GEM/cochrane-simplification huggingface dataset:
Abstract: Five RCTs with a total of 292 babies, were included in the review. Comparisons made within the RCTs were squeezable versus rigid feeding bottles (two studies), breastfeeding versus spoon-feeding (one study) and maxillary plate versus no plate (two studies). No statistically significant differences were shown for any of the primary outcomes when comparing bottle types, although squeezable bottles were less likely to require modification. No difference was shown for infants fitted with a maxillary plate compared to no plate. However, there was some evidence of an effect on weight at 6 weeks post-surgery in favour of breastfeeding when compared to spoon-feeding (mean difference 0.47; 95% confidence interval 0.20 to 0.74). Squeezable bottles appear easier to use than rigid feeding bottles for babies born with clefts of the lip and/or palate, however, there is no evidence of a difference in growth outcomes between the bottle types. There is weak evidence that breastfeeding is better than spoon-feeding following surgery for cleft. There was no evidence to suggest that maxillary plates assist growth in babies with clefts of the palate. No evidence was found to assess the use of any types of maternal advice and/or support for these babies.

Plain-language summary: Maternal advice and support on feeding techniques and breastfeeding positions are often provided, but no studies evaluated the effectiveness of this intervention. Squeezable rather than rigid bottles may be easier to use for feeding babies with cleft lip and/or palate, and breastfeeding may have growth advantages over spoon-feeding following cleft lip surgery. Only five studies (including 292 babies) compared the effects of feeding interventions in babies with cleft lip and/or palate on growth, development or parental satisfaction. Evidence for breastfeeding rather than spoon-feeding following surgery was weak and there was a suggestion that squeezable bottles may be more manageable than rigid ones. No evidence was found to support the use of maxillary plates in babies with unilateral clefts and no studies assessed the effects of maternal advice or support. Further research is required to assess the most effective feeding interventions to prevent developmental delays in infants with cleft lip and/or palate.
Abstract: Of 2313 participants without prior cerebral ischemia from five randomized trials, the mean age was 69 years. Participant features and study quality were similar between trials: the OAC in all five trials was warfarin. About half of participants (N = 1154) were randomized to adjusted-dose warfarin with mean achieved INRs ranging between 2.0 to 2.6. During 1.5 years mean follow up, warfarin was associated with large, highly statistically significant reductions in all strokes (odds ratio (OR) 0.39, 95% confidence interval (CI) 0.26 to 0.59), ischemic stroke (OR 0.34, 95% CI 0.23 to 0.52), all disabling or fatal stroke (OR 0.47, 95% CI 0.28 to 0.80), death (OR 0.69, 95% CI 0.50 to 0.94) and the combined endpoint of all stroke, myocardial infarction or vascular death (OR 0.56, 95% CI 0.42 to 0.76). The observed rates of intracranial and extracranial hemorrhage were not significantly increased by OAC therapy, but the confidence intervals were wide. Treatment with adjusted-dose warfarin to achieved INRs of 2 to 3 reduces stroke, disabling or fatal stroke, and death for patients with non-valvular AF. The benefits were not substantially offset by increased bleeding among these participants in randomized clinical trials. Limitations include relatively short follow up and imprecise estimates of bleeding risks from the selected participants enrolled in the trials. For primary prevention of stroke in AF patients, about 25 strokes and about 12 disabling or fatal strokes would be prevented yearly for every 1000 atrial fibrillation patients given OACs.

