GEM/cochrane-simplification huggingface dataset:
Abstract: We identified one RCT that met the inclusion criteria for this review. The study enrolled only nine adults with MDS over a three-year study duration period. The trial was terminated due to poor recruitment rate (planned recruitment 60 participants over two years). Assessment of the risk of bias was not possible for all domains. The trial was a single-centre, single-blind trial. The clinical and demographic characteristics of the participants were never disclosed. The trial outcomes relevant to this review were bleeding assessments, mortality, quality of life, and length of hospital stay, but no data were available to report on any of these outcomes. We identified no completed non-RCTs or CBAs. We identified no ongoing RCTs, non-RCTs, or CBAs. We found no evidence to determine the safety and efficacy of therapeutic platelet transfusion compared with prophylactic platelet transfusion for people with long-term bone marrow failure disorders. This review underscores the urgency of prioritising research in this area. People with bone marrow failure depend on long-term platelet transfusion support, but the only trial that assessed a therapeutic strategy was halted. There is a need for good-quality studies comparing a therapeutic platelet transfusion strategy with a prophylactic platelet transfusion strategy; such trials should include outcomes that are important to patients, such as quality of life, length of hospital admission, and risk of bleeding.

Plain-language summary: We searched scientific databases for clinical studies (randomised controlled trials and well-designed non-randomised studies) of people of any age with bone marrow disorders and a low platelet count. The evidence is current to 12 October 2017. One study was eligible for inclusion in the review. This study was stopped after recruiting only nine participants because it had taken three years to recruit the nine participants (the study had planned to recruit 60 participants in two years). We found no ongoing studies. The only included study in this review did not report any outcomes. We found no evidence to help us decide whether giving platelet transfusions to treat bleeding is as good as giving platelet transfusions when the platelet count is below a prespecified level. There is an urgent need for good-quality studies to answer the questions of this review. We did not assess the quality of the evidence because no data were available from the one included study.
Abstract: Nine trials involving 117,272 individuals of age 35 years or older are included in this review. The trials were conducted in Australia, Finland, India, Italy, the United Kingdom and the United States, with duration of follow-up ranging from 2.1 to 12 years. The doses of antioxidant vitamins were higher than the recommended daily allowance. There was no evidence of effect of antioxidant vitamin supplementation in reducing the risk of cataract, cataract extraction, progression of cataract or in slowing the loss of visual acuity. In the pooled analyses, there was no evidence of effect of beta-carotene supplementation in reducing the risk of cataract (two trials) (relative risk (RR) 0.99, 95% confidence interval (CI) 0.91 to 1.08; n = 57,703) or in reducing the risk of cataract extraction (three trials) (RR 1.00, 95% CI 0.91 to 1.10; n = 86,836) or of vitamin E supplementation in reducing the risk of cataract (three trials) (RR 0.97, 95% CI 0.91 to 1.04; n = 50,059) or of cataract extraction (five trials) (RR 0.98, 95% CI 0.91 to 1.05; n = 83,956). The proportion of participants developing hypercarotenodermia (yellowing of skin) while on beta-carotene ranged from 7.4% to 15.8%. There is no evidence from RCTs that supplementation with antioxidant vitamins (beta-carotene, vitamin C or vitamin E) prevents or slows the progression of age-related cataract. We do not recommend any further studies to examine the role of antioxidant vitamins beta-carotene, vitamin C and vitamin E in preventing or slowing the progression of age-related cataract. Costs and adverse effects should be weighed carefully with unproven benefits before recommending their intake above recommended daily allowances.

Plain-language summary: The review authors searched for randomized controlled trials in which supplementation with the antioxidant vitamins beta-carotene (provitamin A), vitamin C and vitamin E was compared to inactive placebo or no supplement. Nine trials involving 117,272 adults of age 35 years or older were included in this review. The trials were conducted in Australia, Finland, India, Italy, the United Kingdom and the United States and were of high methodological quality. The doses of antioxidants given in each trial were higher than the recommended daily allowances. The trials provided no evidence of effect of the antioxidant vitamins beta-carotene, vitamin E and vitamin C given alone or in combination on the incidence of cataract, its extraction or progression and on the loss of visual acuity. Some participants (7% to 16%) on beta-carotene developed yellowing of the skin (hypercarotenodermia).
Abstract: We included two trials with 26,340 participants aged 40 to 82 years of whom 11,610 were aged 70 or older. All participants had a history of, or risk factors for, vascular disease. The studies used different statins (simvastatin and pravastatin). Mean follow-up was 3.2 years in one study and five years in one study. The risk of bias was low. Only one study reported on the incidence of dementia (20,536 participants, 31 cases in each group; odds ratio (OR) 1.00, 95% confidence interval (CI) 0.61 to 1.65, moderate quality evidence, downgraded due to imprecision). Both studies assessed cognitive function, but at different times using different scales, so we judged the results unsuitable for a meta-analysis. There were no differences between statin and placebo groups on five different cognitive tests (high quality evidence). Rates of treatment discontinuation due to non-fatal adverse events were less than 5% in both studies and there was no difference between statin and placebo groups in the risk of withdrawal due to adverse events (26,340 participants, 2 studies, OR 0.94, 95% CI 0.83 to 1.05). There is good evidence that statins given in late life to people at risk of vascular disease do not prevent cognitive decline or dementia. Biologically, it seems feasible that statins could prevent dementia due to their role in cholesterol reduction and initial evidence from observational studies was very promising. However, indication bias may have been a factor in these studies and the evidence from subsequent RCTs has been negative. There were limitations in the included studies involving the cognitive assessments used and the inclusion of participants at moderate to high vascular risk only.

