MR000012.pub3 | [
"Randomised controlled trials (RCTs) use the play of chance to allocate participants to comparison groups to prevent selection bias. Other means of treatment allocation are more prone to bias because decisions about which treatment to use can be influenced by the preferences of the physician or patient. This review compares random allocation (allocated to treatment using a random method) versus non-random allocation (allocated to treatment using a non-random method, such as alternation or external, uncontrollable factors, with no clinical judgement involved) and controlled trials with adequate versus inadequate/unclear concealment of allocation. Concealed treatment allocation is best described in general terms as the process used to prevent foreknowledge of group assignment in a controlled trial (such as the use of sequentially numbered opaque, sealed envelopes). The results of randomised and non-randomised studies sometimes differed. Sometimes non-randomised studies yielded larger estimates of effect, and sometimes randomised trials yielded larger estimates of effect. On the other hand, not using concealed random allocation resulted in larger estimates of effect, but sometimes it resulted in similar estimates of effect (from harmful to beneficial or vice versa). It is a paradox that the unpredictability of random allocation is the best protection against the unpredictability of the extent to which non-randomised studies may be biased."
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cochrane-simplification-train-1746 | cochrane-simplification-train-1746 | We included nine trials with low risk of bias, which assessed paracetamol for the treatment of pain in 728 infants. Painful procedures studied included heel lance, assisted vaginal birth, eye examination for retinopathy of prematurity assessment and postoperative care. Results of individual studies could not be combined in meta-analyses as the painful conditions, the use of paracetamol and comparison interventions and the outcome measures differed. Paracetamol compared with water, cherry elixir or EMLA cream (eutectic mixture of lidocaine and prilocaine) did not significantly reduce pain following heel lance. The Premature Infant Pain Profile score (PIPP) within three minutes following lancing was higher in the paracetamol group than in the oral glucose group (mean difference (MD) 2.21, 95% confidence interval (CI) 0.72 to 3.70; one study, 38 infants). Paracetamol did not reduce "modified facies scores" after assisted vaginal birth (one study, 119 infants). In another study (n = 123), the Échelle de Douleur et d'Inconfort du Nouveau-Né score at two hours of age was significantly higher in the group that received paracetamol suppositories than in the placebo suppositories group (MD 1.00, 95% CI 0.60 to 1.40). In that study, when infants were subjected to a heel lance at two to three days of age, Bernese Pain Scale for Neonates scores were higher in the paracetamol group than in the placebo group, and infants spent a longer time crying (MD 19 seconds, 95% CI 14 to 24). For eye examinations, no significant reduction in PIPP scores in the first or last 45 seconds of eye examination was reported, nor at five minutes after the eye examination. In one study (n = 81), the PIPP score was significantly higher in the paracetamol group than in the 24% sucrose group (MD 3.90, 95% CI 2.92 to 4.88). In one study (n = 114) the PIPP score during eye examination was significantly lower in the paracetamol group than in the water group (MD −2.70, 95% CI −3.55 to 1.85). For postoperative care following major surgery, the total amount of morphine (µg/kg) administered over 48 hours was significantly less among infants assigned to the paracetamol group than to the morphine group (MD −157 µg/kg, 95% CI −27 to −288). No adverse events were noted in any study. The quality of evidence according to GRADE was low. The paucity and low quality of existing data do not provide sufficient evidence to establish the role of paracetamol in reducing the effects of painful procedures in neonates. Paracetamol given after assisted vaginal birth may increase the response to later painful exposures. Paracetamol may reduce the total need for morphine following major surgery, and for this aspect of paracetamol use, further research is needed. | We identified nine studies that reported comparisons in 728 infants of paracetamol versus placebo or other pain-reducing interventions. The literature search was updated in May 2016. Paracetamol for heel lance did not reduce pain compared with placebo (water or cherry elixir) or compared with EMLA cream (eutectic mixture of lidocaine and prilocaine). Paracetamol use was associated with a stronger response to pain than was seen with glucose. Paracetamol did not reduce pain in infants exposed to vacuum extraction or forceps at birth, and their response to a subsequent heel lance at two to three days of life was increased compared with placebo. For eye examination, paracetamol was effective in reducing pain compared with water in one study, but the pain response was stronger among paracetamol-treated infants than in infants given 24% sucrose. In infants treated with paracetamol and morphine compared with morphine alone, the total amount of morphine required during the first 48 hours following major surgery to the chest or the abdomen was less in the paracetamol group. Paracetamol did not significantly reduce pain during heel lance. Paracetamol following assisted birth may increase the response to later exposure to painful interventions. Paraetamol may reduce the total need for morphine following major surgery, and further research is needed into this aspect of paracetamol use. In general the studies were of good quality but the numbers of infants enrolled in the different studies were small. The overall quality of evidence was low. | 10.1002/14651858.CD011219.pub4 | [
"We identified nine studies that reported comparisons in 728 infants of paracetamol versus placebo or other pain-reducing interventions. The literature search was updated in May 2016. Paracetamol for heel lance did not reduce pain compared with placebo (water or cherry elixir) or compared with EMLA cream (eutectic mixture of lidocaine and prilocaine). Paracetamol use was associated with a stronger response to pain than was seen with glucose. Paracetamol did not reduce pain in infants exposed to vacuum extraction or forceps at birth, and their response to a subsequent heel lance at two to three days of life was increased compared with placebo. For eye examination, paracetamol was effective in reducing pain compared with water in one study, but the pain response was stronger among paracetamol-treated infants than in infants given 24% sucrose. In infants treated with paracetamol and morphine compared with morphine alone, the total amount of morphine required during the first 48 hours following major surgery to the chest or the abdomen was less in the paracetamol group. Paracetamol did not significantly reduce pain during heel lance. Paracetamol following assisted birth may increase the response to later exposure to painful interventions. Paraetamol may reduce the total need for morphine following major surgery, and further research is needed into this aspect of paracetamol use. In general the studies were of good quality but the numbers of infants enrolled in the different studies were small. The overall quality of evidence was low."
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cochrane-simplification-train-1747 | cochrane-simplification-train-1747 | Twelve RCTs (n=545) with eight to 26 weeks follow-up met our inclusion criteria. The results of the individual trials were heterogeneous. Combining all trials, participants receiving magnesium supplements as compared to control did not significantly reduce SBP (mean difference: -1.3 mmHg, 95% CI: -4.0 to 1.5, I2=67%), but did statistically significantly reduce DBP (mean difference: -2.2 mmHg, 95% CI: -3.4 to -0.9, I2=47%). Sensitivity analyses excluding poor quality trials yielded similar results. Sub-group analyses and meta-regression indicated that heterogeneity between trials could not be explained by dose of magnesium, baseline blood pressure or the proportion of males among the participants. In view of the poor quality of included trials and the heterogeneity between trials, the evidence in favour of a causal association between magnesium supplementation and blood pressure reduction is weak and is probably due to bias. This is because poor quality studies generally tend to over-estimate the effects of treatment. Larger, longer duration and better quality double-blind placebo controlled trials are needed to assess the effect of magnesium supplementation on blood pressure and cardiovascular outcomes. | This review examined whether taking magnesium supplements could be recommended for treating adults with high blood pressure from no known cause. It reviewed 12 trials enrolling 545 people, which compared magnesium supplementation with a dummy drug (placebo) or no treatment, and measured blood pressure 8 weeks to 6 months later. The results of trials varied a lot: some trials found magnesium lowered blood pressure much more than placebo, while others found little difference between magnesium and placebo. On average, people receiving extra magnesium achieved slightly lower diastolic blood pressure at the end of trials. None of the studies reported any serious side effects of taking magnesium supplements. However, most included trials were of poor quality, so their results may not be reliable. The trials were not long enough or large enough to measure whether extra magnesium can reduce possible consequences of high blood pressure: death, heart attack or stroke. The review did not find robust evidence that oral magnesium supplementation reduces high blood pressure in adults. Larger, longer duration, better quality trials are needed to clarify whether magnesium supplementation can lower high blood pressure. | 10.1002/14651858.CD004640.pub2 | [
"This review examined whether taking magnesium supplements could be recommended for treating adults with high blood pressure from no known cause. It reviewed 12 trials enrolling 545 people, which compared magnesium supplementation with a dummy drug (placebo) or no treatment, and measured blood pressure 8 weeks to 6 months later. The results of trials varied a lot: some trials found magnesium lowered blood pressure much more than placebo, while others found little difference between magnesium and placebo. On average, people receiving extra magnesium achieved slightly lower diastolic blood pressure at the end of trials. None of the studies reported any serious side effects of taking magnesium supplements. However, most included trials were of poor quality, so their results may not be reliable. The trials were not long enough or large enough to measure whether extra magnesium can reduce possible consequences of high blood pressure: death, heart attack or stroke. The review did not find robust evidence that oral magnesium supplementation reduces high blood pressure in adults. Larger, longer duration, better quality trials are needed to clarify whether magnesium supplementation can lower high blood pressure."
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cochrane-simplification-train-1748 | cochrane-simplification-train-1748 | Data for the primary outcome (prevention of disease) were lacking. We performed a meta-analysis to pool the results of 20 studies with 5874 participants in an immunogenicity analysis and 5232 participants in the reactogenicity analysis. There were no data on clinical outcomes for the primary outcome (prevention of disease) and all studies used immunogenicity and reactogenicity (adverse events). The number of vaccine doses differed significantly between the studies. Heterogeneous interventions, study location, healthcare environment and combining research across disparate geographical locations, may have lead to bias. The risk of bias was unclear across most of the included studies. Comparisons found little heterogeneity. In two immunological responses the combined vaccine achieved lower responses than the separate vaccines for HIB and tetanus. No significant differences in immunogenicity were found for pertussis, diphtheria, polio and hepatitis B. Serious adverse events were comparable with mainly hospitalisation and acute bronchiolitis cases. Minor adverse events such as pain and redness were more common in children given the combined vaccine. Overall, the direction shown by the results is in favour of the DTPw (diptheria-tetanus-whole cell pertussis)-HBV-HIB vaccine rather than the DTPa (diptheria-tetanus-acellular pertussis)-HBV-HIB vaccine when compared to the separate vaccines (size of effect: risk ratio (RR) 1.43; 95% confidence interval (CI) 0.98 to 2.10, for 5269 participants). We could not conclude that the immune responses elicited by the combined vaccine were different from or equivalent to the separate vaccines. There was significantly less immunological response for HIB and tetanus and more local reactions in the combined injections. However, these differences rely mostly on one study each. Studies did not use an intention-to-treat (ITT) analysis and we were uncertain about the risk of bias in many of the studies. These results are therefore inconclusive. Studies addressing clinical end points whenever possible, using correct methodology and a large enough sample size should be conducted. | We included 20 studies with 5874 participants in the immunogenicity analysis and 5232 in the reactogenicity analysis. In two immunological responses, the combined vaccine achieved lower responses than the separate vaccines for HIB and tetanus. We did not find any significant differences in immunogenicity for pertussis-diphtheria-polio and hepatitis B. Serious adverse events were comparable. Minor adverse events were more common with the combined vaccine. Overall, the level of evidence provided by the studies was low and we could not conclude that the immune responses with the combined vaccine were equivalent to the separate injections. | 10.1002/14651858.CD005530.pub3 | [
"We included 20 studies with 5874 participants in the immunogenicity analysis and 5232 in the reactogenicity analysis. In two immunological responses, the combined vaccine achieved lower responses than the separate vaccines for HIB and tetanus. We did not find any significant differences in immunogenicity for pertussis-diphtheria-polio and hepatitis B. Serious adverse events were comparable. Minor adverse events were more common with the combined vaccine. Overall, the level of evidence provided by the studies was low and we could not conclude that the immune responses with the combined vaccine were equivalent to the separate injections."
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cochrane-simplification-train-1749 | cochrane-simplification-train-1749 | Thirteen studies (1053 women) reported the accuracy of 3D SIS for focal uterine abnormalities; 11 of these (846 women) were suitable for meta-analysis, and eight reported accuracy according to the type of focal abnormality. The design of the included studies seems applicable. The main problem involving the quality of included studies is insufficient reporting of study methods, resulting in unclear risk of bias for several of the quality domains assessed. Therefore, we considered the overall quality of the evidence as low. The summary estimate (11 studies reporting absence or presence of abnormality at 3D SIS) for sensitivity was 94.5% (95% confidence interval (CI) 90.6% to 96.9%) and for specificity 99.4% (95% CI 96.2% to 99.9%). Meta-analysis of the eight studies (N = 716) directly comparing 2D SIS versus 3D SIS showed summary sensitivity of 96.9% (95% CI 91.9% to 98.8%) and summary specificity of 99.5% (95% CI 96.1% to 100%) for 3D SIS. For 2D SIS, summary sensitivity was 90.9% (95% CI 81.2% to 95.8%) and summary specificity was 96.3% (95% CI 86.1% to 99.1%). The difference in accuracy between 2D SIS and 3D SIS was non-significant (P values of 0.07 for sensitivity and 0.10 for specificity). Low-quality evidence suggests that 3D SIS may be very accurate in detecting intracavitary abnormalities. Meta-analysis revealed no statistically significant differences between 2D SIS and 3D SIS. Summary sensitivity and summary specificity are higher for 3D SIS, but margins of improvement are limited because 2D SIS is already very accurate. When the technology and appropriate expertise are available, 3D SIS offers an alternative to 2D SIS. Both 2D SIS and 3D SIS should be considered alternatives to diagnostic hysteroscopy when intracavitary pathology is suspected in subfertile women and in those with abnormal uterine bleeding. | Review authors searched for studies published from inception until March 2016 and found 13 studies (in total 1053 women), eight of which directly compared 3D SIS versus 2D SIS. Data included all women reporting abnormal menstrual bleeding or difficulty getting pregnant. The number of patients in these studies varied from 23 to 180 women. In all studies, researchers checked the results of 2D SIS and 3D SIS against results obtained when a camera was used to look inside the womb (hysteroscopy); this is expected to give the true picture but is also more painful for the patient. All studies were performed in the usual way. Some studies did not report several items that might have influenced the results. For example, not all studies made it clear that the person evaluating the ultrasound pictures was unaware of the hysteroscopy results, and vice versa. The main problem involving the quality of included studies is insufficient reporting of study methods, resulting in unclear risk of bias for several of the quality domains assessed. Therefore, review authors considered the overall quality of the evidence as low. Low-quality evidence suggests that 3D SIS may be very accurate in detecting polyps and fibroids. Our analysis revealed no clear differences between 2D SIS and 3D SIS. Summary results are higher for 3D SIS but margins of improvement are limited because 2D SIS is already very accurate. Results show that 2D SIS missed a fibroid or polyp in 9 of 100 women and 3D SIS missed a polyp or fibroid in 3 of 100 women who had them. In 4 of 100 women, 2D SIS indicated the presence of polyps or fibroids when there were none, and in less than 1 in 100 women, 3D SIS was wrong. In theory, if both tests were used in a group of 1000 women with abnormal menstrual bleeding, 300 with fibroids or polyps, 27 of the 300 women with polyps/fibroids will be missed by 2D SIS, and 9 of 300 will be missed by 3D SIS. 3D SIS is an alternative to 2D SIS for which the technology and appropriate expertise are available. Both 2D SIS and 3D SIS should be considered alternatives to diagnostic hysteroscopy when intracavitary pathology is suspected in subfertile women and in those with abnormal uterine bleeding. | 10.1002/14651858.CD011126.pub2 | [
"Review authors searched for studies published from inception until March 2016 and found 13 studies (in total 1053 women), eight of which directly compared 3D SIS versus 2D SIS. Data included all women reporting abnormal menstrual bleeding or difficulty getting pregnant. The number of patients in these studies varied from 23 to 180 women. In all studies, researchers checked the results of 2D SIS and 3D SIS against results obtained when a camera was used to look inside the womb (hysteroscopy); this is expected to give the true picture but is also more painful for the patient. All studies were performed in the usual way. Some studies did not report several items that might have influenced the results. For example, not all studies made it clear that the person evaluating the ultrasound pictures was unaware of the hysteroscopy results, and vice versa. The main problem involving the quality of included studies is insufficient reporting of study methods, resulting in unclear risk of bias for several of the quality domains assessed. Therefore, review authors considered the overall quality of the evidence as low. Low-quality evidence suggests that 3D SIS may be very accurate in detecting polyps and fibroids. Our analysis revealed no clear differences between 2D SIS and 3D SIS. Summary results are higher for 3D SIS but margins of improvement are limited because 2D SIS is already very accurate. Results show that 2D SIS missed a fibroid or polyp in 9 of 100 women and 3D SIS missed a polyp or fibroid in 3 of 100 women who had them. In 4 of 100 women, 2D SIS indicated the presence of polyps or fibroids when there were none, and in less than 1 in 100 women, 3D SIS was wrong. In theory, if both tests were used in a group of 1000 women with abnormal menstrual bleeding, 300 with fibroids or polyps, 27 of the 300 women with polyps/fibroids will be missed by 2D SIS, and 9 of 300 will be missed by 3D SIS. 3D SIS is an alternative to 2D SIS for which the technology and appropriate expertise are available. Both 2D SIS and 3D SIS should be considered alternatives to diagnostic hysteroscopy when intracavitary pathology is suspected in subfertile women and in those with abnormal uterine bleeding."
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cochrane-simplification-train-1750 | cochrane-simplification-train-1750 | Four studies met the inclusion criteria (331 participants), with two studies producing a statistically and clinically significant benefit in favour of the intervention for dyspnoea post exercise.The quality of life domain for all four included studies produced a statistically significant benefit for the subcategories of dyspnoea and fatigue, in favour of the oxygen group (dyspnoea mean difference (MD) 0.28, 95% confidence interval (CI) 0.10 to 0.45; P value 0.002; fatigue MD 0.17, 95% CI 0.04 to 0.31; P value 0.009). No evidence of any effect was reported for survival, and limited benefits were observed for exercise capacity (as measured by step test and distance walk test), with one study showing a statistically significant improvement in the number of steps taken in the oxygen group for group N-of-1 studies only. No other statistically significant benefits were observed for exercise capacity among the other trials or individual N-of-1 studies. In patients with COPD with moderate hypoxia, current evidence on ambulatory oxygen therapy reveals improvements in dyspnoea post exercise and in the dyspnoea and fatigue domain of quality of life. However, evidence for the clinical utility and effectiveness of ambulatory oxygen in improving mortality and exercise capacity was not evident in this review. Methodologically rigorous RCTs with sufficient power to detect a difference are required to investigate the role of ambulatory oxygen in the management of COPD. | We looked at randomised controlled trials that compared ambulatory oxygen versus a placebo (normal air). We found four studies on 331 people with a mean age of 71 years. Two of the included studies were from Australia, one from New Zealand and one from Canada. The method of oxygen delivery and the dose of oxygen varied, although equipment in all instances consisted of light-weight or portable cylinders with flow ranging from 3 L/min to 6 L/min. Final follow-up was reported as 12 weeks for three studies and two weeks for the Nonoyama study. We found that ambulatory oxygen therapy reduced breathlessness and decreased the number of patients who felt tired. However, the distance that people could walk in five to six minutes and survival (death rate) did not change. The overall quality of evidence from the studies in this review was moderate. The way the studies were conducted (methods) was not fully reported in all cases. Most studies were lacking the pre-published study plan (protocol). From this review, it is not possible to know whether ambulatory oxygen therapy should be provided during exercise or for day-to-day activities for patients with COPD who are not severely hypoxaemic at rest. This Cochrane plain language summary is up-to-date as of November 2012. | 10.1002/14651858.CD000238.pub2 | [
"We looked at randomised controlled trials that compared ambulatory oxygen versus a placebo (normal air). We found four studies on 331 people with a mean age of 71 years. Two of the included studies were from Australia, one from New Zealand and one from Canada. The method of oxygen delivery and the dose of oxygen varied, although equipment in all instances consisted of light-weight or portable cylinders with flow ranging from 3 L/min to 6 L/min. Final follow-up was reported as 12 weeks for three studies and two weeks for the Nonoyama study. We found that ambulatory oxygen therapy reduced breathlessness and decreased the number of patients who felt tired. However, the distance that people could walk in five to six minutes and survival (death rate) did not change. The overall quality of evidence from the studies in this review was moderate. The way the studies were conducted (methods) was not fully reported in all cases. Most studies were lacking the pre-published study plan (protocol). From this review, it is not possible to know whether ambulatory oxygen therapy should be provided during exercise or for day-to-day activities for patients with COPD who are not severely hypoxaemic at rest. This Cochrane plain language summary is up-to-date as of November 2012."
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cochrane-simplification-train-1751 | cochrane-simplification-train-1751 | We included 34 trials with 2848 participants; 26 studies were parallel-group design (2725 participants) and eight used a cross-over design (123 participants). Only three included studies reported data for infants or children. Two further studies (76 participants) are awaiting classification. There was no overall statistical difference in artificial airway occlusion (RR 1.59, 95% CI 0.60 to 4.19; participants = 2171; studies = 15; I2 = 54%), mortality (RR 1.03, 95% CI 0.89 to 1.20; participants = 1951; studies = 12; I2 = 0%) or pneumonia (RR 0.93, 95% CI 0.73 to 1.19; participants = 2251; studies = 13; I2 = 27%). There was some evidence that hydrophobic HMEs may reduce the risk of pneumonia compared to HHs (RR 0.48, 95% CI 0.28 to 0.82; participants = 469; studies = 3; I2 = 0%).. The overall GRADE quality of evidence was low. Although the overall methodological risk of bias was generally unclear for selection and detection bias and low risk for follow-up, the selection of study participants who were considered suitable for HME and in some studies removing participants from the HME group made the findings of this review difficult to generalize. The available evidence suggests no difference between HMEs and HHs on the primary outcomes of airway blockages, pneumonia and mortality. However, the overall low quality of this evidence makes it difficult to be confident about these findings. Further research is needed to compare HMEs to HHs, particularly in paediatric and neonatal populations, but research is also needed to more effectively compare different types of HME to each other as well as different types of HH. | We searched for studies up to May 2017. We included 34 trials in the review, with 2848 participants from 12 countries. The majority of trials (27) were set in an intensive care unit with one in a neonatal intensive care unit. The remaining seven studies were done in an operating department. Participants were infants in three studies with adults (average age of 40 to 69 years) in the remainder. There was no overall difference in the rates of airway blockage, pneumonia or death in adults who were ventilated through heat and moisture exchangers compared to adults ventilated through a heated humidifier. There was some evidence that the occurrence of pneumonia may be lowered by using heat and moisture exchangers that capture less moisture. There was not enough information to make any conclusions about either of these methods in children or infants. The overall low quality of this evidence was low, making it difficult to be confident about these findings. | 10.1002/14651858.CD004711.pub3 | [
"We searched for studies up to May 2017. We included 34 trials in the review, with 2848 participants from 12 countries. The majority of trials (27) were set in an intensive care unit with one in a neonatal intensive care unit. The remaining seven studies were done in an operating department. Participants were infants in three studies with adults (average age of 40 to 69 years) in the remainder. There was no overall difference in the rates of airway blockage, pneumonia or death in adults who were ventilated through heat and moisture exchangers compared to adults ventilated through a heated humidifier. There was some evidence that the occurrence of pneumonia may be lowered by using heat and moisture exchangers that capture less moisture. There was not enough information to make any conclusions about either of these methods in children or infants. The overall low quality of this evidence was low, making it difficult to be confident about these findings."
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cochrane-simplification-train-1752 | cochrane-simplification-train-1752 | The review authors identified 14 relevant RCTs. They excluded four trials. The 10 included studies, four of which have been added in this update, included a total of 258 participants. Six studies compared an immunosuppressant or immunomodulator with placebo control, and four studies compared two immunosuppressant regimes with each other. Most of the studies were small (the largest had 62 participants) and many of the reports contained insufficient information to assess risk of bias. Amongst the six studies comparing immunosuppressant with placebo, one study, investigating intravenous immunoglobulin (IVIg), showed statistically significant improvement in scores of muscle strength in the IVIg group over three months. Another study investigating etanercept showed some evidence of a longer median time to relapse in the etanercept group, a secondary outcome in this review, but no improvement in other assessed outcomes. The other four randomised placebo-controlled trials assessed either plasma exchange and leukapheresis, eculizumab, infliximab or azathioprine against placebo and all produced negative results. Three of the four studies comparing two immunosuppressant regimes (azathioprine with methotrexate, ciclosporin with methotrexate, and intramuscular methotrexate with oral methotrexate plus azathioprine) showed no statistically significant difference in efficacy between the treatment regimes. The fourth study comparing pulsed oral dexamethasone with daily oral prednisolone and found that the dexamethasone regime had a shorter median time to relapse but fewer side effects. Immunosuppressants were associated with significant side effects. This systematic review highlights the lack of high quality RCTs that assess the efficacy and toxicity of immunosuppressants in inflammatory myositis. | Amongst the six studies comparing immunosuppressant with placebo, one study, investigating intravenous immunoglobulin (IVIg), showed statistically significant improvement in scores of muscle strength in the IVIg group over three months. Another study investigating etanercept showed some evidence of a longer median time to relapse in the etanercept group, a secondary outcome in this review, but no improvement in other assessed outcomes. The other four randomised placebo-controlled trials assessed either plasma exchange and leukapheresis, eculizumab, infliximab or azathioprine against placebo and all produced negative results. Three of the four studies comparing two immunosuppressant regimes (azathioprine with methotrexate, ciclosporin with methotrexate, and intramuscular methotrexate with oral methotrexate plus azathioprine) showed no statistically significant difference in efficacy between the treatment regimes. The fourth study comparing pulsed oral dexamethasone with daily oral prednisolone and found that the dexamethasone regime had a shorter median time to relapse but fewer side effects. Most of the studies were small (the largest had 62 participants) and many of the reports contained insufficient information to assess risk of bias. Immunosuppressants were associated with significant side effects. The small number of RCTs of immunosuppressants and immunomodulatory therapies are inadequate to decide whether these agents are beneficial in dermatomyositis and polymyositis. Two small trials, one of IVIg in dermatomyositis, the other of etanercept in dermatomyositis suggested that they are beneficial. More RCTs are needed. | 10.1002/14651858.CD003643.pub4 | [
"Amongst the six studies comparing immunosuppressant with placebo, one study, investigating intravenous immunoglobulin (IVIg), showed statistically significant improvement in scores of muscle strength in the IVIg group over three months. Another study investigating etanercept showed some evidence of a longer median time to relapse in the etanercept group, a secondary outcome in this review, but no improvement in other assessed outcomes. The other four randomised placebo-controlled trials assessed either plasma exchange and leukapheresis, eculizumab, infliximab or azathioprine against placebo and all produced negative results. Three of the four studies comparing two immunosuppressant regimes (azathioprine with methotrexate, ciclosporin with methotrexate, and intramuscular methotrexate with oral methotrexate plus azathioprine) showed no statistically significant difference in efficacy between the treatment regimes. The fourth study comparing pulsed oral dexamethasone with daily oral prednisolone and found that the dexamethasone regime had a shorter median time to relapse but fewer side effects. Most of the studies were small (the largest had 62 participants) and many of the reports contained insufficient information to assess risk of bias. Immunosuppressants were associated with significant side effects. The small number of RCTs of immunosuppressants and immunomodulatory therapies are inadequate to decide whether these agents are beneficial in dermatomyositis and polymyositis. Two small trials, one of IVIg in dermatomyositis, the other of etanercept in dermatomyositis suggested that they are beneficial. More RCTs are needed."
