GEM/cochrane-simplification huggingface dataset:
Abstract: We identified three prospective RCTs for inclusion in this review (319 participants available to assess the primary outcome of anxiety). The studies included people from the outpatient setting, with the majority of participants being male. All three studies assessed psychological therapy (cognitive behavioural therapy) plus co-intervention versus co-intervention alone. We assessed the quality of evidence contributing to all outcomes as low due to small sample sizes and substantial heterogeneity in the analyses. Two of the three studies had prespecified protocols available for comparison between prespecified methodology and outcomes reported within the final publications. We observed some evidence of improvement in anxiety over 3 to 12 months, as measured by the Beck Anxiety Inventory (range from 0 to 63 points), with psychological therapies performing better than the co-intervention comparator arm (mean difference (MD) -4.41 points, 95% confidence interval (CI) -8.28 to -0.53; P = 0.03). There was however, substantial heterogeneity between the studies (I2 = 62%), which limited the ability to draw reliable conclusions. No adverse events were reported. We found only low-quality evidence for the efficacy of psychological therapies among people with COPD with anxiety. Based on the small number of included studies identified and the low quality of the evidence, it is difficult to draw any meaningful and reliable conclusions. No adverse events or harms of psychotherapy intervention were reported. A limitation of this review is that all three included studies recruited participants with both anxiety and depression, not just anxiety, which may confound the results. We downgraded the quality of evidence in the 'Summary of findings' table primarily due to the small sample size of included trials. Larger RCTs evaluating psychological interventions with a minimum 12-month follow-up period are needed to assess long-term efficacy.

Plain-language summary: This systematic review found three studies with a total of 319 participants with COPD and coexisting anxiety. All three studies assessed psychotherapy (CBT) with a co-intervention, versus the co-intervention alone. There was limited evidence showing some improvements in reduced levels of anxiety and improved quality of life in the psychotherapy group. It is important to note that the overall quality of the evidence was low and hence further research is needed to increase our confidence in this effect. A limitation of this review is that all three included studies recruited participants with both anxiety and depression, not just anxiety, which may confound the results. Further research is needed to establish whether this therapy will reduce hospital admissions and length of hospital stays, as this was not assessed in the current evidence base. Larger studies of longer duration need to be conducted. There are at least two more clinical trials currently ongoing for this question. Once they are published, the evidence from them could increase or decrease our confidence in the findings of this review.
Abstract: We found 9 RCTs involving a total of 421 participants of which 6 were studies of egg and milk exclusion (N=288), 1 was a study of few foods (N=85) and 2 were studies of an elemental diet (N=48). There appears to be no benefit of an egg and milk free diet in unselected participants with atopic eczema. There is also no evidence of benefit in the use of an elemental or few-foods diet in unselected cases of atopic eczema. There may be some benefit in using an egg-free diet in infants with suspected egg allergy who have positive specific IgE to eggs - one study found 51% of the children had a significant improvement in body surface area with the exclusion diet compared to normal diet (RR 1.51, 95% CI 1.07 to 2.11) and change in surface area and severity score was significantly improved in the exclusion diet compared to the normal diet at the end of 6 weeks (MD 5.50, 95% CI 0.19 to 10.81) and end of treatment (MD 6.10, 95% CI 0.06 to12.14). Methodological difficulties have made it difficult to interpret these studies. Poor concealment of randomisation allocation, lack of blinding and high dropout rates without an intention-to-treat analysis indicates that these studies should be interpreted with great caution. There may be some benefit in using an egg-free diet in infants with suspected egg allergy who have positive specific IgE to eggs. Little evidence supports the use of various exclusion diets in unselected people with atopic eczema, but that may be because they were not allergic to those substances in the first place. Lack of any benefit may also be because the studies were too small and poorly reported. Future studies should be appropriately powered focusing on participants with a proven food allergy. In addition a distinction should be made between young children whose food allergies improve with time and older children/adults.

