GEM/cochrane-simplification huggingface dataset:
Abstract: Three trials, involving 233 women, are included. There was no evidence of differences in caesarean section rates between the two interventions in the two trials reporting this outcome (risk ratio (RR) 2.04, 95% confidence interval (CI) 0.92 to 4.55). There were no data presented on neonatal or maternal mortality or morbidity. There was no evidence of a difference between castor oil and placebo/no treatment for the rate of instrumental delivery, meconium-stained liquor, or Apgar score less than seven at five minutes. The number of participants was too small to detect all but large differences in outcome. All women who ingested castor oil felt nauseous (RR 59.92, 95% CI 8.46 to 424.52). The three trials included in the review contain small numbers of women. All three studies used single doses of castor oil. The results from these studies should be interpreted with caution due to the risk of bias introduced due to poor methodological quality. Further research is needed to attempt to quantify the efficacy of castor oil as an cervical priming and induction agent.

Plain-language summary: The review of three trials, involving 233 women, found there has not been enough research done to show the effects of castor oil on ripening the cervix or inducing labour or compare it to other methods of induction. The review found that all women who took castor oil by mouth felt nauseous. More research is needed into the effects of castor oil to induce labour.
Abstract: Two randomized controlled trials evaluated the no-scalpel technique and differed in their findings. The larger trial demonstrated less perioperative bleeding (OR 0.49; 95% CI 0.27 to 0.89) and pain during surgery (OR 0.75; 95% CI 0.61 to 0.93), scrotal pain (OR 0.63; 95% 0.50 to 0.80), and incisional infection (OR 0.21; 95% CI 0.06 to 0.78) during follow up than the standard incisional group. Both studies found less hematoma with the no-scalpel technique (OR 0.23; 95% CI 0.15 to 0.36). Operations using the no-scalpel approach were faster and had a quicker resumption of sexual activity. The smaller study did not find these differences; however, the study could have failed to detect differences due to a small sample size as well as a high loss to follow up. Neither trial found differences in vasectomy effectiveness between the two approaches to the vas. The no-scalpel approach to the vas resulted in less bleeding, hematoma, infection, and pain as well as a shorter operation time than the traditional incision technique. No difference in effectiveness was found between the two approaches.

Plain-language summary: In February 2014, we did a computer search for studies comparing the no-scalpel approach to the vas with the scalpel method. We included randomized controlled trials in any language. For the initial review, we also looked at reference lists of articles and book chapters. We found two trials that looked at the no-scalpel approach to the vas. The trials had somewhat different results. The larger trial showed the no-scalpel method led to less bleeding, infection, and pain during and after the procedure. The no-scalpel approach required less time for the operation and had a faster return to sexual activity. The smaller study did not show these differences. However, the study may have been too small and many men dropped out. The two methods did not differ in the numbers of men who became sterile.
Abstract: We included three trials in which a total of 114 infants participated. In one trial, participants were exclusively infants with severe encephalopathy. The other trials also included infants with mild and moderately severe encephalopathy. These studies were generally of good methodological quality, but were too small to exclude clinically important effects of allopurinol on mortality and morbidity. Meta-analysis did not reveal a statistically significant difference in the risk of death (typical risk ratio 0.88; 95% confidence interval (95% CI) 0.56 to 1.38; risk difference -0.04; 95% CI -0.18 to 0.10) or a composite of death or severe neurodevelopmental disability (typical risk ratio 0.78; 95% CI 0.56 to 1.08; risk difference -0.14; 95% CI -0.31 to 0.04). The available data are not sufficient to determine whether allopurinol has clinically important benefits for newborn infants with hypoxic-ischaemic encephalopathy. Much larger trials are needed. Such trials could assess allopurinol as an adjunct to therapeutic hypothermia in infants with moderate and severe encephalopathy and should be designed to exclude important effects on mortality and adverse long-term neurodevelopmental outcomes.

