GEM/cochrane-simplification huggingface dataset:
Abstract: Nine randomised controlled trials were identified as meeting the inclusion criteria. The nine trials enrolled 2,159 participants but looked at a multiplicity of drug combinations. Despite this, a reasonably robust literature suggests no statistically significant difference between the two drug combinations, including severe adverse events and adherence/tolerance/retention. The quality of the literature was found overall to be low to very low for all key outcomes. Only one study reported on drug resistance, and no studies reported on sexual transmission of HIV. The length of follow-up time and study settings varied greatly. While ideally future research would focus on direct comparison of standard therapeutic combinations of d4T+3TC+an NNRTI and AZT+3TC+an NNRTI to compare these regimens more directly, it is unlikely that additional trials will be mounted. Observational studies should focus on understanding outcomes, including toxicity and tolerability, in low- and middle-income countries.

Plain-language summary: The purpose of this review was to assess which of these two medications was the best for initial treatment for people living with HIV, and through our search we identified nine randomised controlled trials. Overall, these studies showed no critical difference between d4T and AZT. Future studies and recommendations should focus on specific toxicities and tolerability when comparing these two medications.
Abstract: Thirteen studies with a total of 1344 participants met the inclusion criteria of the review. They were of varying quality. There was no significant difference between salmeterol and theophylline in FEV1 predicted (6.5%; 95% CI -0.84 to 13.83). However, salmeterol treatment led to significantly better morning PEF (mean difference 16.71 L/min, 95% CI 8.91 to 24.51) and evening PEF (mean difference 15.58 L/min, 95% CI 8.33 to 22.83). Salmeterol also reduced the use of rescue medication. Formoterol, used in two studies was reported to be as effective as theophylline. Bitolterol, used in only one study, was reported to be less effective than theophylline. Participants taking salmeterol experienced fewer adverse events than those using theophylline (Parallel studies: Relative Risk 0.44; 95% CI 0.30 to 0.63, Risk Difference -0.11; 95% CI -0.16 to -0.07, Numbers Needed to Treat (NNT) 9; 95% CI 6 to 14). Significant reductions were reported for central nervous system adverse events (Relative Risk 0.50; 95% CI 0.29 to 0.86, Risk Difference -0.07; 95% CI -0.12 to -0.02, NNT 14; 95% CI 8 to 50) and gastrointestinal adverse events (Relative Risk 0.30; 95% CI 0.17 to 0.55, Risk Difference -0.11; 95% CI -0.16 to -0.06, NNT 9; 95% CI 6 to 16). Long-acting beta-2 agonists, particularly salmeterol, are more effective than theophylline in improving morning and evening PEF, but are not significantly different in their effect on FEV1. There is evidence of decreased daytime and nighttime short-acting beta-2 agonist requirement with salmeterol. Fewer adverse events occurred in participants using long-acting beta-2 agonists (salmeterol and formoterol) as compared to theophylline.

Plain-language summary: This review compared three asthma medications, salmeterol, formoterol (both long acting beta-agonists) and theophylline. These medications are used to help control symptoms of asthma, especially those which occur during the night. This review found that salmeterol showed a greater improvement in lung function, and reduced the need for extra short-term inhalers in the day and the night. Salmeterol and formoterol are less likely to produce side-effects (such as headaches and nausea) when compared to theophylline.
Abstract: Six trials involving 907 patients were identified. For 'death (all causes)' the Peto odds ratio of 0.77 with a 95% confidence interval (CI) of 0.48 to 1.24 did not show a statistically significant difference between both treatment groups. For 'stroke (any)' the Peto odds ratio of 0.58 (95% CI: 0.34 to 0.98) indicated a statistically significant benefit in favour of antiplatelet drugs (P = 0.04). For 'vascular death', 'stroke or vascular death', 'serious vascular events', 'death or dependency', 'myocardial infarction', 'major extracranial haemorrhage', 'local haemorrhage requiring surgery', 'restenosis', 'TIA or amaurosis fugax', neither any benefit nor any hazard of antiplatelet drugs could be shown. For the outcome events 'intracranial haemorrhage', 'ischaemic stroke' and 'occurrence or progression of contralateral stenosis', data were either too sparse for meaningful analyses, or not available at all. Our results may indicate that antiplatelet drugs did not significantly change the odds of death but reduce the outcome 'stroke of any cause' in patients undergoing carotid endarterectomy. However, it can not be excluded that the beneficial effect in reducing stroke is due to chance. There is a suggestion that antiplatelets may increase the odds of haemorrhage, but there are currently too few data to quantify this effect.