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cochrane-simplification-train-1753 | cochrane-simplification-train-1753 | We identified 3745 citations after de-duplication of search results. We excluded 3619 records during title and abstract review. We assessed 126 full-text papers for inclusion in the review, but only one study providing data from 46 people met our eligibility criteria. The included RCT had methodological limitations. We rated it as having high risk of performance and detection bias because of lack of blinding, and as having high risk of attrition bias because study authors did not report reasons for dropouts and did not integrate data from dropouts into the analysis. The included RCT compared preventive use of bright white light (2500 lux via visors), infrared light (0.18 lux via visors) and no light treatment. Overall, white light and infrared light therapy reduced the incidence of SAD numerically compared with no light therapy. In all, 43% (6/14) of participants in the bright light group developed SAD, as well as 33% (5/15) in the infrared light group and 67% (6/9) in the non-treatment group. Bright light therapy reduced the risk of SAD incidence by 36%; however, the 95% confidence interval (CI) was very broad and included both possible effect sizes in favour of bright light therapy and those in favour of no light therapy (risk ratio (RR) 0.64, 95% CI 0.30 to 1.38; 23 participants, very low-quality evidence). Infrared light reduced the risk of SAD by 50% compared with no light therapy, but the CI was also too broad to allow precise estimations of effect size (RR 0.50, 95% CI 0.21 to 1.17; 24 participants, very low-quality evidence). Comparison of both forms of preventive light therapy versus each other yielded similar rates of incidence of depressive episodes in both groups (RR 1.29, 95% CI 0.50 to 3.28; 29 participants, very low-quality evidence). Reasons for downgrading evidence quality included high risk of bias of the included study, imprecision and other limitations, such as self-rating of outcomes, lack of checking of compliance throughout the study duration and insufficient reporting of participant characteristics. Investigators provided no information on adverse events. We could find no studies that compared light therapy versus other interventions of interest such as second-generation antidepressants, psychological therapies, melatonin or agomelatine. Evidence on light therapy as preventive treatment for people with a history of SAD is limited. Methodological limitations and the small sample size of the only available study have precluded review author conclusions on effects of light therapy for SAD. Given that comparative evidence for light therapy versus other preventive options is limited, the decision for or against initiating preventive treatment of SAD and the treatment selected should be strongly based on patient preferences. | The quality of evidence for all outcomes was very low, so we can draw no conclusions about whether light therapy is effective in preventing winter depression. The included study provided no information on side effects of light therapy. Doctors need to discuss with patients considering preventive treatment the advantages and disadvantages of light therapy and other potentially preventive treatments for winter depression, such as drug treatments, psychological therapies or lifestyle interventions. As no available studies have compared these treatments, treatment selection should be strongly based on patient preferences. The review authors recommend that future studies should directly compare light therapy versus other treatments, such as drug treatments, psychological therapies or lifestyle interventions to determine the best treatment for preventing winter depression. | 10.1002/14651858.CD011269.pub3 | [
"The quality of evidence for all outcomes was very low, so we can draw no conclusions about whether light therapy is effective in preventing winter depression. The included study provided no information on side effects of light therapy. Doctors need to discuss with patients considering preventive treatment the advantages and disadvantages of light therapy and other potentially preventive treatments for winter depression, such as drug treatments, psychological therapies or lifestyle interventions. As no available studies have compared these treatments, treatment selection should be strongly based on patient preferences. The review authors recommend that future studies should directly compare light therapy versus other treatments, such as drug treatments, psychological therapies or lifestyle interventions to determine the best treatment for preventing winter depression."
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cochrane-simplification-train-1754 | cochrane-simplification-train-1754 | We included 38 RCTs (6016 participants). There were four main comparisons: chlorhexidine (CHX) mouthrinse or gel versus placebo/usual care; toothbrushing versus no toothbrushing; powered versus manual toothbrushing; and comparisons of oral care solutions. We assessed the overall risk of bias as low in five trials (13%), high in 26 trials (68%), and unclear in seven trials (18%). We did not consider the risk of bias to be serious when assessing the quality of evidence (GRADE) for VAP incidence, but we downgraded other outcomes for risk of bias. High quality evidence from 18 RCTs (2451 participants, 86% adults) shows that CHX mouthrinse or gel, as part of OHC, reduces the risk of VAP compared to placebo or usual care from 24% to about 18% (RR 0.75, 95% confidence intervals (CI) 0.62 to 0.91, P = 0.004, I2 = 35%). This is equivalent to a number needed to treat for an additional beneficial outcome (NNTB) of 17 (95% CI 9 to 50), which indicates that for every 17 ventilated patients in intensive care receiving OHC including chlorhexidine, one outcome of VAP would be prevented. There is no evidence of a difference between CHX and placebo/usual care for the outcomes of mortality (RR 1.09, 95% CI 0.96 to 1.23, P = 0.20, I2 = 0%, 14 RCTs, 2014 participants, moderate quality evidence), duration of mechanical ventilation (MD -0.09 days, 95% CI -1.73 to 1.55 days, P = 0.91, I2 = 36%, five RCTs, 800 participants, low quality evidence), or duration of intensive care unit (ICU) stay (MD 0.21 days, 95% CI -1.48 to 1.89 days, P = 0.81, I2 = 9%, six RCTs, 833 participants, moderate quality evidence). There is insufficient evidence to determine the effect of CHX on duration of systemic antibiotics, oral health indices, caregivers' preferences or cost. Only two studies reported any adverse effects, and these were mild with similar frequency in CHX and control groups. We are uncertain as to the effects of toothbrushing (± antiseptics) on the outcomes of VAP (RR 0.69, 95% CI 0.44 to 1.09, P = 0.11, I2 = 64%, five RCTs, 889 participants, very low quality evidence) and mortality (RR 0.87, 95% CI 0.70 to 1.09, P = 0.24, I2 = 0%, five RCTs, 889 participants, low quality evidence) compared to OHC without toothbrushing (± antiseptics). There is insufficient evidence to determine whether toothbrushing affects duration of mechanical ventilation, duration of ICU stay, use of systemic antibiotics, oral health indices, adverse effects, caregivers' preferences or cost. Only one trial (78 participants) compared use of a powered toothbrush with a manual toothbrush, providing insufficient evidence to determine the effect on any of the outcomes of this review. Fifteen trials compared various other oral care solutions. There is very weak evidence that povidone iodine mouthrinse is more effective than saline/placebo (RR 0.69, 95% CI 0.50 to 0.95, P = 0.02, I2 = 74%, three studies, 356 participants, high risk of bias), and that saline rinse is more effective than saline swab (RR 0.47, 95% CI 0.37 to 0.62, P < 0.001, I2 = 84%, four studies, 488 participants, high risk of bias) in reducing VAP. Due to variation in comparisons and outcomes among trials, there is insufficient evidence concerning the effects of other oral care solutions. OHC including chlorhexidine mouthwash or gel reduces the risk of developing ventilator-associated pneumonia in critically ill patients from 24% to about 18%. However, there is no evidence of a difference in the outcomes of mortality, duration of mechanical ventilation or duration of ICU stay. There is no evidence that OHC including both antiseptics and toothbrushing is different from OHC with antiseptics alone, and some weak evidence to suggest that povidone iodine mouthrinse is more effective than saline/placebo, and saline rinse is more effective than saline swab in reducing VAP. There is insufficient evidence to determine whether powered toothbrushing or other oral care solutions are effective in reducing VAP. There is also insufficient evidence to determine whether any of the interventions evaluated in the studies are associated with adverse effects. | This review of studies was carried out through Cochrane Oral Health, and the evidence is current up to 17 December 2015. We included 38 research studies but only a few (13%) of the studies were well conducted and described. All of the studies took place in ICUs in hospitals. In total there were 6016 participants randomly allocated to treatment. Participants were critically ill and required assistance from nursing staff for their oral hygiene care. Most of the studies involved adults only, but the participants were children in three of the studies, and newborns in one study. We grouped studies into four main comparisons. 1. Chlorhexidine antiseptic mouthrinse or gel compared to placebo (treatment without the active ingredient chlorhexidine) or usual care, (with or without toothbrushing) 2. Toothbrushing compared with no toothbrushing (with or without antiseptics) 3. Powered compared with manual toothbrushing 4. Oral care solutions with other solutions We found high quality evidence that chlorhexidine, either as a mouthrinse or a gel, reduces the risk of VAP from 24% to about 18%. For every 17 people on ventilators for more than 48 hours in intensive care, the use of oral hygiene care including chlorhexidine will prevent one person developing VAP. However, we found no evidence that oral hygiene care with chlorhexidine makes a difference to the numbers of patients who die in ICU, or to the number of days on mechanical ventilation or days in ICU. We have only limited evidence on the effects of toothbrushing (with or without antiseptics) and oral care without toothbrushing (with or without antiseptics) on the risk of developing VAP. Three studies showed some weak evidence of a reduction in VAP with povidone iodine antiseptic mouthrinse compared to placebo/saline. Four studies showed some weak evidence of a reduction in VAP with saline rinse compared to saline swab. There was insufficient evidence to determine whether any of the interventions evaluated in the studies are associated with any unwanted side effects. The evidence presented was limited by how well the included studies were done and reported. Only 13% of the studies were well conducted and well described. For a number of outcomes, there was not enough information to draw a solid conclusion. | 10.1002/14651858.CD008367.pub3 | [
"This review of studies was carried out through Cochrane Oral Health, and the evidence is current up to 17 December 2015. We included 38 research studies but only a few (13%) of the studies were well conducted and described. All of the studies took place in ICUs in hospitals. In total there were 6016 participants randomly allocated to treatment. Participants were critically ill and required assistance from nursing staff for their oral hygiene care. Most of the studies involved adults only, but the participants were children in three of the studies, and newborns in one study. We grouped studies into four main comparisons. 1. Chlorhexidine antiseptic mouthrinse or gel compared to placebo (treatment without the active ingredient chlorhexidine) or usual care, (with or without toothbrushing) 2. Toothbrushing compared with no toothbrushing (with or without antiseptics) 3. Powered compared with manual toothbrushing 4. Oral care solutions with other solutions We found high quality evidence that chlorhexidine, either as a mouthrinse or a gel, reduces the risk of VAP from 24% to about 18%. For every 17 people on ventilators for more than 48 hours in intensive care, the use of oral hygiene care including chlorhexidine will prevent one person developing VAP. However, we found no evidence that oral hygiene care with chlorhexidine makes a difference to the numbers of patients who die in ICU, or to the number of days on mechanical ventilation or days in ICU. We have only limited evidence on the effects of toothbrushing (with or without antiseptics) and oral care without toothbrushing (with or without antiseptics) on the risk of developing VAP. Three studies showed some weak evidence of a reduction in VAP with povidone iodine antiseptic mouthrinse compared to placebo/saline. Four studies showed some weak evidence of a reduction in VAP with saline rinse compared to saline swab. There was insufficient evidence to determine whether any of the interventions evaluated in the studies are associated with any unwanted side effects. The evidence presented was limited by how well the included studies were done and reported. Only 13% of the studies were well conducted and well described. For a number of outcomes, there was not enough information to draw a solid conclusion."
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cochrane-simplification-train-1755 | cochrane-simplification-train-1755 | We identified 19 studies of which we included five, involving 3130 women. We excluded eight studies, one awaits classification and five are ongoing studies. All the included studies looked at women in active labour and at low risk of potentially requiring a general anaesthetic. One study looked at complete restriction versus giving women the freedom to eat and drink at will; two studies looked at water only versus giving women specific fluids and foods and two studies looked at water only versus giving women carbohydrate drinks. When comparing any restriction of fluids and food versus women given some nutrition in labour, the meta-analysis was dominated by one study undertaken in a highly medicalised environment. There were no statistically significant differences identified in: caesarean section (average risk ratio (RR) 0.89, 95% confidence interval (CI) 0.63 to 1.25, five studies, 3103 women), operative vaginal births (average RR 0.98, 95% CI 0.88 to 1.10, five studies, 3103 women) and Apgar scores less than seven at five minutes (average RR 1.43, 95% CI 0.77 to 2.68, four studies, 2902 infants), nor in any of the other outcomes assessed. Women's views were not assessed. The pooled data were insufficient to assess the incidence of Mendelson's syndrome, an extremely rare outcome. Other comparisons showed similar findings, except one study did report a significant increase in caesarean sections for women taking carbohydrate drinks in labour compared with water only, but these results should be interpreted with caution as the sample size was small. Since the evidence shows no benefits or harms, there is no justification for the restriction of fluids and food in labour for women at low risk of complications. No studies looked specifically at women at increased risk of complications, hence there is no evidence to support restrictions in this group of women. Conflicting evidence on carbohydrate solutions means further studies are needed and it is critical in any future studies to assess women's views. | This review looked at any restriction of fluids and food in labour compared with women able to eat and drink. The review identified five studies involving 3130 women. Most studies had looked at specific foods being recommended, though one study let women choose what they wished to eat and drink. The review identified no benefits or harms of restricting foods and fluids during labour in women at low risk of needing anaesthesia. There were no studies identified on women at increased risk of needing anaesthesia. None of the studies looked at women's views of restricting fluids and foods during labour. Thus, given these findings, women should be free to eat and drink in labour, or not, as they wish. | 10.1002/14651858.CD003930.pub3 | [
"This review looked at any restriction of fluids and food in labour compared with women able to eat and drink. The review identified five studies involving 3130 women. Most studies had looked at specific foods being recommended, though one study let women choose what they wished to eat and drink. The review identified no benefits or harms of restricting foods and fluids during labour in women at low risk of needing anaesthesia. There were no studies identified on women at increased risk of needing anaesthesia. None of the studies looked at women's views of restricting fluids and foods during labour. Thus, given these findings, women should be free to eat and drink in labour, or not, as they wish."
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cochrane-simplification-train-1756 | cochrane-simplification-train-1756 | We included seven studies, of which five studies with 4798 participants provided data for analyses in this review. The mean ages of the participants ranged from 56 to 66 years. All participants had a history of adenomas, which had been removed to achieve a polyp-free colon at baseline. The interventions were wheat bran fibre, ispaghula husk, or a comprehensive dietary intervention with high fibre whole food sources alone or in combination. The comparators were low-fibre (2 to 3 g per day), placebo, or a regular diet. The combined data showed no statistically significant difference between the intervention and control groups for the number of participants with at least one adenoma (5 RCTs, n = 3641, RR 1.04, 95% CI 0.95 to 1.13, low-quality evidence), more than one adenoma (2 RCTs, n = 2542, RR 1.06, 95% CI 0.94 to 1.20, low-quality evidence), or at least one adenoma 1 cm or greater (4 RCTs, n = 3224, RR 0.99, 95% CI 0.82 to 1.20, low-quality evidence) at three to four years. The results on the number of participants diagnosed with colorectal cancer favoured the control group over the dietary fibre group (2 RCTS, n = 2794, RR 2.70, 95% CI 1.07 to 6.85, low-quality evidence). After 8 years of comprehensive dietary intervention, no statistically significant difference was found in the number of participants with at least one recurrent adenoma (1 RCT, n = 1905, RR 0.97, 95% CI 0.78 to 1.20), or with more than one adenoma (1 RCT, n = 1905, RR 0.89, 95% CI 0.64 to 1.24). More participants given ispaghula husk group had at least one recurrent adenoma than the control group (1 RCT, n = 376, RR 1.45, 95% CI 1.01 to 2.08). Other analyses by types of fibre intervention were not statistically significant. The overall dropout rate was over 16% in these trials with no reasons given for these losses. Sensitivity analysis incorporating these missing data shows that none of the results can be considered as robust; when the large numbers of participants lost to follow-up were assumed to have had an event or not, the results changed sufficiently to alter the conclusions that we would draw. Therefore, the reliability of the findings may have been compromised by these missing data (attrition bias) and should be interpreted with caution. There is a lack of evidence from existing RCTs to suggest that increased dietary fibre intake will reduce the recurrence of adenomatous polyps in those with a history of adenomatous polyps within a two to eight year period. However, these results may be unreliable and should be interpreted cautiously, not only because of the high rate of loss to follow-up, but also because adenomatous polyp is a surrogate outcome for the unobserved true endpoint CRC. Longer-term trials with higher dietary fibre levels are needed to enable confident conclusion. | Seven studies met the inclusion criteria. However, only five studies with 4798 participants provided data for this review. The mean ages of the participants ranged from 56 to 66 years. The participants all had a history of adenomas and would have had at least one procedure to remove them to achieve a polyp-free colon at baseline.The interventions in the included studies were wheat bran fibre, ispaghula husk, or a comprehensive dietary intervention with high fibre whole food sources used alone or in combination. These were compared to low-fibre (2 to 3 g per day), placebo, or a regular diet. This review found that increasing fibre in a Western diet for two to eight years did not lower the risk of bowel cancer. Paradoxically, after four years participants receiving dietary fibre had higher rates of bowel cancer compared with the control group, with the absolute increase in risk being one percent. The quality of evidence was low. The high risk of bias of included studies, small sample size, large number of missing data and the use of indirect measures gave us little confidence on the findings of this review. | 10.1002/14651858.CD003430.pub2 | [
"Seven studies met the inclusion criteria. However, only five studies with 4798 participants provided data for this review. The mean ages of the participants ranged from 56 to 66 years. The participants all had a history of adenomas and would have had at least one procedure to remove them to achieve a polyp-free colon at baseline.The interventions in the included studies were wheat bran fibre, ispaghula husk, or a comprehensive dietary intervention with high fibre whole food sources used alone or in combination. These were compared to low-fibre (2 to 3 g per day), placebo, or a regular diet. This review found that increasing fibre in a Western diet for two to eight years did not lower the risk of bowel cancer. Paradoxically, after four years participants receiving dietary fibre had higher rates of bowel cancer compared with the control group, with the absolute increase in risk being one percent. The quality of evidence was low. The high risk of bias of included studies, small sample size, large number of missing data and the use of indirect measures gave us little confidence on the findings of this review."
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cochrane-simplification-train-1757 | cochrane-simplification-train-1757 | This review includes 11 studies with 1074 participants. Outcome metrics for which data were available (haemoglobin concentration, quality-of-life scores, serum ferritin, peak oxygen consumption and mild to moderate adverse effects) were similar across the included studies. The incidence of severe adverse events across all studies was zero. None of the studies measured bacterial infection as a specific outcome metric. Substantial heterogeneity influenced the results of the meta-analysis, arising from differing patient populations, definitions of iron deficiency, iron preparations and dosing regimens, and time to end of follow-up. Consequently, many outcomes are reported with small group sizes and wide confidence intervals, with a subsequent downgrading in the quality of evidence. The level of bias in many included studies was high, further reducing confidence in the robustness of the results. We found that intravenous iron therapy may lead to a small increase in haemoglobin concentration of limited clinical significance compared to placebo (MD 3.04 g/L, 95% CI 0.65 to 5.42; I2 = 42%; 8 studies, 548 participants; low-quality evidence). Quality-of-life scores (Piper Fatigue Scale MD 0.73, 95% CI 0.29 to 1.18; I2 = 0%; studies = 3) and peak oxygen consumption (MD 2.77 mL/kg/min, 95% CI −0.89 to 6.43; I2 = 36%; 2 studies, 32 participants) were associated with very low-quality evidence, and we remain uncertain about the role of intravenous iron for these metrics. We were unable to present pooled estimates for the outcomes of serum ferritin at the end of follow-up or mild to moderate adverse effects due to extreme statistical heterogeneity. Ultimately, despite the results of the meta-analysis, the low- or very low-quality evidence for all outcomes precludes any meaningful interpretation of results beyond suggesting that further research is needed. We performed a Trial Sequential Analysis for all major outcomes, none of which could be said to have reached a necessary effect size. Current evidence is insufficient to show benefit of intravenous iron preparations for the treatment of non-anaemic iron deficiency across a variety of patient populations, beyond stating that it may result in a small, clinically insignificant increase in haemoglobin concentration. However, the certainty for even this outcome remains limited. Robust data for the effectiveness of intravenous iron for non-anaemic iron deficiency is still lacking, and larger studies are required to assess the effect of this therapy on laboratory, patient-centric, and adverse-effect outcomes. | We found 11 studies with 1074 participants. A broad range of people were included in these studies, including people with heart failure, elite athletes, people with restless legs syndrome and otherwise fit and well women. We excluded studies that looked at children, pregnant women, and people being treated with erythropoietin (a hormone that stimulates the production of red blood cells). Intravenous iron may lead to a small increase in the level of haemoglobin in the blood. We also assessed the effect of intravenous iron on quality of life, serum ferritin (iron stored in the body), peak exercise capacity, and milder side-effects of iron administration but we were unable to determine whether or not intravenous iron was of benefit for these outcomes. This is because there were many differences between studies in the types of participants studied, the definition of iron deficiency used, the type of intravenous iron preparation prescribed and the length of the studies. We also tried to collect data on severe side effects and bacterial infection after iron infusion, but we were unable to find any studies that measured these effectively. Because of the many differences between the relatively small number of studies included in this review, we are uncertain about the effect of intravenous iron in non-anaemic iron deficiency beyond saying that it might cause an increase in haemoglobin concentration. Furthermore, the starting level of haemoglobin for people included in this review was considered 'normal' prior to their receiving treatment. Therefore, not only is this increase quite small, but the starting level of haemoglobin was considered adequate according to current guidance, and patients may not even notice an improvement in symptoms. We are not suggesting that intravenous iron is not of benefit for adults with non-anaemic iron deficiency, rather that the current quality of evidence is not good enough to be certain about the effects of these drugs. Overall, the evidence for intravenous iron for the treatment of non-anaemic iron deficiency is of low or very low quality. Whilst intravenous iron might cause a small increase in haemoglobin concentration from an already normal level, we are uncertain about its effects in other outcomes that we examined as part of this review. Further research examining the effects of intravenous iron for the treatment of adults with non-anaemic iron deficiency is required to help answer this research question. The evidence is current to October 2019. | 10.1002/14651858.CD013084.pub2 | [
"We found 11 studies with 1074 participants. A broad range of people were included in these studies, including people with heart failure, elite athletes, people with restless legs syndrome and otherwise fit and well women. We excluded studies that looked at children, pregnant women, and people being treated with erythropoietin (a hormone that stimulates the production of red blood cells). Intravenous iron may lead to a small increase in the level of haemoglobin in the blood. We also assessed the effect of intravenous iron on quality of life, serum ferritin (iron stored in the body), peak exercise capacity, and milder side-effects of iron administration but we were unable to determine whether or not intravenous iron was of benefit for these outcomes. This is because there were many differences between studies in the types of participants studied, the definition of iron deficiency used, the type of intravenous iron preparation prescribed and the length of the studies. We also tried to collect data on severe side effects and bacterial infection after iron infusion, but we were unable to find any studies that measured these effectively. Because of the many differences between the relatively small number of studies included in this review, we are uncertain about the effect of intravenous iron in non-anaemic iron deficiency beyond saying that it might cause an increase in haemoglobin concentration. Furthermore, the starting level of haemoglobin for people included in this review was considered 'normal' prior to their receiving treatment. Therefore, not only is this increase quite small, but the starting level of haemoglobin was considered adequate according to current guidance, and patients may not even notice an improvement in symptoms. We are not suggesting that intravenous iron is not of benefit for adults with non-anaemic iron deficiency, rather that the current quality of evidence is not good enough to be certain about the effects of these drugs. Overall, the evidence for intravenous iron for the treatment of non-anaemic iron deficiency is of low or very low quality. Whilst intravenous iron might cause a small increase in haemoglobin concentration from an already normal level, we are uncertain about its effects in other outcomes that we examined as part of this review. Further research examining the effects of intravenous iron for the treatment of adults with non-anaemic iron deficiency is required to help answer this research question. The evidence is current to October 2019."
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cochrane-simplification-train-1758 | cochrane-simplification-train-1758 | This review includes, in total, 19 publications of 18 randomized controlled trials with a total of 1096 participants. We incorporated five of those 19 studies (330 participants) after the June 2016 update. Outcome measures in the included studies were thematically similar, covering perioperative electrolyte status, renal function, and acid-base status; however, we found significant clinical and statistical heterogeneity among the included studies. We identified variable protocols for fluid administration and total volumes of fluid administered to patients intraoperatively. Trial authors variably reported outcome data at disparate time points and with heterogeneous patient groups. Consequently, many outcome measures are reported in small group sizes, reducing overall confidence in effect size, despite relatively low inherent bias in the included studies. Several studies reported orphan outcome measures. We did not include in the results of this review one large, ongoing study of saline versus Ringer's solution. We found insufficient evidence on effects of fluid therapies on mortality and postoperative organ dysfunction (defined as renal insufficiency leading to renal replacement therapy); confidence intervals were wide and included both clinically relevant benefit and harm: mortality (Peto OR 1.85, 95% CI 0.37 to 9.33; I² = 0%; 3 trials, 6 deaths, 276 participants; low-quality evidence); renal insufficiency (OR 0.82, 95% CI 0.34 to 1.98; I² = 0%; 4 trials, 22 events, 276 participants; low-quality evidence). We noted several metabolic differences, including a difference in postoperative pH measured at end of surgery of 0.05 units - lower in the non-buffered fluid group (12 studies with a total of 720 participants; 95% CI 0.04 to 0.07; I² = 61%). However, this difference was not maintained on postoperative day one. We rated the quality of evidence for this outcome as moderate. We observed a higher postoperative serum chloride level immediately after operation, with use of non-buffered fluids reported in 10 studies with a total of 530 participants (MD 6.77 mmol/L, 95% CI 3.38 to 10.17), and this difference persisted until day one postoperatively (five studies with a total of 258 participants; MD 8.48 mmol/L, 95% CI 1.08 to 15.88). We rated the quality of evidence for this outcome as moderate. Current evidence is insufficient to show effects of perioperative administration of buffered versus non-buffered crystalloid fluids on mortality and organ system function in adult patients following surgery. Benefits of buffered fluid were measurable in biochemical terms, particularly a significant reduction in postoperative hyperchloraemia and metabolic acidosis. Small effect sizes for biochemical outcomes and lack of correlated clinical follow-up data mean that robust conclusions on major morbidity and mortality associated with buffered versus non-buffered perioperative fluid choices are still lacking. Larger studies are needed to assess these relevant clinical outcomes. | We searched the literature up to June 2016 and found 19 studies, with a total of 1096 adults randomly assigned to receive buffered or non-buffered fluids. Some included trials involved minor surgery in otherwise fit and healthy patients. Other trials analysed outcomes after major surgery in high-risk patients, and five trials included patients undergoing renal transplant surgery. We reran the search in May 2017 and decided that we will deal with one new study of interest when we update the review. Overall results show that the number of deaths was low and provide no evidence that choice of fluids - buffered or non-buffered - influenced the number of deaths that occurred around the time of surgery in the three trials that looked at this outcome (involving 267 participants). We found no differences between groups in the numbers of participants whose kidney function was adversely affected. Analysis of clinical outcomes suggests that buffered fluids are an equally safe and effective alternative to non-buffered fluids for adult patients undergoing surgery. The pH of the blood after surgery was reduced among patients receiving saline (pH 7.32 vs 7.38), suggesting that buffered fluids are associated with less metabolic acidosis. The saline group had higher serum chloride and sodium levels than the buffered fluid group. This might be expected, as members of the saline group were receiving saline and no other electrolytes. Higher serum chloride is a cause of metabolic acidosis. We assessed the quality of evidence as generally moderate, although quality of evidence showing effects of fluid choice on kidney function was low because of the presence of other factors that could affect kidney function in these participants. Evidence shows wide variation in the types of surgery performed and in drivers for and volumes of fluid administered across trials. Reported outcomes varied a great deal between included trials, and some results were expressed in ways that did not allow their inclusion in our findings. | 10.1002/14651858.CD004089.pub3 | [
"We searched the literature up to June 2016 and found 19 studies, with a total of 1096 adults randomly assigned to receive buffered or non-buffered fluids. Some included trials involved minor surgery in otherwise fit and healthy patients. Other trials analysed outcomes after major surgery in high-risk patients, and five trials included patients undergoing renal transplant surgery. We reran the search in May 2017 and decided that we will deal with one new study of interest when we update the review. Overall results show that the number of deaths was low and provide no evidence that choice of fluids - buffered or non-buffered - influenced the number of deaths that occurred around the time of surgery in the three trials that looked at this outcome (involving 267 participants). We found no differences between groups in the numbers of participants whose kidney function was adversely affected. Analysis of clinical outcomes suggests that buffered fluids are an equally safe and effective alternative to non-buffered fluids for adult patients undergoing surgery. The pH of the blood after surgery was reduced among patients receiving saline (pH 7.32 vs 7.38), suggesting that buffered fluids are associated with less metabolic acidosis. The saline group had higher serum chloride and sodium levels than the buffered fluid group. This might be expected, as members of the saline group were receiving saline and no other electrolytes. Higher serum chloride is a cause of metabolic acidosis. We assessed the quality of evidence as generally moderate, although quality of evidence showing effects of fluid choice on kidney function was low because of the presence of other factors that could affect kidney function in these participants. Evidence shows wide variation in the types of surgery performed and in drivers for and volumes of fluid administered across trials. Reported outcomes varied a great deal between included trials, and some results were expressed in ways that did not allow their inclusion in our findings."
