GEM/cochrane-simplification huggingface dataset:
Abstract: The five randomised trials included in the review involved only 428 elderly patients. One small and potentially biased trial of 23 patients with undisplaced intracapsular fracture showed a reduced risk of non-union for those fractures treated operatively. The four trials on extracapsular fractures tested a variety of surgical techniques and implant devices and only one trial involving 106 patients can be considered to test current practice. In this trial, no differences were found in medical complications, mortality and long-term pain. However, operative treatment was more likely to result in the fracture healing without leg shortening, a shorter hospital stay and a statistically non-significant increase in the return of patients back to their original residence. Although there is a lack of available evidence to inform practice for undisplaced intracapsular fractures, variation in practice has reduced and most fractures are treated surgically. The limited available evidence from randomised trials does not suggest major differences in outcome between conservative and operative management programmes for extracapsular femoral fractures, but operative treatment is associated with a reduced length of hospital stay and improved rehabilitation. Conservative treatment will be acceptable where modern surgical facilities are unavailable, and will result in a reduction in complications associated with surgery, but rehabilitation is likely to be slower and limb deformity more common. Currently, it is difficult to conceive circumstances in which future trials would be practical or viable.

Plain-language summary: The five randomised trials included in the review involved only 428 elderly patients. One small and potentially biased trial of 23 patients with undisplaced intracapsular fracture provided limited evidence that surgical fixation increased the chances of the fracture healing. The four trials on extracapsular fractures tested a variety of surgical techniques and implant devices and only one trial involving 106 patients can be considered to test current practice. This trial found no major difference between surgery and traction for people with extracapsular fractures. However, people who had surgery had better anatomical outcomes, tended to leave hospital sooner, and seemed less likely to lose their independence. The review concluded that overall there was insufficient evidence to determine if surgery is better than bed rest and traction for the two categories of hip fractures tested in randomised trials. However, nowadays most people with hip fracture are treated surgically where it is safe to do so. This reflects advances in surgery and anaesthesia and a clearer understanding of the benefits of early mobilisation and of the risks of prolonged hospital stay.
Abstract: Twelve studies, assessed as high (six) and unclear (six) risk of bias, comprising 689 participants (830 fractures), were included. Interventions examined different plate materials and morphology; use of one or two lag screws; microplate versus miniplate; early and delayed mobilization; eyelet wires versus Rapid IMF™ and the management of angle fractures with intraoral access alone or combined with a transbuccal approach. Patient-oriented outcomes were largely ignored and post-operative pain scores were inadequately reported. Unfortunately, only one or two trials with small sample sizes were conducted for each comparison and outcome. Our results and conclusions should therefore be interpreted with caution. We were able to pool the results for two comparisons assessing one outcome. Pooled data from two studies comparing two miniplates versus one miniplate revealed no significant difference in the risk of post-operative infection of surgical site (risk ratio (RR) 1.32, 95% CI 0.41 to 4.22, P = 0.64, I2 = 0%). Similarly, no difference in post-operative infection between the use of two 3-dimensional (3D) and standard (2D) miniplates was determined (RR 1.26, 95% CI 0.19 to 8.13, P = 0.81, I2 = 27%). The included studies involved a small number of participants with a low number of events. This review illustrates that there is currently inadequate evidence to support the effectiveness of a single approach in the management of mandibular fractures without condylar involvement. The lack of high quality evidence may be explained by clinical diversity, variability in assessment tools used and difficulty in grading outcomes with existing measurement tools. Until high level evidence is available, treatment decisions should continue to be based on the clinician's prior experience and the individual circumstances.

