GEM/cochrane-simplification huggingface dataset:
Abstract: We included six publications, with 125 participants (106 aged under 18 years). Two different comparisons were available: melatonin versus placebo and melatonin 5 mg versus melatonin 10 mg. Despite our primary intention, due to insufficient information on outcomes, we were unable to perform any meta-analyses, but summarized data narratively. Four studies were randomized, double-blind, cross-over, placebo-controlled trials and two were randomized, double-blind, parallel, placebo-controlled trials. Only two studies provided the exact number of seizures during the trial compared to the baseline: none of the participants with seizures during the trial had a change in seizure frequency compared with the baseline. Two studies systematically evaluated adverse effects (worsening of headache was reported in a child with migraine under melatonin treatment). Only one study systematically evaluated quality of life, showing no statistically significant improvement in quality of life in the add-on melatonin group. Included studies were of poor methodological quality, and did not systematically evaluate seizure frequency and adverse events, so that it was impossible to summarize data in a meta-analysis. It is not possible to draw any conclusion about the role of melatonin in reducing seizure frequency or improving quality of life in people with epilepsy.

Plain-language summary: We searched medical databases for clinical trials of melatonin added to another antiepileptic drug (add-on treatment) compared with antiepileptic drug plus add-on pretend treatment (placebo) or add-on no treatment in people with epilepsy. The participants were of any age or sex and included children and adults with disabilities. The studies measured reduction of seizure frequency by half, proportion of people with no seizures (seizure freedom), side effects, and improvement in quality of life. We found six trials representing 125 participants for the present review. They reported two different comparisons: melatonin versus placebo and melatonin 5 mg versus melatonin 10 mg. Included trials did not evaluate seizure frequency, seizure freedom, and adverse events in a methodical way. Only one study reported seizure frequency and none of the participants had a change in frequency occurring during the trial compared to before the trial. Only one trial evaluated the effect of melatonin on quality of life and found no improvement with add-on melatonin compared with add-on placebo. The included trials were of poor methodological quality and it was not possible to draw any definitive conclusions about the role of melatonin in reducing seizure frequency or improving the quality of life in people with epilepsy. The evidence was current to January 2016.
Abstract: Ten trials with 2059 participants were included. The quality of most of the trials was acceptable but not high. Because of this and as the overall result was sensitive to the losses to follow up in the largest trial, the estimates of effect may not be robust and may be subject to bias. Surgery was associated with statistically significant reduction in the odds of being dead or dependent at final follow up (odds ratio (OR) 0.71, 95% confidence interval (CI) 0.58 to 0.88; 2P = 0.001) with no significant heterogeneity among the study results. Surgery was also associated with significant reduction in the odds of death at final follow up (OR 0.74, 95% CI 0.61 to 0.90; 2P = 0.003); however, there was significant heterogeneity for death as outcome. In patients with CT-proven primary supratentorial intracerebral haemorrhage, surgery added to medical management reduces the odds of being dead or dependent compared with medical management alone, but the result is not very robust. Hence, further randomised trials to identify which patients benefit from surgery and to evaluate less invasive methods are indicated.

Plain-language summary: The review authors set out to determine whether surgery within 24 to 72 hours of onset of symptoms decreases the risk of death or dependence; and whether one surgical technique is better than another. Endoscopic or stereotactic surgery inserts a fine catheter rather than having to open up the skull (craniotomy) to get to the blood clot. This updated review included 10 studies in which a total of 2059 participants received medical treatment, but 50% also had surgery within 72 hours of onset of the event. Surgery was associated with significant benefit and improved the proportion of participants alive and independent. However, the benefit was not consistent in all the studies, which suggests that this result may not be very reliable. Overall, surgery appeared promising, though further trials are underway to identify the type of patients most likely to benefit from surgery.
Abstract: Six studies comprising nearly 450 patients were included. In general the quality of the studies was good. No study was blinded due to the type of intervention. Limb salvage after 12 months was significantly higher in the SCS group (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.56 to 0.90; risk difference (RD) -0.11, 95% CI -0.20 to -0.02). Significant pain relief occurred in both treatment groups, but was more prominent in the SCS group where the patients required significantly less analgesics. In the SCS group, significantly more patients reached Fontaine stage II than in the conservative group (RR 4.9, 95% CI 2.0 to 11.9; RD 0.33, 95% CI 0.19 to 0.47). Overall, no significantly different effect on ulcer healing was observed with the two treatments. Complications of SCS treatment consisted of implantation problems (9%, 95% CI 4 to 15%) and changes in stimulation requiring re-intervention (15%, 95% CI 10 to 20%). Infections of the lead or pulse generator pocket occurred less frequently (3%, 95% CI 0 to 6%). Overall risk of complications with additional SCS treatment was 17% (95% CI 12 to 22%), indicating a number needed to harm of 6 (95% CI 5 to 8). Average overall costs (one study) at two years were EUR 36,500 (SCS group) and EUR 28,600 (conservative group). The difference (EUR 7900) was significant (P < 0.009). There is evidence to favour SCS over standard conservative treatment alone to improve limb salvage and clinical situations in patients with NR-CCLI. The benefits of SCS must be considered against the possible harm of relatively mild complications and the costs.

