GEM/cochrane-simplification huggingface dataset:
Abstract: Five trials were included with 787 participants in total. All were randomised, double-blind, placebo-controlled parallel-group studies. We conducted a meta-analysis of two trials (114 participants) and the results gave moderate quality evidence that oral corticosteroids did not prevent postherpetic neuralgia six months after the onset of herpes (RR 0.95, 95% CI 0.45 to 1.99). One of these trials was at high risk of bias because of incomplete outcome data, the other was at low risk of bias overall. The three other trials that fulfilled our inclusion criteria were not included in the meta-analysis because the outcomes were reported at less than one month or not in sufficient detail to add to the meta-analysis. These three trials were generally at low risk of bias. Adverse events during or within two weeks after stopping treatment were reported in all five included trials. There were no significant differences in serious or non-serious adverse events between the corticosteroid and placebo groups. There was also no significant difference between the treatment groups and placebo groups in other secondary outcome analyses and subgroup analyses. The review was first published in 2008 and no new RCTs were identified for inclusion in subsequent updates in 2010 and 2012. There is moderate quality evidence that corticosteroids given acutely during zoster infection are ineffective in preventing postherpetic neuralgia. In people with acute herpes zoster the risks of administration of corticosteroids do not appear to be greater than with placebo, based on moderate quality evidence. Corticosteroids have been recommended to relieve the zoster-associated pain in the acute phase of disease. If further research is designed to evaluate the efficacy of corticosteroids for herpes zoster, long-term follow-up should be included to observe their effect on the transition from acute pain to postherpetic neuralgia. Future trials should include measurements of function and quality of life.

Plain-language summary: Five trials were identified from a systematic search of the literature which were of high enough quality to be included in the review. These trials involved 787 participants in total. We were able to combine the results from two trials (114 participants) and there was no significant difference between the corticosteroid and control groups in the presence of postherpetic neuralgia six months after the onset of the acute herpetic rash. Two of the three other included trials reported results at less than one month, so these participants did not fulfil the current criteria for a diagnosis of postherpetic neuralgia. The last trial reported results in a format unsuitable for meta-analysis. There were no significant differences in serious or non-serious adverse events between the corticosteroids and placebo groups. There was also no significant difference between the treatment groups and placebo groups in other secondary outcome analyses and subgroup analyses. It can be concluded that, based on moderate quality evidence, corticosteroids are not effective in preventing postherpetic neuralgia.
Abstract: Twenty studies were identified for all the comparison groups, involving 1609 patients. There were seven studies (with 443 patients) comparing terlipressin to placebo, five of which were considered to be high quality studies based on the Jadad scale. The meta-analysis indicates that terlipressin was associated with a statistically significant reduction in all cause mortality compared to placebo (relative risk 0.66, 95% confidence interval 0.49 to 0.88). Three studies (with 302 patients) were identified comparing terlipressin to somatostatin, two of which were high quality studies; only one high quality study (219 patients) comparing terlipressin to endoscopic treatment was identified. Within the limited power provided by these small numbers of patients, no statistically significant difference was demonstrated between terlipressin and either somatostatin or endoscopic treatment in any of the outcomes. For the remaining comparison groups (terlipressin versus balloon tamponade, terlipressin versus octreotide, and terlipressin versus vasopressin) only small, low quality studies were identified and no difference was demonstrated in any of the major outcomes. There was no significant difference between the terlipressin group and any of the comparison groups in the number of adverse events that caused death or withdrawal of medication. On the basis of a 34% relative risk reduction in mortality, terlipressin should be considered to be effective in the treatment of acute variceal hemorrhage. Further, since no other vasoactive agent has been shown to reduce mortality in single studies or meta-analyses, terlipressin might be the vasoactive agent of choice in acute variceal bleeding.

