GEM/cochrane-simplification huggingface dataset:
Abstract: Three trials met the inclusion criteria and these randomised 579 women, of whom all were assessed at the end of the trials. Two trials assessing 373 participants with stage III to IV persistent or recurrent disease, found that women who received combination therapy had a significantly lower risk of death and disease progression than women who received single agent ifosfamide, after adjustment for performance status (HR = 0.75, 95% confidence interval (CI): 0.60 to 0.94 and HR = 0.72, 95% CI: 0.58 to 0.90 for OS and PFS respectively). There was no statistically significant difference in all reported adverse events, with the exception of nausea and vomiting, where significantly more women experienced these ailments in the combination therapy group than the Ifosamide group (RR = 3.53, 95% CI: 1.33 to 9.37). In one trial there was no statistically significant difference in the risk of death and disease progression in women who received whole body irradiation and chemotherapy, after adjustment for age and FIGO stage (HR = 0.71, 95% CI: 0.48 to 1.05 and HR = 0.79, 95% CI: 0.53 to 1.18 for OS and PFS respectively). There was no statistically significant difference in all reported adverse events, with the exception of haematological and neuropathy morbidities, where significantly less women experienced these morbidities in the whole body irradiation group than the chemotherapy group (RR= 0.02, 95% CI: 0.00 to 0.16) for haematological morbidity and all nine women in the trial experiencing neuropathy morbidity were in the chemotherapy group). In advanced stage metastatic uterine carcinosarcoma as well as recurrent disease adjuvant combination, chemotherapy with ifosfamide should be considered. Combination chemotherapy with ifosfamide and paclitaxel is associated with lower risk of death compared with ifosfamide alone. In addition, radiotherapy to the abdomen is not associated with improved survival.

Plain-language summary: In addition, radiotherapy to the abdomen was not associated with improved survival, as we found in one trial that there was no difference in the risk of death and disease progression in women who received whole abdominal irradiation and chemotherapy, after adjustment for age and stage of disease. Previous studies have shown that doxorubicin, despite being established in the treatment of uterine carcinoma, does not seem to be highly active. Adverse events were comprehensively reported for the comparisons of combination therapy and ifosfamide and whole body irradiation and chemotherapy. More women experienced side effects when they received combination therapy than ifosamide alone and chemotherapy than whole body irradiation. The effect of therapy on quality of life was not reported in any of the trials.
Abstract: Two placebo-controlled trials were included. One trial administered 10 mg/kg/day sapropterin in 89 children and adults with phenylketonuria whose diets were not restricted and who had previously responded to saproterin.This trial measured change in blood phenylalanine concentration. The second trial screened 90 children (4 to 12 years) with phenylketonuria whose diet was restricted, for responsiveness to sapropterin. Forty-six responders entered the placebo-controlled part of the trial and received 20 mg/kg/day sapropterin. This trial measured change in both phenylalanine concentration and protein tolerance. Both trials reported adverse events. The trials showed an overall low risk of bias; but both are Biomarin-sponsored. One trial showed a significant lowering in blood phenylalanine concentration in the sapropterin group (10 mg/kg/day), mean difference -238.80 μmol/L (95% confidence interval -343.09 to -134.51); a second trial (20 mg/kg/day sapropterin) showed a non-significant difference, mean difference -51.90 μmol/L (95% confidence interval -197.27 to 93.47). The second trial also reported a significant increase in phenylalanine tolerance, mean difference18.00 mg/kg/day (95% confidence interval 12.28 to 23.72) in the 20 mg/kg/day sapropterin group. There is evidence of short-term benefit from using sapropterin in some people with sapropterin-responsive forms of phenylketonuria; blood phenylalanine concentration is lowered and protein tolerance increased. There are no serious adverse events associated with using sapropterin in the short term. There is no evidence on the long-term effects of sapropterin and no clear evidence of effectiveness in severe phenylketonuria.