Plain-language summary: The general quality of the studies was poor. The main findings of the review suggest that there is some evidence from one study for the use of an egg-free diet in infants with a suspected egg allergy who have positive specific IgE antibodies to eggs in their blood. Other studies that compared a dietary exclusion with ordinary diets did not test the people taking part to see if they were allergic to the foods concerned. There appears to be little benefit in eliminating cows milk from the diet or using an elemental (liquid diet containing only amino acids, carbohydrates, fat, minerals and vitamins) or 'few foods diet' for improving atopic eczema in people who have not undergone any form of testing. Three of the studies used soya based substitute which itself can be allergenic to people with atopic eczema. Adhering to elimination diets is difficult. The studies were performed in different populations with only one study describing the severity of the atopic eczema. The clinical relevance of changes in severity scores obtained in many studies is unknown.
Abstract: Two trials with a total of 69 participants met the inclusion criteria. The first study considered the treatment of 403 people but only included 44 participants in the surgical trial, who were randomised into surgical and non-surgical groups. However, the report did not provide information on the method of randomisation. The second study randomly allocated 25 participants into surgical or control groups using statistical charts. There was no attempt in either study to conceal allocation. Neither participants nor outcome assessors were blind to the interventions, in either study. The first study lost seven participants to follow-up and there were no losses to follow-up in the second study. Surgeons in both studies decompressed the nerves of all the surgical group participants using a retroauricular approach. The primary outcome was recovery of facial palsy at 12 months. The first study showed that the operated group and the non-operated group (who received oral prednisolone) had comparable facial nerve recovery at nine months. This study did not statistically compare the groups but the scores and size of the groups suggested that statistically significant differences are unlikely. The second study reported no statistically significant differences between the operated and control (no treatment) groups. One operated participant in the first study had 20 dB sensorineural hearing loss and persistent vertigo. We identified no new studies when we updated the searches in October 2012. There is only very low quality evidence from randomised controlled trials and this is insufficient to decide whether surgical intervention is beneficial or harmful in the management of Bell's palsy. Further research into the role of surgical intervention is unlikely to be performed because spontaneous recovery occurs in most cases.

Plain-language summary: After a wide search for randomised controlled trials, we found two studies to include in our review, which together involved 69 people with Bell's palsy. Our main measure of the effects of surgery was to be the recovery of paralysis at 12 months. The first study compared surgery with a steroid medicine and the second study compared surgery with no treatment. In the first study the surgery and no surgery groups appeared to have similar facial nerve recovery at nine months. The second study found no differences in recovery of the facial paralysis after one year, between the participants who had an operation and those who had no treatment. One participant who had surgery in the first study had mild hearing loss and vertigo (dizziness) afterwards. Both studies had limitations that could have affected the results. This review was first published in 2011. We updated the searches in October 2012 and found no new relevant studies. The review found that there was only very low quality evidence and that this was insufficient to decide whether an operation would be helpful or harmful for people with Bell's palsy. There is unlikely to be further research into the role of an operation because Bell's palsy usually recovers without treatment.
Abstract: Four studies evaluating rimonabant 20 mg versus rimonabant 5 mg versus placebo in addition to a hypocaloric diet lasting at least one year were included. Compared with placebo, rimonabant 20 mg produced a 4.9 kg greater reduction in body weight in trials with one-year results. Improvements in waist circumference, high-density lipoprotein cholesterol, triglyceride levels and systolic and diastolic blood pressure were also seen. However, the results with rimonabant 5 mg demonstrated a weight reduction which was only 1.3 kg greater when compared with placebo. No clinically relevant effects on plasma lipids and blood pressure were found. Rimonabant 20 mg caused significant more adverse effects both of general and serious nature, especially of nervous system, psychiatric or gastro-intestinal origin. Attrition rates were approximately 40% at the end of one year. The use of rimonabant after one year produces modest weight loss of approximately 5%. Even modest amounts of weight loss may be potentially beneficial. The observed results should be interpreted with some caution, though, since the evaluated studies presented some deficiencies in methodological quality. Studies with longer follow-ups after the end of treatment and of more rigorous quality should be done before definitive recommendations can be made regarding the role of this new medication in the management of overweight or obese patients.

