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cochrane-simplification-train-1800 | cochrane-simplification-train-1800 | Thirteen studies were included in this review. All studies used a crossover design and were of high quality. Spirometry performed at the end of the study period and after the administration of treatment (post-bronchodilator) showed a slight but significant increase in FEV1 and FVC when compared to placebo (WMD 0.14 L; 95%CI 0.04, 0.25 & WMD 0.30 L; 95%CI 0.02, 0.58, respectively). In addition, both morning and evening PEFR were significantly better during active treatment than during placebo (WMD 29.17 L/min; 95%CI 0.25, 58.09 & WMD 36.75 L/min; 95%CI 2.56, 70.94, respectively). A significant improvement in daily breathlessness score was observed during treatment with beta-2 agonist when compared to placebo (SMD 1.33; 95%CI 1.0, 1.65). The risk of dropping out of the study (treatment failure) when on treatment with placebo was almost twice that of patients on treatment with beta-2 agonists (RR 0.49; 95%CI 0.33, 0.73). Patients preferred beta-2 agonists almost 10 times more frequently to placebo (OR 9.04; 95%CI 4.64, 17.61). One study that used a validated questionnaire for 'quality of life' assessment, found highly significant improvements in the scores for dyspnoea (p=0.003) and fatigue (p=0.0003) during treatment with salbutamol. No studies reported serious side effects during treatment with inhaled beta-agonists. However, none of the studies were of sufficient length or size in order to allow any meaningful information on long-term occurrence of side effects. Use of short-acting beta-2 agonists on a regular basis for at least seven days in stable COPD is associated with improvements in post bronchodilator lung function and a decrease in breathlessness. Patients are far more likely to prefer treatment with beta-2 agonists than placebo, and less likely to drop out from such treatment. None of the studies included in this review reported sufficient data or were of sufficient length or size in order to provide reliable information on adverse effects. Therefore large scale, parallel, longer term studies would be needed to investigate the effect of treatment with regular inhaled beta-2 agonists on mortality, disease progression and side effects. Newer, long acting bronchodilators (including long-acting beta-2 agonists) are currently available and they may be more practical and/or effective in these patients. However, this review indicates that treatment with these older, inexpensive drugs is beneficial in patients with COPD. | This review has shown that regular use for at least seven days of inhaled beta-2 medicines that relieve airways obstruction and can also improve the symptoms associated with chronic obstructive pulmonary disease (COPD) in most patients but not all. Patients are far more likely to prefer treatment with these type of medicines than with placebo, and less likely to fail or drop-out from treatment when treated with such medicines. Regular treatment with such inhaled medicines should be reserved for those patients who report symptomatic and clinical benefit from their use. Newer, long acting bronchodilators are currently available, and they may be more practical and/or effective in these patients. However, this review indicates that these older inexpensive drugs are effective in the treatment of COPD. | 10.1002/14651858.CD001495 | [
"This review has shown that regular use for at least seven days of inhaled beta-2 medicines that relieve airways obstruction and can also improve the symptoms associated with chronic obstructive pulmonary disease (COPD) in most patients but not all. Patients are far more likely to prefer treatment with these type of medicines than with placebo, and less likely to fail or drop-out from treatment when treated with such medicines. Regular treatment with such inhaled medicines should be reserved for those patients who report symptomatic and clinical benefit from their use. Newer, long acting bronchodilators are currently available, and they may be more practical and/or effective in these patients. However, this review indicates that these older inexpensive drugs are effective in the treatment of COPD."
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cochrane-simplification-train-1801 | cochrane-simplification-train-1801 | We included six trials involving 1438 participants. Three of the six trials had adequate sequence generation while all the trials had unclear allocation concealment There was no evidence of any difference in pain perception during surgery with either retrobulbar or peribulbar anaesthesia. Both were largely effective. There was no evidence of any difference in complete akinesia or the need for further injections of local anaesthetic. Conjunctival chemosis was more common after peribulbar block (relative risk (RR) 2.11, 95% confidence interval (CI) 1.46 to 3.05) and lid haematoma was more common after retrobulbar block (RR 0.36, 95% CI 0.15 to 0.88). Retrobulbar haemorrhage was uncommon and occurred only once, in a patient who had a retrobulbar block. There is little to choose between peribulbar and retrobulbar block in terms of anaesthesia and akinesia during surgery measuring acceptability to patients, need for additional injections and development of severe complications. Severe local or systemic complications were rare for both types of block. | We set out to compare the two forms of local anaesthesia for cataract surgery. Our review showed that pain control and paralysis of the eye muscles to paralyse movement of the eye ball (akinesia) and allow surgery are no different for the two types of anaesthesia. The need for additional injections of local anaesthetic was higher with peribulbar anaesthesia (four trials). Only one case of bleeding behind the eye occurred and this was with retrobulbar anaesthesia (in one trial). The acceptability of the two methods to patients were similar in the two studies that reported on this outcome. None of the trials reported any life-threatening complications. There was a moderate risk of bias in the included trials. | 10.1002/14651858.CD004083.pub3 | [
"We set out to compare the two forms of local anaesthesia for cataract surgery. Our review showed that pain control and paralysis of the eye muscles to paralyse movement of the eye ball (akinesia) and allow surgery are no different for the two types of anaesthesia. The need for additional injections of local anaesthetic was higher with peribulbar anaesthesia (four trials). Only one case of bleeding behind the eye occurred and this was with retrobulbar anaesthesia (in one trial). The acceptability of the two methods to patients were similar in the two studies that reported on this outcome. None of the trials reported any life-threatening complications. There was a moderate risk of bias in the included trials."
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cochrane-simplification-train-1802 | cochrane-simplification-train-1802 | We included 25 RCTs involving 7259 participants including 977 (13.5%) men and 6282 (86.5%) women. Mean age reported ranged from 52.6 to 71 years, and range of age of included participants was 23 to 85 years. The trials reported 27 comparisons and included participants who had survived breast cancer (17 trials), colorectal cancer (2 trials), gynaecological cancer (1 trial), and cancer at mixed sites (5 trials). For overall survival, dietary intervention and control groups showed little or no difference in risk of mortality (hazard ratio (HR) 0.98, 95% confidence interval (CI) 0.77 to 1.23; 1 study; 3107 participants; low-certainty evidence). For secondary malignancies, dietary interventions versus control trials reported little or no difference (risk ratio (RR) 0.99, 95% CI 0.84 to 1.15; 1 study; 3107 participants; low-certainty evidence). Co-morbidities were not measured in any included trials. Subsequent outcomes reported after 12 months found that dietary interventions versus control probably make little or no difference in energy intake at 12 months (mean difference (MD) -59.13 kcal, 95% CI -159.05 to 37.79; 5 studies; 3283 participants; moderate-certainty evidence). Dietary interventions versus control probably led to slight increases in fruit and vegetable servings (MD 0.41 servings, 95% CI 0.10 to 0.71; 5 studies; 834 participants; moderate-certainty evidence); mixed results for fibre intake overall (MD 5.12 g, 95% CI 0.66 to 10.9; 2 studies; 3127 participants; very low-certainty evidence); and likely improvement in Diet Quality Index (MD 3.46, 95% CI 1.54 to 5.38; 747 participants; moderate-certainty evidence). For anthropometry, dietary intervention versus control probably led to a slightly decreased body mass index (BMI) (MD -0.79 kg/m², 95% CI -1.50 to -0.07; 4 studies; 777 participants; moderate-certainty evidence). Dietary interventions versus control probably had little or no effect on waist-to-hip ratio (MD -0.01, 95% CI -0.04 to 0.02; 2 studies; 106 participants; low-certainty evidence). For QoL, there were mixed results; several different quality assessment tools were used and evidence was of low to very low-certainty. No adverse events were reported in any of the included studies. Evidence demonstrated little effects of dietary interventions on overall mortality and secondary cancers. For comorbidities, no evidence was identified. For nutritional outcomes, there was probably little or no effect on energy intake, although probably a slight increase in fruit and vegetable intake and Diet Quality Index. Results were mixed for fibre. For anthropometry, there was probably a slight decrease in body mass index (BMI) but probably little or no effect on waist-to-hip ratio. For QoL, results were highly varied. Additional high-quality research is needed to examine the effects of dietary interventions for different cancer sites, and to evaluate important outcomes including comorbidities and body composition. Evidence on new technologies used to deliver dietary interventions was limited. | The quality of evidence is generally low to very low. Most studies did not evaluate dietary interventions for key review outcomes, particularly mortality and morbidity. However, a few study outcomes with moderate-certainty evidence focused on dietary intake and physical measurements. Included studies compared dietary interventions versus control or usual care. We pooled data from similar randomised controlled trials (RCTs) to provide a summary estimate of the effects of an intervention, and we judged how confident (certain) we were of these findings by using an established method (GRADE). We identified 25 RCTs involving 27 different comparisons. For some outcomes, we found absence of evidence for dietary interventions. We found some evidence showing that dietary interventions probably did not modify energy intake; however, some evidence shows what is probably a slight increase in fruit and vegetable intake (moderate-certainty evidence). Evidence on dietary fibre was mixed for different advice on weight reducing or healthy eating. Dietary interventions compared to control probably improved the Diet Quality Index (moderate-certainty evidence). For physical measurements, we found a probable reduction in body mass index (BMI) with dietary interventions compared to controls (moderate-certainty evidence) but little evidence showing any change in waist-to-hip ratio (low-certainty evidence). For quality of life (QoL), results were mixed due to the wide variety of tools used. No adverse events were reported. Available evidence shows that dietary interventions can be helpful in modifying fruit and vegetable servings and diet quality; modification of fibre intake was variable, and some benefits were seen for anthropometric measurements, including BMI. Most of the evidence is based on women with breast cancer, so more research is needed for patients with other cancers. Gaps identified in the evidence involved the use of new technologies, comorbidities, and body composition data. | 10.1002/14651858.CD011287.pub2 | [
"The quality of evidence is generally low to very low. Most studies did not evaluate dietary interventions for key review outcomes, particularly mortality and morbidity. However, a few study outcomes with moderate-certainty evidence focused on dietary intake and physical measurements. Included studies compared dietary interventions versus control or usual care. We pooled data from similar randomised controlled trials (RCTs) to provide a summary estimate of the effects of an intervention, and we judged how confident (certain) we were of these findings by using an established method (GRADE). We identified 25 RCTs involving 27 different comparisons. For some outcomes, we found absence of evidence for dietary interventions. We found some evidence showing that dietary interventions probably did not modify energy intake; however, some evidence shows what is probably a slight increase in fruit and vegetable intake (moderate-certainty evidence). Evidence on dietary fibre was mixed for different advice on weight reducing or healthy eating. Dietary interventions compared to control probably improved the Diet Quality Index (moderate-certainty evidence). For physical measurements, we found a probable reduction in body mass index (BMI) with dietary interventions compared to controls (moderate-certainty evidence) but little evidence showing any change in waist-to-hip ratio (low-certainty evidence). For quality of life (QoL), results were mixed due to the wide variety of tools used. No adverse events were reported. Available evidence shows that dietary interventions can be helpful in modifying fruit and vegetable servings and diet quality; modification of fibre intake was variable, and some benefits were seen for anthropometric measurements, including BMI. Most of the evidence is based on women with breast cancer, so more research is needed for patients with other cancers. Gaps identified in the evidence involved the use of new technologies, comorbidities, and body composition data."
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cochrane-simplification-train-1803 | cochrane-simplification-train-1803 | We included 16 cohort studies (median N = 126, range 71 to 2504) and three case control studies (38 to100 cases). Only one study was carried out in a primary care population. When used in isolation, diagnostic performance of most physical tests (scoliosis, paresis or muscle weakness, muscle wasting, impaired reflexes, sensory deficits) was poor. Some tests (forward flexion, hyper-extension test, and slump test) performed slightly better, but the number of studies was small. In the one primary care study, most tests showed higher specificity and lower sensitivity compared to other settings. Most studies assessed the Straight Leg Raising (SLR) test. In surgical populations, characterized by a high prevalence of disc herniation (58% to 98%), the SLR showed high sensitivity (pooled estimate 0.92, 95% CI: 0.87 to 0.95) with widely varying specificity (0.10 to 1.00, pooled estimate 0.28, 95% CI: 0.18 to 0.40). Results of studies using imaging showed more heterogeneity and poorer sensitivity. The crossed SLR showed high specificity (pooled estimate 0.90, 95% CI: 0.85 to 0.94) with consistently low sensitivity (pooled estimate 0.28, 95% CI: 0.22 to 0.35). Combining positive test results increased the specificity of physical tests, but few studies presented data on test combinations. When used in isolation, current evidence indicates poor diagnostic performance of most physical tests used to identify lumbar disc herniation. However, most findings arise from surgical populations and may not apply to primary care or non-selected populations. Better performance may be obtained when tests are combined. | We conducted a systematic review to summarize available information on the diagnostic value of different aspects of physical examination. We included 19 different studies in which a wide variety of tests were investigated, such as the straight leg raising test, absence of tendon reflexes, or muscle weakness. The results show that most individual tests carried out during physical examination are not very accurate in discriminating between patients who have, or do not have a herniated disc with sciatica. However, most of the studies were conducted in highly selected patients who had already been referred for surgery, and only one study was carried out in a primary care population. Furthermore, better diagnostic performance of physical examination may be expected when combinations of tests are used, including information from both the patient history and physical examination. However, more research is needed to investigate the performance of such test combinations. | 10.1002/14651858.CD007431.pub2 | [
"We conducted a systematic review to summarize available information on the diagnostic value of different aspects of physical examination. We included 19 different studies in which a wide variety of tests were investigated, such as the straight leg raising test, absence of tendon reflexes, or muscle weakness. The results show that most individual tests carried out during physical examination are not very accurate in discriminating between patients who have, or do not have a herniated disc with sciatica. However, most of the studies were conducted in highly selected patients who had already been referred for surgery, and only one study was carried out in a primary care population. Furthermore, better diagnostic performance of physical examination may be expected when combinations of tests are used, including information from both the patient history and physical examination. However, more research is needed to investigate the performance of such test combinations."
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cochrane-simplification-train-1804 | cochrane-simplification-train-1804 | Seven studies with a total of 225 participants met the inclusion criteria for this review. All seven studies compared the effects of a cognitive training intervention to a control intervention at the end of treatment periods lasting four to eight weeks. Six studies included people with PD living in the community. These six studies recruited people with single-domain (executive) or multiple-domain mild cognitive impairment in PD. Four of these studies identified participants with MCI using established diagnostic criteria, and two included both people with PD-MCI and people with PD who were not cognitively impaired. One study recruited people with a diagnosis of PD dementia who were living in long-term care settings. The cognitive training intervention in three studies targeted a single cognitive domain, whilst in four studies multiple domains of cognitive function were targeted. The comparison groups either received no intervention or took part in recreational activities (sports, music, arts), speech or language exercises, computerised motor therapy, or motor rehabilitation combined with recreational activity. We found no clear evidence that cognitive training improved global cognition. Although cognitive training was associated with higher scores on global cognition at the end of treatment, the result was imprecise and not statistically significant (6 trials, 178 participants, standardised mean difference (SMD) 0.28, 95% confidence interval (CI) −0.03 to 0.59; low-certainty evidence). There was no evidence of a difference at the end of treatment between cognitive training and control interventions on executive function (5 trials, 112 participants; SMD 0.10, 95% CI −0.28 to 0.48; low-certainty evidence) or visual processing (3 trials, 64 participants; SMD 0.30, 95% CI −0.21 to 0.81; low-certainty evidence). The evidence favoured the cognitive training group on attention (5 trials, 160 participants; SMD 0.36, 95% CI 0.03 to 0.68; low-certainty evidence) and verbal memory (5 trials, 160 participants; SMD 0.37, 95% CI 0.04 to 0.69; low-certainty evidence), but these effects were less certain in sensitivity analyses that excluded a study in which only a minority of the sample were cognitively impaired. There was no evidence of differences between treatment and control groups in activities of daily living (3 trials, 67 participants; SMD 0.03, 95% CI −0.47 to 0.53; low-certainty evidence) or quality of life (5 trials, 147 participants; SMD −0.01, 95% CI −0.35 to 0.33; low-certainty evidence). There was very little information on adverse events. We considered the certainty of the evidence for all outcomes to be low due to risk of bias in the included studies and imprecision of the results. We identified six ongoing trials recruiting participants with PD-MCI, but no ongoing trials of cognitive training for people with PDD. This review found no evidence that people with PD-MCI or PDD who receive cognitive training for four to eight weeks experience any important cognitive improvements at the end of training. However, this conclusion was based on a small number of studies with few participants, limitations of study design and execution, and imprecise results. There is a need for more robust, adequately powered studies of cognitive training before conclusions can be drawn about the effectiveness of cognitive training for people with PDD and PD-MCI. Studies should use formal criteria to diagnose cognitive impairments, and there is a particular need for more studies testing the efficacy of cognitive training in people with PDD. | We found seven studies that randomly allocated a total of 225 participants to cognitive training or to a control group. Treatment lasted from four to eight weeks. All the cognitive training interventions were delivered by computer. The control groups received either no intervention or a control intervention such as language or motor exercises or participation in recreational activities. We found no difference between people who received cognitive training and people in the control groups in global cognition shortly after treatment ended. There was no convincing evidence of benefit in specific cognitive skills and no benefit shown in activities of daily living or quality of life. However, these findings were based on a small number of participants in a small number of studies. The overall certainty of the evidence was low, meaning that the results of further research could differ from the results of this review. We found no good evidence that cognitive training is helpful for people with Parkinson's disease and dementia or MCI. The included studies were small and had flaws that may have affected the findings. The certainty of the results was low, and further studies are needed before we can be confident whether or not cognitive training is effective for this group of people. | 10.1002/14651858.CD011961.pub2 | [
"We found seven studies that randomly allocated a total of 225 participants to cognitive training or to a control group. Treatment lasted from four to eight weeks. All the cognitive training interventions were delivered by computer. The control groups received either no intervention or a control intervention such as language or motor exercises or participation in recreational activities. We found no difference between people who received cognitive training and people in the control groups in global cognition shortly after treatment ended. There was no convincing evidence of benefit in specific cognitive skills and no benefit shown in activities of daily living or quality of life. However, these findings were based on a small number of participants in a small number of studies. The overall certainty of the evidence was low, meaning that the results of further research could differ from the results of this review. We found no good evidence that cognitive training is helpful for people with Parkinson's disease and dementia or MCI. The included studies were small and had flaws that may have affected the findings. The certainty of the results was low, and further studies are needed before we can be confident whether or not cognitive training is effective for this group of people."
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cochrane-simplification-train-1805 | cochrane-simplification-train-1805 | We identified seven randomised controlled trials involving 542 breast cancer patients undergoing or having recently undergone chemotherapy. All studies were conducted and published in China. We did not pool the results because few studies were identified and no more than two used the same intervention. All were of low quality and used CMH plus chemotherapy compared with chemotherapy alone. CMH combined with chemotherapy showed no statistically significant difference for the outcomes of phlebitis and alopecia. Only one study showed an improvement in nausea and vomiting, and in fatigue. Three indicated an improvement in white blood cells in the group receiving CMH. Two showed an increase in percentage changes in T-lymphocyte subsets CD4 and CD8. One study showed a statistically significant difference for CMH in percentage changes in T-lymphocyte subsets CD3, CD4 and CD8. Two herbal compounds may have improved quality of life. One study reported that CMH may have some effect on reducing toxicity in liver and kidney, but differences were not statistically significant. This review provides limited evidence about the effectiveness and safety of Chinese medicinal herbs in alleviating chemotherapy induced short term side effects. Chinese medicinal herbs, when used together with chemotherapy, may offer some benefit to breast cancer patients in terms of bone marrow improvement and quality of life, but the evidence is too limited to make any confident conclusions. Well designed clinical trials are required before any conclusions can be drawn about the effectiveness and safety of CHM in the management of breast cancer patients. | The purpose of this systematic review was to evaluate the effectiveness and safety of CMH in alleviating chemotherapy-induced short term side effects for women either undergoing chemotherapy or having recently undergone chemotherapy. Short term side effects are those that occur during the course of the treatment and generally resolve within months of the completion of the therapy and affect up to 60% of patients.They include nausea and vomiting, mucositis (inflammation of the mucous membranes lining the digestive tract from the mouth down to the anus caused by chemotherapy); neutropenia (a decrease in white blood cells caused by chemotherapy); myelosuppression (a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets), and fatigue (loss of energy and tirdness). This review found seven randomised studies involving 542 breast cancer patients addressing this question. These studies used six different herbal remedies to treat the side effects of chemotherapy, all used CMH plus chemotherapy as the intervention compared with chemotherapy alone. The results suggest that using Chinese herbs in conjunction with chemotherapy or CHM alone may be beneficial in terms of improvement in marrow suppression and Immune sytstem, and may improve overall state of quality of life. However, further trials are needed before the effects of TCM for people with breast cancer can be evaluated with any real confidence.There was no evidence of any harms of CMH. | 10.1002/14651858.CD004921.pub2 | [
"The purpose of this systematic review was to evaluate the effectiveness and safety of CMH in alleviating chemotherapy-induced short term side effects for women either undergoing chemotherapy or having recently undergone chemotherapy. Short term side effects are those that occur during the course of the treatment and generally resolve within months of the completion of the therapy and affect up to 60% of patients.They include nausea and vomiting, mucositis (inflammation of the mucous membranes lining the digestive tract from the mouth down to the anus caused by chemotherapy); neutropenia (a decrease in white blood cells caused by chemotherapy); myelosuppression (a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets), and fatigue (loss of energy and tirdness). This review found seven randomised studies involving 542 breast cancer patients addressing this question. These studies used six different herbal remedies to treat the side effects of chemotherapy, all used CMH plus chemotherapy as the intervention compared with chemotherapy alone. The results suggest that using Chinese herbs in conjunction with chemotherapy or CHM alone may be beneficial in terms of improvement in marrow suppression and Immune sytstem, and may improve overall state of quality of life. However, further trials are needed before the effects of TCM for people with breast cancer can be evaluated with any real confidence.There was no evidence of any harms of CMH."
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cochrane-simplification-train-1806 | cochrane-simplification-train-1806 | In this 2014 update, we found no new studies. The one small randomised double-blind placebo-controlled cross-over trial found in 2012, which included only 45 participants and compared intravenous lidocaine against placebo as a means of pain relief in people with burns still remains central to this review. We assessed this study as being at a high risk of bias due to its small size (fewer than 50 participants per treatment arm). Subjective pain ratings, as measured by the verbal rating scale, increased during procedures for both treatment arms; however, the increase was less in the lidocaine treatment group. There were no significant clinical or statistical differences regarding the effects of lidocaine and placebo on opioid requests and consumption, anxiety or level of satisfaction during a wound care procedure, but the small included study provided insufficient data to draw any conclusions. As current clinical evidence is based on only one RCT as well as case series and reports, intravenous lidocaine must be considered a pharmacological agent under investigation in burns care, the effectiveness of which is yet to be determined with further well-designed and conducted clinical trials. | We searched scientific databases for studies assessing the pain-relieving effects of intravenous (given into the blood stream through a vein) lidocaine in adults with a burn injury. We included studies comparing lidocaine with no treatment, placebo (a pretend treatment), other analgesics (pain killers), or a combination of these. We wanted to look at (for example) severity of pain, time to requiring more medication, rescue analgesia (where extra pain relief is needed in addition to that planned) and side effects. The evidence is current to December 2013. Key results We found one small clinical trial, involving only 45 participants, which showed a benefit from intravenous lidocaine for pain relief in people with burns. The trial did not show a difference in opioid use, participant anxiety or level of participant satisfaction with the use of intravenous lidocaine. Quality of the evidence The small included study provided insufficient data to draw any conclusions. | 10.1002/14651858.CD005622.pub4 | [
"We searched scientific databases for studies assessing the pain-relieving effects of intravenous (given into the blood stream through a vein) lidocaine in adults with a burn injury. We included studies comparing lidocaine with no treatment, placebo (a pretend treatment), other analgesics (pain killers), or a combination of these. We wanted to look at (for example) severity of pain, time to requiring more medication, rescue analgesia (where extra pain relief is needed in addition to that planned) and side effects. The evidence is current to December 2013. Key results We found one small clinical trial, involving only 45 participants, which showed a benefit from intravenous lidocaine for pain relief in people with burns. The trial did not show a difference in opioid use, participant anxiety or level of participant satisfaction with the use of intravenous lidocaine. Quality of the evidence The small included study provided insufficient data to draw any conclusions."
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cochrane-simplification-train-1807 | cochrane-simplification-train-1807 | Fifteen trials involving 10 different drugs were included. Two trials enrolling 1156 patients compared interferon gamma-1beta with placebo: interferon gamma-1beta did not significantly improve survival (HR 0.88, 95% CI 0.47 to 1.64; P = 0.68). Four trials involving 1155 patients compared pirfenidone with placebo. Three trials, conducted in 1046 patients, provided data on progression-free survival: pirfenidone significantly reduced the risk of disease progression by 30% (HR 0.70, 95% CI 0.56 to 0.88, P = 0.002). Data on the effect of pirfenidone on pulmonary function could only be assessed for two studies analysing 314 patients. Forced vital capacity or vital capacity was significantly improved by pirfenidone (mean difference 0.08 L, 95% CI 0.03 to 0.13, P = 0.0006). Based on available data, partly still unpublished, pirfenidone appears to improve progression-free survival and, to a lesser extent, pulmonary function in patients with idiopathic pulmonary fibrosis. More data are needed on overall survival and quality of life on treatment. From the studies in this review, interferon gamma-1beta has not been shown to affect survival. Other agents evaluated in single studies either failed to provide evidence for a benefit or need to be assessed in larger randomised controlled trials. | The review found 15 high quality trials of non-steroid drugs tested in idiopathic pulmonary fibrosis patients. Notwithstanding the encouraging results of a first small study included in the first version of this review, the effects of interferon gamma-1beta, as assessed by combining two subsequent large trials, were disappointing and failed to show an effect on improving survival. Four studies did evaluate pirfenidone, an anti-fibrotic oral drug, on a large number of patients: although two of these studies have only been presented in conferences,combining the published and unpublished data showed a significant improvement of pirfenidone on progression-free survival and a small increase in pulmonary function. Current evidence suggests a possible role for pirfenidone in the treatment of idiopathic pulmonary fibrosis, though data on survival are now needed. However, trials with other non-steroid agents are currently ongoing and new evidence may become available soon. | 10.1002/14651858.CD003134.pub2 | [
"The review found 15 high quality trials of non-steroid drugs tested in idiopathic pulmonary fibrosis patients. Notwithstanding the encouraging results of a first small study included in the first version of this review, the effects of interferon gamma-1beta, as assessed by combining two subsequent large trials, were disappointing and failed to show an effect on improving survival. Four studies did evaluate pirfenidone, an anti-fibrotic oral drug, on a large number of patients: although two of these studies have only been presented in conferences,combining the published and unpublished data showed a significant improvement of pirfenidone on progression-free survival and a small increase in pulmonary function. Current evidence suggests a possible role for pirfenidone in the treatment of idiopathic pulmonary fibrosis, though data on survival are now needed. However, trials with other non-steroid agents are currently ongoing and new evidence may become available soon."
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cochrane-simplification-train-1808 | cochrane-simplification-train-1808 | Altogether 2156 participants took part in the 45 randomised controlled studies that were discovered through extensive search efforts. Though many studies had a randomised, double-blind design, most studies were of poor methodological quality. Purified porcine and semi-synthetic insulin were most often investigated. No significant differences in metabolic control or hypoglycaemic episodes between various insulin species could be elucidated. Insulin dose and insulin antibodies did not show relevant dissimilarities. A comparison of the effects of human and animal insulin as well as of the adverse reaction profile did not show clinically relevant differences. Many patient-oriented outcomes like health-related quality of life or diabetes complications and mortality were never investigated in high-quality randomised clinical trials. The story of the introduction of human insulin might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety. | In our systematic review we could not identify substantial differences in the safety and efficacy between insulin species. Many important patient-oriented outcomes like health-related quality of life and effects on diabetic complications and mortality were never investigated. Human insulin was introduced into the market without scientific proof of advantage over existing purified animal insulins, especially porcine insulin. | 10.1002/14651858.CD003816.pub2 | [
"In our systematic review we could not identify substantial differences in the safety and efficacy between insulin species. Many important patient-oriented outcomes like health-related quality of life and effects on diabetic complications and mortality were never investigated. Human insulin was introduced into the market without scientific proof of advantage over existing purified animal insulins, especially porcine insulin."
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cochrane-simplification-train-1809 | cochrane-simplification-train-1809 | Three studies with a combined total of 309 participants were included in the review. One study compared two-stage versus one-stage BKA; one study compared skew flaps BKA versus long posterior flap BKA; and one study compared sagittal flaps BKA versus long posterior flap BKA. Overall the quality of the evidence from these studies was moderate. BKA using skew flaps or sagittal flaps conferred no advantage over the well established long posterior flap technique (primary stump healing was 60% for both skew flaps and long posterior flap (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.71 to 1.42) and primary stump healing was 58% for sagittal flaps and 55% for long posterior flap (Peto odds ratio (OR) 1.04, 95% CI 0.45 to 2.43). For participants with wet gangrene, a two-stage procedure with a guillotine amputation at the ankle followed by a definitive long posterior flap amputation led to better primary stump healing than a one-stage procedure (Peto OR 0.08, 95% CI 0.01 to 0.89). Post-operative infection rate or wound necrosis, reamputation, and mobility with a prosthetic limb were similar in the different comparisons. There is no evidence to show a benefit of one type of incision over another. However, in the presence of wet gangrene a two-stage procedure leads to better primary stump healing compared to a one-stage procedure. The choice of amputation technique can, therefore, be a matter of surgeon preference taking into account factors such as previous experience of a particular technique, the extent of non-viable tissue, and the location of pre-existing surgical scars. | Three randomised controlled studies were identified. Overall the quality of the evidence from these studies was moderate. They were reported on between 1977 and 1991 and involved a total of 309 participants. Each reported on different comparisons. Below knee amputation using skew flaps or sagittal flaps provided no advantage over the long posterior flap technique on primary stump healing, which approached 60% for all groups. In the third study, involving 30 participants with wet gangrene, a two-stage procedure with a guillotine amputation at the ankle followed by long posterior flap amputation led to better primary stump healing than a one-stage procedure with delayed skin closure. Post-operative infection rate or wound necrosis, reamputation and mobility with a prosthetic limb were similar in the different comparisons. Nearly all the surgeons in the study that looked at skew flap amputation versus the long posterior flap technique were new to the skew flap operation and so were on a learning curve. Factors which might have influenced the findings include previous experience of a technique, the extent of non-viable tissue, and location of pre-existing surgical scars. | 10.1002/14651858.CD003749.pub3 | [
"Three randomised controlled studies were identified. Overall the quality of the evidence from these studies was moderate. They were reported on between 1977 and 1991 and involved a total of 309 participants. Each reported on different comparisons. Below knee amputation using skew flaps or sagittal flaps provided no advantage over the long posterior flap technique on primary stump healing, which approached 60% for all groups. In the third study, involving 30 participants with wet gangrene, a two-stage procedure with a guillotine amputation at the ankle followed by long posterior flap amputation led to better primary stump healing than a one-stage procedure with delayed skin closure. Post-operative infection rate or wound necrosis, reamputation and mobility with a prosthetic limb were similar in the different comparisons. Nearly all the surgeons in the study that looked at skew flap amputation versus the long posterior flap technique were new to the skew flap operation and so were on a learning curve. Factors which might have influenced the findings include previous experience of a technique, the extent of non-viable tissue, and location of pre-existing surgical scars."
]
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cochrane-simplification-train-1810 | cochrane-simplification-train-1810 | Primary outcome measure: one cross-over trial including 18 participants showed after four weeks, 2 (95% confidence interval (CI) 0.9 to 3.1) points more improvement on an 11-point disability scale with plasma exchange (10 exchanges over four weeks) than with sham exchange. Rapid deterioration after plasma exchange occurred in eight of 12 who had improved. Secondary outcome measures: when we combined the results of this cross-over trial and a trial with 29 participants treated in a parallel-group design, there were 31 points (95% CI 18 to 45) more improvement on an impairment scale (maximum score 280) after plasma exchange (six exchanges over three weeks) than after sham exchange. There were significant improvements in both trials in an electrophysiological measure, the proximally evoked compound muscle action potential, after three or four weeks. Non-randomised evidence indicates that plasma exchange induces adverse events in 3% to 17% of procedures. These events are sometimes serious. Both trials had a low risk of bias. A trial that showed no significant difference in the benefit between plasma exchange and intravenous immunoglobulin is included in the Cochrane review of intravenous immunoglobulin for this condition. Moderate- to high-quality evidence from two small trials shows that plasma exchange provides significant short-term improvement in disability, clinical impairment, and motor nerve conduction velocity in CIDP but rapid deterioration may occur afterwards. Adverse events related to difficulty with venous access, use of citrate, and haemodynamic changes are not uncommon. We need more research to identify agents that will prolong the beneficial action of plasma exchange. | We found two randomised controlled trials. Both studies compared plasma exchange with sham exchange (in which blood was removed and returned but not exchanged). One trial aimed to compare four weeks' plasma exchange with sham exchange. The 18 participants received both treatments, being randomised to either treatment in the first period of the trial, crossing over to the other treatment for the second period. The other trial compared three-weeks' plasma exchange in 15 participants with sham exchange in 14 participants. We considered both trials at low risk of bias, which means largely free of flaws that could have influenced the results. A charitable grant supported the cross-over trial. The other did not report any support. The cross-over trial showed on average two points more improvement on an 11-point disability scale with plasma exchange than sham exchange. This was unlikely to have occurred by chance. The parallel-group trial did not report this outcome. When we combined the results of both trials, plasma exchange produced significantly more improvement in severity of disease signs measured by neurologists than sham exchange. The results reported were short term. In practice, people with CIDP receive repeated courses or combinations of plasma exchange with additional agents. Another Cochrane review includes a trial showing similar improvement after plasma exchange to that after intravenous infusion of immunoglobulin (the antibody portion of blood). According to non-randomised evidence, plasma exchange causes adverse events in 3% to 17% of procedures. These are sometimes serious. Because of the small size of the only trial reporting changes in disability, the quality of the evidence that plasma exchange reduces disability is moderate. The quality of the evidence that plasma exchange improves the signs of disease measured by a neurologist is high. The evidence is up to date to 30 June 2015. | 10.1002/14651858.CD003906.pub4 | [
"We found two randomised controlled trials. Both studies compared plasma exchange with sham exchange (in which blood was removed and returned but not exchanged). One trial aimed to compare four weeks' plasma exchange with sham exchange. The 18 participants received both treatments, being randomised to either treatment in the first period of the trial, crossing over to the other treatment for the second period. The other trial compared three-weeks' plasma exchange in 15 participants with sham exchange in 14 participants. We considered both trials at low risk of bias, which means largely free of flaws that could have influenced the results. A charitable grant supported the cross-over trial. The other did not report any support. The cross-over trial showed on average two points more improvement on an 11-point disability scale with plasma exchange than sham exchange. This was unlikely to have occurred by chance. The parallel-group trial did not report this outcome. When we combined the results of both trials, plasma exchange produced significantly more improvement in severity of disease signs measured by neurologists than sham exchange. The results reported were short term. In practice, people with CIDP receive repeated courses or combinations of plasma exchange with additional agents. Another Cochrane review includes a trial showing similar improvement after plasma exchange to that after intravenous infusion of immunoglobulin (the antibody portion of blood). According to non-randomised evidence, plasma exchange causes adverse events in 3% to 17% of procedures. These are sometimes serious. Because of the small size of the only trial reporting changes in disability, the quality of the evidence that plasma exchange reduces disability is moderate. The quality of the evidence that plasma exchange improves the signs of disease measured by a neurologist is high. The evidence is up to date to 30 June 2015."
]
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cochrane-simplification-train-1811 | cochrane-simplification-train-1811 | We included three trials with 3851 participants. All three were cluster-RCTs. Two of the trials were of complex, single-component, non-pharmacological interventions and one trial was a feasibility trial of a complex, multicomponent, non-pharmacological intervention. Risk of bias ratings were mixed across the three trials. Due to the heterogeneous nature of the interventions, we did not combine the results statistically, but produced a narrative summary. It was not possible to determine the effect of a hydration-based intervention on delirium incidence (RR 0.85, 95% confidence interval (CI) 0.18 to 4.00; 1 study, 98 participants; very low-certainty evidence downgraded for risk of bias and very serious imprecision). This study did not assess delirium prevalence, severity or mortality. The introduction of a computerised system to identify medications that may contribute to delirium risk and trigger a medication review was probably associated with a reduction in delirium incidence (12-month HR 0.42, CI 0.34 to 0.51; 1 study, 7311 participant-months; moderate-certainty evidence downgraded for risk of bias) but probably had little or no effect on mortality (HR 0.88, CI 0.66 to 1.17; 1 study, 9412 participant-months; moderate-certainty evidence downgraded for imprecision), hospital admissions (HR 0.89, CI 0.72 to 1.10; 1 study, 7599 participant-months; moderate-certainty evidence downgraded for imprecision) or falls (HR 1.03, CI 0.92 to 1.15; 1 study, 2275 participant-months; low-certainty evidence downgraded for imprecision and risk of bias). Delirium prevalence and severity were not assessed. In the enhanced educational intervention study, aimed at changing practice to address key delirium risk factors, it was not possible to determine the effect of the intervention on delirium incidence (RR 0.62, 95% CI 0.16 to 2.39; 1 study, 137 resident months; very low-certainty evidence downgraded for risk of bias and serious imprecision) or delirium prevalence (RR 0.57, 95% CI 0.15 to 2.19; 1 study, 160 participants; very low-certainty evidence downgraded for risk of bias and serious imprecision). There was probably little or no effect on mortality (RR 0.82, CI 0.50 to 1.34; 1 study, 215 participants; moderate-certainty evidence downgraded for imprecision). The intervention was probably associated with a reduction in hospital admissions (RR 0.67, CI 0.57 to 0.79; 1 study, 494 participants; moderate-certainty evidence downgraded due to indirectness). Our review identified limited evidence on interventions for preventing delirium in older people in LTC. A software-based intervention to identify medications that could contribute to delirium risk and trigger a pharmacist-led medication review, probably reduces incidence of delirium in older people in institutional LTC. This is based on one large RCT in the US and may not be practical in other countries or settings which do not have comparable information technology services available in care homes. In the educational intervention aimed at identifying risk factors for delirium and developing bespoke solutions within care homes, it was not possible to determine the effect of the intervention on delirium incidence, prevalence or mortality. This evidence is based on a small feasibility trial. Our review identified three ongoing trials of multicomponent delirium prevention interventions. We identified no trials of pharmacological agents. Future trials of multicomponent non-pharmacological delirium prevention interventions for older people in LTC are needed to help inform the provision of evidence-based care for this vulnerable group. | The evidence is current to February 2019. We found three studies that included 3851 participants. Two studies took place in the US and one study in the UK. One study tested whether delirium could be prevented by calculating how much fluid an older person in a care home needs each day and ensuring hydration was maintained. There were 98 people in the study, which lasted four weeks. One study tested the effect of a computer program which searched for prescriptions of medications that might increase the chance of developing delirium, to enable a pharmacist to adjust or stop them. There were 3538 people in the study, which lasted 12 months. One study tested an enhanced educational intervention which included learning sessions on delirium with care home staff and group meetings to identity targets for preventing delirium. There were 215 people in the study, which lasted 16 months. It was not possible to determine if the hydration intervention reduced the occurrence of delirium. This was a small study of short duration with serious design problems. The study of a computerised medication search programme probably reduced delirium, but there was no clear reduction in hospital admissions, deaths or falls. A potential problem is that it might not be possible to use this computer program in different countries that do not have similar computer systems available. It was not possible to determine if the enhanced education intervention reduced the occurrence of delirium and there was no clear reduction in the number of deaths. The intervention was probably associated with a reduction in hospital admissions. This is based on findings from a small study. There is very low-quality evidence on the effectiveness of hydration interventions for reducing the incidence of delirium. Therefore, it was not possible to draw firm conclusions. There is moderate-quality evidence that a computerised medication search programme may reduce the incidence of delirium. There is no clear evidence for reducing hospitalisations, mortality or falls. There is very low-quality evidence of the effectiveness of an enhanced educational intervention for reducing delirium. Therefore, it was not possible to draw firm conclusions. There is moderate-quality evidence for reducing hospital admissions. As this review only found a small number of research studies, we recommend that further research be conducted, testing different ways of preventing delirium for older people in LTC. | 10.1002/14651858.CD009537.pub3 | [
"The evidence is current to February 2019. We found three studies that included 3851 participants. Two studies took place in the US and one study in the UK. One study tested whether delirium could be prevented by calculating how much fluid an older person in a care home needs each day and ensuring hydration was maintained. There were 98 people in the study, which lasted four weeks. One study tested the effect of a computer program which searched for prescriptions of medications that might increase the chance of developing delirium, to enable a pharmacist to adjust or stop them. There were 3538 people in the study, which lasted 12 months. One study tested an enhanced educational intervention which included learning sessions on delirium with care home staff and group meetings to identity targets for preventing delirium. There were 215 people in the study, which lasted 16 months. It was not possible to determine if the hydration intervention reduced the occurrence of delirium. This was a small study of short duration with serious design problems. The study of a computerised medication search programme probably reduced delirium, but there was no clear reduction in hospital admissions, deaths or falls. A potential problem is that it might not be possible to use this computer program in different countries that do not have similar computer systems available. It was not possible to determine if the enhanced education intervention reduced the occurrence of delirium and there was no clear reduction in the number of deaths. The intervention was probably associated with a reduction in hospital admissions. This is based on findings from a small study. There is very low-quality evidence on the effectiveness of hydration interventions for reducing the incidence of delirium. Therefore, it was not possible to draw firm conclusions. There is moderate-quality evidence that a computerised medication search programme may reduce the incidence of delirium. There is no clear evidence for reducing hospitalisations, mortality or falls. There is very low-quality evidence of the effectiveness of an enhanced educational intervention for reducing delirium. Therefore, it was not possible to draw firm conclusions. There is moderate-quality evidence for reducing hospital admissions. As this review only found a small number of research studies, we recommend that further research be conducted, testing different ways of preventing delirium for older people in LTC."
]
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cochrane-simplification-train-1812 | cochrane-simplification-train-1812 | We identified 15 studies described in 27 articles that met our inclusion criteria. These 15 included studies randomised a total of 3062 participants (PAAP vs no PAAP: 2602 participants; PAAP plus education vs education alone: 460 participants). Ten studies (eight PAAP vs no PAAP; two PAAP plus education vs education alone) provided outcome data that contributed to quantitative analyses. The overall quality of evidence was rated as low or very low. Fourteen studies lasted six months or longer, and the remaining study lasted for 14 weeks. When reported, mean age ranged from 22 to 49 years and asthma severity ranged from mild to severe/high risk. PAAP alone compared with no PAAP Results showed no clear benefit or harm associated with PAAPs in terms of the number of participants requiring an ED visit or hospitalisation for an exacerbation (odds ratio (OR) 0.75, 95% confidence interval (CI) 0.45 to 1.24; 1385 participants; five studies; low-quality evidence), change from baseline in asthma symptoms (mean difference (MD) -0.16, 95% CI -0.25 to - 0.07; 141 participants; one study; low-quality evidence) or the number of serious adverse events, including death (OR 3.26, 95% CI 0.33 to 32.21; 125 participants; one study; very low-quality evidence). Data revealed a statistically significant improvement in quality of life scores for those receiving PAAP compared with no PAAP (MD 0.18, 95% CI 0.05 to 0.30; 441 participants; three studies; low-quality evidence), but this was below the threshold for a minimum clinically important difference (MCID). Results also showed no clear benefit or harm associated with PAAPs on the number of participants reporting at least one exacerbation requiring oral corticosteroids (OR 1.45, 95% CI 0.84 to 2.48; 1136 participants; three studies; very low-quality evidence) nor on respiratory function (change from baseline forced expiratory volume in one second (FEV1): MD -0.04 L, 95% CI -0.25L to 0.17 L; 392 participants; three studies; low-quality evidence). In one study, PAAPs were associated with significantly fewer days lost from work or study (MD -6.20, 95% CI -7.32 to - 5.08; 74 participants; low-quality evidence). PAAP plus education compared with education alone Results showed no clear benefit or harm associated with adding a PAAP to education in terms of the number of participants requiring an ED visit or hospitalisation for an exacerbation (OR 1.08, 95% CI 0.27 to 4.32; 70 participants; one study; very low-quality evidence), change from baseline in asthma symptoms (MD -0.10, 95% CI -0.54 to 0.34; 70 participants; one study; low-quality evidence), change in quality of life scores from baseline (MD 0.13, 95% CI -0.13 to 0.39; 174 participants; one study; low-quality evidence) and number of participants requiring oral corticosteroids for an exacerbation (OR 0.28, 95% CI 0.07 to 1.12; 70 participants; one study; very low-quality evidence). No studies reported serious adverse events, respiratory function or days lost from work or study. Analysis of available studies was limited by variable reporting of primary and secondary outcomes; therefore, it is difficult to draw firm conclusions related to the effectiveness of PAAPs in the management of adult asthma. We found no evidence from randomised controlled trials of additional benefit or harm associated with use of PAAP versus no PAAP, or PAAP plus education versus education alone, but we considered the quality of the evidence to be low or very low, meaning that we cannot be confident in the magnitude or direction of reported treatment effects. In the context of this caveat, we found no observable effect on the primary outcomes of hospital attendance with an asthma exacerbation, asthma symptom scores or adverse events. We recommend further research with a particular focus on key patient-relevant outcomes, including exacerbation frequency and quality of life, in a broad spectrum of adults, including those over 60 years of age. | We searched for studies up to September 2016. We found 15 studies that provided the information we were looking for in conducting this review. A total of 3062 people had taken part in these studies; 2602 people took part in 11 studies looking at PAAP versus no PAAP, and 460 people were included in four studies looking at PAAP and education versus just education. Fourteen studies lasted six months or longer. The average age of people in these studies ranged from 22 to 49 years. Asthma severity ranged from mild to severe. We were able to use data from 10 of these 15 studies to inform our findings. PAAP alone compared with no PAAP: People using a PAAP did not show any difference (good or bad) in terms of having to go to the hospital because their asthma worsened compared with people not using a PAAP. This result was the same for changes in asthma symptom scores and number of deaths due to asthma. People with a PAAP showed no improvement in their quality of life compared with those without a PAAP, but the difference was not large enough to be meaningful. PAAP plus education compared with education alone: Review authors found no real difference - good or bad - between people using a PAAP and education and those just receiving education. This finding was the same for all outcomes, that is, having to go to the hospital because their asthma worsened and changes in symptom scores and quality of life. We rated the quality of the 15 included studies as low or very low because the few studies included in this review had problems with study design, including how to enrol people into the study and how to handle missing data for some people. Also, studies had problems with how outcome data for those who did not finish the study should be managed. This means that as future studies are completed and added to future versions of this review, the findings of the review may change. | 10.1002/14651858.CD011859.pub2 | [
"We searched for studies up to September 2016. We found 15 studies that provided the information we were looking for in conducting this review. A total of 3062 people had taken part in these studies; 2602 people took part in 11 studies looking at PAAP versus no PAAP, and 460 people were included in four studies looking at PAAP and education versus just education. Fourteen studies lasted six months or longer. The average age of people in these studies ranged from 22 to 49 years. Asthma severity ranged from mild to severe. We were able to use data from 10 of these 15 studies to inform our findings. PAAP alone compared with no PAAP: People using a PAAP did not show any difference (good or bad) in terms of having to go to the hospital because their asthma worsened compared with people not using a PAAP. This result was the same for changes in asthma symptom scores and number of deaths due to asthma. People with a PAAP showed no improvement in their quality of life compared with those without a PAAP, but the difference was not large enough to be meaningful. PAAP plus education compared with education alone: Review authors found no real difference - good or bad - between people using a PAAP and education and those just receiving education. This finding was the same for all outcomes, that is, having to go to the hospital because their asthma worsened and changes in symptom scores and quality of life. We rated the quality of the 15 included studies as low or very low because the few studies included in this review had problems with study design, including how to enrol people into the study and how to handle missing data for some people. Also, studies had problems with how outcome data for those who did not finish the study should be managed. This means that as future studies are completed and added to future versions of this review, the findings of the review may change."
