GEM/cochrane-simplification huggingface dataset:
Abstract: We considered 27 studies from the 2007 search. In this update we considered a further 38 studies from the 2013 search, and two in the 2014 search. We identified one RCT of moderate quality with low risk of bias overall which met the inclusion criteria for this update, comparing ABH (Ativan®, Benadryl®, Haldol®) gel, applied to the wrist, with placebo for the relief of nausea in 22 participants. ABH gel includes haloperidol as well as diphenhydramine and lorazepam. The gel was not significantly better than placebo in this small study; however haloperidol is reported not to be absorbed significantly when applied topically, therefore the trial does not address the issue of whether haloperidol is effective or well-tolerated when administered by other routes (e.g. by mouth, subcutaneously or intravenously). We identified one ongoing trial of haloperidol for the management of nausea and vomiting in patients with cancer, with initial results published in a conference abstract suggesting that haloperidol is effective for 65% of patients. The trial had not been fully published at the time of our review. A further trial has opened, comparing oral haloperidol with oral methotrimeprazine (levomepromazine) for patients with cancer and nausea unrelated to their treatment, which we aim to include in the next review update. Since the last version of this review, we found one new study for inclusion but the conclusion remains unchanged. There is incomplete evidence from published RCTs to determine the effectiveness of haloperidol for nausea and vomiting in palliative care. Other than the trial of ABH gel vs placebo, we did not identify any fully published RCTs exploring the effectiveness of haloperidol for nausea and vomiting in palliative care patients for this update, but two trials are underway.

Plain-language summary: This is an update of the original review published in 2009 for which no studies met the inclusion criteria. For this update, in a search of the published literature in November 2014 we found one moderate quality randomised controlled trial which compared ABH (Ativan®, Benadryl®, Haldol®) gel, containing haloperidol and two other medications, to placebo. The trial showed no difference between ABH gel and placebo. However it has previously been shown that haloperidol is not absorbed after applying ABH gel, so this result is not surprising. We identified a trial of haloperidol for nausea and vomiting in patients with cancer, with initial results presented at a conference. This suggests that haloperidol is effective in 65% of patients, but the results were not fully published at the time of our review. A further trial has opened in Australia, comparing haloperidol with another medication used for nausea, methotrimeprazine (levomepromazine).
Abstract: Only one study satisfied our inclusion criteria, comparing percutaneous radiofrequency thermal lumbar sympathectomy with lumbar sympathetic neurolysis using phenol in 20 participants with CRPS. There was no comparison of sympathectomy versus sham or placebo. No dichotomous pain outcomes were reported. Average baseline scores of 8-9/10 on several pain scales fell to about 4/10 initially (1 day) and remained at 3-5/10 over four months. There were no significant differences between groups, except for "unpleasant sensation", which was higher with radiofrequency ablation. One participant in the phenol group experienced post sympathectomy neuralgia, while two in the radiofrequency group and one in the phenol group complained of paraesthesia during needle positioning. All participants had soreness at the injection site. The practice of surgical and chemical sympathectomy for neuropathic pain and CRPS is based on very little high quality evidence. Sympathectomy should be used cautiously in clinical practice, in carefully selected patients, and probably only after failure of other treatment options. In these circumstances, establishing a clinical register of sympathectomy may help to inform treatment options on an individual patient basis.

Plain-language summary: This systematic review found only one small study (20 participants) of good methodological quality, which reported no significant difference between surgical and chemical sympathectomy for relieving neuropathic pain. Potentially serious complications of sympathectomy are well documented in the literature, and one (neuralgia) occurred in this study. The practice of sympathectomy for treating neuropathic pain is based on very weak evidence. Furthermore, complications of the procedure may be significant.
Abstract: Nine studies were identified, with a total of 5,168 participants. Follow-up ranged from 1 to 10 years. Quantitative synthesis was limited by the heterogeneity of populations, settings, and interventions and by the small number of studies that examined outcomes other than weight. Overall, in comparisons with usual care, four studies with a follow-up of one year reduced weight by 2.8 kg (95 % confidence interval (CI) 1.0 to 4.7) (3.3% of baseline body weight) and decreased body mass index by 1.3 kg/m2 (95% CI 0.8 to 1.9). Weight loss at two years was 2.6 kg (95% CI 1.9 to 3.3) (three studies). Modest improvements were noted in the few studies that examined glycemic control, blood pressure, or lipid concentrations (P > 0.05). No data on quality of life or mortality were found. The incidence of diabetes was significantly lower in the intervention groups versus the controls in three of five studies examining this outcome at 3 to 6 years follow-up. Overall, weight loss strategies using dietary, physical activity, or behavioral interventions produced significant improvements in weight among persons with prediabetes and a significant decrease in diabetes incidence. Further work is needed on the long-term effects of these interventions on morbidity and mortality and on how to implement these interventions in diverse community settings.