Plain-language summary: Rimonabant is the first drug of a new class of medications that seems to reduce body weight and improve risk factors for diseases of the blood vessels and heart in people who are overweight or obese. We found four studies which evaluated weight loss, occurrence of disorders and adverse effects of treatment. The four studies involved 6625 people comparing rimonabant 20 mg with rimonabant 5 mg and placebo, in combination with a hypocaloric diet after one or two years of treatment. Greater weight loss and improvement in risk factors were seen after 20 mg of rimonabant. These results have to be interpreted with caution though, due to high discontinuation rates of study participants and the overall low quality of the included studies.  We conclude that: 1. average weight loss with rimonabant appears modest, and 2. more rigorous studies examining the efficacy and safety of rimonabant are required to fully evaluate the benefit risk ratio of this new drug.  In Europe, rimonabant is contraindicated for patients with severe depression and/or patients who are treated with antidepressive medications. Rimonabant is furthermore not recommended for patients with other untreated psychiatric conditions.
Abstract: There was no significant heterogeneity of outcome amongst individual drugs, or of drug classes either for the primary efficacy analysis (death or dependence) or for mortality at final follow up. For the primary efficacy analysis, odds of death or dependence were 1.03 (95% confidence interval (CI) 0.96 to 1.12), and for mortality 1.02 (0.92 to 1.12). Neither ion channel modulators (death or dependence 1.02 (0.90 to 1.16)) nor NMDA antagonists (death or dependence 1.05 (0.95 to 1.16)) differed from the principal analysis including all compounds. Trends for increased mortality with three NMDA antagonists were seen - selfotel (OR 1.19 (0.81 to 1.74)), aptiganel (OR 1.32 (0.91 to 1.93)) and gavestinel (OR 1.12 (0.95 to 1.32)) - but this did not achieve significance for the NMDA antagonists considered as a class (1.09 (0.96 to 1.23)). Aptiganel was also associated with a trend towards worse functional outcome (OR 1.20 (0.88 to 1.65)) although this was not the case for either of the other two compounds. No statistically significant detriment of psychotomimetic NMDA antagonists was found, although a trend towards higher mortality in this sub-group was seen (OR 1.25 (0.96 to 1.64)). There was no evidence of significant benefit or harm from drugs modulating excitatory amino acid action. Reduction of death or dependence by 8% or more has been excluded for gavestinel and lubeluzole, which contribute most of the data for this review. However, mechanistic understanding of neuroprotection is too poor to extrapolate from these two failed development plans to all glutamate modulators. Further clinical trials of neuroprotective agents remain justified, since confidence limits around estimates of effect remain wide for most agents, and cannot reliably exclude benefit. Although numbers of patients are too small to confirm or refute a trend towards increased mortality with some NMDA antagonists, further commercial development of these agents is exceedingly unlikely.

Plain-language summary: These drugs were highly effective in animal studies. Individual clinical trials in stroke patients did not confirm benefit for any of the drugs, however. This review confirms that there are no overall benefits for these drugs in stroke, although only two of them have been tested in a large enough population to be reasonably confident that they have no major effects. Some drugs may be harmful. Over 11,000 patients have participated in trials of 13 different drugs that inhibit glutamate release or binding, but two-thirds of all data are from trials of just two drugs. For most drugs in this class, trials have been too small to provide conclusive evidence of harm or benefit. Major differences among individual drugs mean that it is impossible to conclude that all drugs with this mode of action are ineffective. Further trials remain justified, and several are ongoing.
Abstract: Forty-nine trials involving 8763 women were included. The data were combined to calculate hazard ratios (HR) for survival on an intention-to-treat basis. For single non-platinum versus platinum combination chemotherapy the overall HR for survival was 0.93, 95% confidence interval (CI) 0.83 to1.05 favouring platinum-based combination chemotherapy. For non-platinum regimens compared with the same regimen plus cisplatin the survival HR was 0.88, 95% CI 0.79 to 0.98 in favour of adding platinum to drug regimens. Single platinum compared with platinum combination gave a HR of 0.91, 95% CI 0.79 to 1.05 favouring combination chemotherapy. Cisplatin versus carboplatin gave a HR of 1.02, 95% CI 0.93 to 1.12. Sub-group analyses for age, stage, grade, histology, resection, bulk of residual tumour and performance status were undertaken for cisplatin versus carboplatin only. No difference in effect was found. Available evidence, although not conclusive, suggests platinum-based chemotherapy is better than non-platinum therapy. There is some evidence that combination therapy improves survival compared with platinum alone. No difference in effect has been shown between cisplatin and carboplatin.