]
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cochrane-simplification-train-1813 | cochrane-simplification-train-1813 | We included 25 studies (6293 participants) in this review. All included studies specified inguinal hernias, and two studies reported that femoral hernias were included. Mesh repair probably reduces the risk of hernia recurrence compared to non-mesh repair (21 studies, 5575 participants; RR 0.46, 95% CI 0.26 to 0.80, I2 = 44%, moderate-quality evidence). In absolute numbers, one hernia recurrence was prevented for every 46 mesh repairs compared with non-mesh repairs. Twenty-four studies (6293 participants) assessed a wide range of complications with varying follow-up times. Neurovascular and visceral injuries were more common in non-mesh repair groups (RR 0.61, 95% CI 0.49 to 0.76, I2 = 0%, NNTB = 22, high-quality evidence). Wound infection was found slightly more commonly in the mesh group (20 studies, 4540 participants; RR 1.29, 95% CI 0.89 to 1.86, I2 = 0%, NNTB = 200, low-quality evidence). Mesh repair reduced the risk of haematoma compared to non-mesh repair (15 studies, 3773 participants; RR 0.88, 95% CI 0.68 to 1.13, I2 = 0%, NNTB = 143, low-quality evidence). Seromas probably occur more frequently with mesh repair than with non-mesh repair (14 studies, 2640 participants; RR 1.63, 95% CI 1.03 to 2.59, I2 = 0%, NNTB = 72, moderate-quality evidence), as does wound swelling (two studies, 388 participants; RR 4.56, 95% CI 1.02 to 20.48, I2 = 33%, NNTB = 72, moderate-quality evidence). The comparative effect on wound dehiscence is uncertain due to wide confidence intervals (two studies, 329 participants; RR 0.55, 95% CI 0.12 to 2.48, I2 = 37% NNTB = 77, low-quality evidence). Testicular complications showed nearly equivocal results; they probably occurred slightly more often in the mesh group however the confidence interval around the effect was wide (14 studies, 3741 participants; RR 1.06, 95% CI 0.63 to 1.76, I2 = 0%, NNTB = 2000, low-quality evidence). Mesh reduced the risk of postoperative urinary retention compared to non-mesh (eight studies, 1539 participants; RR 0.53, 95% CI 0.38 to 0.73, I2 = 56%, NNTB = 16, moderate-quality evidence). Postoperative and chronic pain could not be compared due to variations in measurement methods and follow-up time (low-quality evidence). No deaths occurred during the follow-up periods reported in the seven studies (2546 participants) reporting this outcome (high-quality evidence). The average operating time was longer for non-mesh repairs by a mean of 4 minutes 22 seconds, despite wide variation across the studies regarding size and direction of effect, thus this result is uncertain (20 studies, 4148 participants; 95% CI -6.85 to -1.60, I2= 97%, very low-quality evidence). Hospital stay may be shorter with mesh repair, by 0.6 days (12 studies, 2966 participants; 95% CI -0.86 to -0.34, I2 = 98%, low-quality evidence), and participants undergoing mesh repairs may return to normal activities of daily living a mean of 2.87 days sooner than those with non-mesh repair (10 studies, 3183 participants; 95% CI -4.42 to -1.32, I2 = 96%, low-quality evidence), although the results of both these outcomes are also limited by wide variation in the size and direction of effect across the studies. Mesh and non-mesh repairs are effective surgical approaches in treating hernias, each demonstrating benefits in different areas. Compared to non-mesh repairs, mesh repairs probably reduce the rate of hernia recurrence, and reduce visceral or neurovascular injuries, making mesh repair a common repair approach. Mesh repairs may result in a reduced length of hospital stay and time to return to activities of daily living, but these results are uncertain due to variation in the results of the studies. Non-mesh repair is less likely to cause seroma formation and has been favoured in low-income countries due to low cost and reduced availability of mesh materials. Risk of bias in the included studies was low to moderate and generally handled well by study authors, with attention to details of allocation, blinding, attrition and reporting. | In this update of a review originally published in 2001, we included a total of 25 studies (with a total of 6293 people) undertaken in a number of different countries. A variety of outcomes were assessed, including return of the hernia after initial repair (hernia recurrence), a variety of complications including pain, duration of surgery, hospital stay and time before going back to normal activities. One hernia recurrence is prevented for every 46 mesh repairs performed rather than non-mesh repairs. Compared to non-mesh repairs, mesh repairs are more likely to develop collections of fluid next to the surgical wound, but are less likely to result in difficulty urinating following the operation, or injury to nerves, blood vessels or other organs. Postoperative pain could not be clearly compared between studies due to differences in measurement methods and time frames, but overall the studies appeared to indicate that participants who had mesh repairs had less pain. The length of the surgical operation was slightly shorter for mesh repairs. Participants who had a mesh repair were more likely to have a shorter hospital stay and had a shorter average recovery time before returning to their normal activities. The studies included in this review used good-quality methods, considered potential factors which could affect the results, and addressed their proposed outcomes clearly. In our assessment of the quality of evidence, we marked down some outcomes to 'moderate' quality, particularly due to variability within results. Overall, hernia repairs with and without mesh both proved effective in the treatment of hernias, although mesh repairs demonstrated fewer hernia recurrences, a shorter operation time and faster return to normal activities. Non-mesh repairs are still widely used, often due to the cost and poor availability of the mesh product itself. | 10.1002/14651858.CD011517.pub2 | [
"In this update of a review originally published in 2001, we included a total of 25 studies (with a total of 6293 people) undertaken in a number of different countries. A variety of outcomes were assessed, including return of the hernia after initial repair (hernia recurrence), a variety of complications including pain, duration of surgery, hospital stay and time before going back to normal activities. One hernia recurrence is prevented for every 46 mesh repairs performed rather than non-mesh repairs. Compared to non-mesh repairs, mesh repairs are more likely to develop collections of fluid next to the surgical wound, but are less likely to result in difficulty urinating following the operation, or injury to nerves, blood vessels or other organs. Postoperative pain could not be clearly compared between studies due to differences in measurement methods and time frames, but overall the studies appeared to indicate that participants who had mesh repairs had less pain. The length of the surgical operation was slightly shorter for mesh repairs. Participants who had a mesh repair were more likely to have a shorter hospital stay and had a shorter average recovery time before returning to their normal activities. The studies included in this review used good-quality methods, considered potential factors which could affect the results, and addressed their proposed outcomes clearly. In our assessment of the quality of evidence, we marked down some outcomes to 'moderate' quality, particularly due to variability within results. Overall, hernia repairs with and without mesh both proved effective in the treatment of hernias, although mesh repairs demonstrated fewer hernia recurrences, a shorter operation time and faster return to normal activities. Non-mesh repairs are still widely used, often due to the cost and poor availability of the mesh product itself."
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cochrane-simplification-train-1814 | cochrane-simplification-train-1814 | Six trials were included (five on-pump and one off-pump). This update adds the results of one further trial. Data from a total of 255 patients were included in the meta-analysis of mortality outcomes; all on-pump. Generally, the patients were considered as "high risk" and 132 were treated preoperatively with IABP and 123 served as controls. There were four hospital deaths in the intervention arm and 23 in the non-intervention arm (OR 0.18, 95% CI 0.08 to 0.41; P<0.0001). In a subgroup analysis, low cardiac index (<2.0 L/min/m2) was noted in 21 out of 105 patients in the treatment arm and 59 patients out of 88 in the non-treatment arm (OR 0.14, 95% CI: 0.08 to 0.25; P<0.00001). An off-pump versus on-pump analysis was not possible due to the limited number of off-pump studies. However a single well-conducted RCT suggested favourable effect of the preoperative IABP in off-pump patients. Evidence suggests that preoperative IABP may have a beneficial effect on mortality and morbidity in specific high risk patient groups undergoing coronary artery bypass grafting, however there are many problems with the quality, validity and generalisability of the trials. However, the available evidence is not robust enough to extend the use of IABP to truly elective, high risk patients. Defining more precisely which patient groups may benefit would be the challenge for the future. | This review suggests the intra aortic balloon pump may be beneficial in terms of survival from the operation however there are many problems with the validity of the trials used in this review and a categorical answer to this question requires further randomised controlled trials. | 10.1002/14651858.CD004472.pub3 | [
"This review suggests the intra aortic balloon pump may be beneficial in terms of survival from the operation however there are many problems with the validity of the trials used in this review and a categorical answer to this question requires further randomised controlled trials."
]
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cochrane-simplification-train-1815 | cochrane-simplification-train-1815 | The search for the original version of the review identified 635 unique references. We found 31 references (which reported on 30 studies) in full text after inspection of titles and abstracts, but we excluded them all as they did not meet the inclusion criteria. However, we have included a comprehensive narrative account of studies where we identified an analysis of more than 10 women, as this forms the only evidence base in this rare disease. Surgery continues to be the mainstay of treatment in the current literature, with other treatments limited to case reports or treatment of inoperable or recurrent disease. This update between September 2013 and May 2018 identified 35 new studies. None of these met the inclusion criteria. There was only one prospective study of 5% imiquimod in recurrent Paget's disease of the vulva, which although of good quality only included eight women. Since the last version of the review was published there are many more cases in the literature reporting a clinical response to 5% imiquimod cream. There is one prospective study of eight women treated with 5% imiquimod for recurrent Paget's disease of the vulva, and one prospective trial of 20 women was due to be reported. This increasing evidence for the safety and efficacy of 5% imiquimod will be helpful for women and clinicians alike. Ideally, a multicentre RCT of reasonable size is needed, but ongoing publications of high-quality non-randomised prospective studies will enhance the current available literature. | We searched for randomised controlled trials (trials where treatment is allocated to women in a random manner) and well-designed non-randomised studies that compared different treatments in women aged 18 years or older with biopsy-confirmed Paget's disease of the vulva. We searched scientific databases and contacted experts and identified and checked the titles and abstracts of 635 possibly relevant articles and retrieved 31 of these references in full text. However, we found no studies that met our inclusion criteria. We identified several non-randomised studies and drafted a detailed narrative of their results, but these studies were of poor quality and were at high risk of bias. Therefore, there is currently no evidence to determine whether any form of treatment is better or worse in terms of prolonging survival, delaying progression or recurrence, improving QoL or minimising toxicity. The review highlights the need for good-quality studies comparing different interventions for the management of Paget's disease of the vulva. Women and clinicians would value more evidence for guiding surgical and non-surgical management of this disease. In particular, non-invasive medical management would spare women from the side effects and consequences of surgery. | 10.1002/14651858.CD009245.pub3 | [
"We searched for randomised controlled trials (trials where treatment is allocated to women in a random manner) and well-designed non-randomised studies that compared different treatments in women aged 18 years or older with biopsy-confirmed Paget's disease of the vulva. We searched scientific databases and contacted experts and identified and checked the titles and abstracts of 635 possibly relevant articles and retrieved 31 of these references in full text. However, we found no studies that met our inclusion criteria. We identified several non-randomised studies and drafted a detailed narrative of their results, but these studies were of poor quality and were at high risk of bias. Therefore, there is currently no evidence to determine whether any form of treatment is better or worse in terms of prolonging survival, delaying progression or recurrence, improving QoL or minimising toxicity. The review highlights the need for good-quality studies comparing different interventions for the management of Paget's disease of the vulva. Women and clinicians would value more evidence for guiding surgical and non-surgical management of this disease. In particular, non-invasive medical management would spare women from the side effects and consequences of surgery."
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cochrane-simplification-train-1816 | cochrane-simplification-train-1816 | Four studies randomising 163 people could be included in the review. It is not clear if brief family intervention reduces the utilisation of health services by patients, as most results are equivocal at long term and only one study reported data for the primary outcomes of interest of hospital admission (n = 30, 1 RCT, RR 0.50, 95% CI 0.22 to 1.11, very low quality evidence). Data for relapse are also equivocal by medium term (n = 40, 1 RCT, RR 0.50, 95% CI 0.10 to 2.43, low quality evidence). However, data for the family outcome of understanding of family member significantly favoured brief family intervention (n = 70, 1 RCT, MD 14.90, 95% CI 7.20 to 22.60, very low quality evidence). No study reported data for other outcomes of interest including days in hospital; adverse events; medication compliance; quality of life or satisfaction with care; or any economic outcomes. The findings of this review are not outstanding due to the size and quality of studies providing data; the analysed outcomes were also minimal, with no meta-analysis possible. All outcomes in the 'Summary of findings' table were rated low or very low quality evidence. However, the importance of brief family intervention should not be dismissed outright, with the present state of demand and resources available. The designs of such brief interventions could be modified to be more effective with larger studies, which may then have enough power to inform clinical practice. | This review investigates the effects of brief family intervention for people with schizophrenia, compared to standard or usual care. A search of the Cochrane Schizophrenia Group's trial register was carried out in July 2012. Four randomised studies, with a total of 163 participants were included. Results were limited, so it is not clear if brief family intervention reduces admission to hospital, decreases people using health services and reduces relapse for people with schizophrenia. The review found some evidence that brief family intervention might increase the understanding of family members about mental illness. However, all main findings are not strong and based on low or very low quality evidence. Despite this, the authors of the review suggest that brief family intervention should not be completely dismissed, as it is in a current state of demand and there are usually resources or local services available for people with mental health problems and their families to participate in as a part of recovery. The authors also suggest that brief family intervention could be improved to be more effective but this would depend on larger and better studies of brief family intervention being carried out, which would help guide good practice and lead to better outcomes for people with schizophrenia. This plain language summary has been written by a consumer, Ben Gray, from RETHINK. | 10.1002/14651858.CD009802.pub2 | [
"This review investigates the effects of brief family intervention for people with schizophrenia, compared to standard or usual care. A search of the Cochrane Schizophrenia Group's trial register was carried out in July 2012. Four randomised studies, with a total of 163 participants were included. Results were limited, so it is not clear if brief family intervention reduces admission to hospital, decreases people using health services and reduces relapse for people with schizophrenia. The review found some evidence that brief family intervention might increase the understanding of family members about mental illness. However, all main findings are not strong and based on low or very low quality evidence. Despite this, the authors of the review suggest that brief family intervention should not be completely dismissed, as it is in a current state of demand and there are usually resources or local services available for people with mental health problems and their families to participate in as a part of recovery. The authors also suggest that brief family intervention could be improved to be more effective but this would depend on larger and better studies of brief family intervention being carried out, which would help guide good practice and lead to better outcomes for people with schizophrenia. This plain language summary has been written by a consumer, Ben Gray, from RETHINK."
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cochrane-simplification-train-1817 | cochrane-simplification-train-1817 | We included two studies (involving 141 women - with data from 124 women). We considered both studies as being at high risk of bias. Meta-analysis was not possible because the included studies examined different interventions (both in comparison with standard care) and reported on few, but different, outcomes. One study compared cervical adapter (mechanical sealing), and the other study examined an immunological membrane sealant. Neither of the included studies reported on this review's primary outcome of interest - perinatal mortality. Similarly, data were not reported for the majority of this review's secondary infant and maternal outcomes. Cervical adapter (mechanical sealing) versus standard care (one study, data from 35 participants) No data were reported for this review's primary outcome - perinatal mortality. Data were reported for few of this review's infant or maternal secondary outcomes. There was no clear difference between the mechanical sealing group and the standard care control in relation to the incidence of neonatal sepsis (risk ratio (RR) 1.19, 95% confidence interval (CI) 0.28 to 5.09 (very low-quality evidence)) or chorioamnionitis (RR 1.19, 95% CI 0.28 to 5.09 (very low-quality evidence)). Oral immunological membrane sealant versus standard care (one study, data from 94 participants) No data were available for perinatal mortality (this review's primary outcome) or for the majority of this review's infant and maternal secondary outcomes. Compared to standard care, the immunological membrane sealant was associated with a reduction in preterm birth less than 37 weeks (RR 0.48, 95% CI 0.34 to 0.68 (very low-quality evidence)) and a reduction in neonatal death (RR 0.38, 95% CI 0.19 to 0.75 (very low-quality evidence)). However, there was no clear difference between groups in terms of neonatal sepsis (RR 0.64, 95% CI 0.28 to 1.46 (very low-quality evidence)) or respiratory distress syndrome (RR 0.64, 95% CI 0.28 to 1.46 (very low-quality evidence)). There is insufficient evidence to evaluate sealing procedures for PPROM. There were no data relating to this review's primary outcome (perinatal mortality) and the majority of our infant and maternal secondary outcomes were not reported in the two included studies. There was limited evidence to suggest that an immunological membrane sealant was associated with a reduction in preterm birth at less than 37 weeks and neonatal death, but these results should be interpreted with caution as this is based on one small study, with a high risk of bias, and the intervention has not been tested in other studies. Although midtrimester PPROM is not a rare occurrence, there are only a small amount of published data addressing the benefits and risks of sealing procedures. Most of these studies are retrospective and cohort based and could therefore not be included in our data-analysis. This review highlights the paucity of prospective randomised trials in this area. Current evidence provides limited information both on effectiveness and safety for the interventions described. Given the paucity of high-quality data, we recommend that future research efforts focus on the conduct of randomised trials assessing the effect of promising interventions that have been only evaluated to date in cohort studies (e.g. amniopatch). Future trials should address outcomes including perinatal mortality, preterm birth, neonatal death, respiratory distress syndrome, neonatal sepsis and developmental delay. They should also evaluate maternal outcomes including sepsis, mode of delivery, length of hospital stay and emotional well-being. | In our study we assessed the different techniques used for resealing the waters. We aimed to compare the survival of babies affected with this condition before and after birth and look at the rates of complications in both the babies and mothers. We searched for trials (30 May 2016) and found two studies that compared treatments for resealing the membranes after they had broken. These trials involved 141 women in total and compared two completely different modes of treatment. One trial compared the use of an oral immunological membrane sealant to stimulate the body’s immune system to mend the area where the seal has broken and the other trial placed a mechanical sealing device over the cervix (neck of the womb) to stop fluid leaking. Unfortunately, neither trial provided any data relating to death of the baby within the womb or in the first 28 days of life (perinatal mortality). There was limited evidence to suggest that oral immunological membrane sealant was associated with a fewer babies being before 37 weeks’ gestation and a reduction in the number of babies that died within the first 28 days. However, these results are based on very low-quality evidence from one small trial (with data from 94 women) that we judged to be at a high risk of bias. There was no clear difference between the mechanical sealing device group and the control group in relation to the number of babies who contracted a serious infection (neonatal sepsis) or chorioamnionitis (a bacterial infection that causes inflammation of the membranes surrounding the baby in the womb). Although these results are based on very low-quality evidence from one small trial (involving 35 women) judged to be at a high risk of bias. Overall, our question remains unanswered - we do not have enough data to fully evaluate sealing procedures for PPROM. This review demonstrates the lack of research in this area regarding the effectiveness and safety of potential treatments for PPROM. We recommend that more research is needed to look at the different techniques for sealing broken waters and that this research should focus on the effectiveness of the treatment in improving overall outcomes. The safety of the treatments to both mother and baby must be further evaluated before sealing techniques can be recommended to prevent adverse outcomes. | 10.1002/14651858.CD010218.pub2 | [
"In our study we assessed the different techniques used for resealing the waters. We aimed to compare the survival of babies affected with this condition before and after birth and look at the rates of complications in both the babies and mothers. We searched for trials (30 May 2016) and found two studies that compared treatments for resealing the membranes after they had broken. These trials involved 141 women in total and compared two completely different modes of treatment. One trial compared the use of an oral immunological membrane sealant to stimulate the body’s immune system to mend the area where the seal has broken and the other trial placed a mechanical sealing device over the cervix (neck of the womb) to stop fluid leaking. Unfortunately, neither trial provided any data relating to death of the baby within the womb or in the first 28 days of life (perinatal mortality). There was limited evidence to suggest that oral immunological membrane sealant was associated with a fewer babies being before 37 weeks’ gestation and a reduction in the number of babies that died within the first 28 days. However, these results are based on very low-quality evidence from one small trial (with data from 94 women) that we judged to be at a high risk of bias. There was no clear difference between the mechanical sealing device group and the control group in relation to the number of babies who contracted a serious infection (neonatal sepsis) or chorioamnionitis (a bacterial infection that causes inflammation of the membranes surrounding the baby in the womb). Although these results are based on very low-quality evidence from one small trial (involving 35 women) judged to be at a high risk of bias. Overall, our question remains unanswered - we do not have enough data to fully evaluate sealing procedures for PPROM. This review demonstrates the lack of research in this area regarding the effectiveness and safety of potential treatments for PPROM. We recommend that more research is needed to look at the different techniques for sealing broken waters and that this research should focus on the effectiveness of the treatment in improving overall outcomes. The safety of the treatments to both mother and baby must be further evaluated before sealing techniques can be recommended to prevent adverse outcomes."
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cochrane-simplification-train-1818 | cochrane-simplification-train-1818 | We included two RCTs (with a total of 789 participants) comparing LMWH with 5-FU infusion and placebo. However, we did not perform a meta-analysis because of significant heterogeneity between these studies. One study found a significant beneficial effect of LMWH with 5-FU in reducing postoperative PVR compared to placebo (RR: 0.48, 95% confidence interval: 0.25 to 0.92), in 174 patients who were viewed at high-risk of developing postoperative PVR. The other study included 615 unselected cases of rhegmatogenous retinal detachment and could not show a difference between LMWH with 5-FU infusion and placebo in reducing PVR rates (RR:1.45, 95% confidence interval: 0.76 to 2.76). Results from this review indicate that there is inconsistent evidence from two studies on patients at different risk of PVR on the effect of LMWH and 5-FU used during vitrectomy to prevent PVR. Future research should be conducted on high risk patients only, until a benefit is confirmed at least in this patient subgroup. | The two studies included in this review looked at using LMWH with 5-FU during retinal detachment repair to see if there was an effect of reducing PVR levels after surgery. One study focused on patients who are considered at high-risk of developing PVR after surgery because of pre-existing ocular features, and found beneficial effects of this treatment in this group. The other study looked at a wider group of patients and did not find a benefit in using this combination treatment, and in certain patients the treatment was associated with poorer vision. Due to the inconsistency of the evidence, until further data are available, future research on the use of LMWH with 5-FU should be conducted only in retinal detachment patients who are likely to develop considerable retinal scarring after surgery. | 10.1002/14651858.CD006421.pub3 | [
"The two studies included in this review looked at using LMWH with 5-FU during retinal detachment repair to see if there was an effect of reducing PVR levels after surgery. One study focused on patients who are considered at high-risk of developing PVR after surgery because of pre-existing ocular features, and found beneficial effects of this treatment in this group. The other study looked at a wider group of patients and did not find a benefit in using this combination treatment, and in certain patients the treatment was associated with poorer vision. Due to the inconsistency of the evidence, until further data are available, future research on the use of LMWH with 5-FU should be conducted only in retinal detachment patients who are likely to develop considerable retinal scarring after surgery."
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cochrane-simplification-train-1819 | cochrane-simplification-train-1819 | In this updated analysis, we included nine trials (N = 1070 infants) comparing prophylactic ibuprofen (IV or oral) with placebo/no intervention or indomethacin. Ibuprofen (IV or oral) probably decreases the risk of PDA on day 3 or 4 (typical RR 0.39, 95% CI 0.31 to 0.48; typical RD -0.26, 95% CI -0.31 to -0.21; NNTB 4, 95% CI 3 to 5; 9 trials; N = 1029) (moderate-quality evidence). In the control group, the spontaneous closure rate was 58% by day 3 to 4 of age. In addition, ibuprofen probably decreases the need for rescue treatment with cyclo-oxygenase inhibitors (typical RR 0.17, 95% CI 0.11 to 0.26; typical RD -0.27, 95% CI -0.32 to -0.22; NNTB 4; 95% CI 3 to 5),and the need for surgical ductal ligation (typical RR 0.46, 95% CI 0.22 to 0.96; typical RD -0.03, 95% CI -0.05 to -0.00; NNTB 33, 95% CI 20 to infinity; 7 trials; N = 925) (moderate-quality evidence). There was a possible decrease in the risk of grade 3 or 4 intraventricular haemorrhage (IVH) in infants receiving prophylactic ibuprofen (typical RR 0.67, 95% CI 0.45 to 1.00; I² = 34%; typical RD -0.04, 95% CI -0.08 to- 0.00; I² = 60%; 7 trials; N = 925) (moderate-quality evidence). High quality evidence showed increased risk for oliguria (typical RR 1.45, 95% CI 1.04 to 2.02; typical RD 0.06, 95% CI 0.01 to 0.11; NNTH 17, 95% CI 9 to 100; 4 trials; N = 747). Low quality results from four studies (N = 202) showed that administering oral ibuprofen may decrease the risk of PDA (typical RR 0.47, 95% CI 0.30 to 0.74) and may increase risk of gastrointestinal bleeding (NNTH 7, 95% CI 4 to 25). No evidence of a difference was identified for mortality, any intraventricular haemorrhage (IVH), or chronic lung disease. This review shows that prophylactic use of ibuprofen, compared to placebo or no intervention, probably decreases the incidence of patent ductus arteriosus, the need for rescue treatment with cyclo-oxygenase inhibitors, and for surgical ductal closure. Adverse effects associated with ibuprofen (IV or oral) included increased risks for oliguria, increase in serum creatinine levels, and increased risk of gastrointestinal haemorrhage. There was a reduced risk for intraventricular haemorrhage (grade III - IV) but no evidence of a difference in mortality, chronic lung disease, necrotising enterocolitis, or time to reach full feeds. In the control group, the patent ductus arteriosus had closed spontaneously by day 3 or 4 in 58% of neonates. Prophylactic treatment exposes a large proportion of infants unnecessarily to a drug that has important side effects without conferring any important short-term benefits. Current evidence does not support the use of ibuprofen for prevention of patent ductus arteriosus. Until long-term follow-up results of the trials included in this review have been published, no further trials of prophylactic ibuprofen are recommended. A new approach to patent ductus arteriosus management is an early targeted treatment based on echocardiographic criteria within the first 72 hours of life, that have a high sensitivity for diagnosing a patent ductus arteriosus that is unlikely to close spontaneously. Such trials are currently ongoing in many parts of the world. Results of such trials will be included in updates of our "Ibuprofen for treatment of PDA" review. | More than 1000 infants have been enrolled in trials of ibuprofen for prevention of a PDA; most studies were of small sample size. Prophylactic use of ibuprofen reduces the incidence of patent ductus arteriosus (PDA), the need for rescue treatment with other medications, or the need for surgical closure. Adverse effects in the ibuprofen group compared to the placebo or no interventions group included significantly increased risk of kidney complications. Risk of digestive tract bleeding was increased with ibuprofen. Risk of intraventricular haemorrhage, or bleeding into the brain (grade II to IV), of borderline significance was reduced, but researchers reported no statistically significant differences in mortality, chronic lung disease at 28 days' or 36 weeks' postmenstrual age, necrotising enterocolitis, or time to reach full feeds. In the control group, the PDA had closed spontaneously by day 3 or 4 in 58% of neonates. Preventative treatment therefore exposes a large proportion of infants unnecessarily to a drug that has important side effects without conferring any important short-term benefit for outcomes. No long-term follow-up studies have been published. Current evidence does not support the use of ibuprofen for prevention of PDA. A new approach for management of PDA is an early targeted treatment based on echocardiographic (ECG), or image of the heart, criteria within the first 72 hours of life; this has high sensitivity for diagnosing a PDA that is unlikely to close spontaneously. Such trials are currently ongoing in many parts of the world. This updated review of trials found that ibuprofen can prevent PDA but does not confer any other short-term or long-term benefits. The quality of evidence varied from low to high for different outcomes. | 10.1002/14651858.CD004213.pub5 | [
"More than 1000 infants have been enrolled in trials of ibuprofen for prevention of a PDA; most studies were of small sample size. Prophylactic use of ibuprofen reduces the incidence of patent ductus arteriosus (PDA), the need for rescue treatment with other medications, or the need for surgical closure. Adverse effects in the ibuprofen group compared to the placebo or no interventions group included significantly increased risk of kidney complications. Risk of digestive tract bleeding was increased with ibuprofen. Risk of intraventricular haemorrhage, or bleeding into the brain (grade II to IV), of borderline significance was reduced, but researchers reported no statistically significant differences in mortality, chronic lung disease at 28 days' or 36 weeks' postmenstrual age, necrotising enterocolitis, or time to reach full feeds. In the control group, the PDA had closed spontaneously by day 3 or 4 in 58% of neonates. Preventative treatment therefore exposes a large proportion of infants unnecessarily to a drug that has important side effects without conferring any important short-term benefit for outcomes. No long-term follow-up studies have been published. Current evidence does not support the use of ibuprofen for prevention of PDA. A new approach for management of PDA is an early targeted treatment based on echocardiographic (ECG), or image of the heart, criteria within the first 72 hours of life; this has high sensitivity for diagnosing a PDA that is unlikely to close spontaneously. Such trials are currently ongoing in many parts of the world. This updated review of trials found that ibuprofen can prevent PDA but does not confer any other short-term or long-term benefits. The quality of evidence varied from low to high for different outcomes."
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cochrane-simplification-train-1820 | cochrane-simplification-train-1820 | We included eight small trials involving a total of 282 participants with chronic osteomyelitis. Data were available from 248 participants. Most participants were male with post-traumatic osteomyelitis, usually affecting the tibia and femur, where recorded. The antibiotic regimens, duration of treatment and follow-up varied between trials. All trials mentioned surgical debridement before starting on antibiotic therapy as part of treatment, but it was unclear in four trials whether all participants underwent surgical debridement. We found that study quality and reporting were often inadequate. In particular, we judged almost all trials to be at moderate to high risk of bias due to failure to conceal allocation and inadequate follow-up. Four trials compared oral versus parenteral route for administration of antibiotics. There was no statistically significant difference between the two groups in the remission at the end of treatment (70/80 versus 58/70; risk ratio (RR) 1.04, 95% confidence interval (CI) 0.92 to 1.18; four trials, 150 participants). There was no statistically significant difference between the two groups in the remission rate 12 or more months after treatment (49/64 versus 44/54; RR 0.94, 95% CI 0.78 to 1.13; three trials, 118 participants). There was also no significant difference between the two groups in the occurrence of mild adverse events (11/64 versus 8/54; RR 1.08, 95% CI 0.49 to 2.42; three trials, 118 participants) or moderate and severe adverse events (3/49 versus 4/42; RR 0.69, 95% CI 0.19 to 2.57; three trials, 91 participants). Superinfection occurred in participants of both groups (5/66 in the oral group versus 4/58 in the parenteral group; RR 1.08, 95% CI 0.33 to 3.60; three trials, 124 participants). Single trials with few participants found no statistical significant differences for remission or adverse events for the following four comparisons: oral only versus parenteral plus oral administration; parenteral plus oral versus parenteral only administration; two different parenteral antibiotic regimens; and two different oral antibiotic regimens. No trials compared different durations of antibiotic treatment for chronic osteomyelitis, or adjusted the remission rate for bacteria species or severity of disease. Limited and low quality evidence suggests that the route of antibiotic administration (oral versus parenteral) does not affect the rate of disease remission if the bacteria are susceptible to the antibiotic used. However, this and the lack of statistically significant differences in adverse effects need confirmation. No or insufficient evidence exists for other aspects of antibiotic therapy for chronic osteomyelitis. The majority of the included trials were conducted over 20 years ago and currently we are faced with a far higher prevalence of bacteria that are resistant to many of the available antibiotics used for healthcare. This continuously evolving bacterial resistance represents another challenge in the choice of antibiotics for treating chronic osteomyelitis. | We included eight small randomised trials involving 282 people. The trials presented results for a total of 248 people with chronic osteomyelitis. Post-traumatic bone infections were the most frequent type. Surgical removal of the infected tissue (debridement) before starting on antibiotic therapy was mentioned as part of treatment in all trials, but in four trials it was unclear whether all participants underwent surgery. There were five comparisons of different treatments but we could only pool results for the comparison of antibiotic given by mouth with antibiotic given parenterally. The pooled results (which included data from 150 people) did not show any difference between people given antibiotics by mouth or parenterally in terms of the number of people who did not have symptoms (in 'remission') at the end of treatment (four trials) or 12 months later (or more) (three trials); nor in the number of people that had negative side effects or had a superinfection (another infection that is not sensitive to antibiotic treatment). This evidence suggests that the way antibiotics are given does not impact on the disease remission rate if the bacteria causing the infection are sensitive to the antibiotic used. However, confirmation is needed. There was either no or insufficient evidence on which to base judgements about the optimum length of antibiotic treatment or the best antibiotics to use. | 10.1002/14651858.CD004439.pub3 | [
"We included eight small randomised trials involving 282 people. The trials presented results for a total of 248 people with chronic osteomyelitis. Post-traumatic bone infections were the most frequent type. Surgical removal of the infected tissue (debridement) before starting on antibiotic therapy was mentioned as part of treatment in all trials, but in four trials it was unclear whether all participants underwent surgery. There were five comparisons of different treatments but we could only pool results for the comparison of antibiotic given by mouth with antibiotic given parenterally. The pooled results (which included data from 150 people) did not show any difference between people given antibiotics by mouth or parenterally in terms of the number of people who did not have symptoms (in 'remission') at the end of treatment (four trials) or 12 months later (or more) (three trials); nor in the number of people that had negative side effects or had a superinfection (another infection that is not sensitive to antibiotic treatment). This evidence suggests that the way antibiotics are given does not impact on the disease remission rate if the bacteria causing the infection are sensitive to the antibiotic used. However, confirmation is needed. There was either no or insufficient evidence on which to base judgements about the optimum length of antibiotic treatment or the best antibiotics to use."
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cochrane-simplification-train-1821 | cochrane-simplification-train-1821 | Seven studies (581 participants) met our inclusion criteria. Trials had an intervention length of 6 weeks to 12 months and follow-up length of 6 to 12 months. The comparison group in all trials was usual care (without any form of structured exercise training or advice) or a no-exercise comparator. The mean age of participants within the trials ranged from 50 to 66 years, the majority of participants being male (range: 74% to 100%). In terms of risk of bias, the majority of studies were unclear about their generation of the randomisation sequence and concealment processes. One study was at high risk of detection bias as it did not blind its participants or outcome assessors, and two studies had a high risk of attrition bias due to the numbers of participants lost to follow-up. Two trials were at high risk of outcome reporting bias. Given the high risk of bias, small number of trials and participants, and concerns about applicability, we downgraded our assessments of the quality of the evidence using the GRADE tool. Due to the very low-quality of the evidence base, we are uncertain about the effect of exercise-based CR on all-cause mortality (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.18 to 5.67; 195 participants; 3 studies; very low-quality evidence), acute myocardial infarction (RR 0.33, 95% CI 0.07 to 1.63; 254 participants; 3 studies; very low-quality evidence) and cardiovascular-related hospital admissions (RR 0.14, 95% CI 0.02 to 1.1; 101 participants; 1 study; very low-quality evidence). We found low-quality evidence that exercise-based CR may result in a small improvement in exercise capacity compared to control (standardised mean difference (SMD) 0.45, 95% CI 0.20 to 0.70; 267 participants; 5 studies, low-quality evidence). We were unable to draw conclusions about the impact of exercise-based CR on quality of life (angina frequency and emotional health-related quality-of-life score) and CR-related adverse events (e.g. skeletomuscular injury, cardiac arrhythmia), due to the very low quality of evidence. No data were reported on return to work. Due to the small number of trials and their small size, potential risk of bias and concerns about imprecision and lack of applicability, we are uncertain of the effects of exercise-based CR compared to control on mortality, morbidity, cardiovascular hospital admissions, adverse events, return to work and health-related quality of life in people with stable angina. Low-quality evidence indicates that exercise-based CR may result in a small increase in exercise capacity compared to usual care. High-quality, well-reported randomised trials are needed to assess the benefits and harms of exercise-based CR for adults with stable angina. Such trials need to collect patient-relevant outcomes, including clinical events and health-related quality of life. They should also assess cost-effectiveness, and recruit participants that are reflective of the real-world population of people with angina. | The evidence is current to 2 October 2017. We included seven studies that randomly allocated a total of 581 participants with stable angina to either receive cardiac rehabilitation or no exercise control. We identified that there are no ongoing randomised studies. The average age of participants ranged from 50 to 66 years. The majority of people recruited were middle-aged men. Most studies were carried out in European countries and one study in India. Cardiac rehabilitation was most commonly delivered in a combined setting of home and centre or hospital. The length of the cardiac rehabilitation programmes ranged from six weeks to one year. There is insufficient evidence to assess the impact of exercise-based cardiac rehabilitation on the outcomes that matter most to patients: risks of death, heart attack, or future cardiac operation and quality of life. There may be a small improvement in physical fitness following exercise-based cardiac rehabilitation compared to usual treatment. There was no evidence about returning to work. Due to the poor reporting, high risk of bias and small number of trials and participants included in this review, our assessment of the quality of the evidence ranged from low to very low across outcomes. For low-quality evidence our confidence in the result is limited, and for very low-quality evidence we have very little confidence in the result. We need more high-quality studies in more representative populations of people with stable angina. These studies should collect outcomes of relevance to patients and healthcare decision-makers. Then we will be able to better assess the impact of exercise-based cardiac rehabilitation. | 10.1002/14651858.CD012786.pub2 | [
"The evidence is current to 2 October 2017. We included seven studies that randomly allocated a total of 581 participants with stable angina to either receive cardiac rehabilitation or no exercise control. We identified that there are no ongoing randomised studies. The average age of participants ranged from 50 to 66 years. The majority of people recruited were middle-aged men. Most studies were carried out in European countries and one study in India. Cardiac rehabilitation was most commonly delivered in a combined setting of home and centre or hospital. The length of the cardiac rehabilitation programmes ranged from six weeks to one year. There is insufficient evidence to assess the impact of exercise-based cardiac rehabilitation on the outcomes that matter most to patients: risks of death, heart attack, or future cardiac operation and quality of life. There may be a small improvement in physical fitness following exercise-based cardiac rehabilitation compared to usual treatment. There was no evidence about returning to work. Due to the poor reporting, high risk of bias and small number of trials and participants included in this review, our assessment of the quality of the evidence ranged from low to very low across outcomes. For low-quality evidence our confidence in the result is limited, and for very low-quality evidence we have very little confidence in the result. We need more high-quality studies in more representative populations of people with stable angina. These studies should collect outcomes of relevance to patients and healthcare decision-makers. Then we will be able to better assess the impact of exercise-based cardiac rehabilitation."
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cochrane-simplification-train-1822 | cochrane-simplification-train-1822 | We identified one new study with 100 participants for the pooled analysis. We identified two additional reports of a study using an enriched enrolment randomised withdrawal (EERW) design that included participants from earlier randomised controlled trials and an open-label study. Because this study used the same participants already included in our main analysis, and a different design, we dealt with it separately. The main analysis included six studies (five from the earlier review; 4238 participants in total), all of which were placebo-controlled, and used titration to a target dose of milnacipran 100 or 200 mg, with assessment after 8 to 24 weeks of stable treatment. There were no studies with active comparators. Study quality was generally good, although the imputation method used in analyses of the primary outcomes could overestimate treatment effect. Both doses of milnacipran provided moderate levels of pain relief (at least 30% pain intensity reduction) to about 40% of participants treated, compared to 30% with placebo, giving a number needed to treat for an additional beneficial outcome (NNT) of 6 to 10 (high quality evidence). Using a stricter definition for responder and a more conservative method of analysis gave lower levels of response (while maintaining a 10% difference between milnacipran and placebo) and increased the NNT to 11 (high quality evidence). One EERW study was broadly supportive. Adverse events were common in both milnacipran (86%) and placebo (78%) groups (high quality evidence), but serious adverse events did not differ between groups (less than 2%) (low quality evidence). Nausea, constipation, and headache were the most common events showing the greatest difference between groups (number needed to treat for an additional harmful outcome (NNH) of 5.7 for nausea, 13 for constipation, and 29 for headache) (moderate quality evidence). Withdrawals for any reason were more common with milnacipran than placebo, and more common with 200 mg (NNH 9) than 100 mg (NNH 23), compared with placebo. This was largely driven by adverse event withdrawals, where the NNH compared with placebo was 14 for 100 mg and 7.0 for 200 mg (high quality evidence). Withdrawals due to lack of efficacy were less common with milnacipran than placebo but did not differ between doses (number needed to treat to prevent an additional unwanted outcome (NNTp) of 41) (moderate quality evidence). The evidence available indicates that milnacipran 100 mg or 200 mg is effective for a minority in the treatment of pain due to fibromyalgia, providing moderate levels of pain relief (at least 30%) to about 40% of participants, compared with about 30% with placebo. There were insufficient data to assess substantial levels of pain relief (at least 50%), and the use of last observation carried forward imputation may overestimate drug efficacy. Using stricter criteria for 'responder' and a more conservative method of analysis gave lower response rates (about 26% with milnacipran versus 17% with placebo). Milnacipran was associated with increased adverse events and adverse event withdrawals, which were significantly greater for the higher dose. | We searched scientific databases for studies that looked at the effects of milnacipran in adults with fibromyalgia who had moderate or severe pain. The treatment had to last at least eight weeks. The evidence is current to May 2015. We identified six studies that satisfied the inclusion criteria, including one new study for this update. Over 4000 participants were treated with milnacipran 100 or 200 mg, or placebo, for 8 to 24 weeks at the target dose. Overall study quality was good, although the method of analysis for our primary outcomes of pain relief could overestimate treatment effect. Milnacipran at either dose provided moderate pain relief (at least 30% reduction in pain intensity) to 1 in 10 (10%) more people than did placebo (high quality evidence). This relatively modest effect may be clinically important in this difficult-to-treat condition. Adverse events were reported by most participants in all treatment groups, but were more common with milnacipran than placebo (high quality evidence), with nausea (feeling sick) and constipation showing the greatest differences (moderate quality evidence). Serious adverse events were uncommon, fewer than 1 in 50 (2%) participants, and did not differ between treatment groups (low quality evidence). The numbers of participants dropping out of the studies (withdrawals) because of adverse events were also more common with milnacipran than placebo, and were more common with 200 mg than 100 mg (high quality evidence), while withdrawals due to lack of effect were less common with milnacipran, with no difference between doses (moderate quality evidence). Milnacipran gives good pain relief to some people with fibromyalgia, but only a minority; it will not work for most people. | 10.1002/14651858.CD008244.pub3 | [
"We searched scientific databases for studies that looked at the effects of milnacipran in adults with fibromyalgia who had moderate or severe pain. The treatment had to last at least eight weeks. The evidence is current to May 2015. We identified six studies that satisfied the inclusion criteria, including one new study for this update. Over 4000 participants were treated with milnacipran 100 or 200 mg, or placebo, for 8 to 24 weeks at the target dose. Overall study quality was good, although the method of analysis for our primary outcomes of pain relief could overestimate treatment effect. Milnacipran at either dose provided moderate pain relief (at least 30% reduction in pain intensity) to 1 in 10 (10%) more people than did placebo (high quality evidence). This relatively modest effect may be clinically important in this difficult-to-treat condition. Adverse events were reported by most participants in all treatment groups, but were more common with milnacipran than placebo (high quality evidence), with nausea (feeling sick) and constipation showing the greatest differences (moderate quality evidence). Serious adverse events were uncommon, fewer than 1 in 50 (2%) participants, and did not differ between treatment groups (low quality evidence). The numbers of participants dropping out of the studies (withdrawals) because of adverse events were also more common with milnacipran than placebo, and were more common with 200 mg than 100 mg (high quality evidence), while withdrawals due to lack of effect were less common with milnacipran, with no difference between doses (moderate quality evidence). Milnacipran gives good pain relief to some people with fibromyalgia, but only a minority; it will not work for most people."
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cochrane-simplification-train-1823 | cochrane-simplification-train-1823 | We included eleven randomised clinical trials with 1664 participants who were mostly at low anaesthetic risk, low frequency of co-morbidities, low risk of conversion to open surgery, and low risk of infectious complications. None of the trials had low risk of bias. We found no statistically significant differences between antibiotic prophylaxis and no prophylaxis in the proportion of surgical site infections (odds ratio (OR) 0.87, 95% CI 0.49 to 1.54) or extra-abdominal infections (OR 0.77, 95% CI 0.41 to 1.46). Heterogeneity was not statistically significant. This systematic review shows that there is not sufficient evidence to support or refute the use of antibiotic prophylaxis to reduce surgical site infection and global infections in patients with low risk of anaesthetic complications, co-morbidities, conversion to open surgery, and infectious complications, and undergoing elective laparoscopic cholecystectomy. Larger randomised clinical trials with intention-to-treat analysis and patients also at high risk of conversion to open surgery are needed. | This meta-analysis of eleven randomised clinical trials could not find sufficient evidence to support or refute the use of antibiotic prophylaxis to reduce surgical site infection or global infections in patients with low anaesthetic risk, low co-morbidities, and low-risk of conversion to open surgery, and undergoing elective laparoscopic cholecystectomy. This is why large and well-designed randomised trials including patients with high-risk of conversion to open surgery should be conducted in order to define the beneficial or harmful effects of the antibiotics when given as a prophylaxis. | 10.1002/14651858.CD005265.pub2 | [
"This meta-analysis of eleven randomised clinical trials could not find sufficient evidence to support or refute the use of antibiotic prophylaxis to reduce surgical site infection or global infections in patients with low anaesthetic risk, low co-morbidities, and low-risk of conversion to open surgery, and undergoing elective laparoscopic cholecystectomy. This is why large and well-designed randomised trials including patients with high-risk of conversion to open surgery should be conducted in order to define the beneficial or harmful effects of the antibiotics when given as a prophylaxis."