Plain-language summary: The evidence on which this review is based is up to date as of 28 February 2013. Twelve studies with a combined total of 689 participants were included in this review. Participants ranged in age from 16 to 68 years and most participants (90%) were male. All of the studies compared different types of surgical treatments, and each study evaluated a different aspect of surgical treatment such as different types of plates, screws, or wires or how long the jaw was immobilized after surgery. There were concerns about the design and quality of all the studies. All the studies evaluated different aspects of surgical treatment. None of the studies evaluated non-surgical treatments such as intermaxillary fixation and no study compared surgical treatment with non-surgical treatment. As a result there is no clear evidence to indicate which approach is the best to manage these fractures. The quality of the evidence found is poor. Recommendations are made for further well-conducted research studies in this area to be undertaken.
Abstract: Seven studies, 492 participants, met the inclusion criteria Disulfiram versus placebo: no statistically significant results for dropouts but a trend favouring disulfiram, two studies, 87 participants, RR 0.82 (95% CI 0.66 to 1.03). One more study, 107 participants, favouring disulfiram, was excluded from meta-analysis due high heterogeneity, RR 0.34 (95% CI 0.20 to 0.58). For cocaine use, it was not possible to pool together primary studies, results from single studies showed that, one, out of four comparisons, was in favour of disulfiram (number of weeks abstinence, 20 participants, WMD 4.50 (95% CI 2.93 to 6.07). Disulfiram versus naltrexone: no statistically significant results for dropouts but a trend favouring disulfiram, three studies, 131 participants, RR 0.67 (95% CI 0.45 to 1.01). No significant difference for cocaine use was seen in the only study that considered this outcome. Disulfiram versus no pharmacological treatment: for cocaine use: a statistically significant difference in favour of disulfiram, one study, two comparisons, 90 participants: maximum weeks of consecutive abstinence, WMD 2.10 (95% CI 0.69 to 3.51); number of subjects achieving 3 or more weeks of consecutive abstinence, RR 1.88 (95% CI 1.09 to 3.23). There is low evidence, at the present, supporting the clinical use of disulfiram for the treatment of cocaine dependence. Larger randomised investigations are needed investigating relevant outcomes and reporting data to allow comparisons of results between studies. Results from ongoing studies will be added as soon as their results will be available.

Plain-language summary: Disulfiram showed a trend toward fewer dropouts from psychosocial treatment when compared to placebo (three trials) or naltrexone (three trials) but this was not statistically significant. Assessing cocaine use, single studies were in favour of disulfiram on number of weeks of abstinence in one out of four comparisons when compared with placebo and on maximum weeks of consecutive abstinence and number of people achieving three or more weeks of consecutive abstinence in one study comparing disulfiram to no pharmacological treatment.   The included studies did not specifically investigate the adverse effects of disulfiram itself or its potential to increase alcohol and cocaine adverse effects.
Abstract: Twelve trials with a total of 1879 infants fulfilled the inclusion criteria. Four trials compared standard term formula versus donor breast milk and eight compared nutrient-enriched preterm formula versus donor breast milk. Only the five most recent trials used nutrient-fortified donor breast milk. The trials contain various weaknesses in methodological quality, specifically concerns about allocation concealment in four trials and lack of blinding in most of the trials. Most of the included trials were funded by companies that made the study formula. Formula-fed infants had higher in-hospital rates of weight gain (mean difference (MD) 2.51, 95% confidence interval (CI) 1.93 to 3.08 g/kg/day), linear growth (MD 1.21, 95% CI 0.77 to 1.65 mm/week) and head growth (MD 0.85, 95% CI 0.47 to 1.23 mm/week). These meta-analyses contained high levels of heterogeneity. We did not find evidence of an effect on long-term growth or neurodevelopment. Formula feeding increased the risk of necrotising enterocolitis (typical risk ratio (RR) 1.87, 95% CI 1.23 to 2.85; risk difference (RD) 0.03, 95% CI 0.01 to 0.05; number needed to treat for an additional harmful outcome (NNTH) 33, 95% CI 20 to 100; 9 studies, 1675 infants). The GRADE certainty of evidence was moderate for rates of weight gain, linear growth, and head growth (downgraded for high levels of heterogeneity) and was moderate for neurodevelopmental disability, all-cause mortality, and necrotising enterocolitis (downgraded for imprecision). In preterm and LBW infants, moderate-certainty evidence indicates that feeding with formula compared with donor breast milk, either as a supplement to maternal expressed breast milk or as a sole diet, results in higher rates of weight gain, linear growth, and head growth and a higher risk of developing necrotising enterocolitis. The trial data do not show an effect on all-cause mortality, or on long-term growth or neurodevelopment.