Plain-language summary: This review found a small benefit in platinum-based chemotherapy over non-platinum therapy. It also found that platinum combinations may offer improved survival over single platinum and that cisplatin and carboplatin are equally effective. The trials were done when paclitaxel (an effective new drug) was not used routinely. The results therefore, will need to be looked at in the light of new evidence from paclitaxel trials.
Abstract: Eight randomized trials, including 9598 patients, tested adjusted-dose warfarin versus aspirin (in dosages ranging from 75 to 325 mg/day) in AF patients without prior stroke or TIA. The mean overall follow up was 1.9 years/participant. Oral anticoagulants were associated with lower risk of all stroke (odds ratio (OR) 0.68, 95% confidence interval (CI) 0.54 to 0.85), ischemic stroke (OR 0.53, 95% CI 0.41 to 0.68) and systemic emboli (OR 0.48, 95% CI 0.25 to 0.90). All disabling or fatal strokes (OR 0.71, 95% CI 0.59 to 1.04) and myocardial infarction (OR 0.69, 95% CI 0.47 to 1.01) were substantially but not significantly reduced by oral anticoagulants. Vascular death (OR 0.93, 95% CI 0.75 to 1.15) and all cause mortality (OR 0.99, 95% CI 0.83 to 1.18), were similar with these treatments. Intracranial hemorrhages (OR 1.98, 95% CI 1.20 to 3.28) were increased by oral anticoagulant therapy. Adjusted-dose warfarin and related oral anticoagulants reduce stroke, disabling stroke and other major vascular events for those with non-valvular AF by about one third when compared with antiplatelet therapy.

Plain-language summary: Atrial fibrillation (AF) is an irregularity of the heartbeat that leads to blood clots forming in the upper chambers of the heart (the atria). These clots can break free and travel through the bloodstream to the brain and cause a stroke. Drugs that slow clotting, such as oral anticoagulants (warfarin and other coumarin derivates) and antiplatelet agents (aspirin and others), reduce the risk of stroke in patients with atrial fibrillation. In this review of eight randomized trials, including 9598 patients, oral anticoagulants are shown to reduce the risk of stroke in patients with non-valvular AF and with no prior stroke or transient ischemic attack by one-third when compared with antiplatelet agents alone. Antiplatelet agents reduce stroke by about 20% in AF patients compared with no therapy, offering a less efficacious therapeutic option for those deemed not eligible for anticoagulation therapy. The threshold of absolute benefit that warrants anticoagulation remains controversial and depends on patient's preferences and availability of optimal anticoagulation monitoring.
Abstract: We included two trials with 493 randomised participants with various Child-Pugh scores. The trials had a low risk of bias. The rHuFVIIa administration did not reduce the risk of mortality within five days (21/288 (7.3%) versus 15/205 (7.3%); risk ratio (RR) 0.88, 95% confidence interval (CI) 0.48 to 1.64, I2 = 49%) and within 42 days (5/286 (1.7%) versus 36/205 (17.6%); RR 1.01, 95% CI 0.55 to 1.87, I2 = 55%) when compared with placebo. Trial sequential analysis demonstrated that there is sufficient evidence to exclude that rHuFVIIa decreases mortality by 80%, but there is insufficient evidence to exclude smaller effects. The rHuFVIIa did not increase the risk of adverse events by number of patients (218/297 (74%) and 164/210 (78%); RR 0.94, 95% CI 0.84 to 1.04, I2 = 1%), serious adverse events by adverse events reported (164/590 (28%) versus 123/443 (28%); RR 0.91, 95% CI 0.75 to 1.11, I2 = 0%), and thromboembolic adverse events (16/297 (5.4%) versus 14/210 (6.7%); RR 0.80, 95% CI 0.40 to 1.60, I2 = 0%) when compared with placebo. We found no evidence to support or reject the administration of rHuFVIIa for patients with liver disease and upper gastrointestinal bleeding. Further adequately powered randomised clinical trials are needed in order to evaluate the proper role of rHuFVIIa for treating upper gastrointestinal bleeding in patients with liver disease. Although the results are based on trials with low risk of bias, the heterogeneity and the small sample size result in rather large confidence intervals that cannot exclude the possibility that the intervention has some beneficial or harmful effect. Further trials with alow risk of bias are required to make more confident conclusions about the effects of the intervention.

