GEM/cochrane-simplification huggingface dataset:
Abstract: We included 46 randomized studies, 40 on vasovagal syncope and six on carotid sinus syncope. No studies on situational syncope matched the criteria for inclusion in our review. Studies in general were small with a median sample size of 42. A wide range of control treatments were used with 22 studies using a placebo arm. Blinding of patients and treating physicians was applied in eight studies. Results varied considerably between studies and between types of outcomes. For vasovagal syncope, the occurrence of syncope upon provocational head-up tilt testing was lower upon treatment with beta-blockers, ACE-inhibitors and anticholinergic agents compared to standard treatment. For carotid sinus syncope, the occurrence of syncope upon carotid sinus massage was lower on midodrine treatment compared to placebo treatment in one study. There is insufficient evidence to support the use of any of the pharmacological or pacemaker treatments for vasovagal syncope and carotid sinus syncope. Larger studies using patient relevant outcomes are needed.

Plain-language summary: We included 46 randomized studies, 40 on vasovagal syncope and six on carotid sinus syncope. No studies on situational syncope matched the criteria for inclusion in our review. Studies in general were small with a median size of 42 patients. A wide range of control treatments were used with 22 studies using placebo control treatment. Blinding of patients and treating physicians was applied in eight studies. The type of outcomes reported by studies varied considerably with only 16 studies reporting on non-provoked recurrences during follow-up. As a consequence of all these differences, results varied considerably between studies and between types of outcomes. In some studies significant results were reported for one type of outcome, but not for other outcomes. We conclude that there is insufficient evidence either to support or to refute the use of any of the pharmacological or pacemaker treatments for vasovagal syncope and carotid sinus syncope.
Abstract: We included seven RCTs with a total of 651 participants, mean age 31.7 to 55.5 years, conducted in three different countries (Turkey, Jordan and China). The length of follow-up ranged from one week to six months. Most RCTs used continuous TENS, with a frequency of 60 Hz to 100 Hz, pulse width of 40 μs to 250 μs and tolerable intensity, described as a tingling sensation without contraction, in daily sessions lasting 20 to 60 minutes. Due to heterogeneity in interventions and outcomes, we did not pool individual study data into meta-analyses. Overall, we judged most studies as being at low risk for selection bias and high risk for performance and detection bias. Based on the GRADE approach, there was very low-certainty evidence from two trials about the effects of conventional TENS when compared to sham TENS at short-term (up to 3 months after treatment) follow-up, on pain (assessed by the Visual Analogue Scale (VAS)) (MD -0.10, 95% CI -0.97 to 0.77) and the percentage of participants presenting improvement of pain (RR 1.57, 95% CI 0.84 to 2.92). None of the included studies reported on disability or adverse events. This review found very low-certainty evidence of a difference between TENS compared to sham TENS on reducing neck pain; therefore, we are unsure about the effect estimate. At present, there is insufficient evidence regarding the use of TENS in patients with chronic neck pain. Additional well-designed, -conducted and -reported RCTs are needed to reach robust conclusions.