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cochrane-simplification-train-1824 | cochrane-simplification-train-1824 | Two completed and one ongoing clinical trial met the inclusion criteria. One trial (34 patients randomised) examined the effects of H pylori eradication on levodopa absorption and motor symptoms and found significant improvements in both. The ongoing trial has similar objectives and aims to recruit 100 patients. The other completed trial (20 patients analysed) sought to find a causal link between infection with H pylori and Parkinsonism and was non-contributory. A worsening of symptoms was noted with eradication failure. The prevalence of H pylori in Parkinson's disease was reported in four studies and ranged from 37% to 59% which is similar to that of the general population. There is currently a lack of evidence on the effects of screening and treating H pylori in patients with Parkinson's disease. There is limited evidence to suggest that H Pylori eradication improves the absorption of levodopa and improves motor symptoms. Results from an ongoing trial will inform the evidence base and will be incorporated in an update of this review. There is a need for well-conducted randomised controlled trials with standard outcome measures for motor symptoms and incorporating the costs of screening and treatment. | We used clinical trials to see if treatment of H pylori-positive Parkinson's disease patients with antibiotics improved the absorption of levodopa and improved their motor symptoms. Only two completed trials were found from our searching. We did not pool these as they had different objectives and used different outcome measures. One of the trials reported a significant increase in levodopa absorption and improvement in motor symptoms when antibiotics were used to eradicate H pylori. The other completed trial did not have any usable results. A further trial of H pylori eradication in Parkinson's disease is still underway and the results, which are due in 2010, will help inform further studies. Very little information was found about H pylori eradication in Parkinson's disease. More clinical trials are needed using standard measures of motor symptoms. It will be important also to look at the cost of both screening for H pylori and treatment of H pylori in Parkinson's disease patients to see if this is worthwhile. | 10.1002/14651858.CD008453.pub2 | [
"We used clinical trials to see if treatment of H pylori-positive Parkinson's disease patients with antibiotics improved the absorption of levodopa and improved their motor symptoms. Only two completed trials were found from our searching. We did not pool these as they had different objectives and used different outcome measures. One of the trials reported a significant increase in levodopa absorption and improvement in motor symptoms when antibiotics were used to eradicate H pylori. The other completed trial did not have any usable results. A further trial of H pylori eradication in Parkinson's disease is still underway and the results, which are due in 2010, will help inform further studies. Very little information was found about H pylori eradication in Parkinson's disease. More clinical trials are needed using standard measures of motor symptoms. It will be important also to look at the cost of both screening for H pylori and treatment of H pylori in Parkinson's disease patients to see if this is worthwhile."
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cochrane-simplification-train-1825 | cochrane-simplification-train-1825 | We included 13 trials in this review. Eight studies reported data on the Bayley Scales of Infant Development (BSID) in 2134 participants. We combined the data in a meta-analysis to assess the effect on development as measured by the Mental Development Index (MDI) and Psychomotor Development Index (PDI). There was no significant effect of zinc supplementation: the mean difference between the zinc supplementation and placebo groups on the MDI was -0.50 (95% confidence interval (CI) -2.06 to 1.06; P = 0.53; I2 = 70%) and the mean difference between the groups for the PDI was 1.54 (95% CI -2.26 to 5.34; P = 0.43; I2 = 93%). Most studies had low or unclear risk of bias but there was significant heterogeneity, which was not adequately explained by our subgroup analyses. The overall quality of evidence was considered 'moderate'. Two trials provided data on motor milestone attainment. There was no significant difference in the time to attainment of milestones between the placebo group and the zinc supplementation group in either of the studies. No study provided data on cognition score or intelligence quotient (IQ) or on adverse effects of zinc supplementation. There is no convincing evidence that zinc supplementation to infants or children results in improved motor or mental development. | The review authors searched the medical literature for studies that evaluated mental and motor development in infants and children randomly assigned to receive either zinc supplements or a 'placebo' (fake) supplement. We found 13 relevant studies. Eight studies measured development using the Mental Development Index and the Psychomotor Development Index of the Bayley Scales of Infant Development. We found no difference between the results for those who had taken zinc supplements and those who had taken a placebo. Two studies measured children's attainment of motor milestones. Again, no difference as found whether zinc supplements were taken or not. No study measured possible side effects of zinc supplementation such as vomiting, diarrhea or anemia. Overall, the results of the studies provided no convincing evidence that zinc supplements had any beneficial effect on mental and motor development in infants and children. | 10.1002/14651858.CD007991.pub2 | [
"The review authors searched the medical literature for studies that evaluated mental and motor development in infants and children randomly assigned to receive either zinc supplements or a 'placebo' (fake) supplement. We found 13 relevant studies. Eight studies measured development using the Mental Development Index and the Psychomotor Development Index of the Bayley Scales of Infant Development. We found no difference between the results for those who had taken zinc supplements and those who had taken a placebo. Two studies measured children's attainment of motor milestones. Again, no difference as found whether zinc supplements were taken or not. No study measured possible side effects of zinc supplementation such as vomiting, diarrhea or anemia. Overall, the results of the studies provided no convincing evidence that zinc supplements had any beneficial effect on mental and motor development in infants and children."
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cochrane-simplification-train-1826 | cochrane-simplification-train-1826 | This review update added three new studies including 419 participants to the review. In total, we identified eight RCTs, most of which were at low risk of bias, involving 1669 participants with mild to moderate asthma. We included three paediatric (n = 422) and five adult (n = 1247) studies; six were parallel-group trials and two had a cross-over design. All but one study followed participants for six months to one year. Allowed maintenance doses of ICS varied in adult and paediatric studies, as did use of concomitant medications and doses of ICS initiated during exacerbations. Investigators gave participants a study inhaler containing additional ICS or placebo to be started as part of an action plan for treatment of exacerbations. The odds of treatment failure, defined as the need for oral corticosteroids, were not significantly reduced among those randomised to increased ICS compared with those taking their usual stable maintenance dose (odds ratio (OR) 0.89, 95% confidence interval (CI) 0.68 to 1.18; participants = 1520; studies = 7). When we analysed only people who actually took their study inhaler for an exacerbation, we found much variation between study results but the evidence did not show a significant benefit of increasing ICS dose (OR 0.84, 95% CI 0.54 to 1.30; participants = 766; studies = 7). The odds of having an unscheduled physician visit (OR 0.96, 95% CI 0.66 to 1.41; participants = 931; studies = 3) or acute visit (Peto OR 0.98, 95% CI 0.24 to 3.98; participants = 450; studies = 3) were not significantly reduced by an increased versus stable dose of ICS, and evidence was insufficient to permit assessment of impact on the duration of exacerbation; our ability to draw conclusions from these outcomes was limited by the number of studies reporting these events and by the number of events included in the analyses. The odds of serious events (OR 1.69, 95% CI 0.77 to 3.71; participants = 394; studies = 2) and non-serious events, such as oral irritation, headaches and changes in appetite (OR 2.15, 95% CI 0.68 to 6.73; participants = 142; studies = 2), were neither increased nor decreased significantly by increased versus stable doses of ICS during an exacerbation. Too few studies are available to allow firm conclusions on the basis of subgroup analyses conducted to investigate the impact of age, time to treatment initiation, doses used, smoking history and the fold increase of ICS on the magnitude of effect; yet, effect size appears similar in children and adults. Current evidence does not support increasing the dose of ICS as part of a self initiated action plan to treat exacerbations in adults and children with mild to moderate asthma. Increased ICS dose is not associated with a statistically significant reduction in the odds of requiring rescue oral corticosteroids for the exacerbation, or of having adverse events, compared with a stable ICS dose. Wide confidence intervals for several outcomes mean we cannot rule out possible benefits of this approach. | This review update added three new studies including 419 participants to the review. We performed the most recent searches in March 2016. In total, we found eight studies involving 1669 people with mild or moderate asthma. Three were conducted in children, and five in adults. These studies provided participants with an inhaler that contained extra doses of ICS (to increase their usual ICS dose) or a placebo that could be used if their symptoms worsened. Participants were then followed for six months to one year to see whether people taking more inhaled corticosteroids during attacks did better than those who took a placebo. People taking an increased dose of ICS during an attack did not do better than those who took a placebo, regardless of whether we looked at all study participants or only those who actually took the inhalers during an attack. Results showed a lot of variation in studies that focused only on people who took the inhalers, with some studies showing benefit of increasing ICS dose and others showing no benefit. It is unlikely that increasing ICS dose reduces the need for a course of oral steroids to treat the attack, prevents the need for an emergency visit with doctors or at the hospital or reduces the time it takes to recover. We cannot be sure of these last results because few studies reported them. Use of either strategy was not associated with significantly more or less serious and non-serious side effects, but again we cannot say for sure because we did not find enough studies. We have rated results of this review as having moderate or low quality, depending on the outcome. This means that some of the findings were very uncertain, mainly because the studies included very few people who could say definitively whether increasing the dose was better or worse than, or no different from, keeping the dose stable. | 10.1002/14651858.CD007524.pub4 | [
"This review update added three new studies including 419 participants to the review. We performed the most recent searches in March 2016. In total, we found eight studies involving 1669 people with mild or moderate asthma. Three were conducted in children, and five in adults. These studies provided participants with an inhaler that contained extra doses of ICS (to increase their usual ICS dose) or a placebo that could be used if their symptoms worsened. Participants were then followed for six months to one year to see whether people taking more inhaled corticosteroids during attacks did better than those who took a placebo. People taking an increased dose of ICS during an attack did not do better than those who took a placebo, regardless of whether we looked at all study participants or only those who actually took the inhalers during an attack. Results showed a lot of variation in studies that focused only on people who took the inhalers, with some studies showing benefit of increasing ICS dose and others showing no benefit. It is unlikely that increasing ICS dose reduces the need for a course of oral steroids to treat the attack, prevents the need for an emergency visit with doctors or at the hospital or reduces the time it takes to recover. We cannot be sure of these last results because few studies reported them. Use of either strategy was not associated with significantly more or less serious and non-serious side effects, but again we cannot say for sure because we did not find enough studies. We have rated results of this review as having moderate or low quality, depending on the outcome. This means that some of the findings were very uncertain, mainly because the studies included very few people who could say definitively whether increasing the dose was better or worse than, or no different from, keeping the dose stable."
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cochrane-simplification-train-1827 | cochrane-simplification-train-1827 | We included six RCTs with a total of 248 participants; none of the trials were determined to have overall low risk of bias. We found 12 ongoing trials, from which we were unable to retrieve any data. Only two trials provided data on mortality, and one was a zero event study; thus the meta-analysis showed no statistically significant effect on overall mortality (2.6% vs 9.5%, RR 0.28, 95% CI 0.03 to 2.33). Our analyses on blood transfusion data suggest a beneficial effect of fibrinogen concentrate in reducing the incidence of allogenic transfusions (RR 0.47, 95% CI 0.31 to 0.72) but show no effect on other predefined outcomes, including adverse events such as thrombotic episodes. In the six available RCTs of elective surgery, fibrinogen concentrate appears to reduce transfusion requirements, but the included trials are of low quality with high risk of bias and are underpowered to detect mortality, benefit or harm. Furthermore, data on mortality are lacking, heterogeneity is high and acute or severe bleeding in a non-elective surgical setting remains unexplored. Currently, weak evidence supports the use of fibrinogen concentrate in bleeding patients, as tested here in primarily elective cardiac surgery. More research is urgently needed. | In the present Cochrane systematic review, we set out to assess the benefits and harms of fibrinogen concentrate in patients with bleeding. We searched the databases to August 2013, we identified six randomized trials in cardiac and elective surgical settings that compared fibrinogen concentrate (248 participants) with placebo/other sources or no treatment. Additionally, we found 12 ongoing trials, but we were unable to retrieve any data from them. We could not identify beneficial effects of fibrinogen concentrate on patient survival. In our predefined outcomes, we identified a reduced proportion of patients requiring donor blood transfusion. We could not identify reduced blood loss or any harms or adverse events caused by treatment with fibrinogen concentrate. However, all trials were of low quality and were small, so evidence in support of fibrinogen concentrate in patients with bleeding remains weak. | 10.1002/14651858.CD008864.pub2 | [
"In the present Cochrane systematic review, we set out to assess the benefits and harms of fibrinogen concentrate in patients with bleeding. We searched the databases to August 2013, we identified six randomized trials in cardiac and elective surgical settings that compared fibrinogen concentrate (248 participants) with placebo/other sources or no treatment. Additionally, we found 12 ongoing trials, but we were unable to retrieve any data from them. We could not identify beneficial effects of fibrinogen concentrate on patient survival. In our predefined outcomes, we identified a reduced proportion of patients requiring donor blood transfusion. We could not identify reduced blood loss or any harms or adverse events caused by treatment with fibrinogen concentrate. However, all trials were of low quality and were small, so evidence in support of fibrinogen concentrate in patients with bleeding remains weak."
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cochrane-simplification-train-1828 | cochrane-simplification-train-1828 | Four trials involving 91 infants were included. No difference was detected between intravenous doxapram or methylxanthine in the incidence of failed treatment within 48 hours [typical relative risk 0.91, 95% confidence interval (95% CI) 0.45, 1.85] . Only one trial reported results at 7 days and there was no difference in results. No infants were reported to have been given mechanical ventilation on either treatment. No adverse effects were reported. Intravenous doxapram and intravenous methylxanthine appear to be similar in their short term effects for treating apnea in preterm infants, although these trials are too small to exclude an important difference between the two treatments or to exclude the possibility of less common adverse effects. Long term outcome of infants treated in these trials has not been reported. Further studies would require a large number of infants to clarify whether there might be differences in responses or adverse effects with these two drugs at different ages. | The review of four small trials found that there was no large difference between the drugs in the short term. There is not enough evidence to exclude a small difference in benefit, long term effects or a difference in less common adverse effects. More research is needed into the long term and adverse effects of these drugs. | 10.1002/14651858.CD000075 | [
"The review of four small trials found that there was no large difference between the drugs in the short term. There is not enough evidence to exclude a small difference in benefit, long term effects or a difference in less common adverse effects. More research is needed into the long term and adverse effects of these drugs."
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cochrane-simplification-train-1829 | cochrane-simplification-train-1829 | Nineteen studies enrolling approximately 5000 preterm and/or LBW infants met inclusion criteria. No new trials were identified in May 2013. When all studies were combined, a significant reduction in sepsis was noted (typical risk ratio (RR) 0.85, 95% confidence interval (CI) 0.74 to 0.98; typical risk difference (RD) -0.03, 95% CI 0.00 to -0.05; number needed to treat for an additional beneficial outcome (NNTB) 33, 95% CI 20 to infinity), and moderate between-study heterogeneity was reported (I2 54% for RR, 55% for RD). A significant reduction of one or more episodes was found for any serious infection when all studies were combined (typical RR 0.82, 95% CI 0.74 to 0.92; typical RD -0.04, 95% CI -0.02 to -0.06; NNTB 25, 95% CI 17 to 50), and moderate between-study heterogeneity was observed (I2 50% for RR, 62% for RD). No statistically significant differences in mortality from all causes were noted (typical RR 0.89, 95% CI 0.75 to 1.05; typical RD -0.01, 95% CI -0.03 to 0.01), and no heterogeneity for RR (I2 = 21%) or low heterogeneity for RD was documented (I2 = 28%). No statistically significant difference was seen in mortality from infection; in incidence of necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) or intraventricular haemorrhage (IVH) or in length of hospital stay. No major adverse effects of IVIG were reported in any of these studies. IVIG administration results in a 3% reduction in sepsis and a 4% reduction in one or more episodes of any serious infection but is not associated with reductions in other clinically important outcomes, including mortality. Prophylactic use of IVIG is not associated with any short-term serious side effects. The decision to use prophylactic IVIG will depend on the costs and the values assigned to the clinical outcomes. There is no justification for conducting additional RCTs to test the efficacy of previously studied IVIG preparations in reducing nosocomial infections in preterm and/or LBW infants. | To date, approximately 5000 infants have been enrolled in studies conducted to evaluate the effects of prophylactic use of intravenous immunoglobulin on neonatal outcomes. Intravenous administration of immunoglobulin results in a 3% reduction in blood-borne infection and a 4% reduction in serious infection. Intravenous administration of immunoglobulin is not associated with reductions in other important neonatal outcomes or in length of hospital stay. Most important, intravenous immunoglobulin administration does not have any important effect on mortality. Prophylactic use of IVIG is not associated with any short-term serious side effects. From a clinical perspective, a 3% to 4% reduction in nosocomial infection without a reduction in mortality or other important clinical outcomes is of marginal importance. | 10.1002/14651858.CD000361.pub4 | [
"To date, approximately 5000 infants have been enrolled in studies conducted to evaluate the effects of prophylactic use of intravenous immunoglobulin on neonatal outcomes. Intravenous administration of immunoglobulin results in a 3% reduction in blood-borne infection and a 4% reduction in serious infection. Intravenous administration of immunoglobulin is not associated with reductions in other important neonatal outcomes or in length of hospital stay. Most important, intravenous immunoglobulin administration does not have any important effect on mortality. Prophylactic use of IVIG is not associated with any short-term serious side effects. From a clinical perspective, a 3% to 4% reduction in nosocomial infection without a reduction in mortality or other important clinical outcomes is of marginal importance."
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cochrane-simplification-train-1830 | cochrane-simplification-train-1830 | Eight studies are now included in this review. When any dose omega-3 (E-EPA or EPA) is compared with placebo, small short trials suggest that the need for neuroleptics appears to be reduced for people allocated omega-3 supplementation (n=30, 1 RCT, RR 0.73 CI 0.54 to 1.00) and mental state may improve (n=30, 1 RCT, RR not gaining 25% change in PANSS scores 0.54 CI 0.30 to 0.96, NNT 3 CI 2 to 29). There are no differences in the number of people leaving the study early (n=595, 6 RCTs, RR 0.86 CI 0.50 to 1.48). There are few data on the comparison of any dose omega-6 (GLA) with placebo. For movement disorder outcomes, the one small study we found does not show any difference for average short-term endpoint AIMS score (n=16, 1 RCT, WMD 1.30 CI -1.96 to 4.56). When any dose omega-3 (E-EPA or EPA) is compared with any dose omega-3 (DHA) there is no significant difference for mental state outcome of not gaining 25% change in PANSS scores (n=31, 1 RCT, RR 0.66 CI 0.39 to 1.11). When different doses of omega-3 (E-EPA) are compared with placebo there are no differences in measures of global and mental state between the studies. For the outcome of 'experiencing at least one adverse effect' no differences between groups are found for any dose (1 g/day E-EPA vs placebo n=63, 1 RCT, RR 0.97 CI 0.60 to 1.56; 2 g/day E-EPA vs placebo n=63, 1 RCT, RR 0.67 CI 0.37 to 1.20; 4 g/day E-EPA vs placebo n=58, 1 RCT, RR 1.15 CI 0.72 to 1.82). Three updates of this review have resulted in more included studies and more people randomised but still relatively little useful additional data. The results remain inconclusive. The new trials all compare the omega-3 polyunsaturated fatty acids, in particular eicosapentaenoic acid and its ester, ethyl-eicosapentaenoic acid. The use of omega-3 polyunsaturated fatty acids for schizophrenia still remains experimental and this review highlights the need for large, well designed, conducted and reported studies. | The majority of the trials compared two different types of omega 3 fatty acids, EPA (usually as E-EPA) and DHA with placebo, in people with schizophrenia who are stable on antipsychotic medication. Some of these trials show some improvement in general functioning and in mental state but not to a statistically significant degree. In the longest trial there was no difference between the two groups at the end of the study. One trial compared E-EPA with DHA and found a suggestion that E-EPA works better than DHA, but again it was not statistically significant. Where EPA was compared to placebo as a first line treatment for schizophrenia (30 people), those taking EPA had a better overall outcome and improvement in mental state. However, this was a short trial with few people. Finally, one trial compared a type of omega 6 with placebo in men who had the movement disorder tardive dykinesia (16 people). There was no improvement in the symptoms of movement adverse effects in either group at the end of six weeks. These trials were both small and short. In addition most of the data they reported were not able to be used, and half of the trials were funded by the group supplying the trial medication. Therefore it is still not clear whether taking manufactured omega 3 or 6 improves overall functioning or mental state in people with schizophrenia. (Plain language summary prepared for this review by Janey Antoniou of RETHINK, UK www.rethink.org) | 10.1002/14651858.CD001257.pub2 | [
"The majority of the trials compared two different types of omega 3 fatty acids, EPA (usually as E-EPA) and DHA with placebo, in people with schizophrenia who are stable on antipsychotic medication. Some of these trials show some improvement in general functioning and in mental state but not to a statistically significant degree. In the longest trial there was no difference between the two groups at the end of the study. One trial compared E-EPA with DHA and found a suggestion that E-EPA works better than DHA, but again it was not statistically significant. Where EPA was compared to placebo as a first line treatment for schizophrenia (30 people), those taking EPA had a better overall outcome and improvement in mental state. However, this was a short trial with few people. Finally, one trial compared a type of omega 6 with placebo in men who had the movement disorder tardive dykinesia (16 people). There was no improvement in the symptoms of movement adverse effects in either group at the end of six weeks. These trials were both small and short. In addition most of the data they reported were not able to be used, and half of the trials were funded by the group supplying the trial medication. Therefore it is still not clear whether taking manufactured omega 3 or 6 improves overall functioning or mental state in people with schizophrenia. (Plain language summary prepared for this review by Janey Antoniou of RETHINK, UK www.rethink.org)"
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cochrane-simplification-train-1831 | cochrane-simplification-train-1831 | We included 16 studies assessing a median of 54 RCTs (range: 2 to 362). Twelve studies compared protocols to published reports and four compared trial registry entries to published reports. In two studies, eligibility criteria differed between the protocol and publication in 19% and 100% RCTs. In one study, 16% (9/58) of the reports included the same sample size calculation as the protocol. In one study, 6% (4/63) of protocol-report pairs gave conflicting information regarding the method of allocation concealment, and 67% (49/73) of blinded studies reported discrepant information on who was blinded. In one study unacknowledged discrepancies were found for methods of handling protocol deviations (44%; 19/43), missing data (80%; 39/49), primary outcome analyses (60%; 25/42) and adjusted analyses (82%; 23/28). One study found that of 13 protocols specifying subgroup analyses, 12 of these 13 trials reported only some, or none, of these. Two studies found that statistically significant outcomes had a higher odds of being fully reported compared to nonsignificant outcomes (range of odds ratios: 2.4 to 4.7). Across the studies, at least one primary outcome was changed, introduced, or omitted in 4-50% of trial reports. Discrepancies between protocols or trial registry entries and trial reports were common, although reasons for these were not discussed in the reports. Full transparency will be possible only when protocols are made publicly available or the quality and extent of information included in trial registries is improved, and trialists explain substantial changes in their reports. | The non-reporting of a piece of research and the selective reporting of only some of its findings has been identified as a problem for research studies such as randomised trials and systematic reviews of these. If the decision about what to report and what to keep unpublished is based on the results obtained in the trial, this will lead to bias and potentially misleading conclusions by users of the research. One way to see if there might be discrepancies between what was planned or done in a trial and what is eventually reported is to compare the protocol or entry in a trial registry for the trial with the content of its published report. This might reveal that changes were made between the registration and planning of the trial and its eventual analysis. Any such changes should be described in the published report, to reassure readers and others who will use the trial's results that the risk of bias has been kept low. This Cochrane methodology review examines the reporting of randomised trials by reviewing research done by others in which the information in protocols or trial registry entries were compared to that in the published reports for groups of trials, to see if this detected any inconsistencies for any aspects of the trials. We included 16 studies in this review and the results indicate that there are often discrepancies between the information provided in protocol and trial registry entries and that contained in the published reports for randomised trials. These discrepancies cover many aspects of the trials and are not explained or stated in the published reports. | 10.1002/14651858.MR000031.pub2 | [
"The non-reporting of a piece of research and the selective reporting of only some of its findings has been identified as a problem for research studies such as randomised trials and systematic reviews of these. If the decision about what to report and what to keep unpublished is based on the results obtained in the trial, this will lead to bias and potentially misleading conclusions by users of the research. One way to see if there might be discrepancies between what was planned or done in a trial and what is eventually reported is to compare the protocol or entry in a trial registry for the trial with the content of its published report. This might reveal that changes were made between the registration and planning of the trial and its eventual analysis. Any such changes should be described in the published report, to reassure readers and others who will use the trial's results that the risk of bias has been kept low. This Cochrane methodology review examines the reporting of randomised trials by reviewing research done by others in which the information in protocols or trial registry entries were compared to that in the published reports for groups of trials, to see if this detected any inconsistencies for any aspects of the trials. We included 16 studies in this review and the results indicate that there are often discrepancies between the information provided in protocol and trial registry entries and that contained in the published reports for randomised trials. These discrepancies cover many aspects of the trials and are not explained or stated in the published reports."
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cochrane-simplification-train-1832 | cochrane-simplification-train-1832 | The review includes seven trials; five on aspects of lifestyle changes (eg, diet, physical exercise) and two on treatment with a weight reduction drug 'orlistat'. In total, 373 participants were enrolled, and the duration of the trials ranged from 1 month to 1 year. Only one trial on lifestyle programme was judged to be of low risk of bias. We could not perform meta-analyses for the main outcomes as they were either not reported or there were insufficient number of trials for each outcome to be meta-analysed. We could meta-analyse the available data for body weight and body mass index only. Adverse events were poorly reported. The sparse data and high risk of bias preclude us from drawing any definite conclusion on lifestyle programme or orlistat for treatment of NAFLD. Further randomised clinical trials with low risk of bias are needed to test the beneficial and harmful effects of weight reduction for NAFLD patients. The long-term prognosis of development of fibrosis, mortality, and quality of life should be studied. | We performed this systematic review to investigate the beneficial and harmful effects of weight reduction with different measures for NAFLD patients, but we could not find firm evidence. Five trials on lifestyle programme and two trials on orlistat were obtained, and all but one had high risk of bias. There seemed to be some beneficial effects of lifestyle programme involving restricted diet and physical exercise for NAFLD patients. However, the data were sparse, and meta-analyses could not be performed. Well-designed randomised clinical trials are needed to establish the true effect of the weight reduction measures identified for our review. The long-term prognosis of development of fibrosis, mortality, and quality of life modified by weight reduction should be studied. Special attention should be paid to the amount of weight loss. | 10.1002/14651858.CD003619.pub3 | [
"We performed this systematic review to investigate the beneficial and harmful effects of weight reduction with different measures for NAFLD patients, but we could not find firm evidence. Five trials on lifestyle programme and two trials on orlistat were obtained, and all but one had high risk of bias. There seemed to be some beneficial effects of lifestyle programme involving restricted diet and physical exercise for NAFLD patients. However, the data were sparse, and meta-analyses could not be performed. Well-designed randomised clinical trials are needed to establish the true effect of the weight reduction measures identified for our review. The long-term prognosis of development of fibrosis, mortality, and quality of life modified by weight reduction should be studied. Special attention should be paid to the amount of weight loss."
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cochrane-simplification-train-1833 | cochrane-simplification-train-1833 | We included five randomised clinical trials with 265 participants. All trials were prospective, double-blind, placebo-controlled randomised controlled trials on the effects of positive pressure therapy on vertigo complaints in Ménière's disease. Overall, the risk of bias varied: three out of five studies were at low risk, one was at unclear risk and one was at high risk of bias. Control of vertigo For the primary outcome, control of vertigo, it was not possible to pool data due to heterogeneity in the measurement of the outcome measures. In most studies, no significant difference was found between the positive pressure therapy group and the placebo group in vertigo scores or vertigo days. Only one study, at low risk of bias, showed a significant difference in one measure of vertigo control in favour of positive pressure therapy. In this study, the mean visual analogue scale (VAS) score for vertigo after eight weeks of treatment was 25.5 in the positive pressure therapy group and 46.6 in the placebo group (mean difference (MD) -21.10, 95% CI -35.47 to -6.73; scale not stated - presumed to be 0 to 100). Secondary outcomes For the secondary outcomes, we carried out two pooled analyses. We found statistically significant results for loss or gain of hearing . Hearing was 7.38 decibels better in the placebo group compared to the positive pressure therapy group (MD) (95% CI 2.51 to 12.25; two studies, 123 participants). The severity of tinnitus and perception of aural fullness were either not measured or inadequate data were provided in the included studies. For the secondary outcome functional level , it was not possible to perform a pooled analysis. One included study showed less functional impairment in the positive pressure group than the placebo group (AAO-HNS criteria, one- to six-point scale: MD -1.10, 95% CI -1.81 to -0.39, 40 participants); another study did not show any significant results. In addition to the predefined secondary outcome measures, we included sick days as an additional outcome measure, as two studies used this outcome measure and it is a complementary measurement of impairment due to Ménière's disease. We did not find a statistically significant difference in sick days. No complications or adverse effects were noted by any study. There is no evidence, from five included studies, to show that positive pressure therapy is effective for the symptoms of Ménière's disease. There is some moderate quality evidence, from two studies, that hearing levels are worse in patients who use this therapy. The positive pressure therapy device itself is minimally invasive. However, in order to use it, a tympanostomy tube (grommet) needs to be inserted, with the associated risks. These include the risks of anaesthesia, the general risks of any surgery and the specific risks of otorrhoea and tympanosclerosis associated with the insertion of a tympanostomy tube. Notwithstanding these comments, no complications or adverse effects were noted in any of the included studies. | In this review, we included five randomised controlled trials, with a total of 265 participants. All participants had Ménière's disease and their ages ranged from 19 to 74 years. In all of the studies positive pressure therapy was compared with a placebo device. For our primary outcome, control of vertigo, we could not combine the results from the different studies because of differences in the way the outcome was measured. None of the included studies showed significant differences between the active groups and placebo groups in terms of vertigo days. Only one study found significantly lower subjective scores for vertigo in favour of the positive pressure therapy group when compared to the placebo group. When we combined the results from two studies we found that after treatment patients in the placebo group had better hearing levels compared to those in the positive pressure therapy group. The severity of tinnitus and perception of aural fullness were either not measured or the included studies did not provide enough information for us to comment on them. We did not find an overall statistically significant result for functional level. We also looked at 'sick days' but we did not find a statistically significant difference between groups in the two studies that measured this. No complications or adverse effects were noted by any study. Overall, the studies were at varied risk of bias: three out of five studies were at low risk, one was at unclear risk and one was at high risk of bias. The evidence is up to date to June 2014. In conclusion, this review has not found adequate evidence to prove the effectiveness of positive pressure therapy. Further research is needed. | 10.1002/14651858.CD008419.pub2 | [
"In this review, we included five randomised controlled trials, with a total of 265 participants. All participants had Ménière's disease and their ages ranged from 19 to 74 years. In all of the studies positive pressure therapy was compared with a placebo device. For our primary outcome, control of vertigo, we could not combine the results from the different studies because of differences in the way the outcome was measured. None of the included studies showed significant differences between the active groups and placebo groups in terms of vertigo days. Only one study found significantly lower subjective scores for vertigo in favour of the positive pressure therapy group when compared to the placebo group. When we combined the results from two studies we found that after treatment patients in the placebo group had better hearing levels compared to those in the positive pressure therapy group. The severity of tinnitus and perception of aural fullness were either not measured or the included studies did not provide enough information for us to comment on them. We did not find an overall statistically significant result for functional level. We also looked at 'sick days' but we did not find a statistically significant difference between groups in the two studies that measured this. No complications or adverse effects were noted by any study. Overall, the studies were at varied risk of bias: three out of five studies were at low risk, one was at unclear risk and one was at high risk of bias. The evidence is up to date to June 2014. In conclusion, this review has not found adequate evidence to prove the effectiveness of positive pressure therapy. Further research is needed."
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cochrane-simplification-train-1834 | cochrane-simplification-train-1834 | Eight trials involving 3417 people were included. AA may help patients to accept treatment and keep patients in treatment more than alternative treatments, though the evidence for this is from one small study that combined AA with other interventions and should not be regarded as conclusive. Other studies reported similar retention rates regardless of treatment group. Three studies compared AA combined with other interventions against other treatments and found few differences in the amount of drinks and percentage of drinking days. Severity of addiction and drinking consequence did not seem to be differentially influenced by TSF versus comparison treatment interventions, and no conclusive differences in treatment drop out rates were reported. Included studies did not allow a conclusive assessment of the effect of TSF in promoting complete abstinence. No experimental studies unequivocally demonstrated the effectiveness of AA or TSF approaches for reducing alcohol dependence or problems. One large study focused on the prognostic factors associated with interventions that were assumed to be successful rather than on the effectiveness of interventions themselves, so more efficacy studies are needed. | The available experimental studies did not demonstrate the effectiveness of AA or other 12-step approaches in reducing alcohol use and achieving abstinence compared with other treatments, but there were some limitations with these studies. Furthermore, many different interventions were often compared in the same study and too many hypotheses were tested at the same time to identify factors which determine treatment success. | 10.1002/14651858.CD005032.pub2 | [
"The available experimental studies did not demonstrate the effectiveness of AA or other 12-step approaches in reducing alcohol use and achieving abstinence compared with other treatments, but there were some limitations with these studies. Furthermore, many different interventions were often compared in the same study and too many hypotheses were tested at the same time to identify factors which determine treatment success."
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cochrane-simplification-train-1835 | cochrane-simplification-train-1835 | We identified 12 studies (667 participants) and two new ongoing studies for inclusion. Six RCTs were newly included at this update and important non-randomised cohort studies have also been published. Some important studies remain unpublished and not all published studies provide complete outcome data. Primary outcome measure: one two-year deflazacort RCT (n = 28) used prolongation of ambulation as an outcome measure but data were not adequate for drawing conclusions. Secondary outcome measures: meta-analyses showed that corticosteroids (0.75 mg/kg/day prednisone or prednisolone) improved muscle strength and function versus placebo over six months (moderate quality evidence from up to four RCTs). Evidence from single trials showed 0.75 mg/kg/day superior to 0.3 mg/kg/day on most strength and function measures, with little evidence of further benefit at 1.5 mg/kg/day. Improvements were seen in time taken to rise from the floor (Gowers' time), timed walk, four-stair climbing time, ability to lift weights, leg function grade, and forced vital capacity. One new RCT (n = 66), reported better strength, function and quality of life with daily 0.75 mg/kg/day prednisone at 12 months. One RCT (n = 28) showed that deflazacort stabilised muscle strength versus placebo at two years, but timed function test results were too imprecise for conclusions to be drawn. One double-blind RCT (n = 64), largely at low risk of bias, compared daily prednisone (0.75 mg/kg/day) with weekend-only prednisone (5 mg/kg/weekend day), finding no overall difference in muscle strength and function over 12 months (moderate to low quality evidence). Two small RCTs (n = 52) compared daily prednisone 0.75 mg/kg/day with daily deflazacort 0.9 mg/kg/day, but study methods limited our ability to compare muscle strength or function. Adverse effects: excessive weight gain, behavioural abnormalities, cushingoid appearance, and excessive hair growth were all previously shown to be more common with corticosteroids than placebo; we assessed the quality of evidence (for behavioural changes and weight gain) as moderate. Hair growth and cushingoid features were more frequent at 0.75 mg/kg/day than 0.3 mg/kg/day prednisone. Comparing daily versus weekend-only prednisone, both groups gained weight with no clear difference in body mass index (BMI) or in behavioural changes (low quality evidence for both outcomes, one study); the weekend-only group had a greater linear increase in height. Very low quality evidence suggested less weight gain with deflazacort than with prednisone at 12 months, and no difference in behavioural abnormalities. Data are insufficient to assess the risk of fractures or cataracts for any comparison. Non-randomised studies support RCT evidence in showing improved functional benefit from corticosteroids. These studies suggest sustained benefit for up to 66 months. Adverse effects were common, although generally manageable. According to a large comparative longitudinal study of daily or intermittent (10 days on, 10 days off) corticosteroid for a mean period of four years, a daily regimen prolongs ambulation and improves functional scores over the age of seven, but with a greater frequency of side effects than an intermittent regimen. Moderate quality evidence from RCTs indicates that corticosteroid therapy in DMD improves muscle strength and function in the short term (twelve months), and strength up to two years. On the basis of the evidence available for strength and function outcomes, our confidence in the effect estimate for the efficacy of a 0.75 mg/kg/day dose of prednisone or above is fairly secure. There is no evidence other than from non-randomised trials to establish the effect of corticosteroids on prolongation of walking. In the short term, adverse effects were significantly more common with corticosteroids than placebo, but not clinically severe. A weekend-only prednisone regimen is as effective as daily prednisone in the short term (12 months), according to low to moderate quality evidence from a single trial, with no clear difference in BMI (low quality evidence). Very low quality evidence indicates that deflazacort causes less weight gain than prednisone after a year's treatment. We cannot evaluate long-term benefits and hazards of corticosteroid treatment or intermittent regimens from published RCTs. Non-randomised studies support the conclusions of functional benefits, but also identify clinically significant adverse effects of long-term treatment, and a possible divergence of efficacy in daily and weekend-only regimens in the longer term. These benefits and adverse effects have implications for future research and clinical practice. | We found 12 studies of corticosteroid treatment in DMD, involving a total of 667 randomised boys; two other studies are ongoing. Among the 12 completed studies, the treatments were: a corticosteroid versus inactive medicine (placebo) (in nine trials); daily versus weekend-only prednisone (in one trial); and deflazacort versus prednisone (in three trials). Some studies included more than one comparison; some were not fully reported or provided results that could not be analysed. One trial, a two-year study comparing a corticosteroid (deflazacort) with placebo, assessed the effects of corticosteroids on the ability to continue walking, but the data were not suitable for analysis. Most studies did not report ability to continue walking. At the usual 0.75 mg/kg/day dose, corticosteroids improved muscle strength and function over six months compared to placebo. These results are based on combined data (up to 152 participants) from four trials, which provided moderate quality evidence. Improvements were seen in timed tests (eg. timed walk or run, time to stand, stair climb), ability to lift weights, a leg function grade, and a measure of the strength of muscles used in breathing. Evidence from single trials showed 0.75 mg/kg/day prednisone to be superior to 0.3 mg/kg/day on most strength and function tests, with little evidence of greater benefit at 1.5 mg/kg/day. Changes in appearance and hair growth were more common at 0.75 mg/kg/day than 0.3 mg/kg/day. One RCT (n = 66) also reported better strength, function and quality of life at 12 months with daily 0.75 mg/kg/day prednisone. The two-year RCT, which had 28 participants, showed that deflazacort stabilised muscle strength for up to two years compared to placebo. This study did not show benefit on timed tests at two years; however, these results are imprecise and at high risk of bias, with less than half the original participants contributing data. One trial found that changes in muscle strength and function were similar with daily and weekend-only prednisone regimens over a 12-month period (low to moderate quality evidence). Two small RCTs compared daily prednisone 0.75 mg/kg/day with daily deflazacort 0.9 mg/kg/day, but trial methods did not allow comparisons of muscle strength or function. Previous versions of this review have found adverse events such as excessive weight gain, abnormal behaviour, changes in appearance, and abnormal hair growth to be more common with corticosteroids than with placebo. We assessed the quality of evidence for abnormal behaviour and weight gain for this review and found it to be moderate. The newer study of daily versus weekend-only prednisone showed that both groups gained weight. The body mass index (BMI; a measure of weight for height) did not show any clear difference between the regimens (low quality evidence). The weekend-only group had a greater increase in height. According to very low quality evidence from two studies, deflazacort appeared to cause less weight gain at one year than prednisone, and no significant difference in numbers with behaviour change. Data were insufficient to assess the risk of fractures or cataracts. The evidence is up to date to February 2016. | 10.1002/14651858.CD003725.pub4 | [
"We found 12 studies of corticosteroid treatment in DMD, involving a total of 667 randomised boys; two other studies are ongoing. Among the 12 completed studies, the treatments were: a corticosteroid versus inactive medicine (placebo) (in nine trials); daily versus weekend-only prednisone (in one trial); and deflazacort versus prednisone (in three trials). Some studies included more than one comparison; some were not fully reported or provided results that could not be analysed. One trial, a two-year study comparing a corticosteroid (deflazacort) with placebo, assessed the effects of corticosteroids on the ability to continue walking, but the data were not suitable for analysis. Most studies did not report ability to continue walking. At the usual 0.75 mg/kg/day dose, corticosteroids improved muscle strength and function over six months compared to placebo. These results are based on combined data (up to 152 participants) from four trials, which provided moderate quality evidence. Improvements were seen in timed tests (eg. timed walk or run, time to stand, stair climb), ability to lift weights, a leg function grade, and a measure of the strength of muscles used in breathing. Evidence from single trials showed 0.75 mg/kg/day prednisone to be superior to 0.3 mg/kg/day on most strength and function tests, with little evidence of greater benefit at 1.5 mg/kg/day. Changes in appearance and hair growth were more common at 0.75 mg/kg/day than 0.3 mg/kg/day. One RCT (n = 66) also reported better strength, function and quality of life at 12 months with daily 0.75 mg/kg/day prednisone. The two-year RCT, which had 28 participants, showed that deflazacort stabilised muscle strength for up to two years compared to placebo. This study did not show benefit on timed tests at two years; however, these results are imprecise and at high risk of bias, with less than half the original participants contributing data. One trial found that changes in muscle strength and function were similar with daily and weekend-only prednisone regimens over a 12-month period (low to moderate quality evidence). Two small RCTs compared daily prednisone 0.75 mg/kg/day with daily deflazacort 0.9 mg/kg/day, but trial methods did not allow comparisons of muscle strength or function. Previous versions of this review have found adverse events such as excessive weight gain, abnormal behaviour, changes in appearance, and abnormal hair growth to be more common with corticosteroids than with placebo. We assessed the quality of evidence for abnormal behaviour and weight gain for this review and found it to be moderate. The newer study of daily versus weekend-only prednisone showed that both groups gained weight. The body mass index (BMI; a measure of weight for height) did not show any clear difference between the regimens (low quality evidence). The weekend-only group had a greater increase in height. According to very low quality evidence from two studies, deflazacort appeared to cause less weight gain at one year than prednisone, and no significant difference in numbers with behaviour change. Data were insufficient to assess the risk of fractures or cataracts. The evidence is up to date to February 2016."
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cochrane-simplification-train-1836 | cochrane-simplification-train-1836 | We included 28 trials, involving 5855 participants, comparing stroke unit care with an alternative service. More-organised care was consistently associated with improved outcomes. Twenty-one trials (3994 participants) compared stroke unit care with care provided in general wards. Stroke unit care showed reductions in the odds of death recorded at final (median one year) follow-up (odds ratio (OR) 0.81, 95% Confidence Interval (CI) 0.69 to 0.94; P = 0.005), the odds of death or institutionalised care (OR 0.78, 95% CI 0.68 to 0.89; P = 0.0003) and the odds of death or dependency (OR 0.79, 95% CI 0.68 to 0.90; P = 0.0007). Sensitivity analyses indicated that the observed benefits remained when the analysis was restricted to securely randomised trials that used unequivocally blinded outcome assessment with a fixed period of follow-up. Outcomes were independent of patient age, sex, initial stroke severity or stroke type, and appeared to be better in stroke units based in a discrete ward. There was no indication that organised stroke unit care resulted in a longer hospital stay. Stroke patients who receive organised inpatient care in a stroke unit are more likely to be alive, independent, and living at home one year after the stroke. The benefits were most apparent in units based in a discrete ward. We observed no systematic increase in the length of inpatient stay. | This review of 28 trials, involving 5855 participants, showed that patients who receive this care are more likely to survive their stroke, return home and become independent in looking after themselves. A variety of different types of stroke unit have been developed. The best results appear to come from those which are based in a dedicated ward. | 10.1002/14651858.CD000197.pub3 | [
"This review of 28 trials, involving 5855 participants, showed that patients who receive this care are more likely to survive their stroke, return home and become independent in looking after themselves. A variety of different types of stroke unit have been developed. The best results appear to come from those which are based in a dedicated ward."
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cochrane-simplification-train-1837 | cochrane-simplification-train-1837 | Six trials with a total of 556 people were included. These trials were all placebo-controlled and double-blind, but of variable quality. They used different homeopathic treatments which precluded quantitative pooling of results for the primary outcome. Standardised treatments in these trials are unlikely to represent common homeopathic practice, where treatment tends to be individualised. No trial reported a significant difference on validated symptom scales. There were conflicting results in terms of lung function between the studies. There has been only a limited attempt to measure a 'package of care' effect (i.e., the effect of the medication as well as the consultation, which is considered a vital part of individualised homeopathic practice). An update search in August 2005 did not identify any new studies. There is not enough evidence to reliably assess the possible role of homeopathy in asthma. As well as randomised trials, there is a need for observational data to document the different methods of homeopathic prescribing and how patients respond. This will help to establish to what extent people respond to a 'package of care' rather than the homeopathic intervention alone. | The review of trials found that the type of homeopathy varied between the studies, that the study designs used in the trials were varied and that no strong evidence existed that usual forms of homeopathy for asthma are effective. There has been only a limited attempt to measure a 'package of care' effect (i.e., the effect of the medication as well as the consultation, which is considered a vital part of individualised homeopathic practice). Until stronger evidence exists for the use of homeopathy in the treatment of asthma, we are unable to make recommendations about homeopathic treatment. | 10.1002/14651858.CD000353.pub2 | [
"The review of trials found that the type of homeopathy varied between the studies, that the study designs used in the trials were varied and that no strong evidence existed that usual forms of homeopathy for asthma are effective. There has been only a limited attempt to measure a 'package of care' effect (i.e., the effect of the medication as well as the consultation, which is considered a vital part of individualised homeopathic practice). Until stronger evidence exists for the use of homeopathy in the treatment of asthma, we are unable to make recommendations about homeopathic treatment."