Plain-language summary: The reviewers evaluated the safety and effectiveness of a drug called terlipressin: they reported that terlipressin appears to be as safe as other treatments and that terlipressin may reduce the mortality from variceal bleeding as compared to placebo. The reviewers did not have sufficient data to decide whether terlipressin was better or worse than other available treatments such as other drugs (somatostatin, octreotide) or endoscopic treatment.
Abstract: We included 13 RCTs (n=485), with between eight and 15 weeks follow-up. The results of the individual trials were heterogeneous. Combining all trials, participants receiving calcium supplementation as compared to control had a statistically significant reduction in SBP (mean difference: -2.5 mmHg, 95% CI: -4.5 to -0.6, I2 = 42%), but not DBP (mean difference: -0.8 mmHg, 95% CI: -2.1 to 0.4, I2 = 48%). Sub-group analyses indicated that heterogeneity between trials could not be explained by dose of calcium or baseline blood pressure. Heterogeneity was reduced when poor quality trials were excluded. The one trial reporting adequate concealment of allocation and the one trial reporting adequate blinding yielded results consistent with the primary meta-analysis. Due to poor quality of included trials and heterogeneity between trials, the evidence in favour of causal association between calcium supplementation and blood pressure reduction is weak and is probably due to bias. This is because poor quality studies generally tend to over-estimate the effects of treatment. Larger, longer duration and better quality double-blind placebo controlled trials are needed to assess the effect of calcium supplementation on blood pressure and cardiovascular outcomes.

Plain-language summary: This review did not find robust evidence that oral calcium supplementation reduces high blood pressure in adults. It reviewed 13 trials enrolling 485 people, which compared calcium supplementation with placebo or no treatment, and measured blood pressure 8 to 15 weeks later. On average, people receiving extra calcium achieved slightly lower systolic blood pressure at the end of trials. However, most trials were of poor quality, so their results may not be reliable. Trials were too small and short to measure whether extra calcium reduces the risk of death, heart attack or stroke. Calcium usually had no more adverse effects than placebo. Larger, longer duration, better quality trials are needed to clarify whether calcium supplementation can lower high blood pressure.
Abstract: Eleven RCTs were included (N = 574) and 28 excluded. All except one study enrolled infants of more than 32 weeks' gestation. Limited information suggested that infants in both 'once a day' as well as 'multiple doses a day' regimens showed adequate clearance of sepsis (typical RR 1.00, 95% CI 0.84 to 1.19; typical RD 0.00, 95% CI −0.19 to 0.19; 3 trials; N = 37). 'Once a day' gentamicin regimen was associated with fewer failures to attain peak level of at least 5 µg/ml (typical RR 0.22, 95% CI 0.11 to 0.47; typical RD −0.13, 95% CI −0.19 to −0.08; number needed to treat for an additional beneficial outcome (NNTB) = 8; 9 trials; N = 422); and fewer failures to achieve trough levels of 2 µg/ml or less (typical RR 0.38, 95% CI 0.27 to 0.55; typical RD −0.22, 95% CI −0.29 to −0.15; NNTB = 4; 11 trials; N = 503). 'Once a day' gentamicin achieved higher peak levels (MD 2.58, 95% CI 2.26 to 2.89; 10 trials; N = 440) and lower trough levels (MD −0.57, 95% CI −0.69 to −0.44; 10 trials; N = 440) than 'multiple doses a day' regimen. There was no significant difference in ototoxicity between two groups (typical RR 1.69, 95% CI 0.18 to 16.25; typical RD 0.01, 95% CI −0.04 to 0.05; 5 trials; N = 214). Nephrotoxicity was not noted with either of the treatment regimens. Overall, the quality of evidence was considered to be moderate on GRADE analysis, given the small sample size and unclear/high risk of bias in some of the domains in a few of the included studies. There is insufficient evidence from the currently available RCTs to conclude whether a 'once a day' or a 'multiple doses a day' regimen of gentamicin is superior in treating proven neonatal sepsis. However, data suggest that pharmacokinetic properties of a 'once a day' gentamicin regimen are superior to a 'multiple doses a day' regimen in that it achieves higher peak levels while avoiding toxic trough levels. There was no change in nephrotoxicity or auditory toxicity. Based on the assessment of pharmacokinetics, a 'once a day regimen' may be superior in treating sepsis in neonates of more than 32 weeks' gestation.