Plain-language summary: Studies using animal models suggest that allopurinol (a drug commonly used for preventing gout) can reduce the level of brain damage following perinatal asphyxia. Three small randomised controlled trials that examined whether giving allopurinol to newborn infants following perinatal asphyxia affected their outcomes were identified. None of these trials provided any evidence of benefit. Larger trials are needed to exclude important effects on survival and disability.
Abstract: We only considered one study eligible for this review (20 participants). Assessments of risk of bias for most domains were unclear or low. Adverse events were only reported in participants from the zonisamide group, making it possible that they were aware of treatment group assignment. We are uncertain as to the effects of zonisamide on motor tasks (mean difference (MD) -0.00, 95% confidence interval (CI) -1.51 to 1.51, very low-quality evidence) and functional disabilities (MD -0.30, 95% CI -1.23 to 0.63, very low-quality evidence) when compared with placebo. Three participants in the zonisamide group (30%) and two participants in the placebo group (20%) discontinued the treatment and withdrew from the study for any reason (very low-quality evidence), however the increased risk of withdrawal in the zonisamide group was statistically non-significant (risk difference (RD) 0.1, 95% CI -0.28 to 0.48). Six participants in the zonisamide group (60%) and none of the participants in the placebo group (0%) developed adverse events (AEs), with a RD of 0.60 (95% CI 0.28 to 0.92; very low quality evidence). The most common AEs, experienced with zonisamide treatment, were headache, nausea, fatigue, sleepiness, and diarrhoea. Quality of life was not assessed in the study included. Based on currently available data, there is insufficient evidence to assess the efficacy and safety of zonisamide treatment for ET.

Plain-language summary: We found one study comparing zonisamide versus placebo, involving a total of 20 randomised participants with essential tremor. The impact of zonisamide on functional abilities, risk of treatment discontinuation, and adverse events is uncertain because the quality of evidence is very low. Adverse events were only reported in participants from the zonisamide group, making it possible that they were aware of which treatment they had been receiving. Quality of life was not assessed in the study included. The single study we found was small and the possibility of study participants becoming aware of the treatment group means that we cannot be certain about the risk-benefit profile of this treatment.
Abstract: We have no good-quality evidence of the absolute effectiveness of haloperidol for people with long-term aggression. One study randomising 110 chronically aggressive people to three different antipsychotic drugs met the inclusion criteria. When haloperidol was compared with olanzapine or clozapine, skewed data (n=83) at high risk of bias suggested some advantage in terms of scale scores of unclear clinical meaning for olanzapine/clozapine for 'total aggression'. Data were available for only one other outcome, leaving the study early. When compared with other antipsychotic drugs, people allocated to haloperidol were no more likely to leave the study (1 RCT, n=110, RR 1.37, CI 0.84 to 2.24, low-quality evidence). Although there were some data for the outcomes listed above, there were no data on most of the binary outcomes and none on service outcomes (use of hospital/police), satisfaction with treatment, acceptance of treatment, quality of life or economics. Only one study could be included and most data were heavily skewed, almost impossible to interpret and oflow quality. There were also some limitations in the study design with unclear description of allocation concealment and high risk of bias for selective reporting, so no firm conclusions can be made. This review shows how trials in this group of people are possible - albeit difficult. Further relevant trials are needed to evaluate use of haloperidol in treatment of long-term/persistent aggression in people living with psychosis.

