GEM/cochrane-simplification huggingface dataset:
Abstract: We identified 18 potential studies, of which two, currently reported only as abstracts, met the inclusion criteria for this review. Too little information was available for us to present full results or adequately assess risk of bias. The participants were children aged five to 15 years with DMD, ambulant and non-ambulant. The interventions were risedronate versus no treatment in one trial (13 participants) and whole-body vibration versus a placebo device in the second (21 participants). Both studies reported improved bone mineral density with the active treatments, with no improvement in the control groups, but the abstracts did not compare treatment and control conditions. All children tolerated whole-body vibration treatment. No study provided information on adverse events. Two studies are ongoing: one investigating whole-body vibration, the other investigating zoledronic acid. We know of no high-quality evidence from RCTs to guide use of treatments to prevent or treat corticosteroid-induced osteoporosis and reduce the risk of fragility fractures in children and adults with DMD; only limited results from two trials reported in abstracts were available. We await formal trial reports. Findings from two ongoing relevant studies and two trials, for which only abstracts are available, will be important in future updates of this review.

Plain-language summary: We searched the medical literature comprehensively, finding two completed trials. Only brief reports (abstracts) of these trials are available. The participants were children aged from five to 15 years with DMD who were able to walk and not able to walk. The treatments were risedronate versus no treatment in one trial (with 13 participants) and whole-body vibration versus a placebo (inactive) device in the other (with 21 participants). We found two completed studies that were potentially eligible for this review, for which full results have not yet been published, and two studies ongoing at the time of the search. These studies are looking at the effects of whole-body vibration (two studies), risedronate, and zoledronic acid. Both completed trials, presented as abstracts only, reported an improvement in bone mineral density in children who received active treatment and no improvement in children in the control (placebo or no treatment) groups. However, the reports did not report results for the comparison of treatment versus control groups, which means that it is not possible to draw conclusions about the effectiveness of either treatment. All children tolerated whole-body vibration treatment. Neither study provided information on adverse events. We know of no evidence from randomised clinical trials to guide use of treatments to prevent or treat osteoporosis and prevent fragility fractures in people with DMD taking corticosteroids. Searches are current to September 2016.
Abstract: We included four trials, with a combined total of 1439 women in the review; each trial examined a different method of induction and we were unable to pool the results from trials. 1. Vaginal PGE2 (two studies including 1028 women). There were no differences between women managed as outpatients versus inpatients for most review outcomes. There was no evidence of a difference between the likelihood of women requiring instrumental delivery in either setting (risk ratio (RR) 1.29; 95% confidence interval (CI) 0.79 to 2.13). The overall length of hospital stay was similar in the two groups. 2. Controlled release PGE2 10 mg (one study including 300 women). There was no evidence of differences between groups for most review outcomes, including success of induction. During the induction period itself, women in the outpatient group were more likely to report high levels of satisfaction with their care (satisfaction rated seven or more on a nine-point scale, RR 1.42; 95% CI 1.11 to 1.81), but satisfaction scores measured postnatally were similar in the two groups. 3. Foley catheter (one study including 111 women). There was no evidence of differences between groups for caesarean section rates, total induction time and the numbers of babies admitted to neonatal intensive care. The data available to evaluate the efficacy or potential hazards of outpatient induction are limited. It is, therefore, not yet possible to determine whether induction of labour is effective and safe in outpatient settings.

Plain-language summary: Four randomised controlled trials with a combined total of 1439 women assessed the effects of induction of labour for women managed as outpatients versus inpatients. Out of a total of four studies, the induction agents differed in two studies, whereas the remaining two studies evaluated the same induction agent (vaginal PGE2). The limited information from these trials did not support more successful induction within 24 hours, shorter length of stay in hospital or differences in need for further induction or the mode of giving birth. The information available was limited and it is, therefore, not yet possible to determine whether induction of labour is effective and safe in outpatient settings.
Abstract: In this update, we included three trials involving 1398 postoperative participants. Participants were submitted to general surgical procedures, minor and major, and the minimum mean age was 49 years. Pooled analysis showed a significant reduction in the risk of HIT with LMWH compared with UFH (risk ratio (RR) 0.23, 95% confidence interval (CI) 0.07 to 0.73); low-quality evidence. The number needed to treat for an additional beneficial outcome (NNTB) was 59. The risk of HIT was consistently reduced comparing participants undergoing major surgical procedures exposed to LMWH or UFH (RR 0.22, 95% CI 0.06 to 0.75); low-quality evidence. The occurrence of HIT complicated by venous thromboembolism was significantly lower in participants receiving LMWH compared with UFH (RR 0.22, 95% CI 0.06 to 0.84); low-quality evidence. The NNTB was 75. Arterial thrombosis occurred in only one participant who received UFH. There were no amputations or deaths documented. Although limited evidence is available, it appears that HIT induced by both types of heparins is common in people undergoing major surgical procedures (incidence greater than 1% and less than 10%). This updated review demonstrated low-quality evidence of a lower incidence of HIT, and HIT complicated by venous thromboembolism, in postoperative patients undergoing thromboprophylaxis with LMWH compared with UFH. Similarily, the risk of HIT in people undergoing major surgical procedures was lower when treated with LMWH compared to UFH (low-quality evidence). The quality of the evidence was downgraded due to concerns about the risk of bias in the included studies and imprecision of the study results. These findings may support current clinical use of LMWH over UFH as front-line heparin therapy. However, our conclusions are limited and there was an unexpected paucity of RCTs including HIT as an outcome. To address the scarcity of clinically-relevant information on HIT, HIT must be included as a core harmful outcome in future RCTs of heparin.