Plain-language summary: Eleven scientific studies were analysed to derive the best available evidence. The majority of the studies included newborn babies born after 32 weeks' gestation. The main outcomes assessed were drug levels in the blood and kidney functions. The search was updated to 29 April 2016. Safer and potentially more effective levels of the drug were maintained using a 'one dose per day' treatment schedule. No differences in the risk of adverse effects on the kidney function or hearing were noted between two regimens. The quality was evidence was considered as moderate because the sample size was relatively small and two of the studies were scientifically less robust.
Abstract: The included study was a single-institution, randomised, double-blind, placebo-controlled trial of intralesional cidofovir administered at the time of surgical debulking. Adults (n = 15) and children (n = 4) were included. We judged the study to have a reasonably low risk of bias. After a 12-month trial period, no difference was found between the cidofovir and placebo groups. Both groups showed a significant reduction in disease extent (as assessed at the time of surgery using the Derkay Scoring System), but no significant change in health-related quality of life. There is insufficient evidence to support the efficacy of antiviral agents as adjuvant therapy in the management of recurrent respiratory papillomatosis in children or adults. The included randomised controlled trial showed no advantage of intralesional cidofovir over placebo at 12 months. The study was limited by a small sample size and a change in the cidofovir concentration midway through the trial, from 0.3 mg/ml in children and 0.75 mg/ml in adults, to 5 mg/ml in both adults and children. An adequately powered randomised controlled trial of intra-lesional cidofovir, consistently using higher concentrations of cidofovir in comparison with injected placebo, would be required to determine effectiveness convincingly. Future studies must include health-related quality of life and symptom-based outcome measures.

Plain-language summary: This review found one good quality study of cidofovir (an antiviral agent) injected into the warts at the time of surgical removal. After one year of treatment, however, this study found no benefit of the injected cidofovir when compared to injected salt water solution (placebo). There is still a need for a larger randomised study which includes more patients, and higher doses of cidofovir.
Abstract: One completed randomised trial was found. In one subgroup of this trial, 16 patients with symptomatic severe vertebral artery stenosis were randomised to endovascular treatment (eight patients) or medical treatment alone (eight patients). There were no strokes in any arterial territory or deaths from any cause in either group within 30 days of treatment (endovascular group) or 30 days of randomisation (medical group). In the endovascular group, two patients had a posterior circulation transient ischaemic attack at the time of the procedure. In the endovascular group, the mean vessel stenosis at follow up was 47% (range 0% to 80%). Patients were followed up for a mean of 4.5 years in the endovascular group and 4.9 years in the medical group. There were no further vertebrobasilar territory strokes in either group for the duration of follow up. Morbidity and mortality was related to carotid and coronary artery disease in this study. There is currently insufficient evidence to assess the effects of percutaneous transluminal angioplasty with or without stenting or primary stenting for vertebral artery stenosis.