Plain-language summary: Oral anticoagulants prevent stroke and death in people with atrial fibrillation. Atrial fibrillation is an irregularity of the heartbeat that leads to blood clots forming in the upper chambers of the heart (the atria). These clots can break free and travel through the blood stream to the brain and cause a stroke. Anticoagulant drugs, such as warfarin, slow blood clotting. The degree of inhibition of blood clotting during warfarin treatment is measured by a blood test called the international normalized ratio (INR). Dosages of warfarin that lead to INRs of 2.0 to 2.6 reduce death and stroke when given to patients with atrial fibrillation. Oral anticoagulants can cause bleeding into the brain and elsewhere. However, provided that there is careful control of dosage (requiring INR measurements at least monthly with warfarin), the risk of serious bleeding is low. The decision about whether or not to use oral anticoagulants in patients with atrial fibrillation is guided by a number of factors, including the individual's risk of stroke, which varies widely among patients with atrial fibrillation. Most people with atrial fibrillation should be considered for treatment with oral anticoagulants based on their risk of stroke, ability to tolerate anticoagulation without bleeding, and access to adequate anticoagulation monitoring.
Abstract: We identified one new study for this update, resulting in six trials (561 patients) meeting the inclusion criteria. Five of the six trials reported on the main outcome, migraine frequency. Although five of the trials were generally of good methodological quality, all studies were either of unclear or high risk of bias with regards to sample size. Pooled analysis of the results was not possible due to the lack of common outcome measures and heterogeneity between studies in terms of participants, interventions and designs. The most recent trial added to this version of the review is rigorous and larger (n = 218), using a stable feverfew extract at a dose determined by a previous dose-finding trial. It reports that feverfew reduced migraine frequency by 1.9 attacks from 4.8 to 2.9 and placebo by 1.3 from to 4.8 to 3.5 per month, resulting in a difference in effect between feverfew and placebo of 0.6 attacks per month. For the secondary outcome measures intensity and duration of migraine attacks, incidence and severity of nausea and vomiting, and global assessment no statistically significant differences were reported. Results of previous trials are not convincing: three trials reporting positive effects of feverfew are all of small sample size (17 to 60 participants), while two rigorous trials (n = 50, 147) did not find significant differences between feverfew and placebo. Only mild and transient adverse events, most commonly gastrointestinal complaints and mouth ulcers, were reported in the included trials. Since the last version of this review, one larger rigorous study has been included, reporting a difference in effect between feverfew and placebo of 0.6 attacks per month. This adds some positive evidence to the mixed and inconclusive findings of the previous review. However, this constitutes low quality evidence, which needs to be confirmed in larger rigorous trials with stable feverfew extracts and clearly defined migraine populations before firm conclusions can be drawn. It appears from the data reviewed that feverfew is not associated with any major safety concerns.

Plain-language summary: For this update of a previous Cochrane review, we reviewed the available evidence up to January 2015 for or against feverfew in the prevention of migraine and found six studies including 561 participants. Generally the studies were heterogeneous and their results were mixed. The previous version of this review showed no clear benefit of feverfew compared with placebo. We added a new study, which is larger and was carried out to high standards, to this review. It showed that feverfew reduced migraine frequency by a little more than half a migraine (0.6) per month compared to placebo. There was no difference in how severe the pain was, or how long it lasted. These results come from a single study of moderate size, therefore they must be viewed with caution until they are confirmed in other rigorous studies. No major adverse effects were associated with feverfew in the included studies.
Abstract: We included sixteen controlled trials involving 2318 adult participants. The studies measured diverse outcomes. Many of the participants found recordings or summaries of their consultations valuable, with between 60% and 100% of participants (across twelve studies) reading the summary or listening to the recording at least once. The recordings were used to help inform family and friends (range 41.5% to 94.4% of participants in nine studies). Five out of nine studies reported better recall of information for those receiving recordings or summaries. Three out of ten studies found that participants provided with a recording or summary were more satisfied. No studies (out of ten) found any statistically significant difference between groups in terms of anxiety or depression. Three studies evaluated the effects on quality of life, but found no main effects. No study evaluated the intervention's effects on survival. The provision of recordings or summaries of key consultations may benefit most adults with cancer. Although more research is needed to improve our understanding of these interventions, most patients find them very useful. Practitioners should consider offering people recordings or written summaries of their consultations

Plain-language summary: The review of trials examined the effects of giving people with cancer audio recordings or written summaries of consultations. Most people found them useful as a personal reminder, to inform their families or friends, or to play to their general practitioners. People tended to remember more of the information they were given, and some were more satisfied with the information they received. Recordings or summaries did not make people more anxious or depressed. The recordings had no effects on quality of life, and no studies measured survival.
Abstract: A total of 16 randomised controlled trials (n=2277) were included in the meta-analysis.Despite the size of this sample, the pooled 95% confidence intervals were rather wide and there were no statistically significant differences in efficacy, acceptability and tolerability when comparing milnacipran with other antidepressive agents. However, compared with TCAs, patients taking milnacipran were associated with fewer dropouts due to adverse events (OR 0.55; 95%CI 0.35 to 0.85). There was also some weak evidence to suggest that patients taking milnacipran experienced fewer adverse events of sleepiness/ drowsiness, dry mouth or constipation compared with TCAs. Currently, there is inadequate evidence to conclude whether milnacipran is superior, inferior or the same as other antidepressive agents in terms of efficacy, acceptability and tolerability in the acute phase treatment of major depression. However, there is some evidence in favour of milnacipran over TCAs in terms of dropouts due to adverse events (acceptability) and the rates of experiencing adverse events (tolerability). Information about other clinically meaningful outcomes such as cost-effectiveness and social functioning, including the ability to return to work, is lacking. Further study is needed to answer whether milnacipran would be the better choice of antidepressant for acute major depression.