Plain-language summary: This review showed that antiplatelet drugs can also reduce the risk of stroke in patients undergoing carotid endarterectomy. There was limited information on bleeding risk. The review's conclusions supported the routine use of antiplatelet drugs such as aspirin in patients having carotid endarterectomy.
Abstract: Thirteen trials performed between the years 1974 and 2008 were included, involving 1412 patients. Four trials included 520 children with acute lymphoblastic leukemia and the remaining trials included adults with acute leukemia, solid organ transplantation or autologous bone marrow transplantation. Compared to no treatment or treatment with fluoroquinolones (inactive against Pneumocystis), there was an 85% reduction in the occurrence of PCP in patients receiving prophylaxis with trimethoprim/sulfamethoxazole, RR of 0.15 (95% CI 0.04 to 0.62; 10 trials, 1000 patients). The evidence was graded as moderate due to possible risk of bias. PCP-related mortality was also significantly reduced, RR of 0.17 (95% CI 0.03 to 0.94; nine trials, 886 patients) (low quality of evidence due to possible risk of bias and imprecision), but in trials comparing PCP prophylaxis against placebo or no treatment there was no significant effect on all-cause mortality (low quality of evidence due to imprecision). Occurrence of leukopenia or neutropenia and their duration were not reported consistently. No significant differences in overall adverse events or events requiring discontinuation were seen comparing trimethoprim/sulfamethoxazole to no treatment or placebo (four trials, 470 patients, moderate quality evidence). No differences between once daily versus thrice weekly trimethoprim/sulfamethoxazole were seen (two trials, 207 patients). Given an event rate of 6.2% in the control groups of the included trials, prophylaxis for PCP using trimethoprim/sulfamethoxazole is highly effective among non-HIV immunocompromised patients, with a number needed to treat to prevent PCP of 19 patients (95% CI 17 to 42). Prophylaxis should be considered for patients with a similar baseline risk of PCP.

Plain-language summary: The patients included in the 13 trials we identified were adults with acute leukemia or solid organ transplantation and children with acute leukemia. This review of randomised controlled trials (RCTs) found that prophylaxis with trimethoprim/sulfamethoxazole, an antibiotic effective against PCP, significantly reduced the occurrence of PCP by 85%. We found no evidence for a reduction in all cause mortality. Confidence in the results for PCP was moderate to high, while for mortality it was low due to paucity of data. Preventive treatment was not associated with an increased rate of adverse events. Trimethoprim/sulfamethoxazole may be administered thrice weekly as effectively as once daily. Based on our results, the number of people that need to be treated with trimethoprim/sulfamethoxazole for a prolonged period of time (ranging between several weeks to three years in the included trials) in order to prevent one episode of PCP infection was 19; when PCP infection occurs at a rate of about 6% without prophylaxis. Given the low rate of adverse events, prophylaxis should be considered for patients at similar risk of PCP.
Abstract: Ten studies were included in the review but only five reported data that could be used. Three of the ten studies were related to exercise-based psychological interventions. Seven were related to psychological interventions. No meta-analyses were possible due to diversity of participants, interventions and outcomes. Two studies compared a psychosocial intervention versus another intervention. Three studies compared a psychosocial intervention to a control group. Only one primary prevention trial reported data for the primary outcomes and, although this study found a significant difference in depression in favour of the intervention at endpoint, this difference was no longer evident at 18 months. No studies of primary prevention comparing different interventions and reporting primary outcomes of interest were identified. The methodological quality of the included studies was summarised. No study met our full quality criteria and one was regarded as low-quality. The remainder could not be rated because of incomplete data in the published reports and inadequate responses from the trialists. There is evidence only from individual small and low quality trials with minimal data suggesting that police officers benefit from psychosocial interventions, in terms of physical symptoms and psychological symptoms such as anxiety, depression, sleep problems, cynicism, anger, PTSD, marital problems and distress. No data on adverse effects were available. Meta-analyses of the available data were not possible. Further well-designed trials of psychosocial interventions are required. Research is needed on organization-based interventions to enhance psychological health among police officers.