Plain-language summary: We searched medical databases for clinical trials comparing giving a statin to giving a placebo (pretend medicine) to people with normal cognitive function (which is brain activities that allow us to gain and use knowledge) and of sufficient age to be at risk of Alzheimer's disease. We found two suitable randomised trials for inclusion in this review with 26,340 participants; neither showed any reduction in occurrence of Alzheimer's disease or dementia in people treated with statins compared to people given placebo. Side effects were low in both statin and placebo groups with no difference between groups in the risk of dropping out of the trial due to side effects. There were limitations in the included studies involving the methods of assessment of cognition and the inclusion only of participants deemed to be of moderate to high risk of a problem with their blood (vascular) system. Nevertheless, there was good evidence that statins given in late life to people at risk of vascular disease do not prevent cognitive decline or dementia.
Abstract: This review includes eight studies with a total of 250 participants comparing nebuliser versus pMDI plus spacer treatment. We identified no studies comparing DPI with nebulisers. We found two studies assessing the primary outcome of 'change in forced expiratory volume in one second (FEV1) one hour after dosing'. We could not pool these studies, but both showed a non-significant difference in favour of the nebuliser group, with similar frequencies of serious adverse events. For the secondary outcome, 'change in FEV1 closest to one hour after dosing': we found a significant difference of 83 ml (95% CI 10 to 156, P = 0.03) in favour of nebuliser treatment. For the secondary outcome of adverse events, we found a non-significant odds ratio of 1.65 (95% CI 0.42 to 6.48) in favour of the pMDI plus spacer group. There is a lack of evidence in favour of one mode of delivery over another for bronchodilators during exacerbations of COPD. We found no difference between nebulisers versus pMDI plus spacer regarding the primary outcomes of FEV1 at one hour and safety. For the secondary outcome 'change in FEV1 closest to one hour after dosing' during an exacerbation of COPD, we found a greater improvement in FEV1 when treating with nebulisers than with pMDI plus spacers. A limited amount of data are available (eight studies involving 250 participants). These studies were difficult to pool, of low quality and did not provide enough evidence to favour one mode of delivery over another. No data of sufficient quality have been published comparing nebulisers versus DPIs in this setting. More studies are required to assess the optimal mode of delivery during exacerbations of COPD.

Plain-language summary: We found eight studies including 250 participants in a search of the available studies up to 1 July 2016. All of the studies took place in a hospital. The primary outcomes of the review showed no difference between the inhaler with a spacer and the nebuliser. However, in our secondary outcomes, we found some evidence that nebuliser treatment improves lung function more than inhalers with a spacer, but the quality and quantity of the data is limited. We found no difference between the therapies in terms of side effects or for reducing breathlessness. There are no studies available testing dry powder inhalation against a nebuliser. Due to the low quality and quantity of the data, it is not clear whether nebulisers or inhalers with spacers are better for lung attacks. We found no difference between an inhaler with a spacer and the nebuliser in lung function after one hour or in unwanted side effects during lung attacks of COPD. The secondary outcome for lung function did favour nebulisers over inhalers with a spacer.
Abstract: Five studies met the inclusion criteria. The pooled estimates of MMSE cognitive and ADAS-cognitive change scores from three of these studies revealed non-significant cognitive effects for melatonin treatment. In two of these studies, significant improvements in psychopathological behaviours (e.g., decreased mood symptoms of depression, anxiety and apathy and decreased behavior symptoms of hallucinations, delusions, agitation, irritability, and appetite disturbances), were found from meta-analysis of the change scores from the NPI (7 weeks, 2.5 mg melatonin), and ADAS non-cognitive (4 weeks, 3 mg melatonin) scales. Sensitivity analyses found similar results to those of the original meta-analyses, and thus, supported the effect estimates for non-significant cognitive outcomes. Individual study estimates for treatment effect of 2.5 mg melatonin at one year demonstrated a significant worsening of mood (e.g. decrease in positive affect) as measured by the Philadelphia Geriatric Centre Affect Rating Scale (positive). The remainder of the treatment effects for mood, behavior, and function of daily living were non-significant. There were no reported adverse effects associated with melatonin use. The analyses did not support the use of melatonin for treatment of cognitive impairment associated with dementia. Meta-analysis of psychopathologic behavior scale scores suggested that melatonin may be effective in treating these dementia-related disturbances.