Plain-language summary: Major depression, also known as major depressive disorder or unipolar depression, is a common mental disorder characterised by a combination of symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy pleasurable activities. An episode of major depression may occur only once in a person's lifetime, but more often, it recurs throughout a person's life. Antidepressant drugs are frequently used as first-line treatment for major depression in primary and secondary care settings. Milnacipran, a dual serotonin-norepinephrine reuptake inhibitor, is one of the antidepressant drugs that clinicians use for routine depression care in some countries. This systematic review investigated the efficacy, acceptability and tolerability of milnacipran compared to that of other antidepressive agents in the acute phase treatment of major depression. A total of 16 randomised controlled trials (2277 participants) were included in this review. When we brought together the results of approximately 2000 patients, we were unable to say whether milnacipran is better, worse or the same when compared to other antidepressive agents used in practice in terms of efficacy, acceptability and tolerability. However, there is some evidence that fewer people taking milnacipran stop taking the drug ('drop out') due to side effects and fewer people taking milnacipran experience side effects such as sleepiness, dry mouth or constipation than do people who take tricyclic antidepressants.
Abstract: Two randomized controlled trials (331 participants) met the inclusion criteria. They were conducted in the 1970s and 1980s with follow-up reports available after 18 months, three years, and five years; one trial also reported 10 years follow up. Completeness of follow up varied at the different time points, with less than 80% of participants available for analysis at several time points. There was no statistically significant difference for any of the outcome measures: kyphosis angle, neurological deficit (none went on to develop this), bony fusion, absence of spinal tuberculosis, death from any cause, activity level regained, change of allocated treatment, or bone loss. Neither trial reported on pain. Of the 130 participants allocated to chemotherapy only, 12 had a neurological deficit and five needed a decompression operation. One trial suggested that an initial kyphosis angle greater than 30° is likely to deteriorate, especially in children. The two included trials had too few participants to be able to say whether routine surgery might help. Although current medication and operative techniques are now far more advanced, these results indicate that routine surgery cannot be recommended unless within the context of a large, well-conducted randomized controlled trial. Clinicians may judge that surgery may be clinically indicated in some groups of patients. Future studies need to address these topics as well as the patient's view of their disease and treatment.

Plain-language summary: This review of trials found there were insufficient numbers of participants in the two trials located (331 participants) to be able to say if routine surgery early on was of overall benefit. Further trials are needed and such trials should assess the pain that people suffer and their views of the disease and treatment.
Abstract: Twenty-four studies were identified that involved acupuncture for endometriosis; however only one trial, enrolling 67 participants, met all the inclusion criteria. The single included trial defined pain scores and cure rates according to the Guideline for Clinical Research on New Chinese Medicine. Dysmenorrhoea scores were lower in the acupuncture group (mean difference -4.81 points, 95% confidence interval -6.25 to -3.37, P < 0.00001) using the 15-point Guideline for Clinical Research on New Chinese Medicine for Treatment of Pelvic Endometriosis scale. The total effective rate ('cured', 'significantly effective' or 'effective') for auricular acupuncture and Chinese herbal medicine was 91.9% and 60%, respectively (risk ratio 3.04, 95% confidence interval 1.65 to 5.62, P = 0.0004). The improvement rate did not differ significantly between auricular acupuncture and Chinese herbal medicine for cases of mild to moderate dysmenorrhoea, whereas auricular acupuncture did significantly reduce pain in cases of severe dysmenorrhoea. Data were not available for secondary outcomes measures. The evidence to support the effectiveness of acupuncture for pain in endometriosis is limited, based on the results of only a single study that was included in this review. This review highlights the necessity for developing future studies that are well-designed, double-blinded, randomised controlled trials that assess various types of acupuncture in comparison to conventional therapies.

Plain-language summary: This review examined the effectiveness of acupuncture for reducing pain in endometriosis; however only one study met our inclusion criteria. The data from the included study, involving 67 women, indicated that ear acupuncture is more effective compared to Chinese herbal medicine for reducing menstrual pain. The study did not report whether participants suffered any side effects from their treatments. Larger, well-designed studies comparing acupuncture with conventional therapies are necessary to confirm these results.
Abstract: The review contains four studies with a total of 149 participants. Two studies compared NPWT with dressings; one study compared NPWT with a series of gel treatments and one study compared NPWT with 'moist wound healing'. One study had a 24-week follow-up period, and two had a six-week follow-up period, the follow-up time was unclear for one study. Three of the four included studies were deemed to be at a high risk of bias from one or more 'Risk of bias' domains and all evidence was deemed to be of very low quality. Only one study reported usable primary outcome data (complete wound healing), but this had only 12 participants and there were very few events (only one participant healed in the study). There was little other useful data available from the included studies on positive outcomes such as wound healing or negative outcomes such as adverse events. There is currently no rigorous RCT evidence available regarding the effects of NPWT compared with alternatives for the treatment of pressure ulcers. High uncertainty remains about the potential benefits or harms, or both, of using this treatment for pressure ulcer management.

