GEM/cochrane-simplification huggingface dataset:
Abstract: We found 55 trials (163,471 participants) with a median duration of 12 month follow up. Fourteen trials (139,256 participants) with reported clinical event endpoints, the pooled ORs for total and CHD mortality were 1.00 (95% CI 0.96 to 1.05) and 0.99 (95% CI 0.92 to 1.07), respectively. Total mortality and combined fatal and non-fatal cardiovascular events showed benefits from intervention when confined to trials involving people with hypertension (16 trials) and diabetes (5 trials): OR 0.78 (95% CI 0.68 to 0.89) and OR 0.71 (95% CI 0.61 to 0.83), respectively. Net changes (weighted mean differences) in systolic and diastolic blood pressure (53 trials) and blood cholesterol (50 trials) were -2.71 mmHg (95% CI -3.49 to -1.93), -2.13 mmHg (95% CI -2.67 to -1.58 ) and -0.24 mmol/l (95% CI -0.32 to -0.16), respectively. The OR for reduction in smoking prevalence (20 trials) was 0.87 (95% CI 0.75 to 1.00). Marked heterogeneity (I2 > 85%) for all risk factor analyses was not explained by co-morbidities, allocation concealment, use of antihypertensive or cholesterol-lowering drugs, or by age of trial. Interventions using counselling and education aimed at behaviour change do not reduce total or CHD mortality or clinical events in general populations but may be effective in reducing mortality in high-risk hypertensive and diabetic populations. Risk factor declines were modest but owing to marked unexplained heterogeneity between trials, the pooled estimates are of dubious validity. Evidence suggests that health promotion interventions have limited use in general populations.

Plain-language summary: This review is an update of all relevant randomised trials that have evaluated an intervention that aimed to reduce more than one risk factor (multiple risk factor intervention) in people without evidence of cardiovascular disease. The findings are from 55 trials of between six months and 12 years duration conducted in several countries over the course of four decades. The median duration of follow up was 12 months (with a range of six months to 12 years). Multiple risk factor intervention does result in small reductions in risk factors including blood pressure, cholesterol and smoking. Contrary to expectations, multiple risk factor interventions had little or no impact on the risk of coronary heart disease mortality or morbidity. This could be because these small risk factor changes were not maintained in the long term. Alternatively, the small reductions in risk factors may be caused by biases in some of the studies. The methods of attempting behaviour change in the general population are limited and do not appear to be effective. Different approaches to behaviour change are needed and should be tested empirically before being widely promoted, particularly in developing countries where cardiovascular disease rates are rising. Further trials may be warranted.
Abstract: Six trials involving 159 patients satisfied the inclusion criteria. Data could not be analysed from one trial due to changes in patient numbers and from a second because the data provided were not in a usable format. All trials reported intelligibility measures but a statistically significant result was only reported for the diagnostic rhyme test used in the study of Lee Silverman Voice Treatment -LOUD (LSVT-LOUD) versus a modified version of this therapy (LSVT-ARTIC). In this case a difference of 12.5 points (95% confidence interval (CI) -22.2 to -2.8; P = 0.01) between the mean changes in favour of the LSVT-LOUD group was reported for a speech sample overlaid with Babble noise; this difference was not reproduced for the two additional noise conditions under which the speech samples were assessed. LSVT-LOUD also outperformed LSVT-ARTIC and Respiration therapy (RT) in improving loudness, with a difference in reading a sample text of 5.0 dB (95%CI -8.3 to -1.7; P = 0.003) and 5.5 dB (95% CI 3.4 to 7.7; P < 0.00001) respectively, and a difference in monologue speech of 2.9 dB (95% CI 0.6 to 5.2; P = 0.01) versus RT. Considering the small patient numbers in these trials, there is insufficient evidence to support or refute the efficacy of any form of SLT over another to treat speech problems in patients with Parkinson's disease.

