GEM/cochrane-simplification huggingface dataset:
Abstract: We included one randomised controlled trial involving 2782 participants. The study investigated the effects of mobile phone messaging in alleviating anxiety in women waiting for prenatal biochemical screening results for Down syndrome, by providing fast reporting of results before a follow-up appointment. The study measured health outcomes using the Spielberger State-Trait Anxiety Inventory (STAI), which includes a scale (20 to 80 points, higher score indicates higher anxiety) to describe how the respondent feels at a particular moment in time (state anxiety). The study, which was at high risk of bias, found that women who had received their test result early by text message had a mean anxiety score 2.48 points lower than women who had not yet received their result (95% CI - 8.79 to 3.84). Women with a serum-negative test result receiving their result early had a mean anxiety score 5.3 points lower (95% CI - 5.99 to -4.61) than women in the control group. Women with a serum-positive test result receiving their result early by text message had a mean anxiety score 1.2 points higher (95% CI - 3.48 to 5.88) than women in the control group.The evidence was of low quality due to high risk of bias in the included study, and the fact that the evidence comes from one study only. The study did not report on other outcomes of interest, such as patient satisfaction, adverse events or cost. We found very limited evidence of low quality that communicating results of medical investigations by mobile phone messaging may make little or no difference to women's anxiety overall or in women with positive test results, but may reduce anxiety in women with negative test results. However, with only one study included in this review, this evidence is insufficient to inform recommendations at this time. More research is needed on the effectiveness and user evaluation of these interventions. In particular, more research should be conducted into the potential risks and limitations of these interventions.

Plain-language summary: This review studied whether mobile phone applications such as Short Message Service (SMS) and Multimedia Message Service (MMS) can be useful to send information to patients about their test results. We also looked at possible risks of communicating in this way. Our review found only one study evaluating the use of mobile phone messaging for communicating results of medical investigations. This study was at high risk of bias. The study suggested that the early communication of an antenatal screen test result by text messaging would not result in a difference in the anxiety scores of all pregnant women (irrespective of the test result) or when their test result is positive, however may reduce anxiety in pregnant women when their test result is negative. The usefulness of mobile phone messaging in other situations, or potential negative consequences, are not yet known.
Abstract: We included two eligible studies with a total of 287 participants; both had good methodological quality. There was no difference in the duration of catheter patency between heparin-bonded and non-heparin bonded catheters (median duration seven days versus six days) reported in one study. There was no difference in the risk of catheter-related thrombosis (two studies, RR 0.34, 95% CI 0.01 to 7.68; I2 = 80%; RD -0.06, 95% CI -0.17 to 0.06). Data from one study revealed a statistically significant reduction in the risk of catheter occlusion (RR 0.06, 95% CI 0.00 to 1.07; RD -0.08, 95% CI -0.13 to -0.02; NNT 13, 95% CI 8 to 50), catheter-related blood stream infections (RR 0.06, 95% CI 0.01 to 0.41; RD -0.17, 95% CI -0.25 to -0.10; NNT 6, 95% CI 4 to 10) and catheter colonization (RR 0.21, 95% CI 0.06 to 0.71; RD -0.11, 95% CI -0.19 to -0.04; NNT 9, 95% CI 5 to 25) in the heparin-bonded catheter group. The second study did not report on these outcomes. There was no significant difference in risk of thrombocytopenia after catheter placement (RR 0.73, 95% CI 0.38 to 1.39; RD -0.02, 95% CI -0.10 to 0.07). Two eligible studies on the use of heparin-bonded catheters versus placebo in children were identified. Meta-analysis of the two studies revealed no reduction in catheter-related thrombosis with heparin-bonded catheters. One study reported a reduction in catheter-related blood stream infection and colonization following the use of heparin-bonded catheters. The strength of evidence is low and further well-designed multicenter randomized controlled trials are warranted.