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cochrane-simplification-train-1838 | cochrane-simplification-train-1838 | Seven studies are now included in this review. For the comparison of physical healthcare advice versus standard care we identified six studies (total n = 964) of limited quality. For measures of quality of life one trial found no difference (n = 54, 1 RCT, MD Lehman scale 0.20, CI -0.47 to 0.87, very low quality of evidence) but another two did for the Quality of Life Medical Outcomes Scale - mental component (n = 487, 2 RCTs, MD 3.70, CI 1.76 to 5.64). There was no difference between groups for the outcome of death (n = 487, 2 RCTs, RR 0.98, CI 0.27 to 3.56, low quality of evidence). For service use two studies presented favourable results for health advice, uptake of ill-health prevention services was significantly greater in the advice group (n = 363, 1 RCT, MD 36.90, CI 33.07 to 40.73) and service use: one or more primary care visit was significantly higher in the advice group (n = 80, 1 RCT, RR 1.77, CI 1.09 to 2.85). Economic data were equivocal. Attrition was large (> 30%) but similar for both groups (n = 964, 6 RCTs, RR 1.11, CI 0.92 to 1.35). Comparisons of one type of physical healthcare advice with another were grossly underpowered and equivocal. General physical health could lead to people with serious mental illness accessing more health services which, in turn, could mean they see longer-term benefits such as reduced mortality or morbidity. On the other hand, it is possible clinicians are expending much effort, time and financial resources on giving ineffective advice. The main results in this review are based on low or very low quality data. There is some limited and poor quality evidence that the provision of general physical healthcare advice can improve health-related quality of life in the mental component but not the physical component, but this evidence is based on data from one study only. This is an important area for good research reporting outcome of interest to carers and people with serious illnesses as well as researchers and fundholders. | Based on an electronic search carried out in 2012, this review now includes seven studies that randomised a total of 1113 people with serious mental illness. Six studies compared general physical health advice with standard care, one compared advice on healthy living with artistic techniques such as sketching and pottery. Information was of limited low or very low quality, there were a small number of participants and findings were ambiguous. There is some limited evidence that the provision of physical healthcare advice can improve health-related quality of life mentally but not physically. No studies returned results that suggest that physical healthcare advice has a powerful effect on physical healthcare behaviour or risk of ill health. More work is needed in this area. Only one adverse effect outcome was presented, death, but there were no differences between the treatment groups for this outcome. Funders and policy makers should be aware that there may be some benefit for physical health advice for people with serious mental illness. There is an increased demand for preventative health services that involve the provision of advice and which may also reduce costs to health services. This plain language summary has been written by a consumer, Ben Gray from RETHINK. | 10.1002/14651858.CD008567.pub3 | [
"Based on an electronic search carried out in 2012, this review now includes seven studies that randomised a total of 1113 people with serious mental illness. Six studies compared general physical health advice with standard care, one compared advice on healthy living with artistic techniques such as sketching and pottery. Information was of limited low or very low quality, there were a small number of participants and findings were ambiguous. There is some limited evidence that the provision of physical healthcare advice can improve health-related quality of life mentally but not physically. No studies returned results that suggest that physical healthcare advice has a powerful effect on physical healthcare behaviour or risk of ill health. More work is needed in this area. Only one adverse effect outcome was presented, death, but there were no differences between the treatment groups for this outcome. Funders and policy makers should be aware that there may be some benefit for physical health advice for people with serious mental illness. There is an increased demand for preventative health services that involve the provision of advice and which may also reduce costs to health services. This plain language summary has been written by a consumer, Ben Gray from RETHINK."
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cochrane-simplification-train-1839 | cochrane-simplification-train-1839 | Cabergoline has been compared with bromocriptine in five randomised, double-blind, parallel group studies including 1071 patients. Only one of the phase II studies was medium term (36 weeks), the others all being short term (12 -15 weeks). The non-significant difference in off time reduction produced by cabergoline compared with bromocriptine was 0.29 hours/day in favour of the former (weighted mean difference; 95% CI -0.10, 0.68; p = 0.15). Dyskinesia reported as an adverse event was significantly increased with cabergoline compared with bromocriptine (Peto odds ratio 1.57; 95% CI 1.05, 2.35; p = 0.03). Motor impairment and disability were measured in four of the studies using the UPDRS rating scale but the small differences in UPDRS ADL (part II) and motor (part III) scores were not statistically significant in any study. Similarly, no significant difference in Schwab and England score was seen. The number of patients rated as much or very much improved on a clinician's global impression scale was similar with both agonists. Levodopa dose reduction was no different between cabergoline and bromocriptine. There was more confusion with cabergoline (Peto odds ratio 2.02; 95% CI 1.09, 3.76; p = 0.03). Otherwise, dopaminergic adverse events were comparable with these agonists and no significant difference in all cause withdrawal rate was found. Cabergoline produces similar benefits to bromocriptine in off time reduction, motor impairment and disability ratings, and levodopa dose reduction over the first three months of therapy. Dyskinesia and confusion were increased with cabergoline but otherwise the frequency of adverse events and withdrawals from treatment were similar with the two agonists. | Cabergoline has been compared with the older agonist bromocriptine in five studies including 1071 patients. Only one of the smaller studies was medium term (36 weeks), the others all being short term (12 -15 weeks). The time patients spent in the immobile off state was reduced with both agonists but slightly more by cabergoline compared with bromocriptine. This small advantage of cabergoline did not reach statistical significance. Dyskinesia reported as a side effect was significantly increased with cabergoline compared with bromocriptine. Physical impairment and disability were measured in four of the studies but no statistically significant advantage for cabergoline was found. The number of patients rated as much or very much improved on a clinician's global impression scale was similar with both agonists. Levodopa dose reduction was no different between cabergoline and bromocriptine. There was significantly more confusion with cabergoline. Otherwise, dopaminergic side effects were comparable with these agonists and no significant difference in the withdrawal rate from the trials was found. Cabergoline produces similar benefits to bromocriptine in off time reduction, physical impairment and disability ratings, and levodopa dose reduction over the first three months of therapy. The frequency of side effects and withdrawals from treatment were similar with the two agonists apart from increased dyskinesia and confusion with cabergoline. | 10.1002/14651858.CD001519 | [
"Cabergoline has been compared with the older agonist bromocriptine in five studies including 1071 patients. Only one of the smaller studies was medium term (36 weeks), the others all being short term (12 -15 weeks). The time patients spent in the immobile off state was reduced with both agonists but slightly more by cabergoline compared with bromocriptine. This small advantage of cabergoline did not reach statistical significance. Dyskinesia reported as a side effect was significantly increased with cabergoline compared with bromocriptine. Physical impairment and disability were measured in four of the studies but no statistically significant advantage for cabergoline was found. The number of patients rated as much or very much improved on a clinician's global impression scale was similar with both agonists. Levodopa dose reduction was no different between cabergoline and bromocriptine. There was significantly more confusion with cabergoline. Otherwise, dopaminergic side effects were comparable with these agonists and no significant difference in the withdrawal rate from the trials was found. Cabergoline produces similar benefits to bromocriptine in off time reduction, physical impairment and disability ratings, and levodopa dose reduction over the first three months of therapy. The frequency of side effects and withdrawals from treatment were similar with the two agonists apart from increased dyskinesia and confusion with cabergoline."
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cochrane-simplification-train-1840 | cochrane-simplification-train-1840 | Of the 3032 records identified, 10 studies were included in this review. Effect of ITN cost on ownership: Four studies including 4566 households and another study comprising 424 participants evaluated the effect of ITN price on ownership. These studies suggest that providing free ITNs probably increases ITN ownership when compared to subsidized ITNs or ITNs offered at full market price. Effect of ITN Cost on appropriate use of ITNs: Three studies including 9968 households and another study comprising 259 individuals found that there is probably little or no difference in the use of ITNs when they are provided free, compared to providing subsidized ITNs or ITNs offered at full market price. Education: Five studies, including 12,637 households, assessed educational interventions regarding ITN use and concluded that education may increase the number of adults and children using ITNs (sleeping under ITNs) compared to no education. One study, including 519 households, assessed the effects of providing an incentive (an undisclosed prize) to promote ITN ownership and use, and found that incentives probably lead to little or no difference in ownership or use of ITNs, compared to not receiving an incentive. None of the included studies reported on adverse effects. Five studies examined the effect of price on ITN ownership and found moderate-certainty evidence that ownership was highest among the groups who received the ITN free versus those who purchased the ITN at any cost. In economic terms, this means that demand for ITNs is elastic with regard to price. However, once the ITN is supplied, the price paid for the ITN probably has little to no effect on its use; the four studies addressing this outcome failed to confirm the hypothesis that people who purchase nets will use them more than those who receive them at no cost. Educational interventions for promoting ITN use have an additional positive effect. However, the impact of different types or intensities of education is unknown. | The studies included in this review took place in Africa and India. In five of the studies, people were either given insecticide-treated bednets free, or could buy them at a subsidized price or full market price. In the other five studies, people were educated about how to use the bednets properly, for instance through visits at home or through information on the radio, on television and in the community. The included studies show the following: Providing free insecticide-treated bednets: - Probably increases the number of people who own bednets compared to providing subsidized bednets or bednets offered at full market price. - Probably leads to little or no difference in the use of bednets compared to providing subsidized bednets or bednets offered at full market price. Providing education for the appropriate use of insecticide- treated bednets: - May increase the number of adults and children under five using bednets (sleeping under bednets). Providing incentives to encourage use of insecticide-treated bednets: - Probably leads to little or no difference in ownership or use of bednets compared to those who did not receive an incentive. A possible side effect when providing free or subsidized insecticide-treated bednets may be that the governments and institutions who pay for the bednets take this money from other priority issues. However, none of the included studies measured whether these or any other side effects had occurred. | 10.1002/14651858.CD009186.pub2 | [
"The studies included in this review took place in Africa and India. In five of the studies, people were either given insecticide-treated bednets free, or could buy them at a subsidized price or full market price. In the other five studies, people were educated about how to use the bednets properly, for instance through visits at home or through information on the radio, on television and in the community. The included studies show the following: Providing free insecticide-treated bednets: - Probably increases the number of people who own bednets compared to providing subsidized bednets or bednets offered at full market price. - Probably leads to little or no difference in the use of bednets compared to providing subsidized bednets or bednets offered at full market price. Providing education for the appropriate use of insecticide- treated bednets: - May increase the number of adults and children under five using bednets (sleeping under bednets). Providing incentives to encourage use of insecticide-treated bednets: - Probably leads to little or no difference in ownership or use of bednets compared to those who did not receive an incentive. A possible side effect when providing free or subsidized insecticide-treated bednets may be that the governments and institutions who pay for the bednets take this money from other priority issues. However, none of the included studies measured whether these or any other side effects had occurred."
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cochrane-simplification-train-1841 | cochrane-simplification-train-1841 | Four studies involving 127,891 men and 9342 women were included in this review. Only one study included women. Results for men and women were analysed separately. Three to five years after screening there was no significant difference in all-cause mortality between screened and unscreened groups for men or women (men, odds ratio (OR) 0.95; 95% Confidence interval (CI) 0.85 to 1.07; for women OR 1.06; 95% CI 0.93 to 1.21). There was a significant decrease in mortality from AAA in men (OR 0.60; 95% CI 0.47 to 0.78), but not for women (OR 1.99; 95% CI 0.36 to 10.88). In this analysis mortality includes death from rupture and from emergency or elective surgery for aneurysm repair. There was also a decreased incidence of ruptured aneurysm in men (OR 0.45; 95% CI 0.21 to 0.99) but not in women (OR 1.49; 95% CI 0.25 to 8.94). There was a significant increase in surgery for AAA in men (OR 2.03; 95% CI 1.59 to 2.59). This was not reported in women. There were no data on life expectancy, complications of surgery or subjective quality of life. There is evidence of a significant reduction in mortality from AAA in men aged 65 to 79 years who undergo ultrasound screening. There is insufficient evidence to demonstrate benefit in women. The cost effectiveness may be acceptable, but needs further expert analysis. These findings need careful consideration in judging whether a co-ordinated population-based screening programme should be introduced. | This review identified four controlled trials involving 127,891 men and 9342 women who were randomly assigned to aortic aneurysm screening using ultrasound or no screening. Only one trial included women. Two of the trials were conducted in the UK, one in Denmark and one in Australia. The results provide evidence of a benefit from screening in men with a strongly significant reduction in deaths from abdominal aortic aneurysm. The odds ratio (OR) for death was 0.60 (range 0.47 to 0.78, three trials) in men aged 65 to 83 years but was not reduced for women. From one trial there was also a decreased incidence of ruptured aneurysm in men but not women. All-cause mortality was not significantly different between screened and unscreened groups some three to five years after screening, which is to be expected given the relative infrequency of abdominal aortic aneurysm as a cause of death. Men who had been screened underwent more surgery for abdominal aortic aneurysm (OR 2.03; range 1.59 to 2.59, four trials) but resource analysis appears to demonstrate overall cost effectiveness of screening. There were no data on life expectancy, complications of surgery or quality of life. | 10.1002/14651858.CD002945.pub2 | [
"This review identified four controlled trials involving 127,891 men and 9342 women who were randomly assigned to aortic aneurysm screening using ultrasound or no screening. Only one trial included women. Two of the trials were conducted in the UK, one in Denmark and one in Australia. The results provide evidence of a benefit from screening in men with a strongly significant reduction in deaths from abdominal aortic aneurysm. The odds ratio (OR) for death was 0.60 (range 0.47 to 0.78, three trials) in men aged 65 to 83 years but was not reduced for women. From one trial there was also a decreased incidence of ruptured aneurysm in men but not women. All-cause mortality was not significantly different between screened and unscreened groups some three to five years after screening, which is to be expected given the relative infrequency of abdominal aortic aneurysm as a cause of death. Men who had been screened underwent more surgery for abdominal aortic aneurysm (OR 2.03; range 1.59 to 2.59, four trials) but resource analysis appears to demonstrate overall cost effectiveness of screening. There were no data on life expectancy, complications of surgery or quality of life."
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cochrane-simplification-train-1842 | cochrane-simplification-train-1842 | For this update, we identified two additional studies, for a total of five eligible trials that enrolled 166 infants. The methodological quality of these studies ranged from low to high risk of bias. Three studies were performed in resource-limited settings, where iNO and high-frequency ventilation were not available at the time of the study. One study compared sildenafil versus active controls, and another study evaluated sildenafil as adjuvant therapy to iNO. When comparing sildenafil with placebo, investigators noted significant reduction in mortality in the sildenafil alone group (three studies, 77 participants; typical RR 0.20, 95% confidence interval (CI) 0.07 to 0.56; I2 = 0% - none; typical RR -0.36, 95% CI -0.53 to -0.18; number needed to treat for an additional beneficial outcome 3, 95% CI 2 to 6; I2 = 39% - low). Trials reported no significant differences in mortality upon comparison of the sildenafil group versus the active control group (one study, 65 participants; typical RR 0.55, 95% CI 0.05 to 5.75), or when iNO was administered to both groups (one study, 24 participants; typical RR 1.27, 95% CI 0.26 to 6.28). Physiological parameters of oxygenation (oxygenation index, partial pressure of oxygen in arterial blood (PaO2)) suggested steady improvement after the first dose of sildenafil. None of the included trials identified any clinically important side effects. We rated the quality of evidence as low to very low owing to imprecision related to small sample size and unclear methodological features. Sildenafil used for treatment of pulmonary hypertension has potential for reducing mortality and improving oxygenation in neonates, especially in resource-limited settings where iNO is not available. However, large-scale randomised trials comparing sildenafil versus active controls (other pulmonary vasodilators) and providing follow-up for survivors are needed to assess the comparative effectiveness and long-term safety of sildenafil versus other pulmonary vasodilators. | We identified five studies that evaluated effects of sildenafil: three studies that compared sildenafil with placebo (no sildenafil); one that compared sildenafil with other medication (magnesium sulphate); and one that used sildenafil in combination with another medicine (nitric oxide). These studies included 166 newborns and were conducted in Colombia, Mexico, Turkey, and Qatar. Three studies that compared sildenafil and placebo (no sildenafil) reported that sildenafil reduced the number of deaths. Studies that compared sildenafil against another medication or that used another treatment with sildenafil described no significant reduction in the number of deaths. Sildenafil was more effective than placebo in improving oxygen levels. None of the five included studies reported safety concerns. However, these studies enrolled small numbers of infants, and most were conducted in settings where other treatments were not available. Sildenafil may be useful in settings where other treatment approaches are not available. However, additional studies are needed to compare sildenafil against existing treatment in a resourceful environment to assess its effectiveness and safety. The quality of evidence for reducing mortality or improving respiratory parameters was low owing to the small number of included studies and the small number of babies evaluated. Some of the included studies have methodological issues, resulting in low to very low quality of evidence. | 10.1002/14651858.CD005494.pub4 | [
"We identified five studies that evaluated effects of sildenafil: three studies that compared sildenafil with placebo (no sildenafil); one that compared sildenafil with other medication (magnesium sulphate); and one that used sildenafil in combination with another medicine (nitric oxide). These studies included 166 newborns and were conducted in Colombia, Mexico, Turkey, and Qatar. Three studies that compared sildenafil and placebo (no sildenafil) reported that sildenafil reduced the number of deaths. Studies that compared sildenafil against another medication or that used another treatment with sildenafil described no significant reduction in the number of deaths. Sildenafil was more effective than placebo in improving oxygen levels. None of the five included studies reported safety concerns. However, these studies enrolled small numbers of infants, and most were conducted in settings where other treatments were not available. Sildenafil may be useful in settings where other treatment approaches are not available. However, additional studies are needed to compare sildenafil against existing treatment in a resourceful environment to assess its effectiveness and safety. The quality of evidence for reducing mortality or improving respiratory parameters was low owing to the small number of included studies and the small number of babies evaluated. Some of the included studies have methodological issues, resulting in low to very low quality of evidence."
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cochrane-simplification-train-1843 | cochrane-simplification-train-1843 | We included six studies involving 462 participants with chronic peripheral neuropathic pain (442 completers (251 male), mean ages 52 to 63 years). The included studies recruited 403 participants from China and 59 from the UK. Most studies included a small sample size (fewer than 50 participants per treatment arm) and all studies were at high risk of bias for blinding of participants and personnel. Most studies had unclear risk of bias for sequence generation (four out of six studies), allocation concealment (five out of six) and selective reporting (all included studies). All studies investigated manual acupuncture, and we did not identify any study comparing acupuncture with treatment as usual, nor any study investigating other acupuncture techniques (such as electroacupuncture, warm needling, fire needling). One study compared acupuncture with sham acupuncture. We are uncertain if there is any difference between the two interventions on reducing pain intensity (n = 45; MD -0.4, 95% CI -1.83 to 1.03, very low-quality evidence), and neither group achieved 'no worse than mild pain' (visual analogue scale (VAS, 0-10) average score was 5.8 and 6.2 respectively in the acupuncture and sham acupuncture groups, where 0 = no pain). There was limited data on quality of life, which showed no clear difference between groups. Evidence was not available on pain relief, adverse events or other pre-defined secondary outcomes for this comparison. Three studies compared acupuncture alone versus other therapies (mecobalamin combined with nimodipine, and inositol). Acupuncture may reduce the risk of 'no clinical response' to pain than other therapies (n = 209; RR 0.25, 95% CI 0.12 to 0.51), however, evidence was not available for pain intensity, pain relief, adverse events or any of the other secondary outcomes. Two studies compared acupuncture combined with other active therapies (mecobalamin, and Xiaoke bitong capsule) versus other active therapies used alone. We found that the acupuncture combination group had a lower VAS score for pain intensity (n = 104; MD -1.02, 95% CI -1.09 to -0.95) and improved quality of life (n = 104; MD -2.19, 95% CI -2.39 to -1.99), than those receiving other therapy alone. However, the average VAS score of the acupuncture and control groups was 3.23 and 4.25 respectively, indicating neither group achieved 'no worse than mild pain'. Furthermore, this evidence was from a single study with high risk of bias and a very small sample size. There was no evidence on pain relief and we identified no clear differences between groups on other parameters, including 'no clinical response' to pain and withdrawals. There was no evidence on adverse events. The overall quality of evidence is very low due to study limitations (high risk of performance, detection, and attrition bias, and high risk of bias confounded by small study size) or imprecision. We have limited confidence in the effect estimate and the true effect is likely to be substantially different from the estimated effect. Due to the limited data available, there is insufficient evidence to support or refute the use of acupuncture for neuropathic pain in general, or for any specific neuropathic pain condition when compared with sham acupuncture or other active therapies. Five studies are still ongoing and seven studies are awaiting classification due to the unclear treatment duration, and the results of these studies may influence the current findings. | We conducted a search for relevant clinical trials in February 2017. We included six studies of manual acupuncture: one compared acupuncture with sham acupuncture; three investigated acupuncture combined with other active treatments compared with other active treatments alone; two compared acupuncture alone compared with other active treatments. The six studies involved 462 adults with chronic peripheral neuropathic pain. The participants were 52 to 63 years of age, on average. They received treatment for eight weeks or more. We did not find any study comparing acupuncture with treatment as usual, nor any study of other acupuncture techniques (such as electroacupuncture, warm needling, fire needling). We are uncertain about the beneficial effects of manual acupuncture on pain intensity, pain relief and quality of life when compared to sham acupuncture or other therapies (such as mecobalamin, nimodipine, inositol, and Xiaoke bitong capsule). There is a lack of evidence on the potential harms (side effects) of acupuncture. We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. Very low-quality evidence means that we are very uncertain about the results. High-quality evidence means that we are very confident in the results. The quality of the evidence in this review is very low, mostly due to problems in the way the studies were conducted (such as the participants were not blinded to their treatment, or more participants in the sham acupuncture group left the study early). The studies also included a small number of participants. Moreover, these findings only apply to peripheral neuropathic pain in older adults. Overall, we do not have sufficient evidence to support or refute the use of acupuncture in treating neuropathic pain. | 10.1002/14651858.CD012057.pub2 | [
"We conducted a search for relevant clinical trials in February 2017. We included six studies of manual acupuncture: one compared acupuncture with sham acupuncture; three investigated acupuncture combined with other active treatments compared with other active treatments alone; two compared acupuncture alone compared with other active treatments. The six studies involved 462 adults with chronic peripheral neuropathic pain. The participants were 52 to 63 years of age, on average. They received treatment for eight weeks or more. We did not find any study comparing acupuncture with treatment as usual, nor any study of other acupuncture techniques (such as electroacupuncture, warm needling, fire needling). We are uncertain about the beneficial effects of manual acupuncture on pain intensity, pain relief and quality of life when compared to sham acupuncture or other therapies (such as mecobalamin, nimodipine, inositol, and Xiaoke bitong capsule). There is a lack of evidence on the potential harms (side effects) of acupuncture. We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. Very low-quality evidence means that we are very uncertain about the results. High-quality evidence means that we are very confident in the results. The quality of the evidence in this review is very low, mostly due to problems in the way the studies were conducted (such as the participants were not blinded to their treatment, or more participants in the sham acupuncture group left the study early). The studies also included a small number of participants. Moreover, these findings only apply to peripheral neuropathic pain in older adults. Overall, we do not have sufficient evidence to support or refute the use of acupuncture in treating neuropathic pain."
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cochrane-simplification-train-1844 | cochrane-simplification-train-1844 | We included 10 RCTs involving a total of 844 participants. The primary outcome was overall incidence of parastomal herniation. Secondary outcomes were rate of reoperation at 12 months, operative time, postoperative length of hospital stay, stoma-related infections, mesh-related infections, quality of life, and rehospitalisation rate. We judged the risk of bias across all domains to be low in six trials. We judged four trials to have an overall high risk of bias. The overall incidence of parastomal hernia was less in participants receiving a prophylactic mesh compared to those who had a standard ostomy formation (RR 0.53, 95% CI 0.43 to 0.66; 10 studies, 771 participants; I2 = 69%; low-quality evidence). In absolute numbers, the incidence of parastomal hernia was 22 per 100 participants (18 to 27) receiving prophylactic mesh compared to 41 per 100 participants having a standard ostomy formation. There were no differences in the need for reoperation (RR 0.90, 95% CI 0.50 to 1.64; 9 studies, 757 participants; I2 = 0%; low-quality evidence); operative time (MD -6.50 (min), 95% CI -18.24 to 5.24; 6 studies, 671 participants; low-quality evidence); postoperative length of hospital stay (MD -0.95 (days), 95% CI -2.03 to 0.70; 4 studies, 500 participants; moderate-quality evidence); or stoma-related infections (RR 0.89, 95% CI 0.32 to 2.50; 6 studies, 472 participants; I2 = 0%; low-quality evidence) between the two groups. We were unable to analyse mesh-related infections, quality of life, and rehospitalisation rate due to sparse data or because the outcome was not reported in the included studies. This Cochrane Review included 10 RCTs with a total of 844 participants. The review demonstrated a reduction in the incidence of parastomal hernia in people who had a prophylactic synthetic mesh placed at the time of the index operation compared to a standard ostomy formation. However, our confidence in this estimate is low due to the presence of a large degree of clinical heterogeneity, as well as high variability in follow-up duration and technique of parastomal herniation detection. We found the rate of stoma-related infection to be similar in both the intervention and control groups. | Following our data search in January 2018, we included 10 trials with a total of 844 participants, which we assessed using the standard Cochrane Review protocol. The trials compared the incidence of hernia development around a stoma between a group having a mesh placement at the time of stoma formation and a control group having a conventional stoma formation without mesh placement. We found that mesh placement around the stoma at the time of stoma formation reduces the incidence of future hernia formation. The participants having a mesh fitted had a similar level of complications as those not having a mesh. We found low-quality evidence favouring the insertion of a mesh into people having a stoma. | 10.1002/14651858.CD008905.pub3 | [
"Following our data search in January 2018, we included 10 trials with a total of 844 participants, which we assessed using the standard Cochrane Review protocol. The trials compared the incidence of hernia development around a stoma between a group having a mesh placement at the time of stoma formation and a control group having a conventional stoma formation without mesh placement. We found that mesh placement around the stoma at the time of stoma formation reduces the incidence of future hernia formation. The participants having a mesh fitted had a similar level of complications as those not having a mesh. We found low-quality evidence favouring the insertion of a mesh into people having a stoma."
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cochrane-simplification-train-1845 | cochrane-simplification-train-1845 | Fourteen randomised controlled trials comparing exercise against no exercise in type 2 diabetes were identified involving 377 participants. Trials ranged from eight weeks to twelve months duration. Compared with the control, the exercise intervention significantly improved glycaemic control as indicated by a decrease in glycated haemoglobin levels of 0.6% (-0.6 % HbA1c, 95% confidence interval (CI) -0.9 to -0.3; P < 0.05). This result is both statistically and clinically significant. There was no significant difference between groups in whole body mass, probably due to an increase in fat free mass (muscle) with exercise, as reported in one trial (6.3 kg, 95% CI 0.0 to 12.6). There was a reduction in visceral adipose tissue with exercise (-45.5 cm2, 95% CI -63.8 to -27.3), and subcutaneous adipose tissue also decreased. No study reported adverse effects in the exercise group or diabetic complications. The exercise intervention significantly increased insulin response (131 AUC, 95% CI 20 to 242) (one trial), and decreased plasma triglycerides (-0.25 mmol/L, 95% CI -0.48 to -0.02). No significant difference was found between groups in quality of life (one trial), plasma cholesterol or blood pressure. The meta-analysis shows that exercise significantly improves glycaemic control and reduces visceral adipose tissue and plasma triglycerides, but not plasma cholesterol, in people with type 2 diabetes, even without weight loss. | This review found that exercise improves blood sugar control and that this effect is evident even without weight loss. Furthermore, exercise decreases body fat content, thus the failure to lose weight with exercise programmes is probably explained by the conversion of fat to muscle. Exercise improved the body's reaction to insulin and decreased blood lipids. Quality of life was only assessed in one study, which found no difference between the two groups. No significant difference was found between groups in blood levels of cholesterol or blood pressure. A total of 14 randomised controlled trials were assessed. These included 377 participants and compared groups that differed only with respect to an exercise programme intervention. The duration of the interventions in the studies ranged from eight weeks to one year. Two studies reported follow-up information, one at six months after the end of the six month exercise intervention and one at twelve months post-intervention. Generally, the studies were well-conducted, but blinding of outcome assessors was not reported and although all studies reported that randomisation was performed, few gave details of the method. No adverse effects with exercise were reported. The effect of exercise on diabetic complications was not assessed in any of the studies. The relatively short duration of trials prevented the reporting of any significant long term complications or mortality. Another limitation was the small number of participants included in the analyses for adiposity, blood pressure, cholesterol, body's muscle and quality of life. | 10.1002/14651858.CD002968.pub2 | [
"This review found that exercise improves blood sugar control and that this effect is evident even without weight loss. Furthermore, exercise decreases body fat content, thus the failure to lose weight with exercise programmes is probably explained by the conversion of fat to muscle. Exercise improved the body's reaction to insulin and decreased blood lipids. Quality of life was only assessed in one study, which found no difference between the two groups. No significant difference was found between groups in blood levels of cholesterol or blood pressure. A total of 14 randomised controlled trials were assessed. These included 377 participants and compared groups that differed only with respect to an exercise programme intervention. The duration of the interventions in the studies ranged from eight weeks to one year. Two studies reported follow-up information, one at six months after the end of the six month exercise intervention and one at twelve months post-intervention. Generally, the studies were well-conducted, but blinding of outcome assessors was not reported and although all studies reported that randomisation was performed, few gave details of the method. No adverse effects with exercise were reported. The effect of exercise on diabetic complications was not assessed in any of the studies. The relatively short duration of trials prevented the reporting of any significant long term complications or mortality. Another limitation was the small number of participants included in the analyses for adiposity, blood pressure, cholesterol, body's muscle and quality of life."
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cochrane-simplification-train-1846 | cochrane-simplification-train-1846 | We included two randomised controlled trials that involved a total of 147 adult outpatients with acute sinusitis confirmed by radiology or nasal endoscopy who were assigned to Cyclamen europaeum nasal spray or placebo study arms for up to 15 days. The risk of selection and detection bias was unclear, as allocation concealment and blinding of outcome assessors were not reported in either study. Attrition was high (60%) in one study, although dropouts were balanced between study arms. Neither study reported our two primary outcomes: proportion of participants whose symptoms resolved or improved at 14 days and 30 days. No serious adverse events or complications related to treatment were reported; however, more mild adverse events such as nasal and throat irritation, mild epistaxis, and sneezing occurred in Cyclamen europaeum group participants (50%) compared to placebo group participants (24%) (risk ratio 2.11, 95% confidence interval 1.35 to 3.29); moderate-quality evidence. The effectiveness of Cyclamen europaeum for people with acute sinusitis is unknown. Although no serious side effects were observed, 50% of participants who received Cyclamen europaeum reported adverse events compared with 24% of those who received placebo. | We included two studies involving 147 adults with acute sinusitis. Participants were randomly allocated to receive Cyclamen europaeum delivered as an intranasal spray or a non-active substance for up to 15 days. Pharmaceutical companies funded both studies. We wanted to find out the proportion of participants whose symptoms resolved or improved up to 14 days and 30 days, but did not find any evidence. The included studies provided data for changes in symptom scores for acute sinusitis with treatment. One study reported improvement in facial pain up to seven days. Neither study reported complications or days off school or work. People who received Cyclamen europaeum rather than a non-active substance reported more side effects like nasal irritation, sneezing, and mild nasal bleeding. No major side effects occurred. We found no evidence as to whether Cyclamen europaeum is effective or not. We assessed the quality of both studies and judged the evidence to be moderately reliable for the only outcome that could be assessed, that is side effects. One study had a high dropout rate (60%), but dropouts were described and balanced between study arms. We found consistent results between studies for adverse events. Neither study reported whether the outcomes assessors knew which treatments the participants received. Due to the small number of participants and weaknesses in study design, we cannot be sure of the result. | 10.1002/14651858.CD011341.pub2 | [
"We included two studies involving 147 adults with acute sinusitis. Participants were randomly allocated to receive Cyclamen europaeum delivered as an intranasal spray or a non-active substance for up to 15 days. Pharmaceutical companies funded both studies. We wanted to find out the proportion of participants whose symptoms resolved or improved up to 14 days and 30 days, but did not find any evidence. The included studies provided data for changes in symptom scores for acute sinusitis with treatment. One study reported improvement in facial pain up to seven days. Neither study reported complications or days off school or work. People who received Cyclamen europaeum rather than a non-active substance reported more side effects like nasal irritation, sneezing, and mild nasal bleeding. No major side effects occurred. We found no evidence as to whether Cyclamen europaeum is effective or not. We assessed the quality of both studies and judged the evidence to be moderately reliable for the only outcome that could be assessed, that is side effects. One study had a high dropout rate (60%), but dropouts were described and balanced between study arms. We found consistent results between studies for adverse events. Neither study reported whether the outcomes assessors knew which treatments the participants received. Due to the small number of participants and weaknesses in study design, we cannot be sure of the result."
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cochrane-simplification-train-1847 | cochrane-simplification-train-1847 | We included two RCTs involving 3375 women. Tamoxifen after surgery for DCIS reduced recurrence of both ipsilateral (same side) DCIS (HR 0.75; 95% CI 0.61 to 0.92) and contralateral (opposite side) DCIS (RR 0.50; 95% CI 0.28 to 0.87). There was a trend towards decreased ipsilateral invasive cancer (HR 0.79; 95% CI 0.62 to 1.01) and reduced contralateral invasive cancer (RR 0.57; 95% CI 0.39 to 0.83). The number needed to treat in order for tamoxifen to have a protective effect against all breast events is 15. There was no evidence of a difference detected in all cause mortality (RR 1.11; 95% CI 0.89 to 1.39). Only one study, involving 1799 participants followed-up for 163 months (median) reported on adverse events (i.e. toxicity, mood changes, deep vein thrombosis, pulmonary embolism, endometrial cancer) with no significant difference between tamoxifen and placebo groups, but there was a non-significant trend towards more endometrial cancer in the tamoxifen group. While tamoxifen after local excision for DCIS (with or without adjuvant radiotherapy) reduced the risk of recurrent DCIS (in the ipsi- and contralateral breast), it did not reduce the risk of overall mortality. | Our findings are based on two large studies with 3375 participants and should be applicable to most women having treatment for DCIS. Overall tamoxifen did reduce the number of future cancers or DCIS in either breast. However, women taking tamoxifen did not live longer than those who did not take it. A total of 15 women would have to take tamoxifen after treatment of DCIS for one woman to experience a benefit (i.e. no future cancers or DCIS in either breast after taking tamoxifen for five years). There are side effects of tamoxifen treatment such as blood clotting problems (stroke, deep vein thrombosis, pulmonary embolism) and endometrial cancer. However, no risk/benefit conclusions are possible because there was limited information about the side effects in this review. The effects of tamoxifen may have been 'diluted' by the effects of radiotherapy. This review cannot recommend which women might have more benefit from using tamoxifen in terms of age, menopausal status or type of DCIS (oestrogen receptor (ER)-positive versus ER-negative or human epidermal growth factor receptor 2 (HER2)-positive or HER2-negative DCIS). | 10.1002/14651858.CD007847.pub2 | [
"Our findings are based on two large studies with 3375 participants and should be applicable to most women having treatment for DCIS. Overall tamoxifen did reduce the number of future cancers or DCIS in either breast. However, women taking tamoxifen did not live longer than those who did not take it. A total of 15 women would have to take tamoxifen after treatment of DCIS for one woman to experience a benefit (i.e. no future cancers or DCIS in either breast after taking tamoxifen for five years). There are side effects of tamoxifen treatment such as blood clotting problems (stroke, deep vein thrombosis, pulmonary embolism) and endometrial cancer. However, no risk/benefit conclusions are possible because there was limited information about the side effects in this review. The effects of tamoxifen may have been 'diluted' by the effects of radiotherapy. This review cannot recommend which women might have more benefit from using tamoxifen in terms of age, menopausal status or type of DCIS (oestrogen receptor (ER)-positive versus ER-negative or human epidermal growth factor receptor 2 (HER2)-positive or HER2-negative DCIS)."
]
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cochrane-simplification-train-1848 | cochrane-simplification-train-1848 | Seven studies, involving 632 DME eyes were included. Four examined the effectiveness of intravitreal triamcinolone acetate injection (IVTA), three examined intravitreal steroids implantation (fluocinolone acetonide implant (FAI) or dexamethasone drug delivery system (DDS)). Two trials were at low risk of bias, one was at median risk of bias, two were at high risk of bias and the remaining two were at unclear risk of bias. The preponderance of data suggest a beneficial effect from IVTA. Comparing IVTA with controls, the mean difference in visual acuity was -0.15 LogMAR (95% CI -0.21 to -0.09) at 3 months (based on three trials), -0.23 LogMAR (95% CI -0.33 to -0.13) at 6 months (two trials), -0.29 LogMAR (95% CI -0.47 to -0.11) at 9 months (one trial), and -0.11 LogMAR (95% CI -0.20 to -0.03) at 24 months (one trial), all in favor of IVTA. The relative risk (RR) for one or more lines improvement in visual acuity was 2.85 (95% CI 1.59 to 5.10) at 3 months (two trials), 1.25 (95% CI 0.66 to 2.38) at 6 months (one trial), and 2.17 (95% CI 1.15 to 4.11) at 24 months (one trial), all in favor of IVTA. We did not find evidence for three or more lines improvement in visual acuity. The mean difference in retinal thickness was -131.97 um (95% CI -169.08 to -94.86) at 3 months (two trials), -135.00 um (95% CI -194.50 to -75.50) at 6 months (one trial), -133.00 um (95% CI -199.86 to -66.14) at 9 months (one trial), and -59.00 um (95% CI -103.50 to -14.50) at 24 months (one trial), all in favor of IVTA. The RR for at least one grade macular edema resolution was 5.15 (95% CI 2.23 to 11.88) at 3 months in favor of IVTA (one trial). Two trials reported improved clinical outcome when FAI was compared to standard of care. Beneficial effect was also observed in one dexamethasone DDS trial. Increased intraocular pressure and cataract formation were side effects requiring monitoring and management. RCTs included in this review suggest that steroids placed inside the eye by either intravitreal injection or surgical implantation may improve visual outcomes in eyes with persistent or refractory DME. Since the studies in our report focused on chronic or refractory DME, the question arises whether intravitreal steroids therapy could be of value in other stages of DME, especially the earlier stages either as standalone therapy or in combination with other therapies, such as laser photocoagulation. | This systematic review included seven randomized clinical trials involving 632 eyes from five countries evaluating the effectiveness and safety of intravitreal steroids for treating DME. Two trials were at low risk of bias, one was at median risk of bias, two were at high risk of bias, and the remaining two had an unclear risk of bias. In this systematic review, the preponderance of data suggest a beneficial effect from IVTA. The average improvement in visual acuity was 7.5 letters more (-0.15 LogMAR; 95% CI -0.21 to -0.09) in the IVTA treated eyes than in those treated with other therapies at three months (based on three trials), 11.5 letters more (-0.23 LogMAR; 95% CI -0.33 to -0.13) at six months (two trials), 14.5 letters more (-0.29 LogMAR; 95% CI -0.47 to -0.11) at nine months (one trial), and 5.7 letters more (-0.11 LogMAR; 95% CI -0.20 to -0.03) at 24 months (one trial). Improved clinical outcomes were also reported in FAI and dexamethasone DDS trials. Elevation of intraocular pressure and cataract progression occur in both IVTA and implants treated eyes but appear manageable. | 10.1002/14651858.CD005656.pub2 | [
"This systematic review included seven randomized clinical trials involving 632 eyes from five countries evaluating the effectiveness and safety of intravitreal steroids for treating DME. Two trials were at low risk of bias, one was at median risk of bias, two were at high risk of bias, and the remaining two had an unclear risk of bias. In this systematic review, the preponderance of data suggest a beneficial effect from IVTA. The average improvement in visual acuity was 7.5 letters more (-0.15 LogMAR; 95% CI -0.21 to -0.09) in the IVTA treated eyes than in those treated with other therapies at three months (based on three trials), 11.5 letters more (-0.23 LogMAR; 95% CI -0.33 to -0.13) at six months (two trials), 14.5 letters more (-0.29 LogMAR; 95% CI -0.47 to -0.11) at nine months (one trial), and 5.7 letters more (-0.11 LogMAR; 95% CI -0.20 to -0.03) at 24 months (one trial). Improved clinical outcomes were also reported in FAI and dexamethasone DDS trials. Elevation of intraocular pressure and cataract progression occur in both IVTA and implants treated eyes but appear manageable."
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cochrane-simplification-train-1849 | cochrane-simplification-train-1849 | The electronic search yielded 8746 records. We included 12 RCTs (3885 participants) comparing usual care with the following interventions: commonly used drugs (four studies); sedation regimens (four studies); physical therapy or cognitive therapy, or both (one study); environmental interventions (two studies); and preventive nursing care (one study). We found 15 ongoing studies and five studies awaiting classification. The participants were 48 to 70 years old; 48% to 74% were male; the mean acute physiology and chronic health evaluation (APACHE II) score was 14 to 28 (range 0 to 71; higher scores correspond to more severe disease and a higher risk of death). With the exception of one study, all participants were mechanically ventilated in medical or surgical ICUs or mixed. The studies were overall at low risk of bias. Six studies were at high risk of detection bias due to lack of blinding of outcome assessors. We report results for the two most commonly explored approaches to delirium prevention: pharmacologic and a non-pharmacologic intervention. Haloperidol versus placebo (two RCTs, 1580 participants) The event rate of ICU delirium was measured in one study including 1439 participants. No difference was identified between groups, (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.87 to 1.17) (moderate-quality evidence). Haloperidol versus placebo neither reduced or increased in-hospital mortality, (RR 0.98, 95% CI 0.80 to 1.22; 2 studies; 1580 participants (moderate-quality evidence)); the number of delirium- and coma-free days, (mean difference (MD) -0.60, 95% CI -1.37 to 0.17; 2 studies, 1580 participants (moderate-quality of evidence)); number of ventilator-free days (mean 23.8 (MD -0.30, 95% CI -0.93 to 0.33) 1 study; 1439 participants, (high-quality evidence)); length of ICU stay, (MD 0.18, 95% CI 0.60 to 0.97); 2 studies, 1580 participants; high-quality evidence). None of the studies measured cognitive impairment. In one study there were three serious adverse events in the intervention group and five in the placebo group; in the other there were five serious adverse events and three patients died, one in each group. None of the serious adverse events were judged to be related to interventions received (moderate-quality evidence). Physical and cognitive therapy interventions (one study, 65 participants) The study did not measure the event rate of ICU delirium. A physical and cognitive therapy intervention versus standard care neither reduced nor increased in-hospital mortality, (RR 0.94, 95% CI 0.40 to 2.20, I² = 0; 1 study, 65 participants; very low-quality evidence); the number of delirium- and coma-free days, (MD -2.8, 95% CI -10.1 to 4.6, I² = 0; 1 study, 65 participants; very low-quality evidence); the number of ventilator-free days (within the first 28/30 days) was median 27.4 (IQR 0 to 29.2) and 25 (IQR 0 to 28.9); 1 study, 65 participants; very low-quality evidence, length of ICU stay, (MD 1.23, 95% CI -0.68 to 3.14, I² = 0; 1 study, 65 participants; very low-quality evidence); cognitive impairment measured by the MMSE: Mini-Mental State Examination with higher scores indicating better function, (MD 0.97, 95% CI -0.19 to 2.13, I² = 0; 1 study, 30 participants; very low-quality evidence); or measured by the Dysexecutive questionnaire (DEX) with lower scores indicating better function (MD -8.76, 95% CI -19.06 to 1.54, I² = 0; 1 study, 30 participants; very low-quality evidence). One patient experienced acute back pain accompanied by hypotensive urgency during physical therapy. There is probably little or no difference between haloperidol and placebo for preventing ICU delirium but further studies are needed to increase our confidence in the findings. There is insufficient evidence to determine the effects of physical and cognitive intervention on delirium. The effects of other pharmacological interventions, sedation, environmental, and preventive nursing interventions are unclear and warrant further investigation in large multicentre studies. Five studies are awaiting classification and we identified 15 ongoing studies, evaluating pharmacological interventions, sedation regimens, physical and occupational therapy combined or separately, and environmental interventions, that may alter the conclusions of the review in future. | We included 12 randomized controlled trials (3885 participants) in our review. The studies included adults aged 48 to 70 years from surgical and medical ICUs. The studies compared different drugs (three studies) various approaches to sedation (five studies), physical or cognitive therapy or both (one study), noise and light reduction in the ICU (two studies), and preventive nursing care (one study). The studies had mostly small numbers of participants and did not blind the researchers who assessed effects on outcomes. We report the findings regarding the effect of the two most commonly explored approaches for preventing delirium, drug and non-drug interventions, haloperidol versus a sham drug, and early physical and cognitive therapy versus usual care. Our findings suggest that there may be little or no difference between haloperidol and placebo for preventing ICU delirium, but further studies are needed to reduce imprecision and increase our confidence in the findings. More studies of physical and cognitive therapy are needed as there is insufficient evidence to determine whether these non-pharmacological approaches can prevent delirium in the ICU. Additional research is required to explore the benefits and harms of other approaches to prevent delirium in the ICU such as sedation and changes in the ICU environment, and nursing care tailored to prevent delirium. We rated the quality of the evidence as moderate to very low. Several studies had quality shortcomings, including their use of small numbers of participants, and lack of blinding of those assessing effects of interventions for preventing delirium and other outcomes. For the interventions testing sedation approaches, physical and cognitive therapy, and changes in the environment, additional research is required to clarify their effectiveness. The five studies in ‘Studies awaiting classification’ and 15 ongoing studies may alter the conclusions of the review once they are completed and assessed. | 10.1002/14651858.CD009783.pub2 | [
"We included 12 randomized controlled trials (3885 participants) in our review. The studies included adults aged 48 to 70 years from surgical and medical ICUs. The studies compared different drugs (three studies) various approaches to sedation (five studies), physical or cognitive therapy or both (one study), noise and light reduction in the ICU (two studies), and preventive nursing care (one study). The studies had mostly small numbers of participants and did not blind the researchers who assessed effects on outcomes. We report the findings regarding the effect of the two most commonly explored approaches for preventing delirium, drug and non-drug interventions, haloperidol versus a sham drug, and early physical and cognitive therapy versus usual care. Our findings suggest that there may be little or no difference between haloperidol and placebo for preventing ICU delirium, but further studies are needed to reduce imprecision and increase our confidence in the findings. More studies of physical and cognitive therapy are needed as there is insufficient evidence to determine whether these non-pharmacological approaches can prevent delirium in the ICU. Additional research is required to explore the benefits and harms of other approaches to prevent delirium in the ICU such as sedation and changes in the ICU environment, and nursing care tailored to prevent delirium. We rated the quality of the evidence as moderate to very low. Several studies had quality shortcomings, including their use of small numbers of participants, and lack of blinding of those assessing effects of interventions for preventing delirium and other outcomes. For the interventions testing sedation approaches, physical and cognitive therapy, and changes in the environment, additional research is required to clarify their effectiveness. The five studies in ‘Studies awaiting classification’ and 15 ongoing studies may alter the conclusions of the review once they are completed and assessed."
