GEM/cochrane-simplification huggingface dataset:
Abstract: A total of 20 studies including 81,746 patients (median 129.5) were included in this review, with a follow-up ranging from 3 to more than 12 months. Patients' mean age was 42.5 years, 60% were female, and their asthma was mostly rated as moderate to severe. Overall the studies were of moderate to low methodological quality, because of limitations in their design and the wide confidence intervals for certain results. Compared with usual care, chronic disease management programmes resulted in improvements in asthma-specific quality of life (SMD 0.22, 95% confidence interval (CI) 0.08 to 0.37), asthma severity scores (SMD 0.18, 95% CI 0.05 to 0.30), and lung function tests (SMD 0.19, 95% CI 0.09 to 0.30). The data for improvement in self-efficacy scores were inconclusive (SMD 0.51, 95% CI -0.08 to 1.11). Results on hospitalisations and emergency department or unscheduled visits could not be combined in a meta-analysis because the data were too heterogeneous; results from the individual studies were inconclusive overall. Only a few studies reported results on asthma exacerbations, days off work or school, use of an action plan, and patient satisfaction. Meta-analyses could not be performed for these outcomes. There is moderate to low quality evidence that chronic disease management programmes for adults with asthma can improve asthma-specific quality of life, asthma severity, and lung function tests. Overall, these results provide encouraging evidence of the potential effectiveness of these programmes in adults with asthma when compared with usual care. However, the optimal composition of asthma chronic disease management programmes and their added value, compared with education or self-management alone that is usually offered to patients with asthma, need further investigation.

Plain-language summary: This review found 20 studies that compared the effects of chronic disease management programmes in adults with asthma with the effects of usual care. The average age of the patients was 42.5 years, 60% were women, and they had moderate to severe asthma. Overall the evidence that was found was of moderate to low quality. Chronic disease management programmes for adults with asthma probably improve patients' quality of life, reduce the severity of the asthma, and improve breathing as demonstrated by improved performance in lung function tests after 12 months. It is unclear whether chronic disease management programmes improve the patients' abilities to manage their own asthma or decrease the number of hospitalisations or emergency visits.
Abstract: We included three short-term and one long-term trial (total N=221). All participants had schizophrenia that was either treatment-resistant or with prominent negative symptoms. All studies compared sulpiride plus clozapine with clozapine (+/- placebo), were small and at considerable risk of bias. Short-term data of 'no clinically significant response' in global state tended to favour sulpiride augmentation of clozapine compared with clozapine alone (n=193, 3 RCTs, RR 0.58 CI 0.3 to 1.09). People allocated to sulpiride plus clozapine had more movement disorders (n=70, 1 RCT, RR 48.24 CI 3.05 to 762.56) and an increase in serum prolactin (skewed data, 1 RCT), but less incidence of hypersalivation (n=162, 3 RCTs, RR 0.49 CI 0.29 to 0.83) and less weight gain (n=64, 1 RCT, RR 0.30 CI 0.09 to 0.99). The augmentation of clozapine by sulpiride also caused less appetite loss (n=70, 1 RCT, RR 0.09 CI 0.01 to 0.70, NNT 4 CI 4 to 12, Z=2.31, P=0.02) and less abdominal distension (n=70, 1 RCT, RR 0.10 CI 0.01 to 0.78, NNT 5 CI 4 to 19, Z=2.20, P=0.03). Long-term data showed no significant difference in global state (n=70, 1 RCT, RR 0.67 CI 0.42 to 1.08) and relapse (n=70, 1 RCT, RR 0.85 CI 0.5 to 1.3). Sulpiride plus clozapine is probably more effective than clozapine alone in producing clinical improvement in some people whose illness has been resistant to other antipsychotic drugs including clozapine. However, much more robust data are needed.

