GEM/cochrane-simplification huggingface dataset:
Abstract: We included five trials (435 participants randomised) and one ongoing trial. One study is awaiting classification. All trials examined the provision of nuts to increase consumption rather than dietary advice. None of the included trials reported on the primary outcomes, CVD clinical events, but trials were small and short term. All five trials reported on CVD risk factors. Four of these trials provided data in a useable format for meta-analyses, but heterogeneity precluded meta-analysis for most of the analyses. Overall trials were judged to be at unclear risk of bias. There were variable and inconsistent effects of nut consumption on CVD risk factors (lipid levels and blood pressure). Three trials monitored adverse events. One trial reported an allergic reaction to nuts and three trials reported no significant weight gain with increased nut consumption. None of the included trials reported on other secondary outcomes, occurrence of type 2 diabetes as a major risk factor for CVD, health-related quality of life and costs. Currently there is a lack of evidence for the effects of nut consumption on CVD clinical events in primary prevention and very limited evidence for the effects on CVD risk factors. No conclusions can be drawn and further high quality longer term and adequately powered trials are needed to answer the review question.

Plain-language summary: This review includes randomised controlled trials, which lasted at least 12 weeks. Participants were between 37 to 54 years old on average. The evidence is current up to 30 July 2015. We included five trials (435 participants), one of which had two treatment arms. All five trials investigated the effects of eating nuts. No studies were found which investigated the effect of giving advice to eat more nuts. None of the studies reported on deaths or cardiovascular events. None of the results show a clear effect on total cholesterol levels and blood pressure. One study reported one case of an allergic reaction to nuts. Three studies reported no significant weight gain with increased nut consumption. No other adverse events were reported. All included trials are small, with 60 to 100 participants, and have a high level of variation (heterogeneity). Therefore the results should be interpreted with caution. Overall we regarded the included trials as being at unclear risk of bias.
Abstract: Our search strategy identified 18 reports of 14 studies for consideration. The original review included five studies (484 women) which met the inclusion criteria, with a further five studies included in the updated review, involving an additional 655 women. The overall quality of the included trials was considered fair to good. Nine studies compared heparin (alone or in combination with dipyridamole or low-dose aspirin) with no treatment; and one compared trapidil (triazolopyrimidine). While this review identified the use of heparin to be associated with a statistically significant reduction in risk of perinatal mortality (six studies; 653 women; risk ratio (RR) 0.40; 95% confidence intervals (CI) 0.20 to 0.78), preterm birth before 34 (three studies; 494 women; RR 0.46; 95% CI 0.29 to 0.73) and 37 (five studies; 621 women; RR 0.72; 95% CI 0.58 to 0.90) weeks' gestation, and infant birthweight below the 10th centile for gestational age (seven studies; 710 infants; RR 0.41; 95% CI 0.27 to 0.61), there is a lack of reliable information available related to clinically relevant, serious adverse infant health outcomes, which have not been reported to date. While treatment with heparin for women considered to be at particularly high risk of adverse pregnancy complications secondary to placental insufficiency was associated with a statistically significant reduction in risk of perinatal mortality, preterm birth before 34 and 37 weeks' gestation, and infant birthweight below the 10th centile for gestational age when compared with no treatment for women considered at increased risk of placental dysfunction, to date, important information about serious adverse infant and long-term childhood outcomes is unavailable.