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cochrane-simplification-train-1850 | cochrane-simplification-train-1850 | A total of five studies including 868 participants met the inclusion criteria for this review. The five studies included in this review reported the value of drain fluid amylase at different thresholds and different postoperative days. The sensitivities and specificities were variable; the sensitivities ranged between 0.72 and 1.00 while the specificities ranged between 0.73 and 0.99 for different thresholds on different postoperative days. At the median prevalence (pre-test probability) of 15.9%, the post-test probabilities for pancreatic leak ranged between 35.9% and 95.4% for a positive drain fluid amylase test and ranged between 0% and 5.5% for a negative drain fluid amylase test. None of the studies used the reference standard of confirmation by surgery or by a combination of surgery and clinical follow-up, but used the International Study Group on Pancreatic Fistula (ISGPF) grade B and C as the reference standard. The overall methodological quality was unclear or high in all the studies. Because of the paucity of data and methodological deficiencies in the studies, we are uncertain whether drain fluid amylase should be used as a method for testing for pancreatic leak in an unselected population after pancreatic resection; and we judge that the optimal cut-off of drain fluid amylase for making the diagnosis of pancreatic leak is also not clear. Further well-designed diagnostic test accuracy studies with pre-specified index test threshold of drain fluid amylase (at three times more on postoperative day 5 or another suitable pre-specified threshold), appropriate follow-up (for at least six to eight weeks to ensure that there are no pancreatic leaks), and clearly defined reference standards (of surgical, clinical, and radiological confirmation of pancreatic leak) are important to reliably determine the diagnostic accuracy of drain fluid amylase in the diagnosis of pancreatic leak. | We performed a thorough literature search for studies reporting the accuracy of drain fluid amylase in identifying pancreatic leaks. We included studies reported up to 20 February 2017. We identified five studies reporting information on 868 people who underwent pancreatic resections for cancer and non-cancerous growths. Most studies included only people in whom the head of the pancreas (right side of the pancreas) was removed. Variations in when the studies measured the amylase content in the drain and what level was considered abnormal meant that we were not able to combine the data to provide the overall results. We are uncertain whether drain fluid amylase is useful in identifying pancreatic leaks because of the following reasons. 1. The way that study authors confirmed that a participant had or did not have pancreatic leak was itself subject to error (i.e. there was no true 'gold standard'). 2. The studies included few participants. As a result, there was significant uncertainty in the results. 3. The studies were of poor methodological quality. This introduced additional uncertainty in the results. All of the studies were of unclear or low methodological quality, which may result in arriving at false conclusions. | 10.1002/14651858.CD012009.pub2 | [
"We performed a thorough literature search for studies reporting the accuracy of drain fluid amylase in identifying pancreatic leaks. We included studies reported up to 20 February 2017. We identified five studies reporting information on 868 people who underwent pancreatic resections for cancer and non-cancerous growths. Most studies included only people in whom the head of the pancreas (right side of the pancreas) was removed. Variations in when the studies measured the amylase content in the drain and what level was considered abnormal meant that we were not able to combine the data to provide the overall results. We are uncertain whether drain fluid amylase is useful in identifying pancreatic leaks because of the following reasons. 1. The way that study authors confirmed that a participant had or did not have pancreatic leak was itself subject to error (i.e. there was no true 'gold standard'). 2. The studies included few participants. As a result, there was significant uncertainty in the results. 3. The studies were of poor methodological quality. This introduced additional uncertainty in the results. All of the studies were of unclear or low methodological quality, which may result in arriving at false conclusions."
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cochrane-simplification-train-1851 | cochrane-simplification-train-1851 | We included 64 studies (78 references) and 4547 participants in this review, and classified 12 additional studies as ongoing. A further 12 studies await classification, as we were unable to obtain the full texts. Most of the studies were conducted in high altitude mountain areas, while the rest used low pressure (hypobaric) chambers to simulate altitude exposure. Twenty-four trials provided the intervention between three and five days prior to the ascent, and 23 trials, between one and two days beforehand. Most of the included studies reached a final altitude of between 4001 and 5000 metres above sea level. Risks of bias were unclear for several domains, and a considerable number of studies did not report adverse events of the evaluated interventions. We found 26 comparisons, 15 of them comparing commonly-used drugs versus placebo. We report results for the three most important comparisons: Acetazolamide versus placebo (28 parallel studies; 2345 participants) The risk of AMS was reduced with acetazolamide (risk ratio (RR) 0.47, 95% confidence interval (CI) 0.39 to 0.56; I2 = 0%; 16 studies; 2301 participants; moderate quality of evidence). No events of HAPE were reported and only one event of HACE (RR 0.32, 95% CI 0.01 to 7.48; 6 parallel studies; 1126 participants; moderate quality of evidence). Few studies reported side effects for this comparison, and they showed an increase in the risk of paraesthesia with the intake of acetazolamide (RR 5.53, 95% CI 2.81 to 10.88, I2 = 60%; 5 studies, 789 participants; low quality of evidence). Budenoside versus placebo (2 parallel studies; 132 participants) Data on budenoside showed a reduction in the incidence of AMS compared with placebo (RR 0.37, 95% CI 0.23 to 0.61; I2 = 0%; 2 studies, 132 participants; low quality of evidence). Studies included did not report events of HAPE or HACE, and they did not find side effects (low quality of evidence). Dexamethasone versus placebo (7 parallel studies; 205 participants) For dexamethasone, the data did not show benefits at any dosage (RR 0.60, 95% CI 0.36 to 1.00; I2 = 39%; 4 trials, 176 participants; low quality of evidence). Included studies did not report events of HAPE or HACE, and we rated the evidence about adverse events as of very low quality. Our assessment of the most commonly-used pharmacological interventions suggests that acetazolamide is an effective pharmacological agent to prevent acute HAI in dosages of 250 to 750 mg/day. This information is based on evidence of moderate quality. Acetazolamide is associated with an increased risk of paraesthesia, although there are few reports about other adverse events from the available evidence. The clinical benefits and harms of other pharmacological interventions such as ibuprofen, budenoside and dexamethasone are unclear. Large multicentre studies are needed for most of the pharmacological agents evaluated in this review, to evaluate their effectiveness and safety. | The evidence is current to January 2017. We included 64 studies related to six different types of drugs recommended for HAI prevention. Most of the studies were conducted in high altitude mountain areas, while the rest used low pressure (hypobaric) chambers to simulate altitude exposure. The participants' ages ranged between 16 and 65 years. Eleven studies included people at a high risk of this condition due to their history of HAI or other illnesses such as asthma. Twenty-four trials provided the intervention between three and five days prior to the ascent, and 23 trials, between one and two days beforehand. Most of the included studies reached a final altitude of between 4001 and 5000 metres above sea level. In 23 of the included studies, the source of funding was unclear. Only 18 studies declared their possible conflicts of interests. We classed 24 more studies as still ongoing or waiting for assessment. Our findings suggest that acetazolamide is an effective treatment for the prevention of acute HAI in dosages of 250 to 750 mg/day, when this drug is compared to a placebo (i.e. a pill with no active agent). Most of the available information relates to the prevention of uncomplicated HAI (headache, nausea, vomiting and tiredness) rather than to more serious brain or lung problems. We also found that acetazolamide is associated with an increased risk of paraesthesia in the fingers (i.e. a sensation of tingling, tickling, pricking, or burning of the skin), although this outcome is not well reported in the available evidence. The benefits and harms of other drugs such as ibuprofen, budenoside and dexamethasone are unclear, due to the small number of studies. We rated the quality of the evidence as moderate to very low. Several studies had quality shortcomings, including their use of small numbers of participants and a lack of reporting of important outcomes such as side effects. For most of the drugs covered by the studies, additional research is required to clarify their effectiveness and safety. | 10.1002/14651858.CD009761.pub2 | [
"The evidence is current to January 2017. We included 64 studies related to six different types of drugs recommended for HAI prevention. Most of the studies were conducted in high altitude mountain areas, while the rest used low pressure (hypobaric) chambers to simulate altitude exposure. The participants' ages ranged between 16 and 65 years. Eleven studies included people at a high risk of this condition due to their history of HAI or other illnesses such as asthma. Twenty-four trials provided the intervention between three and five days prior to the ascent, and 23 trials, between one and two days beforehand. Most of the included studies reached a final altitude of between 4001 and 5000 metres above sea level. In 23 of the included studies, the source of funding was unclear. Only 18 studies declared their possible conflicts of interests. We classed 24 more studies as still ongoing or waiting for assessment. Our findings suggest that acetazolamide is an effective treatment for the prevention of acute HAI in dosages of 250 to 750 mg/day, when this drug is compared to a placebo (i.e. a pill with no active agent). Most of the available information relates to the prevention of uncomplicated HAI (headache, nausea, vomiting and tiredness) rather than to more serious brain or lung problems. We also found that acetazolamide is associated with an increased risk of paraesthesia in the fingers (i.e. a sensation of tingling, tickling, pricking, or burning of the skin), although this outcome is not well reported in the available evidence. The benefits and harms of other drugs such as ibuprofen, budenoside and dexamethasone are unclear, due to the small number of studies. We rated the quality of the evidence as moderate to very low. Several studies had quality shortcomings, including their use of small numbers of participants and a lack of reporting of important outcomes such as side effects. For most of the drugs covered by the studies, additional research is required to clarify their effectiveness and safety."
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cochrane-simplification-train-1852 | cochrane-simplification-train-1852 | Our searches identified six randomised, double-blind studies involving 292 participants in suitably characterised fibromyalgia. The mean age of participants was between 39 and 50 years, and 89% to 100% were women. The initial pain intensity was around 7/10 on a 0 to 10 pain scale, indicating severe pain. NSAIDs tested were etoricoxib 90 mg daily, ibuprofen 2400 mg daily, naproxen 1000 mg daily, and tenoxicam 20 mg daily; 146 participants received NSAID and 146 placebo. The duration of treatment in the double-blind phase varied between three and eight weeks. Not all studies reported all the outcomes of interest. Analyses consistently showed no significant difference between NSAID and placebo: substantial benefit (at least 50% pain intensity reduction) (risk difference (RD) -0.07 (95% confidence interval (CI) -0.18 to 0.04) 2 studies, 146 participants; moderate benefit (at least 30% pain intensity reduction) (RD -0.04 (95% CI -0.16 to 0.08) 3 studies, 192 participants; withdrawals due to adverse events (RD 0.04 (95% CI -0.02 to 0.09) 4 studies, 230 participants; participants experiencing any adverse event (RD 0.08 (95% CI -0.03 to 0.19) 4 studies, 230 participants; all-cause withdrawals (RD 0.03 (95% CI -0.07 to 0.14) 3 studies, 192 participants. There were no serious adverse events or deaths. Although most studies had some measures of health-related quality of life, fibromyalgia impact, or other outcomes, none reported the outcomes beyond saying that there was no or little difference between the treatment groups. We downgraded evidence on all outcomes to very low quality, meaning that this research does not provide a reliable indication of the likely effect. The likelihood that the effect could be substantially different is very high. This is based on the small numbers of studies, participants, and events, as well as other deficiencies of reporting study quality allowing possible risks of bias. There is only a modest amount of very low-quality evidence about the use of NSAIDs in fibromyalgia, and that comes from small, largely inadequate studies with potential risk of bias. That bias would normally be to increase the apparent benefits of NSAIDs, but no such benefits were seen. Consequently, NSAIDs cannot be regarded as useful for treating fibromyalgia. | We searched for clinical trials in which NSAIDs were used to treat symptoms of fibromyalgia in adults. The latest search was in January 2017. Six studies satisfied the inclusion criteria, randomising 292 participants to treatment with NSAID or placebo. NSAIDs tested were etoricoxib 90 mg daily, ibuprofen 2400 mg daily, naproxen 1000 mg daily, and tenoxicam 20 mg daily; 146 participants received NSAID and 146 placebo. Study duration was between three and eight weeks. Not all studies reported the outcomes of interest. We found no difference between NSAID or placebo for a range of outcomes. Pain reduction by half or better was experienced by 1 in 10 with NSAID and 2 in 10 with placebo. Pain reduction by a third or better was experienced by about 2 in 10 with both NSAID and placebo. Side effects were experienced by 3 in 10 with NSAID and 2 in 10 with placebo. The evidence was of very low quality. This means that the research does not provide a reliable indication of the likely effect. The chance that the real effect of NSAIDs could be substantially different is very high. Small studies like those in this review tend to overestimate results of treatment compared to the effects found in larger, better studies. The very low-quality evidence and the lack of any obvious benefit mean that NSAIDs cannot be regarded as useful for the management of fibromyalgia. | 10.1002/14651858.CD012332.pub2 | [
"We searched for clinical trials in which NSAIDs were used to treat symptoms of fibromyalgia in adults. The latest search was in January 2017. Six studies satisfied the inclusion criteria, randomising 292 participants to treatment with NSAID or placebo. NSAIDs tested were etoricoxib 90 mg daily, ibuprofen 2400 mg daily, naproxen 1000 mg daily, and tenoxicam 20 mg daily; 146 participants received NSAID and 146 placebo. Study duration was between three and eight weeks. Not all studies reported the outcomes of interest. We found no difference between NSAID or placebo for a range of outcomes. Pain reduction by half or better was experienced by 1 in 10 with NSAID and 2 in 10 with placebo. Pain reduction by a third or better was experienced by about 2 in 10 with both NSAID and placebo. Side effects were experienced by 3 in 10 with NSAID and 2 in 10 with placebo. The evidence was of very low quality. This means that the research does not provide a reliable indication of the likely effect. The chance that the real effect of NSAIDs could be substantially different is very high. Small studies like those in this review tend to overestimate results of treatment compared to the effects found in larger, better studies. The very low-quality evidence and the lack of any obvious benefit mean that NSAIDs cannot be regarded as useful for the management of fibromyalgia."
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cochrane-simplification-train-1853 | cochrane-simplification-train-1853 | Six studies were included in this review (3256 children, 4 to 17 years of age). Two studies were published as conference abstracts only. Ciclesonide was compared to budesonide and fluticasone. Ciclesonide compared to budesonide (dose ratio 1:2): asthma symptoms and adverse effect were similar in both groups. Pooled results showed no significant difference in children who experience an exacerbation (risk ratio (RR) 2.20, 95% confidence interval (CI) 0.75 to 6.43). Both studies reported that 24-hour urine cortisol levels showed a statistically significant decrease in the budesonide group compared to the ciclesonide group. Ciclesonide compared to fluticasone (dose ratio 1:1): no significant differences were found for the outcome asthma symptoms. Pooled results showed no significant differences in number of patients with exacerbations (RR 1.37, 95% CI 0.58 to 3.21) and data from a study that could not be pooled in the meta-analysis reported similar numbers of patients with exacerbations in both groups. None of the studies found a difference in adverse effects. No significant difference was found for 24-hour urine cortisol levels between the groups (mean difference 0.54 nmol/mmol, 95% CI -5.92 to 7.00). Ciclesonide versus fluticasone (dose ratio 1:2) was assessed in one study and showed similar results between the two corticosteroids for asthma symptoms. The number of children with exacerbations was significantly higher in the ciclesonide group (RR 3.57, 95% CI 1.35 to 9.47). No significant differences were found in adverse effects (RR 0.98, 95% CI 0.81 to 1.14) and 24-hour urine cortisol levels (mean difference 1.15 nmol/mmol, 95% CI 0.07 to 2.23). The quality of evidence was judged 'low' for the outcomes asthma symptoms and adverse events and 'very low' for the outcome exacerbations for ciclesonide versus budesonide (dose ratio 1:1). The quality of evidence was graded 'moderate' for the outcome asthma symptoms, 'very low' for the outcome exacerbations and 'low' for the outcome adverse events for ciclesonide versus fluticasone (dose ratio 1:1). For ciclesonide versus fluticasone (dose ratio 1:2) the quality was rated 'low' for the outcome asthma symptoms and 'very low' for exacerbations and adverse events (dose ratio 1:2). An improvement in asthma symptoms, exacerbations and side effects of ciclesonide versus budesonide and fluticasone could be neither demonstrated nor refuted and the trade-off between benefits and harms of using ciclesonide instead of budesonide or fluticasone is unclear. The resource use or costs of different ICS should therefore also be considered in final decision making. Longer-term superiority trials are needed to identify the usefulness and safety of ciclesonide compared to other ICS. Additionally these studies should be powered for patient relevant outcomes (exacerbations, asthma symptoms, quality of life and side effects). There is a need for studies comparing ciclesonide once daily with other ICS twice daily to assess the advantages of ciclesonide being a pro-drug that can be administered once daily with possibly increased adherence leading to increased control of asthma and fewer side effects. | We found six studies comparing ciclesonide with either budesonide or fluticasone in 3256 children (aged four to 17 years) with chronic asthma. After three months of treatment with ciclesonide compared to budesonide or fluticasone, no relevant differences could be found on asthma symptoms, exacerbations or side effects. Ciclesonide compared to a double dose of fluticasone was assessed in one study and no differences were found in asthma symptoms, use of rescue medication and adverse effects. However, children receiving ciclesonide experienced more asthma exacerbations than children in the fluticasone group. The results of this review regarding the efficacy and safety of ciclesonide compared to other ICS are not conclusive. Relatively few studies were found, different inhalers were compared and treatment and follow-up time (12 weeks) was too short for the assessment of relevant outcomes such as exacerbations and growth retardation. Future studies should pay attention to those aspects. | 10.1002/14651858.CD010352 | [
"We found six studies comparing ciclesonide with either budesonide or fluticasone in 3256 children (aged four to 17 years) with chronic asthma. After three months of treatment with ciclesonide compared to budesonide or fluticasone, no relevant differences could be found on asthma symptoms, exacerbations or side effects. Ciclesonide compared to a double dose of fluticasone was assessed in one study and no differences were found in asthma symptoms, use of rescue medication and adverse effects. However, children receiving ciclesonide experienced more asthma exacerbations than children in the fluticasone group. The results of this review regarding the efficacy and safety of ciclesonide compared to other ICS are not conclusive. Relatively few studies were found, different inhalers were compared and treatment and follow-up time (12 weeks) was too short for the assessment of relevant outcomes such as exacerbations and growth retardation. Future studies should pay attention to those aspects."
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cochrane-simplification-train-1854 | cochrane-simplification-train-1854 | Twelve trials met the inclusion criteria. Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E2C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E2V) 5 mg. These contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems than progestin-only contraceptives. However, rates were higher for overall discontinuation and discontinuation due to other medical reasons. Acceptability results favored the CIC in one study and the progestin-only in another. Studies comparing two CICs found that NET-EN 50 mg plus E2V 5 mg resulted in less overall discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E2C 5 mg. However, these differences were not detected in all trials. The NET-EN plus E2V group also had more regular bleeding and fewer prolonged bleeding reference periods than the DMPA plus E2C group. The groups did not differ in their amenorrhea rates. While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation depends on many factors. Future research should be directed toward improving the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinics, methods for women to administer their own injections, and counseling about possible bleeding pattern changes. | In January and February 2013, we did computer searches to find randomized trials of combination injectable contraceptives. We included studies that compared a CIC with another birth control method. The other method could be another injectable contraceptive, either combined or having only a progestin. The CIC could also be compared to another hormonal method (like the pill) or to condoms, the diaphragm, or a placebo (or 'dummy'). We found 12 trials that studied four types of CICs. The combined methods required monthly injections. Four trials compared a CIC to 'depo', which has only a progestin. 'Depo' injections should be taken every three months. Five trials compared a CIC with a different combined injectable. Three trials compared a combined injectable with a different dose of the same hormones, with a progestin-only injectable, or with an intrauterine device (IUD). More women using combined injectables had normal bleeding than women using progestin-only injectables like 'depo.' Also, fewer women using CICs stopped using them because of bleeding reasons than progestin-only users. However, users of combined injectables were more likely to stop using them overall and to stop for other medical reasons. Many factors can affect whether women keep using the method, including whether the women liked it. | 10.1002/14651858.CD004568.pub3 | [
"In January and February 2013, we did computer searches to find randomized trials of combination injectable contraceptives. We included studies that compared a CIC with another birth control method. The other method could be another injectable contraceptive, either combined or having only a progestin. The CIC could also be compared to another hormonal method (like the pill) or to condoms, the diaphragm, or a placebo (or 'dummy'). We found 12 trials that studied four types of CICs. The combined methods required monthly injections. Four trials compared a CIC to 'depo', which has only a progestin. 'Depo' injections should be taken every three months. Five trials compared a CIC with a different combined injectable. Three trials compared a combined injectable with a different dose of the same hormones, with a progestin-only injectable, or with an intrauterine device (IUD). More women using combined injectables had normal bleeding than women using progestin-only injectables like 'depo.' Also, fewer women using CICs stopped using them because of bleeding reasons than progestin-only users. However, users of combined injectables were more likely to stop using them overall and to stop for other medical reasons. Many factors can affect whether women keep using the method, including whether the women liked it."
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cochrane-simplification-train-1855 | cochrane-simplification-train-1855 | We included only one small trial (60 participants randomised) which overall was judged to be at low risk of bias. The study examined two doses of menaquinone (vitamin K2) over 3 months in healthy participants aged 40 to 65 years. The primary focus of the trial was to examine the effects of menaquinone (subtype MK7) on different matrix Gla proteins (MGP - vitamin K dependent proteins in the vessel wall) at different doses, but the authors also reported blood pressure and lipid levels. The trial did not report on our primary outcomes (cardiovascular disease clinical events) as it was small, short term and conducted in healthy participants. In terms of cardiovascular disease risk factors, no effects were seen for vitamin K2 on blood pressure or lipid levels, although the trial was small and findings are limited. The trial did not report any of our other secondary outcomes. The very limited results of this review highlight the lack of evidence currently available to determine the effectiveness of vitamin K supplementation for the primary prevention of cardiovascular disease, and demonstrate the need for further high quality trials in this area. | We searched scientific databases for randomised controlled trials (clinical trials where people are allocated at random to one of two or more treatments) looking at the effects of vitamin K supplementation in healthy adults or those at high risk of developing CVD. We did not include people who already had CVD (e.g. heart attacks and strokes). The evidence is current to September 2014. Only one small trial met our inclusion criteria. It included 60 participants aged 40 to 65 years. This study looked at the effects of vitamin K2 supplements on CVD risk factors (blood pressure and lipid levels) over three months in healthy participants. No differences in these risk factors were seen between the comparison groups, but this was a small study and the findings are limited. The trial did not look at fatal and non-fatal cardiovascular endpoints as it was small and short term. The evidence is currently extremely limited and further high-quality trials are needed so that the effectiveness of vitamin K supplementation for CVD prevention can be determined. The only trial identified for this review was judged to be at low risk of bias (so there was less chance of arriving at the wrong conclusions because of favouritism by the participants or researchers). However the evidence is limited to one small trial and no firm conclusions can be reached at this time. | 10.1002/14651858.CD011148.pub2 | [
"We searched scientific databases for randomised controlled trials (clinical trials where people are allocated at random to one of two or more treatments) looking at the effects of vitamin K supplementation in healthy adults or those at high risk of developing CVD. We did not include people who already had CVD (e.g. heart attacks and strokes). The evidence is current to September 2014. Only one small trial met our inclusion criteria. It included 60 participants aged 40 to 65 years. This study looked at the effects of vitamin K2 supplements on CVD risk factors (blood pressure and lipid levels) over three months in healthy participants. No differences in these risk factors were seen between the comparison groups, but this was a small study and the findings are limited. The trial did not look at fatal and non-fatal cardiovascular endpoints as it was small and short term. The evidence is currently extremely limited and further high-quality trials are needed so that the effectiveness of vitamin K supplementation for CVD prevention can be determined. The only trial identified for this review was judged to be at low risk of bias (so there was less chance of arriving at the wrong conclusions because of favouritism by the participants or researchers). However the evidence is limited to one small trial and no firm conclusions can be reached at this time."
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cochrane-simplification-train-1856 | cochrane-simplification-train-1856 | We included 72 RCTs. The included trials studied the effects of 32 drugs belonging to different pharmacological groups. Only two trials mentioned the primary outcome of morbidity and mortality related to the haemodynamic response to tracheal intubation. Of the secondary outcomes, 40 of the included trials observed arrhythmia only, 11 observed myocardial ischaemia only and 20 observed both arrhythmias and myocardial ischaemia. Arrhythmias were observed in 2932 participants and myocardial ischaemia in 1616 participants. Arrhythmias were observed in 134 out of 993 patients in the control group compared to 80 out of 1939 in the intervention group. The risk of arrhythmias was significantly reduced with pharmacological interventions in the pooled data (Peto odds ratio (OR) 0.19, 95% CI 0.14 to 0.26, P < 0.00001, I2= 47%). Local anaesthetics, calcium channel blockers, beta blockers and narcotics reduced the risk of arrhythmia in the intervention group compared to the control group. Myocardial ischaemia was observed in 21 out of 604 patients in the control group compared to 10 out of 1012 in the treatment group; the result was statistically significant (Peto OR 0.45, 95% CI 0.22 to 0.92, P = 0.03, I2 = 19%). However, in subgroup analysis only local anaesthetics significantly reduced the ECG changes indicating ischaemia, but this evidence came from one study. The majority of the studies had a negative outcome. Hypotension and bradycardia were reported with 40 µg kg-1 intravenous alfentanil, chest rigidity with 75 ug kg-1 alfentanil, and increased bronchomotor tone with sympathetic blockers. There were 17 studies which included high risk patients. Pharmacological treatment in this group resulted in the reduction of arrhythmias when the data from nine trials looking at arrhythmias were pooled (Peto OR 0.18, 95% CI 0.05 to 0.59, P = 0.005, I2 = 80%). The analysis from four studies was not included. Three of these trials looked at the effect of sympathetic blockers but arrhythmias or myocardial ischaemia was observed throughout the perioperative period in two studies and some patients had arrhythmias due to atropine premedication in the third study. In the fourth study the authors mentioned myocardial ischaemia in the objectives section but did not report it in the results. The risk of arrhythmias associated with tracheal intubation was significantly reduced with pre-induction administration of local anaesthetics, calcium channel blockers, beta blockers and narcotics compared to placebo. Pharmacological intervention also reduced the risk of ECG evidence of myocardial ischaemia in the pooled data. Lignocaine pretreatment showed a significant effect but evidence came from one study only. The data suggested that there may be a reduction in ECG evidence of myocardial ischaemia with beta blocker pretreatment but this difference was not statistically significant. There is a need to focus on outcomes rather than haemodynamic measurements alone when studying this response in future trials. | We included adult patients aged 18 years and above undergoing elective surgery in the operating room setting. We found that the effects of drugs on the stress response was the subject of 72 studies. The investigators used 32 drugs. Promising results were seen in the reduction of arrhythmias with intravenous injections of beta blockers (drugs that decrease the heart rate), narcotics (drug used to treat pain), local anaesthetics, and calcium channel blockers (drugs that block movement of calcium). Serious side effects were only reported with high doses of narcotics and an increase in airway pressure was seen in some patients with beta blockers. Only local anaesthetic drugs clearly reduced the risk of myocardial ischaemia but this evidence came from only one trial. There was some difficulty in comparing and interpreting the results of these different trials. Patients at a high risk of complications were investigated in 17 trials. A reduction in arrhythmias with treatment was seen in this high risk group but the number of studies was too small to reach a conclusion. Doctors need to further research the effects of drugs used for blunting the haemodynamic response and their effect on outcomes in terms of morbidity, in a standardized manner. | 10.1002/14651858.CD004087.pub2 | [
"We included adult patients aged 18 years and above undergoing elective surgery in the operating room setting. We found that the effects of drugs on the stress response was the subject of 72 studies. The investigators used 32 drugs. Promising results were seen in the reduction of arrhythmias with intravenous injections of beta blockers (drugs that decrease the heart rate), narcotics (drug used to treat pain), local anaesthetics, and calcium channel blockers (drugs that block movement of calcium). Serious side effects were only reported with high doses of narcotics and an increase in airway pressure was seen in some patients with beta blockers. Only local anaesthetic drugs clearly reduced the risk of myocardial ischaemia but this evidence came from only one trial. There was some difficulty in comparing and interpreting the results of these different trials. Patients at a high risk of complications were investigated in 17 trials. A reduction in arrhythmias with treatment was seen in this high risk group but the number of studies was too small to reach a conclusion. Doctors need to further research the effects of drugs used for blunting the haemodynamic response and their effect on outcomes in terms of morbidity, in a standardized manner."
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cochrane-simplification-train-1857 | cochrane-simplification-train-1857 | We included five trials that recruited 14,624 women, with data analysed for 14,185 women. All trials had adequate allocation concealment, but none had adequate blinding of participants, staff or outcome assessors. Overall and apart from lack of blinding, the risk of bias for the included trials was considered to be low. Overall, routine fetal and umbilical Doppler ultrasound examination in low-risk or unselected populations did not result in increased antenatal, obstetric and neonatal interventions. There were no group differences noted for the review's primary outcomes of perinatal death and neonatal morbidity. Results for perinatal death were as follows: (average risk ratio (RR) 0.80, 95% confidence interval (CI) 0.35 to 1.83; four studies, 11,183 participants). Only one included trial assessed serious neonatal morbidity and found no evidence of group differences (RR 0.99, 95% CI 0.06 to 15.75; one study, 2016 participants). For the comparison of a single Doppler assessment versus no Doppler, evidence for group differences in perinatal death was detected (RR 0.36, 95% CI 0.13 to 0.99; one study, 3891 participants). However, these results are based on a single trial, and we would recommend caution when interpreting this finding. There was no evidence of group differences for the outcomes of caesarean section, neonatal intensive care admissions or preterm birth less than 37 weeks. When the quality of the evidence for the main comparison of 'All Doppler versus no Doppler' was assessed with GRADE software, the outcomes of perinatal death and serious neonatal morbidity data were graded as of low quality. Evidence for the outcome of stillbirth was graded according to regimen subgroups - with a moderate quality rating for stillbirth (fetal/umbilical vessels only) and a low quality rating for stillbirth (fetal/umbilical vessels + uterine artery vessels). Evidence for admission to neonatal intensive care unit was assessed as of moderate quality, and evidence for the outcomes of caesarean section and preterm birth less than 37 weeks was graded as of high quality. There is no available evidence to assess the effect on substantive long-term outcomes such as childhood neurodevelopment and no data to assess maternal outcomes, particularly maternal satisfaction. Existing evidence does not provide conclusive evidence that the use of routine umbilical artery Doppler ultrasound, or combination of umbilical and uterine artery Doppler ultrasound in low-risk or unselected populations benefits either mother or baby. Future studies should be designed to address small changes in perinatal outcome, and should focus on potentially preventable deaths. | It is used in pregnancy to study blood circulation in the baby, uterus and placenta. Using it in high-risk pregnancies, where there is concern about the baby's condition, shows benefits. However, its value as a screening tool in all pregnancies needs to be assessed as there is a possibility of unnecessary interventions and adverse effects. The review of trials of routine Doppler ultrasound of the baby’s vessels in pregnancy identified five studies involving more than 14,000 women and babies. The studies were not of high quality and were all undertaken in the 1990s. There were no improvements identified for either the baby or the mother, though more data would be needed to prove whether it is effective or not for improving outcomes. | 10.1002/14651858.CD001450.pub4 | [
"It is used in pregnancy to study blood circulation in the baby, uterus and placenta. Using it in high-risk pregnancies, where there is concern about the baby's condition, shows benefits. However, its value as a screening tool in all pregnancies needs to be assessed as there is a possibility of unnecessary interventions and adverse effects. The review of trials of routine Doppler ultrasound of the baby’s vessels in pregnancy identified five studies involving more than 14,000 women and babies. The studies were not of high quality and were all undertaken in the 1990s. There were no improvements identified for either the baby or the mother, though more data would be needed to prove whether it is effective or not for improving outcomes."
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cochrane-simplification-train-1858 | cochrane-simplification-train-1858 | Ten trials, involving 361 participants, satisfied the inclusion criteria. All the trials were randomised; two had a parallel design while the remainder had a cross-over design. Although some individual studies reported a beneficial effect of pancreatic enzyme over placebo in improving pain, incidence of steatorrhoea and analgesic consumption, the results of the studies could not be pooled for these outcomes. With the use of pancreatic enzymes, we observed a non-significant benefit for weight loss (kg) (SMD 0.06; 95% CI -0.23 to 0.34); a significant reduction in faecal fat (g/day) (SMD -1.03; 95% CI -1.60 to -0.46) and non-significant difference in subjects' Clinical Global Impression of Disease Symptom Scale (SMD -0.63; 95% CI -1.41 to 0.14). We found no significant benefit in reducing faecal fat with any particular schedule of enzyme preparation or type of enzyme. Another small study did not show any significant benefit of timing the administration of enzyme preparations in relation to meals on faecal fat. The role of pancreatic enzymes for abdominal pain, weight loss, steatorrhoea, analgesic use and quality of life in patients with chronic pancreatitis remains equivocal. Good quality, adequately powered studies are much warranted. | This practice is based on studies which have shown the benefit of pancreatic enzymes on various outcomes such as abdominal pain, weight loss, analgesic use, fatty stools and quality of life. However, a collective conclusion about the role of pancreatic enzymes in chronic pancreatitis patients needs to be established from these studies. This systematic review aimed to collect all published and unpublished data on this subject in order to evaluate whether pancreatic enzymes have any benefit on various parameters in chronic pancreatitis, to compare different types of enzyme preparations and to evaluate whether different dosage schedules have any influence on the various outcomes. We included 10 studies in the review. These studies had enrolled small numbers of patients. Though individual studies showed benefit of varying degrees on the parameters mentioned above, we could not pool the results of these studies. With the evidence available so far, no definitive conclusion can be drawn for the benefit of pancreatic enzymes in patients with chronic pancreatitis. | 10.1002/14651858.CD006302.pub2 | [
"This practice is based on studies which have shown the benefit of pancreatic enzymes on various outcomes such as abdominal pain, weight loss, analgesic use, fatty stools and quality of life. However, a collective conclusion about the role of pancreatic enzymes in chronic pancreatitis patients needs to be established from these studies. This systematic review aimed to collect all published and unpublished data on this subject in order to evaluate whether pancreatic enzymes have any benefit on various parameters in chronic pancreatitis, to compare different types of enzyme preparations and to evaluate whether different dosage schedules have any influence on the various outcomes. We included 10 studies in the review. These studies had enrolled small numbers of patients. Though individual studies showed benefit of varying degrees on the parameters mentioned above, we could not pool the results of these studies. With the evidence available so far, no definitive conclusion can be drawn for the benefit of pancreatic enzymes in patients with chronic pancreatitis."
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cochrane-simplification-train-1859 | cochrane-simplification-train-1859 | Thirty two studies were identified, of which four met the inclusion criteria. One of these had been reported in the original Cochrane review. Since then, three other studies have been reported. One large study, comparing atropine, hyoscine hydrobromide and hyoscine butylbromide, showed no difference between the treatment groups. A smaller cross-over study of octreotide and hyoscine hydrobromide also showed no difference whichever treatment was used first. A third study involving 13 participants showed a significant reduction in the sound of noisy breathing when glycopyrronium was given, in comparison to hyoscine hydrobromide, but there was no placebo control. In our original Cochrane review, we concluded that there was no evidence to show that any intervention, be it pharmacological or non-pharmacological, was superior to placebo in the treatment of noisy breathing. This conclusion has not changed. We acknowledge that in the face of heightened emotions when death is imminent, it is difficult for staff not to intervene. It is therefore likely that the current therapeutic options will continue to be used. However, patients need to be closely monitored for lack of therapeutic benefit and adverse effects while relatives need time, explanation and reassurance to relieve their fears and concerns. There remains a need for well-designed multi-centre studies with objective outcome measures which demonstrates the efficacy of intervention against placebo for this condition. | The aim of this review is to find out which treatment, if any, is best. Only four of 32 reports identified met the inclusion criteria for this review; none showed a convincing benefit of any single drug over any others. Some treatments may be worth trying but staff should watch carefully for any side effects of the treatment (e.g. agitation or excessively dry mouth). Anxious relatives need explanation, reassurance and discussion about any fears and concerns associated with the terminal phase and 'death rattle'. Research in this difficult area is necessary to understand the cause of the noise, its effect on the patient and those around them and the best ways of managing this condition. | 10.1002/14651858.CD005177.pub2 | [
"The aim of this review is to find out which treatment, if any, is best. Only four of 32 reports identified met the inclusion criteria for this review; none showed a convincing benefit of any single drug over any others. Some treatments may be worth trying but staff should watch carefully for any side effects of the treatment (e.g. agitation or excessively dry mouth). Anxious relatives need explanation, reassurance and discussion about any fears and concerns associated with the terminal phase and 'death rattle'. Research in this difficult area is necessary to understand the cause of the noise, its effect on the patient and those around them and the best ways of managing this condition."
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cochrane-simplification-train-1860 | cochrane-simplification-train-1860 | We included 14 studies involving 1469 participants with acute middle third clavicle fractures. All studies included adults, with the overall range from 17 to 70 years. Of the studies that reported gender, men were over-represented. Ten studies compared plate fixation with sling or figure-of-eight bandage, or both, and four studies compared intramedullary fixation with wearing either a sling or a figure-of-eight bandage. Almost all studies had design features that carry a high risk of bias, thus limiting the strength of their findings. Low-quality evidence from 10 studies (838 participants), showed that, compared with conservative treatment, surgical treatment of acute middle third clavicle fractures may not improve upper arm function at follow-up of one year or longer: standardised mean difference (SMD) 0.33, 95% confidence interval (CI) −0.02 to 0.67. We downgraded the quality of the evidence because of risk of bias and high statistical heterogeneity (I2 = 83%). This corresponds to a mean improvement of 2.3 points in favour of surgery (0.14 points worse to 4.69 points better), on the 100-point Constant score; this does not represent a clinically important difference. There may be no difference in pain measured using a visual analogue scale (0 to 100 mm; higher scores mean worse pain) between treatments (mean difference (MD) −0.60 mm, 95% CI −3.51 to 2.31; 277 participants, 3 studies; low-quality evidence reflecting risk of bias and imprecision). Surgery may reduce the risk of treatment failure, that is, number of participants who had non-routine secondary surgical intervention (excluding hardware removal), for symptomatic non-union, malunion or other complication (risk ratio (RR) 0.32, 95% CI 0.20 to 0.50; 1197 participants, 12 studies; low-quality evidence, downgraded for risk of bias and imprecision). The main source of treatment failure was mechanical failure (3.4%) in the surgery group and symptomatic non-union (11.6%) in the conservative-treatment group. We are uncertain whether surgery results in fewer people having one or more cosmetic problems, such as deformities, which were more common after conservative treatment, or hardware prominence or scarring, which only occurred in the surgery group (RR 0.55, 95% CI 0.31 to 0.98; 1130 participants, 11 studies; I2 = 63%; very low-quality evidence downgraded for risk of bias, imprecision and inconsistency). We are uncertain whether there is any difference between surgery and conservative treatment in the risk of incurring an adverse outcome that includes local infection, dehiscence, symptomatic malunion, discomfort leading to implant removal, skin and nerve problems: RR 1.34, 95% CI 0.68 to 2.64; 1317 participants, 14 studies; I2 = 72%; very low-quality evidence, downgraded for risk of bias, imprecision and inconsistency). Hardware removal for discomfort was a common adverse outcome in the surgery group (10.2%) while symptomatic malunion was more common in the conservative-treatment group (11.3% versus 1.2% in the surgery group). Infection occurred only in the surgery group (3.2%). There may be no between-group difference in quality of life at one year (SF-12 or SF-36 physical component scores: 0 to 100 scale, where 100 is the best score): MD 0.30 (95% CI −1.95 to 2.56, 321 participants, 2 studies; low-quality evidence downgraded for risk of bias and imprecision). There is low-quality evidence that surgical treatment has no additional benefits in terms of function, pain and quality of life compared with conservative treatment, but may result in fewer treatment failures overall. Very low-quality evidence means that we are very uncertain of the findings of a slightly better cosmetic result after surgery and of no difference between surgical and conservative treatment in the risk of adverse events. For both composite outcomes, there is a need to consider the balance of risks between the individual outcomes; for example, surgical adverse events, including wound infection or dehiscence and hardware irritation, against risk of adverse events that may be more commonly associated with conservative treatment such as symptomatic malunion and shoulder stiffness. Treatment options must be chosen on an individual patient basis, after careful consideration of the relative benefits and harms of each intervention and of patient preferences. | We searched medical databases up to December 2017 and included 14 studies involving 1469 participants with displaced or angulated middle third clavicle fractures. All participants were adults, ranging in age from 17 to 70 years, and there were more men than women. Ten studies compared plate fixation with conservative intervention (sling and/or figure-of-eight bandage), and four studies compared intramedullary fixation with wearing either a sling or a figure-of-eight bandage. Key results The review showed that surgery compared with conservative treatment may not improve upper arm function, pain and quality of life one year later. However, surgery may reduce the risk of treatment failure where secondary surgery is required for fractures that did not heal or that healed incorrectly. We are uncertain whether surgery provides a better cosmetic result overall. Although surgery reduces shoulder deformity, it can result in unsightly scars and prominent metalwork. We are also uncertain if there is a difference between surgery and conservative treatment in the risk of having a complication. However the nature of such complications often differs according to treatment. Complications of surgery, such as wound infection and opening, or hardware irritation requiring additional surgery, need to be balanced against complications more likely to occur with a sling, such as shoulder stiffness and failure of the fracture to heal properly. Quality of the evidence All 14 studies had weaknesses that could affect the reliability of their results. We considered that the evidence for all outcomes was either of low or very low quality. Conclusion Low-quality evidence indicates that surgery may not result in benefits over conservative treatment, or in more complications. However we are uncertain about these effects and further studies may change these conclusions. | 10.1002/14651858.CD009363.pub3 | [
"We searched medical databases up to December 2017 and included 14 studies involving 1469 participants with displaced or angulated middle third clavicle fractures. All participants were adults, ranging in age from 17 to 70 years, and there were more men than women. Ten studies compared plate fixation with conservative intervention (sling and/or figure-of-eight bandage), and four studies compared intramedullary fixation with wearing either a sling or a figure-of-eight bandage. Key results The review showed that surgery compared with conservative treatment may not improve upper arm function, pain and quality of life one year later. However, surgery may reduce the risk of treatment failure where secondary surgery is required for fractures that did not heal or that healed incorrectly. We are uncertain whether surgery provides a better cosmetic result overall. Although surgery reduces shoulder deformity, it can result in unsightly scars and prominent metalwork. We are also uncertain if there is a difference between surgery and conservative treatment in the risk of having a complication. However the nature of such complications often differs according to treatment. Complications of surgery, such as wound infection and opening, or hardware irritation requiring additional surgery, need to be balanced against complications more likely to occur with a sling, such as shoulder stiffness and failure of the fracture to heal properly. Quality of the evidence All 14 studies had weaknesses that could affect the reliability of their results. We considered that the evidence for all outcomes was either of low or very low quality. Conclusion Low-quality evidence indicates that surgery may not result in benefits over conservative treatment, or in more complications. However we are uncertain about these effects and further studies may change these conclusions."
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cochrane-simplification-train-1861 | cochrane-simplification-train-1861 | We identified 10 trials with a total of 1730 participants randomised, and one ongoing trial. Six trials investigated the provision of fruit and vegetables, and four trials examined advice to increase fruit and vegetable consumption.The ongoing trial is examining the provision of an avocado-rich diet.The number and type of intervention components for provision, and the dietary advice provided differed between trials. None of the trials reported clinical events as they were all relatively short term. There was no strong evidence for effects of individual trials of provision of fruit and vegetables on cardiovascular risk factors, but trials were heterogeneous and short term. Furthermore, five of the six trials only provided one fruit or vegetable. Dietary advice showed some favourable effects on blood pressure (systolic blood pressure (SBP): mean difference (MD) -3.0 mmHg (95% confidence interval (CI) -4.92 to -1.09), diastolic blood pressure (DBP): MD -0.90 mmHg (95% CI -2.03 to 0.24)) and low-density lipoprotein (LDL) cholesterol but analyses were based on only two trials. Three of the 10 included trials examined adverse effects, which included increased bowel movements, bad breath and body odour. There are very few studies to date examining provision of, or advice to increase the consumption of, fruit and vegetables in the absence of additional dietary interventions or other lifestyle interventions for the primary prevention of CVD. The limited evidence suggests advice to increase fruit and vegetables as a single intervention has favourable effects on CVD risk factors but more trials are needed to confirm this. | This review assessed the effectiveness of increasing fruit and vegetable consumption as a single intervention without the influence of other dietary patterns or other lifestyle modifications in healthy adults and those at high risk of CVD for the prevention of CVD. We found 10 trials involving 1730 participants in which six examined the provision of fruit and vegetables to increase intake and four trials examined dietary advice to increase fruit and vegetable intake. There were variations in the type of fruit and vegetable provided but all interventions investigating provision involved only one fruit or vegetable component. There were also variations in the number of fruit and vegetables that participants were advised to eat. Some studies advised participants to eat at least five servings of fruit and vegetables a day while others advised at least eight or nine servings per day.The duration of the interventions ranged from three months to one year. Adverse effects were reported in three of the included trials and included increased bowel movements, bad breath and body odour. None of the included trials were long enough to examine the effect of increased fruit and vegetable consumption on cardiovascular disease events such as heart attacks. There was no strong evidence that provision of one type of fruit or vegetable had beneficial effects on blood pressure and lipid levels but most trials were short term. There was some evidence to suggest beneficial effects of dietary advice to increase fruit and vegetable consumption but this is based on findings from two trials. More trials are needed to confirm these findings. | 10.1002/14651858.CD009874.pub2 | [
"This review assessed the effectiveness of increasing fruit and vegetable consumption as a single intervention without the influence of other dietary patterns or other lifestyle modifications in healthy adults and those at high risk of CVD for the prevention of CVD. We found 10 trials involving 1730 participants in which six examined the provision of fruit and vegetables to increase intake and four trials examined dietary advice to increase fruit and vegetable intake. There were variations in the type of fruit and vegetable provided but all interventions investigating provision involved only one fruit or vegetable component. There were also variations in the number of fruit and vegetables that participants were advised to eat. Some studies advised participants to eat at least five servings of fruit and vegetables a day while others advised at least eight or nine servings per day.The duration of the interventions ranged from three months to one year. Adverse effects were reported in three of the included trials and included increased bowel movements, bad breath and body odour. None of the included trials were long enough to examine the effect of increased fruit and vegetable consumption on cardiovascular disease events such as heart attacks. There was no strong evidence that provision of one type of fruit or vegetable had beneficial effects on blood pressure and lipid levels but most trials were short term. There was some evidence to suggest beneficial effects of dietary advice to increase fruit and vegetable consumption but this is based on findings from two trials. More trials are needed to confirm these findings."
