GEM/cochrane-simplification huggingface dataset:
Abstract: Our search identified 604 potentially relevant studies. Of these, 14 studies (15 interventions) were RCTs and met our inclusion criteria. The numbers of participants were 352, 138 and 1745 for aspirin, steroid and NSAIDs groups, respectively. One selected study comprised two separate interventions. Interventions assessed in these studies were grouped into four categories: aspirin (three interventions), steroids (one intervention), traditional NSAIDs (six interventions), and selective cyclooxygenase-2 (COX-2) inhibitors (five interventions). All studies were evaluated for internal validity using a risk of bias assessment tool. The risk of bias was low for five studies, high for seven studies, and unclear for two studies.There was no significant improvement in cognitive decline for aspirin, steroid, traditional NSAIDs and selective COX-2 inhibitors. Compared to controls, patients receiving aspirin experienced more bleeding while patients receiving steroid experienced more hyperglycaemia, abnormal lab results and face edema. Patients receiving NSAIDs experienced nausea, vomiting, elevated creatinine, elevated LFT and hypertension. A trend towards higher death rates was observed among patients treated with NSAIDS compared with placebo and this was somewhat higher for selective COX-2 inhibitors than for traditional NSAIDs. Based on the studies carried out so far, the efficacy of aspirin, steroid and NSAIDs (traditional NSAIDs and COX-2 inhibitors) is not proven. Therefore, these drugs cannot be recommended for the treatment of AD.

Plain-language summary: Fourteen studies met our inclusion criteria for this review and none of the exclusion criteria. Aspirin, steroid and non-steroidal anti-inflammatory drugs (NSAIDs) (traditional and the selective cyclooxygenase-2 (COX-2) inhibitors) showed no significant benefit in the treatment of Alzheimer's disease. Therefore, the use of these drugs cannot be recommended for the treatment of Alzheimer's disease.
Abstract: Two of the seven studies analyzed showed a statistically significant reduction in seizure rate from baseline (72% and 78.9% reduction of seizures per week from the baseline rate, respectively). The other five studies showed no statistically significant difference in seizure frequency following rTMS treatment compared with controls. We were not able to combine the results of the trials in analysis due to differences in the designs of the studies. Four studies evaluated our secondary endpoint of mean number of epileptic discharges, and three of the four showed a statistically significant reduction in discharges. Quality of life was not assessed in any of the studies. Adverse effects were uncommon among the studies and typically involved headache, dizziness, and tinnitus. No significant changes in medication use were found in the trials. Overall, we judged the quality of evidence for the primary outcomes of this review to be low. There is evidence that rTMS is safe and not associated with any adverse events, but given the variability in technique and outcome reporting that prevented meta-analysis, the evidence for efficacy of rTMS for seizure reduction is still lacking despite reasonable evidence that it is effective at reducing epileptiform discharges.

Plain-language summary: Overall, we judged the quality of the evidence in this review for the main outcome of reduction in seizure frequency to be low due to unclear information in the published papers about how the studies were designed and unclear presentation of results. This review provides no information about the effect of TMS on quality of life. It is important that future studies are larger and measure important outcomes, such as the effect of TMS on reducing seizure frequency, improving quality of life, and any side-effects associated with TMS compared with other available treatments.
Abstract: We included a total of 11 studies involving 1275 participants. In three trials (n = 782), EPO therapy was associated with a significant increase in death by the end of the trial (odds ratio (OR) 1.98, 95% confidence interval (CI) 1.19 to 3.3, P = 0.009) and a non-significant increase in serious adverse events. EPO significantly increased the red cell count with no effect on platelet or white cell count, or infarct volume. Two small trials of carbamylated EPO have been completed but have yet to be reported. We included eight small trials (n = 548) of G-CSF. G-CSF was associated with a non-significant reduction in early impairment (mean difference (MD) -0.4, 95% CI -1.82 to 1.01, P = 0.58) but had no effect on functional outcome at the end of the trial. G-CSF significantly elevated the white cell count and the CD34+ cell count, but had no effect on infarct volume. Further trials of G-CSF are ongoing. There are significant safety concerns regarding EPO therapy for stroke. It is too early to know whether other CSFs improve functional outcome.