Plain-language summary: Ten randomised trials involving 1139 women met the inclusion criteria for the review. Nine studies compared heparin (alone or in combination with dipyridamole) with no treatment; and one compared triazolopyrimidine with placebo. The most commonly recognised side effect for women related to this treatment was mild skin bruising. To date, important information about serious adverse infant and long-term childhood outcomes with using anti-clotting medications is unavailable. Further research is required.
Abstract: We identified two randomised trials with 125 patients undergoing pancreatico-duodenectomy; 62 patients underwent ERCP with biliary stenting and 63 had ERCP without biliary stenting prior to surgery. Pre-surgical mortality was not significantly affected by stenting (OR 3.14, 95% CI 0.12 to 79.26), while there were significantly more complications in the stented group (OR 43.75, 95% CI 2.51 to 761.8). Stenting had no significant effect on the post-surgical mortality (OR 0.75, 95% CI 0.25 to 2.24). However, post-surgical complications were significantly less in the stented group (OR 0.45, 95% CI 0.22 to 0.91). Overall mortality (OR 0.81, 95% CI 0.17 to 3.89) and complications (OR 0.50, 95% CI 0.01 to 23.68) were not significantly different in the two groups. We could not find convincing evidence to support or refute endoscopic biliary stenting on the mortality in patients with pancreatico-biliary malignancy. Large randomised trials are needed to settle the question of pre-surgical biliary stenting.

Plain-language summary: Studies have claimed the beneficial role of biliary decompression, which can be performed via endoscopic retrograde cholangiopancreaticography (ERCP) with stent insertion pre-surgically. The review found that pre-surgical biliary stenting via ERCP did not improve the morbidity and mortality in patients with pancreatico-biliary malignancy. Further evidence about its efficiency is needed.
Abstract: Thirty-five studies (9365 participants) compared subcutaneous sumatriptan with placebo or an active comparator. Most of the data were for the 6 mg dose. Sumatriptan surpassed placebo for all efficacy outcomes. For sumatriptan 6 mg versus placebo the NNTs were 2.9, 2.3, 2.2, and 2.1 for pain-free at one and two hours, and headache relief at one and two hours, respectively, and 6.1 for sustained pain-free at 24 hours. Results for the 4 mg and 8 mg doses were similar to the 6 mg dose, with 6 mg significantly better than 4 mg only for pain-free at one hour, and 8 mg significantly better than 6 mg only for headache relief at one hour. There was no evidence of increased migraine relief if a second dose of sumatriptan 6 mg was given after an inadequate response to the first. Relief of headache-associated symptoms, including nausea, photophobia, and phonophobia, was greater with sumatriptan than with placebo, and use of rescue medication was lower with sumatriptan than placebo. For the most part, adverse events were transient and mild and were more common with sumatriptan than placebo. Sumatriptan was compared directly with a number of active treatments, including other triptans, acetylsalicylic acid plus metoclopramide, and dihydroergotamine, but there were insufficient data for any pooled analyses. Subcutaneous sumatriptan is effective as an abortive treatment for acute migraine attacks, quickly relieving pain, nausea, photophobia, phonophobia, and functional disability, but is associated with increased adverse events.

