GEM/cochrane-simplification huggingface dataset:
Abstract: We included two RCTs (involving 154 women) with a low risk of bias. It was not possible to pool the available studies. The two studies do not consistently report outcomes defined in the review. However, no significant differences were observed between the two groups (surgical versus non-surgical repair) in incidence of pain and wound complications, self-evaluated measures of pain at hospital discharge and postpartum and re-initiation of sexual activity. Differences in the use of analgesia varied between the studies, being high in the sutured group in one study. The other trial showed differences in wound closure and poor wound approximation in the non-suturing group, but noted incidentally also that more women were breastfeeding in this group. There is limited evidence available from RCTs to guide the choice between surgical or non-surgical repair of first- or second-degree perineal tears sustained during childbirth. Two studies find no difference between the two types of management with regard to clinical outcomes up to eight weeks postpartum. Therefore, at present there is insufficient evidence to suggest that one method is superior to the other with regard to healing and recovery in the early or late postnatal periods. Until further evidence becomes available, clinicians' decisions whether to suture or not can be based on their clinical judgement and the women's preference after informing them about the lack of long-term outcomes and the possible chance of a slower wound healing process, but possible better overall feeling of well being if left un-sutured.

Plain-language summary: Our review included two randomised controlled trials (involving 154 women) comparing surgical repair of first-degree (involving only the perineal or vaginal skin) or second-degree tears (also involving muscle) with leaving the wound to heal spontaneously. These trials showed no clear differences in clinical outcomes between the groups. The studies did not find any differences in pain immediately and up to eight weeks postpartum. One of the trials reported no difference in wounds complications, but the other showed differences in wound closure and poor wound approximation in the non-sutured group. There was no information about the effect on long-term outcomes such as sexual discomfort or incontinence. More research is needed to provide a strong evidence-based recommendation for clinical practice.
Abstract: Sixteen studies (894 patients) were included. No formulation, route, or schedule of vitamin D compound was found to alter the mortality risk or need for dialysis. Vitamin D compounds significantly lowered serum PTH (4 studies, 153 patients: MD -49.34 pg/mL, 95% CI -85.70 to -12.97 (-5.6 pmol/L, 95% CI -9.77 to -1.48)) and were more likely to reduce serum PTH > 30% from baseline value (264 patients: RR 7.87, 95% CI 4.87 to 12.73). Vitamin D treatment was associated with increased end of treatment serum phosphorus (3 studies, 140 patients: MD 0.37 mg/dL, 95% CI 0.09, 0.66 (0.12 mmol/L, 95% CI 0.03, 0.21)) and serum calcium (5 studies, 184 patients: MD 0.20 mg/dL, 95% CI 0.17 to 0.23 (0.05 mmol/L, 95% CI 0.04 to 0.06)). Few data were available comparing intermittent with daily vitamin D administration, or other schedules of dosing. There are not sufficient data to determine the effect of vitamin D compounds on mortality and cardiovascular outcomes in people with CKD not requiring dialysis. While vitamin D compounds reduce serum PTH (49.3 pg/mL (5.6 pmol/L)) compared with placebo, the relative clinical benefits of PTH lowering versus treatment-related increases in serum phosphorus and calcium remain to be understood.

Plain-language summary: We identified 16 studies of vitamin D preparations in people with CKD and not requiring dialysis (less severe CKD) involving 894 people. No studies were designed to understand the effect of vitamin D therapy on risks of premature cardiovascular disease or mortality. Vitamin D agents lowered PTH significantly compared with no treatment, however also increased both calcium and phosphorus levels. Newer vitamin D therapies have not been compared with older vitamin compounds in CKD directly; whether they are associated with increased calcium and phosphorus is uncertain. In the future, new studies are required to assess outcomes important to patients, such as life expectancy and premature heart disease. It will also be important to know if vitamin D therapy should be used differently (differing target levels of PTH) in differing stages of CKD.
Abstract: Sixteen trials, involving over one million adults, children and infants, fulfilled the inclusion criteria. Twenty-four comparisons reported on vaccine efficacy (cholera cases and/or deaths) and 11 comparisons considered adverse effects (nine reported on both). Compared to placebo, vaccinees had a reduced risk of death from cholera (RR 0.49, 95% CI 0.25 to 0.93; 837,442 participants) and a reduced risk of contracting cholera at 12 months (RR 0.52, 95% CI 0.42 to 0.65, random-effects model; 1,512,573 participants). This translates to an efficacy of 48%, 95% confidence interval 35% to 58%. Significant protection lasted for two years, even after only a single dose, and for three years with an annual booster. Children over five years and adults were protected for up to three years, while children under five years were protected for up to a year. Injected cholera vaccines were associated with more systemic and local adverse effects compared to placebo, but these were not severe or life-threatening. Injected cholera vaccines appear to be safe and relatively more effective than usually realized. Protection against cholera persists for up to two years following a single dose of vaccine, and for three years with an annual booster. However, they have been superseded by oral vaccines.