Plain-language summary: In this review we found that dietary, physical activity, or behavioral interventions produced significant improvements in weight among persons with prediabetes and a significant decrease in diabetes incidence. Modest, but not statistically significant improvements were noted in the few studies that examined blood sugar control, blood pressure, and lipid levels. No data on quality of life or mortality were found.
Abstract: Two studies representing 100 participants with a diagnosis of benign epilepsy of childhood with centrotemporal spikes (BECTS) and one study representing 146 participants with a diagnosis of generalised tonic-clonic seizures (GTCS) were included. STM was given as monotherapy compared with placebo in the BECTS studies and compared with phenytoin in the GTCS study. An English translation of the full text of one of the BECTS studies could not be found, and analysis of this study was based solely on the English translation of the abstract. No data were reported for outcome (1), (2), (3) or (5). Reporting of adverse effects was incomplete. Participants receiving STM were significantly less likely to develop gingival hyperplasia than were participants receiving phenytoin in the GTCS study (risk ratio (RR) 0.03, 95% confidence interval (CI) 0.00 to 0.58). No further statistically significant adverse events were noted when STM was compared with phenytoin or placebo. Two ongoing studies comparing STM monotherapy versus placebo or levetiracetam in BECTS were identified. Small sample size, poor methodological quality and lack of data on important outcome measures prevent any meaningful conclusions regarding the efficacy and safety of sulthiame as monotherapy in epilepsy.

Plain-language summary: Three randomised controlled trials with a total of 246 participants have been conducted to assess the efficacy and safety of sulthiame as monotherapy in epilepsy. Two studies have been conducted on benign epilepsy of childhood with centrotemporal spikes, and one study has been conducted on generalised tonic-clonic seizures. The quality of the evidence is limited by small sample sizes, significant risk of bias and the absence of data on important outcome measures and, in the case of one study, the lack of an English translation of the full-text manuscript. As a result, this review can draw no meaningful conclusions on the efficacy or safety of sulthiame as monotherapy in epilepsy. Our search (carried out in October 2013) revealed two ongoing studies on the use of sulthiame as monotherapy in benign epilepsy of childhood with centrotemporal spikes, the results of which may facilitate a more meaningful analysis in future updates of this review.
Abstract: We included six trials involving 1438 participants. Three of the six trials had adequate sequence generation while all the trials had unclear allocation concealment There was no evidence of any difference in pain perception during surgery with either retrobulbar or peribulbar anaesthesia. Both were largely effective. There was no evidence of any difference in complete akinesia or the need for further injections of local anaesthetic. Conjunctival chemosis was more common after peribulbar block (relative risk (RR) 2.11, 95% confidence interval (CI) 1.46 to 3.05) and lid haematoma was more common after retrobulbar block (RR 0.36, 95% CI 0.15 to 0.88). Retrobulbar haemorrhage was uncommon and occurred only once, in a patient who had a retrobulbar block. There is little to choose between peribulbar and retrobulbar block in terms of anaesthesia and akinesia during surgery measuring acceptability to patients, need for additional injections and development of severe complications. Severe local or systemic complications were rare for both types of block.

Plain-language summary: We set out to compare the two forms of local anaesthesia for cataract surgery. Our review showed that pain control and paralysis of the eye muscles to paralyse movement of the eye ball (akinesia) and allow surgery are no different for the two types of anaesthesia. The need for additional injections of local anaesthetic was higher with peribulbar anaesthesia (four trials). Only one case of bleeding behind the eye occurred and this was with retrobulbar anaesthesia (in one trial). The acceptability of the two methods to patients were similar in the two studies that reported on this outcome. None of the trials reported any life-threatening complications. There was a moderate risk of bias in the included trials.
Abstract: We included 16 cohort studies (median N = 126, range 71 to 2504) and three case control studies (38 to100 cases). Only one study was carried out in a primary care population. When used in isolation, diagnostic performance of most physical tests (scoliosis, paresis or muscle weakness, muscle wasting, impaired reflexes, sensory deficits) was poor. Some tests (forward flexion, hyper-extension test, and slump test) performed slightly better, but the number of studies was small. In the one primary care study, most tests showed higher specificity and lower sensitivity compared to other settings. Most studies assessed the Straight Leg Raising (SLR) test. In surgical populations, characterized by a high prevalence of disc herniation (58% to 98%), the SLR showed high sensitivity (pooled estimate 0.92, 95% CI: 0.87 to 0.95) with widely varying specificity (0.10 to 1.00, pooled estimate 0.28, 95% CI: 0.18 to 0.40). Results of studies using imaging showed more heterogeneity and poorer sensitivity. The crossed SLR showed high specificity (pooled estimate 0.90, 95% CI: 0.85 to 0.94) with consistently low sensitivity (pooled estimate 0.28, 95% CI: 0.22 to 0.35). Combining positive test results increased the specificity of physical tests, but few studies presented data on test combinations. When used in isolation, current evidence indicates poor diagnostic performance of most physical tests used to identify lumbar disc herniation. However, most findings arise from surgical populations and may not apply to primary care or non-selected populations. Better performance may be obtained when tests are combined.