Plain-language summary: The review identified two trials of sapropterin dihydrochloride; one in children and adults with no restricted diet and one in just children whose diet was restricted. The trials used different doses of sapropterin dihydrochloride (10 mg/kg/day and 20 mg/kg/day). We could not combine any data due to different formats of presentation. We found evidence to show that some people with mild or moderate phenylketonuria can benefit from the use of sapropterin dihydrochloride in the short term; the concentration of blood phenylalanine was lowered after treatment in both trials. The trial with the higher dose also measured the outcome change in protein tolerance. It reported an increase in protein tolerance in response to sapropterin. There were no adverse effects associated with the use of sapropterin dihydrochloride in the short term. We found no evidence on the effects of long-term treatment. We could not draw any conclusions on its benefits in severe phenylketonuria.
Abstract: Four trials (1429 participants) comparing PDT with verteporfin to PDT with 5% dextrose in water were included in this review. Participants received on average five treatments over two years. The risk ratio of losing 3 or more lines of visual acuity at 24 months comparing the intervention with the control group was 0.80 (95% confidence interval (CI) 0.73 to 0.88). The risk ratio of losing 6 or more lines of visual acuity at 24 months comparing the intervention with the control group was 0.66 (95% CI 0.56 to 0.83). The results at 12 months were similar to those at 24 months. The most serious adverse outcome, severe visual acuity decrease within one week of treatment, occurred in 11 per 1000 patients (95% CI 3 to 48). Infusion related back pain was experienced by 20 per 1000 (95% CI 6 to 70). Two further trials compared different treatment regimens: standard versus delayed light application; retreatment every two months versus every three months. Neither trial demonstrated differences in effectiveness. The overall quality of the evidence included in this review was considered to be high. Five out of the six trials were funded by the manufacturers of verteporfin. Photodynamic therapy in people with choroidal neovascularisation due to AMD is effective in preventing clinically significant visual loss with a relative risk reduction of approximately 20%. Modified treatment regimens have not convincingly shown increased effectiveness. There was no evidence on quality of life and little on cost.

Plain-language summary: This review includes four randomised trials involving 1429 participants. All four trials compared verteporfin therapy to 5% dextrose water (placebo treatment). Photodynamic therapy reduces the risk of vision loss caused by "wet" age-related macular degeneration. More people treated with verteporfin also experienced improvements in vision compared to the placebo group, however, the absolute numbers experiencing vision improvement after this treatment was low (80 per 1000). A small number of people may experience acute vision loss within one week after treatment (in approximately 1 in 100 people) and infusion related back pain can occur (in approximately 1 in 50 people).
Abstract: Thirty-three trials were included. They recruited 2293 participants with insomnia, aged 15 to 98 years, some with medical conditions contributing to insomnia (stroke, end-stage renal disease, perimenopause, pregnancy, psychiatric diseases). They evaluated needle acupuncture, electroacupuncture, acupressure or magnetic acupressure. Compared with no treatment (two studies, 280 participants) or sham/placebo (two studies, 112 participants), acupressure resulted in more people with improvement in sleep quality (compared to no treatment: OR 13.08, 95% confidence interval (CI) 1.79 to 95.59; compared to sham/placebo: OR 6.62, 95% CI 1.78 to 24.55). However, when assuming that dropouts had a worse outcome in sensitivity analysis the beneficial effect of acupuncture was inconclusive. Compared with other treatment alone, acupuncture as an adjunct to other treatment might marginally increase the proportion of people with improved sleep quality (13 studies, 883 participants, OR 3.08, 95% CI 1.93 to 4.90). On subgroup analysis, only needle acupuncture but not electroacupuncture showed benefits. All trials had high risk of bias and were heterogeneous in the definition of insomnia, participant characteristics, acupoints and treatment regimen. The effect sizes were generally small with wide confidence intervals. Publication bias was likely present. Adverse effects were rarely reported and they were minor. Due to poor methodological quality, high levels of heterogeneity and publication bias, the current evidence is not sufficiently rigorous to support or refute acupuncture for treating insomnia. Larger high-quality clinical trials are required.

