GEM/cochrane-simplification huggingface dataset:
Abstract: Only one trial involving 21 participants was included. The results showed no evidence of an effect of infliximab, one of the known anti-TNF-α drugs, on pelvic pain reduction using the Biberoglu-Behrman (BB) score (0 to 3 scale) for participants (MD -0.14, 95% CI -0.43 to 0.15), the BB score for clinicians (MD -0.14, 95% CI -0.39 to 0.11), or a visual analogue pain score (VAS, 100 mm scale) (MD -5.60, 95% CI -16.10 to 4.90), or on the use of pain killers (ibuprofen, g/day) (MD -0.10, 95% CI -0.30 to 0.10). There was no evidence of an increase in adverse events in the infliximab group compared with placebo (RR 3.73, 95% CI 0.22 to 63.66). We found no evidence of clinical benefits of infliximab for endometriotic lesions, dysmenorrhoea, dyspareunia, or pelvic tenderness. To date, there is no trial that has reported a cost-effectiveness analysis of anti-TNF-α drugs, or the odds of recurrence. This review was updated in 2012. The results of the original review published in 2010 remain unchanged. There is still not enough evidence to support the use of anti-TNF-α drugs in the management of women with endometriosis for the relief of pelvic pain.

Plain-language summary: Endometriosis is a painful condition in which endometrial tissue grows outside the uterus. It potentially affects a woman's ability to conceive. Recent studies support the contributing role of inflammation in endometriosis-related pain. Since anti-TNF-α drugs can inhibit the inflammation process, they may relieve the symptoms of the disease without inhibiting ovulation. However, this systematic review included one randomised controlled trial and found that there was not enough evidence from which to draw conclusions about the effectiveness and safety of anti-TNF-α drugs in relieving pain in women with endometriosis. There was no evidence of an increase in adverse events in the anti-TNF-α drugs group compared with the placebo group.
Abstract: Nine studies were identified. One was judged to be at high risk of bias for random sequence, the rest were judged to be at low risk of bias. All studies had high risk of bias for allocation concealment and performance bias; unclear risk for detection bias and low risk for attrition bias. Two studies had unclear risk reporting bias and the rest had low risk. No other potential threats to validity were found. Compared to control interventions, Huangqi type formulations had a positive effect on plasma albumin (MD 6.41 g/dL, 95% Cl 4.24 to 8.59), urine albumin excretion (-0.57 g/24 h, 95% CI -1.04 to -0.10), cholesterol (MD -1.70 mmol/L, 95% Cl -2.60 to -1.13) and triglycerides (-0.33 mmol/L, 95% CI -0.63 to -0.03); and more patients showed improvement at three months (RR 0.41, 95% CI 0.20 to 0.84). There was no significant difference between Huangqi type formulations and control interventions for complete (RR 1.59, 95% CI 0.29 to 8.65) or partial remission (RR 1.22, 95% CI 0.57 to 2.58). While some formulations showed improvement in the number of patients achieving complete or partial remission, the number of studies (usually one per formulation), and the number patients (ranging from 38 to 78) were small. Relapse was reported at varying time points, ranging from three months to three years, and therefore these results were not pooled. Complications of nephrotic syndrome and adverse events were only reported by two studies; Only one study reported complications of nephrotic syndrome (infection) and another reported adverse reactions to treatment (Cushing's syndrome, steroid withdrawal syndrome, respiratory tract infection, and upper gastrointestinal haemorrhage). Both studies reported those treated with Huangqi type formulations had significantly less complications or adverse reactions. Huangqi and Huangqi type formulations may have some positive effects in treating nephrotic syndrome by increasing plasma albumin and reducing urine albumin excretion, blood cholesterol and triglycerides, and decreasing the number who don't show improvement at three months. Some formulations showed an increase in the number of patients achieving complete or partial remission, however study and participant numbers were small.

Plain-language summary: This review identified nine studies (461 participants) comparing Huangqi type formulations with control drugs. The results of this review suggest that Huangqi type formulations may have a positive effect on nephrotic syndrome by increasing plasma albumin and reducing urine albumin excretion, blood cholesterol and triglycerides. Huangqi type formulation may reduce some adverse effects of other drugs used for treating nephrotic syndrome, however these were only reported in two studies. The methodological quality of the nine included studies was poor and was the major limitation of this review. The types of pathology, sex and age of the patients, as well as the duration and dosage of the Huangqi type formulations could not be analysed.
Abstract: Two RCTs involving 549 women were included. One trial which was identified to be of higher methodological quality demonstrated the therapeutic effectiveness of Jingqianping granule. The other study was considered of lower quality due to the inherent risk of various biases in it. The two studies showed statistically significant differences in favour of taking Jingqianping granule compared with Xiaoyaowan in the elimination of symptoms during the proliferative and premenstrual phases (RR 3.50, 95% CI1.74 to 7.06). Women treated with Cipher decoction had a higher rate of recovery than those taking co-vitamin B6 capsules (RR 48.99, 95% CI 3.06 to 783.99). It is rare in PMS management that efficacy claims are substantiated by clinical trials. One of the identified trials was well designed and reported on the effectiveness of Jingqianping in the treatment of premenstrual syndrome. However, currently there is insufficient evidence to support the use of Chinese herbal medicine for PMS and further, well-controlled trials are needed before any final conclusions can be drawn.