Plain-language summary: The review authors included five randomised and one controlled clinical trial involving a total of nearly 450 patients. In general the quality of the studies was good. Amputation after 12 months was required less often when SCS was added to standard care. Significant pain relief occurred with and without SCS but patients in the SCS group required fewer pain killers. Overall there was no difference on ulcer healing rates between the two treatment groups. Complications of SCS treatment consisted of problems with initially implanting the electrodes, in 8% of patients, and the need for repeat surgery because of electrode or lead failures in 12% of patients; infections occurred less frequently (3%). The average overall costs at two years were calculated in one study and found to be EUR 36,500 in the SCS group and EUR 28,600 in the conservative treatment alone group.
Abstract: Eight trials with 870 patients were included in the review and showed a significant reduction in readmission rates for hospital at home compared with hospital inpatient care of acute exacerbations of COPD (risk ratio (RR)0.76; 95% confidence interval (CI) from 0.59 to 0.99; P=0.04). Moreover, we observed a trend towards lower mortality in the hospital at home group, but the pooled effect estimate did not reach statistical significance (RR 0.65, 95% CI 0.40 to 1.04, P = 0.07). For health-related quality of life, lung function (FEV1) and direct costs, the quality of the available evidence is in general too weak to make firm conclusions. Selected patients presenting to hospital emergency departments with acute exacerbations of COPD can be safely and successfully treated at home with support from respiratory nurses. We found evidence of moderate quality that hospital at home may be advantageous with respect to readmission rates in these patients. Treatment of acute exacerbation of COPD in hospital at home also show a trend towards reduced mortality rate when compared with conventional inpatient treatment, but these results did not reach statistical significance (moderate quality evidence). For other outcomes than readmission and mortality rate, we assessed the evidence to be of low or very low quality.

Plain-language summary: We found eight trials on 870 people comparing hospital at home with  hospital care. The results from these trials show that fewer people are readmitted to hospital if they received their care at home. There was no significant difference in quality of life, although patients and carers said they preferred treatment at home. There was no significant difference in the number of deaths. These results are only applicable to a subgroup of patients who could be treated at home, but for a majority of the patients with acute COPD exacerbations, "hospital at home" schemes are probably not an suitable option.
Abstract: Seven studies (1446 participants) were included. There was no significant difference between doses, or between intravenous and intramuscular administration for 50% pain relief over 6 hours: NNTs compared with placebo were 3.1 (2.4 to 4.5), 2.4 (2.1 to 2.8), and 1.8 (1.5 to 2.3) for 10, 20, and 40 mg parecoxib respectively. Fewer participants required rescue medication over 24 hours with parecoxib than placebo: parecoxib 40 mg was significantly better than parecoxib 20 mg (NNTs to prevent use of rescue medication 7.5 (5.3 to 12.8) and 3.3 (2.6 to 4.5) respectively; P < 0.0007). Median time to use of rescue medication was 3.1 hours, 6.9 hours and 10.6 hours with parecoxib 10 mg, 20 mg and 40 mg respectively, and 1.5 hours with placebo. Adverse events were generally mild to moderate, rarely led to withdrawal, and did not differ in frequency between groups. No serious adverse events were reported with parecoxib or placebo. A single dose of parecoxib 20 mg or 40 mg provided effective analgesia for 50 to 60% of those treated compared to about 15% with placebo, and was well tolerated. Duration of analgesia was longer, and significantly fewer participants required rescue medication over 24 hours with the higher dose.