Plain-language summary: Several clinical trials reported effects of sulpiride augmentation for management of schizophrenia. We included four small trials which compared sulpiride plus clozapine with clozapine alone for very ill people. Evidence from the present review suggested that short-term sulpiride plus clozapine probably is more effective than clozapine alone in producing clinical improvement in some people. The evidence is, however, weak and prone to considerable bias. This is a good area for more research.
Abstract: Electronic searches identified over 300 citations but none were relevant to this review. We found no trials of non-medical day centres. We feel that the inclusion of any studies less rigorous than randomised trials would result in misleading findings and that it is not unreasonable to expect well designed, conducted and reported randomised controlled trials of day centre care. More precise nomenclature would greatly help identify relevant work. At present non-randomised comparative studies give conflicting messages about the roles provided by day centres and the clinical and social needs they are able to meet. It is therefore probably best that people with serious mental illness and their carers, if given the choice, take a pragmatic decision on which type of unit best meets their needs. There is a clear need for randomised controlled trials of day centre care compared to other forms of day care, and when resources are limited, day centre care within the context of a pragmatic randomised trial may be the only way of ensuring equity of provision.

Plain-language summary: In this review we sought, but could not find, any evidence from well-conducted randomised trials of the effects of non-medical day centres. Day centres are currently becoming prominent in service planning, but this is not based on good evidence as to their effectiveness for people suffering from severe mental illness. If a choice between facilities is available, people with serious mental illnesses and their carers are currently left to make their own judgements based on the evidence of experience and a few non-randomised studies.
Abstract: We identified 20 RCTs (total number of participants = 2674), 12 (60%) of which were not included in the previous review. Sample sizes ranged from 36 to 323 (median (IQR) = 108 (61 to 189)). In total, six trials (30% of all included studies) had a low RoB. At most, three RCTs could be identified per comparison, outcome, and time interval; therefore, the amount of data should not be considered robust. In general, for the primary outcomes, there is low to very low quality evidence suggesting no difference in effect for SMT when compared to inert interventions, sham SMT, or when added to another intervention. There was varying quality of evidence (from very low to moderate) suggesting no difference in effect for SMT when compared with other interventions, with the exception of low quality evidence from one trial demonstrating a significant and moderately clinically relevant short-term effect of SMT on pain relief when compared to inert interventions, as well as low quality evidence demonstrating a significant short-term and moderately clinically relevant effect of SMT on functional status when added to another intervention. In general, side-lying and supine thrust SMT techniques demonstrate a short-term significant difference when compared to non-thrust SMT techniques for the outcomes of pain, functional status, and recovery. SMT is no more effective in participants with acute low-back pain than inert interventions, sham SMT, or when added to another intervention. SMT also appears to be no better than other recommended therapies. Our evaluation is limited by the small number of studies per comparison, outcome, and time interval. Therefore, future research is likely to have an important impact on these estimates. The decision to refer patients for SMT should be based upon costs, preferences of the patients and providers, and relative safety of SMT compared to other treatment options. Future RCTs should examine specific subgroups and include an economic evaluation.

Plain-language summary: In this review, a total of 20 randomized controlled trials (RCTs) (representing 2674 participants) assessing the effects of SMT in patients with acute low-back pain were identified. Treatment was delivered by a variety of practitioners, including chiropractors, manual therapists, and osteopaths. Approximately one-third of the trials were considered to be of high methodological quality, meaning these studies provided a high level of confidence in the outcome of SMT. Overall, we found generally low to very low quality evidence suggesting that SMT is no more effective in the treatment of patients with acute low-back pain than inert interventions, sham (or fake) SMT, or when added to another treatment such as standard medical care. SMT also appears to be no more effective than other recommended therapies. SMT appears to be safe when compared to other treatment options but other considerations include costs of care.
Abstract: Twenty-two studies are included in this review. The meta-analysis demonstrates that HFPPV compared to CMV was associated with a reduction in the risk of air leak (typical relative risk (RR) for pneumothorax was 0.69, 95% confidence interval (CI) 0.51 to 0.93). ACV/SIMV compared to CMV was associated with a shorter duration of ventilation (mean difference (MD) −38.3 hours, 95% CI −53.90 to −22.69). SIMV or SIMV + PS was associated with a greater risk of moderate/severe BPD compared to HFO (RR 1.33, 95% CI 1.07 to 1.65) and a longer duration of mechanical ventilation compared to HFO (MD 1.89 days, 95% CI 1.04 to 2.74). ACV compared to SIMV was associated with a trend to a shorter duration of weaning (MD −42.38 hours, 95% CI −94.35 to 9.60). Neither HFPPV nor triggered ventilation was associated with a significant reduction in the incidence of BPD. There was a non-significant trend towards a lower mortality rate using HFPPV versus CMV and a non-significant trend towards a higher mortality rate using triggered ventilation versus CMV. No disadvantage of HFPPV or triggered ventilation was noted regarding other outcomes. Compared to conventional ventilation, benefit is demonstrated for both HFPPV and triggered ventilation with regard to a reduction in air leak and a shorter duration of ventilation, respectively. In none of the trials was complex respiratory monitoring undertaken and thus it is not possible to conclude that the mechanism of producing those benefits is by provocation of synchronised ventilation. Triggered ventilation in the form of SIMV ± PS resulted in a greater risk of BPD and duration of ventilation compared to HFO. Optimisation of trigger and ventilator design with respect to respiratory diagnosis is encouraged before embarking on further trials. It is essential that newer forms of triggered ventilation are tested in randomised trials that are adequately powered to assess long-term outcomes before they are incorporated into routine clinical practice.

