GEM/cochrane-simplification huggingface dataset:
Abstract: The search identified 183 references but only five studies (total n=210) met the inclusion criteria. All of the studies were on inpatient populations and compared the intervention with standard inpatient care. One study had drama therapy as the intervention, one had role-playing, one had a social drama group and two used psychodrama. Two of the included studies were Chinese and it is difficult to know whether psychodrama and indeed inpatient psychiatric care in China is comparable with the drama interventions and inpatient care in the other included studies. There were no significant findings about the value of drama interventions for keeping inpatients engaged in treatment. Due to poor reporting very little data from the five studies could be used and there were no conclusive findings about the harms or benefits of drama therapy for inpatients with schizophrenia. Randomised studies are possible in this field. The use of drama therapy for schizophrenia and schizophrenia-like illnesses should continue to be under evaluation as its benefits, or harms, are unclear.

Plain-language summary: Randomised studies have been successfully conducted in this area but poor study reporting meant that no conclusions could be drawn from them. The benefits or harms of the use of drama therapy in schizophrenia are therefore unclear and further large, high quality studies are required to determine the true value of drama therapy for schizophrenia or schizophrenia-like illnesses.
Abstract: We included two trials involving 754 participants. One new trial of 660 participants showed the same success rate of vacuum procedure of 98.2% by both methods (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.98 to 1.02). The two included trials showed significant reductions in the time between applying the vacuum cup and delivery, (one trial (74 women): mean difference (MD) -6.10 minutes, 95% CI -8.83 to -3.37 and the other trial (660 women): with median difference -4.4 minutes, 95% CI -4.8 to -4.0). The two included trials showed no significant difference in detachment rate (RR 0.85, 95% CI 0.38 to 1.86, 2 studies, 754 women), no significant difference in Apgar score below seven at one minute (RR 1.04, 95% CI 0.51 to 2.09) and five minutes (RR 1.00, 95% CI 0.29 to 3.42), no significant differences in scalp abrasions or lacerations, cephalhematoma, subgaleal hemorrhage and hyperbilirubinemia. There were no significant differences between the two methods in all secondary outcomes. The rapid negative pressure application for vacuum assisted vaginal birth reduces duration of the procedure whilst there is no evidence of differences in maternal and neonatal outcomes. Rapid method of negative application should be recommended for vacuum extraction assisted vaginal delivery.

Plain-language summary: Two good quality randomized controlled trials involving 754 women were identified. Rapid negative pressure application reduced the duration of the procedure without any evidence of differences in outcomes for the mother or infant. Rapid method of negative pressure application should be recommended for vacuum extraction assisted vaginal delivery.
Abstract: We identified five randomised, double-blind studies with 1501 participants, but only four had been published and had relevant outcome data. These four studies were of high quality, although two of the studies were small. Both ibuprofen 200 mg + caffeine 100 mg and ibuprofen 100 mg + caffeine 100 mg produced significantly more participants than placebo who achieved at least 50% of maximum pain relief over six hours, and both doses significantly reduced remedication rates (moderate quality evidence). For at least 50% of maximum pain relief, the NNT was 2.1 (95% confidence interval 1.8 to 2.5) for ibuprofen 200 mg + caffeine 100 mg (four studies, 334 participants) and 2.4 (1.9 to 3.1) for ibuprofen 100 mg + caffeine 100 mg (two studies, 200 participants) (moderate quality evidence). These values were close to those predicted by published models for combination analgesics in acute pain, and were supported by low (good) NNT values for prevention of remedication. Adverse event rates were low, and no sensible analysis was possible. For ibuprofen 200 mg + caffeine 100 mg particularly, the low NNT value is among the lowest (best) values for analgesics in this pain model. The combination is not commonly available, but can be probably be achieved by taking a single 200 mg ibuprofen tablet with a cup of modestly strong coffee or caffeine tablets. In principle, this can deliver good analgesia at lower doses of ibuprofen.

