GEM/cochrane-simplification huggingface dataset:
Abstract: We included one RCT with 34 participants who were randomly assigned to receive IVIg or placebo once daily in addition to azathioprine and prednisolone for remission maintenance. There were no significant differences between adjuvant IVIg and adjuvant placebo in mortality, serious adverse events, time to relapse, open-label rescue therapy, and infection rates. The fall in disease activity score, derived from patient-reported symptoms, was slightly greater in the IVIg group than in the placebo group at one month (MD 2.30; 95% Confidence interval (CI) 1.12 to 3.48, P < 0.01) and three months (MD 1.80; 95% CI 0.35 to 3.25, P = 0.01). There was a significant increase in total adverse events in the IVIg group (relative risk (RR) 3.50; 95% CI 1.44 to 8.48, P < 0.01). There is insufficient evidence from one RCT that IVIg adjuvant therapy provides a therapeutic advantage compared with the combination of steroids and immunosuppressants for patients with WG. Given the high cost of IVIg (one dose at 2 g/kg for a 70 kg patient = $8,400), it should be limited to treat WG in the context of a well conducted RCT powered to detect patient-relevant outcomes.

Plain-language summary: We found one small randomized trial in which 34 participants were randomized to receive IVIg or placebo once daily in addition to azathioprine and prednisolone for remission maintenance. This trial did not provide enough evidence to determine if IVIg has an advantage over corticosteroids and immunosuppressants for the treatment of Wegener's granulomatosis.
Abstract: Three RCTs were identified. A qualitative approach with no meta analysis was performed because of variety in interventions between included studies. Interventions compared were antibiotics to no antibiotics, single to double compound antibiotic therapy and short to long IV administration. None of the studies found significant difference between the tested interventions. Risk of bias varied from low to high. The newest RCT overall had the best quality and statistical power. The newest evidence from one RCT says there is no significant difference between antibiotics versus no antibiotics in the treatment of uncomplicated diverticulitis. Previous RCTs have only suggested a non-inferiority between different antibiotic regimes and treatment lengths. This new evidence needs confirmation from more RCTs before it can be implicated safely in clinical guidelines. Ongoing RCTs will be published in the years to come and more are needed. The role of antibiotics in the treatment of complicated diverticulitis has not been investigated yet.

Plain-language summary: We found 3 randomized controlled trials (RCTs) on the use of antibiotics for uncomplicated diverticulitis tested on hospitalised patients. The newest trial investigating the actual need for antibiotics when compared to no antibiotics, a second investigated two different antibiotic cures and a third investigated the length of IV antibiotic treatment. None of the studies found a statistical difference in the tested antibiotic regimes. The newest trial had the overall best quality and had the biggest groups of patients making it the overall best trial. It found no difference in the occurrence of surgery needing complications like abscesses and perforations of the big bowel. Antibiotics can cause serious adverse events for patients like allergic reactions and can even cause other life threatening infections of the bowel. Ultimately, there is a growing antibiotic resistance meaning that the drugs loose their ability to function as bactericidals. This causes limitations in the clinical use of antibiotics when they are needed for treating patients with infections. Therefore there exists strong arguments for limiting the use of antibiotics. The trial that showed no effect of antibiotics is very new and needs confirmation from other similar trials. Ongoing trials will in the next few years be published on the subject.
Abstract: Three randomised controlled trials (1039 women) published between 1922 and 2005 fulfilled the prespecified criteria. In the earliest trial, 389 women were alternately allocated to receive either skin preparation and perineal shaving or clipping of vulval hair only. In the second trial, which included 150 participants, perineal shaving was compared with the cutting of long hairs for procedures only. In the third and most recent trial, 500 women were randomly allocated to shaving of perineal area or cutting of perineal hair. The primary outcome for all three trials was maternal febrile morbidity; no differences were found (risk ratio (RR) 1.14, 95% confidence interval (CI) 0.73 to 1.76). No differences were found in terms of perineal wound infection (RR 1.47, 95% CI 0.80 to 2.70) and perineal wound dehiscence (RR 0.33, 95% CI 0.01 to 8.00) in the most recent trial involving 500 women, which was the only trial to assess these outcomes. In the smallest trial, fewer women who had not been shaved had Gram-negative bacterial colonisation compared with women who had been shaved (RR 0.83, 95% CI 0.70 to 0.98). There were no instances of neonatal infection in either group in the one trial that reported this outcome. There were no differences in maternal satisfaction between groups in the larger trial reporting this outcome (mean difference (MD) 0.00, 95% CI -0.13 to 0.13). No trial reported on perineal trauma. One trial reported on side-effects and these included irritation, redness, burning and itching. The overall quality of evidence ranged from very low (for the outcomes postpartum maternal febrile morbidity and neonatal infection) to low (for the outcome maternal satisfaction and wound infection). There is insufficient evidence to recommend perineal shaving for women on admission in labour.

