GEM/cochrane-simplification huggingface dataset:
Abstract: Fifteen randomized controlled trials (representing 869 patients) met the inclusion criteria. Two trials included a placebo arm. All studies (except one) were open-label trials. Seven drug classes were evaluated in those trials: nitrates (9 trials), ACE-inhibitors (7), diuretics (3), calcium channel blockers (6), alpha-1 adrenergic antagonists (4), direct vasodilators (2) and dopamine agonists (1).  Mortality event data were reported in 7 trials. No meta-analysis was performed for clinical outcomes, due to insufficient data. The pooled effect of 3 different anti-hypertensive drugs in one placebo-controlled trial showed a statistically significant greater reduction in both systolic [WMD -13, 95%CI -19,-7] and diastolic [WMD -8, 95%CI, -12,-3] blood pressure with antihypertensive therapy. There is no RCT evidence demonstrating that anti-hypertensive drugs reduce mortality or morbidity in patients with hypertensive emergencies. Furthermore, there is insufficient RCT evidence to determine which drug or drug class is most effective in reducing mortality and morbidity. There were some minor differences in the degree of blood pressure lowering when one class of antihypertensive drug is compared to another. However, the clinical significance is unknown. RCTs are needed to assess different drug classes to determine initial and longer term mortality and morbidity outcomes.

Plain-language summary: This review looked for all studies where patients were randomized to one or more treatments to measure the effects of such therapies. The questions of the review were to see whether drug treatments affected death or cardiovascular morbidity or whether there were differences between drug treatments. The available evidence was insufficient to answer these questions.
Abstract: Three independent readers reviewed 120 publications and selected six clinical trials. Overall agreement on study selection was perfect (concordance: 100%). The meta-analysis includes six studies involving 126 patients with septic, cardiogenic, hemorrhagic, or spinal shock. Naloxone therapy was associated with statistically significant hemodynamic improvement (odds ratio 0.24; 95% confidence interval (CI) 0.09 to 0.68). The mean arterial pressure was significantly higher in the naloxone groups than in the placebo groups (weighted mean difference +9.33 mm Hg; 95% CI 7.07 to 11.59). No heterogeneity was found for this outcome. The death rate was lower in the naloxone group (odds ratio 0.59; 95% CI 0.21 was 1.67) but this was consistent with the play of chance. A significant heterogeneity was detected for the latter outcome (P < 0.05). Naloxone improves blood pressure, especially mean arterial blood pressure. However, the clinical usefulness of naloxone to treat shock remains to be determined and additional randomized controlled trials are needed to assess its usefulness.

Plain-language summary: This review of trials found that giving naloxone to people in shock improves their blood pressure. It is not clear whether or not this improves their overall condition or reduces their chances of dying. More trials are needed.
Abstract: One trial, which involved 38,546 subjects and compared vaccination with placebo, met our inclusion criteria. This included study was of high quality. However, its participants were all aged 60 years or more and most of them were white, which may mean that its findings are not applicable to all populations. The vaccine was effective in decreasing the incidence of herpes zoster, but there was no evidence that it had efficacy in reducing the incidence of postherpetic neuralgia beyond its effect on the incidence of herpes zoster. Adverse events at the injection site were more common among vaccine recipients than placebo recipients, but they were mild and resolved in a few days. Serious adverse events were rare. There is insufficient direct evidence from specialised trials to prove the efficacy of vaccine for preventing postherpetic neuralgia beyond its effect on reducing herpes zoster, although vaccination may be efficacious and safe for preventing herpes zoster and thus reduce the incidence of postherpetic neuralgia in adults aged 60 years or older.

Plain-language summary: We identified a single high quality trial with a total of 38,546 participants, comparing vaccination with placebo. It found a significant reduction of herpes zoster, but did not provide enough direct evidence to draw any conclusion about whether the vaccine is effective in preventing postherpetic neuralgia beyond its effect on reducing herpes zoster. Non-serious adverse events were more common among vaccine recipients than placebo recipients, but serious ones were rare. More well designed and specialised trials of vaccination for preventing postherpetic neuralgia are required.
Abstract: We included 11 RCTs with 396 participants on three SGAs. All trials investigated the effects of adding these SGAs to antidepressants (usually SSRIs). The duration of all trials was less than six months. Only 13% of the participants left the trials early. Most trials were limited in terms of quality aspects. Two trials examined olanzapine and found no difference in the primary outcome (response to treatment) and most other efficacy-related outcomes but it was associated with more weight gain than monotherapy with antidepressants. Quetiapine combined with antidepressants was also not any more efficacious than placebo combined with antidepressants in terms of the primary outcome, but there was a significant superiority in the mean Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score at endpoint (MD -2.28, 95% CI -4.05 to -0.52). There were also some beneficial effects of quetiapine in terms of anxiety or depressive symptoms. Risperidone was more efficacious than placebo in terms of the primary outcome (number of participants without a significant response) (OR 0.17, 95% CI 0.04 to 0.66) and in the reduction of anxiety and depression (MD -7.60, 95% CI -12.37 to -2.83). The available data of the effects of olanzapine in OCD are too limited to draw any conclusions. There is some evidence that adding quetiapine or risperidone to antidepressants increases efficacy, but this must be weighed against less tolerability and limited data.