Plain-language summary: The evidence gathered in this review was considered of low quality. We downgraded the quality of the evidence because we had concerns about the risk of bias in the included studies and imprecision of the results. It was possible that patient prognosis or clinicians' preferences influenced the allocation of participants to receive one or another medication. This process should be implemented by chance to allow a fair comparison between the therapies. We were not confident that staff implementing the trials were not aware of which treatment participants were receiving, and it was possible that the incomplete reporting of data could have affected the estimates. The detection of HIT throughout the trials was also problematic, and we were not confident that it was performed adequately. The results may be correct, but they may be changed by future research.
Abstract: 108 trials were located using the specified search strategy in 2001. An additional three trials were located when the search strategy was repeated in 2004. Of the total number of trials located in both searches, only two trials, involving a total of 64 patients, were of sufficient quality to meet inclusion criteria. The available evidence suggests these substances were better than placebo at alleviating depression (Peto Odds Ratio 4.10; 95% confidence interval 1.28-13.15; RD 0.36; NNT 2.78). However, the evidence was of insufficient quality to be conclusive. A large number of studies appear to address the research questions, but few are of sufficient quality to be reliable. Available evidence does suggest these substances are better than placebo at alleviating depression. Further studies are needed to evaluate the efficacy and safety of 5-HTP and tryptophan before their widespread use can be recommended. The possible association between these substances and the potentially fatal Eosinophilia-Myalgia Syndrome has not been elucidated. Because alternative antidepressants exist which have been proven to be effective and safe the clinical usefulness of 5-HTP and tryptophan is limited at present.

Plain-language summary: Until then, the reviewers propose that the use of antidepressants which have no known life threatening side effects remain more attractive. The review sets out the required methodology for effectively studying these substances in proper controlled studies.
Abstract: We included four RCTs involving 758 participants. We did not pool data because of heterogeneity in study designs, outcomes and time points. The studies provided sparse information about effects longer than a few hours, as three of four included studies were short trials of only four to six hours. Participants treated with acetaminophen had significant improvements in nasal obstruction in two of the four studies. One study showed that acetaminophen was superior to placebo in decreasing rhinorrhoea severity, but was not superior for treating sneezing and coughing. Acetaminophen did not improve sore throat or malaise in two of the four studies. Results were inconsistent for some symptoms. Two studies showed that headache and achiness improved more in the acetaminophen group than in the placebo group, while one study showed no difference between the acetaminophen and placebo group. None of the included studies reported the duration of common cold symptoms. Minor side effects (including gastrointestinal adverse events, dizziness, dry mouth, somnolence and increased sweating) in the acetaminophen group were reported in two of the four studies. One of them used a combination of pseudoephedrine and acetaminophen. Acetaminophen may help relieve nasal obstruction and rhinorrhoea but does not appear to improve some other cold symptoms (including sore throat, malaise, sneezing and cough). However, two of the four included studies in this review were small and allocation concealment was unclear in all four studies. The data in this review do not provide sufficient evidence to inform practice regarding the use of acetaminophen for the common cold in adults. Further large-scale, well-designed trials are needed to determine whether this intervention is beneficial in the treatment of adults with the common cold.