Plain-language summary: This review found that a single subcutaneous dose was effective in relieving migraine headache pain and associated symptoms of nausea, sensitivity to light, and sensitivity to sound. Pain was reduced from moderate or severe to no pain by two hours in almost 6 in 10 people (59%) taking sumatriptan 6 mg, compared with about 1 in 7 (15%) taking placebo, and reduced from moderate or severe to no worse than mild pain by two hours in almost 8 in 10 people (79%) taking sumatriptan compared with about 3 in 10 (31%) taking placebo. Subcutaneous sumatriptan was fast-acting, and the majority of people experiencing pain relief had done so by one hour. About 3 in 10 (31%) people had freedom from pain at two hours which was sustained during the 24 hours postdose without the use of rescue medication, compared with about 1 in 7 (15%) with placebo. In addition to relieving headache pain, sumatriptan also relieved symptoms of nausea and sensitivity to light and sound by two hours in about half of those who took it, compared with about one-third of those taking placebo. Adverse events, most of which were of short duration and mild or moderate in severity, were more frequent with sumatriptan than with placebo.
Abstract: Nine trials met the inclusion criteria, including 221 patients randomized to calcitonin and 220 to placebo. The median methodologic quality was two out of a maximum of five points. Calcitonin was more effective than placebo at preserving bone mass at the lumbar spine after six and 12 months of therapy with a WMD of 2.8% (95% CI: 1.4 to 4.3) and 3.2% (95% CI: 0.3 to 6.1). At 24 months, lumbar spine BMD was not statistically different between groups: WMD 4.5% (95% CI: -0.6 to 9.5)]. Bone density at the distal radius was also higher with calcitonin after six months of therapy, but bone density at the femoral neck was not different between placebo and calcitonin treated groups. The relative risk of fractures was not significantly different between calcitonin and placebo with a relative risk (RR) of 0.71 (95% CI: 0.26 to 1.89) for vertebral and 0.52 (95% CI: 0.14 to 1.96) for non vertebral fractures. The subgroup analyses of methodological quality and duration of corticosteroid therapy were confounded. Trials of patients who had been taking steroids for greater than three months (which were of low methodologic quality) demonstrated a larger effect of calcitonin on spine bone density (about 6%) than prevention trials (about 1%). There was no consistent effect of different dosages (50-100 IU compared to 200-400 IU). However, subcutaneous calcitonin showed substantially greater prevention of bone loss. Withdrawals due to side effects were higher in the calcitonin-treated groups: RR 3.19 (95%CI: 0.66 to 15.47). Important side effects included nausea and facial flushing. Calcitonin appears to preserve bone mass in the first year of glucocorticoid therapy at the lumbar spine by about 3% compared to placebo, but not at the femoral neck. Our analysis suggests that the protective effect on bone mass may be greater for the treatment of patients who have been taking corticosteroids for more than three months. Efficacy of calcitonin for fracture prevention in steroid-induced osteoporosis remains to be established.

Plain-language summary: The purpose of this review was to evaluate calcitonin as a means of preventing bone loss with corticosteroid therapy. Nine randomized controlled trials were included in the review, with 221 patients randomized to calcitonin and 220 to placebo. The results showed that calcitonin prevents bone loss at the spine and forearm by about 3% after the first year of therapy. There was no effect on bone loss at the hip. Calcitonin was not statistically different from placebo at preventing fractures of the spine and long bones, such as hip fractures. Calcitonin was associated with four times the side effects of placebo, and these were mostly nausea and facial flushing.
Abstract: Forty-one studies consisting of 1806 participants were included in the analyses. The studies involved children and adolescents with anxiety of mild to moderate severity in university and community clinics and school settings. For the primary outcome of remission of any anxiety diagnosis for CBT versus waiting list controls, intention-to-treat (ITT) analyses with 26 studies and 1350 participants showed an OR of 7.85 (95% CI 5.31 to 11.60, Z = 10.34, P < 0.0001), but with evidence of moderate heterogeneity (P = 0.05, I² = 30%). The number needed to treat (NNT) was 3.0 (95% CI 1.75 to 3.03). No difference in outcome was noted between individual, group and family/parental formats. ITT analyses revealed that CBT was no more effective than non-CBT active control treatments (six studies, 426 participants) or TAU in reducing anxiety diagnoses (two studies, 88 participants). The few controlled follow-up studies (n = 4) indicate that treatment gains in the remission of anxiety diagnosis are not statistically significant. Cognitive behavioural therapy is an effective treatment for childhood and adolescent anxiety disorders; however, the evidence suggesting that CBT is more effective than active controls or TAU or medication at follow-up, is limited and inconclusive.