Plain-language summary: This review found some trials comparing the effects of adding second-generation antipsychotic drugs or placebo to antidepressants in obsessive compulsive disorder. There were only 11 trials on three second-generation antipsychotic drugs (olanzapine, quetiapine and risperidone). While not much can be said about olanzapine, quetiapine and risperidone showed some efficacy benefit, but also adverse effects.
Abstract: We included five double-blind, placebo-controlled trials involving 3821 patients; there was no significant heterogeneity. Oral or intravenous nimodipine was used routinely as a background treatment in both groups in all trials. There was no significant difference between the two groups at the end of follow up for the primary outcome, death (odds ratio (OR) 0.89, 95% confidence interval (CI) 0.74 to 1.06), or in poor outcome (death, vegetative state or severe disability) (OR 1.04, 95% CI 0.90 to 1.21). During the treatment period, fewer patients developed delayed cerebral ischaemia in the tirilazad group than in the control group (OR 0.80, 95% CI 0.69 to 0.93). Subgroup analyses did not demonstrate any significant difference in effects of tirilazad on clinical outcomes. Leukocytosis and prolongation of Q-T interval occurred significantly more frequently in the treatment group in only one trial evaluating tirilazad at high dose. There was no significant difference in infusion site disorders or other laboratory parameters between the two groups. There is no evidence that tirilazad, in addition to nimodipine, reduces mortality or improves poor outcome in patients with aneurysmal SAH.

Plain-language summary: In animal studies, the drug tirilazad appeared to reduce brain damage after SAH. We reviewed the evidence from randomised controlled trials of tirilazad in patients with SAH to see if it could reduce the risk of death or disability. The review did not show any evidence of benefit from tirilazad in patients with aneurysmal SAH.
Abstract: Six trials (807 donors) were eligible: all were substudies, or constituent parts of, larger randomised controlled trials of bone marrow and peripheral blood stem cell allogeneic transplantation. No included trial was designed solely to measure and assess the experience of stem cell donors. The donors in all studies were related to the stem cell recipient. Overall, both types of donors experienced pain subsequent to donation, and psychological morbidity. The trend was for bone marrow donors to experience more pain at the donation site, more overall adverse events, and more days of restricted activity. They were also more likely to require hospitalisation than peripheral blood stem cell donors. In contrast, peripheral blood stem cell donors experienced more pain prior to donation, which may be related to the pre-donation administration of granulocyte colony stimulating factor (G-CSF). The methodological quality of the studies was poor and indicated limitations due to the risk of selection and attrition bias. The proportion of donors from the parent trial not included in the donor substudies was also inadequately explained. The different short-term morbidities associated with each type of haemopoietic stem cell donation were clear, with bone marrow donors experiencing more pain and more restriction post-donation than peripheral blood donors. However, the studies were limited by their methodological quality, failure to provide long-term follow up (for which larger numbers of donors would be required) and a failure to apply consistent measures of quality of life in a way which allows more meaningful evaluation across studies.