Plain-language summary: We included seven studies that enrolled a total of 651 participants (mean age 31.7 to 55.5 years) with chronic neck pain. Each study included between 30 and 218 participants. The participants received TENS or a control intervention (placebo or another type of treatment). The studies were very different in terms of the duration of the TENS sessions (from 20 to 60 minutes), number of sessions (from 1 to 12) and total duration of the treatment programmes (from 1 to 45 days). Because of the differences between each of the included studies, we decided that it would not be appropriate to combine their results. Out of the seven studies included, two reported that TENS was no better than inactive treatment (placebo) in reducing the participants' neck pain. None of the included studies assessed disability or adverse events. There was very low-certainty evidence about the effects of TENS for treating chronic neck pain.
Abstract: Nine studies were identified that compared thyroid hormone treatment to control. Four randomized (Chowdhry 1984, van Wassenaer 1997; Vanhole 1997; Smith 2000) and one quasi-randomized study (Amato 1989) met inclusion criteria. All studies enrolled preterm infants < 32 weeks gestation, but used different timing, dose and duration of treatment with thyroid hormones. Four studies used thyroxine, whereas Amato 1989 used triiodothyronine. Only two studies with neurodevelopmental follow-up were of good methodology (van Wassenaer 1997, Vanhole 1997). All studies were of small size with the largest, van Wassenaer 1997, enrolling 200 infants. Meta-analysis of five studies found no significant difference in mortality to discharge (typical RR 0.70, 95% CI 0.42, 1.17) in infants who received thyroid hormone treatment compared to controls. Meta-analysis of two studies (van Wassenaer 1997; Vanhole 1997) found no significant difference in the Bayley MDI or PDI performed at 7-12 months. van Wassenaer 1997 found no significant differences in the Bayley MDI and PDI at 24 months, incidence of cerebral palsy (RR 0.72, 95% CI 0.28, 1.84), death and cerebral palsy (RR 0.70, 95% CI 0.43, 1.14) or the RAKIT IQ score (WMD -2.10, 95% CI -7.91, 3.71) at 5.7 years of age. Fraction of inspired oxygen was lower in infants receiving triiodothyronine in one small quasi-randomized study, but not in infants receiving thyroxine in a randomized study. Duration of mechanical ventilation and incidence of chronic lung disease were not reduced in infants receiving early thyroid hormone therapy. This review does not support the use of thyroid hormones in preterm infants to reduce neonatal mortality, improve neurodevelopmental outcome or to reduce the severity of respiratory distress syndrome. An analyses of data from one study (van Wassenaer 1997) which showed benefits in infants 24-25 weeks gestation was not prespecified and should be treated with caution. The small number of infants included in trials incorporated in this review limits the power of the meta-analysis to detect clinically important differences in neonatal outcomes. Future trials are warranted and should be of sufficient size to detect clinically important differences in neurodevelopmental outcomes. They should consider enrolling those infants most likely to benefit from thyroid hormone treatment such as infants born at less than 27 weeks gestation.

Plain-language summary: No evidence from trials that thyroid hormone therapy is effective in preventing problems such as respiratory distress syndrome in preterm babies. Thyroid hormones are needed for the normal growth and maturity of the central nervous system, as well as the heart and lungs. Children born without sufficient thyroid hormones can develop serious mental retardation. It is believed that low levels of thyroid hormones in the first few weeks of life (transient hypothyroxinemia) in preterm babies born before 34 weeks may cause this abnormal development. The review of trials found no evidence that using thyroid hormones in preterm babies is effective in reducing the risk of problems caused by insufficient thyroid hormones.
Abstract: We included 13 studies with a total of 445 participants. The quality of the trials was generally poor and no results could be pooled due to the treatments being so heterogeneous. Treatment with thalidomide showed a significant remission of skin lesions compared to acetylsalicylic acid (aspirin) (RR 2.43; 95% CI 1.28 to 4.59) (1 trial, 92 participants). Clofazimine treatment was superior to prednisolone (more treatment successes; RR 3.67; 95% CI 1.36 to 9.91) (1 trial, 24 participants), and thalidomide (fewer recurrences; RR 0.08; 95% CI 0.01 to 0.56) (1 trial, 72 participants). We did not find any significant benefit for intravenous betamethasone compared to dextrose (1 trial, 10 participants), pentoxifylline compared to thalidomide (1 trial, 44 participants), indomethacin compared to prednisolone, aspirin or chloroquine treatments (2 trials, 80 participants), or levamisole compared to placebo (1 trial, 12 participants). Mild to moderate adverse events were significantly lower in participants taking 100 mg thalidomide compared to 300 mg thalidomide daily (RR 0.46; 95% CI 0.23 to 0.93). Significantly more minor adverse events were reported in participants taking clofazimine compared with prednisolone (RR 1.92; 95% CI 1.10 to 3.35). None of the studies assessed quality of life or economic outcomes. There is some evidence of benefit for thalidomide and clofazimine, but generally we did not find clear evidence of benefit for interventions in the management of ENL. However, this does not mean they do not work, because the studies were small and poorly reported. Larger studies using clearly defined participants, outcome measures, and internationally recognised scales are urgently required.