Plain-language summary: Only randomised controlled trials were included in this review. These are studies in which two groups of patients were compared, each group receiving a different form of SLT, with patients assigned to the groups in a random fashion to reduce potential for bias. Six trials were found with a total of 159 patients. Methods varied so much that meta-analysis of the results was not possible. Considering the small number of patients and the methodological flaws in these studies, there is insufficient evidence to support the use of one form of SLT over another for the treatment of speech problems in individuals with Parkinson's disease.
Abstract: Thirty-four trials (1314 participants) were included: fifteen in the empirical treatment group, fifteen in the ENRD group and four in both. In empirical treatment of GORD the risk ratio (RR) for heartburn remission (the primary efficacy variable) in placebo-controlled trials for PPI was 0.37 (two trials, 95% confidence interval (CI) 0.32 to 0.44), for H2RAs 0.77 (two trials, 95% CI 0.60 to 0.99) and for prokinetics 0.86 (one trial, 95% CI 0.73 to 1.01). In a direct comparison PPIs were more effective than H2RAs (seven trials, RR 0.66, 95% CI 0.60 to 0.73) and prokinetics (two trials, RR 0.53, 95% CI 0.32 to 0.87). In treatment of ENRD, the RR for heartburn remission for PPI versus placebo was 0.71 (ten trials, 95% CI 0.65 to 0.78) and for H2RA versus placebo was 0.84 (two trials, 95% CI 0.74 to 0.95). The RR for PPI versus H2RA was 0.78 (three trials, 95% CI 0.62 to 0.97) and for PPI versus prokinetic 0.72 (one trial, 95% CI 0.56 to 0.92). PPIs are more effective than H2RAs in relieving heartburn in patients with GORD who are treated empirically and in those with ENRD, although the magnitude of benefit is greater for those treated empirically.

Plain-language summary: This review found that in the short term PPIs relieve heartburn better than H2RAs in patients who are treated without specific diagnostic testing. Although the difference is smaller, this is also true for patients with gastro-oesophageal reflux disease (GORD), who have a normal upper endoscopy . In summary, proton pump inhibitor drugs appear to be more effective than H2-receptor antagonists for relieving heartburn.
Abstract: Three studies qualified for inclusion in this review (Khilnani 1991; Loisel 1996; Soupre 1998). There was a decrease in the ML-UVCs group in the number of additional PIVs used in the first week of life [WMD -1.42, (95% CI -1.74, -1.10), p<0.00001, number of infants (n) = 99]. There was no significant effect on the number of additional PIVs used in the first four weeks of life [MD -2.30, (95% CI -6.65, 2.05), n=36]. There was an increase in catheter malfunction in the ML-UVCs group [typical RR 3.69 (95% CI 0.99, 13.81), p=0.05; RD 0.15 (95% CI 0.03, 0.27), p=0.01; NNH was 7, 95% CI 4, 33; n=99]. The following outcomes were not significantly different in the two groups: clinical sepsis, catheter related blood stream infection, catheter-associated thrombosis, complications related to catheter malposition in heart and great vessels, NEC and early neonatal mortality. The use of ML-UVCs in comparison to SL-UVCs in neonates is associated with decrease in the usage of PIVs in first week of life, but an increase in catheter malfunctions. As the quality of included randomized studies is poor and the estimates of clinically important complications are imprecise, no firm recommendations can be made regarding the choice of UVC. Adequately powered, properly randomized and properly blinded controlled trials are needed that address the effectiveness and safety of ML-UVCs (double and triple lumen) in comparison to SL-UVCs. These studies should also address the impact of type of catheter material.

Plain-language summary: Three clinical trials involving/completed by 113 babies were identified that compared double-lumen catheters to single-lumen catheters. None of the studies used triple-lumen catheters. All three trials found that use of a double-lumen catheter lowered the number of additional venous placements needed during the first week of life. The double-lumen catheters, however, clogged, leaked, and broke more often. In these studies, no significant difference was found in catheter placement difficulty and misplacement, catheter-related infections or blood clots, other serious complications, or rate of infant mortality. But the quality of studies was poor, and sample sizes were too small to draw valid conclusions about many complication rates. Available clinical trials at present do not provide a basis for recommending one catheter type over another in this setting.
Abstract: Nine trials (1752 women) were included. Analyses of all included trials showed a significant reduction in the rates of all grades of PVH (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.50 to 0.83; nine trials; 1591 women) and severe grades PVH (3 and 4) (RR 0.41, 95% CI 0.20 to 0.85; eight trials; 1527 women) in infants whose mothers had been given prenatal phenobarbital. These results were influenced by trials of poor quality which contributed excessive weight in the analysis due to their higher rates of severe PVH. When only the two higher quality trials were included, these beneficial effects disappeared for all grades of PVH (RR 0.90, 95% CI 0.75 to 1.08; two trials; 945 women), and severe grades of PVH (RR 1.05, 95% CI 0.60 to 1.83; two trials; 945 women). No difference was found in the incidence of neurodevelopmental abnormalities at paediatric follow up at 18 to 24 months or seven years of age between children born to mothers given prenatal phenobarbital and children not so exposed.   Maternal sedation was more likely in women receiving phenobarbital (RR 2.06, 95% CI 1.79 to 2.37; one trial; 576 women). The evidence in this review does not support the use of prophylactic maternal phenobarbital administration to prevent PVH in preterm infants or to protect them from neurological disability in childhood. Phenobarbital administration may lead to maternal sedation. If any future trials are carried out, they should measure neurodevelopmental status at follow up.