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cochrane-simplification-train-1759 | cochrane-simplification-train-1759 | Eighteen trials involving 1174 children were identified which included a complex or educational intervention for nocturnal enuresis. The trials were mostly small and some had methodological problems including the use of a quasi-randomised method of concealment of allocation in three trials and baseline differences between the groups in another three. A complex intervention (such as dry bed training (DBT) or full spectrum home training (FSHT)) including an alarm was better than no-treatment control groups (for example the relative risk (RR) for failure or relapse after stopping DBT was 0.25; 95% CI 0.16 to 0.39) but there was not enough evidence about the effects of complex interventions alone if an alarm was not used. A complex intervention on its own was not as good as an alarm on its own or the intervention supplemented by an alarm (e.g. RR for failure or relapse after DBT alone versus DBT plus alarm was 2.81; 95% CI 1.80 to 4.38). On the other hand, a complex intervention supplemented by a bed alarm might reduce the relapse rate compared with the alarm on its own (e.g. RR for failure or relapse after DBT plus alarm versus alarm alone was 0.5; 95% CI 0.31 to 0.80). There was not enough evidence to judge whether providing educational information about enuresis was effective, irrespective of method of delivery. There was some evidence that direct contact between families and therapists enhanced the effect of a complex intervention, and that increased contact and support enhanced a package of simple behavioural interventions, but these were addressed only in single trials and the results would need to be confirmed by further randomised controlled trials, in particular the effect on use of resources. Although DBT and FSHT were better than no treatment when used in combination with an alarm, there was insufficient evidence to support their use without an alarm. An alarm on its own was also better than DBT on its own, but there was some evidence that combining an alarm with DBT was better than an alarm on its own, suggesting that DBT may augment the effect of an alarm. There was also some evidence that direct contact with a therapist might enhance the effects of an intervention. | The review found 18 trials in 1174 children who had received this sort of training or another treatment. Although an alarm on its own was better than the dry bed training on its own, there was some evidence that using them together might reduce the relapse rate after stopping alarm treatment, and without the adverse effects of drug treatment. However, both using an alarm and dry bed training needs time and effort from the child and family. There was not enough research comparing complex interventions with other techniques. | 10.1002/14651858.CD004668 | [
"The review found 18 trials in 1174 children who had received this sort of training or another treatment. Although an alarm on its own was better than the dry bed training on its own, there was some evidence that using them together might reduce the relapse rate after stopping alarm treatment, and without the adverse effects of drug treatment. However, both using an alarm and dry bed training needs time and effort from the child and family. There was not enough research comparing complex interventions with other techniques."
]
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cochrane-simplification-train-1760 | cochrane-simplification-train-1760 | Thirty-five studies were included (1223 participants received codeine 60 mg, 27 codeine 90 mg, and 1252 placebo). Combining all types of surgery (33 studies, 2411 participants), codeine 60 mg had an NNT of at least 50% pain relief over 4 to 6 hours of 12 (8.4 to 18) compared with placebo. At least 50% pain relief was achieved by 26% on codeine 60 mg and 17% on placebo. Following dental surgery the NNT was 21 (12 to 96) (15 studies, 1146 participants), and following other types of surgery the NNT was 6.8 (4.6 to 13) (18 studies, 1265 participants). The NNT to prevent use of rescue medication within 4 to 6 hours was 11 (6.3 to 50) (11 studies, 765 participants, mostly non-dental); the mean time to its use was 2.7 hours with codeine and 2.0 hours with placebo. More participants experienced adverse events with codeine 60 mg than placebo; the difference was not significant and none were serious. Two adverse event withdrawals occurred with placebo. Single dose codeine 60 mg provides good analgesia to few individuals, and does not compare favourably with commonly used alternatives such as paracetamol, NSAIDs and their combinations with codeine, especially after dental surgery; the large difference between dental and other surgery was unexpected. Higher doses were not evaluated. | This review assessed evidence from 2411 adults with moderate to severe postoperative pain in studies comparing single doses of codeine 60 mg with placebo. The number of individuals achieving a clinically useful amount of pain relief (at least 50%) with codeine compared to placebo was low. In all types of surgery combined, 12 participants would need to be treated with codeine 60 mg for one to experience this amount of pain relief who would not have done so with placebo. The need for use of additional analgesia within 4 to 6 hours was 38% with codeine compared with 46% with placebo, and the mean time to the use of additional analgesia was only slightly longer with codeine (2.7 hours) than with placebo (2 hours). More individuals experienced adverse events with codeine than with placebo, but the difference was not significant and none were serious or led to withdrawal. Other commonly used analgesics, alone and in combination with codeine 60 mg, provide better pain relief. Higher doses of codeine were not investigated in these studies. | 10.1002/14651858.CD008099.pub2 | [
"This review assessed evidence from 2411 adults with moderate to severe postoperative pain in studies comparing single doses of codeine 60 mg with placebo. The number of individuals achieving a clinically useful amount of pain relief (at least 50%) with codeine compared to placebo was low. In all types of surgery combined, 12 participants would need to be treated with codeine 60 mg for one to experience this amount of pain relief who would not have done so with placebo. The need for use of additional analgesia within 4 to 6 hours was 38% with codeine compared with 46% with placebo, and the mean time to the use of additional analgesia was only slightly longer with codeine (2.7 hours) than with placebo (2 hours). More individuals experienced adverse events with codeine than with placebo, but the difference was not significant and none were serious or led to withdrawal. Other commonly used analgesics, alone and in combination with codeine 60 mg, provide better pain relief. Higher doses of codeine were not investigated in these studies."
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cochrane-simplification-train-1761 | cochrane-simplification-train-1761 | We included 17 completed randomised clinical trials, but only 16 studies with 1347 participants provided data for the meta-analyses. Ten of the 16 trials assessed complete postoperative glucocorticosteroid avoidance (excluding intra-operative use or treatment of acute rejection) versus short-term glucocorticosteroids (782 participants) and six trials assessed short-term glucocorticosteroids versus long-term glucocorticosteroids (565 participants). One additional study assessed complete post-operative glucocorticosteroid avoidance but could only be incorporated into qualitative analysis of the results due to limited data published in an abstract. All trials were at high risk of bias. Only eight trials reported on the type of donor used. Overall, we found no statistically significant difference for mortality (RR 1.15, 95% CI 0.93 to 1.44; low-quality evidence), graft loss including death (RR 1.15, 95% CI 0.90 to 1.46; low-quality evidence), or infection (RR 0.88, 95% CI 0.73 to 1.05; very low-quality evidence) when glucocorticosteroid avoidance or withdrawal was compared with glucocorticosteroid-containing immunosuppression. Acute rejection and glucocorticosteroid-resistant rejection were statistically significantly more frequent when glucocorticosteroid avoidance or withdrawal was compared with glucocorticosteroid-containing immunosuppression (RR 1.33, 95% CI 1.08 to 1.64; low-quality evidence; and RR 2.14, 95% CI 1.13 to 4.02; very low-quality evidence). Diabetes mellitus and hypertension were statistically significantly less frequent when glucocorticosteroid avoidance or withdrawal was compared with glucocorticosteroid-containing immunosuppression (RR 0.81, 95% CI 0.66 to 0.99; low-quality evidence; and RR 0.76, 95% CI 0.65 to 0.90; low-quality evidence). We performed Trial Sequential Analysis for all outcomes. None of the outcomes crossed the monitoring boundaries or reached the required information size. Hence, we cannot exclude random errors from the results of the conventional meta-analyses. Many of the benefits and harms of glucocorticosteroid avoidance or withdrawal remain uncertain because of the limited number of published randomised clinical trials, limited numbers of participants and outcomes, and high risk of bias in the trials. Glucocorticosteroid avoidance or withdrawal appears to reduce diabetes mellitus and hypertension whilst increasing acute rejection, glucocorticosteroid-resistant rejection, and renal impairment. We could identify no other benefits or harms of glucocorticosteroid avoidance or withdrawal. Glucocorticosteroid avoidance or withdrawal may be of benefit in selected patients, especially those at low risk of rejection and high risk of hypertension or diabetes mellitus. The optimal duration of glucocorticosteroid administration remains unclear. More randomised clinical trials assessing glucocorticosteroid avoidance or withdrawal are needed. These should be large, high-quality trials that minimise the risk of random and systematic error. | We searched for trials comparing glucocorticosteroid avoidance or withdrawal to continuing glucocorticosteroids. Seventeen randomised clinical trials were included, of which 16 trials involving 1347 participants provided numeric data for the meta-analyses. All of the studies assessed adults who had received a liver transplant. Of the 16 randomised clinical trials included in the meta-analyses, 10 trials assessed avoidance of glucocorticosteroids compared with slowly reducing glucocorticosteroids (782 participants) and six trials assessed withdrawal of glucocorticosteroids following a slow reduction compared with a longer reduction or long-term use of glucocorticosteroids (565 participants). Only eight trials reported on the type of donor used. The evidence is current to May 2017. Rejection, severe rejection, and kidney failure may be increased by avoiding or withdrawing glucocorticosteroids compared with continuing glucocorticosteroids. Diabetes mellitus and high blood pressure may be reduced by avoiding or withdrawing glucocorticosteroids compared with continuing glucocorticosteroids. We did not find any difference in survival of the patients, survival of the liver, other adverse effects, or health-related quality of life. We assessed all of the trials we included as being at high risk of bias, which means that they may overestimate the benefits and underestimate the harms of avoiding or withdrawing glucocorticosteroids. The evidence was either low quality or very low quality. There is still some uncertainty about the benefits and harms of avoiding or withdrawing glucocorticosteroids after transplantation. Avoiding or withdrawing glucocorticosteroids appears to increase rejection, severe rejection, and kidney failure but seems to reduce diabetes mellitus and high blood pressure. We found no other obvious benefits or harms of avoiding or withdrawing glucocorticosteroids. More randomised clinical trials are needed to assess avoidance and withdrawal of glucocorticosteroids for liver transplanted patients. | 10.1002/14651858.CD007606.pub4 | [
"We searched for trials comparing glucocorticosteroid avoidance or withdrawal to continuing glucocorticosteroids. Seventeen randomised clinical trials were included, of which 16 trials involving 1347 participants provided numeric data for the meta-analyses. All of the studies assessed adults who had received a liver transplant. Of the 16 randomised clinical trials included in the meta-analyses, 10 trials assessed avoidance of glucocorticosteroids compared with slowly reducing glucocorticosteroids (782 participants) and six trials assessed withdrawal of glucocorticosteroids following a slow reduction compared with a longer reduction or long-term use of glucocorticosteroids (565 participants). Only eight trials reported on the type of donor used. The evidence is current to May 2017. Rejection, severe rejection, and kidney failure may be increased by avoiding or withdrawing glucocorticosteroids compared with continuing glucocorticosteroids. Diabetes mellitus and high blood pressure may be reduced by avoiding or withdrawing glucocorticosteroids compared with continuing glucocorticosteroids. We did not find any difference in survival of the patients, survival of the liver, other adverse effects, or health-related quality of life. We assessed all of the trials we included as being at high risk of bias, which means that they may overestimate the benefits and underestimate the harms of avoiding or withdrawing glucocorticosteroids. The evidence was either low quality or very low quality. There is still some uncertainty about the benefits and harms of avoiding or withdrawing glucocorticosteroids after transplantation. Avoiding or withdrawing glucocorticosteroids appears to increase rejection, severe rejection, and kidney failure but seems to reduce diabetes mellitus and high blood pressure. We found no other obvious benefits or harms of avoiding or withdrawing glucocorticosteroids. More randomised clinical trials are needed to assess avoidance and withdrawal of glucocorticosteroids for liver transplanted patients."
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cochrane-simplification-train-1762 | cochrane-simplification-train-1762 | We included four trials involving 350 patients. Not all trials contributed data to each outcome. The trials tested either intra-arterial urokinase or recombinant pro-urokinase versus an open control. One trial used guidewire-mediated clot disruption in some patients randomised to the intervention group. Most data came from trials that started treatment up to six hours after stroke; one small trial started treatment up to a median of 12.5 hours after stroke. Most data came from trials of middle cerebral artery territory infarction. Compared with non-thrombolytic standard medical treatment, the intervention administered up to six hours after ischaemic stroke significantly increased the proportion of patients with favourable outcome (modified Rankin 0 to 2) three months after stroke (relative risk (RR) 1.47, 95% confidence interval (CI) 1.07 to 2.02). The intervention also significantly increased the risk of symptomatic intracranial haemorrhage within 24 hours of treatment (RR 3.85, 95% CI 0.91 to 16.36). There was no significant heterogeneity between the included trials. Overall, intervention results in a significant increase in the proportion of patients with a favourable outcome, despite a significant increase in intracranial haemorrhage. Further trials are needed to confirm or refute these findings and, given the cost and practical difficulties, to establish whether percutaneous techniques are feasible and cost effective in wider clinical practice. | This review of four trials involving 350 participants indicated that this form of treatment can remove large artery blood clots and improve the chances of good recovery despite an increased risk of bleeding in the brain. Long term risk of death is unaffected. However, it is still not clear what the time window is within which treatment is beneficial, what types of arterial blockage are most likely to respond, whether mechanical devices are effective, and whether any of these treatments are better than standard intravenous thrombolytic drugs. More information is needed from forthcoming randomised trials to answer these questions. | 10.1002/14651858.CD007574.pub2 | [
"This review of four trials involving 350 participants indicated that this form of treatment can remove large artery blood clots and improve the chances of good recovery despite an increased risk of bleeding in the brain. Long term risk of death is unaffected. However, it is still not clear what the time window is within which treatment is beneficial, what types of arterial blockage are most likely to respond, whether mechanical devices are effective, and whether any of these treatments are better than standard intravenous thrombolytic drugs. More information is needed from forthcoming randomised trials to answer these questions."
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cochrane-simplification-train-1763 | cochrane-simplification-train-1763 | We included 89 studies (of which 40 were new to this update) in 10,583 people with OWCL. The studies included were conducted mainly in the Far or Middle East at regional hospitals, local healthcare clinics, and skin disease research centres. Women accounted for 41.5% of the participants (range: 23% to 80%). The overall mean age of participants was 25 years (range 12 to 56). Most studies lasted between two to six months, with the longest lasting two years; average duration was four months. Most studies were at unclear or high risk for most bias domains. A lack of blinding and reporting bias were present in almost 40% of studies. Two trials were at low risk of bias for all domains. Trials reported the causative species poorly. Here we provide results for the two main comparisons identified: itraconazole (200 mg for six to eight weeks) versus placebo; and paromomycin ointment (15% plus 10% urea, twice daily for 14 days) versus vehicle. In the comparison of oral itraconazole versus placebo, at 2.5 months' follow up, 85/125 participants in the itraconazole group achieved complete cure compared to 54/119 in the placebo group (RR 3.70, 95% CI 0.35 to 38.99; 3 studies; 244 participants). In one study, microbiological or histopathological cure of skin lesions only occurred in the itraconazole group after a mean follow-up of 2.5 months (RR 17.00, 95% CI 0.47 to 612.21; 20 participants). However, although the analyses favour oral itraconazole for these outcomes, we cannot be confident in the results due to the very low certainty evidence. More side effects of mild abdominal pain and nausea (RR 2.36, 95% CI 0.74 to 7.47; 3 studies; 204 participants) and mild abnormal liver function (RR 3.08, 95% CI 0.53 to 17.98; 3 studies; 84 participants) occurred in the itraconazole group (as well as reports of headaches and dizziness), compared with the placebo group, but again we rated the certainty of evidence as very low so are unsure of the results. When comparing paromomycin with vehicle, there was no difference in the number of participants who achieved complete cure (RR of 1.00, 95% CI 0.86, 1.17; 383 participants, 2 studies) and microbiological or histopathological cure of skin lesions after a mean follow-up of 2.5 months (RR 1.03, CI 0.88 to 1.20; 383 participants, 2 studies), but the paromomycin group had more skin/local reactions (such as inflammation, vesiculation, pain, redness, or itch) (RR 1.42, 95% CI 0.67 to 3.01; 4 studies; 713 participants). For all of these outcomes, the certainty of evidence was very low, meaning we are unsure about these results. Trial authors did not report the percentage of lesions cured after the end of treatment or speed of healing for either of these key comparisons. There was very low-certainty evidence to support the effectiveness of itraconazole and paromomycin ointment for OWCL in terms of cure (i.e. microbiological or histopathological cure and percentage of participants completely cured). Both of these interventions incited more adverse effects, which were mild in nature, than their comparisons, but we could draw no conclusions regarding safety due to the very low certainty of the evidence for this outcome. We downgraded the key outcomes in these two comparisons due to high risk of bias, inconsistency between the results, and imprecision. There is a need for large, well-designed international studies that evaluate long-term effects of current therapies and enable a reliable conclusion about treatments. Future trials should specify the species of leishmaniasis; trials on types caused by Leishmania infantum, L aethiopica, andL donovani are lacking. Research into the effects of treating women of childbearing age, children, people with comorbid conditions, and those who are immunocompromised would also be helpful. It was difficult to evaluate the overall efficacy of any of the numerous treatments due to the variable treatment regimens examined and because RCTs evaluated different Leishmania species and took place in different geographical areas. Some outcomes we looked for but did not find were degree of functional and aesthetic impairment, change in ability to detect Leishmania, quality of life, and emergence of resistance. There were only limited data on prevention of scarring. | We reviewed 89 clinical trials, which included 10,583 people, in total, with OWCL. We included participants of both sexes and all ages (mean 24.5 years); most participants were over 18 years of age. Most studies were carried out in single centres in different countries, mainly in the Far or Middle East, and lasted between two to six months. We included a variety of treatments, such as antimonials, antifungals, and antibiotics, which were administered either directly onto the skin or into a wound, taken by mouth, or physically applied (e.g. laser treatment, heat therapy, etc.). Most of the included studies assessed OWCL caused by two species of parasites known as Leishmania major (L. major) andLeishmania tropica (L. tropica). The evidence is current to November 2016. Two of the most important treatments that we assessed in this review were itraconazole, an antifungal drug taken by mouth, and paromomycin, an antibiotic applied as an ointment. Trials compared both to a placebo tablet or inactive cream (vehicle). Participants received 200 mg itraconazole for six to eight weeks or paromomycin ointment at a concentration of 15% plus 10% urea, twice daily for 14 days. When assessed on average 2.5 months after treatment, more participants were completely cured and cleared of the infection-causing parasites with itraconazole than placebo, but they also had more side effects (mild stomach pain, sickness, and abnormal liver function, as well as headaches and dizziness). When paromomycin ointment was compared with placebo, there was no difference in the number of completely cured participants or the number who were found to be cleared of parasites when assessed on average 2.5 months after treatment, but those in the paromomycin treatment group had more contained skin reactions (such as swelling, blistering, pain, redness, or itch). However, as the certainty of the evidence for these outcomes for these particular comparisons was very low, we are not sure of the accuracy of these results. Neither of our key treatment comparisons assessed the percentage of wounds cured after the end of treatment and speed of healing (i.e. time taken to be cured). The overall certainty of the evidence for the different outcomes in the two main comparisons was very low. Important reasons for this were that studies were not blinded, or had a small sample size, making the results less precise. Some of the evidence only focused on young people, and the results greatly varied between each study. We need more research to fill in the following research gaps: 1) trials of OWCL caused by other types of infection such as L. infantum, L. aethiopica,or L. donovani; 2) involving specific subgroups of people such as children; 3) assessing effectiveness and safety of different anti-Leishmania drugs compared with placebo in self-healing forms of leishmaniasis or with traditional first-choice antimonial treatment in complicated form (defined as more than four lesions over 4 cm in size, located close to an opening or small joints, for which previous treatment has failed); and 4) assessing areas such as wound healing and patient-reported outcomes, such as quality of life. In addition, few studies assessed relevant issues such as drug resistance. International collaboration is required to improve the quality and standardisation of future trials in order to develop a better evidence-based approach. | 10.1002/14651858.CD005067.pub5 | [
"We reviewed 89 clinical trials, which included 10,583 people, in total, with OWCL. We included participants of both sexes and all ages (mean 24.5 years); most participants were over 18 years of age. Most studies were carried out in single centres in different countries, mainly in the Far or Middle East, and lasted between two to six months. We included a variety of treatments, such as antimonials, antifungals, and antibiotics, which were administered either directly onto the skin or into a wound, taken by mouth, or physically applied (e.g. laser treatment, heat therapy, etc.). Most of the included studies assessed OWCL caused by two species of parasites known as Leishmania major (L. major) andLeishmania tropica (L. tropica). The evidence is current to November 2016. Two of the most important treatments that we assessed in this review were itraconazole, an antifungal drug taken by mouth, and paromomycin, an antibiotic applied as an ointment. Trials compared both to a placebo tablet or inactive cream (vehicle). Participants received 200 mg itraconazole for six to eight weeks or paromomycin ointment at a concentration of 15% plus 10% urea, twice daily for 14 days. When assessed on average 2.5 months after treatment, more participants were completely cured and cleared of the infection-causing parasites with itraconazole than placebo, but they also had more side effects (mild stomach pain, sickness, and abnormal liver function, as well as headaches and dizziness). When paromomycin ointment was compared with placebo, there was no difference in the number of completely cured participants or the number who were found to be cleared of parasites when assessed on average 2.5 months after treatment, but those in the paromomycin treatment group had more contained skin reactions (such as swelling, blistering, pain, redness, or itch). However, as the certainty of the evidence for these outcomes for these particular comparisons was very low, we are not sure of the accuracy of these results. Neither of our key treatment comparisons assessed the percentage of wounds cured after the end of treatment and speed of healing (i.e. time taken to be cured). The overall certainty of the evidence for the different outcomes in the two main comparisons was very low. Important reasons for this were that studies were not blinded, or had a small sample size, making the results less precise. Some of the evidence only focused on young people, and the results greatly varied between each study. We need more research to fill in the following research gaps: 1) trials of OWCL caused by other types of infection such as L. infantum, L. aethiopica,or L. donovani; 2) involving specific subgroups of people such as children; 3) assessing effectiveness and safety of different anti-Leishmania drugs compared with placebo in self-healing forms of leishmaniasis or with traditional first-choice antimonial treatment in complicated form (defined as more than four lesions over 4 cm in size, located close to an opening or small joints, for which previous treatment has failed); and 4) assessing areas such as wound healing and patient-reported outcomes, such as quality of life. In addition, few studies assessed relevant issues such as drug resistance. International collaboration is required to improve the quality and standardisation of future trials in order to develop a better evidence-based approach."
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cochrane-simplification-train-1764 | cochrane-simplification-train-1764 | We identified 14 trials in which there were 607 participants; one of the trials was newly included at this 2014 update. The use of different outcome measures prevented pooling of data for meta-analysis even when interventions and participants were comparable. All trials displayed bias in four or more areas. One trial reported on the primary outcome of function, though raw data were not available to be analysed. We were able to analyse data on foot alignment (Pirani score), a secondary outcome, from three trials. Two of the trials involved participants at initial presentation. One reported that the Ponseti technique significantly improved foot alignment compared to the Kite technique. After 10 weeks of serial casting, the average total Pirani score of the Ponseti group was 1.15 (95% confidence interval (CI) 0.98 to 1.32) lower than that of the Kite group. The second trial found the Ponseti technique to be superior to a traditional technique, with average total Pirani scores of the Ponseti participants 1.50 lower (95% CI 0.72 to 2.28) after serial casting and Achilles tenotomy. A trial in which the type of presentation was not reported found no difference between an accelerated Ponseti or standard Ponseti treatment. At the end of serial casting, the average total Pirani scores in the standard group were 0.31 lower (95% CI -0.40 to 1.02) than the accelerated group. Two trials in initial cases found relapse following Ponseti treatment was more likely to be corrected with further serial casting compared to the Kite groups which more often required major surgery (risk difference 25% and 50%). There is a lack of evidence for different plaster casting products, the addition of botulinum toxin A during the Ponseti technique, different types of major foot surgery, continuous passive motion treatment following major foot surgery, or treatment of relapsed or neglected cases of CTEV. Most trials did not report on adverse events. In trials evaluating serial casting techniques, adverse events included cast slippage (needing replacement), plaster sores (pressure areas) and skin irritation. Adverse events following surgical procedures included infection and the need for skin grafting. From the limited evidence available, the Ponseti technique produced significantly better short-term foot alignment compared to the Kite technique and compared to a traditional technique. The quality of this evidence was low to very low. An accelerated Ponseti technique may be as effective as a standard technique, according to moderate quality evidence. Relapse following the Kite technique more often led to major surgery compared to relapse following the Ponseti technique. We could draw no conclusions from other included trials because of the limited use of validated outcome measures and lack of available raw data. Future randomised controlled trials should address these issues. | From our searches we found 14 trials with 607 participants. All trials had problems of design or conduct that might have affected the results. Treatments were studied at birth (eight trials, 326 participants), during relapse (four trials, 181 participants) or at an unknown time (two trials, 100 participants). Our main measure of the success of treatment was function (how well the foot worked in everyday life). Only one trial reported on function; however, data were not available to re-analyse. We analysed data from three trials. When treated at birth, foot position was better after Ponseti plaster casting than after Kite plaster casting. The quality of this evidence was low. When treated at birth, foot position was better after Ponseti plaster casting than after a traditional technique (another type of plaster casting). The quality of this evidence was very low. One trial found Ponseti plaster casting three times per week to be as good as weekly Ponseti casting. This trial did not state at which stage the treatment was done. The quality of this evidence was moderate. Relapse following Kite technique more often required major surgery than relapse following the Ponseti technique. Data were not available to assess the results for adding botulinum toxin A to the Ponseti treatment, using different types of plaster casts in the Ponseti treatment, different foot surgeries or the treatment of relapsed or neglected clubfoot. Most trials did not report on harmful effects. When reported, harmful effects during plaster casting included casts slipping, plaster sores and skin irritation. Harmful effects of infection and skin grafting were reported after surgery. Further well-designed trials are needed to confirm these findings and to decide which is the best treatment for each presentation. The searches for the review are up to date to April 2013. | 10.1002/14651858.CD008602.pub3 | [
"From our searches we found 14 trials with 607 participants. All trials had problems of design or conduct that might have affected the results. Treatments were studied at birth (eight trials, 326 participants), during relapse (four trials, 181 participants) or at an unknown time (two trials, 100 participants). Our main measure of the success of treatment was function (how well the foot worked in everyday life). Only one trial reported on function; however, data were not available to re-analyse. We analysed data from three trials. When treated at birth, foot position was better after Ponseti plaster casting than after Kite plaster casting. The quality of this evidence was low. When treated at birth, foot position was better after Ponseti plaster casting than after a traditional technique (another type of plaster casting). The quality of this evidence was very low. One trial found Ponseti plaster casting three times per week to be as good as weekly Ponseti casting. This trial did not state at which stage the treatment was done. The quality of this evidence was moderate. Relapse following Kite technique more often required major surgery than relapse following the Ponseti technique. Data were not available to assess the results for adding botulinum toxin A to the Ponseti treatment, using different types of plaster casts in the Ponseti treatment, different foot surgeries or the treatment of relapsed or neglected clubfoot. Most trials did not report on harmful effects. When reported, harmful effects during plaster casting included casts slipping, plaster sores and skin irritation. Harmful effects of infection and skin grafting were reported after surgery. Further well-designed trials are needed to confirm these findings and to decide which is the best treatment for each presentation. The searches for the review are up to date to April 2013."