Plain-language summary: We searched up to 1 February 2015 and found four studies with a maximum of 334 participants with information for analysis. Ibuprofen 200 mg plus caffeine 100 mg provided effective pain relief for 6 in 10 (59%) participants, compared with 1 in 10 (11%) participants with placebo (moderate quality evidence). Adverse events occurred at similar rates with the ibuprofen plus caffeine combination and placebo in these single dose studies (low quality evidence). No serious adverse events or withdrawals due to adverse events occurred with the combination. The combination of ibuprofen 200 mg + caffeine 100 mg is not commonly available, but can probably be achieved by taking a single 200 mg ibuprofen tablet with a cup of modestly strong coffee. Common sources of caffeine include not only caffeine tablets (100 mg is sufficient), but coffee (100 mg to 150 mg per mug or cup with a volume of about 240 mL or 8 fl oz, or a double espresso), but also tea (75 mg per mug), cola drinks (up to 40 mg per drink), energy drinks (approximately 80 mg per drink), plain chocolate (up to 50 mg per bar), and caffeine tablets (100 mg per tablet). Some people may get good levels of pain relief with a lower dose of ibuprofen when the ibuprofen is combined with caffeine.
Abstract: One single-centred trial (46 participants) was identified comparing a topical steroid (betamethasone) given as nasal drops to placebo. Treatment was given twice daily for six weeks; 22 participants received the active drug. Subjective symptom scores, change in polyp size, and side effects were assessed. There was no difference in nasal symptom scores between the treatment and placebo groups. Betamethasone was effective in reducing the size of polyps, but was associated with increased reports of mild side effects, nasal bleeding and discomfort. Risk of bias was high since over 50% of people enrolled did not complete the study. Follow-up of participants was short (six weeks) also reducing the significance of the results for clinical practice. This review suggests topical steroids for nasal polyposis in people with cystic fibrosis have no demonstrable effect on subjective nasal symptom scores. They have some effect in reducing the size of the polyps, but due to the small sample size, poor completion rates and lack of follow-up, the trial is at high risk of bias and evidence for efficacy is limited. Overall there is no clear evidence for using topical steroids in people with cystic fibrosis and nasal polyposis. A well-designed randomised controlled trial of adequate power and long-term follow-up is needed. Validated measures of symptoms and physical findings should be performed and quality of life issues addressed.

Plain-language summary: Our search found one trial with 46 adult volunteers with cystic fibrosis which compared nasal drops containing a steroid (betamethasone) to identical drops containing no active treatment. Two drops were applied directly to polyps twice a day for six weeks. Volunteers were put into the different treatment groups at random and a total of 22 volunteers received the steroid drops and 24 received the dummy treatment. The trial measured each person's perception of their symptom scores, but found no difference to the scores whether volunteers were using the steroid drops or the dummy treatment. The trial also measured the change in polyp size and found that they shrank. There were no major side effects linked to using betamethasone, and only three volunteers reported increased nose bleeds and discomfort. The small number of volunteers in this trial means the calculations and results should be regarded with some caution. More trials are needed to confirm the findings and these trials should report on measures of symptoms and quality of life issues. We think that volunteers had a truly equal chance of being put in either the steroid group or the control group and wouldn't have known which treatment they were receiving, so these issues would not have influenced the results in any way. However, over 50% of people enrolled did not complete the study and the reasons for dropping out were not very clearly explained. We think it is important to take this fact into account when considering the trial results. Also, the trial only followed the volunteers for six weeks, which is a short time when evaluating a treatment that could be needed for the rest of a person's life.
Abstract: Only one small study (n = 44) fulfilled the inclusion criteria. Results suggested that cell salvage did not affect mortality overall (death rates were 67% (14/21 participants) in the cell salvage group and 65% (15/23) in the control group) (odds ratio (OR) 1.07, 95% confidence interval (CI) 0.31 to 3.72). For individuals with abdominal injury, mortality was also similar in both groups (OR 0.48, 95% CI 0.11 to 2.10). Less donor blood was needed for transfusion within the first 24 hours postinjury in the cell salvage group compared with the control group (mean difference (MD) -4.70 units, 95% CI -8.09 to -1.31). Adverse events, notably postoperative sepsis, did not differ between groups (OR 0.54, 95% CI 0.11 to 2.55). Cost did not notably differ between groups (MD -177.81, 95% CI -452.85 to 97.23, measured in GBP in 2002). Evidence for the use of cell salvage in individuals undergoing abdominal or thoracic trauma surgery remains equivocal. Large, multicentre, methodologically rigorous trials are needed to assess the relative efficacy, safety and cost-effectiveness of cell salvage in different surgical procedures in the emergency context.

