GEM/cochrane-simplification huggingface dataset:
Abstract: We included one randomised clinical trial (N = 304 randomised; 204 completed; 276 analysed) that evaluated opioids (prolonged release oxycodone/naloxone) versus placebo. After 12 weeks, RSL symptoms had improved more in the drug group than in the placebo group (using the IRLSSS: MD -7.0; 95% CI -9.69 to -4.31 and the CGI: MD -1.11; 95% CI -1.49 to -0.73). More patients in the drug group than in the placebo group were drug responders (using the IRLSSS: RR 1.82; 95% CI 1.37 to 2.42 and the CGI: RR1.92; 95% ICI 1.49 to 2.48). The proportion of remitters was greater in the drug group than in the placebo group (using the IRLSSS: RR 2.14; 95% CI 1.45 to 3.16). Quality of life scores also improved more in the drug group than in the placebo group (MD -0.73; 95% CI -1.1 to -0.36). Quality of sleep was improved more in the drug group measured by sleep adequacy (MD -0.74; 95% CI -1.15 to -0.33), and sleep quantity (MD 0.89; 95% CI 0.52 to 1.26). There was no difference between groups for daytime somnolence, trouble staying awake during the day, or naps during the day. More adverse events were reported in the drug group (RR 1.22; 95% CI 1.07 to 1.39). The major adverse events were gastrointestinal problems, fatigue, and headache. Opioids seem to be effective for treating RLS symptoms, but there are no definitive data regarding the important problem of safety. This conclusion is based on only one study with a high dropout rate (low quality evidence).

Plain-language summary: We included one randomised controlled clinical trial with moderate risk of bias that tested a combination of oxycodone and naloxone against placebo capsules, taken twice daily in participants whodid not respond to more usual medications. Researchers used the International RLS severity scale to find out if patients were improved after 12 weeks of treatment. Particpants receiving the combined oxycodone and naloxone reported improvement in RLS symptoms, Quality of life, and sleep quality; 42% of the drug group were symptom-free. Discussion The study was well designed overall, but was at a high risk of bias due to the high percentage of participants who withdrew from treatment (attrition bias). Eighty-four percent of the drug group developed adverse events, which were mostly related to the gastrointestinal system, headache, fatigue, and sleepiness (somnolence); 9.8% left the study because of the adverse events. Conclusion The use of opioids for the treatment of RLS in patients resistant to conventional treatment is supported by low-quality evidence. Prescription of these medications should be based on clinical experience, and caution used due to the potential for abuse, dependency, and adverse events. No patient on opioids complained that their symptoms worsened.
Abstract: Fifteen heterogeneous trials, involving 1022 adults with dorsally displaced and potentially or evidently unstable distal radial fractures, were included. While all trials compared external fixation versus plaster cast immobilisation, there was considerable variation especially in terms of patient characteristics and interventions. Methodological weaknesses among these trials included lack of allocation concealment and inadequate outcome assessment. External fixation maintained reduced fracture positions (redisplacement requiring secondary treatment: 7/356 versus 51/338 (data from 9 trials); relative risk 0.17, 95% confidence interval 0.09 to 0.32) and prevented late collapse and malunion compared with plaster cast immobilisation. There was insufficient evidence to confirm a superior overall functional or clinical result for the external fixation group. External fixation was associated with a high number of complications, such as pin-track infection, but many of these were minor. Probably, some complications could have been avoided using a different surgical technique for pin insertion. There was insufficient evidence to establish a difference between the two groups in serious complications such as reflex sympathetic dystropy: 25/384 versus 17/347 (data from 11 trials); relative risk 1.31, 95% confidence interval 0.74 to 2.32. There is some evidence to support the use of external fixation for dorsally displaced fractures of the distal radius in adults. Though there is insufficient evidence to confirm a better functional outcome, external fixation reduces redisplacement, gives improved anatomical results and most of the excess surgically-related complications are minor.