Plain-language summary: This review assessed seven studies of parecoxib, an injectable COX-2 inhibitor, for acute postoperative pain relief. Single doses of 20 mg or 40 mg provided effective pain relief in 50 to 60% of treated individuals, compared with 15% treated with placebo. Duration of pain relief was longer with the higher dose (10.6 hours for 40 mg versus 6.9 hours for 20 mg), and significantly fewer individuals on the higher dose required rescue medication over 24 hours (66% versus 81%). Adverse events were generally mild to moderate in severity and were reported by just over half of treated individuals in both parecoxib and placebo groups.
Abstract: We identified 14 trials in which a total of 1071 infants participated. The trials were generally small and weak methodologically. Meta-analyses provided low-quality evidence that multi-nutrient fortification of breast milk increases in-hospital rates of growth (MD 1.81 g/kg/d, 95% confidence interval (CI) 1.23 to 2.40); length (MD 0.12 cm/wk, 95% CI 0.07 to 0.17); and head circumference (MD 0.08 cm/wk, 95% CI 0.04 to 0.12). Only very limited data are available for growth and developmental outcomes assessed beyond infancy, and these show no effects of fortification. The data did not indicate other potential benefits or harms and provided low-quality evidence that fortification does not increase the risk of necrotising enterocolitis in preterm infants (typical RR 1.57, 95% CI 0.76 to 3.23; 11 studies, 882 infants). Limited available data do not provide strong evidence that feeding preterm infants with multi-nutrient fortified breast milk compared with unfortified breast milk affects important outcomes, except that it leads to slightly increased in-hospital growth rates.

Plain-language summary: We found 14 trials; most were small (involving 1071 infants in total) and were flawed methodologically. Multi-nutrient fortification of breast milk for preterm infants is associated with small increases in rates of weight gain, length gain and head growth during neonatal unit admission. Only very limited data are available for growth and developmental outcomes assessed beyond infancy, and these show no effects of fortification. Trials report no consistent evidence of other potential benefits or harms of fortification, including effects on risk of feeding or bowel problems. Although available trial data show that multi-nutrient fortification increases growth rates of preterm infants during their initial hospital admission, they do not provide consistent evidence on effects on longer-term growth or development. Additional trials are needed to resolve this issue.
Abstract: We included seven small RCTs involving 691 participants aged 17 to 78 years in our meta analyses. The primary result showed that periodontal therapy combined with H. pylori eradication treatment increased the eradication rate of gastric H. pylori compared with eradication treatment alone (OR 2.15; 95% CI 1.47 to 3.14; P < 0.0001) in people with H. pylori infection. In addition, periodontal therapy also had benefits on long-term gastric H. pylori eradication. After eradication of H. pylori, the non-recurrence rate of gastric H. pylori infection increased in participants treated with periodontal therapy compared with those who received eradication therapy alone (OR 3.60; 95% CI 2.11 to 6.15; P < 0.00001). According to the GRADE approach, the overall quality of the evidence was 'moderate' for eradication rate of gastric H.pylori and 'low' for non-recurrence rate of gastric H. pylori. Overall, periodontal therapy could increase the efficiency of H. pylori eradication and the non-recurrence rate of gastricH. pylori. In view of the limited number and quality of included studies, it will be necessary to conduct more well-designed, multicenter, and large-scale RCTs to determine the effects of periodontal therapy in eradicating gastric H. pylori and suppressing the recurrence of this bacterium in the stomach.

Plain-language summary: After searching for all relevant studies to August 2015, we found seven small randomized controlled trials (considered the highest quality study design) involving 691 participants aged 17 to 78 years. The results indicated that periodontal therapy as an added treatment had some benefits on eradication of gastricH. pylori for short-term and long-term follow-up. The eradication (the reduction of the prevalence of H. pylori in stomach to normal range) and non-recurrence (the proportion of participants that remained free of gastric H. pylori after successful eradication therapy) rates increased in people who received periodontal therapy plus eradication treatment, when compared with those who received eradication treatment alone. Because there were not very many participants or trials included in our analyses, we cannot draw a firm conclusion about the use of periodontal therapy for all patients with gastric H. pylori infection in clinical practice. Based on the results in this review, large-scale randomized controlled trials comparing periodontal therapy plus eradication treatment with eradication treatment alone would be useful to generate stronger evidence on the use of periodontal therapy as an additional treatment for patients with gastric diseases caused by H. pylori.
Abstract: Twelve papers were identified, from which four were included. The remaining eight papers were excluded predominantly due to inappropriate methodology. The four included studies were highly clinically heterogenous, investigating a range of age groups (ie, children, adolescents and adults) across the disease spectrum from early HIV through late-stage AIDS. The settings were either community or palliative care, and the outcome measures were a combination of quality of life and immunological function. The trials were judged to be at moderate risk of bias mostly because of incomplete reporting. For quality of life measures, the studies reported that massage therapy in combination with other modalities, such as meditation and stress reduction, are superior to massage therapy alone or to the other modalities alone. The quality of life domains with significant effect sizes included self-reported reduced use of health care resources, improvement in self-perceived spiritual quality of life and improvement in total quality of life scores. One study also reported positive changes in immune function, in particular CD4+ cell count and natural killer cell counts, due to massage therapy, and one study reported no difference between people given massage therapy and controls in immune parameters. Adverse or harmful effects were not well reported. There is some evidence to support the use of massage therapy to improve quality of life for people living with HIV/AIDS (PLWHA), particularly in combination with other stress-management modalities, and that massage therapy may have a positive effect on immunological function. The trials are small, however, and at moderate risk of bias. Further studies are needed using larger sample sizes and rigorous design/reporting before massage therapy can be strongly recommended for PLWHA.