Plain-language summary: Our review included 13 randomised controlled trials involving 445 participants. These trials assessed: betamethasone (1 trial), thalidomide (5 trials), pentoxifylline (1 trial), clofazimine (3 trials), indomethacin (2 trials), and levamisole (1 trial). Generally, the quality of the studies was poor and many were too small to identify important clinical differences even if they existed. Three small trials showed benefit for thalidomide and clofazimine treatment in terms of fewer further reactions, more treatment successes, and less relapses of ENL. Adverse events were reported in most of the trials, but it was often not possible to compare the occurrence of any adverse events between the experimental group and control group. Most adverse events reported were not too serious, and only a few participants could not complete treatment due to serious adverse events or for other reasons. Whether the interventions improved the quality of life of participants, was not evaluated in any of the trials. Although we did not find clear benefits in these series of small, poorly-performed studies, this does not mean that these drugs do not work in the treatment of ENL, only that scientific evidence is insufficient. Future studies should be better designed and use clear definitions and outcomes, including long-term outcomes and quality of life measures.
Abstract: Despite the fact that 2585 people participated in nine randomised aripiprazole studies, we were unable to extract any usable data on death, service outcomes, general functioning, behaviour, engagement with services, satisfaction with treatment; economic outcomes or cognitive functioning. In general, study attrition was very large for all studies over four weeks' duration. There was high attrition in most of the included studies. Fewer people left the aripiprazole group compared with those in the placebo group (n = 2585, 9 RCTs, RR 0.73 CI 0.60 to 0.87). Compared with placebo, aripiprazole significantly decreased relapse in both the short (n = 310, 1 RCT, RR 0.59 CI 0.45 to 0.77) and medium term (n = 310, 1 RCT, RR 0.66 CI 0.53 to 0.81). It also produced better compliance with study protocol (n = 2275, 8 RCTs, RR 0.74 CI 0.59 to 0.93). Aripiprazole may decrease prolactin levels below those expected from placebo (n = 305, 2 RCT, RR 0.21 CI 0.11 to 0.37). Insomnia (˜23%) and headaches (˜15%) were commonly reported in both groups, with no significant difference. Aripiprazole may be effective for the treatment of schizophrenia. Aripiprazole has a lower risk of raised prolactin and prolongation of the QTc interval. Clearly reported pragmatic short-, medium- and long-term randomised controlled trials should be undertaken to determine its position in everyday clinical practice.

Plain-language summary: When compared with placebo, people taking aripiprazole had fewer relapses, smaller numbers of participants left study early, and needed less additional antipsychotic medications. Insomnia and headache were the most commonly reported side effects, but were not much difference to placebo. Side effects such as akathisia, nausea and weight gain occurred more in the aripripazole group as compared to placebo. There has been a worry with newer antipsychotic medications and their effect on conductance problems in the heart, impaired glucose levels and excessive production of prolactin (which can cause unpleasant breast pain and secretion). On the limited evidence available (due to participants leaving early and fewer studies) aripiprazole appears to have a similar effect to that of placebo. The overall finding on its efficacy in treating schizophrenia is unchanged from those found in the original review.
Abstract: One randomised controlled open label study in 167 adults with chronic lung disease (bronchiectasis and other diseases associated with bronchiectasis) compared 23-valent pneumococcal (PV) and influenza vaccine with influenza vaccine alone (control group). The study found a significant reduction in acute infective respiratory exacerbations in the PV group compared to the control group, OR=0.48 (95%CI 0.26, 0.88); number needed to treat to benefit = 6 (95%CI 4, 32) over 2-years. There was however no difference in episodes of pneumonia between groups and no data on pulmonary decline was available. In another study, a benefit in elimination of Strep. pneumoniae in the sputum was found in a non-randomised trial in children but no clinical effect was described. Current but limited evidence support the use of 23-valent pneumococcal vaccine as routine management in adults with bronchiectasis. Circumstantial evidence also support the use of routine 23-valent pneumococcal vaccination in children with bronchiectasis. Further randomised controlled trials examining the efficacy of this intervention using various vaccine types in different age groups are needed. There is no data on the efficacy of pneumococcal vaccine on pulmonary decline. With the lack of evidence in how often the vaccine should be given, it is recommended that health providers adhere to national guidelines.