Plain-language summary: This review found results from one arm of a trial only involving a very small number of patients. The results suggest that endovascular treatment can be carried out with a high degree of technical success at the time of treatment but there is insufficient evidence to determine whether the risk benefit ratio favours endovascular intervention over conservative management. Randomised trials need to be designed to determine whether the endovascular treatment is more successful than conservative treatment at reducing the long term risk of stroke or death.
Abstract: We identified 14 eligible studies which randomised a total of 5,500 women. Median follow-up ranged from 18 to 124 months. Eight studies described a satisfactory method of randomisation. Data, based on 1139 estimated deaths in 4620 women available for analysis, show equivalent overall survival rates with a HR of 0.98 (95% CI, 0.87 to 1.09; p, 0.67; no heterogeneity). Preoperative chemotherapy increases breast conservation rates, yet at the associated cost of increased loco regional recurrence rates. However, this rate was not increased as long as surgery remains part of the treatment even after complete tumour regression (HR, 1.12; 95% CI, 0.92 to 1.37; p, 0.25; no heterogeneity. Preoperative chemotherapy was associated with fewer adverse effects. Pathological complete response is associated with better survival than residual disease (HR, 0.48; 95% CI, 0.33 to 0.69; p, < 10-4). This review suggests safe application of preoperative chemotherapy in the treatment of women with early stage breast cancer in order to down-stage surgical requirement, to evaluate chemosensitivity and to facilitate translational research.

Plain-language summary: This review identified 14 randomised controlled trials involving 5,500 women addressing this question. The analyses revealed no difference in overall survival and disease-free survival for women who received either preoperative or postoperative chemotherapy. Preoperative treatment makes more breast-conserving surgery possible because of shrinkage of the tumour before surgical intervention (relative risk, 0.82; 95% confidence interval, 0.76 to 0.89). However, this also results in a increase of loco-regional recurrence (recurrence in the same area) rate (hazard ratio, 1.12; 95% confidence interval, 0.92 to 1.37). Preoperative chemotherapy provides the possibility of monitoring tumour response and making appropriate regimen changes once the tumour appears to be resistant to the primary therapy. Adverse effects, which were reported in only half of the studies, were fewer in women receiving preoperative chemotherapy. Although, postoperative complications, nausea and vomiting, and alopecia were equally distributed, events of cardiotoxicity were less likely (relative risk, 0.74; 95% confidence interval, 0.53 to 1.04) in women receiving preoperative chemotherapy. Also, serious infection (analysed in 2799 women) was less likely to occur in women receiving preoperative chemotherapy (relative risk, 0.69; 95% confidence interval, 0.56 to 0.84).
Abstract: Twelve RCTs (comprising 1669 participants) met the eligibility criteria. We judged five studies to have a moderate risk of bias and assessed the remaining seven as having a high risk of bias. It was possible to include SF-36 physical health component scores from five studies in a meta-analysis. Participating in a MDRP was associated with an increase in SF-36 physical health component scores (mean difference (MD) 2.22, 95% confidence interval (CI) 0.12 to 4.31, P = 0.04). The findings from the narrative analysis suggested that MDRPs with a single domain or outcome focus appeared to be more successful than programmes with multiple aims. In addition, programmes that comprised participants with different types of cancer compared to cancer site-specific programmes were more likely to show positive improvements in physical outcomes. The most effective mode of service delivery appeared to be face-to-face contact supplemented with at least one follow-up telephone call. There was no evidence to indicate that MDRPs which lasted longer than six months improved outcomes beyond the level attained at six months. In addition, there was no evidence to suggest that services were more effective if they were delivered by a particular type of health professional. There is some evidence to support the effectiveness of brief, focused MDRPs for cancer survivors. Rigorous and methodologically sound clinical trials that include an economic analysis are required.