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cochrane-simplification-train-1765 | cochrane-simplification-train-1765 | Five studies met our inclusion criteria. Three demonstrated significantly higher quit rates (8% to 20%) for the quit and win group than for the control group at the 12-month assessment. However, the population impact measure, where available, suggests that the effect of contests on community prevalence of smoking is small, with fewer than one in 500 smokers quitting because of the contest. Levels of deception, where they could be quantified, were high. Although surveys suggest that international quit and win contests may be effective, especially in developing countries, the lack of controlled studies precludes any firm conclusions from this review. Quit and win contests at local and regional level appear to deliver quit rates above baseline community rates, although the population impact of the contests seems to be relatively low. Contests may be subject to levels of deception which could compromise the validity of the intervention. International contests may prove to be an effective mechanism, particularly in developing countries, but a lack of well-designed comparative studies precludes any firm conclusions. | Controlled trials suggest that quit and win contests may help some smokers to quit, but they have little effect on community smoking rates. Fewer than one smoker in 500 quits because of the contests. Deception levels, where they can be measured, are often high. International quit and win contests are often well supported, especially in developing countries, but there is no clear evidence from trials that they are effective. | 10.1002/14651858.CD004986.pub3 | [
"Controlled trials suggest that quit and win contests may help some smokers to quit, but they have little effect on community smoking rates. Fewer than one smoker in 500 quits because of the contests. Deception levels, where they can be measured, are often high. International quit and win contests are often well supported, especially in developing countries, but there is no clear evidence from trials that they are effective."
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cochrane-simplification-train-1766 | cochrane-simplification-train-1766 | Seven RCTs with a total of 339 participants were included in this review. One study was assessed as at low risk of bias, three studies were at high risk of bias, and in the remaining three studies risk of bias was unclear. Four studies reported on the use of a facemask, two on the chin cup, one on the tandem traction bow appliance, and one on mandibular headgear. One study reported on both the chin cup and mandibular headgear appliances. One study (n = 73, low quality evidence), comparing a facemask to no treatment, reported a mean difference (MD) in overjet of 4.10 mm (95% confidence interval (CI) 3.04 to 5.16; P value < 0.0001) favouring the facemask treatment. Two studies comparing facemasks to untreated control did not report the outcome of overjet. Three studies (n = 155, low quality evidence) reported ANB (an angular measurement relating the positions of the top and bottom jaws) differences immediately after treatment with a facemask when compared to an untreated control. The pooled data showed a statistically significant MD in ANB in favour of the facemask of 3.93 ° (95% CI 3.46 to 4.39; P value < 0.0001). There was significant heterogeneity between these studies (I2 = 82%). This is likely to have been caused by the different populations studied and the different ages at the time of treatment. One study (n = 73, low quality evidence) reported outcomes of the use of the facemask compared to an untreated control at three years follow-up. This study showed that improvements in overjet and ANB were still present three years post-treatment. In this study, adverse effects were reported but due to the low prevalence of temporomandibular (TMJ) signs and symptoms no analysis was undertaken. Two studies (n = 90, low quality evidence) compared the chin cup with an untreated control. Both studies found a statistically significant improvement in ANB, and one study also found an improvement in the Wits appraisal. Data from these two studies were not suitable for pooling. A single study of the tandem traction bow appliance compared to untreated control (n = 30, very low quality evidence) showed a statistically significant difference in both overjet and ANB favouring the intervention group. The remaining two studies did not report the primary outcome of this review. There is some evidence that the use of a facemask to correct prominent lower front teeth in children is effective when compared to no treatment on a short-term basis. However, in view of the general poor quality of the included studies, these results should be viewed with caution. Further randomised controlled trials with long follow-up are required. | The evidence on which this review is based was found to be up to date as of 7 January 2013. A total of seven suitable studies were identified and included in this review; they included 339 children aged from five to 11 years. There were roughly equal numbers of girls and boys in each study and participants were from different ethnic groups depending on where the study was carried out. Studies included were conducted in Turkey, Egypt, China, the United States of America and the United Kingdom. This review found some evidence that the use of a facemask appliance can help to correct prominent lower front teeth on a short-term basis. There was no evidence available to show whether or not these short-term changes will still be maintained until the child is fully grown. There was not enough evidence to support any other types of treatment for prominent lower front teeth. The quality of the evidence for the use of a facemask was moderate to low, whilst the quality of the rest of the evidence was very low. | 10.1002/14651858.CD003451.pub2 | [
"The evidence on which this review is based was found to be up to date as of 7 January 2013. A total of seven suitable studies were identified and included in this review; they included 339 children aged from five to 11 years. There were roughly equal numbers of girls and boys in each study and participants were from different ethnic groups depending on where the study was carried out. Studies included were conducted in Turkey, Egypt, China, the United States of America and the United Kingdom. This review found some evidence that the use of a facemask appliance can help to correct prominent lower front teeth on a short-term basis. There was no evidence available to show whether or not these short-term changes will still be maintained until the child is fully grown. There was not enough evidence to support any other types of treatment for prominent lower front teeth. The quality of the evidence for the use of a facemask was moderate to low, whilst the quality of the rest of the evidence was very low."
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cochrane-simplification-train-1767 | cochrane-simplification-train-1767 | We included six studies (492 women) that assessed online support groups for women with breast cancer. Online support groups in these six trials lasted from six to 30 weeks. Women participated in these groups between 1.5 and 2.5 hours per week, and investigators conducted all studies in the USA. Participants were predominantly white and well educated and were moderate to high earners. Four studies compared an online support group versus a control group, and the other two compared a 'moderated' versus a 'peer-led' online support group, and a 'standard' versus an 'enhanced' online support group, respectively. None of the included studies measured 'emotional distress' or uncertainty. One study (78 women) for which data for analysis were missing reported no positive effects of online support on 'distress' and 'cancer-specific distress' versus support provided by a control group. Two studies measured anxiety: One study (72 women) found no difference in anxiety at the end of the intervention between the online support group and the control group (MD -0.40, 95% CI -6.42 to 5.62; low-quality evidence), and the second study (184 women) reported a reduction in anxiety levels at the end of the intervention when comparing the 'standard' support group (run by participants without prompting from health professionals) versus an 'enhanced' online support group (in which participants were specifically asked by the researcher to respond to one another's need for support). Five studies (414 women) measured depression. Three studies compared depression in the online support group with depression in the control group. Pooled data from two studies (120 women) showed a small to moderate reduction in depression in the online support group compared with control groups at the end of the intervention (SMD -0.37, 95% CI -0.75 to 0.00; very low-quality evidence). The third study, a pilot study (30 women), provided no data for analysis but reported no difference in depression between participants in support and control groups at the end of the intervention. Of the remaining two studies that measured depression, one study (60 women) provided no extractable data for comparison but reported no difference in depressive symptoms between a 'moderated' and a 'peer-led' support group; the other study (184 women) reported greater reduction in depression in the 'standard' support group than in the 'enhanced' online support group. Three studies measured quality of life. One pilot study (30 women) provided limited data for analysis but reported no change in quality of life at the end of the intervention. Only two studies (140 women) provided data for pooling and showed no positive effects on quality of life at four months post intervention compared with controls (SMD -0.11, 95% CI -0.47 to 0.24; very low-quality evidence). At 12 months post intervention, one study (78 women) reported that the intervention group did not attain better quality of life scores than the control group (MD -10.89, 95% CI -20.41 to -1.37; low-quality evidence). We found no data for subgroup analyses on stage of disease, treatment modality and types and doses of interventions. No studies measured adverse effects. This review did not find the evidence required to show whether participation in online support groups was beneficial for women with breast cancer, because identified trials were small and of low or very low quality. Large, rigorous trials with ethnically and economically diverse participants are needed to provide robust evidence regarding the psychosocial outcomes selected for this review. | We conducted a systematic search of the literature with no restrictions on language or country. We included in this review six studies, with a total population of 492 women with breast cancer. Five of the six studies had small samples. Study participants were predominantly 'white', well-educated women with moderate to high income at any stage of breast cancer who were undergoing a range of treatments. Online support groups in these six trials lasted six to 30 weeks and included eight to 15 members. Women participated in these groups between 1.5 and 2.5 hours per week. Investigators reported all trials in English and conducted their research in the USA. None of the included trials measured emotional distress or uncertainty. Women who participated in online support groups showed no improvement in anxiety or quality of life when compared with those in control groups (which included women with similar characteristics who did not participate in online support groups). However, women who took part in online support groups showed a small to moderate reduction in depression when compared with those in control groups. Results revealed no difference in depression between groups led by peers and those led by health professionals. However, women taking part in standard online groups (run by participants without prompting from health professionals) reported a greater reduction in depression and anxiety than those in other types of online groups (in which women were asked specifically by the health professional to respond to one another's need for support). Small studies of low or very low quality attributed mainly to poor study design and other shortcomings have provided evidence on the effectiveness of online support groups for women with breast cancer. Large, rigorous trials including ethnically and economically diverse participants are needed to provide robust evidence on the effectiveness of online support groups for women with breast cancer. | 10.1002/14651858.CD011652.pub2 | [
"We conducted a systematic search of the literature with no restrictions on language or country. We included in this review six studies, with a total population of 492 women with breast cancer. Five of the six studies had small samples. Study participants were predominantly 'white', well-educated women with moderate to high income at any stage of breast cancer who were undergoing a range of treatments. Online support groups in these six trials lasted six to 30 weeks and included eight to 15 members. Women participated in these groups between 1.5 and 2.5 hours per week. Investigators reported all trials in English and conducted their research in the USA. None of the included trials measured emotional distress or uncertainty. Women who participated in online support groups showed no improvement in anxiety or quality of life when compared with those in control groups (which included women with similar characteristics who did not participate in online support groups). However, women who took part in online support groups showed a small to moderate reduction in depression when compared with those in control groups. Results revealed no difference in depression between groups led by peers and those led by health professionals. However, women taking part in standard online groups (run by participants without prompting from health professionals) reported a greater reduction in depression and anxiety than those in other types of online groups (in which women were asked specifically by the health professional to respond to one another's need for support). Small studies of low or very low quality attributed mainly to poor study design and other shortcomings have provided evidence on the effectiveness of online support groups for women with breast cancer. Large, rigorous trials including ethnically and economically diverse participants are needed to provide robust evidence on the effectiveness of online support groups for women with breast cancer."
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cochrane-simplification-train-1768 | cochrane-simplification-train-1768 | We included 33 studies in the review (2242 participants). Antidepressants were compared to placebo (22 studies), psychotherapy (two studies), other medications (four studies), or other antidepressants (five studies). The mean duration of the trials was 9.9 weeks (range 3 to 26 weeks). Eighteen studies took place in the USA, 12 in Europe, two in Turkey, and one in Australia. The antidepressant included in most of the trials was sertraline; other medications were amitriptyline, citalopram, desipramine, doxepin, escitalopram, fluoxetine, fluvoxamine, imipramine, mianserin, mirtazepine, nefazodone, paroxetine, tianeptine, venlafaxine, and viloxazine. Eighteen studies were conducted in an outpatient setting, nine in an inpatient setting, and six in both settings. Psychosocial treatment was provided in 18 studies. There was high heterogeneity in the selection of outcomes and the rating systems used for diagnosis and outcome assessment. Comparing antidepressants to placebo, low-quality evidence suggested that antidepressants reduced the severity of depression evaluated with interviewer-rated scales at the end of trial (14 studies, 1074 participants, standardized mean difference (SMD) -0.27, 95% confidence interval (CI) -0.49 to -0.04). However, the difference became non-significant after the exclusion of studies with a high risk of bias (SMD -0.17, 95% CI -0.39 to 0.04). In addition, very low-quality evidence supported the efficacy of antidepressants in increasing the response to the treatment (10 studies, 805 participants, risk ratio (RR) 1.40, 95% Cl 1.08 to 1.82). This result became non-significant after the exclusion of studies at high risk of bias (RR 1.27, 95% CI 0.96 to 1.68). There was no difference for other relevant outcomes such as the difference between baseline and final score, evaluated using interviewer-rated scales (5 studies, 447 participants, SMD 0.15, 95% CI -0.12 to 0.42). Moderate-quality evidence found that antidepressants increased the number of participants abstinent from alcohol during the trial (7 studies, 424 participants, RR 1.71, 95% Cl 1.22 to 2.39) and reduced the number of drinks per drinking days (7 studies, 451 participants, mean difference (MD) -1.13 drinks per drinking days, 95% Cl -1.79 to -0.46). After the exclusion of studies with high risk of bias, the number of abstinent remained higher (RR 1.69, 95% CI 1.18 to 2.43) and the number of drinks per drinking days lower (MD -1.21 number of drinks per drinking days, 95% CI -1.91 to -0.51) among participants who received antidepressants compared to those who received placebo. However, other outcomes such as the rate of abstinent days did not differ between antidepressants and placebo (9 studies, 821 participants, MD 1.34, 95% Cl -1.66 to 4.34; low-quality evidence). Low-quality evidence suggested no differences between antidepressants and placebo in the number of dropouts (17 studies, 1159 participants, RR 0.98, 95% Cl 0.79 to 1.22) and adverse events as withdrawal for medical reasons (10 studies, 947 participants, RR 1.15, 95% Cl 0.65 to 2.04). There were few studies comparing one antidepressant versus another antidepressant or antidepressants versus other interventions, and these had a small sample size and were heterogeneous in terms of the types of interventions that were compared, yielding results that were not informative. We found low-quality evidence supporting the clinical use of antidepressants in the treatment of people with co-occurring depression and alcohol dependence. Antidepressants had positive effects on certain relevant outcomes related to depression and alcohol use but not on other relevant outcomes. Moreover, most of these positive effects were no longer significant when studies with high risk of bias were excluded. Results were limited by the large number of studies showing high or unclear risk of bias and the low number of studies comparing one antidepressant to another or antidepressants to other medication. In people with co-occurring depression and alcohol dependence, the risk of developing adverse effects appeared to be minimal, especially for the newer classes of antidepressants (such as selective serotonin reuptake inhibitors). According to these results, in people with co-occurring depression and alcohol dependence, antidepressants may be useful for the treatment of depression, alcohol dependence, or both, although the clinical relevance may be modest. | We identified 33 medical trials involving 2242 participants: 68% were male, and the mean age was 42 years. Most studies compared antidepressants to placebo (22 studies), but some compared one antidepressant to antidepressant (five studies), to another type of medicine (four studies), or to psychotherapy (a talking treatment; two studies). The average duration of the trials was 10 weeks (range 3 to 26 weeks). A total of 18 trials took place in the USA, and the others were in Europe, Turkey, and Australia. The antidepressant used in most of the trials was sertraline; the others were: amitriptyline, citalopram, desipramine, doxepin, escitalopram, fluoxetine, fluvoxamine, imipramine, mianserin, mirtazepine, nefazodone, paroxetine, tianeptine, venlafaxine, and viloxazine. The studies used 49 different rating scales and varied in terms of design, quality, participant characteristics, tested medicines, services provided, and treatments administered. A total of 19 studies reported the source of funding (public funds: six studies; pharmaceutical industry: two studies; both funds: 10 studies). Only four trials reported a declaration of the authors reporting possible conflicts of interest. In the 22 studies comparing antidepressants to placebo, antidepressants may have reduced the severity of depression but we are uncertain whether it increased the number of people with clinical beneficial effects from the reduction of depression severity (response to treatment, i.e. people who halved the severity of depression). However, we found no difference between antidepressants and placebo in other relevant outcomes related to the severity of depression, such as the number of people without depression at the end of the trial (remission). In addition, we found that the administration of antidepressants probably reduced alcohol consumption evaluated as the number of participants abstinent during the treatment (higher among participants who received antidepressants compared to placebo) and the number of drinks consumed per drinking days (lower among participants who received antidepressants compared to placebo). However, similarly to what we found for the severity of depression, we also observed that the administration of antidepressants did not affect other relevant outcomes related to alcohol dependence, such as the rate of abstinent days, number of heavy drinkers, and time before first relapse. In terms of safety issues, the rate of people withdrawing from treatment due to side effects (undesirable effects such as dry mouth) may not differ between antidepressants and placebo. There were few studies comparing one antidepressant to another antidepressant or to other interventions, and these had a small number of participants and the same comparison was not made by more than one study, and were therefore not informative. The quality of the included studies was low or moderate for depression severity, abstinence from alcohol, rate of people withdrawal for medical reasons, and dropouts. In subgroup analyses, in the case of single types of medicines, and comparisons with other medicines, the findings of the review were limited by the small number of available studies. There is low-quality evidence supporting the use of antidepressants in the treatment of people with co-occurring depression and alcohol dependence. Antidepressants have positive effects on certain relevant outcomes related to depression and alcohol use but not on equally relevant other outcomes. However, the risk of developing side effects appears to be minimal, especially for the newer classes of antidepressants. | 10.1002/14651858.CD008581.pub2 | [
"We identified 33 medical trials involving 2242 participants: 68% were male, and the mean age was 42 years. Most studies compared antidepressants to placebo (22 studies), but some compared one antidepressant to antidepressant (five studies), to another type of medicine (four studies), or to psychotherapy (a talking treatment; two studies). The average duration of the trials was 10 weeks (range 3 to 26 weeks). A total of 18 trials took place in the USA, and the others were in Europe, Turkey, and Australia. The antidepressant used in most of the trials was sertraline; the others were: amitriptyline, citalopram, desipramine, doxepin, escitalopram, fluoxetine, fluvoxamine, imipramine, mianserin, mirtazepine, nefazodone, paroxetine, tianeptine, venlafaxine, and viloxazine. The studies used 49 different rating scales and varied in terms of design, quality, participant characteristics, tested medicines, services provided, and treatments administered. A total of 19 studies reported the source of funding (public funds: six studies; pharmaceutical industry: two studies; both funds: 10 studies). Only four trials reported a declaration of the authors reporting possible conflicts of interest. In the 22 studies comparing antidepressants to placebo, antidepressants may have reduced the severity of depression but we are uncertain whether it increased the number of people with clinical beneficial effects from the reduction of depression severity (response to treatment, i.e. people who halved the severity of depression). However, we found no difference between antidepressants and placebo in other relevant outcomes related to the severity of depression, such as the number of people without depression at the end of the trial (remission). In addition, we found that the administration of antidepressants probably reduced alcohol consumption evaluated as the number of participants abstinent during the treatment (higher among participants who received antidepressants compared to placebo) and the number of drinks consumed per drinking days (lower among participants who received antidepressants compared to placebo). However, similarly to what we found for the severity of depression, we also observed that the administration of antidepressants did not affect other relevant outcomes related to alcohol dependence, such as the rate of abstinent days, number of heavy drinkers, and time before first relapse. In terms of safety issues, the rate of people withdrawing from treatment due to side effects (undesirable effects such as dry mouth) may not differ between antidepressants and placebo. There were few studies comparing one antidepressant to another antidepressant or to other interventions, and these had a small number of participants and the same comparison was not made by more than one study, and were therefore not informative. The quality of the included studies was low or moderate for depression severity, abstinence from alcohol, rate of people withdrawal for medical reasons, and dropouts. In subgroup analyses, in the case of single types of medicines, and comparisons with other medicines, the findings of the review were limited by the small number of available studies. There is low-quality evidence supporting the use of antidepressants in the treatment of people with co-occurring depression and alcohol dependence. Antidepressants have positive effects on certain relevant outcomes related to depression and alcohol use but not on equally relevant other outcomes. However, the risk of developing side effects appears to be minimal, especially for the newer classes of antidepressants."
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cochrane-simplification-train-1769 | cochrane-simplification-train-1769 | We included four RCTs, involving 564 participants in this review. We compared the effects of colchicine in addition to a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen, aspirin or indomethacin to the effects of the NSAID alone. Two comparable trials studied the effects of colchicine in 204 participants with recurrent pericarditis and two trials studied 360 people with acute pericarditis. All trials had a moderate quality for the primary outcomes. We identified two on-going trials; one of these trials examines acute pericarditis and the other assesses recurrent pericarditis. There was moderate quality evidence that colchicine reduces episodes of pericarditis in people with recurrent pericarditis over 18 months follow-up (HR 0.37; 95% confidence interval (CI) 0.24 to 0.58). It is expected that at 18 months, the number needed to treat (NNT) is 4. In people with acute pericarditis, there was moderate quality evidence that colchicine reduces recurrence (HR 0.40; 95% CI 0.27 to 0.61) at 18 months follow-up. Colchicine led to a greater chance of symptom relief at 72 hours (risk ratio (RR) 1.4; 95% CI 1.26 to 1.56; low quality evidence). Adverse effects were mainly gastrointestinal and included abdominal pain and diarrhoea. The pooled RR for adverse events was 1.26 (95% CI 0.75 to 2.12). While the number of people experiencing adverse effects was higher in the colchicine than the control groups (9% versus 7%), the quality of evidence was low owing to imprecision, and there was no statistically significant difference between the treatment groups (P = 0.42). There was moderate quality evidence that treatment with colchicine led to more people stopping treatment due to adverse events (RR 1.87; 95% CI 1.02 to 3.41). Colchicine, as adjunctive therapy to NSAIDs, is effective in reducing the number of pericarditis recurrences in patients with recurrent pericarditis or acute pericarditis. However, evidence is based on a limited number of small trials. Patients with multiple resistant recurrences were not represented in any published or on-going trials, and it is these patients that are in the most need for treatment. | We wanted to discover whether colchicine alone or added to other medications is better or worse than alternative therapies in preventing pericarditis. We have reviewed all randomised controlled trials about the effect of colchicine in preventing recurrence of pericarditis in people with pericarditis. We found four trials involving 564 participants, who were followed up for at least 18 months. Two studies examined the use of colchicine in people with recurrent pericarditis and two examined the use of colchicine in people with a first episode of pericarditis. The evidence is current to August 2014. The trials showed that people taking colchicine have a lower risk of developing pericarditis recurrence and a higher proportion experience symptom relief. It is expected that at 18 months, one pericarditis recurrence can be avoided for every four people receiving colchicine with NSAIDs rather than NSAIDs alone. Adverse effects were reported in all trials and affected 15 people (9%) of the 162 taking colchicine. Adverse effects included abdominal pain, nausea and vomiting. Two studies were designed so that participants knew the type of intervention they were taking and people in the comparison group had no dummy pill. The results of these studies could exaggerate the effects of the drug. The evidence suggests beneficial effects of colchicine in preventing recurrence of pericarditis, however this is based on a limited number of small trials. More trials are currently being done and we await their results to see if the benefits of colchicine can be further confirmed. | 10.1002/14651858.CD010652.pub2 | [
"We wanted to discover whether colchicine alone or added to other medications is better or worse than alternative therapies in preventing pericarditis. We have reviewed all randomised controlled trials about the effect of colchicine in preventing recurrence of pericarditis in people with pericarditis. We found four trials involving 564 participants, who were followed up for at least 18 months. Two studies examined the use of colchicine in people with recurrent pericarditis and two examined the use of colchicine in people with a first episode of pericarditis. The evidence is current to August 2014. The trials showed that people taking colchicine have a lower risk of developing pericarditis recurrence and a higher proportion experience symptom relief. It is expected that at 18 months, one pericarditis recurrence can be avoided for every four people receiving colchicine with NSAIDs rather than NSAIDs alone. Adverse effects were reported in all trials and affected 15 people (9%) of the 162 taking colchicine. Adverse effects included abdominal pain, nausea and vomiting. Two studies were designed so that participants knew the type of intervention they were taking and people in the comparison group had no dummy pill. The results of these studies could exaggerate the effects of the drug. The evidence suggests beneficial effects of colchicine in preventing recurrence of pericarditis, however this is based on a limited number of small trials. More trials are currently being done and we await their results to see if the benefits of colchicine can be further confirmed."