Plain-language summary: In this review, our search for randomised control trials that examined the effectiveness of pneumococcal vaccines for people with bronchiectasis revealed one randomised and one quasi-controlled trial. We conclude that, albeit the limitations of the review, adults and children (when age appropriate) with bronchiectasis should be vaccinated with the 23-valent polysaccharide pneumococcal vaccine as suggested in many national guidelines. Due to absence of data on how often the vaccine should be given, we recommend that national guidelines be followed until further evidence is available.
Abstract: In this systematic review, we provide a narrative synthesis of available evidence from three small studies including 136 adult participants. The studies were at high risk of bias. No meta-analysis was possible because of methodological and interventional heterogeneity between included studies. The primary outcomes of quality of life and exacerbations leading to use of steroids were not reported by these studies. For exacerbations leading to health centre/hospital visits, uncertainty was wide because a very small number of events was reported (in a single study). Secondary outcomes symptoms, lung function, changes in medication and adverse effects, where available, described for each included study. The overall quality of the studies was very low, and no clear differences were noted between water-based exercise and comparator treatments. Therefore, we remain very uncertain about the effects of water-based exercise for adults with asthma. The small number of participants in the three included studies, the clinical and methodological heterogeneity observed and the high risk of bias assessed mean that we are unable to assess the place of water-based exercise in asthma. Randomised controlled trials are needed to assess the efficacy and safety of water-based exercise for adults with asthma. For future research, we suggest greater methodological rigour (participant selection, blinding of outcome assessors, reporting of all outcomes analysed and registering of the study protocol).

Plain-language summary: We found a total of three studies involving 136 participants with an average age between 33 and 36 years with well-controlled asthma. They underwent water-based exercise from 40 to 60 minutes three to five times a week; the programme lasted 10 to 24 weeks in two studies, and one day only in one study. We considered data reported on quality of life, asthma general symptoms or asthma exacerbations, measure of lung function (FEV1, forced expiratory volume of the lung in the first second of air expired) and adverse events. The quality of evidence is very low because of issues with selection of participants, small number of participants, differences in exercise duration and intensity and differences in levels of asthma. Often surrogate endpoints were measured instead of patient-important outcomes. To sum up, more studies are needed to find out the effect and safety of water-based exercise for adults with asthma. The quality of evidence is very low because of issues with selection of participants, differences in exercise duration and intensity and differences in levels of asthma; surrogate endpoints were measured instead of patient-important outcomes. This plain language summary is current as of 13 May 2014.
Abstract: This update included 592 participants from seven studies (two new and one that had been excluded in the previous review in 2007. There was no evidence of a difference between groups in the incidence of any pulmonary complications and functional capacity between treatment with IS and treatment with physical therapy, positive pressure breathing techniques (including continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP) and intermittent positive pressure breathing (IPPB), active cycle of breathing techniques (ACBT) or preoperative patient education. Patients treated with IS had worse pulmonary function and arterial oxygenation compared with positive pressure breathing. Based on these studies there was no improvement in the muscle strength between groups who received IS demonstrated by maximal inspiratory pressure and maximal expiratory pressure. Our update review suggests there is no evidence of benefit from IS in reducing pulmonary complications and in decreasing the negative effects on pulmonary function in patients undergoing CABG. In view of the modest number of patients studied, methodological shortcomings and poor reporting of the included trials, these results should still be interpreted cautiously. An appropriately powered trial of high methodological rigour is needed to determine if there are patients who may derive benefit from IS following CABG.

