GEM/cochrane-simplification huggingface dataset:
Abstract: Fourteen trials (1,724 analysed participants or ears). CSOM definitions and severity varied; some included otitis externa, mastoid cavity infections and other diagnoses. Methodological quality varied; generally poorly reported, follow-up usually short, handling of bilateral disease inconsistent. Topical quinolone antibiotics were better than no drug treatment at clearing discharge at one week: relative risk (RR) was 0.45 (95% confidence interval (CI) 0.34 to 0.59) (two trials, N = 197). No statistically significant difference was found between quinolone and non-quinolone antibiotics (without steroids) at weeks one or three: pooled RR were 0.89 (95% CI 0.59 to 1.32) (three trials, N = 402), and 0.97 (0.54 to 1.72) (two trials, N = 77), respectively. A positive trend in favour of quinolones seen at two weeks was largely due to one trial and not significant after accounting for heterogeneity: pooled RR 0.65 (0.46 to 0.92) (four trials, N = 276) using the fixed-effect model, and 0.64 (95% CI 0.35 to 1.17) accounting for heterogeneity with the random-effects model. Topical quinolones were significantly better at curing CSOM than antiseptics: RR 0.52 (95% CI 0.41 to 0.67) at one week (three trials, N = 263), and 0.58 (0.47 to 0.72) at two to four weeks (four trials, N = 519). Meanwhile, non-quinolone antibiotics (without steroids) compared to antiseptics were more mixed, changing over time (four trials, N = 254). Evidence regarding safety was generally weak. Topical quinolone antibiotics can clear aural discharge better than no drug treatment or topical antiseptics; non-quinolone antibiotic effects (without steroids) versus no drug or antiseptics are less clear. Studies were also inconclusive regarding any differences between quinolone and non-quinolone antibiotics, although indirect comparisons suggest a benefit of topical quinolones cannot be ruled out. Further trials should clarify non-quinolone antibiotic effects, assess longer-term outcomes (for resolution, healing, hearing, or complications) and include further safety assessments, particularly to clarify the risks of ototoxicity and whether quinolones may result in fewer adverse events than other topical treatments.

Plain-language summary: Quinolone antibiotic drops (considered to be the 'gold standard' topical antibiotics) are better than no drug treatment or antiseptics at drying the ear. The effects of non-quinolone antibiotics (without steroids) when compared to antiseptics are less clear. Studies were also inconclusive regarding any differences between quinolone and non-quinolone antibiotics, although indirect evidence suggests a benefit of quinolones cannot be ruled out. Less is known about longer-term outcomes (producing a dry ear in the long term, preventing complications, healing the eardrum, and improving hearing), or about treating complicated CSOM. The evidence in these trials about safety is also weak. More research is needed to assess whether there may be fewer adverse events with topical quinolones than with alternative topical treatments.
Abstract: Fourteen trials contributed to this review (753 participants). There was some moderate quality evidence that HBOT was more likely to achieve mucosal coverage with osteoradionecrosis (ORN) (risk ratio (RR) 1.3; 95% confidence interval (CI) 1.1 to 1.6, P value = 0.003, number needed to treat for an additional beneficial outcome (NNTB) 5; 246 participants, 3 studies). There was also moderate quality evidence of a significantly improved chance of wound breakdown without HBOT following operative treatment for ORN (RR 4.2; 95% CI 1.1 to 16.8, P value = 0.04, NNTB 4; 264 participants, 2 studies). From single studies there was a significantly increased chance of improvement or cure following HBOT for radiation proctitis (RR 1.72; 95% CI 1.0 to 2.9, P value = 0.04, NNTB 5), and following both surgical flaps (RR 8.7; 95% CI 2.7 to 27.5, P value = 0.0002, NNTB 4) and hemimandibulectomy (RR 1.4; 95% CI 1.1 to 1.8, P value = 0.001, NNTB 5). There was also a significantly improved probability of healing irradiated tooth sockets following dental extraction (RR 1.4; 95% CI 1.1 to 1.7, P value = 0.009, NNTB 4). There was no evidence of benefit in clinical outcomes with established radiation injury to neural tissue, and no randomised data reported on the use of HBOT to treat other manifestations of LRTI. These trials did not report adverse events. These small trials suggest that for people with LRTI affecting tissues of the head, neck, anus and rectum, HBOT is associated with improved outcome. HBOT also appears to reduce the chance of ORN following tooth extraction in an irradiated field. There was no such evidence of any important clinical effect on neurological tissues. The application of HBOT to selected participants and tissues may be justified. Further research is required to establish the optimum participant selection and timing of any therapy. An economic evaluation should be undertaken.