Plain-language summary: There are a number of studies that suggest a relationship between decline of melatonin function and the symptoms of dementia. Meta-analysis was conducted on data from three randomised, placebo controlled trials that were designed to evaluate melatonin for managing dementia-related cognitive changes; data also were pooled from two of these trials that evaluated melatonin for managing mood and behavioral disturbances. Significantly improved outcomes were found from the meta-analysis of psychopathologic behavior and mood scale scores. Melatonin treatment may be effective for the treatment of dementia-related psychopathologic behavior disturbances. No evidence was found to support the effectiveness of melatonin for the treatment of cognitive impairment.
Abstract: Nine studies (162 participants) are included in this review. No significant difference was noted between NCS and SCG with respect to the maximum percent decrease in FEV1 (WMD = -0.88; 95% CI: -4.50, 2.74), complete protection (i.e. maximum % fall FEV1 still =>10%); OR = 0.95; 95% CI: 0.50 to 1.8, clinical protection (i.e. < 50% improvement over placebo); OR = 0.71; 95% CI: 0.36 to 1.39; unpleasant taste (OR = 6.85; 95% CI: 0.77, 60.73), or sore throat (OR = 3.46; 95% CI: 0.32, 37.48). For these pooled comparisons, no statistically significant heterogeneity was identified. Subgroup analyses based on age, dosage of medications and timing of exercise post-inhalation were consistent with the overall pooled analyses. No significant differences were evident between the effect of NCS and SCG during the immediate post-exercise period in adults and children with EIB with regards to pulmonary function - specifically maximum percent decrease in FEV1, complete protection, clinical protection, or side effects.

Plain-language summary: The review of trials found that both were similarly effective in relieving exercise-induced asthma for both children and adults. More people have sore throats and an unpleasant after-taste after using nedocromil sodium.
Abstract: Three studies, involving a total of 354 participants, met our inclusion criteria for the primary outcome. Compared with intermittent monitoring, continuous monitoring significantly reduced death and disability at three months or discharge (odds ratio (OR) 0.27, 95% confidence interval (CI) 0.13 to 0.56) and was associated with a non-significant reduction in deaths from any cause at discharge (OR 0.72, 95% CI 0.28 to 1.85). These significant results depend on one study that has a high risk of bias. Continuous monitoring was associated with a non-significant reduction of dependency (OR 0.79, 95% CI 0.30 to 2.06), death from vascular causes (OR 0.48, 95% CI 0.10 to 2.39), neurological complications (OR 0.81, 95% CI 0.46 to 1.43), length of stay (mean difference (MD) -5.24, 95% CI -10.51 to 0.03) and institutionalisation (OR 0.83, 95% CI 0.04 to 15.72) (secondary outcomes). For the last two outcomes we detected consistent heterogeneity across trials. Cardiac complications (OR 8.65, 95% CI 2.52 to 29.66), fever (OR 2.17, 95% CI 1.22 to 3.84) and hypotension (OR 4.32, 95% CI 1.68 to 14.38) were detected significantly more often in participants who received continuous monitoring (surrogate outcomes). We detected no significant increase in adverse events due to immobility (pneumonia, other infections or deep vein thrombosis) in participants who were continuously monitored compared with those allocated to intermittent monitoring. Continuous monitoring of physiological variables for the first two to three days may improve outcomes and prevent complications. Attention to the changes in physiological variables is a key feature of a stroke unit, and can most likely be aided by continuous monitoring without complications related to immobility or to treatments triggered by the relief of abnormal physiological variables. Well-designed, high-quality studies are needed because many questions remain open and deserve further research. These include when to start continuous monitoring, when to interrupt it, which people should be given priority, and which treatments are most appropriate after the identification of abnormalities in physiological variables.