Plain-language summary: The review authors identified two good quality controlled trials that randomized 287 children aged one day to 16 years to either a heparin-bonded catheter or a standard catheter. The median duration of time that the catheter could be used to give fluids (its patency) was not clearly different with the two types of catheter. This was seven days in the heparin-bonded catheter group and six days in the standard catheter group. There was a no difference between the two groups for risk of catheter-related thrombosis over the time the catheter was in. There was a trend towards a reduction in the risk of catheter occlusion in the first week after catheter placement, reported in one study only. The risks of catheter-related blood stream infections and bacterial colonization of the catheter were significantly reduced using the heparin-bonded catheter, with a longer time to develop infection (delayed in the heparin-bonded catheter group); however, it was reported in one study only and the strength of evidence was low. There was no significant difference in risk of thrombocytopenia after catheter placement.
Abstract: We identified four new studies for the review update; the review now includes seven studies with 420 participants. Four small studies with 20 to 30 children each, and two larger studies of 80 children each, showed an improvement of congestive heart failure with beta-blocker therapy. A larger study with 161 participants showed no evidence of benefit over placebo in a composite measure of heart failure outcomes. The included studies showed no significant difference in mortality or heart transplantation rates between the beta-blocker and control groups. No significant adverse events were reported with beta-blockers, apart from one episode of complete heart block. A meta-analysis of left ventricular ejection fraction (LVEF) and fractional shortening (LVFS) data showed a very small improvement with beta-blockers. However, there were vast differences in the age, age range, and health of the participants (aetiology and severity of heart failure; heterogeneity of diagnoses and co-morbidities); there was a range of treatments across studies (choice of beta-blocker, dosing, duration of treatment); and a lack of standardised methods and outcome measures. Therefore, the primary outcomes could not be pooled in meta-analyses. There is not enough evidence to support or discourage the use of beta-blockers in children with congestive heart failure, or to propose a paediatric dosing scheme. However, the sparse data available suggested that children with congestive heart failure might benefit from beta-blocker treatment. Further investigations in clearly defined populations with standardised methodology are required to establish guidelines for therapy. Pharmacokinetic investigations of beta-blockers in children are also required to provide effective dosing in future trials.

Plain-language summary: This review summarises and discusses the available information on the use of beta-blockers in children with congestive heart failure. Seven studies, with a total of 420 children were included in the review. Beta-blocker therapy improved heart failure in four small studies with less than 30 participants each, and two larger studies with 80 participants each. However, the largest trial, with 161 participants, did not show a significant effect of the investigated beta-blocker over placebo. None of the studies reported any severe beta-blocker-related adverse events, apart from one child who had a heart rhythm disturbance. There were not enough data to recommend or discourage the use of beta-blockers in children with congestive heart failure. However, the current available data suggest that children with heart failure might benefit from beta-blocker treatment. Further investigations are required to establish guidelines for therapy.
Abstract: We identified two randomised controlled trials that met our inclusion criteria, and we found no new trials when we updated the searches in 2012. The first, a study with overall unclear risk of bias, examined the effects of a twice-daily exercise program of moderate load endurance exercise versus "usual activities" in 25 people with ALS. The second, a study with overall low risk of bias, examined the effects of thrice weekly moderate load and moderate intensity resistance exercises compared to usual care (stretching exercises) in 27 people with ALS. After three months, when the results of the two trials were combined (43 participants), there was a significant mean improvement in the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) measure of function in favour of the exercise groups (mean difference 3.21, 95% confidence interval 0.46 to 5.96). No statistically significant differences in quality of life, fatigue or muscle strength were found. In both trials adverse effects, investigators reported no adverse effects such as increased muscle cramping, muscle soreness or fatigue The included studies were too small to determine to what extent strengthening exercises for people with ALS are beneficial, or whether exercise is harmful. There is a complete lack of randomised or quasi-randomised clinical trials examining aerobic exercise in this population. More research is needed.