Plain-language summary: The authors identified two trials that evaluated herbal medicines in PMS. One of these was a higher quality study that tested the traditional Chinese medicine decoction Jingqianping granule. This was shown to increase the rate of recovery from PMS symptoms. Because the formula for this herbal medicine was provided by the trialists themselves, the review authors recommend further trials to ensure that the results are reproducible with other formulations. Strong evidence in support of other herbal formulae for the treatment of PMS is currently lacking.
Abstract: Seventeen studies, 9 cluster randomised studies, with 253 clusters, 8 individually randomised studies with 1230 participants, evaluating four types of intervention: motivational interviewing or brief intervention, education or skills training, family interventions and multi-component community interventions. Many studies had methodological drawbacks, especially high levels of loss to follow-up. There were too few studies for firm conclusions. One study of motivational interviewing suggested that this intervention was beneficial on cannabis use. Three family interventions (Focus on Families, Iowa Strengthening Families Program and Preparing for the Drug-Free Years), each evaluated in only one study, suggested that they may be beneficial in preventing cannabis use. The studies of multi component community interventions did not find any strong effects on drug use outcomes, and the two studies of education and skills training did not find any differences between the intervention and control groups. There is a lack of evidence of effectiveness of the included interventions. Motivational interviewing and some family interventions may have some benefit. Cost-effectiveness has not yet been addressed in any studies, and further research is needed to determine whether any of these interventions can be recommended.

Plain-language summary: participants. All but two of the studies were conducted in the USA. The other studies were in the UK and China. Follow-up periods varied from at  completion of the intervention to six years. The studies were too few and each intervention too different to draw any firm conclusions on whether  non-school based interventions prevent or reduce drug use by young people.The interventions with suggested benefits need further evaluation before it  can be firmly established that they are effective. One of two studies of motivational interviewing suggested that this intervention was beneficial on  self-reported cannabis use. Three family interventions (Focus on Families, Iowa Strengthening Families Program and Preparing for the Drug-Free Years)  were evaluated, in two separate studies, and may have been beneficial in preventing self-reported cannabis use. The latter two programs were  compared to the school-based Life Skills Training program. All of the eight studies of family interventions included contact with parents, in family  groups or in separate sessions for parents and their children. Multicomponent community interventions did not have any strong effects on  drug use. There were five studies, four of which added the community component to a school drug education program. Education and skills training  was not effective in two studies.  Many of the studies lacked blinding and had high numbers of participants lost to follow up. No study reported cost outcomes.
Abstract: Only one randomised, controlled trial was identified and included. It was of low quality and included only 15 participants. In this 1992 trial, intravenous acyclovir and corticosteroids were compared with corticosteroids alone. Our analysis found no statistically significant difference between the two groups. We found no evidence that anti-viral agents have a beneficial effect on outcomes in Ramsay Hunt syndrome, despite their widespread use in this condition. The use of these drugs in patients with herpes zoster infections in other parts of the body might suggest that they have a role in herpes zoster oticus. As usual, the absence of positive evidence of benefit (or, in this case, the 'negative' result of one small, statistically under-powered study) does not necessarily indicate that antivirals are ineffective. However, these drugs are associated with a number of adverse effects and this must be taken into consideration when undertaking the requisite risk-benefit analysis before instigating treatment.

Plain-language summary: However, trials that might address this issue have not been done and there is therefore some uncertainty about their usefulness. Since patients can experience side-effects when taking these drugs, the risks of these have to be balanced with the unknown prospect of benefit when considering whether to use them in Ramsay Hunt syndrome.
Abstract: Six randomized controlled trials were identified, five of which met the inclusion criteria: four trials from sub-Saharan Africa compared ITNs with no nets, and one trial from Asia compared ITNs with untreated nets. Two trials randomized individual women and three trials randomized communities. In Africa, ITNs, compared with no nets, reduced placental malaria in all pregnancies (risk ratio (RR) 0.79, 95% confidence interval (CI) 0.63 to 0.98). They also reduced low birthweight (RR 0.77, 95% CI 0.61 to 0.98) and fetal loss in the first to fourth pregnancy (RR 0.67, 95% CI 0.47 to 0.97), but not in women with more than four previous pregnancies. For anaemia and clinical malaria, results tended to favour ITNs, but the effects were not significant. In Thailand, one trial randomizing individuals to ITNs or untreated nets showed a significant reduction in anaemia and fetal loss in all pregnancies but not for clinical malaria or low birthweight. ITNs have a beneficial impact on pregnancy outcome in malaria-endemic regions of Africa when used by communities or by individual women. No further trials of ITNs in pregnancy are required in sub-Saharan Africa. Further evaluation of the potential impact of ITNs is required in areas with less intense and Plasmodium vivax transmission in Asia and Latin America.