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cochrane-simplification-train-1770 | cochrane-simplification-train-1770 | We screened 4956 records from the searches, selecting 34 unique studies for full-text scrutiny, of which two met the inclusion criteria: one RCT and one NRS. The included studies assessed 113 female BRCA carriers who had risk-reducing surgery, but there was attrition, and outcome data were not available for all participants at final study assessments. We assessed the RCT as at a high risk of bias whilst the NRS did not have a control group. Our GRADE assessment of the studies was very low-certainty due to the paucity of data and methodological shortcomings of the studies. The primary outcome of quality of life was only measured in the RCT and that was specific to the menopause. Both studies reported on psychological distress and sexual function. Neither study measured body image, perhaps because this is most often associated with risk-reducing mastectomy rather than oophorectomy. The RCT (66 participants recruited with 48 followed to 12 months) assessed the short- and long-term effects of an eight-week mindfulness-based stress reduction (MBSR) training programme on quality of life, sexual functioning, and sexual distress in female BRCA carriers (n = 34) in a specialised family cancer clinic in the Netherlands compared to female BRCA carriers (n = 32) who received usual care. Measurements on the Menopause-Specific Quality of Life Questionnaire (MENQOL) showed some improvement at 3 and 12 months compared to the usual care group. At 3 months the mean MENQOL scores were 3.5 (95% confidence interval (CI) 3.0 to 3.9) and 3.8 (95% CI 3.3 to 4.2) for the MBSR and usual care groups respectively, whilst at 12 months the corresponding values were 3.6 (95% CI 3.1 to 4.0) and 3.9 (95% CI 3.5 to 4.4) (1 study; 48 participants followed up at 12 months). However, these results should be interpreted with caution due to the very low-certainty of the evidence, where a lower score is better. Other outcome measures on the Female Sexual Function Index and the Female Sexual Distress Scale showed no significant differences between the two groups. Our GRADE assessment of the evidence was very low-certainty due to the lack of blinding of participants and personnel, attrition bias and self-selection (as only one-third of eligible women chose to participate in the study) and serious imprecision due to the small sample size and wide 95% CI. The NRS comprised 37 female BRCA carriers selected from three Boston-area hospitals who had undergone a novel sexual health intervention following risk-reducing salpingo-oophorectomy (RRSO) without a history of tubo-ovarian cancer. The intervention consisted of targeted sexual-health education, body awareness and relaxation training, and mindfulness-based cognitive therapy strategies, followed by two sessions of tailored telephone counselling. This was a single-arm study without a control group. Our GRADE assessment of the evidence was very low-certainty, and as there was no comparison group in the included study, we could not estimate a relative effect. The study reported change in psychosexual adjustment from baseline to postintervention (median 2.3 months) using measures of Female Sexual Function Index (n = 34), which yielded change with a mean of 3.91, standard deviation (SD) 9.12, P = 0.018 (1 study, 34 participants; very low-certainty evidence). The Brief Symptom Inventory, Global Severity Index yielded a mean change of 3.92, SD 5.94, P < 0.001. The Sexual Self-Efficacy Scale yielded change with a mean of 12.14, SD 20.56, P < 0.001. The Sexual Knowledge Scale reported mean change of 1.08, SD 1.50, P < 0.001 (n = 36). Participant satisfaction was measured by questionnaire, and 100% participants reported that they enjoyed taking part in the psychoeducation group and felt "certain" or "very certain" that they had learned new skills to help them cope with the sexual side effects of RRSO. The effect of psychosocial interventions on quality of life and emotional well-being in female BRCA carriers who undergo risk-reducing surgery is uncertain given the very low methodological quality in the two studies included in the review. The absence of such interventions highlights the need for partnership between researchers and clinicians in this specific area to take forward the patient-reported outcomes and develop interventions to address the psychosocial issues related to risk-reducing surgery in female BRCA carriers, particularly in this new era of genomics, where testing may become more mainstream and many more women are identified as gene carriers. | We found two studies that examined a psychosocial intervention for women who had undergone removal of their fallopian tubes and ovaries to reduce their risk of tubo-ovarian cancer. One randomised controlled trial (a study in which participants are assigned to one of two or more treatment groups using a random method) assessed a mindfulness-based stress reduction training programme for menopausal symptoms after risk-reducing surgery. Whilst there was improvement in the menopause-specific quality of life scores in the short and the long term for women with menopausal symptoms, the intervention was not associated an with improvement in sexual functioning or distress. Women who participated in a non-randomised study all received the study intervention and scored themselves on certain items related to psychosexual functioning and psychological adjustment before and after the intervention (targeted sexual-health education, body awareness and relaxation training, and mindfulness-based cognitive therapy strategies). They also received a group psychoeducation session and telephone counselling. The outcomes were based on the differences between the before and after scores. All women recruited to the study were at risk of tubo-ovarian cancer based on having a harmful or faulty BRCA gene, but there was no personal history of tubo-ovarian cancer in the group studied. No studies reported on social and psychological interventions following risk-reducing surgery to have breast tissue removed in BRCA carriers. The certainty (quality) of the evidence ranged from moderate to very low, with only one randomised controlled trial and one non-randomised study that had no comparator included in the review. Both studies involved small numbers of women. The limited, moderate- to very low-certainty evidence meant that we were unable to draw any conclusions regarding psychosocial interventions following risk-reducing surgery in female BRCA carriers on improvement in quality of life and psychological (emotional) adjustment. Further research is required to determine how best to support women who choose to have risk-reducing surgery. | 10.1002/14651858.CD012894.pub2 | [
"We found two studies that examined a psychosocial intervention for women who had undergone removal of their fallopian tubes and ovaries to reduce their risk of tubo-ovarian cancer. One randomised controlled trial (a study in which participants are assigned to one of two or more treatment groups using a random method) assessed a mindfulness-based stress reduction training programme for menopausal symptoms after risk-reducing surgery. Whilst there was improvement in the menopause-specific quality of life scores in the short and the long term for women with menopausal symptoms, the intervention was not associated an with improvement in sexual functioning or distress. Women who participated in a non-randomised study all received the study intervention and scored themselves on certain items related to psychosexual functioning and psychological adjustment before and after the intervention (targeted sexual-health education, body awareness and relaxation training, and mindfulness-based cognitive therapy strategies). They also received a group psychoeducation session and telephone counselling. The outcomes were based on the differences between the before and after scores. All women recruited to the study were at risk of tubo-ovarian cancer based on having a harmful or faulty BRCA gene, but there was no personal history of tubo-ovarian cancer in the group studied. No studies reported on social and psychological interventions following risk-reducing surgery to have breast tissue removed in BRCA carriers. The certainty (quality) of the evidence ranged from moderate to very low, with only one randomised controlled trial and one non-randomised study that had no comparator included in the review. Both studies involved small numbers of women. The limited, moderate- to very low-certainty evidence meant that we were unable to draw any conclusions regarding psychosocial interventions following risk-reducing surgery in female BRCA carriers on improvement in quality of life and psychological (emotional) adjustment. Further research is required to determine how best to support women who choose to have risk-reducing surgery."
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cochrane-simplification-train-1771 | cochrane-simplification-train-1771 | We included nine cluster-randomized trials, one individual randomized trial, and seven non-randomized controlled studies. Nine studies were conducted in sub-Saharan Africa (Ethiopia, Nigeria, South Africa, Zambia, and Zimbabwe), six in Asia (Bangladesh, Cambodia, India, Nepal, and Pakistan), and two in South America (Brazil and Colombia); which are all high tuberculosis prevalence areas. Tuberculosis outreach screening, using house-to-house visits, sometimes combined with printed information about going to clinic, may increase tuberculosis case detection (RR 1.24, 95% CI 0.86 to 1.79; 4 trials, 6,458,591 participants in 297 clusters, low-certainty evidence); and probably increases case detection in areas with tuberculosis prevalence of 5% or more (RR 1.52, 95% CI 1.10 to 2.09; 3 trials, 155,918 participants, moderate-certainty evidence; prespecified stratified analysis). These interventions may lower the early default (prior to starting treatment) or default during treatment (RR 0.67, 95% CI 0.47 to 0.96; 3 trials, 849 participants, low-certainty evidence). However, this intervention may have may have little or no effect on treatment success (RR 1.07, 95% CI 1.00 to 1.15; 3 trials, 849 participants, low-certainty evidence), and we do not know if there is an effect on treatment failure or mortality. One study investigated long-term prevalence in the community, but with no clear effect due to imprecision and differences in care between the two groups (RR 1.14, 95% CI 0.65 to 2.00; 1 trial, 556,836 participants, very low-certainty evidence). Four studies examined health promotion activities to encourage people to attend for screening, including mass media strategies and more locally organized activities. There was some increase, but this could have been related to temporal trends, with no corresponding increase in case notifications, and no evidence of an effect on long-term tuberculosis prevalence. Two studies examined the effects of two to six nurse practitioner educational sessions in tuberculosis diagnosis, with no clear effect on tuberculosis cases detected. One trial compared mobile clinics every five days with house-to-house screening every six months, and showed an increase in tuberculosis cases. There was also insufficient evidence to determine if sustained improvements in case detection impact on long-term tuberculosis prevalence; this was evaluated in one study, which indicated little or no effect after four years of either contact tracing, extensive health promotion activities, or both (RR 1.31, 95% CI 0.75 to 2.30; 1 study, 405,788 participants in 12 clusters, very low-certainty evidence). The available evidence demonstrates that when used in appropriate settings, active case-finding approaches may result in increase in tuberculosis case detection in the short term. The effect of active case finding on treatment outcome needs to be further evaluated in sufficiently powered studies. | This review summarized trials evaluating the effects of interventions aiming to increase the diagnosis of tuberculosis and reduce the number of undiagnosed tuberculosis cases in communities. After searching for relevant trials up to 19 December 2016, we included 17 studies conducted in sub-Saharan Africa (nine studies), Asia (six studies), and South America (two studies). Why does tuberculosis go undiagnosed and how might programmes improve this? Tuberculosis is a chronic infectious disease that affects over 10 million people worldwide, with an estimated four million tuberculosis patients remaining undiagnosed each year. Interventions such as outreach tuberculosis screening with or without health promotion that actively screen for tuberculosis among individuals presenting with symptoms of tuberculosis, may increase detection of microbiologically confirmed tuberculosis cases. These interventions may improve treatment outcomes by increasing the number of tuberculosis patients who are cured and complete treatment. However, we do not know if these interventions reduce either tuberculosis treatment failure, or tuberculosis-associated death or long-term tuberculosis burden in moderate- and high-tuberculosis settings. What the research says House-to-house screening for active tuberculosis, and organizing tuberculosis diagnostic clinics nearer to where people live and work, may increase tuberculosis case detection in settings where the prevalence of undiagnosed disease is high (low-certainty evidence). These people may have higher levels of treatment success and lower levels of default from treatment (low-certainty evidence). There was insufficient evidence to determine if health promotion activities alone increase tuberculosis case detection (very low-certainty evidence). There was also insufficient evidence to determine if sustained improvements in case detection impact on long-term tuberculosis prevalence, as the only study to evaluate this found no effect after four years (very low-certainty evidence). | 10.1002/14651858.CD011432.pub2 | [
"This review summarized trials evaluating the effects of interventions aiming to increase the diagnosis of tuberculosis and reduce the number of undiagnosed tuberculosis cases in communities. After searching for relevant trials up to 19 December 2016, we included 17 studies conducted in sub-Saharan Africa (nine studies), Asia (six studies), and South America (two studies). Why does tuberculosis go undiagnosed and how might programmes improve this? Tuberculosis is a chronic infectious disease that affects over 10 million people worldwide, with an estimated four million tuberculosis patients remaining undiagnosed each year. Interventions such as outreach tuberculosis screening with or without health promotion that actively screen for tuberculosis among individuals presenting with symptoms of tuberculosis, may increase detection of microbiologically confirmed tuberculosis cases. These interventions may improve treatment outcomes by increasing the number of tuberculosis patients who are cured and complete treatment. However, we do not know if these interventions reduce either tuberculosis treatment failure, or tuberculosis-associated death or long-term tuberculosis burden in moderate- and high-tuberculosis settings. What the research says House-to-house screening for active tuberculosis, and organizing tuberculosis diagnostic clinics nearer to where people live and work, may increase tuberculosis case detection in settings where the prevalence of undiagnosed disease is high (low-certainty evidence). These people may have higher levels of treatment success and lower levels of default from treatment (low-certainty evidence). There was insufficient evidence to determine if health promotion activities alone increase tuberculosis case detection (very low-certainty evidence). There was also insufficient evidence to determine if sustained improvements in case detection impact on long-term tuberculosis prevalence, as the only study to evaluate this found no effect after four years (very low-certainty evidence)."
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cochrane-simplification-train-1772 | cochrane-simplification-train-1772 | Sixty studies (2773 patients) were included. No formulation, route, or schedule of administration was associated with altered risks of death, bone pain, or parathyroidectomy. Marked heterogeneity in reporting of outcomes resulted in few data available for formal meta-analysis. Compared with placebo, vitamin D compounds lowered serum PTH at the expense of increasing serum phosphorus. Trends toward increased hypercalcaemia and serum calcium did not reach statistical significance but may be clinically relevant. Newer vitamin D compounds (paricalcitol, maxacalcitol, doxercalciferol) lowered PTH compared with placebo, with increased risks of hypercalcaemia, although inadequate data were available for serum phosphorus. Intravenous vitamin D may lower PTH compared with oral treatment, and be associated with lower serum phosphorus and calcium levels, although limitations in the available studies precludes a conclusive statement of treatment efficacy. Few studies were available for intermittent versus daily and intraperitoneal versus oral administration or directly comparative studies of newer versus established vitamin D compounds. We confirm that vitamin D compounds suppress PTH in people with CKD and requiring dialysis although treatment is associated with clinical elevations in serum phosphorus and calcium. All studies were inadequately powered to assess the effect of vitamin D on clinical outcomes and until such studies are conducted the relative importance of changes in serum PTH, phosphorus and calcium resulting from vitamin D therapy remain unknown. Observational data showing vitamin D compounds may be associated with improved survival in CKD need to be confirmed or refuted in specifically designed RCTs. | We identified 60 studies of vitamin D preparations in people with CKD and requiring dialysis involving 2773 people. No studies were designed to understand the effect of vitamin D therapy on risks of death. Vitamin D agents suppress PTH significantly compared with no treatment, however also increase both circulating calcium and phosphorus levels. Intravenous vitamin D may lower PTH more than oral vitamin D. Few studies directly compare newer vitamin D therapies with earlier (and presently more common treatment options; calcitriol and alfacalcidol); newer treatment options therefore cannot be recommended as superior to established treatments. In the future, new studies will required to know if vitamin D effects on parathyroid function improve survival, bone pain, and need for parathyroid removal by surgery. It is possible that vitamin D compounds are beneficial to patients regardless of their effects on parathyroid hormone. This can only be adequately evaluated by conducting specific studies that are large enough to be sure of any treatment differences. | 10.1002/14651858.CD005633.pub2 | [
"We identified 60 studies of vitamin D preparations in people with CKD and requiring dialysis involving 2773 people. No studies were designed to understand the effect of vitamin D therapy on risks of death. Vitamin D agents suppress PTH significantly compared with no treatment, however also increase both circulating calcium and phosphorus levels. Intravenous vitamin D may lower PTH more than oral vitamin D. Few studies directly compare newer vitamin D therapies with earlier (and presently more common treatment options; calcitriol and alfacalcidol); newer treatment options therefore cannot be recommended as superior to established treatments. In the future, new studies will required to know if vitamin D effects on parathyroid function improve survival, bone pain, and need for parathyroid removal by surgery. It is possible that vitamin D compounds are beneficial to patients regardless of their effects on parathyroid hormone. This can only be adequately evaluated by conducting specific studies that are large enough to be sure of any treatment differences."
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cochrane-simplification-train-1773 | cochrane-simplification-train-1773 | Seven studies involving 178 participants were included. Two studies were excluded from the meta-analysis of remission rates on the basis of clinical heterogeneity of the initial endoscopic protocols. There was no significant difference between PD or BTX treatment in remission within four weeks of the initial intervention; with a risk ratio of remission of 1.11 (95% CI 0.97 to 1.27). There was also no significant difference in the mean oesophageal pressures between the treatment groups; with a weighted mean difference for PD of -0.77 (95% CI -2.44 to 0.91, P = 0.37). Data on remission rates following the initial endoscopic treatment were available for three studies at six months and four studies at 12 months. At six months 46 of 57 PD participants were in remission compared to 29 of 56 in the BTX group, giving a risk ratio of 1.57 (95% CI 1.19 to 2.08, P = 0.0015); whilst at 12 months 55 of 75 PD participants were in remission compared to 27 of 72 BTX participants, with a risk ratio of 1.88 (95% CI 1.35 to 2.61, P = 0.0002). No serious adverse outcomes occurred in participants receiving BTX, whilst PD was complicated by perforation in three cases. The results of this meta-analysis suggest that PD is the more effective endoscopic treatment in the long term (greater than six months) for patients with achalasia. | We set out to undertake a systematic review comparing randomised controlled trials that examined the efficacy and safety of PD and BTX injection in people with achalasia. We searched databases (MEDLINE, EMBASE, ISI Web of Science, and The Cochrane Library) in April 2014 for reports of relevant randomised controlled trials. Seven randomised controlled trials were identified for inclusion in the review, and five were suitable for meta-analysis. Meta-analysis suggested that, although both interventions had similar initial response rates, the remission rates at six and 12 months were significantly greater with PD than with BTX injection. | 10.1002/14651858.CD005046.pub3 | [
"We set out to undertake a systematic review comparing randomised controlled trials that examined the efficacy and safety of PD and BTX injection in people with achalasia. We searched databases (MEDLINE, EMBASE, ISI Web of Science, and The Cochrane Library) in April 2014 for reports of relevant randomised controlled trials. Seven randomised controlled trials were identified for inclusion in the review, and five were suitable for meta-analysis. Meta-analysis suggested that, although both interventions had similar initial response rates, the remission rates at six and 12 months were significantly greater with PD than with BTX injection."
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cochrane-simplification-train-1774 | cochrane-simplification-train-1774 | Six open-label studies (257 patients) were identified. One study compared ACEi with other antihypertensive drugs, three compared ARBs with other antihypertensive drugs, and two studies compared an ARB with an ACEi. Long-term use (≥ 12 months) of an ARB showed significantly benefit of preserving residual kidney function in continuous ambulatory PD (CAPD) patients (MD 1.11 mL/min/1.73 m², 95% CI 0.38 to 1.83), although there was no significant benefit when an ARB were used short-term (≤ six months). One study showed that compared with other antihypertensive drugs, long-term use (12 months) of the ACEi ramipril showed a significant reduction in the decline of residual kidney function in patients on CAPD (MD -0.93 mL/min/1.73m², 95% CI -0.75 to -0.11), and delayed the progression to complete anuria (RR 0.64, 95% CI 0.41 to 0.99). There was no significant difference in serum potassium, urinary protein excretion, Kt/V, weekly creatinine clearance and blood pressure for ARBs versus other antihypertensive drugs. Compared with other antihypertensive drugs, ramipril showed no difference in mortality and cardiovascular events. Compared with an ACEi, ARBs did not show any difference in residual kidney function. The selection bias assessment was low in four studies and unclear in two. Five studies were open-label; however the primary outcome (residual kidney function) was obtained objectively from laboratory tests, and were not likely to be influenced by the lack of blinding. Reporting bias was unclear in all six studies. Compared with other antihypertensive drugs, long-term use (≥ 12 months) of ACEis or ARBs showed additional benefits of preserving residual kidney function in CAPD patients. There was no significant difference on residual kidney function preservation between ARBs and ACEis. However, limited by the small number of RCTs enrolling small number of participants, there is currently insufficient evidence to support the use of an ACEi or an ARB as first line antihypertensive therapy in PD patients. | However studies have focused on heart protection rather than residual kidney function. The aim of this review was to assess the benefits and harms of ACEis and ARBs therapy for preserving residual kidney function in PD patients. Six studies (257 patients) were included (three ARB studies, one ACEi study and ACEi versus ARB studies). Long-term use (12 months or more) of an ARB showed a significant benefit in preserving residual kidney function in continuous ambulatory PD (CAPD) patients compared with other antihypertensive drugs, although there was no significant benefit when an ARB were used for less than six months). One study showed that compared with other antihypertensive drugs, long-term use of the ACEi ramipril showed a significant reduction in the decline of residual kidney function in patients on CAPD as well as anuria rate. While dizziness and cough are the main adverse events when an ACEi is used, only one study comparing an ARB with an ACEi reported this outcome and no significant difference between the two groups were found. While the use of an ARB or an ACEi may both be useful in preserving residual kidney function, the small number of studies and small number of patients enrolled means there is currently insufficient evidence to support the use of an ACEi or an ARB as first line antihypertensive therapy in PD patients. | 10.1002/14651858.CD009120.pub2 | [
"However studies have focused on heart protection rather than residual kidney function. The aim of this review was to assess the benefits and harms of ACEis and ARBs therapy for preserving residual kidney function in PD patients. Six studies (257 patients) were included (three ARB studies, one ACEi study and ACEi versus ARB studies). Long-term use (12 months or more) of an ARB showed a significant benefit in preserving residual kidney function in continuous ambulatory PD (CAPD) patients compared with other antihypertensive drugs, although there was no significant benefit when an ARB were used for less than six months). One study showed that compared with other antihypertensive drugs, long-term use of the ACEi ramipril showed a significant reduction in the decline of residual kidney function in patients on CAPD as well as anuria rate. While dizziness and cough are the main adverse events when an ACEi is used, only one study comparing an ARB with an ACEi reported this outcome and no significant difference between the two groups were found. While the use of an ARB or an ACEi may both be useful in preserving residual kidney function, the small number of studies and small number of patients enrolled means there is currently insufficient evidence to support the use of an ACEi or an ARB as first line antihypertensive therapy in PD patients."
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cochrane-simplification-train-1775 | cochrane-simplification-train-1775 | We identified four potential studies, of which three were excluded. The included trial reported clinical pregnancy rates but not live births. There was no evidence of a difference in clinical pregnancy rate between those receiving an amoxycillin and clavulanic acid antibiotic combination (64/178: 36%) and those not (61/172: 35.5%) (OR1.02, 95% CI 0.66 to 1.58). Genital tract colonisation was significantly reduced in women receiving this antibiotic regimen (OR 0.59, 95% CI 0.37 to 0.95). This review suggests that the administration of amoxycillin and clavulanic acid prior to embryo transfer reduced upper genital tract microbial contamination but did not alter clinical pregnancy rates. The effect of this intervention on live birth is unknown. There are no data from randomised controlled trials to support or refute other antibiotic regimens in this setting. Future research is warranted to assess the efficacy of alternative antibiotic regimens. Researchers should assess live birth as the primary outcome and address quantitative microbial colonization as a secondary outcome. | In the only study which addressed this question, the use of an amoxycillin and clavulanic acid antibiotic regimen had no effect on clinical pregnancy rate despite demonstrating a reduction in upper genital tract colonisation. The effect on live birth rate is unknown. The findings of this review do not support the use of an amoxycillin and clavulanic acid antibiotic regimen prior to ET for the purposes of improving IVF success. The effect of alternative antibiotic regimens on IVF outcomes is unknown and needs further research. | 10.1002/14651858.CD008995.pub2 | [
"In the only study which addressed this question, the use of an amoxycillin and clavulanic acid antibiotic regimen had no effect on clinical pregnancy rate despite demonstrating a reduction in upper genital tract colonisation. The effect on live birth rate is unknown. The findings of this review do not support the use of an amoxycillin and clavulanic acid antibiotic regimen prior to ET for the purposes of improving IVF success. The effect of alternative antibiotic regimens on IVF outcomes is unknown and needs further research."
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cochrane-simplification-train-1776 | cochrane-simplification-train-1776 | No studies were included in this review. Although it is generally recognised that cystic fibrosis-related arthritis can be episodic and resolve spontaneously, treatment with analgesics and anti-inflammatory agents may be needed. But when episodic symptoms progress to persistent disease, disease-modifying anti-rheumatic drugs may be needed to limit the course of the disease. It is disappointing that no randomised controlled trials to rigorously evaluate these drugs could be found. This systematic review has identified the need for a well-designed adequately powered randomised controlled trial to assess the efficacy and safety of disease-modifying anti-rheumatic drugs for the management of cystic fibrosis-related arthropathy and hypertrophic osteoarthropathy in adults and children with cystic fibrosis. However, given the infrequency of cystic fibrosis-related arthritis and the range of symptoms and severity, randomised controlled trials may not be feasible and well-designed non-randomised observational studies may be more appropriate. Studies should also better define the two conditions. | We planned to report evidence from clinical trials which compared different disease-modifying drugs compared with placebo (or dummy treatment), with each other or with no treatment. However, we were disappointed that we could not find any completed randomised controlled trials of these treatments or any evidence from non-randomised controlled trials. We suggest that there should be a randomised controlled trial to look at the effects and the safety of using disease modifying anti-rheumatic drugs to slow or stop the progression of arthritis in people with cystic fibrosis. | 10.1002/14651858.CD007336.pub3 | [
"We planned to report evidence from clinical trials which compared different disease-modifying drugs compared with placebo (or dummy treatment), with each other or with no treatment. However, we were disappointed that we could not find any completed randomised controlled trials of these treatments or any evidence from non-randomised controlled trials. We suggest that there should be a randomised controlled trial to look at the effects and the safety of using disease modifying anti-rheumatic drugs to slow or stop the progression of arthritis in people with cystic fibrosis."
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cochrane-simplification-train-1777 | cochrane-simplification-train-1777 | Four trials involving 527 predominantly male participants were included. The main weakness of the studies was the lack of correct stratification of the arthroscopic intervention. The relative risk (RR) of thrombotic events was 0.16 (95% confidence interval (CI); 0.05 to 0.52) comparing any type of low molecular weight heparin (LMWH) versus placebo. All thrombotic events but one (pulmonary embolism in the LMWH group) were distal venous thrombosis. Adverse events were most common in the intervention group than in the control group, RR 2.04 (95% CI 1.21 to 3.44). There were 66 episodes of adverse events. The number needed to harm was 20 for any adverse events. This meta-analysis suggests that LMWH reduces the incidence of distal DVT diagnosed by sonogram. The clinical benefit of this is uncertain. No strong evidence was found to conclude thromboprophylaxis is effective to prevent thromboembolic events and safe, in people with unknown risk factors for thrombosis, undergoing knee arthroscopy. | This review reports that low molecular weight heparin reduces the incidence of distal DVT diagnosed but the clinical benefits of this are uncertain. The review authors identified four completed studies from three countries that randomly assigned a total of 527 adults to low molecular weight heparin (LMWH) or no intervention or placebo. The mean age of participants ranged from 31 to 44 years and nearly three quarters were male. The relative risk (RR) of thrombotic events was 0.16 (range 0.05 to 0.52). The number needed to treat to prevent one thrombotic event was 17. All the blood clots were distal and were mainly diagnosed by sonogram. Adverse events were most common in the intervention group. The most common complication was minor bleeding with a RR of 2.23 (range 0.99 to 4.99). The number needed to harm was 20. No completed studies were found that looked at mechanical devices such as graduated elastic stockings or intermittent pneumatic compression, for patients immobilized in bed. | 10.1002/14651858.CD005259.pub3 | [
"This review reports that low molecular weight heparin reduces the incidence of distal DVT diagnosed but the clinical benefits of this are uncertain. The review authors identified four completed studies from three countries that randomly assigned a total of 527 adults to low molecular weight heparin (LMWH) or no intervention or placebo. The mean age of participants ranged from 31 to 44 years and nearly three quarters were male. The relative risk (RR) of thrombotic events was 0.16 (range 0.05 to 0.52). The number needed to treat to prevent one thrombotic event was 17. All the blood clots were distal and were mainly diagnosed by sonogram. Adverse events were most common in the intervention group. The most common complication was minor bleeding with a RR of 2.23 (range 0.99 to 4.99). The number needed to harm was 20. No completed studies were found that looked at mechanical devices such as graduated elastic stockings or intermittent pneumatic compression, for patients immobilized in bed."