Plain-language summary: This review found only two randomised studies of exercise in people with ALS. The trials compared an exercise program with usual care (stretching exercises). Combining the results from the two trials (43 participants), exercise produced a greater average improvement in function (measured using an ALS-specific measurement scale) than usual care. There were no other differences between the two groups. There were no reported adverse events due to exercise. The studies were too small to determine to what extent exercise for people with ALS is beneficial or whether exercise is harmful. We found no new trials when we updated the searches in 2012. More research is needed.
Abstract: Two RCTs were identified. One compared warfarin, aspirin and no antithrombotic therapy and the second compared warfarin with placebo in patients with idiopathic dilated cardiomyopathy. Three small prospective controlled studies of warfarin in heart failure were also identified, but they were over 50 years old with methods not considered reliable by modern standards. In both WASH 2004 and HELAS 2006, there were no significant differences in the incidence of myocardial infarction, non-fatal stroke and death between patients taking oral anticoagulation and those taking placebo. Four retrospective non-randomised cohort analyses and four observational studies of oral anticoagulation in heart failure included differing populations of heart failure patients and reported contradictory results. Based on the two major randomised trials (HELAS 2006; WASH 2004), there is no convincing evidence that oral anticoagulant therapy modifies mortality or vascular events in patients with heart failure and sinus rhythm. Although oral anticoagulation is indicated in certain groups of patients with heart failure (for example those with atrial fibrillation), the available data does not support the routine use of anticoagulation in heart failure patients who remain in sinus rhythm.

Plain-language summary: Although anticoagulants such as warfarin are of proven benefit in patients in certain subgroups of patients with heart failure, such as those with atrial fibrillation, there is little evidence that warfarin works well in the wider heart failure population. There may also be serious side effects such as bleeding (causing ulcers and haemorrhagic stroke). At present there are no data to recommend the routine use of anticoagulants to prevent thromboembolism in patients with heart failure who are in normal heart rhythm.
Abstract: This review examined 16 trials lasting four weeks to two years involving 1391 participants receiving 15 different Chinese herbal medicines in eight different comparisons. No trial reported on mortality, morbidity or costs. No serious adverse events like severe hypoglycaemia were observed. Meta-analysis of eight trials showed that those receiving Chinese herbal medicines combined with lifestyle modification were more than twice as likely to have their fasting plasma glucose levels return to normal levels (i.e. fasting plasma glucose <7.8 mmol/L and 2hr blood glucose <11.1 mmol/L) compared to lifestyle modification alone (RR 2.07; 95% confidence intervall (CI) 1.52 to 2.82). Those receiving Chinese herbs were less likely to progress to diabetes over the duration of the trial (RR 0.33; 95% CI 0.19 to 0.58). However, all trials had a considerable risk of bias and none of the specific herbal medicines comparison data was available from more than one study. Moreover, results could have been confounded by rates of natural reversion to normal glucose levels. The positive evidence in favour of Chinese herbal medicines for the treatment of IGT or IFG is constrained by the following factors: lack of trials that tested the same herbal medicine, lack of details on co-interventions, unclear methods of randomisation, poor reporting and other risks of bias.