Plain-language summary: There was some evidence that HBOT improved outcome in LRTI affecting bone and soft tissues of the head and neck, for radiation proctitis (inflammation of the lower part of the large intestine caused by radiotherapy treatment) and to prevent the development of osteoradionecrosis (bone death caused by radiotherapy treatment) following tooth extraction in an irradiated field. There was no such evidence of any important clinical effect on tissues in the nervous system. The evidence was generally of moderate quality and limited by small numbers of participants, poor reporting of methods and results, and uncertainty as to the exact degree of improvement with HBOT. The application of HBOT to selected participants and tissues may be justified. Studies of radiation injury suggest that other tissues are also likely to respond (e.g. bladder). Further research is required to establish which people may respond and the best timing of such therapy. A study of costs would also be useful.
Abstract: We located 10 RCTs involving 2961 participating surgeons performing an operation in which the use of blunt needles was compared to the use of sharp needles. Four studies focused on abdominal closure, two on caesarean section, two on vaginal repair and two on hip replacement. On average, a surgeon that used sharp needles sustained one glove perforation in three operations. The use of blunt needles reduced the risk of glove perforations with a relative risk (RR) of 0.46 (95% confidence interval (CI) 0.38 to 0.54) compared to sharp needles. The use of blunt needles will thus prevent one glove perforation in every six operations. In four studies, the use of blunt needles reduced the number of self-reported needle stick injuries with a RR of 0.31 (95% CI 0.14 to 0.68). Because the force needed for the blunt needles is higher, their use was rated as more difficult but still acceptable in five out of six studies. The quality of the evidence was rated as high. There is high quality evidence that the use of blunt needles appreciably reduces the risk of exposure to blood and bodily fluids for surgeons and their assistants over a range of operations. It is unlikely that future research will change this conclusion.

Plain-language summary: We reviewed the literature to evaluate the preventive effect of blunt needles compared to sharp needles on needle stick injuries among surgical staff. We searched multiple medical databases (to May 2011). We included studies if they were randomised controlled trials (RCTs) of blunt versus sharp suture needles for preventing needle stick injuries among surgical staff. We located 10 RCTs with 2961 operations in which blunt needles were compared to sharp needles. Six studies focused on abdominal operations, two on vaginal repair and two on hip replacement. On average, a surgeon that used sharp needles sustained one glove perforation per three operations. The use of blunt needles reduced the risk of glove perforations by 54% (95% confidence interval 46% to 62%) compared to sharp needles. The use of blunt needles in six operations will thus prevent one glove perforation. In four studies the use of blunt needles also reduced the number of self-reported needle stick injuries by 69% (95% confidence interval 14% to 68%). Even though surgeons reported that the force needed for the blunt needles was higher, their use of the needles was still rated as acceptable in five out of six studies. We concluded that there is high quality evidence that the use of blunt needles appreciably reduces the risk of contracting infectious diseases for surgeons and their assistants over a range of operations by reducing the number of needle stick injuries. It is unlikely that future research will change this conclusion.
Abstract: We found nine eligible RCTs including 593 infants in total. These trials compared responsive with scheduled interval regimens in preterm infants in the transition phase from intragastric tube to oral feeding. The trials were generally small and contained various methodological weaknesses including lack of blinding and incomplete assessment of all randomised participants. Meta-analyses, although limited by data quality and availability, suggest that responsive feeding results in slightly slower rates of weight gain (MD −1.36, 95% CI −2.44 to −0.29 g/kg/day), and provide some evidence that responsive feeding reduces the time taken for infants to transition from enteral tube to oral feeding (MD −5.53, 95% CI −6.80 to −4.25 days). GRADE assessments indicated low quality of evidence. The importance of this finding is uncertain as the trials did not find a strong or consistent effect on the duration of hospitalisation. None of the included trials reported any parent, caregiver, or staff views. Overall, the data do not provide strong or consistent evidence that responsive feeding affects important outcomes for preterm infants or their families. Some (low quality) evidence exists that preterm infants fed in response to feeding and satiation cues achieve full oral feeding earlier than infants fed prescribed volumes at scheduled intervals. This finding should be interpreted cautiously because of methodological weaknesses in the included trials. A large RCT would be needed to confirm this finding and to determine if responsive feeding of preterm infants affects other important outcomes.