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cochrane-simplification-train-1778 | cochrane-simplification-train-1778 | We included 47 studies with 5102 women. The evidence for most comparisons was of low or moderate quality. The main limitations were poor reporting and imprecision. Vaginal hysterectomy (VH) versus abdominal hysterectomy (AH) (nine RCTs, 762 women) Return to normal activities was shorter in the VH group (mean difference (MD) -9.5 days, 95% confidence interval (CI) -12.6 to -6.4, three RCTs, 176 women, I2 = 75%, moderate quality evidence). There was no evidence of a difference between the groups for the other primary outcomes. Laparoscopic hysterectomy (LH) versus AH (25 RCTs, 2983 women) Return to normal activities was shorter in the LH group (MD -13.6 days, 95% CI -15.4 to -11.8; six RCTs, 520 women, I2 = 71%, low quality evidence), but there were more urinary tract injuries in the LH group (odds ratio (OR) 2.4, 95% CI 1.2 to 4.8, 13 RCTs, 2140 women, I2 = 0%, low quality evidence). There was no evidence of a difference between the groups for the other primary outcomes. LH versus VH (16 RCTs, 1440 women) There was no evidence of a difference between the groups for any primary outcomes. Robotic-assisted hysterectomy (RH) versus LH (two RCTs, 152 women) There was no evidence of a difference between the groups for any primary outcomes. Neither of the studies reported satisfaction rates or quality of life. Overall, the number of adverse events was low in the included studies. Among women undergoing hysterectomy for benign disease, VH appears to be superior to LH and AH, as it is associated with faster return to normal activities. When technically feasible, VH should be performed in preference to AH because of more rapid recovery and fewer febrile episodes postoperatively. Where VH is not possible, LH has some advantages over AH (including more rapid recovery and fewer febrile episodes and wound or abdominal wall infections), but these are offset by a longer operating time. No advantages of LH over VH could be found; LH had a longer operation time, and total laparoscopic hysterectomy (TLH) had more urinary tract injuries. Of the three subcategories of LH, there are more RCT data for laparoscopic-assisted vaginal hysterectomy and LH than for TLH. Single-port laparoscopic hysterectomy and RH should either be abandoned or further evaluated since there is a lack of evidence of any benefit over conventional LH. Overall, the evidence in this review has to be interpreted with caution as adverse event rates were low, resulting in low power for these comparisons. The surgical approach to hysterectomy should be discussed and decided in the light of the relative benefits and hazards. These benefits and hazards seem to be dependent on surgical expertise and this may influence the decision. In conclusion, when VH is not feasible, LH may avoid the need for AH, but LH is associated with more urinary tract injuries. There is no evidence that RH is of benefit in this population. Preferably, the surgical approach to hysterectomy should be decided by the woman in discussion with her surgeon. | We analysed 47 randomised controlled trials (RCTs). A RCT is a type of study in which the people being studied are randomly allocated one or other of the different treatments being investigated. This type of study is usually the best way to evaluate whether a treatment is truly effective, i.e. truly helps the patient. A systematic review systematically summarises the available RCTs on a subject. A total of 5102 women participated. Comparisons were vaginal versus abdominal hysterectomy (nine trials, 762 women), laparoscopic versus abdominal hysterectomy (25 trials, 2983 women), laparoscopic versus vaginal hysterectomy (16 trials, 1440 women) and laparoscopic versus robot-assisted hysterectomy (two trials, 152 women); in addition there were studies in which three comparisons were made (four trials, 410 women). There were also studies included in which different types of laparoscopic hysterectomies were compared, including single-port versus multi-port (three trials, 203 women), total laparoscopic hysterectomy versus laparoscopic-assisted vaginal hysterectomy (one trial, 101 women) and mini-laparoscopic versus conventional laparoscopic hysterectomy (one trial, 76 women). The main outcomes were return to normal activities, satisfaction, quality of life and surgical complications. We found that vaginal hysterectomy resulted in a quicker return to normal activities than abdominal hysterectomy. There was no evidence of a difference between them for our other main outcomes. Laparoscopic hysterectomy also resulted in a quicker return to normal activities than abdominal hysterectomy. However, laparoscopic hysterectomies had a greater risk of damaging the bladder or ureter. There was no evidence of a difference between laparoscopic and vaginal hysterectomy or between laparoscopic and robot-assisted hysterectomy for our main outcomes. We conclude that vaginal hysterectomy should be performed whenever possible. Where vaginal hysterectomy is not possible, both a laparoscopic approach and abdominal hysterectomy have their pros and cons and these should be incorporated in the decision-making process. The evidence is current to August 2014. The evidence for most comparisons was of low or moderate quality. The main limitations were poor reporting of study methods and wide confidence intervals around the estimate of effect. | 10.1002/14651858.CD003677.pub5 | [
"We analysed 47 randomised controlled trials (RCTs). A RCT is a type of study in which the people being studied are randomly allocated one or other of the different treatments being investigated. This type of study is usually the best way to evaluate whether a treatment is truly effective, i.e. truly helps the patient. A systematic review systematically summarises the available RCTs on a subject. A total of 5102 women participated. Comparisons were vaginal versus abdominal hysterectomy (nine trials, 762 women), laparoscopic versus abdominal hysterectomy (25 trials, 2983 women), laparoscopic versus vaginal hysterectomy (16 trials, 1440 women) and laparoscopic versus robot-assisted hysterectomy (two trials, 152 women); in addition there were studies in which three comparisons were made (four trials, 410 women). There were also studies included in which different types of laparoscopic hysterectomies were compared, including single-port versus multi-port (three trials, 203 women), total laparoscopic hysterectomy versus laparoscopic-assisted vaginal hysterectomy (one trial, 101 women) and mini-laparoscopic versus conventional laparoscopic hysterectomy (one trial, 76 women). The main outcomes were return to normal activities, satisfaction, quality of life and surgical complications. We found that vaginal hysterectomy resulted in a quicker return to normal activities than abdominal hysterectomy. There was no evidence of a difference between them for our other main outcomes. Laparoscopic hysterectomy also resulted in a quicker return to normal activities than abdominal hysterectomy. However, laparoscopic hysterectomies had a greater risk of damaging the bladder or ureter. There was no evidence of a difference between laparoscopic and vaginal hysterectomy or between laparoscopic and robot-assisted hysterectomy for our main outcomes. We conclude that vaginal hysterectomy should be performed whenever possible. Where vaginal hysterectomy is not possible, both a laparoscopic approach and abdominal hysterectomy have their pros and cons and these should be incorporated in the decision-making process. The evidence is current to August 2014. The evidence for most comparisons was of low or moderate quality. The main limitations were poor reporting of study methods and wide confidence intervals around the estimate of effect."
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cochrane-simplification-train-1779 | cochrane-simplification-train-1779 | The update of this review found two additional studies, totaling 11 studies that randomised 2159 participants (3580 eyes) and followed them up to two years, of which six studies (1454 participants) included people with one eye randomised to treatment and one to control. Studies were conducted in Australia, Europe and North America. Overall, the risk of bias in the included studies was low, particularly for the larger studies and for the primary outcome development of CNV. Photocoagulation did not reduce the development of CNV at two years' follow-up (odds ratio (OR) 1.07, 95% confidence interval (CI) 0.79 to 1.46, 11 studies, 2159 participants (3580 eyes), high quality evidence). This estimate means that, given an overall occurrence of CNV of 8.3% in the control group, we estimated an absolute risk reduction by no more than 1.4% in the laser group, according to the lower CI limit. Only two studies investigated the effect on the development of geographic atrophy and could not show a difference, but estimates were imprecise (OR 1.30, 95% CI 0.38 to 4.51, two studies, 148 participants (148 eyes), low quality evidence). Among secondary outcomes, photocoagulation led to drusen reduction (OR 9.16, 95% CI 6.28 to 13.4, three studies, 570 participants (944 eyes), high quality evidence) but was not shown to limit loss of 3 or more lines of visual acuity (OR 0.99, 95% CI 0.81 to 1.22, nine studies, 2002 participants (2386 eyes), moderate quality evidence). In a subgroup analysis, no difference could be shown for conventional visible (eight studies) versus subthreshold invisible (four studies) photocoagulation for the primary outcomes (P value = 0.29). The effect in the subthreshold group did not suggest a relevant benefit (OR 1.27, 95% CI 0.82 to 1.98). No study used micropulse subthreshold photocoagulation. No other adverse effects (apart from development of CNV, geographic atrophy or visual loss) were reported. The trials included in this review confirm the clinical observation that laser photocoagulation of drusen leads to their disappearance. However, treatment does not result in a reduction in the risk of developing CNV, and was not shown to limit the occurrence of geographic atrophy or visual acuity loss. Ongoing studies are being conducted to assess whether the use of extremely short laser pulses (i.e. nanosecond laser treatment) cannot only lead to drusen regression but also prevent neovascular AMD. | This review included data from 11 trials conducted in Australia, Europe and North America. The studies followed up 2159 participants with drusen (3580 eyes) to two years, of which six studies (1454 participants) included people with one eye randomised to treatment and one to control. Four studies (850 eyes) used subthreshold photocoagulation. Three out of four studies using laser subthreshold photocoagulation were sponsored by the laser producer. These studies showed that laser photocoagulation of drusen leads to their disappearance. However, laser photocoagulation of drusen did not reduce the risk of developing CNV, which was about 10% at three years in untreated participants. A smaller number of studies reported on the development of geographic atrophy, that is, atrophy in the centre of the macula, but these studies were inconclusive and the effect of laser treatment of drusen on the development of geographic atrophy was uncertain. The risk of visual loss was similar in treated and untreated groups. There was no suggestion that a benefit may exist with subthreshold photocoagulation. The overall quality of the evidence was high regarding failure to prevent CNV, but it was low for prevention of atrophy due to the small number of participants for whom this outcome was assessed. | 10.1002/14651858.CD006537.pub3 | [
"This review included data from 11 trials conducted in Australia, Europe and North America. The studies followed up 2159 participants with drusen (3580 eyes) to two years, of which six studies (1454 participants) included people with one eye randomised to treatment and one to control. Four studies (850 eyes) used subthreshold photocoagulation. Three out of four studies using laser subthreshold photocoagulation were sponsored by the laser producer. These studies showed that laser photocoagulation of drusen leads to their disappearance. However, laser photocoagulation of drusen did not reduce the risk of developing CNV, which was about 10% at three years in untreated participants. A smaller number of studies reported on the development of geographic atrophy, that is, atrophy in the centre of the macula, but these studies were inconclusive and the effect of laser treatment of drusen on the development of geographic atrophy was uncertain. The risk of visual loss was similar in treated and untreated groups. There was no suggestion that a benefit may exist with subthreshold photocoagulation. The overall quality of the evidence was high regarding failure to prevent CNV, but it was low for prevention of atrophy due to the small number of participants for whom this outcome was assessed."
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cochrane-simplification-train-1780 | cochrane-simplification-train-1780 | This update included one new study in which a subgroup of participants met our inclusion criteria. As none of the four included studies focused solely on people initiating antihypertensive treatment, we asked investigators for data for this subgroup. One study (PREVER-treatment 2016) used a combination of thiazide-type diuretic/potassium-sparing diuretic; as the former is not indicated in monotherapy, we analysed this study separately. The three original trials in the main comparison (monotherapy: 335 participants; combination therapy: 233 participants) included outpatients, mostly European and white people. Two trials only included people with type 2 diabetes; the remaining trial excluded people treated with diabetes, hypocholesterolaemia, or cardiovascular drugs. The follow-up was 12 months in two trials and 36 months in one trial. It is very uncertain whether combination therapy versus monotherapy reduces total mortality (RR 1.35, 95% CI 0.08 to 21.72), cardiovascular mortality (zero events reported), cardiovascular events (RR 0.98, 95% CI 0.22 to 4.41), serious adverse events (RR 0.77, 95% CI 0.31 to 1.92), or withdrawals due to adverse effects (RR 0.85, 95% CI 0.53 to 1.35); all outcomes had 568 participants, and the evidence was rated as of very low certainty due to serious imprecision and for using a subgroup that was not defined in advance. The confidence intervals were extremely wide for all important outcomes and included both appreciable harm and benefit. The PREVER-treatment 2016 trial, which used a combination therapy with potassium-sparing diuretic (monotherapy: 84 participants; combination therapy: 116 participants), included outpatients. This trial was conducted in Brazil and had a follow-up of 18 months. The number of events was very low and confidence intervals very wide, with zero events reported for cardiovascular mortality and withdrawals due to adverse events. It is very uncertain if there are differences in clinical outcomes between monotherapy and combination therapy in this trial. The numbers of included participants, and hence the number of events, were too small to draw any conclusion about the relative efficacy of monotherapy versus combination therapy as initial treatment for primary hypertension. There is a need for large clinical trials that address the review question and report clinically relevant endpoints. | We searched for clinical studies that compared starting treatment of hypertension in adults with monotherapy versus starting with combination therapy. Studies had to report results in terms of deaths, events due to diseases of the heart or the vessels (heart attack, stroke, or heart failure), deaths due to diseases of the heart or the vessels, or any health-related serious side effects. We only selected studies with 50 or more people per group and that lasted at least 12 months. The evidence is current to April 2019. In this update we included one new study, for a total of four studies in the review involving 349 people treated with combination therapy and 419 treated with monotherapy. However, data were insufficient to answer our review question. There is a need for more and larger studies that compare monotherapy with combination therapy as the initial treatment of hypertension. | 10.1002/14651858.CD010316.pub3 | [
"We searched for clinical studies that compared starting treatment of hypertension in adults with monotherapy versus starting with combination therapy. Studies had to report results in terms of deaths, events due to diseases of the heart or the vessels (heart attack, stroke, or heart failure), deaths due to diseases of the heart or the vessels, or any health-related serious side effects. We only selected studies with 50 or more people per group and that lasted at least 12 months. The evidence is current to April 2019. In this update we included one new study, for a total of four studies in the review involving 349 people treated with combination therapy and 419 treated with monotherapy. However, data were insufficient to answer our review question. There is a need for more and larger studies that compare monotherapy with combination therapy as the initial treatment of hypertension."
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cochrane-simplification-train-1781 | cochrane-simplification-train-1781 | This update included three new studies, providing a 26% increase in participants in comparisons between diclofenac and placebo. We included 18 studies involving 3714 participants, 1902 treated with diclofenac and 1007 with placebo. This update has also changed the focus of the review, examining the effects of formulation in more detail than previously. This is a result of increased understanding of the importance of speed of onset in determining analgesic efficacy in acute pain. The largest body of information, for diclofenac potassium 50 mg, in seven studies, produced an NNT for at least 50% of maximum pain relief compared with placebo of 2.1 (95% confidence interval (CI) 1.9 to 2.5) (high quality evidence). There was a graded improvement in efficacy as doses rose from 25 mg to 100 mg, both for participants achieving at least 50% maximum pain relief, and for remedication within 6 to 8 hours. Fast-acting formulations (dispersible products, solutions, and softgel formulations) had a similar efficacy for a 50 mg dose, with an NNT of 2.4 (2.0 to 3.0). Diclofenac sodium in a small number of studies produced a lesser effect, with an NNT of 6.6 (4.1 to 17) for the 50 mg dose. Adverse event rates were low in these single dose studies, with no difference between diclofenac and placebo (moderate quality evidence). Diclofenac potassium provides good pain relief at 25 mg, 50 mg, and 100 mg doses. Diclofenac sodium has limited efficacy and should probably not be used in acute pain. | This is an update of a review published in 2009. New searches in March 2015 identified three new studies, making 18 studies with 3714 participants altogether, 1902 of whom were treated with diclofenac and 1007 with placebo. Diclofenac potassium is a rapidly absorbed formulation, and the 50 mg dose provided the largest amount on information. With this dose of this formulation, more than 6 in 10 (64%) participants had effective pain relief, compared with fewer than 2 in 10 (17%) with placebo (high quality evidence). Adverse events occurred at similar rates with diclofenac and placebo in these single dose studies (moderate quality evidence). There were few serious adverse events or withdrawals due to adverse events. Diclofenac potassium represents a useful option in controlling acute pain. | 10.1002/14651858.CD004768.pub3 | [
"This is an update of a review published in 2009. New searches in March 2015 identified three new studies, making 18 studies with 3714 participants altogether, 1902 of whom were treated with diclofenac and 1007 with placebo. Diclofenac potassium is a rapidly absorbed formulation, and the 50 mg dose provided the largest amount on information. With this dose of this formulation, more than 6 in 10 (64%) participants had effective pain relief, compared with fewer than 2 in 10 (17%) with placebo (high quality evidence). Adverse events occurred at similar rates with diclofenac and placebo in these single dose studies (moderate quality evidence). There were few serious adverse events or withdrawals due to adverse events. Diclofenac potassium represents a useful option in controlling acute pain."
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cochrane-simplification-train-1782 | cochrane-simplification-train-1782 | We included 17 randomised trials (3149 participants) conducted in nine different countries. Seven studies (1325 women) recruited exclusively women undergoing elective CS and five studies (833 women) only included women having a primary CS. Ten studies (1731 women) used conventional feeding protocols (nil by mouth until the return of intestinal function). The gum-chewing regimen varied among studies, in relation to its initiation (immediately after CS, up to 12 hours later), duration of each session (from 15 to 60 minutes) and number of sessions per day (three to more than six). All the studies were classified as having a high risk of bias due to the nature of the intervention, women could not be blinded and most of the outcomes were self-reported. Primary outcomes of this review: for the women that chewed gum, the time to passage of first flatus was seven hours shorter than those women in the 'usual care' control group (MD -7.09 hours, 95% CI -9.27 to -4.91 hours; 2399 women; 13 studies; random-effects Tau² = 14.63, I² = 95%, very low-quality evidence). This effect was consistent in all subgroup analyses (primary and repeat CS, time spent chewing gum per day, early and conventional feeding protocols, elective and non-elective CS and time after CS when gum-chewing was initiated). The rate of ileus was on average over 60% lower in the chewing-gum group compared to the control (RR 0.39, 95% CI 0.19 to 0.80; 1139 participants; four studies; I² = 39%, low-quality evidence). Tolerance to gum-chewing appeared to be high. Three women in one study complained about the chewing gum (but no further information was provided) and none of the studies reported adverse effects (eight studies, 925 women, low-quality evidence). Secondary outcomes of this review: the time to passage of faeces occurred on average nine hours earlier in the intervention group (MD -9.22 hours, 95% CI -11.49 to -6.95 hours; 2016 participants; 11 studies; random-effects Tau² = 12.53, I² = 93%, very low-quality evidence). The average duration of hospital stay was shorter in the intervention compared to the control group (MD -0.36 days, 95% CI -0.53 to -0.18 days; 1489 participants; seven studies; random-effects Tau² = 0.04, I² = 92%). The first intestinal sounds were heard earlier in the intervention than in the control group (MD -4.56 hours, 95% CI -6.18 to -2.93 hours; 1729 participants; nine studies; random-effects Tau² = 5.41, I² = 96%). None of the studies assessed women's satisfaction in relation to having to chew gum. The need for analgesia or antiemetic agents did not differ between the intervention and control groups (average RR 0.50, 95% CI 0.12 to 2.13; 726 participants; three studies; random-effects Tau² = 0.79, I² = 69%). This review found 17 randomised controlled trials (involving 3149 women). We downgraded the quality of the evidence for time to first passage of flatus and of faeces and for adverse effects/intolerance to gum chewing because of the high risk of bias of the studies (due to lack of blinding and self-report). For time to first flatus and faeces, we downgraded the quality of the evidence further because of the high heterogeneity in these meta-analyses and the potential for publication bias based on the visual inspection of the funnel plots. The quality of the evidence for adverse effects/tolerance to gum chewing and for ileus was downgraded because of the small number of events. The quality of the evidence for ileus was further downgraded due to the unclear risk of bias for the assessors evaluating this outcome. The available evidence suggests that gum chewing in the immediate postoperative period after a CS is a well tolerated intervention that enhances early recovery of bowel function. However the overall quality of the evidence is very low to low. Further research is necessary to establish the optimal regimen of gum-chewing (initiation, number and duration of sessions per day) to enhance bowel function recovery and to assess potential adverse effects of and women's satisfaction with this intervention. New studies also need to assess the compliance of the participants to the recommended gum-chewing instructions. Future large, well designed and conducted studies, with better methodological and reporting quality, will help to inform future updates of this review and enhance the body of evidence for this intervention. | We included randomised controlled studies published up to June 2016. We found 17 studies, with 3149 women who had just delivered by CS. In these studies, a group of women chewed gum and a second group did not, receiving usual care. The studies were conducted in nine countries (mostly low- to middle-income countries) and were different in many aspects. For instance, some studies included only women having their first baby and others included women with a previous CS; some studies included only elective (pre-scheduled) CS and others also included emergency CS. The way that gum was given also differed in the studies; in some the women started chewing gum right after the CS and in others they waited for up to 12 hours. Also, the women could not be blinded to receiving the gum. The combination of the results (in a meta-analysis) of these studies showed that the women who chewed gum after a CS had an earlier return of their bowel function. On average, they passed gas seven hours earlier (13 studies, 2399 women). This effect was consistent for first versus repeat CS, time spent chewing gum per day, early feeding versus nothing by mouth until the return of intestinal function, elective versus non-elective or emergency CS, and length of time after CS when gum-chewing was initiated. The quality of the evidence for this outcome was very low. The women chewing gum were at least half as likely to have 'ileus' (a combination of symptoms such as bloating, cramping, nausea, vomiting and inability to defecate) than the women who did not chew gum (four studies, 1139 women, low-quality evidence). Gum chewing reduced the time to first defecation to about nine hours earlier (11 studies, 2016 women, very low-quality evidence) and the time to hospital discharge by some eight hours (seven studies, 1489 women). Only three out of 925 women complained about having to chew gum and there were no reports of adverse effects associated with gum-chewing (eight studies, 925 women, low-quality evidence). None of the studies assessed women's satisfaction in relation to chewing gum. The overall quality of the evidence was low to very low, mostly due to lack of blinding of the participants (the women knew they were chewing gum) and heterogeneity between the studies. The available evidence suggests that gum-chewing in the first 24 hours after a CS is a well-tolerated simple, low-cost, safe and easy intervention that enhances early recovery of bowel function, improves maternal comfort and potentially reduces hospital costs. Further research is necessary to establish the optimal regimen of gum-chewing (when to start, number and duration of sessions per day) to enhance bowel function recovery and to assess potential adverse effects and women's satisfaction with this intervention. | 10.1002/14651858.CD011562.pub2 | [
"We included randomised controlled studies published up to June 2016. We found 17 studies, with 3149 women who had just delivered by CS. In these studies, a group of women chewed gum and a second group did not, receiving usual care. The studies were conducted in nine countries (mostly low- to middle-income countries) and were different in many aspects. For instance, some studies included only women having their first baby and others included women with a previous CS; some studies included only elective (pre-scheduled) CS and others also included emergency CS. The way that gum was given also differed in the studies; in some the women started chewing gum right after the CS and in others they waited for up to 12 hours. Also, the women could not be blinded to receiving the gum. The combination of the results (in a meta-analysis) of these studies showed that the women who chewed gum after a CS had an earlier return of their bowel function. On average, they passed gas seven hours earlier (13 studies, 2399 women). This effect was consistent for first versus repeat CS, time spent chewing gum per day, early feeding versus nothing by mouth until the return of intestinal function, elective versus non-elective or emergency CS, and length of time after CS when gum-chewing was initiated. The quality of the evidence for this outcome was very low. The women chewing gum were at least half as likely to have 'ileus' (a combination of symptoms such as bloating, cramping, nausea, vomiting and inability to defecate) than the women who did not chew gum (four studies, 1139 women, low-quality evidence). Gum chewing reduced the time to first defecation to about nine hours earlier (11 studies, 2016 women, very low-quality evidence) and the time to hospital discharge by some eight hours (seven studies, 1489 women). Only three out of 925 women complained about having to chew gum and there were no reports of adverse effects associated with gum-chewing (eight studies, 925 women, low-quality evidence). None of the studies assessed women's satisfaction in relation to chewing gum. The overall quality of the evidence was low to very low, mostly due to lack of blinding of the participants (the women knew they were chewing gum) and heterogeneity between the studies. The available evidence suggests that gum-chewing in the first 24 hours after a CS is a well-tolerated simple, low-cost, safe and easy intervention that enhances early recovery of bowel function, improves maternal comfort and potentially reduces hospital costs. Further research is necessary to establish the optimal regimen of gum-chewing (when to start, number and duration of sessions per day) to enhance bowel function recovery and to assess potential adverse effects and women's satisfaction with this intervention."
]
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cochrane-simplification-train-1783 | cochrane-simplification-train-1783 | We identified 18 studies, enrolling a total of 2196 randomized patients. The oral fluoroquinolones ciprofloxacin, levofloxacin, lomefloxacin, ofloxacin and prulifloxacin were compared. There were no significant differences in clinical or microbiological efficacy or in the rate of adverse effects between these fluoroquinolones. In chlamydial prostatitis, (i) azithromycin showed improved eradication rates and clinical cure rates compared to ciprofloxacin, with no significant differences regarding adverse effects; (ii) azithromycin was equivalent to clarithromycin, both microbiologically and clinically; (iii) prulifloxacin appeared to improve clinical symptoms, but not eradication rates, compared to doxycycline. In ureaplasmal prostatitis, the comparisons ofloxacin versus minocycline and azithromycin versus doxycycline showed similar microbiological, clinical and toxicity profiles. The microbiological and clinical efficacy, as well as the adverse effect profile, of different oral fluoroquinolones are comparable. No conclusions can be drawn regarding the optimal treatment duration of fluoroquinolones in the treatment of CBP caused by traditional pathogens. Alternative antimicrobial agents tested for the treatment of CBP caused by traditional pathogens are co-trimoxazole, beta-lactams and tetracyclines, but no conclusive evidence can be drawn regarding the role of non-fluoroquinolone antibiotics in the treatment of CBP caused by traditional pathogens. In patients with CBP caused by obligate intracellular pathogens, macrolides showed higher microbiological and clinical cure rates compared to fluoroquinolones. | This review found that fluoroquinolones like ciprofloxacin, levofloxacin, lomefloxacin, ofloxacin or prulifloxacin have equivalent effects and equivalent success rates in CBP patients. If atypical bacteria like chlamydia are suspected to cause CBP, macrolide antibiotics such as azithromycin may achieve better results compared to the fluoroquinolone ciprofloxacin. It must be taken into account that some of the studies that have been performed are of poor quality or have been performed on small numbers of participants. More studies are needed, focusing on new agents or on optimized doses of currently prescribed antibiotics. | 10.1002/14651858.CD009071.pub2 | [
"This review found that fluoroquinolones like ciprofloxacin, levofloxacin, lomefloxacin, ofloxacin or prulifloxacin have equivalent effects and equivalent success rates in CBP patients. If atypical bacteria like chlamydia are suspected to cause CBP, macrolide antibiotics such as azithromycin may achieve better results compared to the fluoroquinolone ciprofloxacin. It must be taken into account that some of the studies that have been performed are of poor quality or have been performed on small numbers of participants. More studies are needed, focusing on new agents or on optimized doses of currently prescribed antibiotics."