Plain-language summary: This review found five trials of ITNs in pregnant women. The four trials in sub-Saharan Africa compared ITNs with no nets and showed a benefit from ITNs in terms of fewer malaria infections, low birthweight babies, and fewer babies died before delivery. The effects on severe anaemia in the mothers were inconclusive. The one trial from Asia compared ITNs with untreated nets and showed a beneficial effect on anaemia in women and fewer babies died before delivery, but it had no impact on other outcomes. ITNs have been shown to be beneficial and should be included in strategies to try to reduce the adverse effects of malaria in pregnant women in endemic areas of the world.
Abstract: We obtained full-text copies of nine potential studies and included five trials with a total of 244 participants in this review. Orbital radiotherapy was compared to sham radiotherapy in two studies and to glucocorticoids in three studies, as a monotherapy or combination therapy. There was heterogeneity (as defined in our protocol) of trial outcome measures. Our primary outcome of a composite score was used in the two trials comparing radiotherapy versus sham radiotherapy and showed a risk ratio of success of 1.92 (95% confidence interval (CI) 1.27 to 2.91) in favour of orbital radiotherapy. The primary outcome was not used in the other three trials. This review found that orbital radiotherapy is more effective than sham radiotherapy for the treatment of mild-to-moderate thyroid eye disease. In a single trial no difference between radiotherapy and steroid monotherapy was found. A meta-analysis of our secondary outcome of disease severity was not possible but results from individual trials suggest a better outcome with combination treatment with steroids versus steroids alone. No significant changes in quality-of-life scores following treatment with radiotherapy versus alternative treatments were found. Short-term adverse events related to radiotherapy that were reported were local and mild but long-term data were lacking and development of retinal changes following radiotherapy was not reported on.

Plain-language summary: This review included five randomised controlled trials involving 244 participants. A combined analysis of trials using our primary outcome showed that the 'risk' of success in a patient who received radiotherapy was 1.92 times that of a patient who did not receive radiotherapy. Single studies suggested that orbital radiotherapy in combination with steroids had a better outcome than steroids alone. There was no significant change in quality-of-life information collected in the orbital radiotherapy groups compared to the other groups. The short-term adverse events reported in the trials were mild and localised to the area of treatment (redness of skin and temporal hair loss). However, trial methodology may have led to a decreased rate of adverse events from radiotherapy. Three trials excluded diabetic patients and these patients have been reported, in the literature, to be at higher risk of developing radiation retinopathy and of having progression of pre-existing diabetic retinopathy. Some studies did not report on retinal changes at all.
Abstract: We included two RCTs with a total of 121 participants. Both RCTs were of short-term parenteral anticoagulation early after ICH: one tested heparin and the other enoxaparin. The risk of bias in the included RCTs was generally unclear or low, with the exception of blinding of participants and personnel, which was not done. The included RCTs did not report our chosen primary outcome (a composite outcome of all serious vascular events including ischaemic stroke, myocardial infarction, other major ischaemic event, ICH, major extracerebral haemorrhage, and vascular death). Parenteral anticoagulation did not cause a statistically significant difference in case fatality (RR 1.25, 95% confidence interval (CI) 0.38 to 4.07 in one RCT involving 46 participants, low-quality evidence), ICH, or major extracerebral haemorrhage (no detected events in one RCT involving 75 participants, low-quality evidence), growth of ICH (RR 1.64, 95% CI 0.51 to 5.29 in two RCTs involving 121 participants, low-quality evidence), deep vein thrombosis (RR 0.99, 95% CI 0.49 to 1.96 in two RCTs involving 121 participants, low quality evidence), or major ischaemic events (RR 0.54, 95% CI 0.23 to 1.28 in two RCTs involving 121 participants, low quality evidence). There is insufficient evidence from RCTs to support or discourage the use of antithrombotic treatment after ICH. RCTs comparing starting versus avoiding antiplatelet or anticoagulant drugs after ICH appear justified and are needed in clinical practice.