Plain-language summary: We searched for all trials that compared continuous monitoring with intermittent monitoring in people with acute stroke. We identified three studies including a total of 354 participants. Stroke unit care with continuous monitoring was associated with a significant reduction in the chance of being dead or disabled after the stroke. Unfortunately this evidence is not entirely reliable because of the small number of participants, differences in the definitions of abnormal results, and the less reliable methods used in the largest trial. Further research is required to answer many remaining questions, such as when to start continuous monitoring, when to interrupt it, which people should be given priority, and which treatments are most appropriate after the identification of abnormalities in physiological variables.
Abstract: Four high-quality RCTs (585 patients) met the selection criteria. Clinical heterogeneity prevented the use of meta-analysis. Therefore, a qualitative synthesis was completed. There was conflicting evidence about whether TENS was beneficial in reducing back pain intensity and consistent evidence in two trials (410 patients) that it did not improve back-specific functional status. There was moderate evidence that work status and the use of medical services did not change with treatment. Conflicting results were obtained from two studies regarding generic health status, with one study showing no improvement on the modified Sickness Impact Profile and another study showing significant improvements on several, but not all subsections of the SF-36 questionnaire. Multiple physical outcome measures lacked statistically significant improvement relative to placebo. In general, patients treated with acupuncture-like TENS responded similarly to those treated with conventional TENS. However, in two of the trials, an inadequate stimulation intensity was used for acupuncture-like TENS, given that muscle twitching was not induced. Optimal treatment schedules could not be reliably determined based on the available data. Adverse effects included minor skin irritation at the site of electrode placement. At this time, the evidence from the small number of placebo-controlled trials does not support the use of TENS in the routine management of chronic LBP. Further research is encouraged.

Plain-language summary: Four high-quality randomized controlled trials (RCTs; 585 patients) comparing TENS with placebo for chronic low-back pain were included in this study.  Due to conflicting evidence, it is unclear if TENS is beneficial in reducing back pain intensity.  However, there was consistent evidence in two trials (410 patients) that TENS did not improve the level of disability due to back pain. There was moderate evidence that use of medical services and work status (e.g. loss of work, sick days) did not change during treatment. Finally, there did not seem to be a difference between conventional and acupuncture-like TENS. Some adverse effects were reported, typically minor skin irritations observed equally in the treatment and placebo groups. However, there was one participant who developed a severe rash four days after the start of treatment. In summary, the review authors found conflicting evidence regarding the benefits of TENS for chronic LBP, which does not support the use of TENS in the routine management of chronic LBP.
Abstract: We identified two RCTs (N=89) eligible for inclusion. These RCTs addressed oral or sublingual immunotherapy, both in adults, with an allergy to apple or peach respectively. Both studies enrolled a small number of participants and used different methods to provide these differing types of immunotherapy. Both studies were judged to be at high risk of bias in at least one domain. Overall, the quality of evidence was judged to be very low due to the small number of studies and participants and possible bias. The studies were clinically heterogeneous and hence we did not pool the results. A study comparing SLIT with placebo for allergy to peach did not detect a significant difference between the number of patients desensitised at six months following a double-blind placebo-controlled food challenge (RR 1.16, 95% confidence interval (CI) 0.49 to 2.74). The second study, comparing OIT versus no treatment for apple allergy, found an effect on desensitisation in favour of the intervention using an oral provocation test at eight months, but results were imprecise (RR 17.50, 95% CI 1.13 to 270.19). Neither study reported data on evidence of immunologic tolerance. In both studies, the incidence of mild and moderate adverse events was higher in the intervention groups than in the controls. In the study comparing SLIT with placebo, patients in the intervention group experienced significantly more local adverse reactions than participants in the control group (RR 3.21, 95% CI 1.51 to 6.82), though there was not a significant difference in the number of participants experiencing systemic adverse reactions (RR 0.81, 95% CI 0.22 to 3.02). In the study of OIT, two of the 25 participants in the intervention group reported relevant side effects, whereas no participants in the control group reported relevant side effects. There is insufficient evidence for using OIT or SLIT to treat allergy to fruit, specifically related to peach and apple. Mild or moderate adverse reactions were reported more frequently in people receiving OIT or SLIT. However, these reactions could be treated successfully with medications.

Plain-language summary: We found two studies with 89 participants in total. One looked at oral immunotherapy in people with an allergy to apple, comparing it to no treatment, and one looked at sublingual immunotherapy in people with an allergy to peach, comparing it to a placebo. Both studies were in adults. The evidence is current to July 2015. The study of oral immunotherapy for apple allergy found participants who received the intervention were less sensitive to apple than people who did not receive the intervention at eight months. The study of sublingual immunotherapy for peach allergy did not find a difference between the groups in terms of sensitivity at six months. In both studies, there were more side effects in people receiving the treatment, but these were not serious. Overall, the quality of evidence is very low because both studies were small, results were not similar between studies, and there were issues with study design. More research is needed before we can tell if oral and sublingual therapy works for food allergy to fruits.