Plain-language summary: This review was conducted to examine the efficacy and safety of acupuncture in treating insomnia. Thirty-three randomised controlled trials were eligible for inclusion in the review, involving 2293 participants. We considered all studies to have a high risk of bias. They were diverse in the types of participants, acupuncture treatments and sleep outcome measures used, which limited our ability to draw reliable conclusions. Currently there is a lack of high-quality clinical evidence to inform us about the efficacy and safety of acupuncture.
Abstract: Nine trials met the inclusion criteria. Live birth rate per woman was significantly lower after IVF/ICSI with PGS compared to IVF/ICSI without PGS in women of advanced maternal age and in women with repeated IVF failure (OR 0.59; 95% CI 0.44 to 0.81 and OR 0.41, 95% CI 0.20 to 0.88 respectively). In good prognosis patients a similar trend was seen, albeit not significant (OR 0.50, 95% CI 0.20 to 1.26, random effects model). PGS as currently performed significantly decreases live birth rates in women of advanced maternal age and those with repeated IVF failure. Trials in which PGS was offered to women with a good prognosis suggested similar outcomes. PGS technique development is still ongoing in an effort to increase its efficacy. This involves biopsy at other stages of development (polar body or trophectoderm biopsy) and other methods of analysis (comparative genome hybridisation (CGH) or array-based technologies) than used by the trials included in this review. These new developments should be properly evaluated before their routine clinical application. Until such trials have been performed, PGS should not be offered as routine patient care in any form.

Plain-language summary: This review shows that PGS in fact decreases live birth rates in women of advanced maternal age and in women with repeated IVF failure. PGS should not be applied in routine patient care. New forms of PGS that perform the procedure at other stages of development and/or use a different method of analysis should first be evaluated in clinical trials before being introduced into clinical practice.
Abstract: We identified two trials of GCS that included 2615 patients and two small studies of IPC that included 177 patients. Overall, physical methods were not associated with a significant reduction in DVTs during the treatment period (odds ratio (OR) 0.85, 95% confidence interval (CI) 0.70 to 1.04) or deaths (OR 1.12, 95% CI 0.87 to 1.45). Use of GCS was not associated with any significant reduction in risk of DVT (OR 0.88, 95% CI 0.72 to 1.08) or death (OR 1.13, 95% CI 0.87 to 1.47) at the end of follow up. IPC was associated with a non-significant trend towards a lower risk of DVTs (OR 0.45, 95% CI 0.19 to 1.10) with no evidence of an effect on deaths (OR 1.04, 95% CI 0.37 to 2.89). Evidence from randomised trials does not support the routine use of GCS to reduce the risk of DVT after acute stroke. There is insufficient evidence to support the routine use of IPC to reduce the risk of DVT in acute stroke and further larger randomised studies of IPC are needed to reliably assess the balance of risks and benefits of this intervention.

Plain-language summary: We found two randomised trials of graduated compression stockings, involving 2615 participants, and two small trials of intermittent pneumatic compression involving 177 participants. Graduated compression stockings were no better than 'best medical treatment' in reducing the risk of DVT after stroke. Stockings caused more skin problems (for example ulcers and blisters) on the legs. Intermittent pneumatic compression appeared promising but was not proven to be definitely beneficial. The evidence does not support routine use of graduated compression stockings or intermittent pneumatic compression in patients with a recent stroke. The trials that are ongoing at present should provide reliable evidence on the benefits and harms of intermittent pneumatic compression.
Abstract: Eleven randomized controlled trials met our criteria for inclusion, representing 7695 patients in the United States, China, India and Sweden. Advance provision did not decrease pregnancy rates (odds ratio (OR) 0.98, 95% confidence interval (CI) 0.76 to 1.25 in studies for which we included twelve-month follow-up data; OR 0.48, 95% CI 0.18 to 1.29 in a study with seven-month follow-up data; OR 0.92, 95% CI 0.70 to 1.20 in studies for which we included six-month follow-up data; OR 0.49, 95% CI 0.09 to 2.74 in a study with three-month follow-up data), despite reported increased use (single use: OR 2.47, 95% CI 1.80 to 3.40; multiple use: OR 4.13, 95% CI 1.77 to 9.63) and faster use (weighted mean difference (WMD) -12.98 hours, 95% CI -16.66 to -9.31 hours). Advance provision did not lead to increased rates of sexually transmitted infections (OR 1.01, 95% CI 0.75 to 1.37), increased frequency of unprotected intercourse, or changes in contraceptive methods. Women who received emergency contraception in advance were equally likely to use condoms as other women. Advance provision of emergency contraception did not reduce pregnancy rates when compared to conventional provision. Results from primary analyses suggest that advance provision does not negatively impact sexual and reproductive health behaviors and outcomes. Women should have easy access to emergency contraception, because it can decrease the chance of pregnancy. However, the interventions tested thus far have not reduced overall pregnancy rates in the populations studied.