Plain-language summary: Fifteen trials, involving 1022 adults with potentially or evidently unstable fractures, were included. While all trials compared external fixation versus plaster cast immobilisation, there was considerable variation in their characteristics especially in terms of patient characteristics and the method of external fixation. Weak methodology, such as using inadequate methods of randomisation and outcome assessment, means that the possibility of serious bias can not be excluded. The review found that external fixation reduced fracture redisplacement that prompted further treatment and generally improved final anatomical outcome. It appears to improve function too but this needs to be confirmed. The complications, such a pin tract infection, associated with external fixation were many but were generally minor. Serious complications occurred in both groups. The review concludes that there is some evidence to support the use of external fixation for these fractures.
Abstract: Five studies (1127 patients) were included in our analysis. Generally the risk of bias of the included studies was judged low or unclear; they addressed the research question and utilised a prospective randomised design. It is uncertain whether early stent removal verus late stent removal improved the incidence of MUC (5 studies, 1127 participants: RR 1.87, 95% CI 0.61 to 5.71; I2 = 21%; low certainty evidence). The incidence of UTI may be reduced in the early stent removal group (5 studies, 1127 participants: RR 0.49 95% CI 0.30 to 0.81; I2 = 59%; moderate certainty evidence). This possible reduction in the UTI incidence was only apparent if a BI stent was used, (3 studies, 539 participants, RR 0.45 95% CI 0.29 to 0.70; I2 = 13%; moderate certainty evidence). However, if an externalised PU stent was used there was no discernible difference in UTI incidence between the early and late group (2 studies, 588 participants: RR 0.60 95% CI 0.17, 2.03; I2 = 83%; low certainty evidence). Data on health economics and quality of life outcomes were lacking. Early removal of ureteric stents following kidney transplantation may reduce the incidence of UTI while it uncertain if there is a higher risk of MUC. BI stents are the optimum method for achieving this benefit.

Plain-language summary: It is uncertain whether the number of major urological complications were different in those patients whose stent was removed early (less than 15 days post-operatively), when compared with those removed later (more than 15 days post-operatively). The number of patients suffering from a urinary tract infection may be less in the early removal group - especially if the stent was not exposed to the external environment. The studies identified for this review were generally of poor quality. It is uncertain whether a bladder indwelling ureteric stent that is removed early following kidney transplantation reduces the risk of complications, however it may prevent urine tract infections.
Abstract: Three studies involving a total of 1945 women were included. Overall, risk of bias across the three trials was mixed. No serious complications were reported in the trials and no neonatal or maternal deaths occurred. The neonatal outcome was not statistically different between groups: Apgar score less than seven at five minutes (RR 1.78, 95% CI 0.83 to 3.83; three studies, n = 1945); umbilical artery pH less than 7.15 (RR 1.31, 95% CI 0.95 to 1.79; one study, n = 1456); umbilical artery pH less than 7.16 (RR 1.23, 95% CI 0.39 to 3.92; one study, n = 239); admission to the neonatal intensive care unit (RR 0.34, 95% CI 0.07 to 1.67; two studies, n = 489); and more than 48 hours hospitalisation (RR 0.92, 95% CI 0.71 to 1.20; one study, n = 1456). The pooled risk for instrumental delivery (including caesarean section, ventouse and forceps extraction) was not statistically significantly different (RR 1.05, 95% CI 0.91 to 1.21; three studies, n = 1945). Hyperstimulation was reported in two studies (n = 489), but there was no statistically significant difference between groups (RR 1.21, 95% CI 0.78 to 1.88). This review found no differences between the two types of monitoring (internal or external tocodynamometry) for any of the maternal or neonatal outcomes. Given that this review is based on three studies (N = 1945 women) of moderate quality, there is insufficient evidence to recommend the use of one form of tocodynamometry over another for women where intravenous oxytocin was administered for induction or augmentation of labour.