Plain-language summary: We identified one randomised controlled trial, which involved people with a penetrating injury to the chest. In this study, 44 people (mostly male and with similar characteristics in terms of type of injury) were given either their own reprocessed blood (through cell salvage) or standard care using donated blood. The study was conducted at a hospital in Johannesburg, South Africa in 2002. Results indicated no important differences between the two groups of participants with regard to survival, postoperative infection, or cost. There was a reduction in the amount of banked blood (blood that has been donated and stored) required for transfusion within the first 24 hours following injury among people receiving cell salvage. Data on other adverse events were not reported. We believe that larger, multicentre, methodologically rigorous trials are needed to assess the relative efficacy, safety and cost-effectiveness of cell salvage in trauma surgery and other surgical procedures. The quality of the one study identified was high, but the number of participants was not large. No firm conclusions can be drawn as to the safety and effectiveness of cell salvage in individuals undergoing abdominal or thoracic trauma surgery.
Abstract: Nineteen randomised studies (2728 participants) of concurrent chemoradiotherapy versus radiotherapy alone were included. Chemoradiotherapy significantly reduced overall risk of death (HR 0.71, 95% CI 0.64 to 0.80; I2 0%; 1607 participants) and overall progression-free survival at any site (HR 0.69, 95% CI 0.58 to 0.81; I2 45%; 1145 participants). Incidence of acute oesophagitis, neutropenia and anaemia were significantly increased with concurrent chemoradiation.  Six trials (1024 patients) of concurrent versus sequential chemoradiation were included. A significant benefit of concurrent treatment was shown in overall survival (HR 0.74, 95% CI 0.62 to 0.89; I2 0%; 702 participants). This represented a 10% absolute survival benefit at 2 years. More treatment-related deaths (4% vs 2%) were reported in the concurrent arm without statistical significance (RR 2.02, 95% CI 0.90 to 4.52; I2 0%; 950 participants). There was increased severe oesophagitis with concurrent treatment (RR 4.96, 95%CI 2.17 to 11.37; I2 66%; 947 participants). This update of the review published in 2004 incorporates additional trials and more mature data. It demonstrates the benefit of concurrent chemoradiation over radiotherapy alone or sequential chemoradiotherapy. Patient selection is an important consideration in view of the added toxicity of concurrent treatment. Uncertainty remains as to how far this is purely due to a radiosensitising effect and whether similar benefits could be achieved by using modern radiotherapy techniques and more dose intensive accelerated and/ or hyperfractionated radiotherapy regimens.

Plain-language summary: A total of twenty-five randomised studies (including 3752 patients) were included in this updated review: nineteen trials (2728 patients) comparing concurrent chemoradiotherapy with radiotherapy alone and six trials (1024 patients) comparing concurrent with sequential chemoradiotherapy. Both comparisons demonstrated significant reduction in risk of death with use of concurrent chemoradiation, with an associated increase in incidence of acute oesophagitis.
Abstract: Twenty one randomised trials with a total of 1371 children met the inclusion criteria. Sample sizes were generally small. All studies but one investigated children with functional faecal incontinence. Interventions varied amongst trials and few outcomes were shared by trials addressing the same comparisons. Combined results of nine trials showed higher rather than lower rates of persisting symptoms of faecal incontinence up to 12 months when biofeedback was added to conventional treatment (OR 1.11 CI 95% 0.78 to 1.58). This result was consistent with that of two trials with longer follow-up (OR 1.31 CI 95% 0.80 to 2.15). In one trial the adjunct of anorectal manometry to conventional treatment did not result in higher success rates in chronically constipated children (OR 1.40 95% CI 0.72 to 2.73 at 24 months). In one small trial the adjunct of behaviour modification to laxative therapy was associated with a significant reduction in children's soiling episodes at both the three month (OR 0.14 CI 95% 0.04 to 0.51) and the 12 month assessment (OR 0.20 CI 95% 0.06 to 0.65). There is no evidence that biofeedback training adds any benefit to conventional treatment in the management of functional faecal incontinence in children. There was not enough evidence on which to assess the effects of biofeedback for the management of organic faecal incontinence. There is some evidence that behavioural interventions plus laxative therapy, rather than laxative therapy alone, improves continence in children with functional faecal incontinence associated with constipation.

Plain-language summary: This review identified 21 studies with a total of 1371 children. Behavioural interventions when used together with laxative therapy may improve continence in children with non-organic faecal incontinence and constipation whilst biofeedback does not add any long-term benefit. Children who received biofeedback treatment had not always been evaluated beforehand for the suitability of the treatment. There was not enough evidence to assess the effects of biofeedback in children with organic faecal incontinence.
Abstract: Three randomized controlled trials were identified. One was of good methodological quality (Markowitz 2000). This study looked at the use of 6-mercaptopurine (6-MP) as a steroid sparing agent. No difference in linear growth was observed between the intervention and placebo groups, although the total steroid dose received over the 18 month follow up period was reduced in the group receiving 6-MP. The two remaining randomized controlled trials (Sanderson 1987; Thomas 1993a) consider the use of enteral feeding versus corticosteroids for induction of remission, with height velocity standard deviation score at 6 months as an outcome measure. Although of less rigorous methodological quality, the results of these studies are discussed in detail in the review. In both studies height velocity standard deviation scores were significantly increased in the enteral feeding group compared with the corticosteroid group. In addition to these randomized controlled trials, a body of lower quality evidence does exist relevant to two other important interventions; the use of supplemental enteral nutrition (Morin 1980; Belli 1988; Israel 1995) and the judicious use of surgical interventions in pre-pubertal children with refractory disease (Alperstein 1985; Lipson 1990; McLain 1990). Newer treatments, such as infliximab, are now becoming more widely used and may offer advantages in promoting growth. These effects are as yet unstudied. This review highlights the need for large, multi centre studies of the different treatment options in paediatric Crohn's disease and the importance of standardised measurements of growth, such as height velocity standard deviation scores and height standard deviation scores as outcome measures.