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cochrane-simplification-train-1862 | cochrane-simplification-train-1862 | 74% of patients had FIGO stage IIIB LACC. Treatment outcome was significantly better for patients receiving the combined treatment (Figures 4 to 6). The pooled data analysis yielded a significantly higher complete response rate (relative risk (RR) 0.56; 95% confidence interval (CI) 0.39 to 0.79; p < 0.001), a significantly reduced local recurrence rate (hazard ratio (HR) 0.48; 95% CI 0.37 to 0.63; p < 0.001) and a significantly better overall survival (OS) following the combined treatment with RHT(HR 0.67; 95% CI 0.45 to 0.99; p = 0.05). No significant difference was observed in treatment related acute (RR 0.99; 95% CI 0.30 to 3.31; p = 0.99) or late grade 3 to 4 toxicity (RR 1.01; CI 95% 0.44 to 2.30; p = 0.96) between both treatments. The limited number of patients available for analysis, methodological flaws and a significant over-representation of patients with FIGO stage IIIB prohibit drawing definite conclusions regarding the impact of adding hyperthermia to standard radiotherapy. However, available data do suggest that the addition of hyperthermia improves local tumour control and overall survival in patients with locally advanced cervix carcinoma without affecting treatment related grade 3 to 4 acute or late toxicity. | In several clinical studies it was found that the respons of these tumours to radiotherapy was improved by adding hyperthermia. Hyperthermia is a type of cancer treatment in which body tissue is exposed to high temperatures (i.e. around 42 to 43 degrees Celcius during one hour) to damage and kill cancer cells.. This temperature is in itself able to kill tumour cells under certain conditions and also increases the lethal effect of radiation on tumour cells. can However, the results observed with this treatment were not consistent in subsequent clinical studies. Therefore we analysed the results of all clinical studies published so far comparing the treatment results of radiotherapy alone with the results of combined radiotherapy and hyperthermia in patients with locally advanced cervix carcinoma. The results do suggest a better outcome for patients treated with the combination of radiotherapy with hyperthermia. Thus following treatment a complete disappearance of the tumour was observed more regularly, regrowth of the tumour at the site of origin during follow up was observed less frequently and more patients were still alive at last follow-up. Treatment related side effects were not increased by the addition of hyperthermia to standard radiotherapy. However, the number of patients included in the clinical studies analysed is limited as the majority of patients had stage IIIB disease. The authors therefore conclude that hyperthermia may provide a clinically relevant improvement in treatment outcome for patients with locally advanced cervix carcinoma, in particular patients with stage IIIB disease. Additional clinical data are needed to warrant its use for all patients with locally advanced cervix carcinoma. | 10.1002/14651858.CD006377.pub3 | [
"In several clinical studies it was found that the respons of these tumours to radiotherapy was improved by adding hyperthermia. Hyperthermia is a type of cancer treatment in which body tissue is exposed to high temperatures (i.e. around 42 to 43 degrees Celcius during one hour) to damage and kill cancer cells.. This temperature is in itself able to kill tumour cells under certain conditions and also increases the lethal effect of radiation on tumour cells. can However, the results observed with this treatment were not consistent in subsequent clinical studies. Therefore we analysed the results of all clinical studies published so far comparing the treatment results of radiotherapy alone with the results of combined radiotherapy and hyperthermia in patients with locally advanced cervix carcinoma. The results do suggest a better outcome for patients treated with the combination of radiotherapy with hyperthermia. Thus following treatment a complete disappearance of the tumour was observed more regularly, regrowth of the tumour at the site of origin during follow up was observed less frequently and more patients were still alive at last follow-up. Treatment related side effects were not increased by the addition of hyperthermia to standard radiotherapy. However, the number of patients included in the clinical studies analysed is limited as the majority of patients had stage IIIB disease. The authors therefore conclude that hyperthermia may provide a clinically relevant improvement in treatment outcome for patients with locally advanced cervix carcinoma, in particular patients with stage IIIB disease. Additional clinical data are needed to warrant its use for all patients with locally advanced cervix carcinoma."
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cochrane-simplification-train-1863 | cochrane-simplification-train-1863 | We included four trials involving 94 participants in this review. There was a significant improvement in activity of daily living (mean difference (MD) 13.20 points on the 'Capacidad funcional' (functional capacity) subscale of the Brazilian-Portuguese version of the SF-36; 95% confidence interval (CI) 8.36 to 18.04; P < 0.00001) and on muscle strength (MD 1.01 Nm/kg; 95% CI 0.19 to 1.83; P = 0.02) but these results should be interpreted with caution because population numbers were small and the results are based on single studies. There was no significant improvement in ability to walk (MD 0.14 m/s; 95% CI -0.32 to 0.606; P = 0.55), postural balance (MD 3.05 points; 95% CI -3.41 to 9.52; P = 0.35) or fitness (MD 3.6 (VO2max; 95% CI -0.53 to 7.73; P = 0.09) after water-based exercises treatment compared to control. Adverse effects were not reported. The evidence from randomised controlled trials so far does not confirm or refute that water-based exercises after stroke might help to reduce disability after stroke. There is a lack of hard evidence for water-based exercises after stroke. Better and larger studies are therefore required. | This review of four trials, which included 94 participants, found there is not enough evidence to decide if water-based exercises may reduce disability after stroke. There is a lack of hard evidence for water-based exercises after stroke. More research is therefore needed. | 10.1002/14651858.CD008186.pub2 | [
"This review of four trials, which included 94 participants, found there is not enough evidence to decide if water-based exercises may reduce disability after stroke. There is a lack of hard evidence for water-based exercises after stroke. More research is therefore needed."
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cochrane-simplification-train-1864 | cochrane-simplification-train-1864 | Ten randomised trials were included, involving 3944 adults with predominantly SUI, randomised to receive duloxetine or placebo and/ or PFMT. All arms in individual trials were comparable for various baseline characteristics. Treatment duration was between three weeks and 12 weeks. Duloxetine was significantly better than placebo in terms of improving patients' quality of life (weighted mean difference 5.26, 95% confidence interval 3.84 to 6.68. P less than 0.00001) and perception of improvement. Individual studies demonstrated a significant reduction in the Incontinence Episode Frequency (IEF) by approximately 50% during treatment with duloxetine. With regard to objective cure, however, meta-analysis of stress pad test and 24 hour pad weight change failed to demonstrate a benefit for duloxetine over placebo though data were relatively few. Subjective cure favoured duloxetine, albeit with a small effect size (3%). One trial suggested that duloxetine was better than pelvic floor muscle training alone in reducing IEF (P less than 0.05) based on median percentage decrease in IEF per week. Although significant side effects were commonly associated with duloxetine, they were reported as acceptable. The available evidence suggests that duloxetine treatment can significantly improve the quality of life of patients with stress urinary incontinence, but it is unclear whether or not benefits are sustainable. Adverse effects are common but not serious. About one in three participants allocated duloxetine reported adverse effects (most commonly nausea) related to treatment, and about one in eight allocated duloxetine stopped treatment as a consequence. | The trials reviewed compared duloxetine against dummy placebo tablets and also pelvic floor muscle training in women with predominantly stress urinary incontinence. Duloxetine reduced the frequency of episodes of incontinence and improved quality of life scores. However, it had little impact on the numbers cured and commonly had side effects, especially nausea. More studies comparing a serotonin and noradrenaline reuptake inhibitor with placebo and surgery are required, especially if conducted independently of pharmaceutical companies. | 10.1002/14651858.CD004742.pub2 | [
"The trials reviewed compared duloxetine against dummy placebo tablets and also pelvic floor muscle training in women with predominantly stress urinary incontinence. Duloxetine reduced the frequency of episodes of incontinence and improved quality of life scores. However, it had little impact on the numbers cured and commonly had side effects, especially nausea. More studies comparing a serotonin and noradrenaline reuptake inhibitor with placebo and surgery are required, especially if conducted independently of pharmaceutical companies."
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cochrane-simplification-train-1865 | cochrane-simplification-train-1865 | Eleven studies were eligible for this systematic review, with a total of 1817 people. Three studies included only people who experienced clinically relevant fatigue (Fatigue Severity Scale score ≥ 4 out of 7 or Multidimensional Fatigue Inventory total score > 48 out of 100), whereas all other studies did not select participants on the basis of experienced fatigue. Nine studies investigated the effects of medication (i.e. levodopa-carbidopa, memantine, rasagiline, caffeine, methylphenidate, modafinil or doxepin) on subjective fatigue. All studies were placebo controlled. There was insufficient evidence to determine the effect of doxepin on the impact of fatigue on activities in daily life (ADL) or fatigue severity (one study, N = 12, standardised mean difference (SMD) = -1.50, 95% confidence interval (CI) -2.84 to -0.15; low quality evidence). We found high quality evidence that rasagiline reduced or slowed down the progression of physical aspects of fatigue (one study, N = 1176, SMD = -0.27, 95% CI -0.39 to -0.16, I2 = 0%). None of the other pharmacological interventions affected subjective fatigue in PD. With regard to adverse effects, only levodopa-carbidopa showed an increase for the risk of nausea (one study, N = 361, risk ratio (RR) = 1.85, 95% CI 1.05 to 3.27; high quality evidence). Two studies investigated the effect of exercise on fatigue compared with usual care. We found low quality evidence for the effect of exercise on reducing the impact of fatigue on ADL or fatigue severity (two studies, N = 57, SMD = -0.45, 95% CI -1.21 to 0.32, I2 = 44%). Based on the current evidence, no clear recommendations for the treatment of subjective fatigue in PD can be provided. Doxepin may reduce the impact of fatigue on ADL and fatigue severity; however, this finding has to be confirmed in high quality studies. Rasagiline may be effective in reducing levels of physical fatigue in PD. No evidence was found for the effectiveness of levodopa-carbidopa, memantine, caffeine, methylphenidate, modafinil or exercise. Studies are needed to investigate the effect of exercise intensity on exercise capacity and subjective fatigue. Future studies should focus on interventions that address the maladaptive behavioural or cognitive aspects of fatigue in people with PD. Characteristics, such as severity and nature of perceived fatigue and underlying mood disorders should be considered to identify responders and non-responders when studying interventions for fatigue. The development of a core-set of self-report fatigue questionnaires with established responsiveness and known minimal important difference values will facilitate the interpretation of change in fatigue scores. | We reviewed the medical literature up to April 2015, and found 11 studies that included a total of 1817 people. Nine studies investigated the effects of medication (i.e. levodopa-carbidopa, memantine, rasagiline, caffeine, methylphenidate, modafinil or doxepin) on fatigue. Two studies investigated the effects of exercise on fatigue. We found no studies that investigated the effect of cognitive-behavioural therapy. We found that doxepin (one study, 12 people, low quality evidence), a drug to treat depression, may reduce fatigue. We found that rasagiline (one study, 1176 people, high quality evidence), an anti-Parkinson drug, reduced or slowed down the progression of physical fatigue. Most drugs were safe; however, levodopa-carbidopa (one study, 361 people, high quality evidence) may cause nausea. We found no evidence that exercise (two studies, 57 people, low quality evidence) reduces fatigue in Parkinson's disease. Based on the current evidence, it is not clear what treatment is most effective to treat fatigue in people with Parkinson's disease. Future studies should investigate the effect of cognitive-behavioural therapy on fatigue in people with Parkinson's disease. | 10.1002/14651858.CD010925.pub2 | [
"We reviewed the medical literature up to April 2015, and found 11 studies that included a total of 1817 people. Nine studies investigated the effects of medication (i.e. levodopa-carbidopa, memantine, rasagiline, caffeine, methylphenidate, modafinil or doxepin) on fatigue. Two studies investigated the effects of exercise on fatigue. We found no studies that investigated the effect of cognitive-behavioural therapy. We found that doxepin (one study, 12 people, low quality evidence), a drug to treat depression, may reduce fatigue. We found that rasagiline (one study, 1176 people, high quality evidence), an anti-Parkinson drug, reduced or slowed down the progression of physical fatigue. Most drugs were safe; however, levodopa-carbidopa (one study, 361 people, high quality evidence) may cause nausea. We found no evidence that exercise (two studies, 57 people, low quality evidence) reduces fatigue in Parkinson's disease. Based on the current evidence, it is not clear what treatment is most effective to treat fatigue in people with Parkinson's disease. Future studies should investigate the effect of cognitive-behavioural therapy on fatigue in people with Parkinson's disease."
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cochrane-simplification-train-1866 | cochrane-simplification-train-1866 | Twenty-five studies met the inclusion criteria, but only 23 studies contributed data to the review. These 23 trials recruited 18,587 women, with 17,842 women included in final analyses. There were no statistically significant differences between women who received calcium supplementation and those who did not in terms of reducing preterm births less than 37 weeks' gestation (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.70 to 1.05; 13 studies, 16,139 women; random-effects model) or less than 34 weeks' gestation (RR 1.04, 95% CI 0.80 to 1.36; four trials, 5669). Most studies were of low risk of bias. We conducted sensitivity analysis for the outcome of preterm birth less than 37 weeks by removing two trials with unclear risk of bias for allocation concealment; the results then favoured treatment with calcium supplementation (RR 0.80, 95% CI 0.65 to 0.99; 11 trials, 15,379 women). There was no significant difference in infant low birthweight between the two treatment groups (RR 0.93, 95% CI 0.81 to 1.07; six trials, 14,162 infants; random-effects model). However, when compared to the control group, women in the calcium supplementation group gave birth to slightly heavier birthweight infants (mean difference 56.40, 95% CI 13.55 to 99.25; 21 trials, 9202 women; random-effects model). Three outcomes were chosen for assessment with the GRADE software: preterm birth less than 37 weeks; preterm birth less than 34 weeks; and low birthweight less than 2500 g. Evidence for these outcomes was assessed as of moderate quality. This review indicates that there are no clear additional benefits to calcium supplementation in prevention of preterm birth or low infant birthweight. While there was a statistically significant difference of 56 g identified in mean infant birthweight, there was significant heterogeneity identified, and the clinical significance of this difference is uncertain. | In our review, regular intake of extra calcium tablets during pregnancy did not improve the number of preterm births or other infant outcomes, except for a slight increase in infant birthweight in the group of women who received calcium supplementation. Most studies included in this review were assessed as of low risk of bias, and evidence for specific outcomes was graded as of moderate quality, Taking calcium supplementation did not appear to have any obvious side effects. Our review included 25 randomised controlled studies, but only 23 studies involving 18,587 women contributed outcome data. The majority of the evidence was based on fewer numbers of studies. | 10.1002/14651858.CD007079.pub3 | [
"In our review, regular intake of extra calcium tablets during pregnancy did not improve the number of preterm births or other infant outcomes, except for a slight increase in infant birthweight in the group of women who received calcium supplementation. Most studies included in this review were assessed as of low risk of bias, and evidence for specific outcomes was graded as of moderate quality, Taking calcium supplementation did not appear to have any obvious side effects. Our review included 25 randomised controlled studies, but only 23 studies involving 18,587 women contributed outcome data. The majority of the evidence was based on fewer numbers of studies."
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cochrane-simplification-train-1867 | cochrane-simplification-train-1867 | We included 25 studies involving 4121 participants (2511 children and 1517 adults; 93 mixed population). Four studies were of high quality with no risk of bias, 14 of medium quality and seven of low quality, indicating a moderate risk of bias for the total analysis. Nine studies were performed in low-income countries and 16 in high-income countries. There was insufficient evidence that corticosteroids caused a reduction in mortality overall (17.8% versus 19.9%; risk ratio (RR) 0.90, 95% confidence interval (CI) 0.80 to 1.01; P = 0.07), or for adults (RR 0.74, 95% CI 0.53 to 1.05; P = 0.09). However they caused lower rates of severe hearing loss (RR 0.67, 95% CI 0.51 to 0.88), any hearing loss (RR 0.74, 95% CI 0.63 to 0.87) and neurological sequelae (RR 0.83, 95% CI 0.69 to 1.00). Subgroup analyses for causative organisms showed that corticosteroids reduced mortality in Streptococcus pneumoniae (S pneumoniae) meningitis (RR 0.84, 95% CI 0.72 to 0.98), but not in Haemophilus influenzae (H influenzae) orNeisseria meningitidis (N meningitidis) meningitis. Corticosteroids reduced severe hearing loss in children with H influenzae meningitis (RR 0.34, 95% CI 0.20 to 0.59) but not in children with meningitis due to non-Haemophilus species. In high-income countries, corticosteroids reduced severe hearing loss (RR 0.51, 95% CI 0.35 to 0.73), any hearing loss (RR 0.58, 95% CI 0.45 to 0.73) and short-term neurological sequelae (RR 0.64, 95% CI 0.48 to 0.85). There was no beneficial effect of corticosteroid therapy in low-income countries. Subgroup analysis for study quality showed no effect of corticosteroids on severe hearing loss in high-quality studies. Corticosteroid treatment was associated with an increase in recurrent fever (RR 1.27, 95% CI 1.09 to 1.47), but not with other adverse events. Corticosteroids significantly reduced hearing loss and neurological sequelae, but did not reduce overall mortality. Data support the use of corticosteroids in patients with bacterial meningitis in high-income countries. We found no beneficial effect in low-income countries. | The evidence is current to February 2015. We identified 25 trials, including 4121 participants with acute bacterial meningitis of which seven were performed in adults (over 16 years old), two included both children and adults and the other were performed in children. In 22 studies the corticosteroid used was dexamethasone, in three others hydrocortisone or prednisone were used. Nine studies were performed in low-income countries and 16 in high-income countries. This review found that the corticosteroid dexamethasone did not significantly reduce the death rate (17.8% versus 19.9%). Patients treated with corticosteroids had significantly lower rates of severe hearing loss (6.0% versus 9.3%), any hearing loss (13.8% versus 19.0%) and neurological sequelae (17.9% versus 21.6%). An analysis for different bacteria causing meningitis showed that patients with meningitis due to Streptococcus pneumoniae (S pneumoniae) treated with corticosteroids had a lower death rate (29.9% versus 36.0%), while no effect on mortality was seen in patients with Haemophilus influenzae (H influenzae) and Neisseria meningitidis (N meningitidis) meningitis. In high-income countries, corticosteroids reduced severe hearing loss, any hearing loss and short-term neurological sequelae. There was no beneficial effect of corticosteroid therapy in low-income countries. Corticosteroids decreased the rate of hearing loss in children with meningitis due to H influenzae (4% versus 12%), but not in children with meningitis due to other bacteria. Dexamethasone increased the rate of recurrent fever (28% versus 22%) but was not associated with other adverse events. Out of 25 studies, four were of high quality, 14 of medium quality and seven of low quality, leading to a moderate overall quality of evidence. | 10.1002/14651858.CD004405.pub5 | [
"The evidence is current to February 2015. We identified 25 trials, including 4121 participants with acute bacterial meningitis of which seven were performed in adults (over 16 years old), two included both children and adults and the other were performed in children. In 22 studies the corticosteroid used was dexamethasone, in three others hydrocortisone or prednisone were used. Nine studies were performed in low-income countries and 16 in high-income countries. This review found that the corticosteroid dexamethasone did not significantly reduce the death rate (17.8% versus 19.9%). Patients treated with corticosteroids had significantly lower rates of severe hearing loss (6.0% versus 9.3%), any hearing loss (13.8% versus 19.0%) and neurological sequelae (17.9% versus 21.6%). An analysis for different bacteria causing meningitis showed that patients with meningitis due to Streptococcus pneumoniae (S pneumoniae) treated with corticosteroids had a lower death rate (29.9% versus 36.0%), while no effect on mortality was seen in patients with Haemophilus influenzae (H influenzae) and Neisseria meningitidis (N meningitidis) meningitis. In high-income countries, corticosteroids reduced severe hearing loss, any hearing loss and short-term neurological sequelae. There was no beneficial effect of corticosteroid therapy in low-income countries. Corticosteroids decreased the rate of hearing loss in children with meningitis due to H influenzae (4% versus 12%), but not in children with meningitis due to other bacteria. Dexamethasone increased the rate of recurrent fever (28% versus 22%) but was not associated with other adverse events. Out of 25 studies, four were of high quality, 14 of medium quality and seven of low quality, leading to a moderate overall quality of evidence."
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cochrane-simplification-train-1868 | cochrane-simplification-train-1868 | The search identified 813 references on MEDLINE, 418 on EMBASE, 22 on CINAHL, 666 on PubMed, 291 on PsycINFO and 145 on CENTRAL. When all references were imported into EndNote and duplications were removed, 1348 references remained. Initial screening of titles and abstracts of these references revealed that 42 references were potentially eligible for this review. After reading the full-text versions, we identified no relevant trials comparing hrHPV and cytology testing versus cytology testing alone for detecting residual or recurrent disease during follow-up to LLETZ treatment of adult women with CIN. We found no evidence on the effects of hrHPV and cytology testing on residual or recurrent CIN2 or higher lesions, anxiety and psychosexual morbidity outcomes in women undergoing colposcopy and treatment for CIN. We found no evidence from RCTs to inform decisions about the best surveillance strategy for women following treatment for CIN. A prognostic systematic review is needed to investigate the risk of developing recurrent cervical intraepithelial neoplasia 2+ (CIN2+) in women with a positive hrHPV test after large loop excision of the transformation zone (LLETZ) treatment. | We searched for randomised control trials (RCTs) that compared follow-up management strategies following LLETZ treatment for CIN. We checked 1348 titles and abstracts of potentially relevant references, but we identified no randomised controlled trials (RCTs) that met our inclusion criteria. We identified trials of interest, but they were deemed not relevant because of their focus on diagnostic outcomes and examination of how sensitive tests are, rather than on the effects of different follow-up strategies on long-term outcomes. Currently no evidence indicates whether hrHPV post-treatment testing is better or worse in terms of important long-term clinical outcomes. This review highlights the need for good quality trials in this area that do not focus solely on the diagnostic accuracy of testing. We found no evidence from RCTs to inform decisions about the best surveillance strategy following treatment for CIN. A prognostic systematic review is needed to investigate the risks and benefits of different follow-up strategies for women after LLETZ treatment. | 10.1002/14651858.CD010757.pub2 | [
"We searched for randomised control trials (RCTs) that compared follow-up management strategies following LLETZ treatment for CIN. We checked 1348 titles and abstracts of potentially relevant references, but we identified no randomised controlled trials (RCTs) that met our inclusion criteria. We identified trials of interest, but they were deemed not relevant because of their focus on diagnostic outcomes and examination of how sensitive tests are, rather than on the effects of different follow-up strategies on long-term outcomes. Currently no evidence indicates whether hrHPV post-treatment testing is better or worse in terms of important long-term clinical outcomes. This review highlights the need for good quality trials in this area that do not focus solely on the diagnostic accuracy of testing. We found no evidence from RCTs to inform decisions about the best surveillance strategy following treatment for CIN. A prognostic systematic review is needed to investigate the risks and benefits of different follow-up strategies for women after LLETZ treatment."
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cochrane-simplification-train-1869 | cochrane-simplification-train-1869 | Ten of 31 studies identified were included (959 patients). Five studies with a low risk of bias examined azithromycin versus placebo and demonstrated consistent improvement in forced expiratory volume in one second over six months (mean difference at six months 3.97% (95% confidence interval 1.74% to 6.19%; n = 549, from four studies)). Patients treated with azithromycin were approximately twice as likely to be free of pulmonary exacerbation at six months, odds ratio 1.96 (95% confidence interval 1.15 to 3.33). With respect to secondary outcomes, there was a significant reduction in need for oral antibiotics and greater weight gain in those taking azithromycin. Adverse events were uncommon and not obviously associated with azithromycin, although a once-weekly high dose regimen was associated with more frequent gastrointestinal adverse events. Treatment with azithromycin was associated with reduced identification of Staphylococcus aureus on respiratory culture, but also a significant increase in macrolide resistance. This review provides evidence of improved respiratory function after six months of azithromycin. Data beyond six months were less clear, although reduction in pulmonary exacerbation was sustained. Treatment appeared safe over a six-month period; however, emergence of macrolide resistance was a concern. A multi-centre trial examining long-term effects of this antibiotic treatment is needed, especially for infants recognised through newborn screening. | We have included ten randomised controlled trials with a total of 959 participants in this review. Eight of these trials compared azithromycin (a macrolide antibiotic) to placebo and two compared different doses of azithromycin. Four trials in children and adults (549 participants) showed significant improvements in lung function after treatment with azithromycin compared to placebo at six months; although data from later time points are not so clear. Patients treated with azithromycin were about twice as likely to be free of pulmonary exacerbation; needed fewer oral antibiotics and had fewer instances of Staphylococcus aureus in cultures from their lungs and airways. Adverse events were not common and not obviously associated with azithromycin, although there was an increase in resistance to macrolides. Most studies used a three times a week dosing schedule. Taking a high weekly dose was linked to an increase in mild gastrointestinal adverse events. Further multicentre studies are needed to look at the long-term effects of this antibiotic treatment, especially for infants diagnosed through newborn screening. | 10.1002/14651858.CD002203.pub4 | [
"We have included ten randomised controlled trials with a total of 959 participants in this review. Eight of these trials compared azithromycin (a macrolide antibiotic) to placebo and two compared different doses of azithromycin. Four trials in children and adults (549 participants) showed significant improvements in lung function after treatment with azithromycin compared to placebo at six months; although data from later time points are not so clear. Patients treated with azithromycin were about twice as likely to be free of pulmonary exacerbation; needed fewer oral antibiotics and had fewer instances of Staphylococcus aureus in cultures from their lungs and airways. Adverse events were not common and not obviously associated with azithromycin, although there was an increase in resistance to macrolides. Most studies used a three times a week dosing schedule. Taking a high weekly dose was linked to an increase in mild gastrointestinal adverse events. Further multicentre studies are needed to look at the long-term effects of this antibiotic treatment, especially for infants diagnosed through newborn screening."
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cochrane-simplification-train-1870 | cochrane-simplification-train-1870 | Twelve studies (2146 participants) that compared 5-ASA to placebo were included. We did not identify any studies that compared sulphasalazine to placebo. Seven studies were judged to be at low risk of bias. The other studies were judged to have an unclear risk of bias for various items due to insufficient details to allow for a judgement. There was no statistically significant difference in relapse rates at 12 months. Fifty-three per cent (526/998) of 5-ASA patients (dose 1.6 g to 4 g/day) relapsed at 12 months compared to 54% (544/1016) of placebo patients (RR 0.98, 95% CI 0.91 to 1.07; 11 studies; 2014 patients; moderate-quality evidence). Sensitivity analyses based on an available case analysis and a random-effects model had no impact on the results. One study found no difference in relapse rates at 24 months. Fifty-four per cent (31/57) of 5-ASA patients (dose 2 g/day) relapsed at 24 months compared to 58% (36/62) of placebo patients (RR 0.94, 95% CI 0.68 to 1.29, 119 patients; low-quality evidence). One paediatric study found no statistically significant difference in relapse rates at 12 months. Sixty-two per cent (29/47) of paediatric 5-ASA patients (dose 50 mg/kg/day) relapsed at 12 months compared to 64% (35/55) of paediatric placebo patients (RR 0.97, 95% CI 0.72 to 1.31; 102 patients; moderate-quality evidence). There was no statistically significant difference in the proportion of patients who experienced an adverse event, withdrawal due to adverse events or serious adverse events. Thirty-four per cent (307/900) of 5-ASA patients had at least one adverse event compared to 33% (301/914) of placebo patients (RR 1.05, 95% CI 0.95 to 1.17; 10 studies; 1814 patients). Fourteen per cent (127/917) of 5-ASA patients withdrew due to adverse events compared to 13% (119/916) of placebo patients (RR 1.11, 95% CI 0.88 to 1.38; 9 studies; 1833 patients). One per cent (3/293) of 5-ASA patients had a serious adverse event compared to 0.7% (2/283) of placebo patients (RR 1.43, 95% CI 0.24 to 2.83; 3 studies; 576 patients). Common adverse events reported in the studies included diarrhoea, nausea and vomiting, abdominal pain, headache and skin rash. We found no evidence in this review to suggest that oral 5-ASA preparations are superior to placebo for the maintenance of medically-induced remission in patients with Crohn's disease. Additional randomised trials may not be justified. | We found 12 studies that included a total of 2146 participants. Eleven studies including 2014 adult participants compared oral 5-ASA to a placebo (i.e. inactive pills or tablets). One study including 132 children compared oral 5-ASA to a placebo. Eleven studies were conducted for 12 months and one study was conducted for 24 months. Seven studies were judged to be of high quality and the other studies were judged to be of unclear quality because insufficient details were reported to allow for a judgement about quality. The studies with insufficient details were generally older studies that were published 20 or more years ago. A combined analysis of eleven studies including 2014 adult participants found no difference between oral 5-ASA (at daily doses between 1.6 g to 4 g) and placebo in the proportion of participants who remained in remission at 12 months. Similarly, a study including 161 adult participants found no difference between oral 5-ASA (at a dose of 2 g per day) and placebo in the proportion of participants who remained in remission at 24 months. The study involving children found no difference between oral 5-ASA (at a daily dose of 50 mg/kg) and placebo in the proportion of participants who remained in remission at 12 months. There does not appear to be an increased risk of side effects in people who take oral 5-ASA compared to placebo. Common adverse events reported in the studies included diarrhoea, nausea and vomiting, abdominal pain, headache and skin rash. In conclusion, there is no evidence that oral 5-ASA is superior to placebo for helping people with Crohn's disease remain in remission that was achieved by medical therapy. | 10.1002/14651858.CD003715.pub3 | [
"We found 12 studies that included a total of 2146 participants. Eleven studies including 2014 adult participants compared oral 5-ASA to a placebo (i.e. inactive pills or tablets). One study including 132 children compared oral 5-ASA to a placebo. Eleven studies were conducted for 12 months and one study was conducted for 24 months. Seven studies were judged to be of high quality and the other studies were judged to be of unclear quality because insufficient details were reported to allow for a judgement about quality. The studies with insufficient details were generally older studies that were published 20 or more years ago. A combined analysis of eleven studies including 2014 adult participants found no difference between oral 5-ASA (at daily doses between 1.6 g to 4 g) and placebo in the proportion of participants who remained in remission at 12 months. Similarly, a study including 161 adult participants found no difference between oral 5-ASA (at a dose of 2 g per day) and placebo in the proportion of participants who remained in remission at 24 months. The study involving children found no difference between oral 5-ASA (at a daily dose of 50 mg/kg) and placebo in the proportion of participants who remained in remission at 12 months. There does not appear to be an increased risk of side effects in people who take oral 5-ASA compared to placebo. Common adverse events reported in the studies included diarrhoea, nausea and vomiting, abdominal pain, headache and skin rash. In conclusion, there is no evidence that oral 5-ASA is superior to placebo for helping people with Crohn's disease remain in remission that was achieved by medical therapy."
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cochrane-simplification-train-1871 | cochrane-simplification-train-1871 | We identified 33 randomised controlled trials, from 6 countries and in a range of settings. A total of 8244 patients was randomised and entered into studies. The most common interventions were question checklists and patient coaching. Most interventions were delivered immediately before the consultations. Commonly-occurring outcomes were: question asking, patient participation, patient anxiety, knowledge, satisfaction and consultation length. A minority of studies showed positive effects for these outcomes. Meta-analyses, however, showed small and statistically significant increases for question asking (standardised mean difference (SMD) 0.27 (95% confidence interval (CI) 0.19 to 0.36)) and patient satisfaction (SMD 0.09 (95% CI 0.03 to 0.16)). There was a notable but not statistically significant decrease in patient anxiety before consultations (weighted mean difference (WMD) -1.56 (95% CI -7.10 to 3.97)). There were small and not statistically significant changes in patient anxiety after consultations (reduced) (SMD -0.08 (95%CI -0.22 to 0.06)), patient knowledge (reduced) (SMD -0.34 (95% CI -0.94 to 0.25)), and consultation length (increased) (SMD 0.10 (95% CI -0.05 to 0.25)). Further analyses showed that both coaching and written materials produced similar effects on question asking but that coaching produced a smaller increase in consultation length and a larger increase in patient satisfaction. Interventions immediately before consultations led to a small and statistically significant increase in consultation length, whereas those implemented some time before the consultation had no effect. Both interventions immediately before the consultation and those some time before it led to small increases in patient satisfaction, but this was only statistically significant for those immediately before the consultation. There appear to be no clear benefits from clinician training in addition to patient interventions, although the evidence is limited. Interventions before consultations designed to help patients address their information needs within consultations produce limited benefits to patients. Further research could explore whether the quality of questions is increased, whether anxiety before consultations is reduced, the effects on other outcomes and the impact of training and the timing of interventions. More studies need to consider the timing of interventions and possibly the type of training provided to clinicians. | We identified 33 randomised controlled trials involving 8244 patients from six countries, mainly the USA, in a range of clinical settings. Most interventions, which included written materials (for example, question prompt sheets) and coaching sessions, were delivered in the waiting room immediately before the consultation. They were compared to dummy interventions or usual care. Health issues included primary care and family medicine, cancer, diabetes, heart problems, women's issues, peptic ulcer and mental illness. We found small increases in question asking and patient satisfaction and a possible reduction in patient anxiety before and after consultations. We also found a possible reduction in patient knowledge and a possible small increase in consultation length. Both coaching and written materials produced similar effects on asking questions but coaching had a larger benefit in terms of patient satisfaction. Interventions immediately before the consultation led to a small increase in patient satisfaction whereas giving the intervention some time before did not. Interventions immediately before the consultation also resulted in small increases in consultation length, particularly when using written materials rather than coaching. Interventions some time before the consultation did not alter consultation time. The interventions seem to help patients ask more questions in consultations, but do not have other clear benefits. Doctors and nurses need to continue to try to help their patients ask questions in consultations and question prompt sheets or coaching may help in some circumstances. | 10.1002/14651858.CD004565.pub2 | [
"We identified 33 randomised controlled trials involving 8244 patients from six countries, mainly the USA, in a range of clinical settings. Most interventions, which included written materials (for example, question prompt sheets) and coaching sessions, were delivered in the waiting room immediately before the consultation. They were compared to dummy interventions or usual care. Health issues included primary care and family medicine, cancer, diabetes, heart problems, women's issues, peptic ulcer and mental illness. We found small increases in question asking and patient satisfaction and a possible reduction in patient anxiety before and after consultations. We also found a possible reduction in patient knowledge and a possible small increase in consultation length. Both coaching and written materials produced similar effects on asking questions but coaching had a larger benefit in terms of patient satisfaction. Interventions immediately before the consultation led to a small increase in patient satisfaction whereas giving the intervention some time before did not. Interventions immediately before the consultation also resulted in small increases in consultation length, particularly when using written materials rather than coaching. Interventions some time before the consultation did not alter consultation time. The interventions seem to help patients ask more questions in consultations, but do not have other clear benefits. Doctors and nurses need to continue to try to help their patients ask questions in consultations and question prompt sheets or coaching may help in some circumstances."
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cochrane-simplification-train-1872 | cochrane-simplification-train-1872 | The updated search in June 2011 did not identify any new trials. One study is included in the review. This study assessed the effect of intraventricular gentamicin in a mixed population of neonates (69%) and older infants (31%) with gram-negative meningitis and ventriculitis. Mortality was statistically significantly higher in the group that received intraventricular gentamicin in addition to intravenous antibiotics compared to the group receiving intravenous antibiotics alone (RR 3.43; 95% CI 1.09 to 10.74; RD 0.30; 95% CI 0.08 to 0.53); NNTH 3; 95% CI 2 to 13). Duration of CSF culture positivity did not differ significantly (MD -1.20 days; 95% CI -2.67 to 0.27). In one trial that enrolled infants with gram-negative meningitis and ventriculitis, the use of intraventricular antibiotics in addition to intravenous antibiotics resulted in a three-fold increased RR for mortality compared to standard treatment with intravenous antibiotics alone. Based on this result, intraventricular antibiotics as tested in this trial should be avoided. Further trials comparing these interventions are not justified in this population. | Only one trial was identified. In this trial enrolling infants with gram-negative meningitis and ventriculitis, the use of intraventricular antibiotics in addition to intravenous antibiotics resulted in a three-fold increased risk for mortality compared to standard treatment with intravenous antibiotics alone. Based on this result, intraventricular antibiotics should be avoided. Further trials comparing these interventions are not justified in newborn infants. | 10.1002/14651858.CD004496.pub3 | [
"Only one trial was identified. In this trial enrolling infants with gram-negative meningitis and ventriculitis, the use of intraventricular antibiotics in addition to intravenous antibiotics resulted in a three-fold increased risk for mortality compared to standard treatment with intravenous antibiotics alone. Based on this result, intraventricular antibiotics should be avoided. Further trials comparing these interventions are not justified in newborn infants."
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cochrane-simplification-train-1873 | cochrane-simplification-train-1873 | We included 11 studies in our synthesis, involving 267 participants (one study did not report the number of participants). Five more studies are awaiting classification and will be dealt with when we update the review. The quality of the evidence was mixed; of the 35 summary statements, we assessed 17 as ‘low’, 13 as ‘moderate’ and five as ‘high’ confidence. Our synthesis produced nine analytical themes, which report potential barriers and facilitators to the use of protocols. The themes are: the need for continual staff training and development; clinical experience as this promotes felt and perceived competence and confidence to wean; the vulnerability of weaning to disparate interprofessional working; an understanding of protocols as militating against a necessary proactivity in clinical practice; perceived nursing scope of practice and professional risk; ICU structure and processes of care; the ability of protocols to act as a prompt for shared care and consistency in weaning practice; maximizing the use of protocols through visibility and ease of implementation; and the ability of protocols to act as a framework for communication with parents. There is a clear need for weaning protocols to take account of the social and cultural environment in which they are to be implemented. Irrespective of its inherent strengths, a protocol will not be used if it does not accommodate these complexities. In terms of protocol development, comprehensive interprofessional input will help to ensure broad-based understanding and a sense of ‘ownership’. In terms of implementation, all relevant ICU staff will benefit from general weaning as well as protocol-specific training; not only will this help secure a relevant clinical knowledge base and operational understanding, but will also demonstrate to others that this knowledge and understanding is in place. In order to maximize relevance and acceptability, protocols should be designed with the patient profile and requirements of the target ICU in mind. Predictably, an under-resourced ICU will impact adversely on protocol implementation, as staff will prioritize management of acutely deteriorating and critically-ill patients. | Our synthesis included 11 studies, involving around 267 participants; five more studies are awaiting classification. We identified several potential barriers and facilitators to the use of protocols. First, doctors used protocols only in certain circumstances; otherwise they preferred to wean using their own knowledge and skills. Relatively inexperienced nurses often lacked confidence. A protocol could encourage their involvement in weaning because it set out clear instructions and also helped them to feel more secure. Although more experienced nurses also recognized these positive qualities, they criticized protocols as sometimes instructing them to wean contrary to their own clinical judgement. Second, the practical arrangements for care within an ICU could either help or hinder healthcare professionals to work together, and in this way influence how (well) a protocol was used. Third, the use of a protocol reflected how healthcare professionals interact with one another generally. For example, the degree of experience a nurse or doctor possessed could influence the confidence others had that they could wean safely. For this reason, doctors tended to be reluctant to involve nurses they considered to be relatively inexperienced in weaning, even when there was a protocol in place. Furthermore, the fact that doctors occupied a higher professional status or position meant that it was difficult for nurses to be involved in weaning, including by using a protocol, unless the doctors s/he worked with permitted this to happen. We developed 35 summary statements. Of these: we assessed 17 statements as ‘low’ confidence, largely because the evidence used to develop them came from only a small number of studies. We rated 13 statements as ‘moderate’ confidence, largely because the evidence used to develop them came from very well-conducted studies, and we rated five statements as ‘high’ confidence, largely because the evidence used to develop them came from a majority of the studies. | 10.1002/14651858.CD011812.pub2 | [
"Our synthesis included 11 studies, involving around 267 participants; five more studies are awaiting classification. We identified several potential barriers and facilitators to the use of protocols. First, doctors used protocols only in certain circumstances; otherwise they preferred to wean using their own knowledge and skills. Relatively inexperienced nurses often lacked confidence. A protocol could encourage their involvement in weaning because it set out clear instructions and also helped them to feel more secure. Although more experienced nurses also recognized these positive qualities, they criticized protocols as sometimes instructing them to wean contrary to their own clinical judgement. Second, the practical arrangements for care within an ICU could either help or hinder healthcare professionals to work together, and in this way influence how (well) a protocol was used. Third, the use of a protocol reflected how healthcare professionals interact with one another generally. For example, the degree of experience a nurse or doctor possessed could influence the confidence others had that they could wean safely. For this reason, doctors tended to be reluctant to involve nurses they considered to be relatively inexperienced in weaning, even when there was a protocol in place. Furthermore, the fact that doctors occupied a higher professional status or position meant that it was difficult for nurses to be involved in weaning, including by using a protocol, unless the doctors s/he worked with permitted this to happen. We developed 35 summary statements. Of these: we assessed 17 statements as ‘low’ confidence, largely because the evidence used to develop them came from only a small number of studies. We rated 13 statements as ‘moderate’ confidence, largely because the evidence used to develop them came from very well-conducted studies, and we rated five statements as ‘high’ confidence, largely because the evidence used to develop them came from a majority of the studies."
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cochrane-simplification-train-1874 | cochrane-simplification-train-1874 | There were 18 trials that were eligible for inclusion, five of these were still ongoing.Thirteen completed published trials (2331 participants) were included for analysis in the review. The original review contained nine trials (718 participants). This updated review includes six new trials (1818 participants).Two trials (205 participants) in the original review are now excluded because fewer than 80% of participants had a haematological disorder. The four different types of prophylactic platelet transfusion trial, that were the focus of this review, were included within these thirteen trials. Three trials compared prophylactic platelet transfusions versus therapeutic-only platelet transfusions. There was no statistical difference between the number of participants with clinically significant bleeding in the therapeutic and prophylactic arms but the confidence interval was wide (RR 1.66; 95% CI 0.9 to 3.04).The time taken for a clinically significant bleed to occur was longer in the prophylactic platelet transfusion arm. There was a clear reduction in platelet transfusion usage in the therapeutic arm. There was no statistical difference between the number of participants in the therapeutic and prophylactic arms with platelet refractoriness, the only adverse event reported. Three trials compared different platelet count thresholds to trigger administration of prophylactic platelet transfusions. No statistical difference was seen in the number of participants with clinically significant bleeding (RR 1.35; 95% CI 0.95 to 1.9), however, this type of bleeding occurred on fewer days in the group of patients transfused at a higher platelet count threshold (RR 1.72; 95% CI 1.33 to 2.22).The lack of a difference seen for the number of participants with clinically significant bleeding may be due to the studies, in combination, having insufficient power to demonstrate a difference, or due to masking of the effect by a higher number of protocol violations in the groups of patients with a lower platelet count threshold. Using a lower platelet count threshold led to a significant reduction in the number of platelet transfusions used. There were no statistical differences in the number of adverse events reported between the two groups. Six trials compared different doses of prophylactic platelet transfusions. There was no evidence to suggest that using a lower platelet transfusion dose increased: the number of participants with clinically significant (WHO grade 2 or above) (RR 1.02; 95% CI 0.93 to 1.11), or life-threatening (WHO grade 4) bleeding (RR 1.87; 95% CI 0.86 to 4.08). A higher platelet transfusion dose led to a reduction in the number of platelet transfusion episodes, but an increase in total platelet utilisation. Only one adverse event, wheezing after transfusion, had a significantly higher incidence when standard and high dose transfusions were compared but this difference was not seen when low dose and high dose transfusions were compared. It is therefore likely to be a type I error (false positive). One small trial compared prophylactic platelet transfusions versus platelet-poor plasma. The risk of a significant bleed was decreased in the prophylactic platelet transfusion arm (RR 0.47; 95% CI 0.23 to 0.95) and this was statistically significant. All studies had threats to validity; the majority of these were due to methodology of the studies not being described in adequate detail. Although it was not the main focus of the review, it was interesting to note that in one of the pre-specified sub-group analyses (treatment type) two studies showed that patients receiving an autologous transplant have a lower risk of bleeding than patients receiving intensive chemotherapy or an allogeneic transplant (RR 0.73, 95% CI 0.65 to 0.82). These conclusions refer to the four different types of platelet transfusion trial separately. Firstly, there is no evidence that a prophylactic platelet transfusion policy prevents bleeding. Two large trials comparing a therapeutic versus prophylactic platelet transfusion strategy, that have not yet been published, should provide important new data on this comparison. Secondly, there is no evidence, at the moment, to suggest a change from the current practice of using a platelet count of 10 x 109/L. However, the evidence for a platelet count threshold of 10 x 109/L being equivalent to 20 x 109/L is not as definitive as it would first appear and further research is required. Thirdly, platelet dose does not affect the number of patients with significant bleeding, but whether it affects number of days each patient bleeds for is as yet undetermined. There is no evidence that platelet dose affects the incidence of WHO grade 4 bleeding.Prophylactic platelet transfusions were more effective than platelet-poor plasma at preventing bleeding. | This review was undertaken to determine the best use of platelet transfusions for the prevention of bleeding in patients who have haematological disorders and are receiving intensive (myelosuppressive) chemotherapy or stem cell transplantation. The review aimed to look at three main topics. One, what is the evidence to indicate if platelet transfusions should be given to prevent bleeding as compared to a strategy aimed at transfusion when bleeding occurs? Second, if platelet transfusions are given to prevent bleeding, when should they be given, for example, at what level of platelet count when measured in a blood sample? Three, if platelet transfusions are given what platelet dose should be used? We are unable to answer the first question, however new data from two large studies should be available when this review is updated in approximately two years time. With regard to the second question, there is no evidence to suggest a change from the current practice of using a platelet count of 10 x 109/L to trigger the use of platelet transfusions to prevent bleeding. However, more research is required to clarify this issue. The final question can be answered. Using a lower platelet dose did not lead to an increased risk of bleeding and fewer platelets were required. The reduction in the number of platelets used should, theoretically, reduce the risk of adverse events although no true differences were seen in the studies. However, adverse events are uncommon and therefore a statistically significant difference may not be seen. | 10.1002/14651858.CD004269.pub3 | [
"This review was undertaken to determine the best use of platelet transfusions for the prevention of bleeding in patients who have haematological disorders and are receiving intensive (myelosuppressive) chemotherapy or stem cell transplantation. The review aimed to look at three main topics. One, what is the evidence to indicate if platelet transfusions should be given to prevent bleeding as compared to a strategy aimed at transfusion when bleeding occurs? Second, if platelet transfusions are given to prevent bleeding, when should they be given, for example, at what level of platelet count when measured in a blood sample? Three, if platelet transfusions are given what platelet dose should be used? We are unable to answer the first question, however new data from two large studies should be available when this review is updated in approximately two years time. With regard to the second question, there is no evidence to suggest a change from the current practice of using a platelet count of 10 x 109/L to trigger the use of platelet transfusions to prevent bleeding. However, more research is required to clarify this issue. The final question can be answered. Using a lower platelet dose did not lead to an increased risk of bleeding and fewer platelets were required. The reduction in the number of platelets used should, theoretically, reduce the risk of adverse events although no true differences were seen in the studies. However, adverse events are uncommon and therefore a statistically significant difference may not be seen."