Plain-language summary: Six trials (807 donors) were identified for this review. The review found that donors donating via a bone marrow harvest experienced more pain at the donation site (hip bone area) in the days following the donation, more days of restricted activity (e.g. sick days), more days in hospital and more side effects than donors donating through a peripheral blood stem cell harvest. In contrast, peripheral blood stem cell harvest donors experienced more pain prior to the donation of blood stem cells than bone marrow harvest donors. This pain was as a result of G-CSF administration. All donors had increased levels of tiredness and reduced levels of energy and anxiety following their donation. There were three main limitations of this review. Firstly, in two trials more than 40% of the donors did not complete the trial. Secondly, there was no long-term follow up of the donors in any trial. Thirdly, the trials used different questionnaires to record the donors emotional experience of the donation procedure which made it difficult to compare the results of these measurements across the six trials. Further research, with larger numbers of included donors, would provide a greater understanding of the donation experience.
Abstract: The review now includes seven trials with a total of 479 participants. In only one trial, with 95 participants, perazine appeared superior to 'active placebo' (trimipramine) at five weeks for the outcome of 'no important global improvement' (n = 95, RR 0.43 CI 0.2 to 0.8, low quality evidence), but there was no statistically significant difference in most measures of mental state. Perazine did not induce more general adverse events than placebo but more participants received at least one dose of antiparkinson medication (n = 95, RR 4.50 CI 1.0 to 19.5, very low quality evidence). Six small trials comparing perazine with other antipsychotics, including 384 participants in total, were incompletely reported and the outcomes were presented in various ways so that meta-analysis was not possible on most occasions. In the six studies, a similar number of participants receiving perazine or comparator antipsychotics (amisulpride, haloperidol, olanzapine, ziprasidone, zotepine) left the studies early (n = 384, RR 0.97 CI 0.68 to 1.38, low quality evidence). The results on efficacy could not be meta-analysed because the authors presented their results in very different ways. No obvious differences in adverse events between perazine and other antipsychotics could be derived from the limited data. Two haloperidol comparisons did not present extrapyramidal side-effects in a way that was suitable for use in meta-analysis, but three small comparisons with the second-generation antipsychotics zotepine and amisulpride showed no higher risk of akathisia (n = 111, RR 0.31 CI 0.1 to 1.1), dyskinesia (n = 111, RR 0.47 CI 0.1 to 3.5), parkinsonism (n = 81, RR 1.21 CI 0.5 2.8) or tremor (n = 40, RR 0.80 CI 0.3 to 2.6) with perazine. The number, size and reporting of randomised controlled perazine trials are insufficient to present firm conclusions about the properties of this antipsychotic. It is possible that perazine is associated with a similar risk of extrapyramidal side-effects as some atypical antipsychotics but this is based on small comparisons. This should be clarified in larger, well-designed trials.

Plain-language summary: A search for trials was carried out in July 2012. The review now includes seven studies with a total of 479 participants and assesses the effects of perazine for people with schizophrenia. Comparisons of perazine versus placebo (‘dummy’ treatment) and versus other antipsychotic drugs revealed no clear differences or superiority of perazine. However, only a handful of studies have been undertaken and the number of participants in each study was small. In addition the studies avialable were of limited quality with data for the main outcomes of interest rated as low or very low quality. As perazine is a cheap drug and there is some limited evidence that it may cause less side effects than other older antipsychotic drugs, further large scale, well designed and well-reported studies are much needed. This plain language summary has been written by a consumer Benjamin Gray from Rethink Mental Illness, Email: [email protected].
Abstract: Four randomised controlled studies including a total of 695 participants were eligible for inclusion. Three studies evaluated neonates with MAS, and one study assessed asymptomatic neonates exposed to meconium in amniotic fluid. These studies exhibited varying degrees of methodological rigour: Two studies were at low risk of bias, and two were at unclear risk. We graded evidence derived from these studies as low quality. We downgraded overall evidence owing to the large number of participants lost to follow-up in one trial, the small sample sizes of all trials, and unclear methodological details provided for two trials. The primary outcome was risk of early- and late-onset neonatal sepsis. Antibiotics did not decrease the risk of sepsis in neonates with a diagnosis of MAS (RR 1.54, 95% confidence interval (CI) 0.27 to 8.96; RD 0.00, 95% CI -0.02 to 0.03; 445 participants, three studies; I² = 0%) nor in asymptomatic neonates exposed to meconium in amniotic fluid (RR 0.76, 95% CI 0.25 to 2.34; RD -0.01, 95% CI -0.07 to 0.04; 250 participants, one study; I² = 0%). Results show no significant differences in mortality or duration of stay in hospital between groups given antibiotics and control groups of symptomatic and asymptomatic neonates. One study in asymptomatic neonates reported a significant reduction in duration of mechanical ventilation for the control group compared with the antibiotic group (MD 0.26, 95% CI 0.15 to 0.37; 250 participants, one study; I² = 0%). Upon review of available evidence, we found no differences in infection rates following antibiotic treatment among neonates born through meconium-stained fluid and those with meconium aspiration syndrome. The overall quality of evidence is low owing to the small number of included studies. Well-controlled studies of adequate power are needed.