Plain-language summary: The review of trials found, when compared to conventional mechanical ventilation (CMV), high-frequency positive pressure ventilation (HFPPV) reduced the risk of air leak and triggered ventilation was associated with a shorter duration of ventilation. Compared to high-frequency oscillation, however, certain triggered modes of ventilation resulted in a greater risk of moderate to severe chronic lung disease and a longer duration of ventilation. Newer forms of triggered ventilation have only been evaluated in small randomised trials and have not been demonstrated to have advantages in important clinical outcomes.
Abstract: Seven randomised controlled trials involving 1919 participants were included. All trials involved people, predominantly young adults, participating in regular sporting activities. Some trials were compromised by poor methodology, including lack of blinding and incomplete outcome data. Four trials, including 287 participants, examined interventions directly targeted at preventing hamstring injuries. Three of these trials, which tested hamstring strengthening protocols, had contradictory findings, with one small trial showing benefit (although the control rate of mainly minor hamstring injury was unusually high). The other two trials found no benefit, with a greater incidence of hamstring injury in the intervention group. One unpublished and underpowered trial provided some evidence that manual therapy may prevent lower-limb muscle strain (RR 0.13, 95% CI 0.02 to 0.97), although the finding for hamstring injury did not reach statistical significance (RR 0.21, 95% CI 0.03 to 1.66). Three trials testing interventions for preventing lower limb injuries for which data for hamstring injury were available found no statistically significant effect for hamstring injury for either proprioceptive protocols (two cluster randomised trials) or a warm up/cool down and stretching protocol (one trial). There is insufficient evidence from randomised controlled trials to draw conclusions on the effectiveness of interventions used to prevent hamstring injuries in people participating in football or other high risk activities for these injuries. The findings for manual therapy need confirmation.