Plain-language summary: The aim of this review was to evaluate the effectiveness of various treatments for growth failure in childhood Crohn's disease. Three randomized controlled trials were identified. One trial did not show any benefit for linear growth with 6-mercaptopurine treatment compared to placebo among children being treated with steroids. The other two trials looked at nutritional treatment (elemental feedings) versus steroids (prednisolone). Both trials showed a statistically significant benefit for height velocity standard deviation scores with nutritional treatment. However, these results need to be confirmed by large, multi-centre, randomized controlled trials of therapeutic interventions in pre-pubertal children with Crohn's disease. These trials should use growth as an outcome measure. In conclusion, more research is needed to identify effective treatments for growth failure in childhood Crohn's disease.
Abstract: We included three trials involving 386 participants randomized to either creatine 5 to 10 g per day or placebo. When we updated the searches in 2012 we found no additional trials. Creatine was reportedly well-tolerated in all three included studies, with no evidence of renal failure or serious adverse events specifically attributable to creatine. Using a pooled log-rank statistical test, we found no statistical difference in survival between the placebo and creatine groups across all three studies (Chi2 = 0.09, P = 0.76). In addition, we found no statistical difference in ALSFRS-R slopes between the two groups across all three studies using a pooled linear mixed-effects model (slope difference of +0.03 ALSFRS-R/month in the creatine group; P = 0.76). Interestingly, there was a trend towards slightly worsened FVC slope in the creatine group (slope difference of -0.63 FVC/month in the creatine group) using a pooled linear mixed-effects model across the two studies which included FVC as an outcome, but this difference was not statistically significant (P = 0.054). In patients already diagnosed with clinically probable or definite ALS, creatine at doses ranging from 5 to 10 g per day did not have a statistically significant effect on survival, ALSFRS-R progression or percent predicted FVC progression.

Plain-language summary: However, human trials have shown mixed results thus far. Therefore, we systematically reviewed all available clinical trial evidence as of July 2012 to determine if creatine benefits or harms people with ALS/MND. This review included three well-designed clinical trials involving a total of 386 participants receiving either creatine or placebo. Overall, creatine was well-tolerated with no serious side effects. Using various statistical methods, we found that creatine at a dose of 5 to 10 g per day did not improve ALS survival or slow ALS progression in any meaningful way. There was a hint that creatine may slightly worsen breathing ability, but this may have just been misleading statistical variability.
Abstract: Twenty-two small trials involving 2676 people were included. One trial was placebo controlled, 18 compared two or more drug treatments, three compared treatment regimens, and one compared different drug vehicles. Fewer treatment failures occurred by day seven with oral ivermectin compared with placebo in one small trial (55 participants). Topical permethrin appeared more effective than oral ivermectin (140 participants, 2 trials), topical crotamiton (194 participants, 2 trials), and topical lindane (753 participants, 5 trials). Permethrin also appeared more effective in reducing itch persistence than either crotamiton (94 participants, 1 trial) or lindane (490 participants, 2 trials). No difference was detected between permethrin (a synthetic pyrethroid) and a natural pyrethrin-based topical treatment (40 participants, 1 trial), and between permethrin and benzyl benzoate (53 participants, 1 trial), however both these trials were small. No significant difference was detected in the number of treatment failures between crotamiton and lindane (100 participants, 1 trial), lindane and sulfur (68 participants, 1 trial), benzyl benzoate and sulfur (158 participants, 1 trial), and benzyl benzoate and natural synergized pyrethrins (240 participants, 1 trial); all were topical treatments. No trials of malathion were identified. No serious adverse events were reported. A number of trials reported skin reactions in participants randomized to topical treatments. There were occasional reports of headache, abdominal pain, diarrhoea, vomiting, and hypotension. Topical permethrin appears to be the most effective treatment for scabies. Ivermectin appears to be an effective oral treatment. More research is needed on the effectiveness of malathion, particularly when compared to permethrin, and on the management of scabies in an institutional setting and at a community level.

Plain-language summary: The review of trials attempted to cover all these. The authors identified 22 small trials involving 2676 people, with 19 of the trials taking place in resource-poor countries. Permethrin appeared to be the most effective topical treatment for scabies, and ivermectin appeared to be an effective oral treatment. However, ivermectin is unlicensed for this indication in many countries. Adverse events such as rash, vomiting, and abdominal pain were reported, but the trials were too small to properly assess serious but rare potential adverse effects. No trials of herbal or traditional medicines were identified for inclusion.