Plain-language summary: We searched for studies comparing women who got emergency contraception in advance to women who got it in standard ways. We examined whether these groups had different rates of pregnancy or sexually transmitted infections. We also studied how often and how quickly both groups used emergency contraception. Finally, we looked at whether advance provision of emergency contraception changed sexual behavior. Studies showed that the chance of pregnancy was similar regardless of whether or not women have emergency contraception on hand before unprotected sex. Women who had emergency contraception in advance were more likely to report use of the medication, and to use it sooner after sex. Having emergency contraception on hand did not change use of other kinds of contraception or change sexual behavior.
Abstract: Six trials, all from the USA, involving 2343 participants, were included. A meta-analysis of four trials comparing CBT with a no-intervention control (1771 participants) reported that the relative risk of violence was 0.86 (favouring the intervention group) with a 95% confidence interval (CI) of 0.54 to 1.38. This is a small effect size, and the width of the CI suggests no clear evidence for an effect. One study (Wisconsin Study) compared CBT with process-psychodynamic group treatment and reported a relative risk of new violence of 1.07 (95% CI 0.68 to 1.68). Even though the process-psychodynamic treatment did marginally better than CBT, this result is equivocal. Finally, one small study (N = 64) compared a combined CBT treatment for substance abuse and domestic violence (SADV) with a Twelve-Step Facilitation (TSF) group. An analysis involving 58 participants investigated the effect on reduction in frequency of physical violence episodes. The effect size was 0.30 (favouring TSF) with 95% CI from -0.22 to 0.81. There are still too few randomised controlled trials to draw conclusions about the effectiveness of cognitive behaviour therapy for male perpetrators of domestic violence.

Plain-language summary: We included trials that involved both types of participants. The review found all randomised controlled evaluations of the effects of CBT on men's physical violence to their female partners worldwide, but there were only six small trials with a total of 2343 participants that met the inclusion criteria. The results of four of these trials, which compared men who received CBT with men getting no treatment, were combined. This was not able to show us whether or not CBT was better than no treatment. Similarly, the individual results of the other two trials, which compared CBT with another treatment, were inconclusive. Overall, the evidence from the included studies is insufficient to draw any conclusions.
Abstract: Five randomised trials met our inclusion criteria (n = 302). Three studies objectively measured infant breastfeeding using standardised assessment tools. Pooled analysis of two studies (n = 155) showed no change on a 10-point feeding scale following frenotomy (mean difference (MD) -0.1, 95% confidence interval (CI) -0.6 to 0.5 units on a 10-point feeding scale). A third study (n = 58) showed objective improvement on a 12-point feeding scale (MD 3.5, 95% CI 3.1 to 4.0 units of a 12-point feeding scale). Four studies objectively assessed maternal pain. Pooled analysis of three studies (n = 212) based on a 10-point pain scale showed a reduction in maternal pain scores following frenotomy (MD -0.7, 95% CI -1.4 to -0.1 units on a 10-point pain scale). A fourth study (n = 58) also showed a reduction in pain scores on a 50-point pain scale (MD -8.6, 95% CI -9.4 to -7.8 units on a 50-point pain scale). All studies reported no adverse effects following frenotomy. These studies had serious methodological shortcomings. They included small sample sizes, and only two studies blinded both mothers and assessors; one did not attempt blinding for mothers nor for assessors. All studies offered frenotomy to controls, and most controls underwent the procedure, suggesting lack of equipoise. No study was able to report whether frenotomy led to long-term successful breastfeeding. Frenotomy reduced breastfeeding mothers’ nipple pain in the short term. Investigators did not find a consistent positive effect on infant breastfeeding. Researchers reported no serious complications, but the total number of infants studied was small. The small number of trials along with methodological shortcomings limits the certainty of these findings. Further randomised controlled trials of high methodological quality are necessary to determine the effects of frenotomy.