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cochrane-simplification-train-1784 | cochrane-simplification-train-1784 | We included 26 studies (21,704 participants). Moderate-quality evidence found that adrenaline increased survival to hospital discharge compared to placebo (RR 1.44, 95% CI 1.11 to 1.86; 2 studies, 8538 participants; an increase from 23 to 32 per 1000, 95% CI 25 to 42). We are uncertain about survival to hospital discharge for high-dose compared to standard-dose adrenaline (RR 1.10, 95% CI 0.75 to 1.62; participants = 6274; studies = 10); an increase from 33 to 36 per 1000, 95% CI 24 to 53); standard-dose adrenaline versus vasopressin (RR 1.25, 95% CI 0.84 to 1.85; 6 studies; 2511 participants; an increase from 72 to 90 per 1000, 95% CI 60 to 133); and standard-dose adrenaline versus vasopressin plus adrenaline (RR 0.76, 95% CI 0.47 to 1.22; 3 studies; 3242 participants; a possible decrease from 24 to 18 per 1000, 95% CI 11 to 29), due to very low-quality evidence. Moderate-quality evidence found that adrenaline compared with placebo increased survival to hospital admission (RR 2.51, 95% CI 1.67 to 3.76; 2 studies, 8489 participants; an increase from 83 to 209 per 1000, 95% CI 139 to 313). We are uncertain about survival to hospital admission when comparing standard-dose with high-dose adrenaline, due to very low-quality evidence. Vasopressin may improve survival to hospital admission when compared with standard-dose adrenaline (RR 1.27, 95% CI 1.04 to 1.54; 3 studies, 1953 participants; low-quality evidence; an increase from 260 to 330 per 1000, 95% CI 270 to 400), and may make little or no difference when compared to standard-dose adrenaline plus vasopressin (RR 0.95, 95% CI 0.83 to 1.08; 3 studies; 3249 participants; low-quality evidence; a decrease from 218 to 207 per 1000 (95% CI 181 to 236). There was no evidence that adrenaline (any dose) or vasopressin improved neurological outcomes. The rate of return of spontaneous circulation (ROSC) was higher for standard-dose adrenaline versus placebo (RR 2.86, 95% CI 2.21 to 3.71; participants = 8663; studies = 3); moderate-quality evidence; an increase from 115 to 329 per 1000, 95% CI 254 to 427). We are uncertain about the effect on ROSC for the comparison of standard-dose versus high-dose adrenaline and standard-does adrenaline compared to vasopressin, due to very low-quality evidence. Standard-dose adrenaline may make little or no difference to ROSC when compared to standard-dose adrenaline plus vasopressin (RR 0.97, 95% CI 0.87 to 1.08; 3 studies, 3249 participants; low-quality evidence; a possible decrease from 299 to 290 per 1000, 95% CI 260 to 323). The source of funding was not stated in 11 of the 26 studies. The study drugs were provided by the manufacturer in four of the 26 studies, but neither drug represents a profitable commercial option. The other 11 studies were funded by organisations such as research foundations and government funding bodies. This review provides moderate-quality evidence that standard-dose adrenaline compared to placebo improves return of spontaneous circulation, survival to hospital admission and survival to hospital discharge, but low-quality evidence that it did not affect survival with a favourable neurological outcome. Very low -quality evidence found that high-dose adrenaline compared to standard-dose adrenaline improved return of spontaneous circulation and survival to admission. Vasopressin compared to standard dose adrenaline improved survival to admission but not return of spontaneous circulation, whilst the combination of adrenaline and vasopressin compared with adrenaline alone had no effect on these outcomes. Neither standard dose adrenaline, high-dose adrenaline,vasopressin nor a combination of adrenaline and vasopressin improved survival with a favourable neurological outcome. Many of these studies were conducted more than 20 years ago. Treatment has changed in recent years, so the findings from older studies may not reflect current practice. | We identified 26 randomised controlled trials, involving 21,704 participants, that examined the effect of adrenaline or vasopressin on survival after cardiac arrest that occurred in and out of hospital and in adults and children. Some studies compared adrenaline in standard doses with placebo (dummy medication); some examined standard-dose versus high-dose adrenaline; and others compared vasopressin alone or vasopressin plus adrenaline to standard doses of adrenaline. The source of funding was not stated in 11 of the 26 studies. The study drugs were provided by the manufacturer in four of the 26 studies, but neither drug represents a profitable commercial option. The other 11 studies were funded by organisations such as research foundations and government funding bodies. The studies found evidence that adrenaline was effective at restarting the heart and helping people recover enough to go home from hospital. However, there was no evidence that any of the drugs improved survival with a good neurological outcome. The overall quality of evidence ranged from low to moderate (for studies comparing adrenaline to placebo), but mainly low or very low for the other comparisons, due to risks of bias within the studies. Many of these studies were conducted more than 20 years ago. Treatment has changed in recent years, so the findings from older studies may not reflect current practice. The studies examined the drugs in many different situations (in and outside of hospitals, at different dosages, and in both adults and children), which may make combining findings misleading. | 10.1002/14651858.CD003179.pub2 | [
"We identified 26 randomised controlled trials, involving 21,704 participants, that examined the effect of adrenaline or vasopressin on survival after cardiac arrest that occurred in and out of hospital and in adults and children. Some studies compared adrenaline in standard doses with placebo (dummy medication); some examined standard-dose versus high-dose adrenaline; and others compared vasopressin alone or vasopressin plus adrenaline to standard doses of adrenaline. The source of funding was not stated in 11 of the 26 studies. The study drugs were provided by the manufacturer in four of the 26 studies, but neither drug represents a profitable commercial option. The other 11 studies were funded by organisations such as research foundations and government funding bodies. The studies found evidence that adrenaline was effective at restarting the heart and helping people recover enough to go home from hospital. However, there was no evidence that any of the drugs improved survival with a good neurological outcome. The overall quality of evidence ranged from low to moderate (for studies comparing adrenaline to placebo), but mainly low or very low for the other comparisons, due to risks of bias within the studies. Many of these studies were conducted more than 20 years ago. Treatment has changed in recent years, so the findings from older studies may not reflect current practice. The studies examined the drugs in many different situations (in and outside of hospitals, at different dosages, and in both adults and children), which may make combining findings misleading."
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cochrane-simplification-train-1785 | cochrane-simplification-train-1785 | Forty-five RCTs were identified and, from these, 26 trials including a total of 1217 participants and 2120 implants were included. Two trials were at low risk of bias, 12 were at high risk of bias and for the remaining 12 the risk of bias was unclear. In nine of the included studies there were no prosthetic failures within the first year, with no implant failures in seven studies and the mean rate of implant failure in all 26 trials was a low 2.5%. From 15 RCTs comparing immediate with conventional loading there was no evidence of a difference in either prosthesis failure (RR 1.90; 95% CI 0.67 to 5.34; 8 trials) or implant failure (RR 1.50; 95% CI 0.60 to 3.77; 10 trials) in the first year, but there is some evidence of a small reduction in bone loss favouring immediate loading (MD -0.10 mm; 95% CI -0.20 to -0.01; P = 0.03; 9 trials), with some heterogeneity (Tau² = 0.01; Chi² = 14.37, df = 8 (P = 0.07); I² = 44%). However, this very small difference may not be clinically important. From three RCTs which compared early loading with conventional loading, there is insufficient evidence to determine whether or not there is a clinically important difference in prosthesis failure, implant failure or bone loss. Six RCTs compared immediate and early loading and found insufficient evidence to determine whether or not there is a clinically important difference in prosthesis failure, implant failure or bone loss. From the two trials which compared occlusal loading with non-occlusal loading there is insufficient evidence to determine whether there is a clinically important difference in the outcomes of prosthesis failure, implant failure or bone loss. We did not identify any trials which evaluated progressive loading of implants. Overall there was no convincing evidence of a clinically important difference in prosthesis failure, implant failure, or bone loss associated with different loading times of implants. The quality of the evidence is assessed as very low due to high and unclear risk of bias of primary studies and there is some evidence of reporting bias so clinicians should treat these findings with caution. A high value of insertion torque (at least 35 Ncm) seems to be one of the prerequisites for a successful immediate/early loading procedure. More well-designed RCTs are needed and should be reported according to the CONSORT guidelines (www.consort-statement.org/), and registered with a trials registry. | This review looked at the effects of attaching artificial teeth either the same day that the implant was placed, or early (after only 6 weeks) compared to the usual delay of at least 3 months. Some studies also compared the artifical tooth being attached so that it did not touch the opposite tooth (non-occlusal loading). The search of studies was updated on 8th June 2012. The review found no evidence that attaching artificial teeth either immediately, after 6 weeks (early) or after at least 3 months (conventional) led to any important differences in the failure of the implant or the artifical tooth, or to the amount of bone which surrounded the implant (any bone loss would be an undesirable consequence). More research is needed in this area. | 10.1002/14651858.CD003878.pub5 | [
"This review looked at the effects of attaching artificial teeth either the same day that the implant was placed, or early (after only 6 weeks) compared to the usual delay of at least 3 months. Some studies also compared the artifical tooth being attached so that it did not touch the opposite tooth (non-occlusal loading). The search of studies was updated on 8th June 2012. The review found no evidence that attaching artificial teeth either immediately, after 6 weeks (early) or after at least 3 months (conventional) led to any important differences in the failure of the implant or the artifical tooth, or to the amount of bone which surrounded the implant (any bone loss would be an undesirable consequence). More research is needed in this area."
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cochrane-simplification-train-1786 | cochrane-simplification-train-1786 | Fourty RCTs were included, addressing various agents for pregnancy termination and methods of administration. When used alone, misoprostol was an effective inductive agent, though it appeared to be more effective in combination with mifepristone. However, the evidence from RCTs is limited. Misoprostol was preferably administered vaginally, although among multiparous women sublingual administration appeared equally effective. A range of doses of vaginally administered misoprostol has been used. No randomised trials comparing doses of misoprostol were identified; however low doses of misoprostol appear to be associated with fewer side-effects while moderate doses appear to be more efficient in completing abortion. Four RCTs showed that the induction to abortion interval with 3-hourly vaginal administration of prostaglandins is shorter than 6-hourly administration without an increase in side-effects. Many studies reported the need for surgical evacuation. Indications for surgical evacuation include retained products of the placenta and heavy vaginal bleeding. Fewer women required surgical evacuation when misoprostol was administrated vaginally compared with women receiving intra-amniotical PGF2a. Mild, self-limiting diarrhoea was more common among women who received misoprostol compared to other agents. Medical abortion in the second trimester using the combination of mifepristone and misoprostol appeared to have the highest efficacy and shortest abortion time interval. Where mifepristone is not available, misoprostol alone is a reasonable alternative. The optimal route for administering misoprostol is vaginally, preferably using tablets at 3-hourly intervals. Apart from pain, the side-effects of vaginal misoprostol are usually mild and self limiting. Conclusions from this review are limited by the gestational age ranges and variable medical regimens, including dosing, administrative routes and intervals of medication, of the included trials. | We identified 38 studies and came to the conclusion that misoprostol is the drug of choice for medical pregnancy termination, preferably in combination with mifepristone which facilitates the effectiveness of misoprostol. Misoprostol works best when it is administered into the vagina. Women who had previously given birth could take misoprostol by mouth (under the tongue). Irrespective of the medication used for second trimester termination there is a considerable risk of surgical intervention because of vaginal bleeding or incomplete abortion. | 10.1002/14651858.CD005216.pub2 | [
"We identified 38 studies and came to the conclusion that misoprostol is the drug of choice for medical pregnancy termination, preferably in combination with mifepristone which facilitates the effectiveness of misoprostol. Misoprostol works best when it is administered into the vagina. Women who had previously given birth could take misoprostol by mouth (under the tongue). Irrespective of the medication used for second trimester termination there is a considerable risk of surgical intervention because of vaginal bleeding or incomplete abortion."
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cochrane-simplification-train-1787 | cochrane-simplification-train-1787 | Eleven randomized controlled trials with a total of 833 women were included in this review. However, the results of this review are based on single studies with small numbers of participants.The majority of included studies reported insufficient information on sequence generation, allocation concealment as well as blinding. There were no included studies that assessed PTL or PTB as the primary outcome. The included studies were different in terms of intervention, practice, and time, and there were no clear coherent hypotheses. For women not in PTL, the benefits of relaxation was found in one study for maternal stress (Anxiety Stress Scale) at 26 to 29 weeks gestational age (mean difference (MD) -7.04; 95% confidence interval (CI) -13.91 to -0.17). In addition, there were some beneficial effects of relaxation including baby birthweight (MD 285.00 g; 95% CI 76.94 to 493.06); type of delivery; (vaginal delivery; risk ratio (RR) 1.52; 95% CI 1.13 to 2.04), (cesarean section; RR 0.38; 95% CI 0.19 to 0.78); maternal anxiety (MD -15.79; 95% CI -18.33 to -13.25); and stress (MD -13.08; 95% CI -15.29 to -10.87) when applying relaxation therapy together with standard treatment. For women in PTL, the results for the main outcome of PTB in the intervention and control groups from a single study were not different (RR 0.95; 95% CI 0.57 to 1.59). The MD of birthweight in grams from the fixed-effect model from two included studies was MD -5.68; (95% CI -174.09 to 162.74). According to the results of this review, there is some evidence that relaxation during pregnancy reduces stress and anxiety. However, there was no effect on PTL/PTB. These results should be interpreted with caution as they were drawn from included studies with limited quality. | We searched the medical literature for the information from clinical studies and found 11 randomized controlled studies that met our inclusion criteria. We included 11 studies randomising a total of 833 women, although nearly all the results we report are based on single studies with small numbers of participants. We were unable to pool the findings in any meta-analyses due to each study using different forms of relaxation in different comparisons, to prevent preterm births in seven studies and to treat preterm labour in five with insufficient information. No valid conclusion can be summarized from this review. For women not in preterm labour, relaxation therapy (alone or combined with standard treatment) reduced maternal stress compared with routine prenatal care and increased birthweight with fewer cesarean deliveries in a single study. For women in preterm labour, there was no evidence of benefits or harms. More rigorous studies are required in order to assess the effects of relaxation therapies in preventing and treating preterm labour. | 10.1002/14651858.CD007426.pub2 | [
"We searched the medical literature for the information from clinical studies and found 11 randomized controlled studies that met our inclusion criteria. We included 11 studies randomising a total of 833 women, although nearly all the results we report are based on single studies with small numbers of participants. We were unable to pool the findings in any meta-analyses due to each study using different forms of relaxation in different comparisons, to prevent preterm births in seven studies and to treat preterm labour in five with insufficient information. No valid conclusion can be summarized from this review. For women not in preterm labour, relaxation therapy (alone or combined with standard treatment) reduced maternal stress compared with routine prenatal care and increased birthweight with fewer cesarean deliveries in a single study. For women in preterm labour, there was no evidence of benefits or harms. More rigorous studies are required in order to assess the effects of relaxation therapies in preventing and treating preterm labour."
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cochrane-simplification-train-1788 | cochrane-simplification-train-1788 | We included 90 studies; 88 from field settings in Africa. The median S. haematobium infection prevalence was 41% (range 1% to 89%) and 36% for S. mansoni (range 8% to 95%). Study design and conduct were poorly reported against current standards. Tests for S. haematobium Urine reagent test strips versus microscopy Compared to microscopy, the detection of microhaematuria on test strips had the highest sensitivity and specificity (sensitivity 75%, 95% CI 71% to 79%; specificity 87%, 95% CI 84% to 90%; 74 studies, 102,447 participants). For proteinuria, sensitivity was 61% and specificity was 82% (82,113 participants); and for leukocyturia, sensitivity was 58% and specificity 61% (1532 participants). However, the difference in overall test accuracy between the urine reagent strips for microhaematuria and proteinuria was not found to be different when we compared separate populations (P = 0.25), or when direct comparisons within the same individuals were performed (paired studies; P = 0.21). When tests were evaluated against the higher quality reference standard (when multiple samples were analysed), sensitivity was marginally lower for microhaematuria (71% vs 75%) and for proteinuria (49% vs 61%). The specificity of these tests was comparable. Antigen assay Compared to microscopy, the CCA test showed considerable heterogeneity; meta-analytic sensitivity estimate was 39%, 95% CI 6% to 73%; specificity 78%, 95% CI 55% to 100% (four studies, 901 participants). Tests for S. mansoni Compared to microscopy, the CCA test meta-analytic estimates for detecting S. mansoni at a single threshold of trace positive were: sensitivity 89% (95% CI 86% to 92%); and specificity 55% (95% CI 46% to 65%; 15 studies, 6091 participants) Against a higher quality reference standard, the sensitivity results were comparable (89% vs 88%) but specificity was higher (66% vs 55%). For the CAA test, sensitivity ranged from 47% to 94%, and specificity from 8% to 100% (four studies, 1583 participants). Among the evaluated tests for S. haematobium infection, microhaematuria correctly detected the largest proportions of infections and non-infections identified by microscopy. The CCA POC test for S. mansoni detects a very large proportion of infections identified by microscopy, but it misclassifies a large proportion of microscopy negatives as positives in endemic areas with a moderate to high prevalence of infection, possibly because the test is potentially more sensitive than microscopy. | We included 90 studies involving almost 200,000 people, with 88 of these studies carried out in Africa in field settings. Study design and conduct were poorly reported against current expectations. Based on our statistical model, we found: • Among the urine strips for detecting urinary schistosomiasis, the strips for detecting blood were better than those detecting protein or white cells (sensitivity and specificity for blood 75% and 87%; for protein 61% and 82%; and for white cells 58% and 61%, respectively). • For urinary schistosomiasis, the parasite antigen test performance was worse (sensitivity, 39% and specificity, 78%) than urine strips for detecting blood. • For intestinal schistosomiasis, the parasite antigen urine test, detected many infections identified by microscopy but wrongly labelled many uninfected people as sick (sensitivity, 89% and specificity, 55%). What are the consequences of using these tests? If we take 1000 people, of which 410 have urinary schistosomiasis on microscopy testing, then using the strip detecting blood in the urine would misclassify 77 uninfected people as infected, and thus may receive unnecessary treatment; and it would wrongly classify 102 infected people as uninfected, who thus may not receive treatment. If we take 1000 people, of which 360 have intestinal schistosomiasis on microscopy testing, then the antigen test would misclassify 288 uninfected people as infected. These people may be given unnecessary treatment. This test also would wrongly classify 40 infected people as uninfected who thus may not receive treatment. Conclusion of review For urinary schistosomiasis, the urine strip for detecting blood leads to some infected people being missed and some non-infected people being diagnosed with the condition, but is better than the protein or white cell tests. The parasite antigen test is not accurate. For intestinal schistosomiasis, the parasite antigen urine test classifies many microscopy negative people as being infected. This finding may be explained by the low sensitivity of microscopy. | 10.1002/14651858.CD009579.pub2 | [
"We included 90 studies involving almost 200,000 people, with 88 of these studies carried out in Africa in field settings. Study design and conduct were poorly reported against current expectations. Based on our statistical model, we found: • Among the urine strips for detecting urinary schistosomiasis, the strips for detecting blood were better than those detecting protein or white cells (sensitivity and specificity for blood 75% and 87%; for protein 61% and 82%; and for white cells 58% and 61%, respectively). • For urinary schistosomiasis, the parasite antigen test performance was worse (sensitivity, 39% and specificity, 78%) than urine strips for detecting blood. • For intestinal schistosomiasis, the parasite antigen urine test, detected many infections identified by microscopy but wrongly labelled many uninfected people as sick (sensitivity, 89% and specificity, 55%). What are the consequences of using these tests? If we take 1000 people, of which 410 have urinary schistosomiasis on microscopy testing, then using the strip detecting blood in the urine would misclassify 77 uninfected people as infected, and thus may receive unnecessary treatment; and it would wrongly classify 102 infected people as uninfected, who thus may not receive treatment. If we take 1000 people, of which 360 have intestinal schistosomiasis on microscopy testing, then the antigen test would misclassify 288 uninfected people as infected. These people may be given unnecessary treatment. This test also would wrongly classify 40 infected people as uninfected who thus may not receive treatment. Conclusion of review For urinary schistosomiasis, the urine strip for detecting blood leads to some infected people being missed and some non-infected people being diagnosed with the condition, but is better than the protein or white cell tests. The parasite antigen test is not accurate. For intestinal schistosomiasis, the parasite antigen urine test classifies many microscopy negative people as being infected. This finding may be explained by the low sensitivity of microscopy."
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cochrane-simplification-train-1789 | cochrane-simplification-train-1789 | No studies met the inclusion criteria for this review. We excluded one study and one other study is ongoing. We set out to evaluate the RCT evidence pertaining to the impact of antenatal education on perineal wound healing in postnatal women who have birthed in a hospital setting, and who experienced a break in the skin of the perineum as a result of a tear or episiotomy, or both. However, no studies met the inclusion criteria. There is a lack of evidence concerning whether or not antenatal education relating to perineal wound healing in this cohort of women will change the outcome for these women in relation to wound healing, infection rate, re-attendance or re-admission to hospital, pain, health-related quality of life, maternal bonding, and negative emotional experiences. Further study is warranted in this area given the significant physical, psychological and economic impact of perineal wounds, and the large proportion of childbearing women who have experienced a postnatal wound. The benefits of any future research in this field would be maximised by incorporating women in a range of socio-economic groups, and with a range of healthcare options. This research could take both a qualitative and a quantitative approach and examine the outcomes identified in this review in order to assess fully the potential benefits of a tailored antenatal package, and to make recommendations for future practice. There is currently no evidence to inform practice in this regard. | We searched for evidence in September 2017 but did not find any randomised controlled studies relating to our area of interest. We excluded one study and one other study is not yet complete. We cannot say whether or not antenatal education has an effect on perineal wound healing after childbirth among women who have birthed in a hospital setting. We do not know from randomised controlled trials what the benefits and harms of this education might be. More research is this area is needed to determine the impact of education delivered before childbirth on perineal wound healing in women who have birthed in a hospital setting. Trials may also examine the outcome on related issues including infection rate, re-attendance or re-admission to hospital, pain, health-related quality of life, maternal bonding, and negative emotional experiences relating to a perineal wound. A large proportion of childbearing women experience a perineal wound in childbirth, and these wounds are known to have a significant physical, psychological and economic impact. Future research could examine the potential benefits of a tailor-made education package to be delivered to this cohort of women, as there is currently no evidence to support this. | 10.1002/14651858.CD012258.pub2 | [
"We searched for evidence in September 2017 but did not find any randomised controlled studies relating to our area of interest. We excluded one study and one other study is not yet complete. We cannot say whether or not antenatal education has an effect on perineal wound healing after childbirth among women who have birthed in a hospital setting. We do not know from randomised controlled trials what the benefits and harms of this education might be. More research is this area is needed to determine the impact of education delivered before childbirth on perineal wound healing in women who have birthed in a hospital setting. Trials may also examine the outcome on related issues including infection rate, re-attendance or re-admission to hospital, pain, health-related quality of life, maternal bonding, and negative emotional experiences relating to a perineal wound. A large proportion of childbearing women experience a perineal wound in childbirth, and these wounds are known to have a significant physical, psychological and economic impact. Future research could examine the potential benefits of a tailor-made education package to be delivered to this cohort of women, as there is currently no evidence to support this."
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cochrane-simplification-train-1790 | cochrane-simplification-train-1790 | Five trials were identified by the searches, of which three trials (880 children randomised) met the inclusion criteria. All of the included trials showed a reduced incidence of infection in children with SCD (SS or Sβ0Thal) receiving prophylactic penicillin. In trials which investigated initiation of penicillin on risk of pneumococcal infection, the odds ratio was 0.37 (95% confidence interval 0.16 to 0.86) (two trials, 457 children) (low-quality evidence), while for withdrawal the odds ratio was 0.49 (95% confidence interval 0.09 to 2.71) (one trial, 400 children) (low-quality evidence). Adverse drug effects were rare and minor. Rates of pneumococcal infection were found to be relatively low in children over the age of five. Overall, the quality of the evidence for all outcomes was judged to be low. The results from the risk of bias assessment undertaken identified two domains in which the risk of bias was considered to be high, these were incomplete outcome data (attrition bias) (two trials) and allocation concealment (selection bias) (one trial). Domains considered to have a low risk of bias for all three trials were selective reporting (reporting bias) and blinding (performance and detection bias). The evidence examined suggests that prophylactic penicillin significantly reduces risk of pneumococcal infection in children with homozygous SCD, and is associated with minimal adverse reactions. Further research may help to determine the ideal age to safely withdraw penicillin. | We gathered evidence for this Cochrane Review by examining three clinical trials with over 800 children included. All three clinical trials showed a reduced rate of pneumococcal infection in children with SCD receiving penicillin preventatively. Two of these trials looked at whether treatment was effective. The third trial followed on from one of the early trials and looked at when it was safe to stop treatment. Adverse drug effects were rare and minor. However, there were problems with children keeping to the treatment schedule and with the development of antibiotic resistance. The quality of the evidence for both primary and secondary outcomes (end result) was judged to be low. We conclude that penicillin given preventatively reduces the rate of pneumococcal infections in children with SCD under five years of age. The risk of infection in older children is lower, and the follow-on trial did not show a significant increase in risk when regular penicillin was halted at five years old. Further research is needed to look at how commonly bacteria develop that are resistant to treatment and how clinically important this is. | 10.1002/14651858.CD003427.pub4 | [
"We gathered evidence for this Cochrane Review by examining three clinical trials with over 800 children included. All three clinical trials showed a reduced rate of pneumococcal infection in children with SCD receiving penicillin preventatively. Two of these trials looked at whether treatment was effective. The third trial followed on from one of the early trials and looked at when it was safe to stop treatment. Adverse drug effects were rare and minor. However, there were problems with children keeping to the treatment schedule and with the development of antibiotic resistance. The quality of the evidence for both primary and secondary outcomes (end result) was judged to be low. We conclude that penicillin given preventatively reduces the rate of pneumococcal infections in children with SCD under five years of age. The risk of infection in older children is lower, and the follow-on trial did not show a significant increase in risk when regular penicillin was halted at five years old. Further research is needed to look at how commonly bacteria develop that are resistant to treatment and how clinically important this is."
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cochrane-simplification-train-1791 | cochrane-simplification-train-1791 | Four trials were included in the review. One new trial of botulinum toxin was identified in the updated search. Only one trial of custom-made foot orthoses fully met the inclusion criteria. Three additional studies (botulinum toxin, footwear and off-the-shelf foot orthoses), all assessing secondary outcomes were included. We could not pool data used in the four studies due to heterogeneity of diagnostic groups and outcome measures. The one trial that fully met the inclusion criteria investigated the treatment of pes cavus pain in 154 adults over three months. The trial showed a significant reduction in the level of foot pain with custom-made foot orthoses versus sham orthoses (WMD 10.90; 95% CI 3.21 to 18.59). Furthermore, a significant improvement in self-reported foot function and physical functioning was reported with custom-made foot orthoses. There was no difference in reported adverse events following the allocation of custom-made or sham orthoses. Secondary biomechanical outcomes improved with the use of custom-made foot orthoses and footwear (pedobarography), but not with intramuscular injections of botulinum toxin (radiographic) or off-the-shelf foot orthoses (electromyography). This updated review shows that custom-made foot orthoses are significantly more beneficial than sham orthoses for treating foot pain associated with pes cavus in a variety of clinical populations. We also show that some secondary biomechanical outcomes improve with custom-made foot orthoses and footwear, but not with botulinum toxin or off-the-shelf foot orthoses. There is an absence of evidence for any other type of intervention for the treatment or prevention of pes cavus. | Population based studies suggest the prevalence of pes cavus is approximately 10%, and its cause is primarily neuromuscular (for example Charcot-Marie-Tooth disease) or idiopathic (unknown) in nature. It has been estimated that 60% of people with cavus feet will experience chronic foot pain at some time in their life, most commonly beneath the forefoot (for example metatarsalgia, sesamoiditis) or heel (for example plantar fasciitis). Conditions such as these are thought to be the result of abnormal pressure distribution across the sole of the foot during walking. Many conservative therapies and surgical procedures have been recommended for cavus-related foot pain. In particular, foot orthoses (aids applied and worn on the outside of the body to support the bony structures) customised to an individual's foot shape are increasingly prescribed by podiatrists, physiotherapists, orthopaedic surgeons and rehabilitation specialists for people with pes cavus pain. This updated review analysed four relevant trials, but only one fully met the inclusion criteria. This trial with 154 adults showed that custom-made foot orthoses can reduce and redistribute plantar foot pressure and subsequently decrease foot pain by approximately 75%. Some biomechanical outcomes, such as pressure distribution, improve with custom-made foot orthoses and footwear, but many other biomechanical outcomes, such as foot alignment or muscle activity, do not improve with botulinum toxin or off-the-shelf foot orthoses, respectively. More research is needed to determine the effectiveness of other interventions for people with painful high-arched feet. | 10.1002/14651858.CD006154.pub2 | [
"Population based studies suggest the prevalence of pes cavus is approximately 10%, and its cause is primarily neuromuscular (for example Charcot-Marie-Tooth disease) or idiopathic (unknown) in nature. It has been estimated that 60% of people with cavus feet will experience chronic foot pain at some time in their life, most commonly beneath the forefoot (for example metatarsalgia, sesamoiditis) or heel (for example plantar fasciitis). Conditions such as these are thought to be the result of abnormal pressure distribution across the sole of the foot during walking. Many conservative therapies and surgical procedures have been recommended for cavus-related foot pain. In particular, foot orthoses (aids applied and worn on the outside of the body to support the bony structures) customised to an individual's foot shape are increasingly prescribed by podiatrists, physiotherapists, orthopaedic surgeons and rehabilitation specialists for people with pes cavus pain. This updated review analysed four relevant trials, but only one fully met the inclusion criteria. This trial with 154 adults showed that custom-made foot orthoses can reduce and redistribute plantar foot pressure and subsequently decrease foot pain by approximately 75%. Some biomechanical outcomes, such as pressure distribution, improve with custom-made foot orthoses and footwear, but many other biomechanical outcomes, such as foot alignment or muscle activity, do not improve with botulinum toxin or off-the-shelf foot orthoses, respectively. More research is needed to determine the effectiveness of other interventions for people with painful high-arched feet."
