GEM/cochrane-simplification huggingface dataset:
Abstract: Twenty-two trials evaluating 1409 patients were included. All trials had problems of method. Shunt therapy compared with ET demonstrated significantly less rebleeding (OR 0.24, 95% CI 0.18 to 0.30) at the cost of significantly increased acute hepatic encephalopathy (OR 2.07, 95% CI 1.59 to 2.69) and chronic encephalopathy (OR 2.09, 95% CI 1.20 to 3.62). There were no significant differences regarding mortality (hazard ratio 1.00, 95% CI 0.82 to 1.21) and duration of in-patient stay (weighed mean difference 0.78 day, 95% CI -1.48 to 3.05). The proportion of patients with shunt occlusion or dysfunction was 3.1% (95% CI 0.4 to 10.7%) following TS (two trials), 7.8% (95% CI 3.8 to 13.9%) following DSRS (four trials), and 59% (range 18% to 72%) following TIPS (14 trials). All shunts resulted in a significantly lower rebleeding rate at the expense of a higher incidence of encephalopathy. TIPS was complicated by a high incidence of shunt dysfunction. No survival advantage was demonstrated with any shunt.

Plain-language summary: Randomised clinical trials have compared three types of portosystemic shunting separately against endoscopic therapy. The shunts included in these trials have been total portocaval shunts, distal splenorenal shunts, and transjugular intrahepatic portocaval shunts. The authors found that when compared to endoscopic therapy all three types of shunt lowered the rate of rebleeding at the cost of a higher incidence of hepatic encephalopathy, without any statistically significant difference in survival.
Abstract: Three studies involving 112 participants were included. Comparison interventions included different dosages of mifepristone, placebo and vitamin B tablets. There is evidence that treatment with mifepristone relieves heavy menstrual bleeding compared with placebo (Peto OR 17.84; 95% CI 6.72 to 47.38; 2 RCTs, 77 women, I2 = 0%). Three studies (Bagaria 2009; Engman 2009; Fiscella 2006) were included in the meta-analysis of this comparison. There was no evidence of an effect of mifepristone on the fibroid volume (standardised mean difference (SMD) -0.02; 95% CI -0.38 to 0.41; 99 women). Two studies (Bagaria 2009; Fiscella 2006) were included in the meta-analysis of this comparison. There was no evidence of an effect of mifepristone on uterine volume (mean difference (MD) -77.24; 95% CI -240.62 to 86.14; 72 women). The pooled data suggest an increased adverse event (abnormal endometrial histology) in the mifepristone group compared to placebo (OR 31.65; 95% CI 4.83 to 207.35; 2 RCTs; 54 women; I2 = 0%). Only one study (Bagaria 2009) reported endometrial hyperplasia at the end of the therapy (12/19 women in the mifepristone group versus 0/16 in the placebo group; OR 55.0; 95% CI 2.86 to 105.67). Engman 2009 found a significantly higher rate of cystic glandular dilatation in women in the mifepristone group (5/8 women biopsied) compared with the placebo group (1/11 women biopsied) (OR 16.67; 95% CI 1.36 to 204.03). One study (Fiscella 2006) suggested significant improvements (P < 0.001) for specific quality of life outcomes. Mifepristone reduced heavy menstrual bleeding and improved fibroid-specific quality of life. However, it was not found to reduce fibroid volume. Further well-designed, adequately powered RCTs are needed before a recommendation can be made on the use of mifepristone for the treatment of uterine fibroids.