Plain-language summary: Five randomised controlled trials enrolling 302 infants met the inclusion criteria. In an infant with tongue-tie and feeding difficulties, surgical release of the tongue-tie does not consistently improve infant feeding but is likely to improve maternal nipple pain. Further research is needed to clarify and confirm this effect. The quality of the evidence is very low to moderate because overall only a small number of studies have looked at this condition, the total number of babies included in these studies was low and some studies could have been better designed.
Abstract: The risk of bias in the included studies was low. The overall quality of the evidence based on the GRADE approach was moderate. No statistically significant differences were found between interleukin 10 and placebo for complete remission (CDAI < 150 with a 100 point decrease in CDAI from baseline; RR=1.43; 95% CI 0.62 to 3.29; I2=40%) or clinical remission (CDAI < 150; RR=1.29; 95% CI 0.79 to 2.11; I2= 0%). Patients treated with interleukin 10 were significantly more likely to withdraw from the studies due to adverse events (RR=13.50; 95% CI 3.89 to 46.79; I2=0%). Interleukin 10 does not appear to provide any benefit for the treatment of active Crohn's disease. This systematic review shows that interleukin 10 does not increase the number of remissions (complete or clinical), but increases the rate of withdrawal due to adverse events relative to placebo. The quality of the evidence regarding the efficacy of IL-10 is moderate and although further research may have an impact on point estimates of efficacy further randomized trials are unlikely to be undertaken.

Plain-language summary: This systematic review showed that this drug does not increase the number of remissions but increases the number of patients that withdrew from the included studies due to side effects. The methodological quality of the included studies was high. Further studies of this agent for the treatment of active Crohn's disease are unlikely to be undertaken.
Abstract: We included 15 trials (39,908 participants) that evaluated antihypertensive pharmacotherapy for a mean duration of follow-up of 4.2 years. This review provides moderate-quality evidence to show that antihypertensive drugs do not reduce sudden death (risk ratio (RR) 0.96, 95% confidence interval (CI) 0.81 to 1.15) but do reduce both non-fatal myocardial infarction (RR 0.85, 95% CI 0.74, 0.98; absolute risk reduction (ARR) 0.3% over 4.2 years) and fatal myocardial infarction (RR 0.75, 95% CI 0.62 to 0.90; ARR 0.3% over 4.2 years). Withdrawals due to adverse effects were increased in the drug treatment group to 12.8%, as compared with 6.2% in the no treatment group. Although antihypertensive drugs reduce the incidence of fatal and non-fatal myocardial infarction, they do not appear to reduce the incidence of sudden death. This suggests that sudden cardiac death may not be caused primarily by acute myocardial infarction. Continued research is needed to determine the causes of sudden cardiac death.

Plain-language summary: We found 15 trials including 39,908 people that investigated whether blood pressure-lowering drugs reduce sudden death. This review presents moderate-quality evidence to show that blood pressure-lowering drugs reduce heart attacks but do not appear to reduce sudden cardiac death. This suggests that sudden cardiac death may not be caused primarily by heart attack. Continued research is needed to determine the causes of sudden cardiac death.