Plain-language summary: The Cochrane Schizophrenia Group ran an electronic search for clinical trials involving the use of haloperidol for psychosis-induced aggression in July 2011 and April 2015. We found one study with 110 participants, diagnosed with schizophrenia or schizoaffective disorder. Participants had been physically aggressive during recent hospitalisation and involved in at least one other aggressive event. The study randomised participants to receive either haloperidol, clozapine or olanzapine. Most data presented were impossible to use and it is unclear if haloperidol is effective for reducing aggression or improving mental state for people who are aggressive due to psychosis. There were no data regarding side effects. The number of people leaving the study early from each treatment group was similar. The quality of evidence available is low, only one study with a high risk of selective reporting of results provided data. No firm conclusions can be made until further good-quality data are available.
Abstract: Nine trials were included in the review. Seven trials, comparing antibiotics to placebo or no treatment, were meta-analysed. Systematic bias in design or publication is suggested by trial results. The randomisation results suggest that the probability that true randomisation took place in all trials is very small and the report of most trials regarding design was poor. The proportion of participants with spontaneous bacterial peritonitis varied between the trials from 15% to 50%. The calculated relative risks (95% confidence interval) of spontaneous bacterial peritonitis and mortality among patients treated with antibiotics compared with no treatment/placebo were 0.20 (0.11 to 0.37) and 0.61 (0.43 to 0.87). There were very few reports of adverse events. The pooled estimates suggest that antibiotic prophylaxis might be prudent among cirrhotic patients with ascites and no gastrointestinal bleeding. However, poor trial methodology and report coupled with findings suggesting systematic bias in publication and design reflect the fragility of these findings. Potential hazard to society and the patients themselves from resistant pathogens should be considered when promoting long-lasting antibiotic prophylaxis. It seems that recommending antibiotic prophylaxis is still far from being a substantiated prevention strategy. Trials of better design, well reported, and of longer follow-up are greatly needed.

Plain-language summary: This systematic review of randomised clinical trials assesses whether antibiotic prophylaxis prevents spontaneous bacterial peritonitis and mortality among cirrhotic patients with ascites (excess fluid in the abdominal cavity) and no gastrointestinal bleeding. Nine trials are included in the review. The pooled rates of spontaneous bacterial peritonitis and mortality indicate that antibiotic prophylaxis reduces both. There are very few reports of adverse events. Reviewing these trials, we found poor methodology, evidence suggesting publication bias, and limited follow-up periods. Thus, the recommendation to prescribe prophylactic antibiotics to cirrhotic patients without gastrointestinal bleeding is hampered by quality of the trials that generated the data. Due to potential hazards, both to society as a whole and the patients, as individuals, before antibiotic prophylaxis can be confidently recommended, trials of better design, well reported, and of longer follow-up are required.
Abstract: A single study enrolling 68 non-intubated children was found eligible for inclusion in review. The study had low or unclear risk of bias. It demonstrated no significant difference in respiratory rate, oxygen saturation, hospital admission rate (odds ratio (OR) 0.77; 95% confidence interval (CI) 0.23 to 2.58) and need for mechanical ventilation between ketamine (0.2 mg/kg intravenous bolus over one to two minutes, followed by a 0.5 mg/kg per hour continuous infusion for two hours) and placebo group. There were no significant side effects of ketamine in the study. There was also no difference in need for other adjuvant therapy (OR 2.19; 95% CI 0.19 to 25.40) and in Pulmonary Index Score (mean difference (MD) -0.40; 95% CI -1.21 to 0.41) between the groups. The single study on non-intubated children with severe acute asthma did not show significant benefit and does not support the case studies and observational reports showing benefits of ketamine in both non-ventilated and ventilated children. There were no significant side effects of ketamine. We could not find any trials on ventilated children. To prove that ketamine is an effective treatment for acute asthma in children, there is need for sufficiently powered randomised trials of high methodological quality with objective outcome measures of clinical importance. Future trials should also explore different doses of ketamine and its role in children needing ventilation because of severe acute asthma.