Plain-language summary: Seven randomised controlled trials involving a total of 1919 participants were included. All trials involved people, predominantly young adults, participating in regular sporting activities. Some trials were compromised by poor methodology, including lack of blinding and incomplete outcome data. Four trials, including 287 participants, examined interventions directly targeted at preventing hamstring injuries. Three of these trials, which tested hamstring strengthening protocols, had contradictory findings and we could not conclude whether strengthening exercises of the hamstrings was beneficial or not. One small trial found that manual therapy (involving manipulation, massage and specific stretches to joints and muscles of the spine and leg) may prevent injuries of leg muscles, including the hamstrings. Three inconclusive trials tested interventions for preventing all leg injuries for which data for hamstring injury were available. Two trials found no evidence for an effect for balance training on a wobble board (proprioceptive protocol). One trial found no evidence for a warm up/cool down and stretching protocol for distance runners. Based on currently available research findings, no specific intervention can be recommended for decreasing the risk of incurring hamstring injuries.
Abstract: We included four trials involving 422 women. Three trials had high risk of bias and none included any long-term follow-up of infants. No differences in the incidence of preterm birth or perinatal mortality were seen when magnesium maintenance therapy was compared with placebo or no treatment; or alternative therapies (ritodrine or terbutaline). The risk ratio (RR) for preterm birth (less than 37 weeks) for magnesium compared with placebo or no treatment was 1.05, 95% confidence interval (CI) 0.80 to 1.40 (two trials, 99 women); and 0.99, 95% CI 0.57 to 1.72 (two trials, 100 women) for magnesium compared with alternative therapies. The RR for perinatal mortality for magnesium compared with placebo or no treatment was 5.00, 95% CI 0.25 to 99.16 (one trial, 50 infants); and 5.00, 95% CI 0.25 to 99.16 (one trial, 50 infants) for magnesium compared with alternative treatments. Women taking magnesium preparations were less likely to report side effects (RR 0.67, 95% CI 0.47 to 0.96, three trials, 237 women), including palpitations or tachycardia (RR 0.26, 95% CI 0.13 to 0.52, three trials, 237 women) than women receiving alternative therapies. Women receiving magnesium were however, more likely to experience diarrhoea (RR 6.79, 95% CI 1.26 to 36.72, three trials, 237 women). There is not enough evidence to show any difference between magnesium maintenance therapy compared with either placebo or no treatment, or alternative therapies (ritodrine or terbutaline) in preventing preterm birth after an episode of threatened preterm labour.

Plain-language summary: We included four randomised controlled trials involving a total of 422 women in this review. The trials did not demonstrate any differences between magnesium maintenance therapy and placebo or other treatments (ritodrine or terbutaline) in the prevention of preterm birth or perinatal deaths. The trials were too small to exclude either important benefits or harms from magnesium maintenance therapy. Magnesium was less likely than the alternative tocolytics (betamimetics) to result in side effects, particularly palpitations or tachycardia, although diarrhoea was more likely. This finding is based on very few studies of low quality, and none of them looked at the infants' later development.
Abstract: Of the nine studies (1075 participants): five investigated Micronised Purified Flavonoid Fraction (MPFF), and four investigated hydroxyethylrutosides (HR). Meta-analysis involving 723 participants from five trials - four of which were characterised by poor reporting - showed more venous leg ulcers were healed in the MPFF groups than in the control groups (RR 1.36; 95% CI 1.07 to 1.74). However, the most rigorously conducted trial, which was at low risk of bias, did not show any additional benefit of MPFF (RR 0.94; 95% CI 0.73 to 1.22). Since this trial was unpublished, the possibility of publication bias in trials involving flavonoids must be acknowledged. Overall, the quality of reporting of trials on HR was also poor. Pooling three trials, all at unclear risk of bias, involving 279 participants showed a statistically significant effect in favour of HR with respect to number of ulcers healed (RR 1.70; 95% CI 1.24 to 2.34). Although the overall estimate of the number of healed ulcers appeared to show a significant effect in favour of flavonoids (both MPFF and HR), this result needs to be interpreted cautiously, as most of these trials were poorly reported, and so had an unclear risk of bias for randomisation, allocation concealment, blinding and methods for addressing incomplete outcome data. There was also a possibility of publication bias.