Plain-language summary: This review includes three trials and 112 women with uterine fibroids under mifepristone treatment. These clinical trials included a small number of participants and show limited methodological quality. The studies included in this review show that mifepristone had a moderate effect in relief of bleeding and showed an improvement in fibroid-specific quality of life. Determination of the effects of mifepristone on uterine fibroid volume requires much larger trials to draw a confident conclusion for mifepristone in clinical use.
Abstract: This review includes six RCTs. Trial results show that lactoferrin supplementation to enteral feeds decreased late-onset sepsis (typical risk ratio (RR) 0.59, 95% confidence interval (CI) 0.40 to 0.87; typical risk difference (RD) -0.06, 95% CI -0.10 to -0.02; number needed to treat for an additional beneficial outcome (NNTB) 17, 95% CI 10 to 50; six trials, 886 participants; low-quality evidence) and NEC stage II or III (typical RR 0.40, 95% CI 0.18 to 0.86; typical RD -0.04, 95% CI -0.06 to -0.01; NNTB 25, 95% CI 17 to 100; four studies, 750 participants; low-quality evidence). Lactoferrin supplementation did not have an effect on "all-cause mortality" (typical RR 0.65, 95% CI 0.37 to 1.11; typical RD -0.02, 95% CI -0.05 to 0; six studies, 1041 participants; low-quality evidence). Lactoferrin supplementation to enteral feeds with probiotics decreased late-onset sepsis (RR 0.27, 95% CI 0.12 to 0.60; RD -0.13, 95% CI -0.19 to -0.06; NNTB 8, 95% CI 5 to 17; one study, 321 participants; low-quality evidence) and NEC stage II or III (RR 0.04, 95% CI 0.00 to 0.62; RD -0.05, 95% CI -0.08 to -0.03; NNTB 20, 95% CI 12.5 to 33.3; one study, 496 participants; low-quality evidence), but not "all-cause mortality" (low-quality evidence). Lactoferrin supplementation to enteral feeds with or without probiotics decreased bacterial and fungal sepsis but not CLD or length of hospital stay (low-quality evidence). Investigators reported no adverse effects and did not evaluate long-term neurological outcomes and PVL. Evidence of low quality suggests that lactoferrin supplementation to enteral feeds with or without probiotics decreases late-onset sepsis and NEC stage II or III in preterm infants without adverse effects. Completed ongoing trials will provide data from more than 6000 preterm neonates, which may enhance the quality of the evidence. Clarification regarding optimal dosing regimens, types of lactoferrin (human or bovine), and long-term outcomes is needed.

Plain-language summary: Through literature searches updated to December 2016, we found six studies that enrolled 1041 preterm babies and tested the role of lactoferrin along with feeds. We also found large ongoing studies that may increase the strength of our findings when their results become available. Evidence of low quality suggests that oral lactoferrin with or without a probiotic decreases blood infection and NEC in preterm infants with no adverse effects. Clarification regarding dosing, duration, type of lactoferrin (human or bovine), and development of preterm babies is still needed. Evidence is of low quality.
Abstract: Eighteen studies (14,303 patients) compared early statin treatment versus placebo or no treatment in patients with ACS. The new search did not identify any new studies for inclusion. There were some concerns about risk of bias and imprecision of summary estimates. Based on moderate quality evidence, early statin therapy did not decrease the combined primary outcome of death, non-fatal myocardial infarction, and stroke at one month (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.80 to 1.08) or four months (RR 0.93, 95% CI 0.81 to 1.06) of follow-up when compared to placebo or no treatment. There were no statistically significant risk reductions from statins for total death, total myocardial infarction, total stroke, cardiovascular death, revascularization procedures, and acute heart failure at one month or at four months, although there were favorable trends related to statin use for each of these endpoints. Moderate quality evidence suggests that the incidence of unstable angina was significantly reduced at four months following ACS (RR 0.76, 95% CI 0.59 to 0.96). There were nine individuals with myopathy (elevated creatinine kinase levels more than 10 times the upper limit of normal) in statin-treated patients (0.13%) versus one (0.015%) in the control groups. Serious muscle toxicity was mostly limited to patients treated with simvastatin 80 mg. Based on moderate quality evidence, due to concerns about risk of bias and imprecision, initiation of statin therapy within 14 days following ACS does not reduce death, myocardial infarction, or stroke up to four months, but reduces the occurrence of unstable angina at four months following ACS. Serious side effects were rare.