Plain-language summary: Nine trials involving 1752 women were included in the review. The trials with low risk of bias found that phenobarbital given to women immediately prior to a very preterm birth did not decrease the risk of bleeding in the brains of the babies. No differences in child development were found on follow up at 18 to 24 months or at seven years. Maternal sedation was more likely in women receiving phenobarbital. The use of prenatal corticosteroids, known to reduce rates of periventricular haemorrhage, varied between trials and may have influenced findings.
Abstract: We included 25 studies with a total of 2488 participants. Our primary outcome 'symptoms rated by participant or medical practitioner or proportion symptom-free' was commonly reported. No two trials examined the same drugs, therefore we grouped similar types of drugs together. Macrolides/streptogramins were found to be more effective than penicillin antibiotics (Risk ratio (RR) 0.84, 95% CI 0.73 to 0.97). In 3 trials involving 419 people, 2 of these studies used oral macrolide against intravenous (iv) penicillin demonstrating that oral therapies can be more effective than iv therapies (RR 0.85, 95% CI 0.73 to 0.98). Three studies with a total of 88 people comparing a penicillin with a cephalosporin showed no difference in treatment effect (RR 0.99, 95% CI 0.68 to 1.43). Six trials which included 538 people that compared different generations of cephalosporin, showed no difference in treatment effect (RR 1.00, 95% CI 0.94 to1.06). We found only small single studies for duration of antibiotic treatment, intramuscular versus intravenous route, the addition of corticosteroid to antibiotic treatment compared with antibiotic alone, and vibration therapy, so there was insufficient evidence to form conclusions. Only two studies investigated treatments for severe cellulitis and these selected different antibiotics for their comparisons, so we cannot make firm conclusions. We cannot define the best treatment for cellulitis and most recommendations are made on single trials. There is a need for trials to evaluate the efficacy of oral antibiotics against intravenous antibiotics in the community setting as there are service implications for cost and comfort.

Plain-language summary: We identified 25 randomised controlled trials. No two trials investigated the same antibiotics, and there was no standard treatment regime used as a comparison. We are not able to define the best treatment for cellulitis and our limited conclusions are mostly based on single trials. No single treatment was clearly superior. Surprisingly, oral antibiotics appeared to be more effective than antibiotics given into a vein for moderate and severe cellulitis. This merits further study. Antibiotics given by injection into a muscle were as effective as when given into a vein, with a lower incidence of adverse events. In one study the addition of corticosteroids to an antibiotic appeared to shorten the length of hospital stay, however further trials are needed. A single small study indicated vibration therapy may increase the rate of recovery but the results of single trials should be viewed with caution. We had insufficient data to give meaningful results for adverse events.
Abstract: We included two trials involving a total of 66 patients in this review. Pooling analyses of data was not possible due to considerable heterogeneity between the trials and a lack of data in both trials. One study found a significant increase in respiratory muscle strength favouring inspiratory muscle training over sham inspiratory muscle training, but there was no significant difference between groups on quality of life. The other study showed that patients receiving inspiratory muscle training were more likely to improve their activities of daily living, quality of life and cardiorespiratory fitness than those patients who received no intervention. However, the main results were not compared directly with breathing retraining. Furthermore, neither of the trials assessed the safety and tolerance of inspiratory muscle training. There is insufficient evidence to support inspiratory muscle training as an effective treatment to improve function after stroke, and no evidence relating to the safety of inspiratory muscle training. Further well-designed RCTs are required.

Plain-language summary: The authors found two small heterogeneous randomised trials that investigated the effect of inspiratory muscle training. These studies do not provide enough evidence to draw any conclusions about the effect of inspiratory muscle training for patients with stroke. There is also no evidence relating to the safety of inspiratory muscle training. Future well-designed studies are needed.
Abstract: We identified no new studies for this updated review, which includes six studies with 1214 participants in comparisons of etoricoxib with placebo. All six studies reported on the 120 mg dose (798 participants in a comparison with placebo). Sixty-six per cent of participants with etoricoxib 120 mg and 12% with placebo reported at least 50% pain relief (NNT 1.8 (1.7 to 2.0); high-quality evidence). For dental studies only, the NNT was 1.6 (1.5 to 1.8). A single dose of 90 mg produced similar results in one large trial. Other doses (60, 180, and 240 mg) were each studied in only one treatment arm. Significantly fewer participants used rescue medication over 24 hours when taking etoricoxib 120 mg than placebo (NNT to prevent remedication 2.2 (1.9 to 2.8)), and the median time to use of rescue medication was 20 hours for etoricoxib and two hours for placebo. Adverse events were reported at a similar rate to placebo (moderate-quality evidence), with no serious events. Single-dose oral etoricoxib produces high levels of good quality pain relief after surgery, and adverse events did not differ from placebo in these studies. The 120 mg dose is as effective as, or better than, other commonly used analgesics.