Plain-language summary: In this analysis, we assessed the effect of CSFs on outcome after stroke using data from clinical trials of people with recent stroke. We included a total of 11 studies and 1275 participants. A higher death rate was observed in participants treated with erythropoietin (EPO) in three trials (782 participants); whether further trials of EPO will be performed early after stroke remains unclear. In eight small trials involving 548 participants, patterns of improvement after a stroke were observed using granulocyte colony stimulating factor (G-CSF) and further trials are ongoing. Currently, there is insufficient evidence to support the use of CSFs in the treatment of people with recent stroke.
Abstract: We only identified one trial that met the inclusion criteria but this trial did not have any results so we could not perform the planned subgroup and sensitivity analyses in the absence of data. Two ongoing trials were identified which may provide data for analyses in a later version of this review. The completion date of these trials is currently unknown. The current review failed to find any completed randomised clinical trials with results. Therefore we are unable to conclude whether intensive glycaemic control when compared to conventional glycaemic control has a positive or detrimental effect on the treatment of foot ulcers in people with diabetes. Previous evidence has however highlighted a reduction in risk of limb amputation (from various causes) in people with type 2 diabetes with intensive glycaemic control. Whether this applies to people with foot ulcers in particular is unknown. The exact role that intensive glycaemic control has in treating foot ulcers in multidisciplinary care (alongside other interventions targeted at treating foot ulcers) requires further investigation.

Plain-language summary: We did not find any trials which have been completed on this topic with available results. The only trial which met our criteria for inclusion had been terminated due to encountering difficulties with recruiting participants. Therefore we cannot be sure whether controlling blood glucose intensively when people have diabetic foot ulcers is beneficial or harmful. The lack of evidence however should not deter efforts to achieve optimal glycaemic control in people with diabetic foot ulcers to encourage healing as is current practice. We believe there are currently two trials underway which may provide some evidence on this topic once completed. This Plain Language Summary is up to date as of 7 December 2015.
Abstract: We included 17 trials (2596 participants); three had low overall risk of bias. Baseline severity, glucocorticoid schemes, comparators and outcomes were heterogeneous. Glucocorticoids did not significantly reduce outpatient admissions by days 1 and 7 when compared to placebo (pooled risk ratios (RRs) 0.92; 95% confidence interval (CI) 0.78 to 1.08 and 0.86; 95% CI 0.7 to 1.06, respectively). There was no benefit in LOS for inpatients (mean difference -0.18 days; 95% CI -0.39 to 0.04). Unadjusted results from a large factorial low risk of bias RCT found combined high-dose systemic dexamethasone and inhaled epinephrine reduced admissions by day 7 (baseline risk of admission 26%; RR 0.65; 95% CI 0.44 to 0.95; number needed to treat 11; 95% CI 7 to 76), with no differences in short-term adverse effects. No other comparisons showed relevant differences in primary outcomes. Current evidence does not support a clinically relevant effect of systemic or inhaled glucocorticoids on admissions or length of hospitalisation. Combined dexamethasone and epinephrine may reduce outpatient admissions, but results are exploratory and safety data limited. Future research should further assess the efficacy, harms and applicability of combined therapy.

Plain-language summary: Our systematic review found 17 controlled studies involving 2596 affected children that used these drugs for a short duration and assessed short-term outcomes. When comparing glucocorticoids to placebo, no differences were found for either hospital admissions or length of hospital stay. There was no substantial benefit in other health outcomes. These findings are consistent and likely to be applicable in diverse settings. Exploratory results from one large high-quality trial suggest that combined treatment of systemic glucocorticoids (dexamethasone) and bronchodilators (epinephrine) may significantly reduce hospital admissions. There were no relevant short-term adverse effects that were any different from those seen with an inactive placebo, while long-term safety was not assessed. Further research is needed to confirm the efficacy, safety and applicability of this promising approach.
Abstract: Only one study enrolling 182 patients (reported as an abstract in conference proceedings) was identified and found eligible for inclusion; the authors reported only limited results. The trial was stopped prematurely and was, therefore, under-powered to detect any significant differences and at high risk of bias. The only available outcome of clinical significance was 28-day mortality. There was no statistically significant difference between groups, with a relative risk for 28-day mortality in the partial liquid ventilation group of 1.54 (95% confidence interval 0.82 to 2.9). There is no evidence from RCTs to support or refute the use of partial liquid ventilation in children with acute lung injury or acute respiratory distress syndrome. Adequately powered, high quality RCTs are still needed to assess its efficacy. Clinically relevant outcome measures should be assessed (mortality at discharge and later, duration of both respiratory support and hospital stay, and long-term neurodevelopmental outcomes). The studies should be published in full.