Plain-language summary: We identified 12 studies which were suitable for use in the review. However, each study had some problems in the way that it was carried out. These problems make it difficult to be certain about the usefulness of MDRPs. Overall, the reviewed articles suggest that MDRPs are more likely to help patients cope with their physical needs than their emotional needs. MDRPs which looked at one specific behaviour area, such as diet, physical activity or stress, appeared to be more helpful for patients than programmes which attempted to address several different behaviours. Successful MDRPs usually involved face-to-face contact between a patient and a health professional (usually a nurse or physical therapist) and included at least one follow-up phone call. Programmes which took place over longer time periods (more than six months), or which were delivered by a specific type of health professional, or were delivered to a single cancer site were not more successful than brief, focused MDRPs delivered to mixed groups of cancer patients.
Abstract: Combined data from two eating disorder prevention programs based on a media literacy and advocacy approach indicate a reduction in the internalisation or acceptance of societal ideals relating to appearance at a 3- to 6-month follow-up (Kusel 1999; Neumark* 2000) [SMD -0.28, -0.51 to -0.05, 95% CI]. There is insufficient evidence to support the effect of five programs designed to address eating attitudes and behaviours and other adolescent issues in the general community or those classified as being at high risk for eating disorder (Buddeberg* 1998; Dalle Grave 2001; Killen 1993; Santonastaso 1999; Zanetti 1999) and insufficient evidence to support the effect of two programs designed to improve self-esteem (O'Dea 2000; Wade 2003). Data from two didactic eating disorder awareness programs could not be pooled for analysis. There is not sufficient evidence to suggest that harm resulted from any of the prevention programs included in the review. The one significant pooled effect in the current review does not allow for any firm conclusions to be made about the impact of prevention programs for eating disorders in children and adolescents, although none of the pooled comparisons indicated evidence of harm. The meta-analysis is in the process of being revised to account for the impact of cluster randomised trials.

Plain-language summary: Several eating disorder prevention programs have been developed and trialled with children and adolescents. There is currently limited evidence in the published literature to suggest that any particular type of program is effective in preventing eating disorders and there has been concern that some interventions have the potential to cause harm. The aim of this systematic review is to determine whether these interventions are effective in the prevention of eating disorders in children and adolescents. Only one statistically significant result was found in the present meta-analysis - a slight effect of media literacy and advocacy programs in reducing acceptance of societal body image ideals. There is not sufficient evidence to suggest that harm was caused by any of the 12 randomised controlled trials included in the review at short-term follow-up. The meta-analysis is in the process of being revised to account for the impact of cluster randomised trials.
Abstract: Our searches found no randomised controlled trials or quasi-randomised controlled trials that met the eligibility criteria for this review. There is very low quality evidence from one randomised trial involving 79 participants with acute Bell's palsy, but this study was excluded as the outcome assessor was not blinded to treatment allocation and thus did not meet pre-defined eligibility criteria. The trial compared 42 people who received hyperbaric oxygen therapy (2.8 atmospheres for 60 minutes twice daily, five days per week until the facial palsy resolved; maximum 30 'dives') and placebo tablets with 37 people who received placebo hyperbaric oxygen therapy (achieving only a normal partial pressure of oxygen) and prednisone (40 mg twice daily, reducing over eight days). Facial function recovered in more participants treated with hyperbaric oxygen therapy than with prednisone (hyperbaric oxygen therapy, 40/42 (95%); prednisone, 28/37 (76%); risk ratio 1.26, 95% CI 1.04 to 1.53). There were no reported major complications and all participants completed the trial. Very low quality evidence from one trial suggests that hyperbaric oxygen therapy may be an effective treatment for moderate to severe Bell's palsy, but this study was excluded as the outcome assessor was not blinded to treatment allocation. Further randomised controlled trials are needed.

Plain-language summary: We searched for evidence from randomised controlled trials on hyperbaric oxygen therapy in adults with moderate to severe Bell's palsy. Our searches revealed no trials that met the inclusion criteria for the review. We found very low quality evidence from one trial to suggest that hyperbaric oxygen therapy might be beneficial for moderate to severe Bell's palsy. The trial involved 79 participants and compared hyperbaric oxygen therapy to prednisone, a corticosteroid, which is a proven active treatment. The participants did not know which treatment they were being given. Those treated with hyperbaric oxygen recovered more quickly and recovered normal facial movement more often (95% versus 76%). All participants tolerated the treatment well, and there were no major complications. The quality of evidence from this trial was very low because the assessors of facial function were aware of which treatment each participant had been given, which introduces a high risk of bias. There is therefore no high quality evidence on which to base conclusions about the efficacy of hyperbaric oxygen therapy in Bell's palsy.