Plain-language summary: The aim of this review was to compare the effectiveness of IT compared with ET. We included three randomised controlled studies (1945 women). The methodological quality of the studies was considered to be moderate. When comparing internal registration of contractions with external registration of contractions during induced or augmented labour, there were no differences in any of the outcomes for mother or child: adverse neonatal outcomes, instrumental deliveries, caesarean section, use of analgesia or time to delivery. No increased risk for infection was reported when an intrauterine catheter was used in these studies. There is insufficient evidence to recommend the use of one form of tocodynamometry over another for women where intravenous oxytocin is administered for induction or augmentation of labour.
Abstract: Ten randomised clinical trials (RCTs) with a total of 4052 participants fulfilled our inclusion criteria and were included in this review. Four RCTs (1881 participants) compared misoprostol with placebo given in addition to conventional uterotonics. Adjunctive use of misoprostol (in the dose of 600 to 1000 mcg) with simultaneous administration of additional uterotonics did not provide additional benefit for our primary outcomes including maternal mortality (risk ratio (RR) 6.16, 95% confidence interval (CI) 0.75 to 50.85), serious maternal morbidity (RR 0.34, 95% CI 0.01 to 8.31), admission to intensive care (RR 0.79, 95% CI 0.30 to 2.11) or hysterectomy (RR 0.93, 95% CI 0.16 to 5.41). Two RCTs (1787 participants) compared 800 mcg sublingual misoprostol versus oxytocin infusion as primary PPH treatment; one trial included women who had received prophylactic uterotonics, and the other did not. Primary outcomes did not differ between the two groups, although women given sublingual misoprostol were more likely to have additional blood loss of at least 1000 mL (RR 2.65, 95% CI 1.04 to 6.75). Misoprostol was associated with a significant increase in vomiting and shivering. Two trials attempted to test the effectiveness of estrogen and tranexamic acid, respectively, but were too small for any meaningful comparisons of pre-specified outcomes. One study compared lower segment compression but was too small to assess impact on primary outcomes. We did not identify any trials evaluating surgical techniques or radiological interventions for women with primary PPH unresponsive to uterotonics and/or haemostatics. Clinical trials included in the current review were not adequately powered to assess impact on the primary outcome measures. Compared with misoprostol, oxytocin infusion is more effective and causes fewer side effects when used as first-line therapy for the treatment of primary PPH. When used after prophylactic uterotonics, misoprostol and oxytocin infusion worked similarly. The review suggests that among women who received oxytocin for the treatment of primary PPH, adjunctive use of misoprostol confers no added benefit. The role of tranexamic acid and compression methods requires further evaluation. Furthermore, future studies should focus on the best way to treat women who fail to respond to uterotonic therapy.

Plain-language summary: The review identified 10 randomised controlled trials involving 4052 women. Seven of these trials looked at a drug called misoprostol, which is a prostaglandin and so works by increasing muscle contractions. Overall, the trials suggest that misoprostol does not work as well as oxytocin infusion, and it has more side effects. However, oxytocin needs to be kept in a refrigerator, and so in settings where refrigeration and infusions are not readily available, misoprostol can be used. Other clinical trials looked into using other types of drugs or squeezing the main artery that supplies blood to the woman. The number of women included in these studies was too small for any useful conclusions regarding their effectiveness and safety.
Abstract: Six trials fulfilled entry criteria. The majority of patients in these trials were preterm. Five small trials evaluated short-term cysteine supplementation of cysteine-free PN. One large multicenter RCT evaluated short-term N-acetylcysteine supplementation of cysteine-containing PN in extremely low birth weight infants (≤ 1000 grams). Growth was not significantly affected by cysteine supplementation (1 trial) or by N-acetylcysteine supplementation (1 trial). Nitrogen retention was significantly increased by cysteine supplementation (4 trials) (WMD 31.8 mg/kg/day, 95% confidence interval +8.2, +55.4, n = 95, including 73 preterm infants). Plasma levels of cysteine were significantly increased by cysteine supplementation but not by N-acetylcysteine supplementation. N-acetylcysteine supplementation did not significantly affect the risks of death by 36 postmenstrual weeks, bronchopulmonary dysplasia (BPD), death or BPD, retinopathy of prematurity (ROP), severe ROP, necrotizing enterocolitis requiring surgery, periventricular leukomalacia, intraventricular hemorrhage (IVH), or severe IVH. Available evidence from RCTs shows that routine short-term cysteine chloride supplementation of cysteine-free PN in preterm infants improves nitrogen balance. However, there is insufficient evidence to assess the risks of cysteine supplementation, especially regarding metabolic acidosis, which has been reported during the first two weeks of cysteine chloride administration. Available evidence from a large RCT trial does not support routine N-acetylcysteine supplementation of cysteine-containing PN in extremely low birth weight infants.