Plain-language summary: This review examined 16 randomised controlled trials of 15 different Chinese herbal medicines. The trials lasted from four weeks to two years (average nine months) and involved altogether 1391 participants. Death from any cause, diabetic complications and economic outcomes were not investigated. No serious adverse events were reported. The available evidence suggests that Chinese herbal medicines are able to lower and normalise high blood glucose. Due to considerable distortions (bias) in the trials, further high-quality and rigorously evaluated studies are required before any conclusions can confidently be reached about the effects of Chinese herbal medicines for the treatment of impaired glucose tolerance and the delay of diabetes onset.
Abstract: Fourteen trials compared escitalopram with another SSRI and eight compared escitalopram with a newer antidepressive agent (venlafaxine, bupropion and duloxetine). Escitalopram was shown to be significantly more effective than citalopram in achieving acute response (OR 0.67, 95% CI 0.50 to 0.87). Escitalopram was also more effective than citalopram in terms of remission (OR 0.53, 95% CI 0.30 to 0.93). Significantly fewer patients allocated to escitalopram withdrew from trials compared with patients allocated to duloxetine, for discontinuation due to any cause (OR 0.62, 95% CI 0.38 to 0.99). Some statistically significant differences favouring escitalopram over other antidepressive agents for the acute phase treatment of major depression were found, in terms of efficacy (citalopram and fluoxetine) and acceptability (duloxetine). There is insufficient evidence to detect a difference between escitalopram and other antidepressants in early response to treatment (after two weeks of treatment). Cost-effectiveness information is also needed in the field of antidepressant trials. Furthermore, as with most standard systematic reviews, the findings rely on evidence from direct comparisons. The potential for overestimation of treatment effect due to sponsorship bias should also be borne in mind.

Plain-language summary: In the present review we assessed the evidence for the efficacy, acceptability and tolerability of escitalopram in comparison with all other antidepressants in the acute-phase treatment of major depression. Twenty-two randomised controlled trials (about 4000 participants) were included in the present review. Escitalopram appears to be suitable as first-line antidepressant treatment for people with moderate to severe major depression. It has been compared with only a few other antidepressants and so we are unable to say whether it is better, worse or the same as many of the other drugs used in practice. However, it did perform better than citalopram when we brought together the results of six studies in nearly two thousand patients
Abstract: For this update we included one RCT with 17,802 participants that assessed rosuvastatin compared with placebo for the prevention of VTE. The quality of the evidence was moderate because of imprecision, as the required sample size for the outcomes of this review was not achieved. Analysis showed that when compared with placebo rosuvastatin reduced the incidence of VTE (odds ratio (OR) 0.57, 95% confidence interval (CI) 0.37 to 0.86) and deep vein thrombosis (DVT) (OR 0.45, 95% CI 0.25 to 0.79), the risk of any (fatal and non-fatal) myocardial infarction (MI) (OR 0.45, 95% CI 0.30 to 0.69), and any (fatal and non-fatal) stroke (OR 0.51, 95% CI 0.34 to 0.78). There was no difference in the incidence of pulmonary embolism (PE) (OR 0.77, 95% CI 0.41 to 1.46), fatal MI (OR 1.50, 95% CI 0.53 to 4.22), fatal stroke (OR 0.30, 95% CI 0.08 to 1.09) or death after VTE (OR 0.50, 95% CI 0.20 to 1.24). The incidence of any serious adverse events was no different between the rosuvastatin and placebo groups (OR 1.07, 95% CI 0.95 to 1.20). Available evidence showed that rosuvastatin was associated with a reduced incidence of VTE, but the evidence was limited to a single RCT and any firm conclusions and suggestions could be not drawn. Randomised controlled trials of statins (including rosuvastatin) are needed to evaluate their efficacy in the prevention of VTE.