Plain-language summary: CBT is significantly more effective than no therapy in reducing symptoms of anxiety in children and young people. No clear evidence indicates that one way of providing CBT is more effective than another (e.g. in a group, individually, with parents). CBT is no more effective than other 'active therapies' such as self-help books. The small number of studies meant the review authors could not compare CBT with medication. Only four studies looked at longer-term outcomes after CBT. No clear evidence showed maintained improvement in symptoms of anxiety among children and young people. The review authors recommend that future research should look in greater detail at what makes CBT work best for children and young people, how CBT can be provided in the most cost-effective way, and how CBT can be adapted for different age groups.
Abstract: CMHT management did not reveal any statistically significant difference in death by suicide and in suspicious circumstances (n=587, 3 RCTs, RR 0.49 CI 0.1 to 2.2) although overall, fewer deaths occurred in the CMHT group. We found no significant differences in the number of people leaving the studies early (n=253, 2 RCTs, RR 1.10 CI 0.7 to 1.8). Significantly fewer people in the CMHT group were not satisfied with services compared with those receiving standard care (n=87, RR 0.37 CI 0.2 to 0.8, NNT 4 CI 3 to 11). Also, hospital admission rates were significantly lower in the CMHT group (n=587, 3 RCTs, RR 0.81 CI 0.7 to 1.0, NNT 17 CI 10 to 104) compared with standard care. Admittance to accident and emergency services, contact with primary care, and contact with social services did not reveal any statistical difference between comparison groups. Community mental health team management is not inferior to non-team standard care in any important respects and is superior in promoting greater acceptance of treatment. It may also be superior in reducing hospital admission and avoiding death by suicide. The evidence for CMHT based care is insubstantial considering the massive impact the drive toward community care has on patients, carers, clinicians and the community at large.

Plain-language summary: This review aims to compare CMHTs with inpatient care, hospital-based out-patient care or day hospital (standard care) for people living in the community with a serious mental health problem. Three randomised control trials were found that fulfilled these criteria.  They included a total of 587 people, took place in urban areas of the UK and lasted from three months to one year. In the two studies that recorded it, a total of 52 people from 253 left the study early, though there was no significant difference in numbers between CMHT and control. Deaths in each study were recorded (suicide, suspicious circumstances and physical ill-health), and although there were no significant differences between the two groups, those in the CMHT group were consistently lower than in standard care.  People in CMHTs were also significantly less likely to be admitted to hospital during the period of the study, and were less likely to use social services. However, there was no significant difference between the groups in the use of accident and emergency services, general hospital services and primary care (family doctors). One study looked at satisfaction with care and found those in CMHTs were more satisfied with their care than the standard care group. In the UK and other Western world countries, the move to CMHT has happened despite the limited evidence given above, therefore improving the evidence base is difficult.  This should be borne in mind when comparing CMHTs with more specialised services such as early intervention or crisis resolution.  (Plain language summary prepared for this review by Janey Antoniou of RETHINK, UK www.rethink.org)
Abstract: Fifty-two reports were identified in the original review as possible randomised trials which assessed dihydrocodeine in postoperative pain. Four reports met the inclusion criteria; all assessed oral dihydrocodeine. Three reports (194 participants) compared dihydrocodeine with placebo and one (120 participants) compared dihydrocodeine (30 mg or 60 mg) with ibuprofen 400 mg. For a single dose of dihydrocodeine 30 mg in moderate to severe postoperative pain the NNT for at least 50% pain relief was 8.1 (95% confidence interval 4.1 to 540) when compared with placebo over a period of four to six hours. Pooled data showed significantly more participants to have reported adverse effects with dihydrocodeine 30 mg than with placebo. When compared to ibuprofen 400 mg both dihydrocodeine 30 mg and 60 mg were significantly inferior. No additional studies were found for this update. A single 30 mg dose of dihydrocodeine is not sufficient to provide adequate pain relief in postoperative pain. Statistical superiority of ibuprofen 400 mg over dihydrocodeine (30 mg or 60 mg) was shown. Since the last version of this review no new relevant studies have been identified.