Plain-language summary: Three controlled trials that involved a total of 1039 women were reported on between 1922 and 2005. They each used an antiseptic skin preparation and compared perineal shaving with cutting vulval hairs. The overall quality of evidence ranged from very low (for the outcomes postpartum maternal febrile morbidity and neonatal infection) to low (for the outcomes wound infection and maternal satisfaction). When the findings of the trials were combined, no differences were found, with and without shaving, on the number of mothers who experiencing high body temperatures after the birth. One trial also looked at perineal wound infection, the incidence of open wounds and maternal satisfaction immediately after a perineal repair had been completed and found no difference between groups. Most of the side-effects attributable to shaving occurred later, as described by one of the trials. These included irritation, redness, multiple superficial scratches from the razor and burning and itching of the vulva. One trial assessed maternal satisfaction and found no difference between groups. Other outcomes such as pain, embarrassment or discomfort during hair regrowth, were not reported. The present review found no evidence of any clinical benefit with perineal shaving. Not routinely shaving women before labour appeared safe.
Abstract: Twenty-three published and unpublished studies (6061 participants) were included in the review. There was a significant change in forced expiratory volume in 1 second (FEV1) in favour of salmeterol 50 mcg twice daily (BID) of 51 mls (95% confidence intervals (CI) 32 to 70), end of study morning peak expiratory flow (PEF) 14.89 L/min (95% CI 10.86 to 18.91). Supplemental short-acting bronchodilator usage was reduced by just under one puff per day. There were significant differences in the total, activity and impact domain scores of the St George's respiratory questionnaire in favour of salmeterol 50 mcg BID. Findings from other health status measurements and symptom scores were conflicting. There was no significant difference in exercise tolerance. The number of participants experiencing exacerbations was significantly reduced with salmeterol 50 mcg treatment compared with placebo (numbers needed to treat to benefit 24). This review shows that the treatment of patients with COPD with salmeterol 50 mcg produces modest increases in lung function. There were varying effects for other important outcomes such as health related quality of life or reduction in symptoms. However, there was a consistent reduction in exacerbations which may help people with COPD who suffer frequent deterioration of symptoms prompting healthcare utilisation. The strength of evidence for the use of salmeterol 100 mcg, formoterol 12 mcg, 18 mcg, 24 mcg was insufficient to provide clear indications for practice.

Plain-language summary: This review aims to determine the effectiveness of long-acting beta-agonists, salmeterol or formoterol, in the treatment of COPD (emphysema/chronic bronchitis). These drugs improve airflow in the lungs, and enable people with COPD to get on with their daily activities. Twenty-four studies (6061 participants) reported the effects of LABAs in people with COPD. People taking salmeterol 50 mcg daily do have fewer exacerbations than those on placebo, and some improvement in lung function and certain quality of life scores. The findings were not consistent enough to support a general recommendation for the use of these drugs in the group of people with COPD with minimal variation in their lung function, although there is some evidence of improvement in important outcomes and these findings require further exploration in additional trials.
Abstract: The original review included 10 studies with 996 participants. This updated review included 15 studies (1509 participants); 11 assessed naproxen sodium and four naproxen. In nine studies (784 participants) using 500/550 mg naproxen or naproxen sodium the NNT for at least 50% pain relief over four to six hours was 2.7 (95% CI 2.3 to 3.2). No dose response was demonstrated over the range 200/220 mg to 500/550 mg, but limited data was identified. Median time to use of rescue medication was 8.9 hours for naproxen 500/550 mg and 2.0 hours for placebo. Use of rescue medication was significantly less common with naproxen than placebo. Associated adverse events were generally of mild to moderate severity and rarely led to withdrawal. Doses equivalent to 500 mg and 400 mg naproxen administered orally provided effective analgesia to adults with moderate to severe acute postoperative pain. About half of participants treated with these doses experienced clinically useful levels of pain relief, compared to 15% with placebo, and half required additional medication within nine hours, compared to two hours with placebo. Associated adverse events did not differ from placebo.

Plain-language summary: This review assessed evidence from 1509 participants in 15 randomised, double blind, placebo-controlled clinical trials of naproxen or naproxen sodium (a non-steroidal anti-inflammatory drug) in adults with moderate to severe acute postoperative pain. At doses equivalent to 500 mg and 400 mg, orally administered naproxen provides effective analgesia. About half of those treated experienced at least half pain relief over four to six hours, and the effects lasted, on average, up to nine hours. Associated adverse events did not differ from placebo, but these studies are of limited use for studying adverse effects.
Abstract: Three trials with a total of 81 patients were included in the analysis. Forty patients were randomized to azathioprine and forty-one to placebo. A pooled estimate was calculated for two outcomes. A statistically significant benefit was observed for azathioprine when compared to placebo for tender joint scores. The standardized weighted mean difference between treatment and placebo was -0.98 (95% CI -1.45, -0.50). Withdrawals from adverse reactions were significantly higher in the azathioprine group OR=4.56 (95% CI 1.16, 17.85). Azathioprine appears to have a statistically significant benefit on the disease activity in joints of patients with RA. This evidence however is based on a small number of patients, included in older trials. Its effects on long-term functional status and radiological progression were not assessed due to lack of data. Toxicity is shown to be higher and more serious than that observed with other disease-modifying anti-rheumatic drugs (DMARDs). Given this high risk to benefit ratio, there is no evidence to recommend the use of azathioprine over other DMARDs.