Plain-language summary: This systemic review was done to analyze whether adding cysteine (or related compounds) to intravenous nutrition affects growth and other outcomes in newborn infants. Five trials studied the effects of adding cysteine to intravenous nutrition that did not contain cysteine. Addition of cysteine significantly improved the babies' ability to build body proteins (analyzed in four studies); however, it did not improve growth (analyzed in one study); no other outcomes were available. One large randomized trial studied the effect of adding another chemical, N-acetyl-cysteine, to intravenous nutrition that already contained cysteine. This study showed no benefit and no toxicity of this intervention. We conclude that present data are insufficient to justify routine addition of cysteine to the intravenous nutrition of newborn infants that does not contain cysteine. Available evidence does not support routine addition of N-acetylcysteine to intravenous nutrition of newborn infants containing cysteine.
Abstract: We included four trials with 450 participants. Data on functional outcome and death at end of follow-up were available for 443 participants from three trials. Compared with intravenous thrombolytic therapy, percutaneous vascular intervention did not improve the proportion of participants with good functional outcome (modified Rankin Scale score 0 to 2, risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.25, P = 0.92). The quality of evidence was low (outcome assessment was blinded, but not the treating physician or participants). At the end of follow-up, there was a non-significant increase in the proportion of participants who died in the percutaneous vascular intervention group (RR 1.34, 95% CI 0.84 to 2.14, P = 0.21). The quality of evidence was low (wide confidence interval). There was no difference in the proportion of participants with symptomatic intracranial haemorrhages between the intervention and control groups (RR 0.99, 95% CI 0.50 to 1.95, P = 0.97). The quality of evidence was low (wide confidence interval). Data on vascular status (recanalisation rate) were only available for seven participants from one trial; we considered this inadequate for statistical analyses. The present review directly compared intravenous thrombolytic treatment with percutaneous vascular interventions for ischaemic stroke. We found no evidence from RCTs that percutaneous vascular interventions are superior to intravenous thrombolytic treatment with respect to functional outcome. Quality of evidence was low (outcome assessment was blinded, but not the treating physician or participants). New trials with adequate sample sizes are warranted because of the rapid development of new techniques and devices for such interventions.

Plain-language summary: We included four trials with 450 participants randomised to either percutaneous vascular intervention or clot-dissolving drugs given by injection. The evidence is current as of September 2017. Compared with clot-dissolving drugs, percutaneous vascular interventions did not increase the chance of making a good recovery by the end of the trial. There was no significant increase in the risk of dying or of suffering a brain bleed. New, larger trials are needed, particularly because of the rapid development of new techniques and devices for percutaneous vascular interventions. We judged the quality of the evidence to be low because of the limited amount of trial information available.
Abstract: In total, 126 reports describing 30 scoring indices were identified through the screening process. Eleven of the 30 scoring indices have undergone some form of index validation. Intra-rater reliability was assessed for eight scoring indices. Inter-rater reliability was evaluated for all 11 of the scoring indices. Three of the indices underwent content validation. Two of the included scoring indices assessed criterion validity. Six of the included scoring indices explored content validity. Two of the included scoring indices were tested for responsiveness. The Nancy Index and the Robarts Histopathology Index have undergone the most validation in that four operating properties including reliability, content validity, construct validity (hypothesis testing) and criterion validity have been tested. However, none of the currently available histologic scoring indices have been fully validated. In order to determine the optimal endpoint for histologic healing in UC, more research is required. The optimal index would need to be fully validated.