Plain-language summary: We found only one multicentre randomized controlled study, reported as an abstract in conference proceedings, that was eligible for inclusion in this updated Cochrane review. The company sponsored study enrolled 182 patients in 65 centres. The trial was stopped early, before recruiting sufficient numbers of participants and before it could detect any clear differences between partial liquid ventilation and conventional mechanical ventilation (the control group). The number of deaths at 28 days was 22% of patients in the partial liquid ventilation group and 14% in the control group, the difference was not statistically significant; there was a wide variation in results and a clinically significant difference could not be excluded. There were other problems with the trial that made its results unreliable in terms of eligible patients, use of other rescue therapies, and that the measured outcomes were altered at least twice during the study; additional therapies such as high frequency ventilation or inhaled nitric oxide were allowed in the control group.
Abstract: Combined results from the 4 eligible randomised controlled trials shows that participants allocated to FOBT screening had a statistically significant 16% reduction in the relative risk of colorectal cancer mortality (RR 0.84; CI: 0.78-0.90). In the 3 studies that used biennial screening (Funen, Minnesota, Nottingham) there was a 15% relative risk reduction (RR 0.85, CI: 0.78-0.92) in colorectal cancer mortality. When adjusted for mean screening attendance in the individual studies, there was a 25% relative risk reduction (RR 0.75, CI: 0.66 - 0.84) for those attending at least one round of screening using the faecal occult blood test. Benefits of screening include a modest reduction in colorectal cancer mortality, a possible reduction in cancer incidence through the detection and removal of colorectal adenomas, and potentially, the less invasive surgery that earlier treatment of colorectal cancers may involve.  Harmful effects of screening include the psycho-social consequences of receiving a false-positive result, the potentially significant complications of colonoscopy or a false-negative result, the possibility of overdiagnosis (leading to unnecessary investigations or treatment) and the complications associated with treatment.

Plain-language summary: The screening test used in these trials to detect colorectal (bowel) cancer was the faecal occult blood test (FOBT). If the FOBT is positive, the bowels are examined closely with further diagnostic test (coloscopy, flexible sigmoidoscopy, double-contrast barium enema), but these tests often cause discomfort and can cause serious adverse consequences. As blood identified in faeces may be due to several reason (unrelated to cancer), it may cause people unnecessary stress and expose them to possible harm. This review found that FOBT screening is likely to avoid approximately 1 in 6 colorectal cancer deaths.
Abstract: We included two trials with a total of 37 children diagnosed with ASD who were randomised into groups that received either omega-3 fatty acids supplementation or a placebo. We excluded six trials because they were either non-randomised controlled trials, did not contain a control group, or the control group did not receive a placebo. Overall, there was no evidence that omega-3 supplements had an effect on social interaction (mean difference (MD) 0.82, 95% confidence interval (CI) -2.84 to 4.48, I2 = 0%), communication (MD 0.62, 95% CI -0.89 to 2.14, I2 = 0%), stereotypy (MD 0.77, 95% CI -0.69 to 2.22, I2 = 8%), or hyperactivity (MD 3.46, 95% CI -0.79 to 7.70, I2 = 0%). To date there is no high quality evidence that omega-3 fatty acids supplementation is effective for improving core and associated symptoms of ASD. Given the paucity of rigorous studies in this area, there is a need for large well-conducted randomised controlled trials that examine both high and low functioning individuals with ASD, and that have longer follow-up periods.

Plain-language summary: The purpose of this review was to assess the evidence for the effectiveness of omega-3 supplementation for core features of ASD and associated symptoms. We found only two small randomised controlled trials that evaluated omega-3 fatty acids for ASD. There is insufficient evidence that omega-3 fatty acids supplementation is an effective treatment for ASD. However, high quality large randomised controlled trials are needed before definite recommendations about this treatment can be made.
Abstract: We found only one trial, which randomized 11 infants to intravenous doxapram and 10 infants to placebo. There were fewer treatment failures after 48 hours in the group of preterm infants treated with doxapram (4/11) compared with the group treated with placebo (8/10). The wide confidence intervals made this result non-significant [summary relative risk 0.45 (0.20 to 1.05)]. Only one infant, who was from the placebo group, was given IPPV. Of the seven responders by 48 hours in the group of 11 who received doxapram, five failed to respond between 48 hours and seven days after commencement of therapy. This gives a late failure rate of 9/11, similar to the short-term failure rate in the placebo group of 8/10. It is not possible to evaluate the late responses of all those in the placebo group since they crossed over to a treatment arm. Although intravenous doxapram might reduce apnea within the first 48 hours of treatment, there are insufficient data to evaluate the precision of this result or to assess potential adverse effects. No long-term outcomes have been measured. Further studies are needed to determine the role of this treatment in clinical practice.

Plain-language summary: The review of one small trial found that apnea might be reduced in the first few days after treatment, but there were not enough infants studied to know if this was a significant effect. There is no evidence from this trial on longer term effects or less common adverse effects. More research is needed on the effectiveness, potential harm and long-term benefits or adverse effects of these drugs.
Abstract: Only one trial was found and this showed that rescue HFOV caused a reduction in any new pulmonary air leak (PAL) [RR 0.73 (95% CI 0.55,0.96), RD -0.17 (95% CI -0.32, -0.03)]. The number of infants that needed to be treated (NNT) to prevent one infant having any PAL was six (95% CI 3, 37). There was no significant difference in the rate of PIE or of gross pulmonary air leak, such as pneumomediastinum or pneumothorax. There was no significant effect on mortality or the use of IPPV at 30 days. The rate of intraventricular haemorrhage (IVH) of any grade was increased in infants treated with HFOV, [RR 1.77 (95% CI 1.06, 2.96), RD 0.16 (95% CI 0.02, 0.29)]. Thus, for every six infants (95% CI 3, 50) given rescue HFOV, one infant developed IVH of any grade. There was a stronger, but non-significant trend towards an increase in severe IVH (grades 3 or 4 IVH). There is insufficient information on the use of rescue HFOV to make recommendations for practice. The small amount of data that exists suggest that harm might outweigh any benefit. Any future use of HFOV as rescue therapy for preterm infants with severe RDS should be within randomised controlled trials and address important outcomes such as longer term pulmonary and neurological function.