Plain-language summary: We found, through systematic search, only one study where investigators assessed the usefulness of ketamine for management of severe acute asthma in children. While this single study suggested that there is a lack of evidence for usefulness of ketamine in acute exacerbation of asthma in children, more trials are needed regarding the use of ketamine in acute asthma before more specific recommendations can be made.
Abstract: 31 papers reporting the results of 26 trials were included in the review. For studies that compared a step down approach to a constant moderate/low ICS dose, there were no significant differences in lung function, symptoms, rescue medications or asthma control between the two treatment approaches. Significant but clinically small improvements in percent predicted FEV1 ( WMD 5.32, 95% CI 0.65 to 9.99) and non significant improvements in the change in morning PEF were found for high dose ICS compared to moderate dose ICS. There were no significant differences in efficacy between high and low dose ICS. For moderate dose ICS, compared to low dose ICS, there were significant improvements in the change in morning PEF L/min from baseline (WMD 11.14, 95% CI 1.34 to 20.93) and nocturnal symptoms (SMD -0.29, 95% CI -0.53 to -0.06 ) . Commencing ICS at double or quadruple a base moderate or low dose had no greater effect than commencing with the base dose. Several studies reported greater improvement in airway hyperresponsiveness for high dose ICS. For patients with asthma who require ICS, commencing with a moderate dose ICS is equivalent to commencing with a high dose ICS and down-titrating. The small significant benefits of commencing with a high ICS dose are not of sufficient clinical benefit to warrant its use when compared to moderate or low dose ICS. Initial moderate ICS dose appears to be more effective than initial low ICS dose. High dose ICS may be more effective than moderate or low dose ICS for airway hyperresponsiveness. There is no benefit in doubling or quadrupling ICS in subjects with stable asthma.

Plain-language summary: This review compared initial ICS doses for asthma . The results showed that commencing with a moderate dose ICS is as effective as commencing with a high dose ICS and then reducing the dose whilst monitoring symptoms. These results also show that initial moderate dose ICS maybe more effective than initial low dose ICS. No extra benefit was gained by doubling or quadrupling the starting ICS dose. People with asthma should start their treatment with low to moderate doses of ICS.
Abstract: In this update, we did not identify any new RCT studies for inclusion. We identified two RCT studies as ongoing that we are likely to include in future updates. Accordingly, our results are unchanged and include three RCTs with a total of 316 participants. All three studies compared the effectiveness of VM in reverting SVT with that of other vagal manoeuvres in a cross-over design. Two studies induced SVT within a controlled laboratory environment. Participants had ceased all medications prior to engaging in these studies. The third study reported on people presenting to a hospital emergency department with an episode of SVT. These participants were not controlled for medications or other factors prior to intervention. The two laboratory studies demonstrated reversion rates of 45.9% and 54.3%, whilst the clinical study demonstrated reversion success of 19.4%. This discrepancy may be due to methodological differences between studies, the effect of induced SVT versus spontaneous episodic SVT, and participant factors such as medications and comorbidities. We were unable to assess any of these factors, or adverse effects, further, since they were either not described in enough detail or not reported at all. Statistical pooling was not possible due to heterogeneity between the included studies. We did not find sufficient evidence to support or refute the effectiveness of VM for termination of SVT. Further research is needed, and this research should include a standardised approach to performance technique and methodology.

Plain-language summary: Three studies involving a total of 316 participants were included in this review. Analysis of the results showed that reversion success lies somewhere between 19.4% and 54.3%. We could not calculate the likelihood and severity of side effects (adverse events) as the studies provided insufficient information to perform this analysis. Potential side effects have been reported in other articles on the subject; these have included hypotension (sudden lowering of blood pressure) or syncope (brief loss of consciousness). No side effects were reported in the three studies reviewed here. In the three studies, reversion was achieved on completion of each VM. Overall, the VM appears to be a simple, non-invasive method of stopping abnormal heart rhythm, but its safety and overall effectiveness are difficult to quantify. Further research is required to improve the evidence surrounding this practice.
Abstract: Twenty two randomised controlled trials were included. Five studies analysed the use of a GnRH agonist versus control. No significant benefit was demonstrated when using GnRH agonists. No evidence of statistically significant benefit was found for one GnRH agonist over another, or vaginal over intramuscular progesterone administration. No difference in pregnancy rate was demonstrated when no treatment was compared to aspirin, steroids, ovarian stimulation, or human chorionic gonadotropin (hCG) prior to embryo transfer, although using hCG several times before the oocyte retrieval decreases the pregnancy rate. Finally, when oocyte recipients were studied further, starting progesterone on the day of oocyte pick-up (OPU) or the day after OPU produced a significantly higher pregnancy rate (OR 1.87, 95% CI 1.13 to 3.08) than when recipients started progesterone the day prior to OPU. There is insufficient evidence to recommend any one particular protocol for endometrial preparation over another with regard to pregnancy rates after embryo transfers. These were either frozen embryos or embryos derived from donor oocytes. However, there is evidence of a lower pregnancy rate and a higher cycle cancellation rate when the progesterone supplementation is commenced prior to oocyte retrieval in oocyte donation cycles. Adequately powered studies are needed to evaluate each treatment more accurately.

