GEM/cochrane-simplification huggingface dataset:
Abstract: We retrieved 2398 citations: 30 studies were eligible for further examination of their full text, and we found one registered clinical trial in progress. No studies could be included in the analysis or review. We assigned one study as awaiting classification, as it has not been accepted for publication. This systematic review failed to locate relevant published RCTs to support or refute the assertion that vascular access specialist teams are superior to the generalist model. A vascular access specialist team has advanced knowledge with regard to insertion techniques, clinical care, and management of vascular access devices, whereas a generalist model comprises nurses, doctors, or other designated healthcare professionals in the healthcare facility who may have less advanced insertion techniques and who care for vascular access devices amongst other competing clinical tasks. However, this conclusion may change once the one study awaiting classification and one ongoing study are published. There is a need for good-quality RCTs to evaluate the efficacy of a vascular access specialist team approach for vascular access device insertion and care for the prevention of failure.

Plain-language summary: We searched a wide range of medical databases on 7 February 2018. We identified 2398 potential studies, 30 of which we looked at in detail. We found one suitable study, however although the study is complete the manuscript has not yet been accepted for publication, and so we were unable to analyse the data. We have assigned the study as awaiting classification; once its results are published we will evaluate it again and decide if it is eligible for inclusion in the review. We found one registered trial that is investigating our review question, but it is still ongoing and not yet completed or published. We failed to locate any published randomized controlled trials (RCTs) to support or refute the assertion that vascular access specialist teams are superior to the generalist model for device insertion and prevention of failure. However, this conclusion may change once the one study awaiting classification and the one ongoing study are published. There is a need for good-quality RCTs to evaluate the efficacy of a VAST approach for VAD insertion and prevention of failure. An RCT is a study (or trial) that aims to reduce bias when testing a new treatment. The people taking part in the trial are randomly allocated to either the group receiving the treatment under investigation or to a group receiving standard treatment (or placebo treatment) as the control. We did not analyse the quality of the evidence as we did not find any suitable studies to include in our review.
Abstract: Ten papers describing 10 unique trials met the inclusion criteria. Analysis of data from two trials (63 participants) showed that sodium valproate reduced headache frequency by approximately four headaches per 28 days as compared to placebo (MD -4.31; 95% confidence interval (CI) -8.32 to -0.30). Data from four trials (542 participants) showed that divalproex sodium (a stable combination of sodium valproate and valproic acid in a 1:1 molar ratio) more than doubled the proportion of responders relative to placebo (RR 2.18; 95% CI 1.28 to 3.72; NNT 4; 95% CI 2 to 11). One study of sodium valproate (34 participants) versus placebo supported the latter findings (RR for responders 2.83; 95% CI 1.27 to 6.31; NNT 3; 95% CI 2 to 9). There was no significant difference in the proportion of responders between sodium valproate versus flunarizine (one trial, 41 participants) or between divalproex sodium versus propranolol (one trial, 32 participants). Pooled analysis of post-treatment mean headache frequencies in two trials (88 participants) demonstrates a slight but significant advantage for topiramate 50 mg over valproate 400 mg (MD -0.90; 95% CI -1.58 to -0.22). For placebo-controlled trials of sodium valproate and divalproex sodium, NNHs for clinically important adverse events ranged from 7 to 14. Valproate is effective in reducing headache frequency and is reasonably well tolerated in adult patients with episodic migraine.