Plain-language summary: We systematically investigated studies that have compared massage therapy with other forms of therapy or no therapy. We found four randomised controled trials that used massage therapy with children, adolescents or adults with HIV or late-stage AIDS. This review of the literature supports that massage therapy can benefit people with HIV/AIDS by improving quality of life, particularly if they receive the therapy in conjunction with other techniques, such as meditation and relaxation training, and provide more benefit than any one of these techniques individually. Furthermore, it may be that massage therapy can improve their body's ability to fight the disease; however, this is not yet convincingly proven. We recommend further studies be undertaken to investigate this question and recommend that in the meantime, people with HIV/AIDS use massage therapy to improve quality of life, provided they have clear goals and monitor their response to the therapy.
Abstract: Thirty-four methodological studies were included.  The methods used by these included studies were: 1) Targeted approaches (n=22); 2) gap approaches (n=12) and gradient approach (n=1).  Gender or sex was assessed in eight out of 34 studies, socioeconomic status in ten studies, race/ethnicity in seven studies, age in seven studies, low and middle income countries in 14 studies, and two studies assessed multiple factors across health inequity may exist. Only three studies provided a definition of health equity. Four methodological approaches to assessing effects on health equity were identified: 1) descriptive assessment of reporting and analysis in systematic reviews (all 34 studies used a type of descriptive method); 2) descriptive assessment of reporting and analysis in original trials (12/34 studies); 3) analytic approaches (10/34 studies); and 4) applicability assessment (11/34 studies). Both analytic and applicability approaches were not reported transparently nor in sufficient detail to judge their credibility. There is a need for improvement in conceptual clarity about the definition of health equity, describing sufficient detail about analytic approaches (including subgroup analyses) and transparent reporting of judgments required for applicability assessments in order to assess and report effects on health equity in systematic reviews.

Plain-language summary: This review identified thirty-four methodological studies in which collections of systematic reviews were examined.  We identified four methodological approaches to assess the effects on health equity, a descriptive assessment in the reviews, a descriptive assessment of the trials included in the reviews, analytic approaches, and applicability assessment. However, the most appropriate way to address any of these approaches is unclear. There is a need for methodological guidance on how to assess effects on health equity in systematic reviews.  Analysis of particular groups of populations need to be justified and reported in sufficient detail to allow their credibility to be assessed. There is a need for improved transparency of judgments about applicability and relevance to disadvantaged populations.
Abstract: Twenty three randomised controlled trials (1075 participants) were included with a mean treatment duration of 8.9 weeks. The mean dose of omega-3 PUFA used in the trials was 3.5 g/d. No trials with vascular events or mortality endpoints were identified. Among those taking omega-3 PUFA triglyceride levels were significantly lowered by 0.45 mmol/L (95% confidence interval (CI) -0.58 to -0.32, P < 0.00001) and VLDL cholesterol lowered by -0.07 mmol/L (95% CI -0.13 to 0.00, P = 0.04). LDL cholesterol levels were raised by 0.11 mmol/L (95% CI 0.00 to 0.22, P = 0.05). No significant change in or total or HDL cholesterol, HbA1c, fasting glucose, fasting insulin or body weight was observed. The increase in VLDL remained significant only in trials of longer duration and in hypertriglyceridemic patients. The elevation in LDL cholesterol was non-significant in subgroup analyses. No adverse effects of the intervention were reported. Omega-3 PUFA supplementation in type 2 diabetes lowers triglycerides and VLDL cholesterol, but may raise LDL cholesterol (although results were non-significant in subgroups) and has no statistically significant effect on glycemic control or fasting insulin. Trials with vascular events or mortality defined endpoints are needed.

Plain-language summary: We identified 23 randomised trials (maximum duration of eight months) including 1075 people in which omega-3 PUFA was compared to a vegetable oil or placebo. None of the trials looked at cardiovascular endpoints in cardiovascular disease or death as an outcome measure.  The review shows that although some types of fat in the blood are reduced through omega-3 supplementation, others including LDL cholesterol (which may promote heart disease) were increased. Control of blood sugar levels was not affected by the treatment. There were no other adverse effects of the interventions noted. Clinical outcome trials of sufficient duration are required to establish conclusively the role of omega-3 PUFA in type 2 diabetes but our results do not suggest a major harmful effect on the balance of blood fats and confirm that it has no adverse affect on blood sugar control.