Plain-language summary: This review of clinical trials concluded that there is some evidence to show that flavonoids can help heal venous leg ulcers, however, many trials were not reported well, and we could not know for certain whether the apparently beneficial effects were real or not. This meant that we could not draw firm conclusions, or recommend routine use of flavonoids for people with leg ulcers. Larger and better conducted trials are needed to assess the true clinical effect of flavonoids.
Abstract: We included nine randomised trials involving 3122 people comparing aripiprazole with typical antipsychotic drugs. None of the studies reported on relapse - our primary outcome of interest. Attrition from studies was high and data reporting poor. Participants given aripiprazole were comparable to those receiving typical drugs in improving global state and mental state. Aripiprazole provided a significant advantage over typical antipsychotics in terms of fewer occurrences of extra-pyramidal symptom (n=968, 3 RCT, RR 0.46 CI 0.3 to 0.9, NNT 13 CI 17 to 10), and particularly akathisia (n=897, 3 RCT, RR 0.39 CI 0.3 to 0.6, NNT 11 CI 14 to 9). Fewer participants given aripiprazole developed hyperprolactinaemia (n=300, 1 RCT, RR 0.07 CI 0.03 to 0.2, NNT 2 CI 3 to 1). Aripiprazole presented a lesser risk of sinus tachycardia (n=289, 1 RCT, RR 0.09 CI 0.01 to 0.8, NNT 22 CI 63 to 13) and blurred vision (n=308, 1 RCT, RR 0.19 CI 0.1 to 0.7, NNT 14 CI 25 to 10); but enhanced risk of occurrence of dizziness (n=957, 3 RCT, RR 1.88 CI 1.1 to 3.2, NNH 20 CI 33 to 14) and nausea (n=957, 3 RCT, RR 3.03 CI 1.5 to 6.1, NNH 17 CI 25 to 13). Attrition rates were high in both groups, although significantly more participants in the aripiprazole group completed the study in the long term (n=1294, 1 RCT, RR 0.81 CI 0.8 to 0.9 NNT 8 CI 5 to 14). Aripiprazole differs little from typical antipsychotic drugs with respect to efficacy, however it presents significant advantages in terms of tolerability. Clearly reported pragmatic short, medium and long term randomised controlled trials are required to replicate and validate these findings and determine the position of aripiprazole in everyday clinical practice.

Plain-language summary: The data for nine clinical trials containing a total of 3622 patients were analysed. In the trials of less than 12 weeks that reported improvement of general well-being and mental state, there was no statistically significant difference between typical antipsychotics and aripiprazole. However, when looking at adverse effects, people on aripiprazole were less likely to suffer from movement side effects, blurred vision, high levels of the hormone prolactin or increased heart rate. These people were also less likely to withdraw their consent to being in the study in short (less than 12 weeks) and longer (more than 12 weeks) trials. Conversely, people on typical antipsychotics were significantly less likely to feel dizzy or nauseous. These trials were all quite different from each other - they had varying settings, enrolled different groups of people, were for varying lengths of times (from 24 hours to 52 weeks) and compared aripiprazole to different first generation antipsychotics. This made it difficult to compare outcomes from trial to trial. In addition, a lot of the data were not able to be used because measurements were not given in full. This medication looks promising but there needs to be more trials, particularly longer-term well-planned trials. (Plain language summary prepared for this review by Janey Antoniou of RETHINK, UK www.rethink.org).
Abstract: Only one trial (123 participants) was included in the review. Several excluded trials did not follow the strict protocol for TRT, evaluating instead a modified form of TRT. The included trial showed TRT to be more effective than a tinnitus masking (TM) approach. In this study outcome data for tinnitus severity were presented using three instruments (Tinnitus Handicap Inventory (THI), Tinnitus Handicap Questionnaire (THQ), Tinnitus Severity Index (TSI)) for patients in three groups (participants' tinnitus being a 'moderate problem', big problem' or 'very big problem'). At 18 months, improvements for the three groups in the three scores (TRT versus TM) were respectively: 'moderate problem' - THI: 18.2 versus 4.6, THQ: 489 versus 178, TSI 7.5 versus 1.6; 'big problem' - THI: 29.2 versus 16.7, THQ: 799 versus 256, TSI: 12.1 versus 6.7; and 'very big problem' - THI: 50.4 versus 10.3, THQ; 1118 versus 300, TSI: 19.7 versus 4.8. A single, low-quality randomised controlled trial suggests that TRT is much more effective as a treatment for patients with tinnitus than tinnitus masking.

Plain-language summary: A form of treatment called Tinnitus Retraining Therapy (TRT) is used in many countries to treat this symptom. This treatment comprises a form of educational counselling and sound therapy given according to a specific protocol. Only one study, involving 123 participants, matched the inclusion criteria for this review. Although this study suggested considerable benefit for TRT in the treatment of tinnitus the study quality was not good enough to draw firm conclusions. No side effects of treatment were described. Further research is required.