Plain-language summary: In view of the importance of the functions performed by law enforcement officers, and the fact that there is no definitive approach to deal with psychological problems they may develop, a systematic review of the evidence is needed to determine the effectiveness of psychosocial interventions in preventing these problems in this select population. We found ten randomised trials, but not of all these contributed useful data for this review and quantitative meta-analyses were not possible. No data on adverse effects were available. The available evidence is, therefore, limited to the analysis of single, small and low quality trials. This suggests that police officers may benefit from psychosocial interventions in terms of psychological symptoms and physical symptoms. Further well-designed trials of psychosocial interventions to enhance the psychological health of police officers are required. Trials of organisation-based interventions are also needed.
Abstract: The curves for the life-table cumulative pregnancy rates for the Prentif cap and the diaphragm did not differ. However, the Kaplan-Meier six-month cumulative pregnancy rates for the FemCap and the diaphragm were not clinically equivalent. The Prentif cap had more Class I to Class III cervical cytologic conversions than the diaphragm (OR 2.31; 95% CI 1.04 to 5.11). The FemCap trial did not find differences in Papanicolaou smear results between the groups. Fewer Prentif cap users had vaginal ulcerations or lacerations (OR 0.31; 95% CI 0.14 to 0.71) than diaphragm users. Fewer FemCap users had blood in the device (OR 2.29; 95% CI 1.27 to 4.14), but more had urinary tract infections (OR 0.59; 95% CI 0.39 to 0.95). In the FemCap trial, similar proportions of women reported liking their device. However, FemCap users were less likely to use the device alone after the trial (OR 0.47; 95% CI 0.31 to 0.71) or recommend it to a friend (OR 0.48; 95% CI 0.29 to 0.81). The Prentif cap was as effective as its comparison diaphragm in preventing pregnancy, but the FemCap was not. Both cervical caps appear to be medically safe.

Plain-language summary: In February 2012, we did a computer search for studies of cervical caps. We wrote to manufacturers and researchers for information about other trials. We included randomized controlled trials that compared a cervical cap with a diaphragm. We found two trials that compared the cervical cap with the diaphragm. Two types of cervical caps were studied: the Prentif cap and the FemCap. The Prentif cap prevented pregnancy as well as the diaphragm, but the FemCap did not. Women who used the Prentif cap had more abnormal changes in the cervix than diaphragm users. The FemCap users did not have more abnormal changes than the diaphragm users. Many women from both groups dropped out early from the two trials. Similar numbers of FemCap users and diaphragm users reported liking their assigned method. The Prentif cap worked as well as the diaphragm to prevent pregnancy. The FemCap did not prevent pregnancy as well as the diaphragm. Both cervical caps appear to be medically safe.
Abstract: No immediate mortality was reported. There was no significant difference in serious cardio-respiratory complications suffered by patients in either sedation group. Failure to complete the procedure due to sedation-related problems was reported in one study. Three studies found faster and better recovery in patients receiving propofol for their ERCP procedures. Study protocols regarding use of supplemental oxygen, intravenous fluid administration and capnography monitoring varied considerably. The studies showed either moderate or high risk of bias. Results from individual studies suggested that patients have a better recovery profile after propofol sedation for ERCP procedures than after midazolam and meperidine sedation. As there was no difference between the two sedation techniques as regards safety, propofol sedation is probably preferred for patients undergoing ERCP procedures. However, in all of the studies that were identified only non-anaesthesia personnel were involved in administering the sedation. It would be helpful if further research was conducted where anaesthesia personnel were involved in the administration of sedation for ERCP procedures. This would clarify the extent to which anaesthesia personnel should be involved in the administration of propofol sedation.