Plain-language summary: This review is an update of a review previously published in 2011 that included 18 studies, enrolling 14,303 patients. The update of this review did not identify any new studies for inclusion. We did not find a significant risk reduction for all-cause mortality, heart attack, or stroke within the first four months. We had some concerns about risk of bias and imprecision of the results. The risk of unstable angina was reduced by about 25% at four months following acute coronary syndrome. Serious side effects from early treatment with statins were rare (0.1%), and serious muscle toxicity was mostly observed with simvastatin 80 mg.
Abstract: We included four RCTs involving 610 participants. All four trials aimed to investigate the effects of orientation programs for cancer patients to a cancer facility. There was high risk of bias across studies. Findings from two of the RCTs demonstrated significant benefits of the orientation intervention in relation to levels of distress (mean difference (MD) -8.96 (95% confidence interval (CI) -11.79 to -6.13), but non-significant benefits in relation to state anxiety levels (MD -9.77 (95% CI -24.96 to 5.41). Other outcomes for participants were generally positive (e.g. more knowledgeable about the cancer centre and cancer therapy, better coping abilities). No harms or adverse effects were measured or reported by any of the included studies. There were insufficient data on the other outcomes of interest. This review has demonstrated the feasibility and some potential benefits of orientation interventions. Orientation interventions may reduce distress in patients, but the quality of the evidence is low. However, most of the other outcomes remain inconclusive (patient knowledge recall/ satisfaction). The majority of studies were subject to high risk of bias, and were likely to be insufficiently powered. Further well conducted and powered RCTs are required to provide evidence for determining the most appropriate intensity, nature, mode and resources for such interventions. Patient and carer-focused outcomes should be included.

Plain-language summary: This review focuses on the effects of information programs which provide information specifically related to the facility and the services available to patients, their families and care givers. A broad search of published reports located only four studies with 610 participants which met the criteria for inclusion in this review. Orientation interventions may reduce distress in patients, but the quality of the evidence is low. The effects of such intervention on patient/carer satisfaction, knowledge and recall were not sufficiently evaluated or reported by the included trials. Although the studies generally reported positive outcomes for participants (e.g. more knowledgeable about the cancer centre and cancer therapy, better coping abilities), the studies generally were of poor quality and did not have a sufficient number of participants to eliminate the possibility of bias.
Abstract: Three trials tested aspirin in dosages ranging from 75 mg to 325 mg per day and 125 mg every other day to placebo (in two trials) or control (in one trial) in 1965 AF patients without prior stroke or TIA. The mean duration of follow up averaged 1.3 years per participant. Aspirin was associated with non-significant lower risks of all stroke (odds ratio (OR) 0.70, 95% confidence interval (CI) 0.47 to 1.07), ischemic stroke (OR 0.70, 95% CI 0.46 to 1.07), all disabling or fatal stroke (OR 0.86, 95% CI 0.50 to 1.49) and all-cause death (OR 0.75, 95% CI 0.54 to 1.04). The combination of stroke, myocardial infarction or vascular death was significantly reduced (OR 0.71, 95% CI 0.51 to 0.97 ). No increase in intracranial hemorrhage or major extracranial hemorrhage was observed. Aspirin appears to reduce stroke and major vascular events in patients with non-valvular AF similar to its effect in other high-risk patients (i.e. by about 25%). For primary prevention among AF patients with an average stroke rate of 4% per year, about 10 strokes would likely be prevented yearly for every 1000 AF patients given aspirin.