Plain-language summary: Sixteen trials, involving over one million adults, children, and infants, were included. Injected cholera vaccines reduced the risk of death from cholera and the risk of contracting cholera at 12 months. Significant protection lasted for two years. Injected cholera vaccines had more systemic and local adverse effects than placebo, but these adverse effects were relatively well tolerated and were not severe or life-threatening. The authors conclude that injected cholera vaccines appear to be relatively safe and more effective than usually realized. However, they are not currently available and therefore cannot be recommended for use. This review provides a solid background of evidence for the effects of cholera injected vaccines, against which to compare the effects of oral vaccines.
Abstract: Five trials with 196 people were included. One three-arm trial (47 participants) compared arthrographic distension using steroid and air to distension using air alone and to steroid injection alone. One trial (46 participants) compared arthrographic distension using steroid and saline to placebo. Two trials (45 and 22 participants) compared arthrographic distension using steroid to steroid injection alone. One trial (36 participants) compared arthrographic distension using steroid and saline plus physical therapy to physical therapy alone. Trials included similar study participants, but quality and reporting of data were variable. Only one trial was at low risk of bias. No meta-analysis was performed. The trial with low risk of bias demonstrated that distension with saline and steroid was better than placebo for pain (number needed to treat to benefit (NNTB) = 2), function (NNTB = 3) and range of movement at three weeks. This benefit was maintained at six and 12 weeks only for one of two scores measuring function (NNT = 3). A second trial with high risk of bias also reported that distension combined with physical therapy improved range of movement and median percent improvement in pain (but not pain score) at eight weeks compared to physical therapy alone. Three further trials, all at high risk of bias, reported conflicting, variable effects of arthrographic distension with steroid compared to distension alone, and arthrographic distension with steroid compared to intra-articular steroid injection. The trials reported a small number of minor adverse effects, mainly pain during and after the procedure. There is "silver" level evidence that arthrographic distension with saline and steroid provides short-term benefits in pain, range of movement and function in adhesive capsulitis. It is uncertain whether this is better than alternative interventions.

Plain-language summary: Disability: One study found that at three weeks after treatment, people's disability was improved by 11 points on a scale of 0-100, possibly as few as 4 or as many as 11 points on a scale of 0-100. Another study found disability was improved by 17 points. This improvement could possibly be as low as 6 or as many as 28 points on a scale of 0-100. At six weeks after treatment, people's disability was improved by 46 points on a scale of 0-500. This improvement could possibly be as little as 20 points or as many as 80 points on a scale of 0-500. At 12 weeks after treatment, people's disability was improved by 54 points on a scale of 0-500. This improvement could be as little as 15 points or as many as 95 points on a scale of 0-500. The numbers given are our best estimate. When possible, we have also presented a range because there is a 95 percent chance that the true effect of the treatment lies somewhere between that range.
Abstract: Six trials involving 988 patients (645 women and 343 men) and reporting eight comparisons were found. Two studies reported withdrawals and dropouts, but none mentioned analysis by intention to treat (ITT). 5-FU presented better results for cure than placebo or no treatment (relative risk (RR) 0.39, 95% confidence interval (CI) 0.23 to 0.67), meta-cresol-sulfonic acid (MCSA) (RR 2.11, 95% CI 0.83 to 5.37), Podophylin 2%, 4% or 25% (RR 1.26, 95% CI 0.86 to 1.82). There were no statistical differences for treatment failure for 5-FU versus CO2 Laser (RR 0.69, 95% CI 0.43 to 1.11) versus 5-FU + INFα-2a (low dose) (RR 1.02, 95% CI 0.87 to 1.119). Worse results were found for 5-FU versus 5-FU + INFα-2a (high dose) (RR 10.78, 95% CI 1.50 to 77.36), and 5-FU + CO2 Laser INFα-2a (high dose) (RR 7.97, 95% CI 2.87 to 22.13). The reviewed trials were highly variable in methods and quality, and the evidence provided by these studies was weak. Cure rates with several treatments were variable, and although 5-FU presents therapeutic results that are inferior to those seen with 5-FU + Inf α-2a (high dose) and 5-FU + CO2 Laser + Inf α-2a (high dose), the treatment should not be abandoned. Topical treatment with 5-FU has a therapeutic effect; however, the benefits and risks have not been determined clearly and further studies are needed.