Plain-language summary: From extensive searches conducted on 8 March 2017, we identified two relevant randomised controlled trials (RCTs), which are the fairest tests of treatment. There were 121 participants in these two trials, which compared blood-thinning 'anticoagulant' drugs (heparin in one and enoxaparin in the other) delivered by injections under the skin versus no anticoagulant drug soon after ICH. The primary outcome of this review was the combined risk of several important clinical outcome events (such as another intracerebral haemorrhage, ischaemic stroke, or death from a cardiovascular cause). We were not able to calculate this outcome for the included studies. Neither RCT reported on recovery of independence or mental abilities. One RCT involving 46 participants reported on case fatality associated with short-term antithrombotic treatment, and did not find a statistically meaningful effect. For the consequences of treatment that could be analysed, the risk estimates were imprecise and uncertain. Therefore, the potential benefits and harms of antithrombotic drugs soon after a stroke due to bleeding in the brain remain unclear. New high-quality RCTs investigating the use of antithrombotic treatment after stroke due to ICH appear justified and are needed. The overall quality of the evidence was low. This is due to the way the included trials were conducted and reported, as well as the small number of participants, which may not have been high enough to detect small differences between the antithrombotic treatment and no antithrombotic treatment groups.
Abstract: The repeat searches conducted in May 2012 did not identify any additional studies for inclusion. One study enrolling 130 infants of 26 to 34 weeks PMA (mean postnatal age at entry 11 days) was identified and no identified study was excluded. The study was a double blind randomized controlled trial of high quality. Lactase treated feeds were initiated when enteral feedings provided > 75% of daily intake. None of the primary outcomes outlined in the protocol for this review and only one of the secondary outcomes, necrotizing enterocolitis (NEC) were reported on. The RR for NEC was 0.32 (95% CI 0.01 to 7.79); the RD was -0.02 (95% CI -0.06 to 0.03) (a reduction which was not statistically significant). There was a statistically significant increase in weight gain at study day 10 in the lactase treated feeds group but not at any other time points. Overall, there was not a statistically significant effect on weight gain. No adverse effects were noted. The only randomized trial to date provides no evidence of significant benefit to preterm infants from adding lactase to their feeds. Further research regarding effectiveness and safety are required before practice recommendations can be made. Randomized controlled trials comparing lactase versus placebo treated feeds and enrolling infants when enteral feeds are introduced are required. The primary and secondary outcomes for effectiveness and safety should include those identified in this review.

Plain-language summary: There was not a significant effect on weight gain in the one randomized controlled trial identified that investigated addition of lactase. The review authors searched the medical literature thoroughly but found only this one high quality trial enrolling 130 preterm infants. No adverse effects were noted and lactase treated feeds appeared to be well tolerated.
Abstract: The review included one randomised controlled trial. The study included 385 pregnant women with a short cervix of 25 mm or less who were between 18 to 22 weeks of pregnancy. The use of cervical pessary (192 women) was associated with a statistically significantly decrease in the incidence of spontaneous preterm birth less than 37 weeks' gestation compared with expectant management (22% versus 59 %; respectively, risk ratio (RR) 0.36, 95% confidence interval (CI) 0.27 to 0.49). Spontaneous preterm birth before 34 weeks was statistically significantly reduced in the pessary group (6% and 27% respectively, RR 0.24; 95% CI 0.13 to 0.43). Mean gestational age at delivery was 37.7 + 2 weeks in the pessary group and 34.9 + 4 weeks in the expectant group. Women in the pessary group used less tocolytics (RR 0.63; 95% CI 0.50 to 0.81) and corticosteroids (RR 0.66; 95% CI 0.54 to 0.81) than the expectant group. Vaginal discharge was more common in the pessary group (RR 2.18; 95% CI 1.87 to 2.54). Among the pessary group, 27 women needed pessary repositioning without removal and there was one case of pessary removal. Ninety-five per cent of women in the pessary group would recommend this intervention to other people. Neonatal paediatric care admission was reduced in the pessary group in comparison to the expectant group (RR 0.17; 95% CI 0.07 to 0.42). The review included only one well-designed randomised clinical trial that showed beneficial effect of cervical pessary in reducing preterm birth in women with a short cervix. There is a need for more trials in different settings (developed and developing countries), and with different risk factors including multiple pregnancy.

Plain-language summary: To date, data obtained from one well-designed randomised clinical trial suggest that inserting a cervical pessary is superior to expectant management in the prevention of preterm birth in 385 women between 18 and 22 weeks of pregnancy. Neonatal paediatric care admission was reduced in the pessary group in comparison to the expectant group. These women had a singleton pregnancy and high risk of preterm birth because of the short length of the neck of the womb (cervix). Among the pessary group, 27 women needed pessary repositioning without removal and there was one case of pessary removal. Results of both the randomised trial and non-randomised trials show that pessary users complained of increased vaginal discharge. More studies are needed in different settings, with singleton and multiple pregnancies where the weakness of the cervix is from other causes, to confirm the results of the single trial included in this review. Some studies are ongoing.