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cochrane-simplification-train-1875 | cochrane-simplification-train-1875 | We identified only one study for inclusion in this review. This study was a prospective, double-blind cross-over trial that compared the effect of systemic metronidazole with a placebo on odour in malignant wounds. Nine participants with a fungating wound and for whom the smell was troublesome were recruited and six of these completed both the intervention and control (placebo) stages of the trial. Each stage lasted fourteen days, with a fourteen day gap (washout period) between administration of the metronidazole and the placebo. The study, in comparing metronidazole and placebo, reported on two of this review's pre-specified primary outcomes (malodour and adverse effects of the treatment) and on none of the review's pre-specified secondary outcomes. Malodour The mean malodour (smell) scores for the metronidazole group was 1.17 (standard deviation (SD) 1.60) and the mean for the placebo group was 3.33 (SD 0.82). It is unclear if systemic antibiotics were associated with a difference in malodour (1 study with 6 participants; MD —2.16, 95% CI —3.6 to —0.72) as the quality of the evidence (GRADE) was very low for this outcome. The study was downgraded due to high risk of attrition bias (33% loss to follow-up) and very serious imprecision due to the small sample size. Adverse effects No adverse effects of the treatment were reported in either the intervention or control group by the trial authors. It is uncertain whether systemic metronidazole leads to a reduction in malodour in patients with malignant wounds. This is because we were only able to include a single study at high risk of bias with a very small sample size, which focused only on patients with breast cancer. More research is needed to substantiate these findings and to investigate the effects of systemic metronidazole and other antibiotics on quality of life, pain relief, exudate and tumour containment in patients with malignant wounds. | In March 2017 we searched for randomised controlled trials looking at the effects of systemic antibiotics on malignant wounds. We found only one trial, dating from 1984, which compared the effectiveness of the antibiotic metronidazole with a placebo (sugar pill) on six participants with malignant wounds resulting from breast cancer. The trial was a cross-over trial which means that participants receive both the treatment being tested and the comparison treatment, at different time-points, with a break between the treatments to ensure that the effects of the first treatment have worn off before the second treatment is taken. This is called the 'washout' period. In the one trial in this review, half the participants took the antibiotic first, for 14 days, and half took the placebo. Both groups then had 14 days with no medication before swapping over (cross-over) and trying the alternative treatment for 14 days. It is unclear if metronidazole reduces the smell of malignant wounds when taken orally (by mouth) in tablet form, without any side effects occurring. Its effectiveness in relation to other outcomes such as pain or quality of life was not measured in this trial. No change in the size or appearance of participants' tumours was reported. It is uncertain whether metronidazole reduces the smell of malignant wounds when taken orally in tablet form because the quality of the evidence is very low. This evidence came from a very small study with serious study design flaws, and more research is needed involving more people with different types of cancer. Trials looking at how antibiotics can affect other outcomes, such as quality of life, pain relief and reducing any bleeding or ooze from the wound are also needed. This plain language summary is up to date as of March 2017. | 10.1002/14651858.CD011609.pub2 | [
"In March 2017 we searched for randomised controlled trials looking at the effects of systemic antibiotics on malignant wounds. We found only one trial, dating from 1984, which compared the effectiveness of the antibiotic metronidazole with a placebo (sugar pill) on six participants with malignant wounds resulting from breast cancer. The trial was a cross-over trial which means that participants receive both the treatment being tested and the comparison treatment, at different time-points, with a break between the treatments to ensure that the effects of the first treatment have worn off before the second treatment is taken. This is called the 'washout' period. In the one trial in this review, half the participants took the antibiotic first, for 14 days, and half took the placebo. Both groups then had 14 days with no medication before swapping over (cross-over) and trying the alternative treatment for 14 days. It is unclear if metronidazole reduces the smell of malignant wounds when taken orally (by mouth) in tablet form, without any side effects occurring. Its effectiveness in relation to other outcomes such as pain or quality of life was not measured in this trial. No change in the size or appearance of participants' tumours was reported. It is uncertain whether metronidazole reduces the smell of malignant wounds when taken orally in tablet form because the quality of the evidence is very low. This evidence came from a very small study with serious study design flaws, and more research is needed involving more people with different types of cancer. Trials looking at how antibiotics can affect other outcomes, such as quality of life, pain relief and reducing any bleeding or ooze from the wound are also needed. This plain language summary is up to date as of March 2017."
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cochrane-simplification-train-1876 | cochrane-simplification-train-1876 | Thirty-five RCTs were included; 20 were published in English, seven in Japanese, five in Chinese and one each in Norwegian, Polish and German. There were only three trials of acupuncture for acute low-back pain. They did not justify firm conclusions, because of small sample sizes and low methodological quality of the studies. For chronic low-back pain there is evidence of pain relief and functional improvement for acupuncture, compared to no treatment or sham therapy. These effects were only observed immediately after the end of the sessions and at short-term follow-up. There is evidence that acupuncture, added to other conventional therapies, relieves pain and improves function better than the conventional therapies alone. However, effects are only small. Dry-needling appears to be a useful adjunct to other therapies for chronic low-back pain. No clear recommendations could be made about the most effective acupuncture technique. The data do not allow firm conclusions about the effectiveness of acupuncture for acute low-back pain. For chronic low-back pain, acupuncture is more effective for pain relief and functional improvement than no treatment or sham treatment immediately after treatment and in the short-term only. Acupuncture is not more effective than other conventional and "alternative" treatments. The data suggest that acupuncture and dry-needling may be useful adjuncts to other therapies for chronic low-back pain. Because most of the studies were of lower methodological quality, there certainly is a further need for higher quality trials in this area. | Thirty-five RCTs covering 2861 patients were included in this systematic review. There is insufficient evidence to make any recommendations about acupuncture or dry-needling for acute low-back pain. For chronic low-back pain, results show that acupuncture is more effective for pain relief than no treatment or sham treatment, in measurements taken up to three months. The results also show that for chronic low-back pain, acupuncture is more effective for improving function than no treatment, in the short-term. Acupuncture is not more effective than other conventional and "alternative" treatments. When acupuncture is added to other conventional therapies, it relieves pain and improves function better than the conventional therapies alone. However, effects are only small. Dry-needling appears to be a useful adjunct to other therapies for chronic low-back pain. | 10.1002/14651858.CD001351.pub2 | [
"Thirty-five RCTs covering 2861 patients were included in this systematic review. There is insufficient evidence to make any recommendations about acupuncture or dry-needling for acute low-back pain. For chronic low-back pain, results show that acupuncture is more effective for pain relief than no treatment or sham treatment, in measurements taken up to three months. The results also show that for chronic low-back pain, acupuncture is more effective for improving function than no treatment, in the short-term. Acupuncture is not more effective than other conventional and \"alternative\" treatments. When acupuncture is added to other conventional therapies, it relieves pain and improves function better than the conventional therapies alone. However, effects are only small. Dry-needling appears to be a useful adjunct to other therapies for chronic low-back pain."
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cochrane-simplification-train-1877 | cochrane-simplification-train-1877 | Ten studies, reporting data from 354 participants, were included in this review, the majority of which were carried out in a university dental hospital setting. The studies were published between 2005 and 2011 and were conducted in Europe and in Brazil. The age range of participants was from nine to 15 years, with an even distribution of males and females in seven of the studies, and a slight predominance of female patients in three of the studies. The quality of the studies was generally poor; seven studies were at an overall high risk of bias, three studies were at an unclear risk of bias, and we judged no study to be at low risk of bias. We carried out random-effects meta-analyses as appropriate for the primary clinical outcomes of movement of upper first molars (mm), and loss of anterior anchorage, where there were sufficient data reported in the primary studies. Four studies, involving 159 participants, compared a distalising appliance to an untreated control. Meta-analyses were not undertaken for all primary outcomes due to incomplete reporting of all summary statistics, expected outcomes, and differences between the types of appliances. The degree and direction of molar movement and loss of anterior anchorage varied with the type of appliance. Four studies, involving 150 participants, compared a distalising appliance versus headgear. The mean molar movement for intraoral distalising appliances was -2.20 mm and -1.04 mm for headgear. There was a statistically significant difference in mean distal molar movement (mean difference (MD) -1.45 mm; 95% confidence interval (CI) -2.74 to -0.15) favouring intraoral appliances compared to headgear (four studies, high or unclear risk of bias, 150 participants analysed). However, a statistically significant difference in mean mesial upper incisor movement (MD 1.82 mm; 95% CI 1.39 to 2.24) and overjet (fixed-effect: MD 1.64 mm; 95% CI 1.26 to 2.02; two studies, unclear risk of bias, 70 participants analysed) favoured headgear, i.e. there was less loss of anterior anchorage with headgear. We reported direct comparisons of intraoral appliances narratively due to the variation in interventions (three studies, high or unclear risk of bias, 93 participants randomised). All appliances were reported to provide some degree of distal movement, and loss of anterior anchorage varied with the type of appliance. No included studies reported on the incidence of adverse effects (harm, injury), number of attendances or rate of non-compliance. It is suggested that intraoral appliances are more effective than headgear in distalising upper first molars. However, this effect is counteracted by loss of anterior anchorage, which was not found to occur with headgear when compared with intraoral distalising appliance in a small number of studies. The number of trials assessing the effects of orthodontic treatment for distilisation is low, and the current evidence is of low or very low quality. | This review of existing studies was carried out by the Cochrane Oral Health Group, and the evidence is current as of December 2012. In this review there are 10 studies published between 2005 and 2011 in which a total of 354 children were randomised to receive treatment with a distalising orthodontic appliance and compared to either no treatment, headgear or another distalising appliance. The age range of children in nine of the studies was from 11 to 15 years, although the children recruited to one study were younger, from nine to 10 years old. Both girls and boys participated in the studies. Where it was mentioned, the funding was from a university or dental research foundation. The authors did not assess the impact of the funding sources. When intraoral appliances are compared to headgear they will probably move the upper molar teeth backwards more than headgear. However, the use of intraoral appliances was also associated with movement of the upper front teeth when compared to extraoral appliances in four studies. This is an unwanted effect that was not observed with the use of the headgear appliances. Harm, injury from the appliances and other characteristics of the appliances which may be important to patients were not reported in the studies. The evidence presented is generally of low quality. The main shortcomings were related to trial design. | 10.1002/14651858.CD008375.pub2 | [
"This review of existing studies was carried out by the Cochrane Oral Health Group, and the evidence is current as of December 2012. In this review there are 10 studies published between 2005 and 2011 in which a total of 354 children were randomised to receive treatment with a distalising orthodontic appliance and compared to either no treatment, headgear or another distalising appliance. The age range of children in nine of the studies was from 11 to 15 years, although the children recruited to one study were younger, from nine to 10 years old. Both girls and boys participated in the studies. Where it was mentioned, the funding was from a university or dental research foundation. The authors did not assess the impact of the funding sources. When intraoral appliances are compared to headgear they will probably move the upper molar teeth backwards more than headgear. However, the use of intraoral appliances was also associated with movement of the upper front teeth when compared to extraoral appliances in four studies. This is an unwanted effect that was not observed with the use of the headgear appliances. Harm, injury from the appliances and other characteristics of the appliances which may be important to patients were not reported in the studies. The evidence presented is generally of low quality. The main shortcomings were related to trial design."
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cochrane-simplification-train-1878 | cochrane-simplification-train-1878 | We included one double-blind, double-dummy RCT comparing a quadriphasic oral contraceptive composed of dienogest and estradiol valerate with a monophasic oral contraceptive composed of levonorgestrel and ethinylestradiol. Contraceptive effectiveness, intracyclic bleeding and discontinuation due to side effects were similar for quadriphasic and monophasic pills. The number of women experiencing withdrawal bleeding was higher in the monophasic group compared to the quadriphasic group. Users of quadriphasic pills reported fewer bleeding/spotting days and fewer bleeding/spotting episodes than users of monophasic pills but the report did not specify whether the bleeding/spotting was scheduled or unscheduled. More women using quadriphasic oral contraceptives reported breast pain compared to women using monophasic oral contraceptives. The available evidence is insufficient to determine whether quadriphasic differ from monophasic oral contraceptives in contraceptive effectiveness, bleeding pattern, minor side effects and acceptability. Studies that compare quadriphasic and monophasic oral contraceptives with an identical progestogen and estrogen type are needed to determine whether the quadriphasic approach differs from the monophasic approach. Studies that compare quadriphasic pills with monophasic pills containing 30 μg ethinylestradiol are indicated to determine whether quadriphasic oral contraceptives have an advantage over the current, first choice oral contraceptive. Until then, we recommend monophasic pills containing 30 μg estrogen as the first choice for women starting oral contraceptive use. | We did a computer search for randomized controlled trials comparing four-phase birth control pills with one-phase birth control pills. We also wrote to researchers and makers of birth control pills to find other trials. Studies had to report on pregnancy, bleeding problems, side effects or stopping the use of pills. We did not include studies where the pills were used as a treatment for disorders like acne, hirsutism, polycystic ovary syndrome, bleeding problems or endometrioses, or where the pills were administered for less than three months. We assessed whether the studies were conducted properly. We included one study comparing a four-phase pill composed of the progestogen dienogest and the estrogen estradiol valerate with an one-phase pill composed of the progestogen levonorgestrel and the estrogen ethinylestradiol. Four-phase birth control pills and one-phase birth control pills had similar pregnancy rates. The number of women with blood loss in the period between two menstruations was similar for four-phase pills and one-phase pills. More women using one-phase birth control pills had a menstruation compared to women using four-phase birth control pills. The number of women who stopped using the pills because of side effects was similar for four-phase pills and one-phase pills. Breast pain was reported more frequently by women who used four-phase birth control pills than women who used one-phase birth control pills. The presence of only one study made it impossible to adequately compare four-phase birth control pills with one-phase birth control pills. More studies are needed to determine whether four-phase pills have advantages over one-phase pills. Until then, we recommend one-phase pills containing 30 μg estrogen for women starting to use birth control pills. | 10.1002/14651858.CD009038.pub2 | [
"We did a computer search for randomized controlled trials comparing four-phase birth control pills with one-phase birth control pills. We also wrote to researchers and makers of birth control pills to find other trials. Studies had to report on pregnancy, bleeding problems, side effects or stopping the use of pills. We did not include studies where the pills were used as a treatment for disorders like acne, hirsutism, polycystic ovary syndrome, bleeding problems or endometrioses, or where the pills were administered for less than three months. We assessed whether the studies were conducted properly. We included one study comparing a four-phase pill composed of the progestogen dienogest and the estrogen estradiol valerate with an one-phase pill composed of the progestogen levonorgestrel and the estrogen ethinylestradiol. Four-phase birth control pills and one-phase birth control pills had similar pregnancy rates. The number of women with blood loss in the period between two menstruations was similar for four-phase pills and one-phase pills. More women using one-phase birth control pills had a menstruation compared to women using four-phase birth control pills. The number of women who stopped using the pills because of side effects was similar for four-phase pills and one-phase pills. Breast pain was reported more frequently by women who used four-phase birth control pills than women who used one-phase birth control pills. The presence of only one study made it impossible to adequately compare four-phase birth control pills with one-phase birth control pills. More studies are needed to determine whether four-phase pills have advantages over one-phase pills. Until then, we recommend one-phase pills containing 30 μg estrogen for women starting to use birth control pills."
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cochrane-simplification-train-1879 | cochrane-simplification-train-1879 | We included 11 RCTs with a total of 428 participants 18 years of age or older with low to moderate myopia. These trials were conducted in the Czech Republic, Brazil, Italy, Iran, China, Korea, Mexico, Turkey, USA, and UK. Investigators of 10 out of 11 trials randomly assigned one eye of each participant to be treated with LASEK and the other with PRK, but did not perform paired-eye (matched) analysis. Because of differences in outcome measures and follow-up times among the included trials, few trials contributed data for many of the outcomes we analyzed for this review. Overall, we judged RCTs to be at unclear risk of bias due to poor reporting; however, because of imprecision, inconsistency, and potential reporting bias, we graded the quality of the evidence from very low to moderate for outcomes assessed in this review. The proportion of eyes with uncorrected visual acuity of 20/20 or better at 12-month follow-up was comparable in LASEK and PRK groups (risk ratio (RR) 0.98, 95% confidence interval (95% CI) 0.92 to 1.05). Although the 95% CI suggests little to no difference in effect between groups, we judged the quality of the evidence to be low because only one trial reported this outcome (102 eyes). At 12 months post treatment, data from two trials suggest no difference or a possibly small effect in favor of PRK over LASEK for the proportion of eyes achieving ± 0.50 D of target refraction (RR 0.93, 95% CI 00.84 to 1.03; 152 eyes; low-quality evidence). At 12 months post treatment, one trial reported that one of 51 eyes in the LASEK group lost one line or more best-spectacle corrected visual acuity compared with none of 51 eyes in the PRK group (RR 3.00, 95% CI 0.13 to 71.96; very low-quality evidence). Three trials reported adverse outcomes at 12 months of follow-up or longer. At 12 months post treatment, three trials reported corneal haze score; however, data were insufficient and were inconsistent among the trials, precluding meta-analysis. One trial reported little or no difference in corneal haze scores between groups; another trial reported that corneal haze scores were lower in the LASEK group than in the PRK group; and one trial did not report analyzable data to estimate a treatment effect. At 24 months post treatment, one trial reported a lower, but clinically unimportant, difference in corneal haze score for LASEK compared with PRK (MD -0.22, 95% CI -0.30 to -0.14; 184 eyes; low-quality evidence). Uncertainty surrounds differences in efficacy, accuracy, safety, and adverse effects between LASEK and PRK for eyes with low to moderate myopia. Future trials comparing LASEK versus PRK should follow reporting standards and follow correct analysis. Trial investigators should expand enrollment criteria to include participants with high myopia and should evaluate visual acuity, refraction, epithelial healing time, pain scores, and adverse events. | We identified 11 trials that enrolled 428 adult participants. These trials were conducted in various countries, including the Czech Republic, Brazil, Italy, Iran, China, Korea, Mexico, Turkey, USA, and UK. Ten out of 11 trials used a paired-eye design, in which one eye of each participant received LASEK and the other eye received PRK. The remaining trial included one eye of six participants and both eyes of 15 participants. Most participants included in the trials had low to moderate myopia. The evidence is current as of 15 December 2015. Because these trials reported different outcomes at different time points, it is difficult to compare the effectiveness of LASEK versus PRK across trials. We assessed our primary outcomes 12 months after the surgeries were performed. Available data were insufficient to clarify whether LASEK performed better than PRK with respect to correcting visual acuity to 20/20 or better, achieving within 0.50 diopters of target refraction, or preventing loss of corrected visual acuity. Data were insufficient for assessment of whether differences between procedures in adverse outcomes occurred at 12 months after the surgeries. At 24 months post treatment, one trial reported that eyes treated LASEK with may have better corneal haze scores than those treated with PRK, but that the difference may not be noticeable. Available data were insufficient for investigation of whether LASEK or PRK is better at correcting near-sightedness. We judged the evidence for most outcomes as very low to moderate quality because of variation in reporting and differences in effects among trials. | 10.1002/14651858.CD009799.pub2 | [
"We identified 11 trials that enrolled 428 adult participants. These trials were conducted in various countries, including the Czech Republic, Brazil, Italy, Iran, China, Korea, Mexico, Turkey, USA, and UK. Ten out of 11 trials used a paired-eye design, in which one eye of each participant received LASEK and the other eye received PRK. The remaining trial included one eye of six participants and both eyes of 15 participants. Most participants included in the trials had low to moderate myopia. The evidence is current as of 15 December 2015. Because these trials reported different outcomes at different time points, it is difficult to compare the effectiveness of LASEK versus PRK across trials. We assessed our primary outcomes 12 months after the surgeries were performed. Available data were insufficient to clarify whether LASEK performed better than PRK with respect to correcting visual acuity to 20/20 or better, achieving within 0.50 diopters of target refraction, or preventing loss of corrected visual acuity. Data were insufficient for assessment of whether differences between procedures in adverse outcomes occurred at 12 months after the surgeries. At 24 months post treatment, one trial reported that eyes treated LASEK with may have better corneal haze scores than those treated with PRK, but that the difference may not be noticeable. Available data were insufficient for investigation of whether LASEK or PRK is better at correcting near-sightedness. We judged the evidence for most outcomes as very low to moderate quality because of variation in reporting and differences in effects among trials."
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cochrane-simplification-train-1880 | cochrane-simplification-train-1880 | Nine studies met the inclusion criteria: three compared supervision with no supervision, five compared enhanced supervision with routine supervision, and one study compared less intensive supervision with routine supervision. Most outcomes were scores relating to providers’ practice, knowledge and provider or user satisfaction. The majority of the outcomes were measured within nine months after the interventions were introduced. In two studies comparing supervision with no supervision, small benefits on provider practice and knowledge were found. For methods of enhancing supervision, we identified five studies, and two studies of frequent supportive supervision demonstrated small benefits on workers performance. The one study examining the impact of less intensive supervision found no evidence that reducing the frequency of visits had any effect on the utilisation of services. The GRADE evidence quality for all comparisons and outcomes was "low" or "very low". It is uncertain whether supervision has a substantive, positive effect on the quality of primary health care in low- and middle-income countries. The long term effectiveness of supervision is unknown. | The studies in this review took place in nine countries in Africa, Asia and Latin America, in both rural and urban areas. Most of the studies looked at the supervision of health care professionals (including nurses, midwives, health officers and physicians), while two studies examined the effect of supervision on community or lay health workers. The number of supervisory visits generally varied from one to six over a period of up to nine months. What happens when health workers are supervised? The evidence was of low to very low quality and the studies showed mixed results. Compared to no supervision, some studies showed that supervision had a small benefit on health worker practices and knowledge, while other studies showed no benefit or were inconclusive. We are therefore uncertain about the effects of supervision on the quality of primary healthcare services. A summary of this review for policy-makers is availablehere | 10.1002/14651858.CD006413.pub2 | [
"The studies in this review took place in nine countries in Africa, Asia and Latin America, in both rural and urban areas. Most of the studies looked at the supervision of health care professionals (including nurses, midwives, health officers and physicians), while two studies examined the effect of supervision on community or lay health workers. The number of supervisory visits generally varied from one to six over a period of up to nine months. What happens when health workers are supervised? The evidence was of low to very low quality and the studies showed mixed results. Compared to no supervision, some studies showed that supervision had a small benefit on health worker practices and knowledge, while other studies showed no benefit or were inconclusive. We are therefore uncertain about the effects of supervision on the quality of primary healthcare services. A summary of this review for policy-makers is availablehere"
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cochrane-simplification-train-1881 | cochrane-simplification-train-1881 | This second update of the review identified 19 additional eligible trials resulting in a total of 33 studies (2793 participants) that met the inclusion criteria. There was low quality evidence that sutures were significantly better than tissue adhesives for reducing the risk of wound breakdown (dehiscence; RR 3.35; 95% CI 1.53 to 7.33; 10 trials, 736 participants that contributed data to the meta-analysis). The number needed to treat for an additional harmful outcome was calculated as 43. For all other outcomes - infection, patient and operator satisfaction and cost - there was no evidence of a difference for either sutures or tissue adhesives. No evidence of differences was found between tissue adhesives and tapes for minimising dehiscence, infection, patients' assessment of cosmetic appearance, patient satisfaction or surgeon satisfaction. However there was evidence in favour of using tape for surgeons' assessment of cosmetic appearance (mean difference (VAS 0 to 100) 9.56 (95% CI 4.74 to 14.37; 2 trials, 139 participants). One trial compared tissue adhesives with a variety of methods of wound closure and found both patients and clinicians were significantly more satisfied with the alternative closure methods than the adhesives. There appeared to be little difference in outcome for different types of tissue adhesives. One study that compared high viscosity with low viscosity adhesives found that high viscosity adhesives were less time-consuming to use than low viscosity tissue adhesives, but the time difference was small. Sutures are significantly better than tissue adhesives for minimising dehiscence. In some cases tissue adhesives may be quicker to apply than sutures. Although surgeons may consider the use of tissue adhesives as an alternative to other methods of surgical site closure in the operating theatre, they need to be aware that sutures minimise dehiscence. There is a need for more well designed randomised controlled trials comparing tissue adhesives with alternative methods of closure. These trials should include people whose health may interfere with wound healing and surgical sites of high tension. | The researchers searched the medical literature up to March 2014, and identified 33 medical studies that investigated the use of tissue adhesives for closure of wounds. They compared tissue adhesive with another method of closure such as sutures, staples, tape, or another type of tissue adhesive. The main outcomes of interest were whether wounds stayed closed - and did not break down - and whether they became infected. The results of the review showed clearly that fewer wounds broke down when sutures were used. Studies also reported that some types of tissue adhesives might be slightly quicker to use than other types. There was no clear difference between tissue adhesives and the alternative closure methods for cosmetic results or costs. Results regarding surgeons' and patients' preferred skin closure method were mixed. | 10.1002/14651858.CD004287.pub4 | [
"The researchers searched the medical literature up to March 2014, and identified 33 medical studies that investigated the use of tissue adhesives for closure of wounds. They compared tissue adhesive with another method of closure such as sutures, staples, tape, or another type of tissue adhesive. The main outcomes of interest were whether wounds stayed closed - and did not break down - and whether they became infected. The results of the review showed clearly that fewer wounds broke down when sutures were used. Studies also reported that some types of tissue adhesives might be slightly quicker to use than other types. There was no clear difference between tissue adhesives and the alternative closure methods for cosmetic results or costs. Results regarding surgeons' and patients' preferred skin closure method were mixed."
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cochrane-simplification-train-1882 | cochrane-simplification-train-1882 | This review includes 38 studies, of which 34 studies examined survival following transportation by HEMS compared with GEMS for adults with major trauma. Four studies were of inter-facility transfer to a higher level trauma center by HEMS compared with GEMS. All studies were NRS; we found no RCTs. The primary outcome was survival at hospital discharge. We calculated unadjusted mortality using data from 282,258 people from 28 of the 38 studies included in the primary analysis. Overall, there was considerable heterogeneity and we could not determine an accurate estimate of overall effect. Based on the unadjusted mortality data from six trials that focused on traumatic brain injury, there was no decreased risk of death with HEMS. Twenty-one studies used multivariate regression to adjust for confounding. Results varied, some studies found a benefit of HEMS while others did not. Trauma-Related Injury Severity Score (TRISS)-based analysis methods were used in 14 studies; studies showed survival benefits in both the HEMS and GEMS groups as compared with MTOS. We found no studies evaluating the secondary outcome, morbidity, as assessed by quality-adjusted life years (QALYs) and disability-adjusted life years (DALYs). Four studies suggested a small to moderate benefit when HEMS was used to transfer people to higher level trauma centers. Road traffic and helicopter crashes are adverse effects which can occur with either method of transport. Data regarding safety were not available in any of the included studies. Overall, the quality of the included studies was very low as assessed by the GRADE Working Group criteria. Due to the methodological weakness of the available literature, and the considerable heterogeneity of effects and study methodologies, we could not determine an accurate composite estimate of the benefit of HEMS. Although some of the 19 multivariate regression studies indicated improved survival associated with HEMS, others did not. This was also the case for the TRISS-based studies. All were subject to a low quality of evidence as assessed by the GRADE Working Group criteria due to their nonrandomized design. The question of which elements of HEMS may be beneficial has not been fully answered. The results from this review provide motivation for future work in this area. This includes an ongoing need for diligent reporting of research methods, which is imperative for transparency and to maximize the potential utility of results. Large, multicenter studies are warranted as these will help produce more robust estimates of treatment effects. Future work in this area should also examine the costs and safety of HEMS, since multiple contextual determinants must be considered when evaluating the effects of HEMS for adults with major trauma. | We searched the medical literature for clinical studies comparing the transport of adults who had major injuries by helicopter ambulance (HEMS) or ground ambulance (GEMS). The evidence is current to April 2015. We found 38 studies which included people from 12 countries around the world. Researchers wanted to find out if using a helicopter ambulance was any better than a ground ambulance for improving an injured person's chance of survival, or reducing the severity of long-term disability. Some of these studies indicated some benefit of HEMS for survival after major trauma, but other studies did not. The studies were of varying sizes and used different methods to determine if more people survived when transported by HEMS versus GEMS. Some studies included helicopter teams that had specialized physicians on board whereas other helicopter crews were staffed by paramedics and nurses. Furthermore, people transported by HEMS or GEMS had varying numbers and types of procedures during travel to the trauma center. The use of some of these procedures, such as the placement of a breathing tube, may have helped improve survival in some of the studies. However, these medical procedures can also be provided during ground ambulance transport. Data regarding safety were not available in any of the included studies. Road traffic and helicopter crashes are adverse effects which can occur with either method of transport. Overall, the quality of the included studies was low. It is possible that HEMS may be better than GEMS for people with certain characteristics. There are various reasons why HEMS may be better, such as staff having more specialty training in managing major injuries. But more research is required to determine what elements of helicopter transport improve survival. Some studies did not describe the care available to people in the GEMS group. Due to this poor reporting it is impossible to compare the treatments people received. Based on the current evidence, the added benefits of HEMS compared with GEMS are unclear. The results from future research might help in better allocation of HEMS within a healthcare system, with increased safety and decreased costs. | 10.1002/14651858.CD009228.pub3 | [
"We searched the medical literature for clinical studies comparing the transport of adults who had major injuries by helicopter ambulance (HEMS) or ground ambulance (GEMS). The evidence is current to April 2015. We found 38 studies which included people from 12 countries around the world. Researchers wanted to find out if using a helicopter ambulance was any better than a ground ambulance for improving an injured person's chance of survival, or reducing the severity of long-term disability. Some of these studies indicated some benefit of HEMS for survival after major trauma, but other studies did not. The studies were of varying sizes and used different methods to determine if more people survived when transported by HEMS versus GEMS. Some studies included helicopter teams that had specialized physicians on board whereas other helicopter crews were staffed by paramedics and nurses. Furthermore, people transported by HEMS or GEMS had varying numbers and types of procedures during travel to the trauma center. The use of some of these procedures, such as the placement of a breathing tube, may have helped improve survival in some of the studies. However, these medical procedures can also be provided during ground ambulance transport. Data regarding safety were not available in any of the included studies. Road traffic and helicopter crashes are adverse effects which can occur with either method of transport. Overall, the quality of the included studies was low. It is possible that HEMS may be better than GEMS for people with certain characteristics. There are various reasons why HEMS may be better, such as staff having more specialty training in managing major injuries. But more research is required to determine what elements of helicopter transport improve survival. Some studies did not describe the care available to people in the GEMS group. Due to this poor reporting it is impossible to compare the treatments people received. Based on the current evidence, the added benefits of HEMS compared with GEMS are unclear. The results from future research might help in better allocation of HEMS within a healthcare system, with increased safety and decreased costs."
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cochrane-simplification-train-1883 | cochrane-simplification-train-1883 | Sixteen studies involving 1063 participants were identified. The risk of bias for fifteen studies was high and along with imprecision and possible publication bias, this lowered our confidence in the results. There was low quality evidence that Tong-xi-luo reduced the rates of angiographic restenosis (RR 0.16, 95% CI 0.07 to 0.34), myocardial infarction (RR 0.32, 95% CI 0.16 to 0.66), heart failure (RR 0.26, 95% CI 0.11 to 0.62), and use of revascularisation (RR 0.26, 95% CI 0.15 to 0.45). There was very low quality evidence for the effect of Tong-xin-luo on all-cause mortality (RR 0.38, 95% CI 0.06 to 2.56), angina (RR 0.24, 95% CI 0.17 to 0.34) and death due to any cardiovascular event (RR 0.31, 95% CI 0.08 to 1.12). Adverse events were seldom reported, and included gastrointestinal reactions and nausea. The addition of Tong-xin-luo to conventional Western medicine may possibly prevent restenosis and recurrence of cardiovascular events in patients with CHD after PCI. However, the data are limited by publication bias and high risk of bias for included studies. Further high-quality trials are required to evaluate the potential effects of this intervention. | Study characteristics: We included sixteen randomised controlled trials (1063 participants) comparing Tong-xin-luo capsules plus conventional treatment with placebo plus/or conventional treatment (literature search date: though June 2014). All studies were undertaken in China. The sample size was from 50 to 178 and the duration of follow-up ranged from three months to two years. Key results: We found that Tong-xin-luo may possibly reduce the risk of narrowing of a blood vessel detected by angiography, cardiovascular events (including myocardial infarction, angina and heart failure) and use of repeat procedure. Adverse events were seldom reported. Quality of evidence: Because of high risk of bias for fifteen studies, imprecision and possible publication bias, the quality of evidence was low or very low for all study outcomes. | 10.1002/14651858.CD010237.pub2 | [
"Study characteristics: We included sixteen randomised controlled trials (1063 participants) comparing Tong-xin-luo capsules plus conventional treatment with placebo plus/or conventional treatment (literature search date: though June 2014). All studies were undertaken in China. The sample size was from 50 to 178 and the duration of follow-up ranged from three months to two years. Key results: We found that Tong-xin-luo may possibly reduce the risk of narrowing of a blood vessel detected by angiography, cardiovascular events (including myocardial infarction, angina and heart failure) and use of repeat procedure. Adverse events were seldom reported. Quality of evidence: Because of high risk of bias for fifteen studies, imprecision and possible publication bias, the quality of evidence was low or very low for all study outcomes."
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cochrane-simplification-train-1884 | cochrane-simplification-train-1884 | We included 10 studies (12 trial reports) from which 5041 women contributed data for the primary outcome. The overall risk of bias was low. When comparing prophylactic intravenous (IV) antibiotic administration in women undergoing cesarean delivery, there was a reduction in composite maternal infectious morbidity (risk ratio (RR) 0.57, 95% confidence interval (CI) 0.45 to 0.72, high quality evidence), which was specifically due to the reduction in endometritis (RR 0.54, 95% CI 0.36 to 0.79, high quality evidence) and wound infection (RR 0.59, 95% CI 0.44 to 0.81, high quality evidence) in those that received antibiotics preoperatively as compared to those who received antibiotics after neonatal cord clamping. There were no clear differences in neonatal sepsis (RR 0.76, 95% CI 0.51 to 1.13, moderate quality evidence). There were no clear differences for other maternal outcomes such as urinary tract infection (UTI), cystitis and pyelonephritis (moderate quality evidence), respiratory infection (low quality evidence), or any neonatal outcomes. Maternal side effects were not reported in the included studies. The quality of the evidence using GRADE was high for composite morbidity, endomyometritis, wound infection and neonatal intensive care unit admission, moderate for UTI/cystitis/pyelonephritis and neonatal sepsis, and low for maternal respiratory infection. Based on high quality evidence from studies whose overall risk of bias is low, intravenous prophylactic antibiotics for cesarean administered preoperatively significantly decreases the incidence of composite maternal postpartum infectious morbidity as compared with administration after cord clamp. There were no clear differences in adverse neonatal outcomes reported. Women undergoing cesarean delivery should receive antibiotic prophylaxis preoperatively to reduce maternal infectious morbidities. Further research may be needed to elucidate short- and long-term adverse effects for neonates. | This review of randomized controlled studies looked at the different timing options for administration of prophylactic antibiotics to prevent infectious complications in women undergoing cesarean delivery. We compared preoperative administration to administration after the cord had been clamped. The review includes 10 studies (with data from 5041 women). The studies were at a low risk of bias. Antibiotics given to women before cesarean delivery nearly halved the risks of combined infections (43%), endometritis (46%), and wound infection (41%) compared to giving the antibiotics after clamping of the baby’s umbilical. Other maternal infections such as urinary or lung infections were no different between the two groups of women, nor were adverse effects in newborns. High quality evidence shows that preoperative intravenous antibiotic administration decreases postpartum infections and is, therefore, beneficial for the mother. Maternal side effects were not consistently reported. Numbers were limited with respect to information on newborns and any adverse outcomes. Further research may be needed to determine adverse effects on the babies. | 10.1002/14651858.CD009516.pub2 | [
"This review of randomized controlled studies looked at the different timing options for administration of prophylactic antibiotics to prevent infectious complications in women undergoing cesarean delivery. We compared preoperative administration to administration after the cord had been clamped. The review includes 10 studies (with data from 5041 women). The studies were at a low risk of bias. Antibiotics given to women before cesarean delivery nearly halved the risks of combined infections (43%), endometritis (46%), and wound infection (41%) compared to giving the antibiotics after clamping of the baby’s umbilical. Other maternal infections such as urinary or lung infections were no different between the two groups of women, nor were adverse effects in newborns. High quality evidence shows that preoperative intravenous antibiotic administration decreases postpartum infections and is, therefore, beneficial for the mother. Maternal side effects were not consistently reported. Numbers were limited with respect to information on newborns and any adverse outcomes. Further research may be needed to determine adverse effects on the babies."
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cochrane-simplification-train-1885 | cochrane-simplification-train-1885 | No randomised controlled trials or controlled clinical trials were identified for the original review or this update. We summarised the results of five observational studies (including one with two reports) in the Discussion section of this review. In the absence of randomised controlled trials or controlled clinical trials, the 'best' evidence to date is based on three ‘low’ and two ‘very low quality’ observational studies. These suggest 'very low quality evidence' for an advantage for mental health domains (only) of quality of life without increasing healthcare costs, and 'low level quality' evidence for reduced hospitalisation for MDC in low-intensity outpatient settings; and 'very low quality' evidence for improved disability in high-intensity settings. The evidence for survival is conflicting. These conclusions are tentative and the gap in current research should not be interpreted as proof that MDC is ineffective. Further research is needed into appropriate study designs; outcome measurement; caregiver needs; and the evaluation of optimal settings, type, intensity or frequency and cost-effectiveness of MDC in the MND population. Future research should focus on observational designs to assess care and outcomes in 'real-life' settings. The interface between neurology, rehabilitation and palliative care should be explored to provide long-term support for MND. | This review did not find any high quality randomised controlled trials that examined the effectiveness of such multidisciplinary care, either when originally published in 2009 or for the update in 2011. The evidence from low quality studies suggests that such care may improve some aspects of quality of life, reduce the frequency of hospitalisation and hospital length of stay and improve disability in persons with ALS or MND. The evidence for multidisciplinary care on survival is conflicting. The gap in current research should not be interpreted as proof that multidisciplinary care is ineffective. Further research into types of appropriate studies, caregiver needs and various aspects of multidisciplinary care in the MND population is needed. | 10.1002/14651858.CD007425.pub2 | [
"This review did not find any high quality randomised controlled trials that examined the effectiveness of such multidisciplinary care, either when originally published in 2009 or for the update in 2011. The evidence from low quality studies suggests that such care may improve some aspects of quality of life, reduce the frequency of hospitalisation and hospital length of stay and improve disability in persons with ALS or MND. The evidence for multidisciplinary care on survival is conflicting. The gap in current research should not be interpreted as proof that multidisciplinary care is ineffective. Further research into types of appropriate studies, caregiver needs and various aspects of multidisciplinary care in the MND population is needed."
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cochrane-simplification-train-1886 | cochrane-simplification-train-1886 | We identified no placebo-controlled comparisons of beta-2 agonists. Three studies permitted comparison of ipratropium to an inhaled beta-2 agonist. These studies included a total of 103 patients. The beta2-agonists used were: fenoterol and metaproterenol. One study was a parallel group trial of regular therapy for seven days. The other two were cross over studies of single dose treatments, with efficacy measured 90 min post dose. There was no washout period between treatments. Both treatments produced an improvement in forced expiratory volume (FEV1) after 90 min in the range 150-250 ml. The was no difference between treatments, mean difference in FEV1 10 ml; 95% CI -220, 230 ml. In one small crossover study (n=10) there was a significant improvement in arterial PaO2 after 30 minutes with ipratropium (+5.8 mm Hg ± 3.0 (SEM)) compared to metaproterenol (-6.2 ± 1.2 mm Hg), but this was not significant at 90 min. There were no data concerning respiratory symptoms. The crossover studies showed no evidence of an additive effect of the two treatments, although they were not designed specifically to test this. An update search conducted in February 2002 yielded one further excluded study. There are few controlled trial data concerning the use of inhaled beta2-agonist agents in acute exacerbations of COPD and none that have compared these agents directly with placebo. None of the studies used the more modern beta2-agonists used most widely in this setting (salbutamol and terbutaline). Beta2-agonists and ipratropium both produce small improvements in FEV1, but beta2-agonists may worsen PaO2 for a period. We could not draw conclusions concerning possible additive effects. | These days the drugs of the latter type that are used for acute COPD are salbutamol and terbutaline, but neither of these drugs have been used in the only studies that we could find. We found only three small studies. Overall, both types of drug showed a small but worthwhile effect. There was no difference between them. Our review was not designed to test whether they would have had a greater effect if both were given at the same time. | 10.1002/14651858.CD002984 | [
"These days the drugs of the latter type that are used for acute COPD are salbutamol and terbutaline, but neither of these drugs have been used in the only studies that we could find. We found only three small studies. Overall, both types of drug showed a small but worthwhile effect. There was no difference between them. Our review was not designed to test whether they would have had a greater effect if both were given at the same time."
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cochrane-simplification-train-1887 | cochrane-simplification-train-1887 | Seventeen RCTs (1806 participants) were included. Five RCTs compared acupuncture versus sham acupuncture. The risk of bias in these studies was low. We found no evidence of an improvement with acupuncture relative to sham (placebo) acupuncture for symptom severity (SMD -0.11, 95% CI -0.35 to 0.13; 4 RCTs; 281 patients) or quality of life (SMD = -0.03, 95% CI -0.27 to 0.22; 3 RCTs; 253 patients). Sensitivity analyses based on study quality did not change the results. A GRADE analysis indicated that the overall quality of the evidence for the primary outcomes in the sham controlled trials was moderate due to sparse data. The risk of bias in the four Chinese language comparative effectiveness trials that compared acupuncture with drug treatment was high due to lack of blinding. The risk of bias in the other studies that did not use a sham control was high due to lack of blinding or inadequate methods used for randomization and allocation concealment or both. Acupuncture was significantly more effective than pharmacological therapy and no specific treatment. Eighty-four per cent of patients in the acupuncture group had improvement in symptom severity compared to 63% of patients in the pharmacological treatment group (RR 1.28, 95% CI 1.12 to 1.45; 5 studies, 449 patients). A GRADE analysis indicated that the overall quality of the evidence for this outcome was low due to a high risk of bias (no blinding) and sparse data. Sixty-three per cent of patients in the acupuncture group had improvement in symptom severity compared to 34% of patients in the no specific therapy group (RR 2.11, 95% CI 1.18 to 3.79; 2 studies, 181 patients). There was no statistically significant difference between acupuncture and Bifidobacterium (RR 1.07, 95% CI 0.90 to 1.27; 2 studies; 181 patients) or between acupuncture and psychotherapy (RR 1.05, 95% CI 0.87 to 1.26; 1 study; 100 patients). Acupuncture as an adjuvant to another Chinese medicine treatment was significantly better than the other treatment alone. Ninety-three per cent of patients in the adjuvant acupuncture group improved compared to 79% of patients who received Chinese medicine alone (RR 1.17, 95% CI 1.02 to 1.33; 4 studies; 466 patients). There was one adverse event (i.e. acupuncture syncope) associated with acupuncture in the 9 trials that reported this outcome, although relatively small sample sizes limit the usefulness of these safety data. Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life. In comparative effectiveness Chinese trials, patients reported greater benefits from acupuncture than from two antispasmodic drugs (pinaverium bromide and trimebutine maleate), both of which have been shown to provide a modest benefit for IBS. Future trials may help clarify whether or not these reportedly greater benefits of acupuncture relative to pharmacological therapies are due entirely to patients’ preferences for acupuncture or greater expectations of improvement on acupuncture relative to drug therapy. | This review included 17 randomized controlled trials (RCTs) including a total of 1806 participants. Five RCTs (411 participants) compared acupuncture to sham acupuncture for the treatment of IBS. Sham acupuncture is a procedure in which the patient believes he or she is receiving true acupuncture. However, in sham acupuncture the needles either do not penetrate the skin or are not placed at the correct places on the body, or both. Sham acupuncture is intended to be a placebo for true acupuncture. The sham-controlled studies were well designed and of high methodological quality. These studies tested the effects of acupuncture on IBS symptom severity or health-related quality of life. None of these RCTs found acupuncture to be better than sham acupuncture for either of these two outcomes, and pooling the results of these RCTs also did not show acupuncture to be better than sham acupuncture. Evidence from four Chinese language comparative effectiveness trials showed acupuncture to be superior to two antispasmodic drugs (pinaverium bromide and trimebutine maleate), both of which provide a modest benefit for the treatment of IBS, although neither is approved for treatment of IBS in the United States. It is unclear whether or not the greater benefits of acupuncture reported by patients in these unblinded studies are due entirely to patients’ greater expectations of improvement from acupuncture than drugs or preference for acupuncture over drug therapy. There was one side effect (i.e. fainting in one patient) associated with acupuncture in the nine trials that reported side effects, although relatively small sample sizes limit the usefulness of this safety data. | 10.1002/14651858.CD005111.pub3 | [
"This review included 17 randomized controlled trials (RCTs) including a total of 1806 participants. Five RCTs (411 participants) compared acupuncture to sham acupuncture for the treatment of IBS. Sham acupuncture is a procedure in which the patient believes he or she is receiving true acupuncture. However, in sham acupuncture the needles either do not penetrate the skin or are not placed at the correct places on the body, or both. Sham acupuncture is intended to be a placebo for true acupuncture. The sham-controlled studies were well designed and of high methodological quality. These studies tested the effects of acupuncture on IBS symptom severity or health-related quality of life. None of these RCTs found acupuncture to be better than sham acupuncture for either of these two outcomes, and pooling the results of these RCTs also did not show acupuncture to be better than sham acupuncture. Evidence from four Chinese language comparative effectiveness trials showed acupuncture to be superior to two antispasmodic drugs (pinaverium bromide and trimebutine maleate), both of which provide a modest benefit for the treatment of IBS, although neither is approved for treatment of IBS in the United States. It is unclear whether or not the greater benefits of acupuncture reported by patients in these unblinded studies are due entirely to patients’ greater expectations of improvement from acupuncture than drugs or preference for acupuncture over drug therapy. There was one side effect (i.e. fainting in one patient) associated with acupuncture in the nine trials that reported side effects, although relatively small sample sizes limit the usefulness of this safety data."