Plain-language summary: This review evaluated the effectiveness and safety of topical 5-FU for treatment of genital warts in nonimmunocompromised individuals. Evidence from the studies we reviewed showed that 5-FU had better results for cure than placebo or no treatment; MCSA; and Podophylin 2%, 4% or 25%. No statistical difference was found when 5-FU was compared with CO2 Laser treatment, and results were poor when 5-FU was compared with 5-FU + INFα-2a (high dose) or 5-FU + CO2 Laser INFα-2a (high dose). The weak point of this review was the great variability in the methods and quality of the studies that we included.
Abstract: Only three trials, involving 189 participants, satisfied the inclusion criteria and these were of low methodological quality. One study showed a significant difference in hearing recovery in the vasodilator group (carbogen combined with a course of several other drugs) compared to the control group (a course of several other drugs alone). Another study only showed a significant improvement in higher frequencies in the vasodilator group (prostaglandin E1 + steroid) compared with the control group (placebo and steroid), no difference having been shown in overall hearing gain. In the third study the vasodilator group (naftidrofuryl and low-molecular weight dextran) showed an improvement only in lower frequencies over the control group (placebo and low-molecular weight dextran). Two of the studies reported adverse effects from vasodilator treatment, whereas there was no mention of any side effects in the third. Five patients in one study developed a sensation of heaviness in the head which settled spontaneously and did not interfere with treatment. In the other study one patient developed an allergic reaction and had to be excluded from the study. The effectiveness of vasodilators in the treatment of ISSHL remains unproven. The included studies were of relatively poor quality and the number of patients included was small. Moreover, there were differences in the type, dosage and duration of vasodilator used in each study. Due to the degree of heterogeneity the results could not be combined to reach a conclusion.

Plain-language summary: We found three trials, involving 189 participants, which showed improvement in hearing thresholds in those treated with vasodilators compared to control groups. However, as the number of patients included in the studies was small, and there were differences in the type, dosage and duration of vasodilator treatment used in each of these studies, the results could not be combined to reach a conclusion. The effectiveness of vasodilators in the treatment of ISSHL could not be proven. Further research is needed.
Abstract: Four randomised controlled trials with up to three months duration and investigating 479 participants met the inclusion criteria. Risk of bias of these trials (only two studies were published as a full peer-reviewed publication) was generally high. Two RCTs compared the effects of preparations from different parts of the momordica charantia plant with placebo on glycaemic control in type 2 diabetes mellitus. There was no statistically significant difference in the glycaemic control with momordica charantia preparations compared to placebo. When momordica charantia was compared to metformin or glibenclamide, there was also no significant change in reliable parameters of glycaemic control. No serious adverse effects were reported in any trial. No trial investigated death from any cause, morbidity, health-related quality of life or costs. There is insufficient evidence on the effects of momordica charantia for type 2 diabetes mellitus. Further studies are therefore required to address the issues of standardization and the quality control of preparations. For medical nutritional therapy, further observational trials evaluating the effects of momordica charantia are needed before RCTs are established to guide any recommendations in clinical practice.

Plain-language summary: This review of trials found only four studies which had an overall low quality. Three trials showed no significant differences between momordica charantia and placebo or antidiabetic drugs (glibenclamide and metformin) in the blood sugar response. The duration of treatment ranged from four weeks to three months, and altogether 479 patients with type 2 diabetes mellitus participated. No trial investigated death from any cause, morbidity, health-related quality of life or costs. Adverse effects were mostly moderate, including diarrhoea and abdominal pain. However, reporting of adverse effects was incomplete in the included studies. There are many varieties of preparations of momordica charantia, as well as variations in its use as a vegetable. Further studies are needed to assess the quality of the various momordica charantia preparations as well as to further evaluate its use in the diet of diabetic people.
Abstract: Nine trials including more than 25,000 participants were included in this review. No effect was observed on child health, measures of child mental health or emotional state. Non-significant effects favouring the intervention group were seen for child cognitive development and educational achievement, and a non-significant effect favouring controls in rates of teenage pregnancy. The review set out to examine the potential of financial support to poor families to improve circumstances for children. However, on the basis of current evidence we cannot state unequivocally whether financial benefits delivered as an intervention are effective at improving child health or well-being in the short term. Our conclusions are limited by the fact that most of the studies had small effects on total household income and that, while no conditions were attached to how money was spent, all studies included strict conditions for receipt of payments. We note particular concerns by some authors that sanctions and conditions (such as working hours) placed on families may increase family stress.