Plain-language summary: Azathioprine is a drug that suppresses the immune system. This review includes three trials with a total of 81 patients. Forty patients were given azathioprine and forty-one were given placebo. Patients taking azathioprine had lower tender joint scores when compared to patients taking placebo. Significantly more patients in the azathioprine group withdrew from the studies due to adverse reactions compared to patients in the placebo group. This evidence is based on a small number of patients in older trials. These findings suggest that several other drugs should be used before considering azathioprine for a patient with rheumatoid arthritis.
Abstract: Six trials were included, involving 606 participants. Five trials included comparisons of ultrasound therapy with sham ultrasound; and three trials included single comparisons of ultrasound with three other treatments. The assessment of risk of bias was hampered by poor reporting of trial methods and results. None of the five placebo-controlled trials (sham ultrasound) demonstrated statistically significant differences between true and sham ultrasound therapy for any outcome measure at one to four weeks of follow-up. The pooled risk ratio for general improvement at one week was 1.04 (random-effects model, 95% confidence interval 0.92 to 1.17) for active versus sham ultrasound. The differences between intervention groups were generally small, between zero and six per cent, for most dichotomous outcomes. The evidence from the five small placebo-controlled trials included in this review does not support the use of ultrasound in the treatment of acute ankle sprains. The potential treatment effects of ultrasound appear to be generally small and of probably of limited clinical importance, especially in the context of the usually short-term recovery period for these injuries. However, the available evidence is insufficient to rule out the possibility that there is an optimal dosage schedule for ultrasound therapy that may be of benefit.

Plain-language summary: The review aimed to look at the evidence from studies testing the use of ultrasound in clinical practice. Six trials were included in the review. Poor reporting of trial methods made it difficult to assess the risk of bias of the included studies. The six trials involved a total of 606 participants with acute ankle sprains of relatively short duration. Five trials compared ultrasound therapy with sham ultrasound (machine turned off). Three of the six trials included single comparisons of ultrasound with three other treatments. The main results were from the review of the five placebo-controlled trials (sham ultrasound). These found that ultrasound therapy does not seem to enhance recovery or help to reduce pain and swelling after an ankle sprain, or improve the ability to stand on the affected foot and ankle. Most ankle sprains heal quickly. While ultrasound may still improve recovery in a small way, this potential benefit is probably too small to be important.
Abstract: Eleven trials (550 women) compared corticosteroids with placebo or no treatment. There was no difference in the risk of maternal death (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.28 to 3.21), maternal death or severe maternal morbidity (RR 0.27, 95% CI 0.03 to 2.12), or perinatal/infant death (RR 0.64, 95% CI 0.21 to 1.97). The only clear effect of treatment on individual outcomes was improved platelet count (standardized mean difference (SMD) 0.67, 95% CI 0.24 to 1.10). The effect on platelet count was strongest for women who commenced treatment antenatally (SMD 0.80, 95% CI 0.25 to 1.35). Two trials (76 women) compared dexamethasone with betamethasone. There was no clear evidence of a difference between groups in respect to perinatal/infant death (RR 0.95, 95% CI 0.15 to 6.17) or severe perinatal/infant morbidity or death (RR 0.64, 95% CI 0.27 to 1.48). Maternal death and severe maternal morbidity were not reported. In respect to platelet count, dexamethasone was superior to betamethasone (MD 6.02, 95% CI 1.71 to 10.33), both when treatment was commenced antenatally (MD 8.10, 95% CI 6.23 to 9.97) and postnatally (MD 3.70, 95% CI 0.96 to 6.44). There was no clear evidence of any effect of corticosteroids on substantive clinical outcomes. Those receiving steroids showed significantly greater improvement in platelet counts which was greater for those receiving dexamethasone than those receiving betamethasone. There is to date insufficient evidence of benefits in terms of substantive clinical outcomes to support the routine use of steroids for the management of HELLP. The use of corticosteroids may be justified in clinical situations in which increased rate of recovery in platelet count is considered clinically worthwhile.