Plain-language summary: This review assessed the efficacy of single-dose dihydrocodeine in adults with moderate/severe postoperative pain using information from randomised placebo controlled trials. There was a lack of data that could be included in the analyses; all assessed the oral form of the drug and none assessed dihydrocodeine 60 mg. The results were not robust. The implication was that single-dose oral dihydrocodeine 30 mg was more effective than placebo, but was inferior to ibuprofen 400 mg. Dizziness, drowsiness and confusion were commonly reported.
Abstract: We included one pharmacological (modafinil) study and three non-pharmacological studies (resistance exercise, respiratory exercise, and repetitive transcranial magnetic stimulation (rTMS)), involving a total of 86 participants with ALS/MND. None of the included studies were free from risk of bias. Since there was only one trial for each intervention, no meta-analysis was possible. All studies assessed fatigue using the Fatigue Severity Scale (FSS; scale from 9 to 63, higher scores indicate more fatigue). Information for assessing bias was often lacking in study reports, making the risk of bias unclear across several domains in all trials. Blinding of participants was not possible in exercise trials, but the outcome assessment was blinded. We found very low-quality evidence suggesting possible improvements in fatigue for modafinil treatment versus placebo (MD -11.00, 95% CI -23.08 to 1.08), respiratory exercise versus a sham intervention (MD -9.65, 95% CI -22.04 to 2.73), and rTMS versus sham rTMS (data not provided), which warrant further investigation to clarify the efficacy of these treatments for fatigue in ALS/MND. We found no clear improvements in fatigue for resistance exercise versus usual care (MD 0.20, 95% CI -10.98 to 11.38; very low-quality evidence). Three participants in the modafinil group dropped out of the modafinil study, two citing issues with headache and one with chest tightness; other adverse effects were anxiety, nausea, dizziness, and sialorrhoea (probably ALS-related). The trials reported no adverse effects of exercise or rTMS. We cannot be certain about the effects of any of the interventions studied because of imprecision (small numbers of participants, wide CI), and possible study limitations. It is impossible to draw firm conclusions about the effectiveness of interventions to improve fatigue for people with ALS/MND as there are few randomised studies, and the quality of available evidence is very low.

Plain-language summary: The review included four small studies with a total of 86 participants. Each study investigated a different treatment. These were a drug treatment (modafinil) compared to placebo, breathing exercises compared to sham (inactive) breathing exercises, exercises with weights compared to usual care, and magnetic brain stimulation compared to sham rTMS. We are very uncertain about the effects of modafinil, breathing exercises, exercises with weights, or magnetic brain stimulation on fatigue in people with ALS/MND, as the evidence was very low quality. It was often unclear whether studies were adequately designed and performed, as trial reports often lacked details. The results of these small studies were not precise. Three participants stopped taking modafinil because of side effects: headache in two, and chest tightness in one; participants also reported anxiety, nausea, dizziness, and sialorrhoea (inability to control oral secretions). We need more research on effective treatments for fatigue in ALS/MND. The searches are up to date to September 2017.
Abstract: Two studies were included, comprising 104 participants with dementia. The trials differed in design: one a parallel-group study of patients with Alzheimer's disease and another a cross-over study of patients with frontotemporal dementia with an-open label follow-up trial of three years. The results from this extension study have not been used in the analysis. It was not possible to pool the data. The studies were respectively of 16 and six weeks duration, using trazodone from 50 to 300 mg daily. Both trials examined global clinical state, behavioural disturbances and cognitive function. The parallel study also assessed activities of daily living and caregiver burden. Compared with placebo, the use of trazodone was not associated with statistically significant benefits for behavioural manifestations as measured by various rating scales. Analysis of changes from baseline for clinical impression of change and for cognitive function did not produce statistically significant results in favour of trazodone. A variety of adverse effects were recorded with no significant differences between trazodone and placebo. There is insufficient evidence to recommend the use of trazodone as a treatment for behavioural and psychological manifestations of dementia. In order to assess effectiveness and safety of trazodone, longer-term randomized controlled trials are needed, involving larger samples of participants with a wider variety of types and severities of dementia.

Plain-language summary: The conclusion is based on limited data from two small studies. The larger of the studies, conducted in 73 patients with Alzheimer's disease, showed no beneficial effect of trazodone at all. A smaller cross-over study in patients with frontal lobe dementia showed a trend for reduction in some symptoms in the first study period. Larger, longer studies are needed to explore the efficacy, effectiveness and safety of trazodone.