Plain-language summary: Our review included one published randomised controlled trial, involving 17,802 participants, which reported outcomes of VTE. This trial investigated rosuvastatin compared with placebo for the primary prevention of VTE. Analysis showed that, compared with placebo, rosuvastatin reduced the incidence of VTE and DVT, the risk of any (fatal and non-fatal) myocardial infarction, and any (fatal and non-fatal) stroke. There were no differences between rosuvastatin and placebo in the incidence of pulmonary embolism, fatal myocardial infarction, fatal stroke, and death after VTE. The incidence of any serious adverse events was not different between rosuvastatin and placebo. No firm conclusions or suggestions could be made from these findings. More randomised controlled trials of statins (including rosuvastatin) are needed to evaluate the efficacy of statins in the prevention of VTE. Quality of the evidence The quality of the evidence was moderate because of imprecision, as the required sample size for the outcomes of this review was not achieved.
Abstract: Three cohort studies were included in the review. They examined 484 patients with HIV infection who received YF immunisation. Patients with HIV infection developed significantly lower concentrations of neutralising antibodies in the first year post immunisation compared to uninfected patients, though decay patterns were similar for recipients regardless of HIV infection. No study patient with HIV infection suffered serious adverse events as a result of YF vaccination. YF vaccination can produce protective levels of neutralising antibodies in HIV patients. Immunogenicity of YF vaccine is slightly less in HIV-infected patients compared to HIV-uninfected patients. No serious adverse events related to YF vaccine were observed in HIV-infected study participants. At time of immunisation, higher CD4 cell counts and lower HIV RNA levels in patients with HIV infection seem to be key determinants for development of protective titres of neutralising antibodies. The quality of the evidence for all outcomes was low to very low. YF vaccine may potentially be used safely in HIV-infected patients, although our conclusions are limited by small numbers of patients who have been reported. To assure maximum effectiveness YF vaccine should be given to HIV-infected patients after HIV replication has been suppressed.

Plain-language summary: The purpose of this review was to assess the risks and benefits of YF vaccine for people living with HIV. We found three cohort studies that addressed this question. One study in children, from a time before effective widespread use of antiretroviral drugs, found that YF vaccine worked much less well in children with HIV than it did in those without HIV. Two studies in adults found that the immune response to yellow fever vaccine was slightly lower in HIV-infected patients. No severe adverse events were observed in patients in these studies. However, because the numbers of people with HIV who have received YF vaccine is small, and serious side effects are uncommon in people without HIV infection, we are not positive about its safety. When it does need to be used, it should be given to people whose viral loads are low and CD4 counts are high.
Abstract: Only one randomised trial was identified and included in the review. The bias risk in the trial was high. The trial compared chlorambucil versus no intervention in 24 patients with primary biliary cirrhosis. Fisher's exact test did not show a significant reduction of mortality when comparing chlorambucil with no treatment (0/13 (0%) versus (2/11 (18.2%); P = 0.20). There was no significant difference regarding adverse events for chlorambucil compared with no treatment, but all patients receiving chlorambucil experienced adverse events (13/13 (100%) versus (3/11 (27%); P = 0.1). According to the authors of the trial, chlorambucil led to a significant improvement in mean serum levels of bilirubin (P < 0.05), albumin (P < 0.05), immunoglobulin M (P < 0.01), serum aspartate aminotransferase activity (P < 0.01), and hepatic inflammatory infiltrates (P < 0.01). There is not sufficient evidence to support or reject the use of chlorambucil for patients with primary biliary cirrhosis. Chlorambucil may show benefit in some unvalidated surrogate outcome measures (for example, serum bilirubin and immunoglobulin M levels). Chlorambucil is, however, connected with a number of adverse events. Bone marrow suppression should be noted in particular. Further randomised clinical trials are necessary to assess the benefits and harms of chlorambucil in this indication.

Plain-language summary: This review aimed to assess the beneficial or harmful effects of chlorambucil for primary biliary cirrhosis. The authors identified only one randomised trial, with 24 participants included. This trial compared chlorambucil with no intervention. The trial is small and at a high risk of bias, which suggests that the results may not be reliable. Meta-analyses were not possible because of the inclusion of one trial only. Fisher's exact test and t-test were used instead. Chlorambucil was not associated with significantly lower mortality when compared with no intervention. All patients on chlorambucil experienced adverse events, especially bone marrow suppression. Chlorambucil led to a significant improvement in mean serum levels of bilirubin, albumin, immunoglobulin M, serum aspartate aminotransferase activity, and hepatic inflammatory infiltrates. However, these outcomes are unvalidated surrogate outcomes for patient-relevant outcomes. This means that improvement of these biochemistry measures cannot be taken as proof of improvement of patient-relevant outcomes. It remains unclear whether chlorambucil can be supported or rejected for use in patients with primary biliary cirrhosis.