Plain-language summary: For the present review, researchers in The Cochrane Collaboration reviewed the evidence about the effects of valproate (valproic acid or sodium valproate or a combination of the two) in adult patients (≥ 16 years of age) with 'episodic' migraine (headache on < 15 days per month). They examined research published up to 15 January 2013 and found 10 relevant studies. Compared with placebo, valproate reduced the frequency of migraine headaches by approximately four per month (two studies, 63 participants). Patients were also more than twice as likely to reduce the number of their migraine headaches by 50% or more with valproate than with placebo (five studies, 576 participants). Side effects associated with valproate were common but generally mild; valproate can, however, cause birth defects and so should be used with caution in women of childbearing age. Further research is needed comparing valproate with other active drugs used for preventing migraine attacks.
Abstract: We included 12 studies (508 participants) in comparisons with placebo or an active control. Six studies enrolled participants with moderate or severe postherpetic neuralgia, and the remaining studies enrolled different, or mixed, neuropathic pain conditions, including trigeminal neuralgia and postsurgical or post-traumatic neuralgia. Four different formulations were used: 5% medicated patch, 5% cream, 5% gel, and 8% spray. Most studies used a cross-over design, and two used a parallel-group design. Two studies used enriched enrolment with randomised withdrawal. Seven studies used multiple doses, with one to four-week treatment periods, and five used single applications. We judged all of the studies at high risk of bias because of small size or incomplete outcome assessment, or both. There was no first or second tier evidence, and no pooling of data was possible for efficacy outcomes. Only one multiple-dose study reported our primary outcome of participants with ≥ 50% or ≥ 30% pain intensity reduction. Three single-dose studies reported participants who were pain-free at a particular time point, or had a 2-point (of 10) reduction in pain intensity. The two enriched enrolment, randomised withdrawal studies reported time to loss of efficacy. In all but one study, third tier (very low quality) evidence indicated that lidocaine was better than placebo for some measure of pain relief. Pooling multiple-dose studies across conditions demonstrated no clear evidence of an effect of lidocaine on the incidence of adverse events or withdrawals, but there were few events and the withdrawal phase of enriched enrolment designs is not suitable to assess the true impact of adverse events (very low quality evidence). This review found no evidence from good quality randomised controlled studies to support the use of topical lidocaine to treat neuropathic pain, although individual studies indicated that it was effective for relief of pain. Clinical experience also supports efficacy in some patients. Several large ongoing studies, of adequate duration, with clinically useful outcomes should provide more robust conclusions about both efficacy and harm.

Plain-language summary: In July 2014 we performed searches to look for clinical trials where topical lidocaine was used to treat neuropathic pain. We found 12 small studies of modest quality that tested topical lidocaine against topical placebo for a number of weeks. One study also tested a cream containing amitriptyline, which is an antidepressant. The 508 people in the studies had different types of neuropathic pain, with pain after herpes zoster infection the most common. There was some indication that topical lidocaine was beneficial in these studies (very low quality evidence). There was no clear evidence of an effect of lidocaine on the incidence of adverse events or withdrawals (very low quality evidence). A number of studies of topical lidocaine in neuropathic pain are ongoing. Several are large and of long duration. They will be of great help in working out the benefits of topical lidocaine when they are completed and results can be incorporated in this review.
Abstract: We identified 29 randomised clinical trials, five of which were considered high quality. Only three trials reported inclusion of hepatitis B e-antigen negative mothers. Compared with placebo/no intervention, vaccine reduced hepatitis B occurrence (RR 0.28, 95% confidence interval (CI) 0.20 to 0.40, 4 trials). No significant differences of hepatitis B occurrence were found comparing recombinant vaccine (RV) versus plasma-derived vaccine (PDV) (RR 1.00, 95% CI 0.71 to 1.42, 4 trials) and high-dose versus low-dose vaccine (PDV: RR 0.97, 95% CI 0.55 to 1.68, 3 trials; RV: RR 0.78, 95% CI 0.31 to 1.94, 1 trial). Compared with placebo/no intervention, hepatitis B immunoglobulin or the combination of vaccine plus hepatitis B immunoglobulin reduced hepatitis B occurrence (hepatitis B immunoglobulin: RR 0.50, 95% CI 0.41 to 0.60, 1 trial; PDV plus hepatitis B immunoglobulin: RR 0.08, 95% CI 0.03 to 0.17, 3 trials). Compared with vaccine, vaccine plus hepatitis B immunoglobulin reduced hepatitis B occurrence (RR 0.54, 95% CI 0.41 to 0.73, 10 trials). Hepatitis B vaccine and hepatitis B immunoglobulin seem safe, but few trials reported on adverse events. Vaccine, hepatitis B immunoglobulin, and vaccine plus hepatitis B immunoglobulin prevent hepatitis B occurrence in newborn infants of HBsAg positive mothers.