Plain-language summary: A total of 22 randomised controlled trials were included in this review. There is insufficient evidence from these trials to be able to identify one particular intervention for endometrial preparation that clearly improves the treatment outcome for women receiving embryo transfers with either frozen embryos or embryos derived from donated oocytes. Better quality studies are needed to more accurately evaluate each treatment.
Abstract: We included eight trials with a total of 5762 participants. The data showed that anticoagulants (in any intensity) are not more efficacious in the prevention of recurrent ischaemic stroke than antiplatelet therapy (medium intensity anticoagulation: relative risk (RR) 0.80, 95% confidence interval (CI) 0.56 to 1.14; high intensity anticoagulation: RR 1.02, 95% CI 0.49 to 2.13). There is no evidence that treatment with low intensity anticoagulation gives a higher bleeding risk than treatment with antiplatelet agents: RR 1.27 (95% CI 0.79 to 2.03). However, it was clear that medium and high intensity anticoagulation with vitamin K antagonists, with an INR of 2.0 to 4.5, were not safe because they yielded a higher risk of major bleeding complications (medium intensity anticoagulation: RR 1.93, 95% CI 1.27 to 2.94; high intensity anticoagulation: RR 9.0, 95% CI 3.9 to 21). For the secondary prevention of recurrent ischemic stroke after TIA or minor stroke of presumed arterial origin, there is sufficient evidence to conclude that vitamin K antagonists in any dose are not more efficacious than antiplatelet therapy and that medium and high intensity anticoagulation leads to a significant increase in major bleeding complications.

Plain-language summary: We reviewed eight trials involving 5762 participants that compared anticoagulants with antiplatelet agents for preventing recurrent stroke and found no benefit of low intensity anticoagulation over aspirin, and an increased risk of bleeding with high intensity anticoagulation.
Abstract: We found no completed RCT and included 21 observational studies with 71,693 participants. The only eligible RCT is currently ongoing among MSM in China. The pooled effect estimate for HIV acquisition was not statistically significant (20 studies; 65,784 participants; OR 0.86, 95% CI 0.70 to 1.06) and showed significant heterogeneity (I²=53%). In a subgroup analysis, the results were statistically significant in studies of men reporting an insertive role (7 studies, 3465 participants; OR 0.27, 95% CI 0.17 to 0.44; I²=0%) but not in studies of men reporting a receptive role (3 studies, 1792 participants; OR 1.20, 95% CI 0.63 to 2.29; I² = 0%). There was no significant association between male circumcision and syphilis (8 studies; 34,999 participants: OR 0.96, 95% CI 0.82 to 1.13; I² = 0%), herpes simplex virus 1 (2 studies, 2740 participants; OR 0.90, 95% CI 0.53 to 1.52; I²=0%), or herpes simplex virus 2 (5 studies;10,285 participants; OR 0.86, 95% CI 0.62 to 1.21; I²=0%). The overall GRADE quality of evidence was low. None of the included studies assessed adverse effects associated with male circumcision. Current evidence suggests that male circumcision may be protective among MSM who practice primarily insertive anal sex, but the role of male circumcision overall in the prevention of HIV and other sexually transmitted infections among MSM remains to be determined. Therefore, there is not enough evidence to recommend male circumcision for HIV prevention among MSM at present. Further research should be of high quality and further explore interaction with the predominant sexual role.

Plain-language summary: At present there is no completed randomised controlled trial that has assessed the effects of male circumcision on acquisition of HIV and other sexually transmitted infections among men who have sex with men (MSM). Results from observational studies suggest that circumcision may be protective among MSM who practice primarily insertive anal sex, but the role of male circumcision overall in the prevention of HIV and other sexually transmitted infections among MSM remains to be determined.