Plain-language summary: There was no significant difference between the sedation techniques as regards safety. There were no deaths in the trials and the number of major complications, such as lack of oxygen (hypoxaemia) and low blood pressure (hypotension), was comparable in both techniques. There was no difference in patient satisfaction in either group. However, the recovery of patients who received propofol was significantly better than for those who had received midazolam and meperidine for the procedure. In conclusion, patients undergoing ERCP procedures under propofol sedation recover faster and better than those patients receiving midazolam and meperidine sedation. This would make propofol the preferred choice for these procedures as there was no difference in the safety of either technique. Further research should focus on the safety of the sedative techniques and involve anaesthesia personnel in the administration of the sedation.
Abstract: Three trials including 255 patients qualified for this review. In two of the trial, a total of 150 patients were randomised to absorbable clips (n = 75) and non-absorbable clips (n = 75). In the third trial, a total of 105 patients were randomised to absorbable ligatures (n = 53) and non-absorbable clips (n = 52). All three trials were of high risk of bias. There was no difference in the morbidity between the groups. There was statistically significant longer operating time (MD 12.00 minutes, 95% CI 1.59 to 22.41) in the absorbable ligature group than non-absorbable clips. The duration and method of follow-up were not adequate to determine the incidence of long-term complications. We are unable to determine the benefits and harms of different methods of cystic duct occlusion because of the small sample size, short period of follow-up, and lack of reporting of important outcomes in the included trials. Adequately powered randomised trials with low risk of bias and with long periods of follow-up and assessing all of the important outcomes for patients and professionals are necessary.

Plain-language summary: A total of three trials including 255 patients qualified for this review of randomised clinical trials. Two trials randomised 150 patients in total to absorbable clips (n = 75) and non-absorbable clips (n = 75). A third trial randomised a total of 105 patients to absorbable ligatures (n = 53) and non-absorbable clips (n = 52). All three trials were of high risk of bias. There was no difference in the morbidity between the groups. The operating time was 12 minutes longer in the absorbable ligature group than in the group randomised to non-absorbable clips.The duration and method of follow-up were not adequate to determine the incidence of long-term complications. We are unable to determine the benefits and harms of different methods of cystic duct occlusion because of the small sample size, short period of follow-up, and lack of reporting of important outcomes in the included trials. New trials with long periods of follow-up and assessing the important outcomes are necessary. Such trials should be designed well to decrease the risk of random errors and systematic errors.
Abstract: The review currently includes eleven RCTs with 4144 participants on three second-generation antipsychotics (olanzapine, quetiapine, risperidone). Nine studies investigated the effects of second-generation antipsychotics in generalised anxiety disorder, only two studies investigated the effects in social phobia. There were no studies on panic disorder or any other primary anxiety disorder. Seven studies investigated the effects of quetiapine. Participants with generalised anxiety disorder responded significantly better to quetiapine than to placebo (4 RCTs, N = 2265, OR = 2.21, 95% CI 1.10 to 4.45). However, they were more likely to drop out due to adverse events, to gain weight, to suffer from sedation or to suffer from extrapyramidal side effects. When quetiapine was compared with antidepressants, there was no significant difference in efficacy-related outcomes, but more participants in the quetiapine groups dropped out due to adverse events, gained weight and feeling sedated. Only two very small studies with a total of 36 participants examined olanzapine and found no difference in response to treatment. Two trials compared adjunctive treatment with risperidone with placebo and found no difference in response to treatment. We identified eligible trials on quetiapine, risperidone and olanzapine. The available data on olanzapine and risperidone are too limited to draw any conclusions. Monotherapy with quetiapine seems to be efficacious in reducing symptoms of generalised anxiety disorder and this effect may be similar to that of antidepressants. However, quetiapine's efficacy must be weighed against its lower tolerability.