Plain-language summary: When all the identified trials were combined, hepatitis B vaccine alone, hepatitis B immunoglobulin alone, and hepatitis B vaccine plus hepatitis B immunoglobulin reduced perinatal transmission of hepatitis B compared with placebo or no intervention. Hepatitis B vaccine plus hepatitis B immunoglobulin were superior to hepatitis B vaccination alone. Adverse events were rare and mostly non-serious.
Abstract: Fourteen studies (involving 1879 couples) were included. Three studies reported live birth rate and these did not identify a significant difference after pooling the (preliminary) results (OR 1.21, 95% CI 0.67 to 2.19). With regard to pregnancy rates, there was also no evidence that glucocorticoids improved clinical outcome (13 RCTs; OR 1.16, 95% CI 0.94 to 1.44). However, a subgroup analysis of 650 women undergoing IVF (6 RCTs) revealed a significantly higher pregnancy rate for women using glucocorticoids (OR 1.50, 95% CI 1.05 to 2.13). There were no significant differences in adverse events, but these were poorly and inconsistently reported. Overall, there was no clear evidence that administration of peri-implantation glucocorticoids in ART cycles significantly improved the clinical outcome. The use of glucocorticoids in a subgroup of women undergoing IVF (rather than ICSI) was associated with an improvement in pregnancy rates of borderline statistical significance and should be interpreted with care. These findings were limited to the routine use of glucocorticoids and cannot be extrapolated to women with autoantibodies, unexplained infertility or recurrent implantation failure. Further well designed randomised studies are required to elucidate the possible role of this therapy in well defined patient groups.

Plain-language summary: This review investigated whether the administration of glucocorticoids around the time of implantation improved clinical outcomes in women undergoing IVF or ICSI when compared to no glucocorticoid administration. The review of trials found no evidence that glucocorticoids helped to improve live birth rates. However, there was some evidence of increased pregnancy rates, rather than live birth rates, among women undergoing IVF. This was not found in women undergoing ICSI. More research is needed to elucidate the possible role of this therapy in well defined patient groups.
Abstract: After screening 1808 abstracts, and the references of 65 reviews, we found only seven relevant studies (1050 patients) that met our inclusion criteria. None of these were considered, methodologically, a high quality randomized controlled trial. Four of the included RCTs on fibromyalgia were graded low quality and suggest no quantifiable benefits. The three included RCTs on widespread musculoskeletal pain showed that based on limited evidence, overall, no evidence of efficacy was observed. However, behavioral treatment and stress management appear to be important components. Education combined with physical training showed some positive effects in long term follow up. We conclude that there appears to be little scientific evidence for the effectiveness of multidisciplinary rehabilitation for these musculoskeletal disorders. However, multidisciplinary rehabilitation is a commonly used intervention for chronic musculoskeletal disorders, which cause much personal suffering and substantial economic loss to the society. There is a need for high quality trials in this field.

Plain-language summary: The main purpose of this systematic review was to determine the effectiveness of multidisciplinary rehabilitation for fibromyalgia and wide spread musculoskeletal pain among working age adults. Patients included in the controlled trials in this review ranged in age from 18-65 years. Seven studies, with 1050 patients were included. The effectiveness of multidisciplinary rehabilitation was graded limited, showing no quantifiable benefit for both fibromyalgia and widespread musculoskeletal pain.
Abstract: Five RCTs involving 895 sporadic and 52 familial ALS/MND participants were included. There was no statistical evidence for a differential response to treatment in participants with familial ALS/MND compared to those with sporadic ALS/MND. The pooled estimate of the hazard ratio for the interaction term (treatment x familial ALS) suggested a more beneficial response with respect to survival among participants with familial ALS/MND, but the result was not statistically significant. Pooled estimates of the rate of decline on the ALSFRS suggested a slightly better overall response to treatment among those with familial ALS/MND, but the result was not statistically significant. Based on the available data, there is little evidence for a differential response to treatment among people with familial and sporadic ALS/MND. Future randomized controlled trials should document whether people with familial ALS/MND are included and the presence or absence of a mutation in an ALS susceptibility gene amongst those with familial ALS/MND.