Plain-language summary: This update included 592 participants from seven studies (two new and one that had been excluded in the previous 2007 review). We found evidence from four small trials that incentive spirometry offers no advantage over standard post-surgical physical therapy, or preoperative education in preventing breathing complications and pneumonia, improving lung function, or shortening length of hospital stay in patients undergoing CABG. Bigger and better designed trials are needed to determine if there is any role for incentive spirometry.
Abstract: We identified nine randomised controlled trials (including 489 people in total). Only one trial was at low risk of bias overall having reported adequate randomisation, allocation concealment and blinded outcome assessment.  In one trial (80 people) more ulcers healed with IPC than with dressings (62% vs 28%; p=0.002). Five trials compared IPC plus compression with compression alone. Two of these (97 people) found increased ulcer healing with IPC plus compression than with compression alone. The remaining three trials (122 people) found no evidence of a benefit for IPC plus compression compared with compression alone. Two trials (86 people) found no difference between IPC (without additional compression) and compression bandages alone. One trial (104 people) compared different ways of delivering IPC and found that rapid IPC healed more ulcers than slow IPC (86% vs 61%). IPC may increase healing compared with no compression. It is unclear whether it can be used instead of compression bandages. There is some limited evidence that IPC may improve healing when added to compression bandages. Rapid IPC was better than slow IPC in one trial. Further trials are required to determine the reliability of current evidence, which patients may benefit from IPC in addition to compression bandages, and the optimum treatment regimen.

Plain-language summary: However, the review of trials found conflicting evidence about whether or not IPC is better than compression bandages and hosiery. Intermittent pneumatic compression (IPC) is better for healing leg ulcers than no compression. . Some studies suggest IPC might be a beneficial addition to bandages for some ulcers, but these studies might be biased. Delivering the IPC therapy in a rapid manner by inflating and deflating the IPC device more quickly resulted in more ulcers being healed than with a slower deflation regime.
Abstract: We found 17 controlled before-after studies of street lighting, all reporting crash data, of which 15 contributed data to the meta-analysis. Seven trials included a designated control site; the other ten collected data at one site with the day-time data being used as the control. The methodological quality of the trials was generally poor. Three trials compared street lighting with an area control on total crashes; pooled rate ratio (RR) = 0.45 (95% confidence interval (CI) 0.29 to 0.69). Two trials compared street lighting with an area control on total injury crashes (all severities); RR = 0.78 (95% CI 0.63 to 0.97). No trials compared the number of fatal crashes with an area control. Eleven trials compared street lighting with a day-time control on total crashes; pooled RR = 0.68 (95% CI 0.57 to 0.82). Six trials compared street lighting with a day-time control on total injury crashes; pooled RR = 0.68 (95% CI 0.61 to 0.77). Four trials compared street lighting with a day-time control on fatal crashes; pooled RR = 0.34 (95% CI 0.17 to 0.68). The results from this systematic review suggest that street lighting may prevent road traffic crashes, injuries and fatalities. However, further well designed studies are needed to determine the effectiveness of street lighting, particularly in middle and low-income countries.

Plain-language summary: This systematic review was conducted to assess how street lighting affects the occurrence of road traffic crashes and associated injuries. The authors searched for all controlled trials comparing the effects of new street lighting with unlit roads, or improved street lighting with the pre-existing lighting level. They found 17 controlled before-after studies, all of which were conducted in high-income countries. Twelve studies investigated the effects of newly installed street lighting, four the effects of improved lighting and one investigated both new and improved lighting. Five of the studies compared the effects of street lighting with a separate area control, while the remaining 12 used data from a day-time control. The authors were able to pool crash or injury data from 15 of the studies. The risk of bias in these studies was judged to be high. The results indicate that street lighting can prevent road traffic crashes, injuries and fatalities. This finding might be of particular interest to low and middle-income countries where the policy on street lighting is less developed and the installation of suitable lighting systems is less common than in high-income countries. However, further well designed studies are needed to determine the effectiveness of street lighting in middle and low-income countries.