Plain-language summary: Antiplatelet agents like aspirin are effective for preventing serious vascular events in patients with atrial fibrillation not suitable for oral anticoagulants. 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 bloodstream to the brain and cause a stroke. Drugs that slow clotting, such as antiplatelet agents (aspirin and others) and anticoagulants reduce the risk of stroke in patients with atrial fibrillation. In this review the benefits of antiplatelet agents are shown to be modest (nearly 25% decrease in stroke), but they are relatively safe, easy to take, and therefore an important treatment option for many atrial fibrillation patients. Anticoagulation with warfarin and related drugs offers more protection against stroke (nearly two-thirds reduction), but anticoagulant drugs can cause severe bleeding and require careful regulation with regular blood tests. The choice of antiplatelet drugs versus anticoagulants should be individualized based on the patient's inherent risk of stroke, ability to tolerate anticoagulation without bleeding, access to adequate anticoagulation monitoring, and patient preferences.
Abstract: Five RCTs met the inclusion criteria. The maximum number of studies compared in the meta-analysis was three (31 on oxygen versus 32 control participants), because all included studies did not measure the same outcomes. When two studies were pooled, statistically significant improvements of oxygen-supplemented exercise training were found in constant power exercise time, WMD 2.68 minutes (95% CI 0.07 to 5.28 minutes). Supplemental oxygen increased the average exercise time from 6 to 14 minutes; the control intervention increased average exercise time from 6 to 12 minutes. Constant power exercise end-of-test Borg score (on a scale from 1 to 10) also showed statistically significant improvements with oxygen-supplemented exercise training, WMD -1.22 units (95% CI -2.39 to -0.06). One study showed a significant improvement in the change of Borg score after the shuttle walk test, by -1.46 units (95% CI -2.72 to -0.19). There were no significant differences in maximal exercise outcomes, functional exercise outcomes (six-minute walk test), shuttle walk distance, health-related quality of life or oxygenation status. According to the GRADE system most outcomes were rated as low quality because they were limited by study quality. This review provides little support for oxygen supplementation during exercise training for individuals with COPD, but the evidence is very limited. Studies with larger number of participants and strong design are required to permit strong conclusions, especially for functional outcomes such as symptom alleviation, health-related quality of life and ambulation.

Plain-language summary: We conducted a review to determine the effectiveness of adding oxygen to exercise training in comparison to exercise training without oxygen supplementation in people with COPD. Five studies addressed the question although, because of measurement of different outcomes, the maximum number available for looking at any individual outcome was three (31 patients receiving oxygen versus 32 not). People with COPD may exercise longer and have less shortness of breath when using oxygen during an exercise-training program. These studies did not look at the effect of oxygen on shortness of breath in daily life. From the evidence to date, it is not possible to determine whether individuals with COPD should use oxygen during exercise training. Stronger studies with more participants are required in order to understand how oxygen-supplemented exercise training for people with COPD will affect their shortness of breath, activity and quality of life.
Abstract: We included three trials after screening a total of 1503 abstracts and 21 full-text articles. The three trials included a total of 809 participants. One trial compared different doses of acetonide anecortave acetate with placebo, a second trial compared triamcinolone acetonide versus placebo, and the third trial compared anecortave acetate against photodynamic therapy (PDT). We did not conduct a meta-analysis owing to heterogeneity of interventions and comparisons. The risk ratio for loss of 3 or more lines of vision at 12 months follow-up was 0.8 (95% confidence interval (CI) 0.45 to 1.45) with 3 mg anecortave acetate, 0.45 (95% CI = 0.21 to 0.97) with 15 mg anecortave acetate, 0.91 (0.52 to 1.58) with 30 mg anecortave acetate, 0.97 (95% CI 0.74 to 1.26) with triamcinolone acetonide, all compared to placebo and 1.08 (95% CI 0.91 to 1.29) with anecortave acetate compared with PDT. Based on the included trials, we found no evidence that antiangiogenic steroids prevent visual loss in patients with neovascular AMD. With the emergence of anti-vascular endothelial growth factor modalities, based on evidence summarized in this review, it is unclear what role steroids have in treating patients with neovascular AMD.