Plain-language summary: The review includes two randomised clinical trials with 493 participants. The risk of bias was low. Both trials compared recombinant human activated factor VII with placebo. The meta-analysis showed that the recombinant human activated factor VII does not seem to reduce mortality in patients with liver disease and suffering from upper gastrointestinal bleeding, irrespective of the grade of liver damage. The current evidence is insufficient to support or reject recombinant human activated factor VII for these patients.
Abstract: A total of 43 trials were identified with 1673 participants. All trials used small patient numbers (average trial size of 39 participants); the methods of randomisation and concealment of allocation were poor or not stated in most trials. Blinded assessors were used in just over half of the trials and only 10 stated that they used intention-to-treat analysis. A wide variety of validated and customised outcome measures were used to assess the effectiveness of physiotherapy interventions. The most frequently reported physiotherapy outcomes were gait speed and timed up and go, in 19 and 15 trials respectively. Only five of the 43 trials reported data on falls (12%). The motor subscales of the Unified Parkinson’s Disease Rating Scale and Parkinson’s Disease Questionnaire-39 were the most commonly reported clinician-rated disability and patient-rated quality of life outcome measures, used in 22 and 13 trials respectively. The content and delivery of the physiotherapy interventions varied widely in the trials included within this review, so no quantitative meta-analysis could be performed. Considering the small number of participants examined, the methodological flaws in many of the studies, the possibility of publication bias, and the variety of interventions, formal comparison of the different physiotherapy techniques could not be performed. There is insufficient evidence to support or refute the effectiveness of one physiotherapy intervention over another in PD. This review shows that a wide range of physiotherapy interventions to treat PD have been tested . There is a need for more specific trials with improved treatment strategies to underpin the most appropriate choice of physiotherapy intervention and the outcomes measured.

Plain-language summary: Only randomised controlled trials were included in this review. These were studies where a group of participants were given one physiotherapy intervention and were compared with another group who received a different physiotherapy intervention. The participants were assigned to a group in a random fashion to reduce the potential for bias. A total of 43 randomised trials involving 1673 participants (average trial size of just 39 participants) were identified as suitable for this review. The trials assessed various physiotherapy interventions, so they were grouped according to the type of intervention being used (general physiotherapy, exercise, treadmill training, cueing, dance or martial arts). However, despite this grouping, the physiotherapy interventions delivered and the outcomes assessed varied so much that the results of the individual trials could not be combined. This review highlights that a wide range of different physiotherapy techniques have been tested to treat PD. Considering the small number of participants, the wide variety of physiotherapy interventions and the outcomes assessed, there is insufficient evidence to support the use of one approach of physiotherapy intervention over another for the treatment of PD.