Plain-language summary: We searched for all available evidence up to January 2016. We found nine eligible randomised controlled trials (including a total of 593 infants) that examined whether feeding preterm infants in response to their own feeding and satiation cues (sometimes called 'demand' feeding) is better than feeding set volumes of milk at predefined intervals. These trials compared responsive with scheduled interval regimens in preterm infants in the transition phase from intragastric tube to oral feeding. Although the trials were generally small and most had some methodological weaknesses, analysis suggests that responsive feeding results in slightly slower rates of weight gain and reduces the time taken for infants to transition from enteral tube to oral feeding. The quality of this evidence is low, and the importance of this finding is uncertain as the trials did not find a strong or consistent effect on the length of hospitalisation. None of the included trials reported any parent, caregiver, or staff views. This Cochrane review does not provide strong or consistent evidence that responsive feeding improves outcomes for preterm infants or their families. Responsive feeding might help infants transition more quickly to oral feeding, but more randomised controlled trials would be needed to confirm this finding.
Abstract: Two randomised trials with a total of 161 participants were included in this review. The studies did not report on mortality and rate of limb loss. One randomised trial with a total of 133 participants showed that there was a significant improvement in ankle brachial index (ABI) in participants who received folic acid compared with placebo (mean difference (MD) 0.07, 95% confidence interval (CI) 0.04 to 0.11, P < 0.001) and in participants who received 5-methyltetrahydrofolate (5-MTHF) versus placebo (MD 0.05, 95% CI 0.01 to 0.10, P = 0.009). A second trial with a total of 18 participants showed that there was no difference (P non-significant) in ABI in participants who received a multivitamin B supplement (mean ± SEM: 0.7 ± 01) compared with placebo (mean ± SEM: 0.8 ± 0.1). No major events were reported. Currently, no recommendation can be made regarding the value of treatment of hyperhomocysteinaemia in peripheral arterial disease. Further, well constructed trials are urgently required.

Plain-language summary: We looked at studies where treatments to lower homocysteine were used in people with PAD and hyperhomocysteinaemia. Two trials with 161 participants with PAD were included in this review. One trial showed a significant  improvement in the ankle brachial index (ABI) in participants treated daily with 400 μg folic acid or 5-methyltetrahydrofolate (5-MTHF). A second trial showed that there was no difference in ABI in participants who received a multivitamin B supplement compared with placebo. None of the other predefined primary outcomes (mortality and rate of limb loss) were assessed in these studies. More research about the effect of homocysteine lowering therapy on the clinical progression of disease in people with PAD and hyperhomocysteinaemia is needed.
Abstract: We included 21 randomised controlled trials (RCTs) reported in 54 papers involving over 17,000 women and their babies. One trial did not contribute data. Trials were generally at low risk of bias. Zinc supplementation resulted in a small reduction in preterm birth (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.76 to 0.97 in 16 RCTs; 16 trials of 7637 women). This was not accompanied by a similar reduction in numbers of babies with low birthweight (RR 0.93, 95% CI 0.78 to 1.12; 14 trials of 5643 women). No clear differences were seen between the zinc and no zinc groups for any of the other primary maternal or neonatal outcomes, except for induction of labour in a single trial. No differing patterns were evident in the subgroups of women with low versus normal zinc and nutrition levels or in women who complied with their treatment versus those who did not. The GRADE quality of the evidence was moderate for preterm birth, small-for-gestational age, and low birthweight, and low for stillbirth or neonatal death and birthweight. The evidence for a 14% relative reduction in preterm birth for zinc compared with placebo was primarily represented by trials involving women of low income and this has some relevance in areas of high perinatal mortality. There was no convincing evidence that zinc supplementation during pregnancy results in other useful and important benefits. Since the preterm association could well reflect poor nutrition, studies to address ways of improving the overall nutritional status of populations in impoverished areas, rather than focusing on micronutrient and or zinc supplementation in isolation, should be an urgent priority.