Plain-language summary: We searched the medical literature up to May 2015 for robust medical studies (randomised controlled studies) that compared NPWT with other treatments for pressure ulcers. We identified four studies involving a total of 149 participants. Two studies compared NPWT with dressings, one compared NPWT with a series of topical treatments and one study compared it with what was described only as 'moist wound healing'. The trials were small, and poorly described, of fairly short or unclear duration, and contained little in the way of useful data. As a result of the limited amount of research evidence available, we were not able to draw any conclusions regarding the potential value (or harm) of NPWT as a treatment for pressure ulcers. More, better quality research is needed if this is an important and relevant question for decision makers. This plain language summary is up-to-date as of May 2015.
Abstract: A total of three studies involving 466 participants were included. There was no statistically significant difference between the asthma clinic group and the control group for most outcomes (primary outcomes: asthma exacerbations leading to hospitalisation or accident and emergency (A&E) visit, use of reliever and preventer medication, quality of life; secondary outcomes: symptoms, time lost from work and withdrawals from the intervention or usual care). However, the confidence intervals were wide for all outcomes and there was substantial heterogeneity between the studies for both A&E visits and time lost from work. One study (101 patients) looked at nocturnal awakenings due to asthma and found a statistically significant reduction in the number of patients reporting this symptom in the asthma clinic group compared to the usual care group (OR 0.31; 95% CI 0.12 to 0.77). There were no studies looking at the secondary outcome of exacerbations requiring oral steroids. There is limited evidence of efficacy for primary care based asthma clinics, and firm conclusions cannot be formed until more good quality trials have been carried out.

Plain-language summary: This review aimed to explore this question and included three studies with a total of 466 participants. These studies did not find any overall difference between asthma clinic and usual clinical practice care by a general practitioner for the following outcomes: A&E department visits for asthma, use of reliever or preventer medication for asthma and quality of life measures, but there was considerable uncertainty about these results. One study found that there was a reduction in nocturnal awakening due to asthma in the asthma clinic group compared to control but no difference in other symptom outcomes reported. Given the limited evidence found in this review, we believe that there is a need for further evidence in order to assess the effectiveness of asthma clinics.
Abstract: One randomised controlled trial has compared pramipexole with bromocriptine using a double-blind, parallel group, multicentre design. It was not powered to examine differences between active treatment arms. There was a larger reduction in off time with pramipexole therapy compared with bromocriptine (weighted mean difference 1.4 hours; 0, 2.8, 95% CI). No differences occurred in dyskinesia rating scale, dyskinesia as an adverse event or UPDRS complication score. The UPDRS ADL and motor scores showed similar improvements compared to placebo with both agonists. Levodopa dose reduction was similar with both agonists. Subscales of the Functional Status Questionnaire showed significant improvements compared to placebo with both agonists. The finding that the EuroQol improved significantly compared with placebo with pramipexole but not bromocriptine should be treated with caution. Dopaminergic adverse events were similar with each agonist, as was the all cause withdrawal rate. Although pramipexole and bromocriptine improved off time and reduced parkinsonian motor impairments and disability compared with placebo, no conclusions regarding their comparative effectiveness and safety can be drawn as this single trial did not have adequate power to assess such differences. Further larger trials are required to examine this issue in the future.

Plain-language summary: One trial compared pramipexole with bromocriptine but this was not designed to examine differences between the two treatments as there were too few patients included. However, there was a larger reduction in the time patients spent in the immobile off state with pramipexole therapy compared with bromocriptine by an average of 1.4 hours. No differences occurred in dyskinesia rating scale, dyskinesia as a side effect or Unified Parkinson's Disease Rating Scale (UPDRS) complication score. The UPDRS activities of daily living and motor scores showed similar improvements compared to placebo with both agonists. Levodopa dose reduction was similar with both agonists. Subscales of a quality of life measure, the Functional Status Questionnaire, showed significant improvements compared to placebo with both agonists. The finding that another quality of life scale, the EuroQol, improved significantly compared with placebo with pramipexole but not bromocriptine should be treated with caution. Side effects such as nausea, vomiting, and faintness were similar with each agonist, as was the withdrawal from treatment rate. No conclusions regarding the comparative effectiveness and safety of pramipexole versus bromocriptine can be drawn as this single trial did not have adequate numbers of patients to assess such differences. Further larger trials are required to examine this issue in the future.