Plain-language summary: This review aimed to assess whether additional monies provided to socially or economically disadvantaged families could affect children's health, well-being and educational attainment. Nine studies were identified that met inclusion criteria. There was tentative evidence of benefit in early language development, but given lack of effect on all other outcomes, authors conclude that the evidence did not show an effect on child outcomes in the short to medium term in response to direct financial benefits to families. In the context of the monetary value of interventions observed, and the conditions placed on receipt of benefits, authors conclude this is a statement of "no evidence of effect" rather than "evidence of no effect". Implications for research and practice are noted.
Abstract: Overall, 10 RCTs with 565 participants which investigated different non-pharmacological interventions for the management of chronic pain in MS fulfilled the review inclusion criteria. The non-pharmacological interventions evaluated included: transcutaneous electrical nerve stimulation (TENS), psychotherapy (telephone self-management, hypnosis and electroencephalogram (EEG) biofeedback), transcranial random noise stimulation (tRNS), transcranial direct stimulation (tDCS), hydrotherapy (Ai Chi) and reflexology. There is very low-level evidence for the use of non-pharmacological interventions for chronic pain such as TENS, Ai Chi, tDCS, tRNS, telephone-delivered self-management program, EEG biofeedback and reflexology in pain intensity in pwMS. Although there were improved changes in pain scores and secondary outcomes (such as fatigue, psychological symptoms, spasm in some interventions), these were limited by methodological biases within the studies. Despite the use of a wide range of non-pharmacological interventions for the treatment of chronic pain in pwMS, the evidence for these interventions is still limited or insufficient, or both. More studies with robust methodology and greater numbers of participants are needed to justify the effect of these interventions for the management of chronic pain in pwMS.

Plain-language summary: Overall, we found 10 studies evaluating different non-medication treatments to treat chronic pain in persons with MS. The treatments evaluated included: transcutaneous electrical nerve stimulation, transcranial direct stimulation, transcranial random noise stimulation, reflexology, psychotherapy and hydrotherapy. These studies included 565 participants and used a range of different methods to measure pain and other outcomes. Comparison groups also varied. Results from these studies show a very low level of evidence for the use of any non-medication treatments for chronic pain in persons with MS. We assessed the overall quality of the studies as very low, as many studies included only small numbers of participants and had other methodological issues. More research with good methodological quality and greater number of participants are needed to determine the effectiveness of such treatments.
Abstract: We included 12 studies involving 2887 participants with LBP. Three studies had low risk of bias. Included studies evaluated a range of chiropractic procedures in a variety of sub-populations of people with LBP. No trials were located of combined chiropractic interventions compared to no treatment. For acute and subacute LBP, chiropractic interventions improved short- and medium-term pain (SMD -0.25 (95% CI -0.46 to -0.04) and MD -0.89 (95%CI -1.60 to -0.18)) compared to other treatments, but there was no significant difference in long-term pain (MD -0.46 (95% CI -1.18 to 0.26)). Short-term improvement in disability was greater in the chiropractic group compared to other therapies (SMD -0.36 (95% CI -0.70 to -0.02)). However, the effect was small and all studies contributing to these results had high risk of bias. There was no difference in medium- and long-term disability. No difference was demonstrated for combined chiropractic interventions for chronic LBP and for studies that had a mixed population of LBP. Combined chiropractic interventions slightly improved pain and disability in the short-term and pain in the medium-term for acute and subacute LBP. However, there is currently no evidence that supports or refutes that these interventions provide a clinically meaningful difference for pain or disability in people with LBP when compared to other interventions. Future research is very likely to change the estimate of effect and our confidence in the results.

Plain-language summary: The review shows that while combined chiropractic interventions slightly improved pain and disability in the short term and pain in the medium term for acute and subacute low-back pain, there is currently no evidence to support or refute that combined chiropractic interventions provide a clinically meaningful advantage over other treatments for pain or disability in people with low-back pain. Any demonstrated differences were small and were only seen in studies with a high risk of bias. Future research is very likely to change the results and our confidence in them. Well conducted randomised trials are required that compare combined chiropractic interventions to other established therapies for low-back pain.