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cochrane-simplification-train-1792 | cochrane-simplification-train-1792 | From 6396 citations, we included six studies with a total of 562 participants. Five studies were performed in participants undergoing abdominal surgery (including one study in participants undergoing cytoreductive abdominal surgery with hyperthermic intraperitoneal chemotherapy (HIPEC)), and one study was performed in participants undergoing orthopaedic surgery. In all studies, surgeries were elective. In five studies, crystalloids were used for basal infusion and colloids for boluses, and in one study, colloid was used for both basal infusion and boluses. Five studies reported the ASA (American Society of Anesthesiologists) status of participants. Most participants were ASA II (60.4%), 22.7% were ASA I, and only 16.9% were ASA III. No study participants were ASA IV. For the GDFT group, oesophageal doppler monitoring was used in three studies, uncalibrated invasive arterial pressure analysis systems in two studies, and a non-invasive arterial pressure monitoring system in one study. In all studies, GDFT optimization was conducted only intraoperatively. Only one study was at low risk of bias in all domains. The other five studies were at unclear or high risk of bias in one to three domains. RFT may have no effect on the rate of major complications compared to GDFT, but the evidence is very uncertain (RR 1.61, 95% CI 0.78 to 3.34; 484 participants; 5 studies; very low-certainty evidence). RFT may increase the risk of all-cause mortality compared to GDFT, but the evidence on this is also very uncertain (RD 0.03, 95% CI 0.00 to 0.06; 544 participants; 6 studies; very low-certainty evidence). In a post-hoc analysis using a Peto odds ratio (OR) or a Poisson regression model, the odds of all-cause mortality were 4.81 times greater with the use of RFT compared to GDFT, but the evidence again is very uncertain (Peto OR 4.81, 95% CI 1.38 to 16.84; 544 participants; 6 studies; very low-certainty evidence). Nevertheless, sensitivity analysis shows that exclusion of a study in which the final volume of fluid received intraoperatively was higher in the RFT group than in the GDFT group revealed no differences in mortality. Based on analysis of secondary outcomes, such as length of hospital stay (464 participants; 5 studies; very low-certainty evidence), surgery-related complications (364 participants; 4 studies; very low-certainty evidence), non-surgery-related complications (74 participants; 1 study; very low-certainty evidence), renal failure (410 participants; 4 studies; very low-certainty evidence), and quality of surgical recovery (74 participants; 1 study; very low-certainty evidence), GDFT may have no effect on the risk of these outcomes compared to RFT, but the evidence is very uncertain. Included studies provided no data on administration of vasopressors or inotropes to correct haemodynamic instability nor on cost of treatment. Based on very low-certainty evidence, we are uncertain whether RFT is inferior to GDFT in selected populations of adults undergoing major non-cardiac surgery. The evidence is based mainly on data from studies on abdominal surgery in a low-risk population. The evidence does not address higher-risk populations or other surgery types. Larger, higher-quality RCTs including a wider spectrum of surgery types and a wider spectrum of patient groups, including high-risk populations, are needed to determine effects of the intervention. | The evidence is current to 11 October 2019. We included studies that randomly assigned adults to intervention groups comparing the two techniques described above. We found six studies including a total of 562 participants. Five studies involved abdominal surgery, and one involved orthopaedic surgery. No studies involved emergency surgery nor patients suffering from serious medical conditions before surgery. The number of deaths was slightly lower in the GDFT group compared with the RFT group, but this may be due to chance. No difference in the frequency of major complications was observed between the two groups. In addition, no differences were observed between RFT and GDFT groups in the following outcomes: length of hospital stay, surgery-related complications (related directly to the operation site, e.g. problems with wound healing), non-surgery-related complications (related to problems with other organs, e.g. heart or lungs), renal failure, and quality of surgical recovery. We judged the certainty of evidence obtained for this review as very low because conclusions are based on very small numbers of participants in included studies, the quality of included studies is low, and studies were performed only on selected groups of patients that did not reflect the real population of people undergoing surgery. This means that new studies are very likely to change the results of this review. The review does not answer the question of whether results would be the same for adults who have other serious health problems before surgery, or for adults undergoing other types of surgery besides abdominal surgery and orthopaedic surgery. | 10.1002/14651858.CD012767.pub2 | [
"The evidence is current to 11 October 2019. We included studies that randomly assigned adults to intervention groups comparing the two techniques described above. We found six studies including a total of 562 participants. Five studies involved abdominal surgery, and one involved orthopaedic surgery. No studies involved emergency surgery nor patients suffering from serious medical conditions before surgery. The number of deaths was slightly lower in the GDFT group compared with the RFT group, but this may be due to chance. No difference in the frequency of major complications was observed between the two groups. In addition, no differences were observed between RFT and GDFT groups in the following outcomes: length of hospital stay, surgery-related complications (related directly to the operation site, e.g. problems with wound healing), non-surgery-related complications (related to problems with other organs, e.g. heart or lungs), renal failure, and quality of surgical recovery. We judged the certainty of evidence obtained for this review as very low because conclusions are based on very small numbers of participants in included studies, the quality of included studies is low, and studies were performed only on selected groups of patients that did not reflect the real population of people undergoing surgery. This means that new studies are very likely to change the results of this review. The review does not answer the question of whether results would be the same for adults who have other serious health problems before surgery, or for adults undergoing other types of surgery besides abdominal surgery and orthopaedic surgery."
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cochrane-simplification-train-1793 | cochrane-simplification-train-1793 | We included 33 trials with 36 intervention-control pairs and 1853 participants. The risk of bias present in many studies was unclear due to poor reporting; the evidence has therefore been rated 'moderate' or 'low' when using the GRADE system. There is low-quality evidence that RTT improves arm function (standardised mean difference (SMD) 0.25, 95% confidence interval (CI) 0.01 to 0.49; 11 studies, number of participants analysed = 749), hand function (SMD 0.25, 95% CI 0.00 to 0.51; eight studies, number of participants analysed = 619), and lower limb functional measures (SMD 0.29, 95% CI 0.10 to 0.48; five trials, number of participants analysed = 419). There is moderate-quality evidence that RTT improves walking distance (mean difference (MD) 34.80, 95% CI 18.19 to 51.41; nine studies, number of participants analysed = 610) and functional ambulation (SMD 0.35, 95% CI 0.04 to 0.66; eight studies, number of participants analysed = 525). We found significant differences between groups for both upper-limb (SMD 0.92, 95% CI 0.58 to 1.26; three studies, number of participants analysed = 153) and lower-limb (SMD 0.34, 95% CI 0.16 to 0.52; eight studies, number of participants analysed = 471) outcomes up to six months post treatment but not after six months. Effects were not modified by intervention type, dosage of task practice or time since stroke for upper or lower limb. There was insufficient evidence to be certain about the risk of adverse events. There is low- to moderate-quality evidence that RTT improves upper and lower limb function; improvements were sustained up to six months post treatment. Further research should focus on the type and amount of training, including ways of measuring the number of repetitions actually performed by participants. The definition of RTT will need revisiting prior to further updates of this review in order to ensure it remains clinically meaningful and distinguishable from other interventions. | We identified 33 studies with 1853 participants. Studies included a wide range of tasks to practice, including lifting a ball, walking, standing up from sitting and circuit training with a different task at each station. The evidence is current to June 2016. In comparison with usual care (standard physiotherapy) or placebo groups, people who practiced functional tasks showed small improvements in arm function, hand function, walking distance and measures of walking ability. Improvements in arm and leg function were maintained up to six months later. There was not enough evidence to be certain about the risk of adverse events, for example falls. Further research is needed to determine the best type of task practice, and whether more sustained practice could show better results. We classified the quality of the evidence as low for arm function, hand function and lower limb functional measures, and as moderate for walking distance and functional ambulation. The quality of the evidence for each outcome was limited due poor reporting of study details (particularly in earlier studies), inconsistent results across studies and small numbers of study participants in some comparisons. | 10.1002/14651858.CD006073.pub3 | [
"We identified 33 studies with 1853 participants. Studies included a wide range of tasks to practice, including lifting a ball, walking, standing up from sitting and circuit training with a different task at each station. The evidence is current to June 2016. In comparison with usual care (standard physiotherapy) or placebo groups, people who practiced functional tasks showed small improvements in arm function, hand function, walking distance and measures of walking ability. Improvements in arm and leg function were maintained up to six months later. There was not enough evidence to be certain about the risk of adverse events, for example falls. Further research is needed to determine the best type of task practice, and whether more sustained practice could show better results. We classified the quality of the evidence as low for arm function, hand function and lower limb functional measures, and as moderate for walking distance and functional ambulation. The quality of the evidence for each outcome was limited due poor reporting of study details (particularly in earlier studies), inconsistent results across studies and small numbers of study participants in some comparisons."
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cochrane-simplification-train-1794 | cochrane-simplification-train-1794 | Thirty RCTs (4704 participants) met the eligibility criteria, including 19 comparisons of iron supplementation and placebo or control; one comparison of oral and parenteral iron supplementation; four comparisons of different doses of iron supplementation; one comparison of different treatment durations of iron supplementation; and 12 comparisons of different iron supplementation preparations. Many studies were of low or uncertain methodological quality and therefore at high or uncertain risk of bias. We therefore rated the quality of the evidence for our outcomes as moderate. There was a statistically significant reduction in deferral due to low haemoglobin in donors who received iron supplementation compared with donors who received no iron supplementation, both at the first donation visit after commencement of iron supplementation (risk ratio (RR) 0.34; 95% confidence interval (CI) 0.21 to 0.55; four studies; 1194 participants; P value < 0.0001) and at subsequent donations (RR 0.25; 95% CI 0.15 to 0.41; three studies; 793 participants; P value < 0.00001). Supplementation also resulted in significantly higher haemoglobin levels (mean difference (MD) 2.36 g/L; 95% CI 0.06 to 4.66; eight studies; 847 participants, P value =0.04), and iron stores, including serum ferritin (MD 13.98 ng/mL; 95% CI 8.92 to 19.03; five studies; 640 participants; P value < 0.00001) and transferrin saturation (MD 3.91%; 95% CI 2.02 to 5.80; four studies; 344 participants; P value < 0.0001) prior to further donation. The differences were maintained after subsequent donation(s). Adverse effects were widely reported and were more frequent in donors who received iron supplementation (RR 1.60; 95% CI 1.23 to 2.07; four studies; 1748 participants; P value = 0.0005). Adverse effects included constipation, diarrhoea, nausea, vomiting and taste disturbances, and some participants stopped treatment due to side effects. There is moderate quality evidence that rates of donor deferral due to low haemoglobin are considerably less in those taking iron supplements compared with those without iron supplementation, both at the first donation visit and at subsequent donation. Iron-supplemented donors also show elevated haemoglobin and iron stores. These beneficial effects are balanced by more frequent adverse events in donors who receive iron supplementation than in those who do not; this is likely to limit acceptability and compliance. The long-term effects of iron supplementation without measurement of iron stores are unknown. These considerations are likely to preclude widespread use of iron supplementation by tablets. Blood services may consider targeted use of supplementation in those at greatest risk of iron deficiency, personalised donation intervals and providing dietary advice. | We found 30 randomised trials of iron supplementation in blood donors with a total of 4704 participants. We found that some of the studies did not report details of their design very well and people in some of the studies left the study early and did not contribute data. Combining the results from four studies, we have shown that around 3% of donors who were given iron supplements were unable to give blood when they next came to donate because the levels of iron in their blood were too low, compared with 10% of donors who did not take iron. More than this, 4% of iron-supplemented donors were unable to give blood at any future donation due to low iron levels, compared with around 20% of donors not given iron supplementation. However, 29% of donors who took iron tablets experienced side effects compared with 17% of donors who were given dummy tablets. Combined data from two studies showed that the iron-supplemented donors had nearly five times the chance of stomach upsets and changes in their taste compared to donors who did not take these tablets. Due to the issues around how reliable the studies were, the quality of evidence is moderate and these results could change with more research. Donors can benefit from iron tablets but the rate of side effects is high, which means in practice that giving all donors iron tablets is unlikely to be acceptable and we do not know whether giving iron causes extra problems over a long period of time. Blood services may target iron supplementation at groups or individuals who are at risk of iron deficiency or may try to reduce deferral by adjusting donation intervals to suit the donor's ability to give blood without becoming iron deficient or to give specific dietary advice to donors. | 10.1002/14651858.CD009532.pub2 | [
"We found 30 randomised trials of iron supplementation in blood donors with a total of 4704 participants. We found that some of the studies did not report details of their design very well and people in some of the studies left the study early and did not contribute data. Combining the results from four studies, we have shown that around 3% of donors who were given iron supplements were unable to give blood when they next came to donate because the levels of iron in their blood were too low, compared with 10% of donors who did not take iron. More than this, 4% of iron-supplemented donors were unable to give blood at any future donation due to low iron levels, compared with around 20% of donors not given iron supplementation. However, 29% of donors who took iron tablets experienced side effects compared with 17% of donors who were given dummy tablets. Combined data from two studies showed that the iron-supplemented donors had nearly five times the chance of stomach upsets and changes in their taste compared to donors who did not take these tablets. Due to the issues around how reliable the studies were, the quality of evidence is moderate and these results could change with more research. Donors can benefit from iron tablets but the rate of side effects is high, which means in practice that giving all donors iron tablets is unlikely to be acceptable and we do not know whether giving iron causes extra problems over a long period of time. Blood services may target iron supplementation at groups or individuals who are at risk of iron deficiency or may try to reduce deferral by adjusting donation intervals to suit the donor's ability to give blood without becoming iron deficient or to give specific dietary advice to donors."
]
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cochrane-simplification-train-1795 | cochrane-simplification-train-1795 | Thirteen new studies were identified for the update of this review. In total, we included 33 cohort studies including 7876 participants investigating hepatic late adverse effects after antineoplastic treatment (especially chemotherapy and radiotherapy) for different types of childhood cancer, both haematological and solid malignancies. All studies had methodological limitations. The prevalence of hepatic late adverse effects, all defined in a biochemical way, varied widely, between 0% and 84.2%. Selecting studies where the outcome of hepatic late adverse effects was well-defined as alanine aminotransferase (ALT) above the upper limit of normal, indicating cellular liver injury, resulted in eight studies. In this subgroup, the prevalence of hepatic late adverse effects ranged from 5.8% to 52.8%, with median follow-up durations varying from three to 23 years since cancer diagnosis in studies that reported the median follow-up duration. A more stringent selection process using the outcome definition of ALT as above twice the upper limit of normal, resulted in five studies, with a prevalence ranging from 0.9% to 44.8%. One study investigated biliary tract injury, defined as gamma-glutamyltransferase (γGT) above the upper limit of normal and above twice the upper limit of normal and reported a prevalence of 5.3% and 0.9%, respectively. Three studies investigated disturbance in biliary function, defined as bilirubin above the upper limit of normal and reported prevalences ranging from 0% to 8.7%. Two studies showed that treatment with radiotherapy involving the liver (especially after a high percentage of the liver irradiated), higher BMI, and longer follow-up time or older age at evaluation increased the risk of cellular liver injury in multivariable analyses. In addition, there was some suggestion that busulfan, thioguanine, hepatic surgery, chronic viral hepatitis C, metabolic syndrome, use of statins, non-Hispanic white ethnicity, and higher alcohol intake (> 14 units per week) increase the risk of cellular liver injury in multivariable analyses. Chronic viral hepatitis was shown to increase the risk of cellular liver injury in six univariable analyses as well. Moreover, one study showed that treatment with radiotherapy involving the liver, higher BMI, higher alcohol intake (> 14 units per week), longer follow-up time, and older age at cancer diagnosis increased the risk of biliary tract injury in a multivariable analysis. The prevalence of hepatic late adverse effects among studies with an adequate outcome definition varied considerably from 1% to 53%. Evidence suggests that radiotherapy involving the liver, higher BMI, chronic viral hepatitis and longer follow-up time or older age at follow-up increase the risk of hepatic late adverse effects. In addition, there may be a suggestion that busulfan, thioguanine, hepatic surgery, higher alcohol intake (>14 units per week), metabolic syndrome, use of statins, non-Hispanic white ethnicity, and older age at cancer diagnosis increase the risk of hepatic late adverse effects. High-quality studies are needed to evaluate the effects of different therapy doses, time trends, and associated risk factors after antineoplastic treatment for childhood cancer. | The evidence is current to January 2018. We found 33 cohort studies examining liver adverse effects after treatment for childhood cancer. There were 7876 cancer patients included that were treated for different types of childhood cancer, especially with chemotherapy, radiotherapy, and bone marrow transplantation. The average follow-up duration in the studies that reported this varied from two years after the end of treatment to 25 years since primary cancer diagnosis. We found that 1% to 53% of the childhood cancer survivors developed adverse effects on the liver after cancer treatment, measured by liver enzymes in the blood. Radiotherapy to the liver increases the risk of liver late adverse effects. In addition, busulfan, thioguanine, or liver surgery may increase the risk as well. Also, survivors with chronic viral hepatitis, metabolic syndrome, higher body mass index, higher alcohol intake, statin use, non-Hispanic white ethnicity, longer time since cancer diagnosis, and older age at cancer diagnosis seemed to have an increased risk of liver adverse effects. All studies had problems related to the quality of the evidence. | 10.1002/14651858.CD008205.pub3 | [
"The evidence is current to January 2018. We found 33 cohort studies examining liver adverse effects after treatment for childhood cancer. There were 7876 cancer patients included that were treated for different types of childhood cancer, especially with chemotherapy, radiotherapy, and bone marrow transplantation. The average follow-up duration in the studies that reported this varied from two years after the end of treatment to 25 years since primary cancer diagnosis. We found that 1% to 53% of the childhood cancer survivors developed adverse effects on the liver after cancer treatment, measured by liver enzymes in the blood. Radiotherapy to the liver increases the risk of liver late adverse effects. In addition, busulfan, thioguanine, or liver surgery may increase the risk as well. Also, survivors with chronic viral hepatitis, metabolic syndrome, higher body mass index, higher alcohol intake, statin use, non-Hispanic white ethnicity, longer time since cancer diagnosis, and older age at cancer diagnosis seemed to have an increased risk of liver adverse effects. All studies had problems related to the quality of the evidence."
]
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cochrane-simplification-train-1796 | cochrane-simplification-train-1796 | We considered 27 studies from the 2007 search. In this update we considered a further 38 studies from the 2013 search, and two in the 2014 search. We identified one RCT of moderate quality with low risk of bias overall which met the inclusion criteria for this update, comparing ABH (Ativan®, Benadryl®, Haldol®) gel, applied to the wrist, with placebo for the relief of nausea in 22 participants. ABH gel includes haloperidol as well as diphenhydramine and lorazepam. The gel was not significantly better than placebo in this small study; however haloperidol is reported not to be absorbed significantly when applied topically, therefore the trial does not address the issue of whether haloperidol is effective or well-tolerated when administered by other routes (e.g. by mouth, subcutaneously or intravenously). We identified one ongoing trial of haloperidol for the management of nausea and vomiting in patients with cancer, with initial results published in a conference abstract suggesting that haloperidol is effective for 65% of patients. The trial had not been fully published at the time of our review. A further trial has opened, comparing oral haloperidol with oral methotrimeprazine (levomepromazine) for patients with cancer and nausea unrelated to their treatment, which we aim to include in the next review update. Since the last version of this review, we found one new study for inclusion but the conclusion remains unchanged. There is incomplete evidence from published RCTs to determine the effectiveness of haloperidol for nausea and vomiting in palliative care. Other than the trial of ABH gel vs placebo, we did not identify any fully published RCTs exploring the effectiveness of haloperidol for nausea and vomiting in palliative care patients for this update, but two trials are underway. | This is an update of the original review published in 2009 for which no studies met the inclusion criteria. For this update, in a search of the published literature in November 2014 we found one moderate quality randomised controlled trial which compared ABH (Ativan®, Benadryl®, Haldol®) gel, containing haloperidol and two other medications, to placebo. The trial showed no difference between ABH gel and placebo. However it has previously been shown that haloperidol is not absorbed after applying ABH gel, so this result is not surprising. We identified a trial of haloperidol for nausea and vomiting in patients with cancer, with initial results presented at a conference. This suggests that haloperidol is effective in 65% of patients, but the results were not fully published at the time of our review. A further trial has opened in Australia, comparing haloperidol with another medication used for nausea, methotrimeprazine (levomepromazine). | 10.1002/14651858.CD006271.pub3 | [
"This is an update of the original review published in 2009 for which no studies met the inclusion criteria. For this update, in a search of the published literature in November 2014 we found one moderate quality randomised controlled trial which compared ABH (Ativan®, Benadryl®, Haldol®) gel, containing haloperidol and two other medications, to placebo. The trial showed no difference between ABH gel and placebo. However it has previously been shown that haloperidol is not absorbed after applying ABH gel, so this result is not surprising. We identified a trial of haloperidol for nausea and vomiting in patients with cancer, with initial results presented at a conference. This suggests that haloperidol is effective in 65% of patients, but the results were not fully published at the time of our review. A further trial has opened in Australia, comparing haloperidol with another medication used for nausea, methotrimeprazine (levomepromazine)."
]
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cochrane-simplification-train-1797 | cochrane-simplification-train-1797 | Only one study satisfied our inclusion criteria, comparing percutaneous radiofrequency thermal lumbar sympathectomy with lumbar sympathetic neurolysis using phenol in 20 participants with CRPS. There was no comparison of sympathectomy versus sham or placebo. No dichotomous pain outcomes were reported. Average baseline scores of 8-9/10 on several pain scales fell to about 4/10 initially (1 day) and remained at 3-5/10 over four months. There were no significant differences between groups, except for "unpleasant sensation", which was higher with radiofrequency ablation. One participant in the phenol group experienced post sympathectomy neuralgia, while two in the radiofrequency group and one in the phenol group complained of paraesthesia during needle positioning. All participants had soreness at the injection site. The practice of surgical and chemical sympathectomy for neuropathic pain and CRPS is based on very little high quality evidence. Sympathectomy should be used cautiously in clinical practice, in carefully selected patients, and probably only after failure of other treatment options. In these circumstances, establishing a clinical register of sympathectomy may help to inform treatment options on an individual patient basis. | This systematic review found only one small study (20 participants) of good methodological quality, which reported no significant difference between surgical and chemical sympathectomy for relieving neuropathic pain. Potentially serious complications of sympathectomy are well documented in the literature, and one (neuralgia) occurred in this study. The practice of sympathectomy for treating neuropathic pain is based on very weak evidence. Furthermore, complications of the procedure may be significant. | 10.1002/14651858.CD002918.pub3 | [
"This systematic review found only one small study (20 participants) of good methodological quality, which reported no significant difference between surgical and chemical sympathectomy for relieving neuropathic pain. Potentially serious complications of sympathectomy are well documented in the literature, and one (neuralgia) occurred in this study. The practice of sympathectomy for treating neuropathic pain is based on very weak evidence. Furthermore, complications of the procedure may be significant."
]
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cochrane-simplification-train-1798 | cochrane-simplification-train-1798 | Nine studies were identified, with a total of 5,168 participants. Follow-up ranged from 1 to 10 years. Quantitative synthesis was limited by the heterogeneity of populations, settings, and interventions and by the small number of studies that examined outcomes other than weight. Overall, in comparisons with usual care, four studies with a follow-up of one year reduced weight by 2.8 kg (95 % confidence interval (CI) 1.0 to 4.7) (3.3% of baseline body weight) and decreased body mass index by 1.3 kg/m2 (95% CI 0.8 to 1.9). Weight loss at two years was 2.6 kg (95% CI 1.9 to 3.3) (three studies). Modest improvements were noted in the few studies that examined glycemic control, blood pressure, or lipid concentrations (P > 0.05). No data on quality of life or mortality were found. The incidence of diabetes was significantly lower in the intervention groups versus the controls in three of five studies examining this outcome at 3 to 6 years follow-up. Overall, weight loss strategies using dietary, physical activity, or behavioral interventions produced significant improvements in weight among persons with prediabetes and a significant decrease in diabetes incidence. Further work is needed on the long-term effects of these interventions on morbidity and mortality and on how to implement these interventions in diverse community settings. | In this review we found that dietary, physical activity, or behavioral interventions produced significant improvements in weight among persons with prediabetes and a significant decrease in diabetes incidence. Modest, but not statistically significant improvements were noted in the few studies that examined blood sugar control, blood pressure, and lipid levels. No data on quality of life or mortality were found. | 10.1002/14651858.CD005270 | [
"In this review we found that dietary, physical activity, or behavioral interventions produced significant improvements in weight among persons with prediabetes and a significant decrease in diabetes incidence. Modest, but not statistically significant improvements were noted in the few studies that examined blood sugar control, blood pressure, and lipid levels. No data on quality of life or mortality were found."
]
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cochrane-simplification-train-1799 | cochrane-simplification-train-1799 | Two studies representing 100 participants with a diagnosis of benign epilepsy of childhood with centrotemporal spikes (BECTS) and one study representing 146 participants with a diagnosis of generalised tonic-clonic seizures (GTCS) were included. STM was given as monotherapy compared with placebo in the BECTS studies and compared with phenytoin in the GTCS study. An English translation of the full text of one of the BECTS studies could not be found, and analysis of this study was based solely on the English translation of the abstract. No data were reported for outcome (1), (2), (3) or (5). Reporting of adverse effects was incomplete. Participants receiving STM were significantly less likely to develop gingival hyperplasia than were participants receiving phenytoin in the GTCS study (risk ratio (RR) 0.03, 95% confidence interval (CI) 0.00 to 0.58). No further statistically significant adverse events were noted when STM was compared with phenytoin or placebo. Two ongoing studies comparing STM monotherapy versus placebo or levetiracetam in BECTS were identified. Small sample size, poor methodological quality and lack of data on important outcome measures prevent any meaningful conclusions regarding the efficacy and safety of sulthiame as monotherapy in epilepsy. | Three randomised controlled trials with a total of 246 participants have been conducted to assess the efficacy and safety of sulthiame as monotherapy in epilepsy. Two studies have been conducted on benign epilepsy of childhood with centrotemporal spikes, and one study has been conducted on generalised tonic-clonic seizures. The quality of the evidence is limited by small sample sizes, significant risk of bias and the absence of data on important outcome measures and, in the case of one study, the lack of an English translation of the full-text manuscript. As a result, this review can draw no meaningful conclusions on the efficacy or safety of sulthiame as monotherapy in epilepsy. Our search (carried out in October 2013) revealed two ongoing studies on the use of sulthiame as monotherapy in benign epilepsy of childhood with centrotemporal spikes, the results of which may facilitate a more meaningful analysis in future updates of this review. | 10.1002/14651858.CD010062.pub2 | [
"Three randomised controlled trials with a total of 246 participants have been conducted to assess the efficacy and safety of sulthiame as monotherapy in epilepsy. Two studies have been conducted on benign epilepsy of childhood with centrotemporal spikes, and one study has been conducted on generalised tonic-clonic seizures. The quality of the evidence is limited by small sample sizes, significant risk of bias and the absence of data on important outcome measures and, in the case of one study, the lack of an English translation of the full-text manuscript. As a result, this review can draw no meaningful conclusions on the efficacy or safety of sulthiame as monotherapy in epilepsy. Our search (carried out in October 2013) revealed two ongoing studies on the use of sulthiame as monotherapy in benign epilepsy of childhood with centrotemporal spikes, the results of which may facilitate a more meaningful analysis in future updates of this review."
]
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