Plain-language summary: The researchers found that 11 out of the 30 histologic scoring indices that exist have been partially validated. The Nancy Index and the Robarts Histopathology Index have undergone the most validation compared to the other nine indices. However, none of the currently available histologic scoring indices have been fully validated. In order to determine the ideal index to measure histologic healing in UC, more research is required. The ideal index would need to be fully validated.
Abstract: We included 11 studies involving a total of 38,742 participants: eight studies compared BPLDs versus placebo or no treatment (35,110 participants), and three studies compared different systolic blood pressure targets (3632 participants). The risk of bias varied greatly between included studies. The pooled risk ratio (RR) of BPLDs for recurrent stroke was 0.81 (95% confidence interval (CI) 0.70 to 0.93; 8 RCTs; 35,110 participants; moderate-quality evidence), for major vascular event 0.90 (95% CI 0.78 to 1.04; 4 RCTs; 28,630 participants; high-quality evidence), and for dementia 0.88 (95% CI 0.73 to 1.06; 2 RCTs; 6671 participants; high-quality evidence). We mainly observed a reduced risk of recurrent stroke in the subgroup of participants using an angiotensin-converting enzyme (ACE) inhibitor or a diuretic (I2 statistic for subgroup differences 72.1%; P = 0.006). The pooled RR of intensive blood pressure-lowering for recurrent stroke was 0.80 (95% CI 0.63 to 1.00), and for major vascular event 0.58 (95% CI 0.23 to 1.46). Our results support the use of BPLDs in people with stroke or TIA for reducing the risk of recurrent stroke. Current evidence is primarily derived from trials studying an ACE inhibitor or a diuretic. No definite conclusions can be drawn from current evidence regarding an optimal systolic blood pressure target after stroke or TIA.

Plain-language summary: this review is up-to-date to August 2017. We included 11 trials involving 38,742 participants: eight trials assessed the effect of blood pressure drugs, and three trials compared different blood pressure targets. Ten studies were hospital-based and one trial was performed in a general practitioner setting. Not all trials contributed information to all outcomes. blood pressure drugs lowered the risk of recurrent stroke in patients with a stroke or TIA, whereas there is insufficient evidence to conclude whether they reduce the risk of other blood vessel diseases and dementia. There is also insufficient evidence to conclude which blood pressure target is best for patients with a stroke or TIA. overall, the quality of the trials in this review was moderate. However, we found similar results in an analysis using only high-quality trials. More research is needed to investigate whether blood pressure drugs also prevent dementia, and what blood pressure targets are best for patients with a stroke or TIA.
Abstract: Five hundred nineteen men from four randomized, placebo-controlled, double-blind trials, (lasting 4 to 26 weeks) were assessed. Three trials used non-glucosidic B-sitosterols and one utilized a preparation that contained 100% B-sitosteryl-B-D-glucoside. B-Sitosterols improved urinary symptom scores and flow measures. The weighted mean difference (WMD) for the IPSS was -4.9 IPSS points (95% CI = -6.3 to -3.5, n = 2 studies). The WMD for peak urine flow was 3.91 mL/s (95% CI = 0.91 to 6.90, n = 4 studies) and the WMD for residual volume was -28.62 mL (95% CI = -41.42 to -15.83, n = 4 studies). The trial using 100% B-sitosteryl-B-D-glucoside (WA184) show improvement in urinary flow measures. B-sitosterols did not significantly reduce prostate size compared to placebo. Withdrawal rates for men assigned to B-sitosterol and placebo were 7.8% and 8.0%, respectively. The evidence suggests non-glucosidic B-sitosterols improve urinary symptoms and flow measures. Their long term effectiveness, safety and ability to prevent BPH complications are not known.

Plain-language summary: The review found that beta-sitosterol treatments were well tolerated and improved urinary symptoms and flow measures in men with mild to moderate BPH. More research into long-term effects of beta-sitosterols is needed.