Plain-language summary: We searched the medical literature for eligible studies through June 2016. We found four studies that compared antibiotics versus placebo for reducing infection among babies born with meconium-stained amniotic fluid. Two studies were of good quality, and two studies were missing some details regarding study methods. These four studies included 695 babies, who were given various antibiotics or were placed in the control group (no antibiotics). Researchers evaluated several different antibiotic types and treatment lengths. Overall, we found no differences in rate of infection or death between the two groups. We graded the evidence as low quality owing to a poor quality study design and the small number of included babies. We are uncertain as to whether antibiotics have an important effect on infection in babies exposed to meconium-stained amniotic fluid. Our results are imprecise, and more studies are needed to determine the role of antibiotics in this situation.
Abstract: We could not identify any studies in which the only difference between the treatment groups was the use of MTX. We did identify a RCT comparing MTX with cisplatin (n=30 children). The risk of bias in this study was difficult to assess due to a lack of reporting. Survival could not be evaluated, but no evidence of a significant difference in response rate between the treatment groups was identified (RR=0.44; 95% CI 0.17 to 1.13; P=0.09). A significant difference in the occurrence of toxicities in favour of MTX was identified, but with regard to quality of life treatment with cisplatin seemed to give better results. For other combinations of treatment including and not including MTX no studies were identified. Since no RCTs or CCTs in which only the use of MTX differed between the treatment groups were identified, no definitive conclusions can be made about the effects on antitumour efficacy, toxicities and quality of life of the addition of MTX to treatment of children and young adults with primary high-grade osteosarcoma. The same is true for combinations of treatment including and not including MTX other than treatment with MTX versus treatment with cisplatin. Only 1 RCT comparing MTX with cisplatin treatment was available and therefore, no definitive conclusions can be made about the effectiveness of these agents in children and young adults with primary high-grade osteosarcoma. Furthermore, this study was performed in a different treatment era. Nowadays single agent treatment of osteosarcoma is considered inadequate. Based on the currently available evidence, we are not able to give recommendations for the use of MTX in clinical practice. More high quality research is needed.

Plain-language summary: This systematic review focused on (randomised) controlled studies. The authors found that there were no studies in which the only difference between the intervention and control group was the use of MTX. They did identify a RCT comparing MTX with cisplatin. The risk of bias in this study was difficult to assess due to a lack of reporting. Survival could not be evaluated, but no evidence of a significant difference in response rate between the treatment groups was identified. However, a significant difference in the occurrence of toxicities in favour of treatment with MTX was identified, but treatment with cisplatin seemed to give better results with regard to quality of life. It should be noted that this study was performed in a different treatment era. Nowadays single agent treatment of osteosarcoma is considered inadequate. For other combinations of treatment including and not including MTX no studies are available. More high quality research is needed. At the moment, the authors are awaiting more details on 5 studies for which the currently available data were insufficient to assess eligibility for inclusion in this review.
Abstract: The initial search produced 217 citations, and 15 were added from experts, abstracts and review of reference lists. Authors of 4 trials being prepared for publication (and subsequently published) kindly shared their data. After application of eligibility criteria 15 studies and 1,414 patients were included. The majority of trials studied early RA (disease duration up to 2 years), and the mean cumulative dose of glucocorticoid was 2,300 mg prednisone equivalent (range 270 mg - 5,800 mg) over the first year. Glucocorticoids were mostly added to other disease modifying anti-rheumatoid drug (DMARD) treatment. The standardised mean difference in progression was 0.40 in favour of glucocorticoids (95% CI 0.27, 0.54). In studies lasting 2 years (806 patients included), the standardised mean difference in progression in favour of glucocorticoids at 1 year was 0.45 (0.24, 0.66) and at 2 years was 0.42 (0.30, 0.55). All studies except one showed a numerical treatment effect in favour of glucocorticoids. The beneficial effects of glucocorticoids were generally achieved when used in conjunction with other DMARD treatment. Even in the most conservative estimate, the evidence that glucocorticoids given in addition to standard therapy can substantially reduce the rate of erosion progression in rheumatoid arthritis is convincing. There remains concern about potential long-term adverse reactions to glucocorticoid therapy, such as increased cardiovascular risk, and this issue requires further research.

Plain-language summary: The studies looked at people who had rheumatoid for up to 2 years. Low doses of glucocorticoid pills were taken and usually with a disease-modifying anti-rheumatoid drug (DMARD). Glucocorticoids reduce progression of the disease on x-rays over 1 to 2 years. This result is based on high quality evidence. Harms were not reviewed. We often do not have precise information about side effects and complications. This is particularly true for rare but serious side effects and long term side effects. Low doses of glucocorticoids may not lead to side effects, but possible side effects may include osteoporosis or heart problems.