Plain-language summary: We found six clinical trials with 1214 people. A single 120 mg dose of etoricoxib produced useful pain relief in 7 in 10 (66%) people with moderate or severe pain, compared with just over 1 in 10 (12%) with placebo. A single 90 mg dose produced similar results in one large trial. Pain relief lasted for 20 hours in half of people treated. Adverse events occurred at similar rates with etoricoxib and placebo in these single-dose studies. No serious adverse events or withdrawals due to adverse events occurred with etoricoxib.
Abstract: : With regards to the effect of adjuvant therapy on stage II colon cancer, the pooled relative risk ratio for overall survival was 0.96 (95% confidence interval 0.88, 1.05). With regards to disease-free survival, the pooled relative risk ratio was 0.83 (95% confidence interval 0.75, 0.92). : Although there was no improvement in overall survival in the pooled analysis, we did find that disease-free survival in patients with stage II colon cancer was signficantly better with the use of adjuvant therapy. It seems reasonable to discuss the benefits of adjuvant systemic chemotherapy with those stage II patients who have high risk features, including obstruction, perforation, inadequate lymph node sampling or T4 disease. The co-morbidities and likelihood of tolerating adjuvant systemic chemotherapy should be considered as well. There exists a need to further define which high-risk features in stage II colon cancer patients should be used to select patients for adjuvant therapy. Also, researchers must continue to search for other therapies which might be more effective, shorter in duration and less toxic than those available today.

Plain-language summary: We performed a systematic review looking at all randomized clinical trials evaluating stage II colon cancer patients and adjuvant therapy versus surgery alone. Our review found that adjuvant therapy -either systemic or regional chemotherapy or immunotherapy- can improve the outcomes of stage II patients. In counselling individual patients, the advice given should be conditioned by the patient's age and comorbidities. In addition, the high risk features of the tumour should also be considered when contemplating the benefits of systemic therapy in patients with stage II colon cancer. Further investigation is needed to elucidate which patient and tumour factors can be used to select stage II colon cancer patients for adjuvant therapy. There also exists a need to continue to search for other adjuvant therapies which might be more effective, shorter in duration and less toxic than those available today.
Abstract: Eight randomised controlled trials were identified. A total 976 men were allocated to receive a PDE-5 inhibitor and 741 were randomised to the control groups. Overall, 80% of the participants suffered from type 2 diabetes mellitus. The weighted mean difference (WMD) for the International Index of Erectile Function (IIEF) questions 3 and 4 (frequency of penetration during and maintaining erection to completion of intercourse) was 0.9 (95% CI 0.8 to 1.1) and 1.1 (95% CI 1.0 to 1.2) at the end of the study period, in favour of the intervention group. The WMD for the IIEF erectile dysfunction domain at the end of the study period was 6.6 (95% CI 5.2 to 7.9) in favour of the PDE-5 inhibitors arm. The relative risk (RR) for answering "yes" to a global efficacy question ( "did the treatment improve your erections?") was 3.8 (CI 95% 3.1 to 4.5) in the PDE-5 inhibitors compared with the control arm. The WMD between the percentage of successful attempts in the PDE-5 inhibitors and in the control arm was 26.7 (95% CI 23.1 to 30.3). Mortality was not reported in any of the included trials. Adverse cardiovascular effects were reported in one study. Headache was the most frequent adverse event reported, flushing was the second most common event, with upper respiratory tract complaints and flu like syndromes, dyspepsia, myalgia, abnormal vision and back pain also reported in a descending order of frequency. The overall risk ratio for developing any adverse reaction was 4.8 (CI 95% 3.74 to 6.16) in the PDE-5 inhibitors arm as compared to the control. Sufficient evidence exists that PDE-5 inhibitors form a care that improves erectile dysfunction in diabetic men.

Plain-language summary: In this review we assessed the effect of these agents on erectile dysfunction in diabetic people. Eight studies with 976 men randomised to PDE-5 inhibitor therapy and a duration of mainly 12 weeks were evaluated. Compared to placebo treatment, these agents showed favourable effects in scores estimating sexual life, with an increased rate of adverse effects like headache and flushing after PDE-inhibitor therapy. Mortality was not reported in any of the included trials. Quality of life, with the exception of scores for sexual life, was not relevantly affected. If taken as prescribed, PDE-5 inhibitors comprise a valuable treatment option for erectile dysfunction in men with diabetes.