Plain-language summary: This systematic review evaluated the efficacy and tolerability of second-generation antipsychotics in the treatment of anxiety disorders. We found eleven randomised placebo-controlled trials, comparing quetiapine, olanzapine and risperidone with placebo and antidepressants. The vast majority of the available data was on quetiapine (> 3000 participants). Participants with generalised anxiety disorder responded significantly better to quetiapine than to placebo, measured as a reduction in the Hamilton Anxiety Scale (HAM-A). Participants treated with quetiapine were more likely to drop out due to adverse events, to gain weight, to suffer from sedation or to suffer from extrapyramidal side effects. The evidence on the other second-generation antipsychotics is currently too limited to draw any conclusions.
Abstract: Overall 16 studies were identified and included. MR1: three trials (n=145). Some evidence of effectiveness of cognitive rehabilitation on cognitive outcomes, although this was difficult to interpret because of the large number of outcome measures used. MR2: three trials (n=80). One small trial suggesting psychotherapy may help with depression. MR3: seven studies (n=688). Some evidence that cognitive behavioural therapy may help people adjust to, and cope with, having MS (three trials). The other trials were diverse in nature and some difficult to interpret because of multiple outcome measures. MR4: three trials (n=93). Two small studies of cognitive behavioural therapy showed significant improvements in depression. The diversity of psychological interventions identified indicates the many ways in which they can potentially help people with MS. No definite conclusions can be made from this review. However there is reasonable evidence that cognitive behavioural approaches are beneficial in the treatment of depression, and in helping people adjust to, and cope with, having MS.

Plain-language summary: Sixteen relevant studies were identified and included in this review. They have researched a variety of different interventions, having different purposes, and so a single overall definite conclusion cannot be made. However the authors cautiously conclude that Cognitive Behavioural Therapy, a therapy that addresses thoughts and behaviours, can help people with MS adjust to, and cope with, having MS, and can help them if they get depressed. Psychological interventions can potentially help people with MS in many ways, including the management of symptoms such as pain and fatigue. Additional studies are needed, particularly those that include larger numbers of people.
Abstract: Ten studies (1785 participants) met the inclusion criteria. The two new studies in this update had been identified in the earlier update, but data were not available. There remain three potentially relevant unpublished studies for which data are not available at this time. The NNT for celecoxib 200 mg and 400 mg compared with placebo for at least 50% of maximum pain relief over four to six hours was 4.2 (95% confidence interval (CI) 3.4 to 5.6) and 2.6 (95% CI 2.3 to 3.0) respectively. The median time to use of rescue medication was 6.6 hours with celecoxib 200 mg, 8.4 hours with celecoxib 400 mg, and 2.3 hours with placebo. The proportion of participants requiring rescue medication over 24 hours was 74% with celecoxib 200 mg, 63% for celecoxib 400 mg, and 91% for placebo. The NNT to prevent one patient using rescue medication was 4.8 (95% CI 3.5 to 7.7) and 3.5 (95% CI 2.9 to 4.6) for celecoxib 200 mg and 400 mg respectively. Adverse events were generally mild to moderate in severity, and were experienced by a similar proportion of participants in the celecoxib and placebo groups. One serious adverse event that was probably related to celecoxib was reported. Single-dose oral celecoxib is an effective analgesic for postoperative pain relief. Indirect comparison suggests that the 400 mg dose has similar efficacy to ibuprofen 400 mg.

Plain-language summary: This review assessed information from 10 studies which used celecoxib for acute pain. Just over 3 in 10 people (33%) taking celecoxib 200 mg, and over 4 in 10 (43%) taking celecoxib 400 mg, experienced good pain relief (at least 50%) compared to about 1 in 10 (range 1% to 11%) with placebo. Comparing the results of the different studies showed that the 200 mg dose of celecoxib was at least as good as aspirin 600 to 650 mg and paracetamol (acetaminophen) 1000 mg for relieving postoperative pain, while a 400 mg dose was at least as good as ibuprofen 400 mg. The number of people who experienced negative (adverse) reactions was similar for celecoxib and placebo, and stopping the medication due to these adverse reactions also occurred at similar rates. One serious adverse event, muscle breakdown (rhabdomyolysis), was probably related to celecoxib.