Plain-language summary: We conducted a systematic review to summarize available information on the diagnostic value of different aspects of physical examination. We included 19 different studies in which a wide variety of tests were investigated, such as the straight leg raising test, absence of tendon reflexes, or muscle weakness. The results show that most individual tests carried out during physical examination are not very accurate in discriminating between patients who have, or do not have a herniated disc with sciatica. However, most of the studies were conducted in highly selected patients who had already been referred for surgery, and only one study was carried out in a primary care population. Furthermore, better diagnostic performance of physical examination may be expected when combinations of tests are used, including information from both the patient history and physical examination. However, more research is needed to investigate the performance of such test combinations.
Abstract: In this 2014 update, we found no new studies. The one small randomised double-blind placebo-controlled cross-over trial found in 2012, which included only 45 participants and compared intravenous lidocaine against placebo as a means of pain relief in people with burns still remains central to this review. We assessed this study as being at a high risk of bias due to its small size (fewer than 50 participants per treatment arm). Subjective pain ratings, as measured by the verbal rating scale, increased during procedures for both treatment arms; however, the increase was less in the lidocaine treatment group. There were no significant clinical or statistical differences regarding the effects of lidocaine and placebo on opioid requests and consumption, anxiety or level of satisfaction during a wound care procedure, but the small included study provided insufficient data to draw any conclusions. As current clinical evidence is based on only one RCT as well as case series and reports, intravenous lidocaine must be considered a pharmacological agent under investigation in burns care, the effectiveness of which is yet to be determined with further well-designed and conducted clinical trials.

Plain-language summary: We searched scientific databases for studies assessing the pain-relieving effects of intravenous (given into the blood stream through a vein) lidocaine in adults with a burn injury. We included studies comparing lidocaine with no treatment, placebo (a pretend treatment), other analgesics (pain killers), or a combination of these. We wanted to look at (for example) severity of pain, time to requiring more medication, rescue analgesia (where extra pain relief is needed in addition to that planned) and side effects. The evidence is current to December 2013. Key results We found one small clinical trial, involving only 45 participants, which showed a benefit from intravenous lidocaine for pain relief in people with burns. The trial did not show a difference in opioid use, participant anxiety or level of participant satisfaction with the use of intravenous lidocaine. Quality of the evidence The small included study provided insufficient data to draw any conclusions.
Abstract: Fifteen trials involving 10 different drugs were included. Two trials enrolling 1156 patients compared interferon gamma-1beta with placebo: interferon gamma-1beta did not significantly improve survival (HR 0.88, 95% CI 0.47 to 1.64; P = 0.68). Four trials involving 1155 patients compared pirfenidone with placebo. Three trials, conducted in 1046 patients, provided data on progression-free survival: pirfenidone significantly reduced the risk of disease progression by 30% (HR 0.70, 95% CI 0.56 to 0.88, P = 0.002). Data on the effect of pirfenidone on pulmonary function could only be assessed for two studies analysing 314 patients. Forced vital capacity or vital capacity was significantly improved by pirfenidone (mean difference 0.08 L, 95% CI 0.03 to 0.13, P = 0.0006). Based on available data, partly still unpublished, pirfenidone appears to improve progression-free survival and, to a lesser extent, pulmonary function in patients with idiopathic pulmonary fibrosis. More data are needed on overall survival and quality of life on treatment. From the studies in this review, interferon gamma-1beta has not been shown to affect survival. Other agents evaluated in single studies either failed to provide evidence for a benefit or need to be assessed in larger randomised controlled trials.