Plain-language summary: We found 12 completed trials (involving 1871 infants). Most trials, particularly those trials conducted more recently, used reliable methods. Evidence is up to date as of 3 May 2019. The combined analysis of data from these trials shows that feeding with formula increases rates of growth during the hospital stay, but is associated with a higher risk of developing the severe gut disorder called 'necrotising enterocolitis'. There is no evidence of an effect on survival or longer-term growth and development. The currently available evidence suggests that feeding preterm infants with artificial formula (rather than donor breast milk when mother's own breast milk is not available) is associated with faster rates of growth, but with a near-doubling of the risk of developing necrotising enterocolitis. Further, larger trials could provide stronger and more precise evidence to help clinicians and families make informed choices about this issue. Currently, four such trials (involving more than 1100 infants) are ongoing internationally, and we plan to include the data from these trials in this review when these become available.
Abstract: Two randomised controlled trials including a total of 148 people aged 70 years or over with unstable extracapsular hip fractures in the trochanteric region were identified and included in this review. Both had methodological limitations, including inadequate assessment of longer-term outcome. One trial compared a cemented arthroplasty with a sliding hip screw. This found no significant differences between the two methods of treatment for operating time, local wound complications, mechanical complications, reoperation, mortality or loss of independence of previously independent patients at one year. There was, however, a higher blood transfusion need in the arthroplasty group. The other trial compared a cementless arthroplasty versus a proximal femoral nail. It also found a higher blood transfusion need in the arthroplasty group, together with a greater operative blood loss, and a longer length of surgery. There were no significant differences between the two interventions for mechanical complications, local wound complications, reoperation, general complications, mortality at one year or long-term function. None of the pooled outcome data yielded statistically significant differences between the arthroplasty and internal fixation, with the exception of the significantly higher numbers of participants in the arthroplasty group requiring blood transfusion (relative risk 1.71, 95% confidence interval 1.05 to 2.77). There is insufficient evidence from randomised trials to determine whether replacement arthroplasty has any advantage over internal fixation for extracapsular hip fractures. Further larger well-designed randomised trials comparing arthroplasty versus internal fixation for the treatment of unstable fractures are required.