Plain-language summary: This review of the evidence from one randomised controlled trial suggests there might be less short-term lung injury from high frequency oscillatory ventilation. However, more babies in this group developed haemorrhage in and around the fluid spaces in the brain (cerebral ventricles) and this harm might outweigh any benefit. More information is needed to clarify the balance between benefits and harms of high frequency oscillatory ventilation instead of conventional positive pressure ventilation for preterm infants with severe lung disease.
Abstract: Eleven randomised trials with 1205 participants with asymptomatic or mild-to-moderate cholelithiasis were included. None of the randomised clinical trials compared a single Chinese medicinal herb with a Western medicine or with surgery. No placebo-controlled trials were identified. In the trials comparing one Chinese herbal medicine (Gandanxiaoshi tablet) versus another (Aihuodantong tablet), there was no significant difference in the improvement of upper abdominal pain after the end of treatment (RR 1.21; 95% CI 0.71 to 2.05), and the heterogeneity among trials was not substantial. No other outcomes could be assessed. The remaining trials of Chinese medicinal herbs (Qingdan capsule, Danshu capsule, Paishi capsule, Rongdanpaishi capsule), did not offer specific data on symptoms, signs, or change in gallstones that would permit assessment of significant differences in curative effects between the treatment and control groups. No serious adverse events were reported. This review reveals no strong evidence that the analysed Chinese medicinal herbs have any beneficial effects on asymptomatic or mild-to-moderate cholelithiasis. Definitive conclusions will require much better designed randomised trials to reduce risk of bias and allow detailed assessment of clinical outcomes.

Plain-language summary: The objective of this review was to evaluate the benefits and harms of Chinese medicinal herbs for people with cholelithiasis. Though some Chinese medicinal herbs appear to be safe for people with asymptomatic, mild, or moderate disease, they have not been conclusively shown to have curative effects on gallstones due to the low methodological quality (high risk of bias) of the included trials. Thus, randomised clinical trials with low risk of bias should be conducted to assess the effects of Chinese medicinal herbs before they can be used widely in the clinic.
Abstract: Thirteen trials met the inclusion criteria. Two hundred ninety-four individuals randomized to anabolic steroid therapy and 238 individuals randomized to placebo were included in the analysis of efficacy for change from baseline in lean body mass. Three hundred forty-three individuals randomized to anabolic steroid and 286 randomized to placebo were included in the analysis of efficacy for change from baseline in body weight. The mean methodologic quality of the included studies was 4.1, of a maximum 5 points. Although significant heterogeneity was present for both outcomes, the average change in lean body mass was 1.3 kg (95% CI: 0.6, 2.0), while the average change in total body weight was 1.1 kg (95% CI: 0.3, 2.0). A total of eight deaths occurred during the treatment period; four in the anabolic steroid treatment groups and four in the placebo-treatment groups (risk difference 0.00, 95% CI -0.03, 0.03). The risk difference for withdrawals or discontinuations of study medication due to adverse events was 0.00 (95% CI: -0.02, 0.03). Although the results of the trials were heterogeneous, on average, the administration of anabolic steroids appeared to result in a small increase in both lean body mass and body weight as compared with placebo. While these results suggest that anabolic steroids may be useful in the treatment of weight loss in HIV infected individuals, due to limitations, treatment recommendations cannot be made. Further information is required regarding the long-term benefit and adverse effects of anabolic steroid use, the specific populations for which anabolic steroid therapy may be most beneficial, and the optimal regime. In addition, the correlation of improvement in lean body mass with more clinically relevant endpoints, such as physical functioning and survival, needs to be determined.

Plain-language summary: The purpose of this review was to evaluate anabolic steroids as a means of treatment of weight loss in individuals with HIV infection. The review includes 13 randomized clinical trials in the primary analysis. The results suggested that anabolic steroids increased both lean body mass and body weight. However, the results were not consistent among individual trials and the average increase was small and may not be clinically relevant. Furthermore, the results need to be interpreted with caution as this meta-analysis was limited due to small sample sizes; short duration of treatment and of follow-up; and heterogeneity of the study populations, the anabolic interventions, and concomitant therapies.