Plain-language summary: We identified four trials that included 758 participants. We excluded studies in which the participants had complications. Two of the four included studies in this review were small and the quality of the evidence was low to moderate. We do not know if acetaminophen is effective for reducing common cold symptoms or its adverse effects. We cannot either 'recommend' or 'not recommend' its use in common practice because we do not have enough well-designed trials to reach a conclusion. There is a need for more high-quality studies to determine the effectiveness of acetaminophen in relieving common cold symptoms.
Abstract: Thirty-one published RCTs of all forms of surgical treatment for degenerative lumbar spondylosis were identified. The trials varied in quality: only the more recent trials used appropriate methods of randomization, blinding and independent assessment of outcome. Most of the earlier published results were of technical surgical outcomes with some crude ratings of clinical outcome. More of the recent trials also reported patient-centered outcomes of pain or disability, but there is still very little information on occupational outcomes. There was a particular lack of long term outcomes beyond two to three years. Seven heterogeneous trials on spondylolisthesis, spinal stenosis and nerve compression permitted limited conclusions. Two new trials on the effectiveness of fusion showed conflicting results. One showed that fusion gave better clinical outcomes than conventional physiotherapy, while the other showed that fusion was no better than a modern exercise and rehabilitation programme. Eight trials showed that instrumented fusion produced a higher fusion rate (though that needs to be qualified by the difficulty of assessing fusion in the presence of metal-work), but any improvement in clinical outcomes is probably marginal, while there is other evidence that it may be associated with higher complication rates. Three trials with conflicting results did not permit any conclusions about the relative effectiveness of anterior, posterior or circumferential fusion. Preliminary results of two small trials of intra-discal electrotherapy showed conflicting results. Preliminary data from three trials of disc arthroplasty did not permit any firm conclusions. Limited evidence is now available to support some aspects of surgical practice. Surgeons should be encouraged to perform further RCTs in this field.

Plain-language summary: This review considers the available evidence on the procedures of spinal decompression (widening the spinal canal or laminectomy), nerve root decompression (of one or more individual nerves) and fusion of adjacent vertebrae. There is moderate evidence that instrumentation can increase the fusion rate, but any improvement in clinical outcomes is probably marginal. The effectiveness of intra-discal electrotherapy (IDET) remains unproven. Only preliminary results are available on disc replacement and it is not possible to draw any conclusions on this subject.
Abstract: We did not identify any new trials from the updated search so the results remain unchanged as follows. We included four trials involving 852 women. Three trials (involving 500 women) evaluating the effects of IAP versus no treatment were included. The use of IAP did not significantly reduce the incidence of all cause mortality, mortality from GBS infection or from infections caused by bacteria other than GBS. The incidence of early GBS infection was reduced with IAP compared to no treatment (risk ratio (RR) 0.17, 95% confidence interval (CI) 0.04 to 0.74, three trials, 488 infants; risk difference -0.04, 95% CI -0.07 to -0.01; number needed to treat to benefit 25, 95% CI 14 to 100, I² 0%). The incidence of LOD or sepsis from organisms other than GBS and puerperal infection was not significantly different between groups. One trial (involving 352 women) compared intrapartum ampicillin versus penicillin and reported no significant difference in neonatal or maternal outcomes. We found a high risk of bias for one or more key domains in the study methodology and execution. Intrapartum antibiotic prophylaxis appeared to reduce EOGBSD, but this result may well be due to bias as we found a high risk of bias for one or more key domains in the study methodology and execution. There is lack of evidence from well designed and conducted trials to recommend IAP to reduce neonatal EOGBSD. Ideally the effectiveness of IAP to reduce neonatal GBS infections should be studied in adequately sized double-blind controlled trials. The opportunity to conduct such trials has likely been lost, as practice guidelines (albeit without good evidence) have been introduced in many jurisdictions.