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cochrane-simplification-train-1888 | cochrane-simplification-train-1888 | Twelve trials were included. They were of variable quality. Limited asthma education did not reduce hospitalisation for asthma (weighted mean difference -0.03 average hospitalisations per person per year, 95% confidence interval -0.09 to 0.03). There was no significant effect on doctor visits, lung function and medication use. The effects on asthma symptoms were variable. There was no reduction in days lost from normal activity, but in two studies, perceived asthma symptoms did improve after limited asthma education (odds ratio 0.44, 95% confidence interval 0.26 to 0.74). In one study, limited asthma education was associated with reduced emergency department visits (reduction of -2.76 average visits per person per year, 95% confidence interval -4.34 to 1.18). Use of limited asthma education as it has been practiced does not appear to improve health outcomes in adults with asthma although perceived symptoms may improve. Provision of information in the emergency department may be effective, but this needs to be confirmed. | Using a systematic approach, the medical literature was searched thoroughly to find reliable studies that looked at the effects of improving patients' knowledge about asthma, but which did not attempt to improve practical self-management skills. The results of the studies were combined to see if patient education designed to improve patient knowledge about their condition made a difference to their asthma. Improving patient knowledge alone does not seem to reduce hospitalisations, doctor visits or medication use for asthma, but may play a role in improving patients perceptions of their symptoms. However, education programmes designed to improve knowledge alone may reduce Emergency Room visits in high-risk adults. | 10.1002/14651858.CD001005 | [
"Using a systematic approach, the medical literature was searched thoroughly to find reliable studies that looked at the effects of improving patients' knowledge about asthma, but which did not attempt to improve practical self-management skills. The results of the studies were combined to see if patient education designed to improve patient knowledge about their condition made a difference to their asthma. Improving patient knowledge alone does not seem to reduce hospitalisations, doctor visits or medication use for asthma, but may play a role in improving patients perceptions of their symptoms. However, education programmes designed to improve knowledge alone may reduce Emergency Room visits in high-risk adults."
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cochrane-simplification-train-1889 | cochrane-simplification-train-1889 | We identified 12 randomised controlled trials that meet the criteria for the review. Six were ongoing trials, four had been completed and two had been terminated early. Six studies with a total of 9849 participants provided data for this review. The trials evaluated the following: daily oral tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) versus placebo; TDF versus placebo and daily TDF-FTC versus intermittent TDF-FTC. One of the trials had three study arms: TDF, TDF-FTC and placebo arm. The studies were carried out amongst different risk groups, including HIV-uninfected men who have sex with men, serodiscordant couples and other high risk men and women. Overall results from the four trials that compared TDF-FTC versus placebo showed a reduction in the risk of acquiring HIV infection (RR 0.49; 95% CI 0.28 to 0.85; 8918 participants). Similarly, the overall results of the studies that compared TDF only versus placebo showed a significant reduction in the risk of acquiring HIV infection (RR 0.33; 95% CI 0.20 to 0.55, 4027 participants). There were no significant differences in the risk of adverse events across all the studies that reported on adverse events. Also, adherence and sexual behaviours were similar in both the intervention and control groups. Finding from this review suggests that pre-exposure prophylaxis with TDF alone or TDF-FTC reduces the risk of acquiring HIV in high-risk individuals including people in serodiscordant relationships, men who have sex with men and other high risk men and women. | This review evaluated the effects of giving people at high risk for HIV infection drugs to prevent infection (called antiretroviral pre-exposure prophylaxis, or PrEP). We found six randomised controlled trials that assessed the effects of oral tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) versus placebo; TDF versus placebo, and daily TDF-FTC versus intermittent TDF-FTC. One of the trials had three study arms (TDF, TDF-FTC and placebo arm). The trials were carried out amongst different risk groups, including HIV-uninfected men who have sex with men, people in serodiscordant sexual relationships where one partner is infected and the other is not, and other high risk men and women. The findings suggests that the use of TDF alone or TDF+FTC reduces the risk of becoming infected with HIV. However, further studies are need to evaluate the method of administration (daily versus intermittent dosing), long-term safety and cost effectiveness of PrEP in different risk groups and settings. | 10.1002/14651858.CD007189.pub3 | [
"This review evaluated the effects of giving people at high risk for HIV infection drugs to prevent infection (called antiretroviral pre-exposure prophylaxis, or PrEP). We found six randomised controlled trials that assessed the effects of oral tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) versus placebo; TDF versus placebo, and daily TDF-FTC versus intermittent TDF-FTC. One of the trials had three study arms (TDF, TDF-FTC and placebo arm). The trials were carried out amongst different risk groups, including HIV-uninfected men who have sex with men, people in serodiscordant sexual relationships where one partner is infected and the other is not, and other high risk men and women. The findings suggests that the use of TDF alone or TDF+FTC reduces the risk of becoming infected with HIV. However, further studies are need to evaluate the method of administration (daily versus intermittent dosing), long-term safety and cost effectiveness of PrEP in different risk groups and settings."
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cochrane-simplification-train-1890 | cochrane-simplification-train-1890 | Ten trials, involving 6533 women, were included in this review, five trials were rated high quality. For the majority of trials, the antioxidant assessed was combined vitamin C and E therapy. There was no significant difference between antioxidant and control groups for the relative risk (RR) of pre-eclampsia (RR 0.73, 95% confidence intervals (CI) 0.51 to 1.06; nine trials, 5446 women) or any other primary outcome: severe pre-eclampsia (RR 1.25, 95% CI 0.89 to 1.76; two trials, 2495 women), preterm birth (before 37 weeks) (RR 1.10, 95% CI 0.99 to 1.22; five trials, 5198 women), small-for-gestational-age infants (RR 0.83, 95% CI 0.62 to 1.11; five trials, 5271 babies) or any baby death (RR 1.12, 95% CI 0.81 to 1.53; four trials, 5144 babies). Women allocated antioxidants were more likely to self-report abdominal pain late in pregnancy (RR 1.61, 95% CI 1.11 to 2.34; one trial, 1745 women), require antihypertensive therapy (RR 1.77, 95% CI 1.22 to 2.57; two trials, 4272 women) and require an antenatal hospital admission for hypertension (RR 1.54, 95% CI 1.00 to 2.39; one trial, 1877 women). However, for the latter two outcomes, this was not clearly reflected in an increase in any other hypertensive complications. Evidence from this review does not support routine antioxidant supplementation during pregnancy to reduce the risk of pre-eclampsia and other serious complications in pregnancy. | The review covered 10 trials, involving 6533 women, and looked at several antioxidants. Overall the review found no reduction in pre-eclampsia, high blood pressure or preterm birth with the use of antioxidant supplements. When antioxidants were assessed separately, there were insufficient data to be clear about whether there was any benefit or not, except for vitamin C and E. The current evidence does not support the use of antioxidants to reduce the risk of pre-eclampsia or other complications in pregnancy, but there are trials still in progress. | 10.1002/14651858.CD004227.pub3 | [
"The review covered 10 trials, involving 6533 women, and looked at several antioxidants. Overall the review found no reduction in pre-eclampsia, high blood pressure or preterm birth with the use of antioxidant supplements. When antioxidants were assessed separately, there were insufficient data to be clear about whether there was any benefit or not, except for vitamin C and E. The current evidence does not support the use of antioxidants to reduce the risk of pre-eclampsia or other complications in pregnancy, but there are trials still in progress."
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cochrane-simplification-train-1891 | cochrane-simplification-train-1891 | We included eight reviews in this overview: five Cochrane Reviews (33 included trials) and three non-Cochrane reviews (11 included trials). Three reviews (all Cochrane Reviews) scored low risk across all the ROBIS domains in Phase 2 and low risk of bias overall. The remaining five reviews scored high risk on Domain 4 of Phase 2 because the 'Risk of bias' assessment had not been specifically considered and discussed in the review Results and Conclusions. The trials included in the reviews varied in both size and risk of bias. Interventions were compared to usual care. Moderate-quality evidence indicated that C-reactive protein (CRP) point-of-care testing (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.66 to 0.92, 3284 participants, 6 trials), shared decision making (odds ratio (OR) 0.44, 95% CI 0.26 to 0.75, 3274 participants, 3 trials; RR 0.64, 95% CI 0.49 to 0.84, 4623 participants, 2 trials; risk difference -18.44, 95% CI -27.24 to -9.65, 481,807 participants, 4 trials), and procalcitonin-guided management (adjusted OR 0.10, 95% CI 0.07 to 0.14, 1008 participants, 2 trials) probably reduce antibiotic prescribing in general practice. We found moderate-quality evidence that procalcitonin-guided management probably reduces antibiotic prescribing in emergency departments (adjusted OR 0.34, 95% CI 0.28 to 0.43, 2605 participants, 7 trials). The overall effect of these interventions was small (few achieving greater than 50% reduction in antibiotic prescribing, most about a quarter or less), but likely to be clinically important. Compared to usual care, shared decision making probably makes little or no difference to reconsultation for the same illness (RR 0.87, 95% CI 0.74 to 1.03, 1860 participants, 4 trials, moderate-quality evidence), and may make little or no difference to patient satisfaction (RR 0.86, 95% CI 0.57 to 1.30, 1110 participants, 2 trials, low-quality evidence). Similarly, CRP testing probably has little or no effect on patient satisfaction (RR 0.79, 95% CI 0.57 to 1.08, 689 participants, 2 trials, moderate-quality evidence) or reconsultation (RR 1.08, 95% CI 0.93 to 1.27, 5132 participants, 4 trials, moderate-quality evidence). Procalcitonin-guided management probably results in little or no difference in treatment failure in general practice compared to normal care (adjusted OR 0.95, 95% CI 0.73 to 1.24, 1008 participants, 2 trials, moderate-quality evidence), however it probably reduces treatment failure in the emergency department compared to usual care (adjusted OR 0.76, 95% CI 0.61 to 0.95, 2605 participants, 7 trials, moderate-quality evidence). The quality of evidence for interventions focused on clinician educational materials and decision support in reducing antibiotic prescribing in general practice was either low or very low (no pooled result reported) and trial results were highly heterogeneous, therefore we were unable draw conclusions about the effects of these interventions. The use of rapid viral diagnostics in emergency departments may have little or no effect on antibiotic prescribing (RR 0.86, 95% CI 0.61 to 1.22, 891 participants, 3 trials, low-quality evidence) and may result in little to no difference in reconsultation (RR 0.86, 95% CI 0.59 to 1.25, 200 participants, 1 trial, low-quality evidence). None of the trials in the included reviews reported on management costs for the treatment of an ARI or any associated complications. We found evidence that CRP testing, shared decision making, and procalcitonin-guided management reduce antibiotic prescribing for patients with ARIs in primary care. These interventions may therefore reduce overall antibiotic consumption and consequently antibiotic resistance. There do not appear to be negative effects of these interventions on the outcomes of patient satisfaction and reconsultation, although there was limited measurement of these outcomes in the trials. This should be rectified in future trials. We could gather no information about the costs of management, and this along with the paucity of measurements meant that it was difficult to weigh the benefits and costs of implementing these interventions in practice. Most of this research was undertaken in high-income countries, and it may not generalise to other settings. The quality of evidence for the interventions of educational materials and tools for patients and clinicians was either low or very low, which prevented us from drawing any conclusions. High-quality trials are needed to further investigate these interventions. | We identified five Cochrane Reviews and three non-Cochrane reviews. The reviews varied in how many trials they included and the number of participants within trials. The quality of both the reviews and trials varied. We found moderate-quality evidence that three types of strategies probably help to reduce antibiotic prescribing in primary care. Strategies that encourage the use of shared decision making between doctors and their patients, C-reactive protein tests, and procalcitonin-guided management (both tests that measure the amount of proteins in the blood, which may be raised in the case of infection) all probably reduce antibiotic prescribing in general practice. Procalcitonin-guided management also probably reduces antibiotic prescribing in emergency departments. These strategies seem to change antibiotic prescribing whilst keeping patients happy with their consultation and ensuring that they did not need to return to their doctor for the same illness. There was no information about the cost of these strategies, so it was difficult to weigh up the benefits and costs. The quality of the evidence for strategies that aim to educate doctors about antibiotic prescribing, that provide decision aids for doctors to help them change their prescribing, and for the use of rapid viral diagnostics in emergency departments was either low or very low, meaning that we were unable to draw firm conclusions about the effects of these strategies. In conclusion, we determined that some strategies aimed at doctors can probably help to reduce antibiotic prescribing in primary care. Further studies are needed for other types of strategies where there is less information about whether they can change prescribing. | 10.1002/14651858.CD012252.pub2 | [
"We identified five Cochrane Reviews and three non-Cochrane reviews. The reviews varied in how many trials they included and the number of participants within trials. The quality of both the reviews and trials varied. We found moderate-quality evidence that three types of strategies probably help to reduce antibiotic prescribing in primary care. Strategies that encourage the use of shared decision making between doctors and their patients, C-reactive protein tests, and procalcitonin-guided management (both tests that measure the amount of proteins in the blood, which may be raised in the case of infection) all probably reduce antibiotic prescribing in general practice. Procalcitonin-guided management also probably reduces antibiotic prescribing in emergency departments. These strategies seem to change antibiotic prescribing whilst keeping patients happy with their consultation and ensuring that they did not need to return to their doctor for the same illness. There was no information about the cost of these strategies, so it was difficult to weigh up the benefits and costs. The quality of the evidence for strategies that aim to educate doctors about antibiotic prescribing, that provide decision aids for doctors to help them change their prescribing, and for the use of rapid viral diagnostics in emergency departments was either low or very low, meaning that we were unable to draw firm conclusions about the effects of these strategies. In conclusion, we determined that some strategies aimed at doctors can probably help to reduce antibiotic prescribing in primary care. Further studies are needed for other types of strategies where there is less information about whether they can change prescribing."
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cochrane-simplification-train-1892 | cochrane-simplification-train-1892 | The search identified 20 studies (1615 infants). Most were small, single-centre, prospective cohort studies conducted in neonatal units in high- or middle-income countries since the late 1990s. Risk of bias in the included studies was generally low with independent assessment of index and reference tests. Most studies used a prespecified serum CRP threshold level as the definition of a 'positive' index test (typical cut-off level between 5 mg/L and 10 mg/L) and the culture of a pathogenic micro-organism from blood as the reference standard. At median specificity (0.74), sensitivity was 0.62 (95% CI 0.50 to 0.73). Heterogeneity was evident in the forest plots but it was not possible to conduct subgroup or meta-regression analyses by gestational ages, types of infection, or types of infecting micro-organism. Covariates for whether studies used a predefined threshold or not, and whether studies used a standard threshold of between 5 mg/L and 10 mg/L, were not statistically significant. The serum CRP level at initial evaluation of an infant with suspected late-onset infection is unlikely to be considered sufficiently accurate to aid early diagnosis or select infants to undergo further investigation or treatment with antimicrobial therapy or other interventions. | We found 20 studies that assessed the accuracy of measuring the blood level of CRP to diagnose infections in newborn infants. These studies were similar enough to justify a combined analysis of their findings. The combined analysis indicated that a positive CRP test correctly identified infants with infection about six times out of 10. Measuring the blood level of CRP is not sufficiently accurate to help early diagnosis of infection in newborn infants. | 10.1002/14651858.CD012126.pub2 | [
"We found 20 studies that assessed the accuracy of measuring the blood level of CRP to diagnose infections in newborn infants. These studies were similar enough to justify a combined analysis of their findings. The combined analysis indicated that a positive CRP test correctly identified infants with infection about six times out of 10. Measuring the blood level of CRP is not sufficiently accurate to help early diagnosis of infection in newborn infants."
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cochrane-simplification-train-1893 | cochrane-simplification-train-1893 | We included one RCT (a total of 50 participants, 25 in both the intervention and comparator group). The intervention focused on laparoscopic adjustable gastric banding surgery, which was compared to a control group receiving a multi component lifestyle programme. The participating population consisted of Australian adolescents (a higher proportion of girls than boys) aged 14 to 18 years, with a mean age of 16.5 and 16.6 years in the gastric banding and lifestyle group, respectively which was conducted in a private hospital, receiving funding from the gastric banding manufacturer. The study authors were unable to blind participants, personnel and outcome assessors which may have resulted in a high risk of performance and detection bias. Attrition bias was noted as well. The study authors reported a mean reduction in weight of 34.6 kg (95% confidence interval (CI) 30.2 to 39.0) at two years, representing a change in body mass index (BMI) of 12.7 (95% CI 11.3 to 14.2) for the surgery intervention; and a mean reduction in weight of 3.0 kg (95% CI 2.1 to 8.1) representing a change in BMI of 1.3 (95% CI 0.4 to 2.9) for the lifestyle intervention. The differences between groups were statistically significant for all weight measures at 24 months (P < 0.001). The overall quality of the evidence according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) was low. Adverse events were reported in 12/25 (48%) participants in the intervention group compared to 11/25 (44%) in the control group (low quality evidence). A total of 28% of the adolescents undergoing gastric banding required revisional surgery. No data were reported for all-cause mortality, behaviour change, participants views of the intervention and socioeconomic effects. At two years, the gastric banding group performed better than the lifestyle group in two of eight health-related quality of life concepts (very low quality evidence) as measured by the Child Health Questionnaire (physical functioning score (94 versus 78, community norm 95) and change in health score (4.4 versus 3.6, community norm 3.5)). Laparoscopic gastric banding led to greater body weight loss compared to a multi component lifestyle program in one small study with 50 patients. These results do not provide enough data to assess efficacy across populations from different countries, socioeconomic and ethnic backgrounds, who may respond differently. This systematic review highlights the lack of RCTs in this field. Future studies should assess the impact of the surgical procedure and post operative care to minimise adverse events, including the need for post operative adjustments and revisional surgery. Long-term follow-up is also critical to comprehensively assess the impact of surgery as participants enter adulthood. | We found one randomised controlled trial with a total of 50 participants (25 in both the intervention and comparator group) and a follow-up of two years. The surgery used was 'laparoscopic adjustable gastric banding' (gastric band placed around the entrance of the stomach by means of keyhole surgery). The control group received a program consisting of reduced energy intake (individualised diet plans ranging between 800 and 2000 kcal per day, depending on age and weight), increased activity (target of 10,000 steps per day) with a structured exercise schedule of at least 30 minutes a day and behavioural modification. Australian adolescents (higher proportion of girls than boys) with an average age of 16.5 and 16.6 years in the gastric banding and 'lifestyle' group participated. The study authors reported an average reduction in weight of 34.6 kg at two years, representing a change in body mass index units (kg/m²) of 12.7 for the gastric banding group; and an average reduction in weight of 3.0 kg representing a change in body mass index units of 1.3 for the lifestyle intervention. Side effects were reported in 12 of 25 (48%) participants in the intervention group and in 11 of 25 (44%) in the control group. A total of 28% of the adolescents undergoing gastric banding required a 'revisional procedure' (surgery because of complications from the gastric banding surgery). No data were reported for all-cause mortality, behaviour change, participants views of the intervention and socioeconomic effects. At two years, the gastric banding participants performed better than the lifestyle participants in two of eight health-related quality of life concepts as measured by the Child Health Questionnaire (physical functioning score (94 versus 78, community norm 95) and change in health score (4.4 versus 3.6, community norm 3.5). Our results are limited to two years of follow-up and are based on just one small Australian study with some risk of bias which was conducted in a private hospital, receiving funding from the gastric banding manufacturer. There is currently insufficient evidence to make an informed judgement about surgery for the treatment of obesity in children and adolescents. This evidence is up to date as of March 2015. | 10.1002/14651858.CD011740 | [
"We found one randomised controlled trial with a total of 50 participants (25 in both the intervention and comparator group) and a follow-up of two years. The surgery used was 'laparoscopic adjustable gastric banding' (gastric band placed around the entrance of the stomach by means of keyhole surgery). The control group received a program consisting of reduced energy intake (individualised diet plans ranging between 800 and 2000 kcal per day, depending on age and weight), increased activity (target of 10,000 steps per day) with a structured exercise schedule of at least 30 minutes a day and behavioural modification. Australian adolescents (higher proportion of girls than boys) with an average age of 16.5 and 16.6 years in the gastric banding and 'lifestyle' group participated. The study authors reported an average reduction in weight of 34.6 kg at two years, representing a change in body mass index units (kg/m²) of 12.7 for the gastric banding group; and an average reduction in weight of 3.0 kg representing a change in body mass index units of 1.3 for the lifestyle intervention. Side effects were reported in 12 of 25 (48%) participants in the intervention group and in 11 of 25 (44%) in the control group. A total of 28% of the adolescents undergoing gastric banding required a 'revisional procedure' (surgery because of complications from the gastric banding surgery). No data were reported for all-cause mortality, behaviour change, participants views of the intervention and socioeconomic effects. At two years, the gastric banding participants performed better than the lifestyle participants in two of eight health-related quality of life concepts as measured by the Child Health Questionnaire (physical functioning score (94 versus 78, community norm 95) and change in health score (4.4 versus 3.6, community norm 3.5). Our results are limited to two years of follow-up and are based on just one small Australian study with some risk of bias which was conducted in a private hospital, receiving funding from the gastric banding manufacturer. There is currently insufficient evidence to make an informed judgement about surgery for the treatment of obesity in children and adolescents. This evidence is up to date as of March 2015."
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cochrane-simplification-train-1894 | cochrane-simplification-train-1894 | A total of 31 trials, involving 12,587 participants, across a range of clinical specialities (e.g. surgery, critical care) met the eligibility criteria. The trial interventions were split fairly equally with regard to the haemoglobin concentration used to define the restrictive transfusion group. About half of them used a 7 g/dL threshold, and the other half used a restrictive transfusion threshold of 8 g/dL to 9 g/dL. The trials were generally at low risk of bias .Some items of methodological quality were unclear, including definitions and blinding for secondary outcomes. Restrictive transfusion strategies reduced the risk of receiving a RBC transfusion by 43% across a broad range of clinical specialties (risk ratio (RR) 0.57, 95% confidence interval (CI) 0.49 to 0.65; 12,587 participants, 31 trials; high-quality evidence), with a large amount of heterogeneity between trials (I² = 97%). Overall, restrictive transfusion strategies did not increase or decrease the risk of 30-day mortality compared with liberal transfusion strategies (RR 0.97, 95% CI 0.81 to 1.16, I² = 37%; N = 10,537; 23 trials; moderate-quality evidence) or any of the other outcomes assessed (i.e. cardiac events (low-quality evidence), myocardial infarction, stroke, thromboembolism (high-quality evidence)). Liberal transfusion did not affect the risk of infection (pneumonia, wound, or bacteraemia). Transfusing at a restrictive haemoglobin concentration of between 7 g/dL to 8 g/dL decreased the proportion of participants exposed to RBC transfusion by 43% across a broad range of clinical specialities. There was no evidence that a restrictive transfusion strategy impacts 30-day mortality or morbidity (i.e. mortality at other points, cardiac events, myocardial infarction, stroke, pneumonia, thromboembolism, infection) compared with a liberal transfusion strategy. There were insufficient data to inform the safety of transfusion policies in certain clinical subgroups, including acute coronary syndrome, myocardial infarction, neurological injury/traumatic brain injury, acute neurological disorders, stroke, thrombocytopenia, cancer, haematological malignancies, and bone marrow failure. The findings provide good evidence that transfusions with allogeneic RBCs can be avoided in most patients with haemoglobin thresholds above 7 g/dL to 8 g/dL. | We examined the results of RCTs that randomly allocated participants to one of two groups. In one group, trial participants received blood at lower blood counts. In the other group, trial participants received blood at higher blood counts. The data are current up to May 2016. We identified a total of 31 relevant trials, which involved 12,587 participants. All of the studies compared different policies for blood transfusions. We found that participants who were assigned to receive blood at lower blood counts were 43% less likely to receive a blood transfusion than those who were given blood at higher blood counts. The risk of dying within 30 days of the transfusion was the same whether the participants received transfusion at lower or higher blood counts. We also evaluated harmful events that occurred after participants received, or did not receive, blood transfusions, including infection (pneumonia, wound infection, and blood poisoning), heart attacks, strokes, and problems with blood clots, and found that there was no clear difference in the instance of these events between the group that received transfusions at lower blood counts and the group that received transfusions at higher blood counts. We found that most of the RCTs provided a high quality of evidence, in that they were adequately conducted and used appropriate methods that minimised any possible biases that could make the validity of the results uncertain. We concluded that it was not harmful to the participants' health status to give blood at lower or higher blood counts. If a policy of giving blood only at lower blood counts were followed routinely in clinical practice, it would reduce the amount of blood patients receive substantially and reduce the risk of patients receiving blood transfusions unnecessarily, as transfusions can have harmful effects. Additional studies are needed to establish the blood count at which a blood transfusion is needed in patients who have suffered a heart attack, brain injury, or have cancer. | 10.1002/14651858.CD002042.pub4 | [
"We examined the results of RCTs that randomly allocated participants to one of two groups. In one group, trial participants received blood at lower blood counts. In the other group, trial participants received blood at higher blood counts. The data are current up to May 2016. We identified a total of 31 relevant trials, which involved 12,587 participants. All of the studies compared different policies for blood transfusions. We found that participants who were assigned to receive blood at lower blood counts were 43% less likely to receive a blood transfusion than those who were given blood at higher blood counts. The risk of dying within 30 days of the transfusion was the same whether the participants received transfusion at lower or higher blood counts. We also evaluated harmful events that occurred after participants received, or did not receive, blood transfusions, including infection (pneumonia, wound infection, and blood poisoning), heart attacks, strokes, and problems with blood clots, and found that there was no clear difference in the instance of these events between the group that received transfusions at lower blood counts and the group that received transfusions at higher blood counts. We found that most of the RCTs provided a high quality of evidence, in that they were adequately conducted and used appropriate methods that minimised any possible biases that could make the validity of the results uncertain. We concluded that it was not harmful to the participants' health status to give blood at lower or higher blood counts. If a policy of giving blood only at lower blood counts were followed routinely in clinical practice, it would reduce the amount of blood patients receive substantially and reduce the risk of patients receiving blood transfusions unnecessarily, as transfusions can have harmful effects. Additional studies are needed to establish the blood count at which a blood transfusion is needed in patients who have suffered a heart attack, brain injury, or have cancer."
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cochrane-simplification-train-1895 | cochrane-simplification-train-1895 | Three placebo-controlled studies with a total of 263 participants (age range 0.8 to 61 years old, 122 males and 141 females, with variable lengths of study duration) were included in the review. We found high-quality evidence except for response to skin lesions which was judged to be low quality due to the risk of attrition bias. Overall, there are 175 participants in the treatment arm (rapamycin or everolimus) and 88 in the placebo arm. Participants all had tuberous sclerosis complex as proven by consensus diagnostic criteria as a minimum. The quality in the description of the study methods was mixed, although we assessed most domains as having a low risk of bias. Blinding of treatment arms was successfully carried out in all of the studies. However, two studies did not report allocation concealment. Two of the included studies were funded by Novartis Pharmaceuticals. Two studies (235 participants) used oral (systemic) administration of everolimus (rapalog). These studies reported response to tumour size in terms of the number of individuals with a reduction in the total volume of tumours to 50% or more relative to baseline. Significantly more participants in the treatment arm (two studies, 162 participants, high quality evidence) achieved a 50% reduction in renal angiomyolipoma size, risk ratio 24.69 (95% confidence interval 3.51 to 173.41) (P = 0.001). For the sub-ependymal giant cell astrocytoma, our analysis of one study (117 participants, high quality evidence) showed significantly more participants in the treatment arm achieved a 50% reduction in tumour size, risk ratio 27.85 (95% confidence interval 1.74 to 444.82) (P = 0.02). The proportion of participants who showed a skin response from the two included studies analysed was significantly increased in the treatment arms, risk ratio 5.78 (95% confidence interval 2.30 to 14.52) (P = 0.0002) (two studies, 224 participants, high quality evidence). In one study (117 participants), the median change of seizure frequency was -2.9 in 24 hours (95% confidence interval -4.0 to -1.0) in the treatment group versus -4.1 in 24 hour (95% confidence interval -10.9 to 5.8) in the placebo group. In one study, one out of 79 participants in the treatment group versus three of 39 in placebo group had increased blood creatinine levels, while the median percentage change of forced expiratory volume at one second in the treatment arm was -1% compared to -4% in the placebo arm. In one study (117 participants, high quality evidence), we found that those participants who received treatment had a similar risk of experiencing adverse events compared to those who did not, risk ratio 1.07 (95% confidence interval 0.96 - 1.20) (P = 0.24). However, as seen from two studies (235 participants, high quality evidence), the treatment itself led to significantly more adverse events resulting in withdrawal, interruption of treatment, or reduction in dose level, risk ratio 3.14 (95% confidence interval 1.82 to 5.42) (P < 0.0001). One study (28 participants) used topical (skin) administration of rapamycin. This study reported response to skin lesions in terms of participants' perception towards their skin appearance following the treatment. There was a tendency of an improvement in the participants' perception of their skin appearance, although not significant, risk ratio 1.81 (95% confidence interval 0.80 to 4.06, low quality evidence) (P = 0.15). This study reported that there were no serious adverse events related to the study product and there was no detectable systemic absorption of the rapamycin during the study period. We found evidence that oral everolimus significantly increased the proportion of people who achieved a 50% reduction in the size of sub-ependymal giant cell astrocytoma and renal angiomyolipoma. Although we were unable to ascertain the relationship between the reported adverse events and the treatment, participants who received treatment had a similar risk of experiencing adverse events as compared to those who did not receive treatment. Nevertheless, the treatment itself significantly increased the risk of having dose reduction, interruption or withdrawal. This supports ongoing clinical applications of oral everolimus for renal angiomyolipoma and subependymal giant cell astrocytoma. Although oral everolimus showed beneficial effect on skin lesions, topical rapamycin only showed a non-significant tendency of improvement. Efficacy on skin lesions should be further established in future research. The beneficial effects of rapamycin or rapalogs on tuberous sclerosis complex should be further studied on other manifestations of the condition. | The review included three studies with 263 people with tuberous sclerosis complex aged between 0.8 and 61 years of age. However, one study involved five people with sporadic lymphangioleiomyomatosis (without tuberous sclerosis complex) which we could not remove from the analysis. Studies compared rapamycin or rapalogs with placebo and people were selected for one treatment or the other randomly. The duration of the studies was variable. Two of the included studies were funded by Novartis Pharmaceuticals. There is evidence that oral everolimus (rapalog) increased the number of people who achieved a 50% reduction in the size of subependymal giant cell astrocytoma and renal angiomyolipoma. Oral everolimus also showed benefit in terms of response to skin lesions, although applying rapamycin to the skin only showed a tendency for improvement. Those who received treatment had a similar risk of experiencing adverse events as compared to those who did not receive treatment. However, more people receiving the active treatment had severe adverse events causing them to withdraw from the trial, temporarily stop treatment or reduce their dose compared to the control group. Two of the included studies generally showed a low risk of bias in study design, except for one study where it was unclear whether people knew which group they would be put into. Another included study showed different degrees of risk of bias with regards to study design, for example, due to missing data and lack of clarity about how people where put into the different groups. The results from the studies were generally of high quality, except for response to skin lesions from topical rapamycin due to missing outcome data and seizure frequency due to the way participants were selected. | 10.1002/14651858.CD011272.pub2 | [
"The review included three studies with 263 people with tuberous sclerosis complex aged between 0.8 and 61 years of age. However, one study involved five people with sporadic lymphangioleiomyomatosis (without tuberous sclerosis complex) which we could not remove from the analysis. Studies compared rapamycin or rapalogs with placebo and people were selected for one treatment or the other randomly. The duration of the studies was variable. Two of the included studies were funded by Novartis Pharmaceuticals. There is evidence that oral everolimus (rapalog) increased the number of people who achieved a 50% reduction in the size of subependymal giant cell astrocytoma and renal angiomyolipoma. Oral everolimus also showed benefit in terms of response to skin lesions, although applying rapamycin to the skin only showed a tendency for improvement. Those who received treatment had a similar risk of experiencing adverse events as compared to those who did not receive treatment. However, more people receiving the active treatment had severe adverse events causing them to withdraw from the trial, temporarily stop treatment or reduce their dose compared to the control group. Two of the included studies generally showed a low risk of bias in study design, except for one study where it was unclear whether people knew which group they would be put into. Another included study showed different degrees of risk of bias with regards to study design, for example, due to missing data and lack of clarity about how people where put into the different groups. The results from the studies were generally of high quality, except for response to skin lesions from topical rapamycin due to missing outcome data and seizure frequency due to the way participants were selected."
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cochrane-simplification-train-1896 | cochrane-simplification-train-1896 | Twenty-four trials involving 4422 participants were reviewed. Most examined symptomatic women only. Only seven trials analysed results by intention to treat; we re-analysed the remainder. Compared with placebo, clindamycin showed a lower rate of treatment failure (relative risk (RR) 0.25, 95% confidence interval (CI) 0.16 to 0.37). Clindamycin and metronidazole showed identical rates of treatment failure, irrespective of regimen type, at two and four-week follow up (RR 1.01, 95% CI 0.69 to 1.46; RR 0.91, 95% CI 0.70 to 1.18, respectively). Clindamycin tended to cause a lower rate of adverse events (RR 0.75, 95% CI 0.56 to 1.02); metallic taste, and nausea and vomiting were more common in the metronidazole group (RR 0.08, 95% CI 0.1 to 0.59; RR 0.23, 95% CI 0.10 to 0.51, respectively). Given intravaginally as gelatin tablets, lactobacillus was more effective than oral metronidazole (RR 0.20, 95% CI 0.05 to 0.08). Similarly, oral lactobacillus combined with metronidazole was more effective than metronidazole alone (RR 0.33, 95% CI 0.14 to 0.77). Clindamycin showed a lower rate of clinical failure than triple sulfonamide cream (RR 0.46, 95% CI 0.29 to 0.72). Hydrogen peroxide douche showed a higher rate of clinical failure (RR 1.75, 95% CI 1.02 to 3.00) and adverse events (RR 2.33, 95% CI 1.21 to 4.52) than a single 2 g dose of metronidazole. Clindamycin preparations, oral metronidazole, and oral and intravaginal tablets of lactobacillus were effective for bacterial vaginosis. Hydrogen peroxide douche and triple sulphonamide cream were ineffective. Metronidazole caused metallic taste, nausea and vomiting. We need better-designed trials with larger sample sizes to test the effectiveness of promising drugs. | This review evaluated the effectiveness and adverse effects of antimicrobial agents used to treat BV in non-pregnant women. Twenty-four trials involving 4422 women were reviewed. With regard to less treatment failure, clindamycin was superior to placebo but comparable to metronidazole, irrespective of the dose regimen. Metronidazole tended to cause a higher rate of adverse events, such as metallic taste and nausea and vomiting, than did clindamycin. Oral lactobacillus combined with metronidazole was more effective than metronidazole alone. Administered in an intravaginal gelatin tablet, lactobacillus was also more effective than oral metronidazole. Triple sulfonamide cream was less effective compared with clindamycin. Hydrogen peroxide douche was not as effective as a single 2 g dose of metronidazole yet caused more harms. Only one trial involved asymptomatic women and the result was not conclusive. There was insufficient evidence to reach a conclusion on the effectiveness of other promising drugs. Drugs effective for bacterial vaginosis include clindamycin preparations, oral metronidazole, and oral and intravaginal tablets of lactobacillus. Adverse effects of metronidazole include metallic taste, and nausea and vomiting. Information on possible side effects of lactobacillus preparations is required. | 10.1002/14651858.CD006055.pub2 | [
"This review evaluated the effectiveness and adverse effects of antimicrobial agents used to treat BV in non-pregnant women. Twenty-four trials involving 4422 women were reviewed. With regard to less treatment failure, clindamycin was superior to placebo but comparable to metronidazole, irrespective of the dose regimen. Metronidazole tended to cause a higher rate of adverse events, such as metallic taste and nausea and vomiting, than did clindamycin. Oral lactobacillus combined with metronidazole was more effective than metronidazole alone. Administered in an intravaginal gelatin tablet, lactobacillus was also more effective than oral metronidazole. Triple sulfonamide cream was less effective compared with clindamycin. Hydrogen peroxide douche was not as effective as a single 2 g dose of metronidazole yet caused more harms. Only one trial involved asymptomatic women and the result was not conclusive. There was insufficient evidence to reach a conclusion on the effectiveness of other promising drugs. Drugs effective for bacterial vaginosis include clindamycin preparations, oral metronidazole, and oral and intravaginal tablets of lactobacillus. Adverse effects of metronidazole include metallic taste, and nausea and vomiting. Information on possible side effects of lactobacillus preparations is required."
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cochrane-simplification-train-1897 | cochrane-simplification-train-1897 | We included one RCT of 100 participants with ocular burns that were randomised to treatment with AMT and medical therapy or medical therapy alone. A subset of patients (n = 68) who were treated within the first seven days of the injury met the inclusion criteria and were included in the analysis. The remaining 32 eyes were excluded. The included subset consisted of 36 moderate (Dua classification II-III) and 32 severe (Dua classification IV-VI) ocular burns from alkali, acid and thermal injuries. In the moderate category, 13/20 control eyes and 14/16 treatment eyes had complete epithelialisation by 21 days. The RR of failure of epithelialisation by day 21 was 0.18 in the treatment group (95% confidence interval (CI) 0.02 to 1.31; P = 0.09). Mean LogMAR final visual acuities were 0.06 (standard deviation (SD) 0.10) in the treatment group and 0.38 (SD 0.52) in the control group, representing a MD of -0.32 (95% CI -0.05 to -0.59). In the severe category, 1/17 treatment and 1/15 control eyes were epithelialised by day 21. The RR of failure of epithelialisation in the treatment group was 1.01 (95% CI 0.84 to 1.21; P = 0.93). Final visual acuity was 1.77 (SD 1.31) in the treated eyes and 1.64 (SD 1.48) in the control group (MD 0.13; 95% CI -0.88 to 1.14). The risks of performance and detection biases were high, because treating personnel and outcome assessors could not be masked to treatment. There was also a high risk of bias in the visual outcomes of the moderate category, since mean visual acuity was significantly worse at presentation in the control eyes. This reduced confidence in the study findings. Conclusive evidence supporting the treatment of acute ocular surface burns with AMT is lacking. Heterogeneity of disease presentation, variations in treatment, undefined criteria for treatment success and failure, and non-uniform outcome measures are some of the factors complicating the search for clear evidence regarding this treatment. | The historical use of amniotic membrane transplantation (AMT) to treat eye burns during the acute phase has re-emerged in recent years, although its precise effects on the healing process have not been proven by randomised controlled trials (RCTs). One RCT conducted in India included a subset of patients who fulfilled the criteria for analysis in this review. The participants included 68 men and women of all ages with chemical or thermal burns to the ocular surface, who were randomised to treatment with conventional medical therapy alone or to medical therapy and AMT in the first seven days after injury. Conventional medical therapy included topical steroids, antibiotics, sodium ascorbate, sodium citrate, tear substitutes and cycloplegic drops, and oral vitamin C. Pressure-lowering drops and/or oral acetazolamide were prescribed if required. Data from the RCT were analysed to compare corneal wound closure rates by the 21st day after the injury and visual outcomes at final follow-up. The burns were classified as moderate or severe. In the moderate category, the AMT group had a higher proportion of eyes with complete epithelial closure by day 21 (not statistically significant) and significantly better visual acuity at final follow-up. There was a high risk of bias resulting from the uneven characteristics of the control and treatment eyes at presentation and from the failure to mask personnel and outcome assessors involved in the study. This reduced confidence in the study findings. | 10.1002/14651858.CD009379.pub2 | [
"The historical use of amniotic membrane transplantation (AMT) to treat eye burns during the acute phase has re-emerged in recent years, although its precise effects on the healing process have not been proven by randomised controlled trials (RCTs). One RCT conducted in India included a subset of patients who fulfilled the criteria for analysis in this review. The participants included 68 men and women of all ages with chemical or thermal burns to the ocular surface, who were randomised to treatment with conventional medical therapy alone or to medical therapy and AMT in the first seven days after injury. Conventional medical therapy included topical steroids, antibiotics, sodium ascorbate, sodium citrate, tear substitutes and cycloplegic drops, and oral vitamin C. Pressure-lowering drops and/or oral acetazolamide were prescribed if required. Data from the RCT were analysed to compare corneal wound closure rates by the 21st day after the injury and visual outcomes at final follow-up. The burns were classified as moderate or severe. In the moderate category, the AMT group had a higher proportion of eyes with complete epithelial closure by day 21 (not statistically significant) and significantly better visual acuity at final follow-up. There was a high risk of bias resulting from the uneven characteristics of the control and treatment eyes at presentation and from the failure to mask personnel and outcome assessors involved in the study. This reduced confidence in the study findings."
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cochrane-simplification-train-1898 | cochrane-simplification-train-1898 | Nine trials were included in the review, involving 1384 randomised participants. Studies varied in risk of bias, although two studies were identified as being at high risk of selection bias because of problems with concealment of allocation. All studies were from primary care in the United Kingdom and thus comparability was high. The analysis found significantly greater clinical effectiveness in the counselling group compared with usual care in terms of mental health outcomes in the short-term (standardised mean difference -0.28, 95% CI -0.43 to -0.13, n = 772, 6 trials) but not in the long-term (standardised mean difference -0.09, 95% CI -0.27 to 0.10, n = 475, 4 trials), nor on measures of social function (standardised mean difference -0.09, 95% CI -0.29 to 0.11, n = 386, 3 trials). Levels of satisfaction with counselling were high. There was some evidence that the overall costs of counselling and usual care were similar. There were limited comparisons between counselling and other psychological therapies, medication, or other psychosocial interventions. Counselling is associated with significantly greater clinical effectiveness in short-term mental health outcomes compared to usual care, but provides no additional advantages in the long-term. Participants were satisfied with counselling. Although some types of health care utilisation may be reduced, counselling does not seem to reduce overall healthcare costs. The generalisability of these findings to settings outside the United Kingdom is unclear. | In this review we found nine studies involving counselling in primary care for 1384 participants. There were some problems with the methods in some studies. The evidence suggested that counselling is better than usual general practitioner care in improving mental health outcomes in the short term, although the advantages are modest. People who receive counselling in primary care from a trained counsellor are more likely to feel better immediately after treatment and be more satisfied than those who receive care from their general practitioner. However, in the long term, counselling does not seem to be any better than GP care. Although some types of healthcare utilisation may be reduced, counselling does not seem to reduce overall healthcare costs. There is very limited evidence comparing counselling with other psychological therapies (2 studies with 272 participants) or with antidepressant medication (1 study with 83 participants). | 10.1002/14651858.CD001025.pub3 | [
"In this review we found nine studies involving counselling in primary care for 1384 participants. There were some problems with the methods in some studies. The evidence suggested that counselling is better than usual general practitioner care in improving mental health outcomes in the short term, although the advantages are modest. People who receive counselling in primary care from a trained counsellor are more likely to feel better immediately after treatment and be more satisfied than those who receive care from their general practitioner. However, in the long term, counselling does not seem to be any better than GP care. Although some types of healthcare utilisation may be reduced, counselling does not seem to reduce overall healthcare costs. There is very limited evidence comparing counselling with other psychological therapies (2 studies with 272 participants) or with antidepressant medication (1 study with 83 participants)."
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cochrane-simplification-train-1899 | cochrane-simplification-train-1899 | Of 241 records retrieved by the search, 17 trials conducted between 1961 and 2011, involving 2252 participants with follow-up from six weeks to two years, were included. Homogenous data demonstrated that instances of relapse were significantly higher in people receiving any intermittent drug treatment in the long term (n = 436, 7 RCTs, RR 2.46, 95% CI 1.70 to 3.54, moderate quality evidence). Intermittent treatment was shown to be more effective than placebo, however, and demonstrated that significantly less people receiving intermittent antipsychotics experienced full relapse by medium term (n = 290, 2 RCTs, RR 0.37, 95% CI 0.24 to 0.58, very low quality evidence). Hospitalisation rates were higher for people receiving any intermittent drug treatment by long term (n = 626, 5 RCTs, RR 1.65, 95% CI 1.33 to 2.06, moderate quality evidence). Results demonstrated little difference in instances of tardive dyskinesia in groups with any intermittent drug technique versus maintenance therapy, with equivocal results (displaying slight heterogeneity) at long term (n = 165, 4 RCTs, RR 1.15, 95% CI 0.58 to 2.30, low quality evidence). Results of this review support the existing evidence that intermittent antipsychotic treatment is not as effective as continuous, maintained antipsychotic therapy in preventing relapse in people with schizophrenia. More research is needed to assess any potential benefits or harm of intermittent treatment regarding adverse effects typically associated with maintained antipsychotic treatment, as well as any cost-effectiveness of this experimental treatment. | This review assesses different intermittent drug techniques compared with maintenance treatment in people with schizophrenia or related disorders. Seventeen studies with 2252 participants compared intermittent drug techniques with standard maintenance on medication. Relapse was significantly higher in people receiving intermittent drug treatment. Hospitalisation was higher for people receiving intermittent drug treatment. Results suggest that intermittent treatment is not as effective as continuous or maintained treatment in preventing relapse. Although information favours maintenance and continuous treatment, this is not always the case in real settings, where people may stop their medication due to debilitating side effects that affect their quality of life. More research is needed to assess any potential benefits or harm of intermittent treatment, particularly regarding the side effects commonly associated with maintained antipsychotic treatment. There was no exploration of economic/money savings, specifically relating to the potential cost-effectiveness of intermittent techniques. Until further evidence is available concerning the potential benefits or harms of intermittent treatment, managers, psychiatrists and policy makers should consider it an experimental therapy. This plain language summary has been written by a consumer Ben Gray, Service User and Service User Expert, Rethink Mental Illness. | 10.1002/14651858.CD006196.pub2 | [
"This review assesses different intermittent drug techniques compared with maintenance treatment in people with schizophrenia or related disorders. Seventeen studies with 2252 participants compared intermittent drug techniques with standard maintenance on medication. Relapse was significantly higher in people receiving intermittent drug treatment. Hospitalisation was higher for people receiving intermittent drug treatment. Results suggest that intermittent treatment is not as effective as continuous or maintained treatment in preventing relapse. Although information favours maintenance and continuous treatment, this is not always the case in real settings, where people may stop their medication due to debilitating side effects that affect their quality of life. More research is needed to assess any potential benefits or harm of intermittent treatment, particularly regarding the side effects commonly associated with maintained antipsychotic treatment. There was no exploration of economic/money savings, specifically relating to the potential cost-effectiveness of intermittent techniques. Until further evidence is available concerning the potential benefits or harms of intermittent treatment, managers, psychiatrists and policy makers should consider it an experimental therapy. This plain language summary has been written by a consumer Ben Gray, Service User and Service User Expert, Rethink Mental Illness."
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