Plain-language summary: We identified all randomized controlled trials in ALS/MND and wrote to the authors to request the data needed to complete this review. Although many more studies were eligible for inclusion, only five authors were willing and able to share the data from their individual randomized controlled trials. Based on the analyses of these data, we find no evidence to support a statistically significant difference in the response to treatment between people with the familial and sporadic forms of ALS/MND.
Abstract: Nine studies involving 751 participants were included. Two of them produced effect sizes which showed a consistent and statistically significant difference in favour of the active drug. Combining all studies produced a pooled estimate of effect of 0.39 standard deviations (confidence interval, 0.24 to 0.54) in favour of the antidepressant measured by improvement in mood. There was high heterogeneity due to one strongly positive trial. Sensitivity analysis omitting this trial reduced the pooled effect to 0.17 (0.00 to 0.34). The pooled effect for inpatient and outpatient trials was highly sensitive to decisions about which combination of data was included but inpatient trials produced the lowest effects. The more conservative estimates from the present analysis found that differences between antidepressants and active placebos were small. This suggests that unblinding effects may inflate the efficacy of antidepressants in trials using inert placebos. Further research into unblinding is warranted.

Plain-language summary: This review examined trials which compared antidepressants with 'active' placebos, that is placebos containing active substances which mimic side effects of antidepressants. Small differences were found in favour of antidepressants in terms of improvements in mood. This suggests that the effects of antidepressants may generally be overestimated and their placebo effects may be underestimated.
Abstract: Five trials including 391 children aged three to 18 years met our criteria. Two studies (117 children) compared anaesthetic ear drops versus placebo immediately at diagnosis. All children received some form of oral pain relief. In all five studies it was clear that ear pain diminishes rapidly for most sufferers. Nevertheless there was a statistically significant difference in the proportion of children achieving a 50% reduction in pain in favour of anaesthetic drops 10 minutes after instillation (risk ratio (RR) 2.13, 95% confidence interval (CI) 1.19 to 3.80) and 30 minutes after instillation (RR 1.43, 95% CI 1.12 to 1.81) on the day AOM was diagnosed but not at 20 minutes (RR 1.24, 95% CI 0.88 to 1.74). Three trials (274 children) compared anaesthetic ear drops with naturopathic herbal ear drops. Naturopathic drops were favoured 15 and 30 minutes after instillation, one to three days after diagnosis, but the differences were not statistically significant. Only one trial looked at adverse reactions and found none. Overall the findings of this review are based on trial evidence that is at low or unclear risk of bias. Evidence from five RCTs, only two of which addressed the most relevant question of primary effectiveness, provides limited evidence that ear drops are effective 30 minutes after administration in older children with AOM. Uncertainty exists as to the magnitude of this effect and more high-quality studies are needed.

Plain-language summary: Children in all the trials experienced a rapid, short-term reduction in pain after using ear drops. It is hard to know if this was the result of the natural course of the illness; the placebo effect of receiving treatment; the soothing effect of any liquid in the ear or the pharmacological effects of the ear drops themselves. Nevertheless, there is some evidence that when combined with oral pain medication, anaesthetic ear drops may help to relieve pain more rapidly in children aged three to 18 years. More good-quality trials are needed.
Abstract: No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow-up, in general there is little information on the longer-term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence). In general, HBOT was well-tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521). For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review.

Plain-language summary: We first searched the literature in 2004 and most recently in September 2014, finding 6 studies in total. All studies included patients with heart attack and some also included patients with severe angina. The dose of hyperbaric oxygen was similar in most studies. Overall, we found some evidence that people with ACS are less likely to die or to have major adverse events, and to have more rapid relief from their pain if they receive hyperbaric oxygen therapy as part of their treatment. However, our conclusions are based on relatively small randomised trials. Our confidence in these findings is further reduced because in most of these studies both the patients and researchers were aware of who was receiving HBOT and it is possible a 'placebo effect' has biased the result in favour of HBOT. HBOT was generally well-tolerated. Some patients complained of claustrophobia when treated in small (single person) chambers and there was no evidence of important toxicity from oxygen breathing in any subject. One individual suffered damage to the eardrum from pressurisation. While HBOT may reduce the risk of dying, time to pain relief and the chance of adverse heart events in people with heart attack and unstable angina, more work is needed to be sure that HBOT should be recommended.