Plain-language summary: This review finds that giving antibiotics is not supported by conclusive evidence. The review identified four trials involving 852 GBS positive women. Three trials, which were more than 20 years old, compared ampicillin or penicillin to no treatment and found no clear differences in newborn deaths although the occurrence of early GBS infection in the newborn was reduced with antibiotics. The antibiotics ampicillin and penicillin were no different from each other in one trial with 352 GBS positive women. All cases of perinatal GBS infections are unlikely to be prevented even if an effective vaccine is developed.
Abstract: One hundred and eighteen studies with 138 treatment groups and 17,364 participants were included in this review. Fifty-seven of these studies were included in the original version of this review while 61 were added, including 27 on interventions that were not considered in the original version. Interventions included amiodarone, beta-blockers, sotalol, magnesium, atrial pacing and posterior pericardiotomy. Each of the studied interventions significantly reduced the rate of post-operative atrial fibrillation after cardiac surgery compared with a control. Beta-blockers (odds ratio (OR) 0.33; 95% confidence interval) CI 0.26 to 0.43; I2 = 55%) and sotalol (OR 0.34; 95% CI 0.26 to 0.43; I2 = 3%) appear to have similar efficacy while magnesium's efficacy (OR 0.55; 95% CI 0.41 to 0.73; I2 = 51%) may be slightly less. Amiodarone (OR 0.43; 95% CI 0.34 to 0.54; I2 = 63%), atrial pacing (OR 0.47; 95% CI 0.36 to 0.61; I2 = 50%) and posterior pericardiotomy (OR 0.35; 95% CI 0.18 to 0.67; I2 = 66%) were all found to be effective. Prophylactic intervention decreased the hospital length of stay by approximately two-thirds of a day and decreased the cost of hospital treatment by roughly $1250 US. Intervention was also found to reduce the odds of post-operative stroke, though this reduction did not reach statistical significance (OR 0.69; 95% CI 0.47 to 1.01; I2 = 0%). No significant effect on all-cause or cardiovascular mortality was demonstrated. Prophylaxis to prevent atrial fibrillation after cardiac surgery with any of the studied pharmacological or non-pharmacological interventions may be favored because of its reduction in the rate of atrial fibrillation, decrease in the length of stay and cost of hospital treatment and a possible decrease in the rate of stroke. However, this review is limited by the quality of the available data and heterogeneity between the included studies. Selection of appropriate interventions may depend on the individual patient situation and should take into consideration adverse effects and the cost associated with each approach.

Plain-language summary: Atrial fibrillation after heart surgery is a common complication that has been associated with poor outcomes. We reviewed the literature to better understand the role of preventative interventions for this condition. By combining the results of 118 studies with 17,364 participants, we are able to gain a better understanding of the evidence behind each of these interventions. All of the interventions studied were effective in reducing the occurrence of atrial fibrillation, length of hospital stay, cost of hospital treatment and may be effective in reducing the risk of stroke. The interventions did not have an effect on death after heart surgery. It was not possible to analyze the adverse events associated with the medications studied in this review, but these should be considered by clinicians when choosing an appropriate intervention for their patients. Furthermore, differences in the design between the studies combined in this review may complicate interpretation of these results.
Abstract: We identified 115 trial reports representing 55 trials, of which five trials (providing data on 122 participants) met our inclusion criteria. All five trials used a cross-over design. Intervention periods ranged from two to eight weeks. Four trials (98 participants) compared dornase alfa inhalation before versus after airway clearance techniques. Inhalation after instead of before airway clearance did not significantly change forced expiratory volume at one second (very-low quality evidence). Similarly, forced vital capacity (low-quality evidence) and quality of life (very-low quality evidence) were not significantly affected; forced expiratory flow at 25% was significantly worse with dornase alfa inhalation after airway clearance, mean difference -0.17 litres (95% confidence interval -0.28 to -0.05), based on the pooled data from two small trials in children (7 to 19 years) with well-preserved lung function. All other secondary outcomes were statistically non-significant. In one trial (25 participants), morning versus evening inhalation had no impact on lung function or symptoms (low-quality evidence). The current evidence derived from a small number of participants does not indicate that inhalation of dornase alfa after airway clearance techniques is more or less effective than the traditional recommendation to inhale nebulised dornase alfa 30 minutes prior to airway clearance techniques, for most outcomes. For children with well-preserved lung function, inhalation before airway clearance may be more beneficial for small airway function than inhalation after. However, this result relied on a measure with high variability and trials with variable follow-up. In the absence of strong evidence to indicate that one timing regimen is better than another, the timing of dornase alfa inhalation can be largely based on pragmatic reasons or individual preference with respect to the time of airway clearance and time of day. Further research is warranted.

Plain-language summary: We included five trials with a total of 122 participants. In these trials the length of treatment ranged from two to eight weeks. Four of the trials compared inhaling before to inhaling after the airways had been cleared and found no overall difference in clinical outcomes. However, in children with well-preserved lung function, inhaling of dornase alfa after airway clearance techniques was better for small airways function. However, this did not affect quality of life or other outcomes. In the remaining trial, morning versus evening inhalation had no impact on lung function or symptoms. Therefore, for many people with cystic fibrosis, the timing of dornase alfa inhalation (before or after airway clearance or the time of day) can be based on practical reasons or individual preference. Apart from one trial published only in abstract form, the quality of the evidence ranged from low to very low. This was due to issues relating to group allocation, blinding, incomplete reporting of outcome data and the the limited age range of participants.