Plain-language summary: Many women of childbearing age may have mild to moderate zinc deficiency. Low zinc concentrations may cause preterm birth or they may even prolong labour. It is also possible that zinc deficiency may affect infant growth as well. This review of 21 randomised controlled trials, involving over 17,000 women and their babies, found that although zinc supplementation has a small effect on reducing preterm births, it does not help to prevent low birthweight babies compared with not giving zinc supplements before 27 weeks of pregnancy. One trial did not contribute data. The overall risk of bias was unclear in half of the studies. No clear differences were seen for development of pregnancy hypertension or pre-eclampsia. The 14% relative reduction in preterm birth for zinc compared with placebo was primarily represented by trials of women with low incomes. In some trials all women were also given iron, folate or vitamins or combinations of these. UNICEF is already promoting antenatal use of multiple-micronutrient supplementation, including zinc, to all pregnant women in developing countries. Finding ways to improve women's overall nutritional status, particularly in low-income areas, will do more to improve the health of mothers and babies than supplementing pregnant women with zinc alone. In low- to middle- income countries, addressing anaemia and infections, such as malaria and hookworm, is also necessary.
Abstract: We included 15 RCTs with a total of 1048 participants. Most of the trials were conducted in India, followed by Europe and the United States. The majority of participants were adults of both sexes with mild to moderate asthma for six months to more than 23 years. Five studies included yoga breathing alone, while the other studies assessed yoga interventions that included breathing, posture, and meditation. Interventions lasted from two weeks to 54 months, for no more than six months in the majority of studies. The risk of bias was low across all domains in one study and unclear or high in at least one domain for the remainder. There was some evidence that yoga may improve quality of life (MD in Asthma Quality of Life Questionnaire (AQLQ) score per item 0.57 units on a 7-point scale, 95% CI 0.37 to 0.77; 5 studies; 375 participants), improve symptoms (SMD 0.37, 95% CI 0.09 to 0.65; 3 studies; 243 participants), and reduce medication usage (RR 5.35, 95% CI 1.29 to 22.11; 2 studies) in people with asthma. The MD for AQLQ score exceeded the minimal clinically important difference (MCID) of 0.5, but whether the mean changes exceeded the MCID for asthma symptoms is uncertain due to the lack of an established MCID in the severity scores used in the included studies. The effects of yoga on change from baseline forced expiratory volume in one second (MD 0.04 litres, 95% CI -0.10 to 0.19; 7 studies; 340 participants; I2 = 68%) were not statistically significant. Two studies indicated improved asthma control, but due to very significant heterogeneity (I2 = 98%) we did not pool data. No serious adverse events associated with yoga were reported, but the data on this outcome was limited. We found moderate-quality evidence that yoga probably leads to small improvements in quality of life and symptoms in people with asthma. There is more uncertainty about potential adverse effects of yoga and its impact on lung function and medication usage. RCTs with a large sample size and high methodological and reporting quality are needed to confirm the effects of yoga for asthma.

Plain-language summary: We reviewed 15 studies that compared the effects of yoga with usual treatment or a 'sham' yoga in 1048 participants. We found that yoga probably improves quality of life and asthma symptoms to some extent. However, our confidence in the results is low as most of the studies were flawed in various ways. The effects of yoga on lung function were inconsistent, and we found a small amount of evidence indicating that yoga can reduce medication usage. Information on unwanted side effects was very limited; more studies are needed to assess this. High-quality studies involving large numbers of participants are required for us to be able to draw a firm conclusion about the effects of yoga for asthma.
Abstract: No new trials were identified for this first update. We included nine RCTs (3144 participants). Linezolid was associated with a significantly better clinical (RR 1.09, 95% CI 1.03 to 1.16) and microbiological cure rate in adults (RR 1.08, 95% CI 1.01 to 1.16). For those infections due to MRSA, linezolid was significantly more effective than vancomycin in clinical (RR 1.09, 95% CI 1.03 to 1.17) and microbiological cure rates (RR 1.17, 95% CI 1.04 to 1.32). No RCT reported SSTI-related and treatment-related mortality. There was no significant difference in all-cause mortality between linezolid and vancomycin (RR 1.44, 95% CI 0.75 to 2.80). There were fewer incidents of red man syndrome (RR 0.04, 95% CI 0.01 to 0.29), pruritus (RR 0.36, 95% CI 0.17 to 0.75) and rash (RR 0.27, 95% CI 0.12 to 0.58) in the linezolid group compared with vancomycin, however, more people reported thrombocytopenia (RR 13.06, 95% CI 1.72 to 99.22), and nausea (RR 2.45, 95% CI 1.52 to 3.94) when treated with linezolid. It seems, from the available data, that length of stay in hospital was shorter for those in the linezolid group than the vancomycin group. The daily cost of outpatient therapy was less with oral linezolid than with intravenous vancomycin. Although inpatient treatment with linezolid cost more than inpatient treatment with vancomycin per day, the median length of hospital stay was three days shorter with linezolid. Thus, total hospital charges per patient were less with linezolid treatment than with vancomycin treatment. Linezolid seems to be more effective than vancomycin for treating people with SSTIs, including SSTIs caused by MRSA. The available evidence is at high risk of bias and is based on studies that were supported by the pharmaceutical company that makes linezolid. Further well-designed, independently-funded, RCTs are needed to confirm the available evidence.

Plain-language summary: This review identified nine RCTs, with a total of 3144 participants, and compared treatment with linezolid against treatment with vancomycin for skin and soft tissue infections. No new trials were identified for this first update. Linezolid was found to be more effective than vancomycin for treating these infections. There were fewer skin complications in the group that were treated with linezolid. There were no differences between the two groups in the number of reported deaths, and those treated with linezolid had shorter lengths of hospital stay than those treated with vancomycin. The daily cost of outpatient therapy was less with oral linezolid than with intravenous vancomycin, although for inpatient treatment, linezolid was more expensive than vancomycin. Well-designed trials will be required in future to confirm these results, as the trials from which these conclusions were drawn were of poor methodological quality, at high risk of bias, and were funded by the pharmaceutical company that makes linezolid.