Plain-language summary: The two randomised controlled trials included in this review tested arthroplasty versus internal fixation in a total of 148 mainly female and older participants. Both trials had methodological flaws that may affect the validity of their results and there was a general lack of evidence on long-term effects. One of the trials found a longer length of surgery for the arthroplasty and both trials found an increased need for blood transfusion for the arthroplasty. Pooled data from the two trials showed no statistically significant differences between the two procedures for reoperations, wound healing complications or mortality at one year. Neither trial found a significant difference in longer-term function. Overall, the evidence from the two small trials comparing these two approaches for treating extracapsular hip fractures was too limited to make any definite conclusions as to which is better.
Abstract: Seven trials recruiting 3123 babies were included in the meta-analysis. Four trials recruiting 765 babies compared CPAP with supportive care and three trials (2364 infants) compared CPAP with mechanical ventilation. Apart from a lack of blinding of the intervention all studies were of low risk of bias. In the comparison of CPAP with supportive care there was a reduction in failed treatment (typical risk ratio (RR) 0.66, 95% confidence interval (CI) 0.45 to 0.98; typical risk difference (RD) −0.16, 95% CI −0.34 to 0.02; 4 studies, 765 infants, very low quality evidence). There was no reduction in bronchopulmonary dysplasia (BPD) or mortality. In trials comparing CPAP with assisted ventilation with or without surfactant, CPAP resulted in a small but clinically significant reduction in the incidence of BPD at 36 weeks, (typical RR 0.89, 95% CI 0.79 to 0.99; typical RD −0.04, 95% CI −0.08 to 0.00; 3 studies, 772 infants, moderate-quality evidence); and death or BPD (typical RR 0.89, 95% CI 0.81 to 0.97; typical RD −0.05, 95% CI −0.09 to 0.01; 3 studies, 1042 infants, moderate-quality evidence). There was also a clinically important reduction in the need for mechanical ventilation (typical RR 0.50, 95% CI 0.42 to 0.59; typical RD −0.49, 95% CI −0.59 to −0.39; 2 studies, 760 infants, moderate-quality evidence); and the use of surfactant in the CPAP group (typical RR 0.54, 95% CI 0.40 to 0.73; typical RD −0.41, 95% CI −0.54 to −0.28; 3 studies, 1744 infants, moderate-quality evidence). There is insufficient evidence to evaluate prophylactic CPAP compared to oxygen therapy and other supportive care. However when compared to mechanical ventilation prophylactic nasal CPAP in very preterm infants reduces the need for mechanical ventilation and surfactant and also reduces the incidence of BPD and death or BPD.

Plain-language summary: Randomised controlled trials of preterm babies below 32 weeks' gestation or below 1500 grams at birth who were treated with CPAP applied within the first 15 minutes of life compared with babies who were given either (1) routine supportive care such as oxygen therapy or (2) mechanical ventilation. There were a total of seven studies involving 3123 infants. They were generally of moderate quality. Parents and care-givers would have known which treatment group the babies were in, but we judged this not to be important for most outcomes measured. In the four studies (765 babies) comparing CPAP with supportive care, CPAP resulted in fewer infants requiring further breathing assistance but there was considerable inconsistency between the studies. In the three studies (2354 babies) that compared CPAP with assisted ventilation with or without surfactant, CPAP resulted in a small but clinically important reduction in BPD and the combined outcome of BPD and mortality. There was a reduction in the need for mechanical ventilation and the use of surfactant in the CPAP group.
Abstract: The literature search yielded 359 reports of which only one study was identified that met our inclusion criteria and reported relevant clinical endpoints. This study randomised 4110 adult participants with a functioning kidney transplant and elevated homocysteine levels to folic acid plus high dose B multivitamins or low dose multivitamins who were followed for a mean 4.0 years. Despite effectively lowering homocysteine levels) in homocysteine levels at follow-up (MD -4.40 μmol/L, 95% CI -5.98 to -2.82) there was no evidence the intervention impacted on any of the outcomes reported including cardiovascular mortality (RR 0.91, 95% CI 0.69 to 1.20), all-cause mortality (RR 1.04, 95% CI 0.88 to 1.22), myocardial infarction (RR 1.02, 95% CI 0.77 to 1.35), stroke (RR 1.08, 95% CI 0.69 to 1.71), commencement of renal replacement therapy (RR 1.12, 95% CI 0.91 to 1.37) or all reported adverse events (RR 1.02, 95% CI 0.87 to 1.20). There was no evidence the intervention impacted on the primary endpoint of the study, a cardiovascular event composite (RR 0.99, 95% CI 0.85 to 1.15). The study was of high quality. There is no current evidence to support the use of homocysteine lowering therapy for cardiovascular disease prevention in kidney transplant recipients.