Plain-language summary: Infant health may also be poor, primarily due to premature birth and growth restriction.This review examined the effect of treating women with HELLP syndrome using corticosteroids (which can reduce inflammation). The results of this review did not indicate that there was a clear effect on the health of pregnant women when treated with corticosteroids, or their babies. Corticosteroids did appear to improve some components of the women's blood tests, but it is not clear that this had an effect on their overall health. The review identified 11 randomized controlled trials involving 550 women that compared corticosteroid (dexamethasone, betamethasone, or prednisolone) given during pregnancy, just after delivery or in the postnatal period, or both before and after birth, with placebo or no treatment. Two further trials showed that there was no clear difference between dexamethasone and betamethasone on the substantive clinical outcomes for women or their infants. Dexamethasone did improve maternal platelet count and some biochemical measures to a greater extent than betamethasone.
Abstract: Twelve trials were eligible for inclusion. Three of these trials, involving a total of 909 patients, compared ICS plus systemic corticosteroids versus oral corticosteroid therapy alone. There was no demonstrated benefit of ICS therapy when used in addition to oral corticosteroid therapy in the trials. Relapses were reduced; however, this was not statistically significant with the addition of ICS therapy (OR 0.68; 95% CI 0.46 to 1.02; 3 studies; N = 909). In addition, no statistically significant differences were demonstrated between the two groups for relapses requiring admission, quality of life, symptom scores or adverse effects. Nine trials, involving a total of 1296 patients compared high-dose ICS therapy alone versus oral corticosteroid therapy alone after ED discharge. There were no significant differences demonstrated between ICS therapy alone versus oral corticosteroid therapy alone for relapse rates (OR 1.00; 95% CI 0.66 to 1.52; 4 studies; N = 684), admissions to hospital, or in the secondary outcomes of beta2-agonist use, symptoms or adverse events. However, the sample size was not adequate to exclude the possibility of either treatment being significantly inferior and people with severe asthma were excluded from these trials. There is insufficient evidence that ICS therapy provides additional benefit when used in combination with standard systemic corticosteroid therapy upon ED discharge for acute asthma. There is some evidence that high-dose ICS therapy alone may be as effective as oral corticosteroid therapy when used in mild asthmatics upon ED discharge; however, the confidence intervals were too wide to be confident of equal effectiveness. Further research is needed to clarify whether ICS therapy should be employed in acute asthma treatment following ED discharge. The review does not suggest any reason to stop usual treatment with ICS following ED discharge, even if a course of oral corticosteroids are prescribed.

Plain-language summary: This review of trials found that there was insufficient evidence that inhaling corticosteroids as well as taking the drugs orally is better than oral use alone, after emergency department treatment for an asthma attack. There is also insufficient evidence that taking ICS alone is as good as taking them orally, although there is some evidence to support using ICS alone for mild asthma attacks after emergency department discharge. More research is needed.
Abstract: After conducting initial searches and screening the titles and abstracts of the identified literature, 77 full text papers were retrieved and read. Ultimately three studies were included. Two controlled before-after studies were conducted in hospital settings (one in the UK and one in the Netherlands) and one cluster randomised controlled trial was conducted in a primary care setting (in the USA). The study conducted in primary care reported that physicians were receptive to the screening intervention, but the intervention did not result in any improvements in the malnutrition detection rate or nutritional intervention rate. The two studies conducted in hospitals had important methodological limitations. One study reported that as a result of the intervention, the recording of patients' weight increased in the intervention wards. No significant changes were observed in the referral rates to dietitians or care at meal time. The third study reported weight gains and a reduction in hospital acquired infection rate in the intervention hospital. They found no significant differences in length of stay, pressure sores, malnutrition and treatment costs per patient between the two hospitals. Current evidence is insufficient to support the effectiveness of nutritional screening, although equally there is no evidence of no effect. Therefore, more high quality studies should be conducted to assess the effectiveness of nutritional screening in different settings.

Plain-language summary: We searched for studies evaluating the effects of nutritional screening as a main intervention in hospital and primary care settings on patient outcomes such as mortality, illness, health related quality of life, and change in BMI or weight. We also searched for studies evaluating process outcomes like identification of patients requiring nutritional care, data recording (e.g. weight and BMI), or referral of patients to dietitians or similar. Three studies met our inclusion criteria, but they were very dissimilar in their design, setting, intervention and outcomes. One study found that primary care physicians were receptive to the intervention but it did not result in any improvement in detection rate and nutritional intervention rate. Two studies were conducted in hospitals: one reported that patients’ weight documentation increased as a result of the intervention, and the other reported significant weight gains and reduction in hospital acquired infection rate in the intervention hospital. Both of these studies suffered from limitations in their design, and it was not possible to rule out the impact of confounding factors on their findings. As a result, we conclude that evidence on the effectiveness of nutritional screening is insufficient. Therefore, further high quality studies should be conducted to assess the effectiveness of nutritional screening programmes in hospitals and communities.