Plain-language summary: This review included three trials evaluating two different types of steroids, triamcinolone acetonide and anecortave acetate, for the treatment of neovascular AMD. The findings across the three trials, which included a total of 809 participants, were consistent with no evidence of benefit, in terms of preventing vision loss, with antiangiogenic steroids compared with placebo or photodynamic therapy. Based on available evidence, there is little benefit of steroids with anti-angiogenic properties in the treatment of neovascular age-related macular degeneration. ".
Abstract: Seven trials met the inclusion criteria (380 participants). Methodological quality was high. All studies recruited children with acute severe asthma and requiring hospital admission. Six studies sought participants who were unresponsive to nebulised short-acting beta-agonist and administered systemic steroids to study participants. In two studies where some children were able to perform spirometry, baseline FEV1 was between 35 and 45% predicted. The addition of aminophylline to steroids and ß2-agonist significantly improved FEV1% predicted over placebo at 6-8 hours, 12-18 hours and 24 hours. Aminophylline led to a greater improvement in PEF% predicted over placebo at 12-18 hours. There was no significant difference in length of hospital stay, symptoms, frequency of nebulisations and mechanical ventilation rates. There were insufficient data to permit aggregation for oxygenation and duration of supplemental oxygen therapy. Aminophylline led to a three-fold increase in the risk of vomiting. There was no significant difference between treatment groups with regard to hypokalaemia, headaches, tremor, seizures, arrhythmias and deaths. In children with a severe asthma exacerbation, the addition of intravenous aminophylline to ß2-agonists and glucocorticoids (with or without anticholinergics) improves lung function within 6 hours of treatment. However there is no apparent reduction in symptoms, number of nebulised treatment and length of hospital stay. There is insufficient evidence to assess the impact on oxygenation, PICU admission and mechanical ventilation. Aminophylline is associated with a significant increased risk of vomiting.

Plain-language summary: The purpose of this review was to assess whether the use of intravenous aminophylline in children receiving maximised inhaled bronchodilators and glucocorticoids produced additional beneficial effects. We identified a small number of good quality trials which compared aminophylline with placebo in children given inhaled bronchodilators and glucocorticoid therapy. This review found evidence that children treated with aminophylline had a greater improvement in lung function than children treated with placebo, when both groups received inhaled bronchodilators and steroids and they responded incompletely to these initial therapies. However, aminophylline use also resulted in greater risk of vomiting. Aminophylline use in children may be appropriate if children have a role in severe acute exacerbations of asthma where response to maximised therapy (inhaled bronchodilators and glucocorticoids) is poor. These results are based on small numbers and further work in this area is required.
Abstract: We found no significant differences in overall survival, whether chest radiotherapy was delivered within 30 days after the start of chemotherapy or later, even after exclusion of the only study that delivered chest radiotherapy during cycles of non-platinum chemotherapy (HR 0.86 in favour of early radiation, P = 0.11). The same was observed for studies having early chest radiotherapy delivered in an overall treatment time of less than 30 days compared to a longer treatment time (HR 0.82, P = 0.13). These results should be interpreted with caution because the largest trial has follow-up data up to three years only. The outcome of longer follow up for overall survival remains to be seen. Local tumour control was not significantly different between early and late chest radiotherapy, nor the incidence of severe pneumonitis or severe oesophagitis. However, we observed a trend towards a higher chance of developing oesophagitis and pneumonitis when early chest radiotherapy was delivered during chemotherapy, which remained for oesophagitis, but not pneumonitis, after exclusion of studies with non-platinum based chemotherapy. At present, it is uncertain whether the timing of chest radiotherapy as such is important for survival. The optimal integration of chemotherapy and chest radiotherapy in patients with limited-stage small cell lung cancer is unknown. Further research is needed to establish the best combination of radiotherapy and chemotherapy in this disease.

Plain-language summary: This review indicates that it is unclear whether administering chest radiotherapy within 30 days of beginning chemotherapy or later improves survival. The effect on patients' overall survival is not statistically different, although there is a possibility that the effect is in favour of early chest radiotherapy. The interpretation of the current data is difficult and further research is needed.