Plain-language summary: The aim of this review was to determine if homocysteine lowering therapies effectively reduce cardiovascular event rates in kidney transplant recipients. A single study was identified that randomised 4110 adult participants with a functioning kidney transplant to homocysteine lowering with folic acid and high dose multivitamins or to low dose multivitamins and followed them for an average of four years. Despite effectively lowering homocysteine levels, there was no evidence of benefit for any of a range of cardiovascular events. Similarly there was no evidence of harm.
Abstract: Twenty-two trials which randomised approximately 6200 people to pioglitazone treatment were identified. Longest duration of therapy was 34.5 months. Published studies of at least 24 weeks pioglitazone treatment in people with type 2 diabetes mellitus did not provide convincing evidence that patient-oriented outcomes like mortality, morbidity, adverse effects, costs and health-related quality of life are positively influenced by this compound. Metabolic control measured by glycosylated haemoglobin A1c (HbA1c) as a surrogate endpoint did not demonstrate clinically relevant differences to other oral antidiabetic drugs. Occurrence of oedema was significantly raised. The results of the single trial with relevant clinical endpoints (Prospective Pioglitazone Clinical Trial In Macrovascular Events - PROactive study) have to be regarded as hypothesis-generating and need confirmation. Until new evidence becomes available, the benefit-risk ratio of pioglitazone remains unclear. Different therapeutic indications for pioglitazone of the two big U.S. and European drug agencies should be clarified to reduce uncertainties amongst patients and physicians.

Plain-language summary: Twenty-two trials randomised approximately 6200 people to pioglitazone treatment. The longest duration of pioglitazone therapy was 34.5 months. Unfortunately, the published studies of at least 24 weeks pioglitazone treatment in people with type 2 diabetes mellitus did not provide convincing evidence that patient-oriented outcomes are positively influenced by this compound. The occurrence of oedema was significantly raised. The results of the single trial with relevant endpoints (Prospective Pioglitazone Clinical Trial In Macrovascular Events - PROactive study) have to be confirmed by other independent investigations. Until new evidence becomes available (several large trials are ongoing) the place of pioglitazone in the treatment of type 2 diabetes mellitus remains unclear.  Furthermore, confusion arises due to different labelling of pioglitazone, for example in Europe and the USA. Consumers and physicians need clear guidance and transparent information about which studies exactly are used for the decisions of the relevant drug authorities.
Abstract: Sixty-five RCTs (N=166,206) were included, evaluating four classes of anti-hypertensive drugs: ACE inhibitors (12 trials), beta-blockers (20), calcium channel blockers (18) and nitrates (18). Acute stroke was studied in 6 trials (all involving CCBs). Acute myocardial infarction was studied in 59 trials. In the latter setting immediate nitrate treatment (within 24 hours) reduced all-cause mortality during the first 2 days (RR 0.81, 95%CI [0.74,0.89], p<0.0001). No further benefit was observed with nitrate therapy beyond this point. ACE inhibitors did not reduce mortality at 2 days (RR 0.91,95%CI [0.82, 1.00]), but did after 10 days (RR 0.93, 95%CI [0.87,0.98] p=0.01). No other blood pressure lowering drug administered as an immediate treatment or short-term treatment produced a statistical significant mortality reduction at 2, 10 or ≥30 days. There was not enough data studying acute stroke, and there were no RCTs evaluating other acute cardiovascular events. Nitrates reduce mortality (4-8 deaths prevented per 1000) at 2 days when administered within 24 hours of symptom onset of an acute myocardial infarction. No mortality benefit was seen when treatment continued beyond 48 hours. Mortality benefit of immediate treatment with ACE inhibitors post MI at 2 days did not reach statistical significance but the effect was significant at 10 days (3-5 deaths prevented per 1000). There is good evidence for lack of a mortality benefit with immediate or short-term treatment with beta-blockers and calcium channel blockers for acute myocardial infarction.

Plain-language summary: This review looked at all studies where patients were randomized to one of these drugs or placebo, in this period. One class of blood pressure lowering drug, the so-called nitrates, demonstrated reduction in mortality in patients with heart attack. For 1000 patients treated 4 to 8 deaths were prevented during the first 2 days of this acute event. The ACE-inhibitors class also decrease mortality when continued for 10 days (3 to 5 deaths prevented per 1000). No other class of drug showed a reduction in mortality.