Plain-language summary: The review found 15 high quality trials of non-steroid drugs tested in idiopathic pulmonary fibrosis patients. Notwithstanding the encouraging results of a first small study included in the first version of this review, the effects of interferon gamma-1beta, as assessed by combining two subsequent large trials, were disappointing and failed to show an effect on improving survival. Four studies did evaluate pirfenidone, an anti-fibrotic oral drug, on a large number of patients: although two of these studies have only been presented in conferences,combining the published and unpublished data showed a significant improvement of pirfenidone on progression-free survival and a small increase in pulmonary function. Current evidence suggests a possible role for pirfenidone in the treatment of idiopathic pulmonary fibrosis, though data on survival are now needed. However, trials with other non-steroid agents are currently ongoing and new evidence may become available soon.
Abstract: Altogether 2156 participants took part in the 45 randomised controlled studies that were discovered through extensive search efforts. Though many studies had a randomised, double-blind design, most studies were of poor methodological quality. Purified porcine and semi-synthetic insulin were most often investigated. No significant differences in metabolic control or hypoglycaemic episodes between various insulin species could be elucidated. Insulin dose and insulin antibodies did not show relevant dissimilarities. A comparison of the effects of human and animal insulin as well as of the adverse reaction profile did not show clinically relevant differences. Many patient-oriented outcomes like health-related quality of life or diabetes complications and mortality were never investigated in high-quality randomised clinical trials. The story of the introduction of human insulin might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety.

Plain-language summary: In our systematic review we could not identify substantial differences in the safety and efficacy between insulin species. Many important patient-oriented outcomes like health-related quality of life and effects on diabetic complications and mortality were never investigated. Human insulin was introduced into the market without scientific proof of advantage over existing purified animal insulins, especially porcine insulin.
Abstract: Three studies with a combined total of 309 participants were included in the review. One study compared two-stage versus one-stage BKA; one study compared skew flaps BKA versus long posterior flap BKA; and one study compared sagittal flaps BKA versus long posterior flap BKA. Overall the quality of the evidence from these studies was moderate. BKA using skew flaps or sagittal flaps conferred no advantage over the well established long posterior flap technique (primary stump healing was 60% for both skew flaps and long posterior flap (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.71 to 1.42) and primary stump healing was 58% for sagittal flaps and 55% for long posterior flap (Peto odds ratio (OR) 1.04, 95% CI 0.45 to 2.43). For participants with wet gangrene, a two-stage procedure with a guillotine amputation at the ankle followed by a definitive long posterior flap amputation led to better primary stump healing than a one-stage procedure (Peto OR 0.08, 95% CI 0.01 to 0.89). Post-operative infection rate or wound necrosis, reamputation, and mobility with a prosthetic limb were similar in the different comparisons. There is no evidence to show a benefit of one type of incision over another. However, in the presence of wet gangrene a two-stage procedure leads to better primary stump healing compared to a one-stage procedure. The choice of amputation technique can, therefore, be a matter of surgeon preference taking into account factors such as previous experience of a particular technique, the extent of non-viable tissue, and the location of pre-existing surgical scars.

Plain-language summary: Three randomised controlled studies were identified. Overall the quality of the evidence from these studies was moderate. They were reported on between 1977 and 1991 and involved a total of 309 participants. Each reported on different comparisons. Below knee amputation using skew flaps or sagittal flaps provided no advantage over the long posterior flap technique on primary stump healing, which approached 60% for all groups. In the third study, involving 30 participants with wet gangrene, a two-stage procedure with a guillotine amputation at the ankle followed by long posterior flap amputation led to better primary stump healing than a one-stage procedure with delayed skin closure. Post-operative infection rate or wound necrosis, reamputation and mobility with a prosthetic limb were similar in the different comparisons. Nearly all the surgeons in the study that looked at skew flap amputation versus the long posterior flap technique were new to the skew flap operation and so were on a learning curve. Factors which might have influenced the findings include previous experience of a technique, the extent of non-viable tissue, and location of pre-existing surgical scars.
Abstract: Six trials were included (five on-pump and one off-pump). This update adds the results of one further trial. Data from a total of 255 patients were included in the meta-analysis of mortality outcomes; all on-pump. Generally, the patients were considered as "high risk" and 132 were treated preoperatively with IABP and 123 served as controls. There were four hospital deaths in the intervention arm and 23 in the non-intervention arm (OR 0.18, 95% CI 0.08 to 0.41; P<0.0001). In a subgroup analysis, low cardiac index (<2.0 L/min/m2) was noted in 21 out of 105 patients in the treatment arm and 59 patients out of 88 in the non-treatment arm (OR 0.14, 95% CI: 0.08 to 0.25; P<0.00001). An off-pump versus on-pump analysis was not possible due to the limited number of off-pump studies. However a single well-conducted RCT suggested favourable effect of the preoperative IABP in off-pump patients. Evidence suggests that preoperative IABP may have a beneficial effect on mortality and morbidity in specific high risk patient groups undergoing coronary artery bypass grafting, however there are many problems with the quality, validity and generalisability of the trials. However, the available evidence is not robust enough to extend the use of IABP to truly elective, high risk patients. Defining more precisely which patient groups may benefit would be the challenge for the future.

Plain-language summary: This review suggests the intra aortic balloon pump may be beneficial in terms of survival from the operation however there are many problems with the validity of the trials used in this review and a categorical answer to this question requires further randomised controlled trials.