GEM/cochrane-simplification huggingface dataset:
Abstract: Of the 12 RCTs included, the effect of patient education on primary end points was reported in only five. Pooling of outcome data was precluded by marked, mainly clinical, heterogeneity. One of the RCTs showed reduced incidence of foot ulceration (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.14 to 0.66) and amputation (RR 0.33, 95% CI 0.15 to 0.76) during one-year follow-up of diabetes patients at high risk of foot ulceration after a one-hour group education session. However, one similar study, with lower risk of bias, did not confirm this finding (RR amputation 0.98, 95% CI 0.41 to 2.34; RR ulceration 1.00, 95% CI 0.70 to 1.44). Three other studies, also did not demonstrate any effect of education on the primary end points, but were most likely underpowered. Patients' foot care knowledge was improved in the short term in five of eight RCTs in which this outcome was assessed, as was patients' self-reported self-care behaviour in the short term in seven of nine RCTs. Callus, nail problems and fungal infections improved in only one of five RCTs. Only one of the included RCTs was at low risk of bias. In some trials, foot care knowledge and self reported patient behaviour seem to be positively influenced by education in the short term. Yet, based on the only two sufficiently powered studies reporting the effect of patient education on primary end points, we conclude that there is insufficient robust evidence that limited patient education alone is effective in achieving clinically relevant reductions in ulcer and amputation incidence.

Plain-language summary: Foot ulcers not only lead to physical disability and loss of quality of life but also to economic burden (healthcare costs, industrial disability). The aim is therefore to prevent foot ulcers occurring. This review of high-level studies found that educating people with diabetes about the need to look after their feet seems to improve people's foot care knowledge and behaviour in the short term. There is insufficient evidence that education alone, without any additional preventive measures, will effectively reduce the occurrence of ulcers and amputations.
Abstract: We included nine trials, with 316 participants in total, that compared the effects of naloxone versus placebo or no drug in newborn infants exposed to maternal opioid analgesia prior to delivery. None of the included trials investigated infants born to mothers who had used a prescribed or non-prescribed opioid during pregnancy. None of these trials specifically recruited infants with cardiorespiratory or neurological depression. The main outcomes reported were measures of respiratory function in the first six hours after birth. There is some evidence that naloxone increases alveolar ventilation. The trials did not assess the effect on the primary outcomes of this review (admission to a neonatal unit and failure to establish breastfeeding). The existing evidence from randomised controlled trials is insufficient to determine whether naloxone confers any important benefits to newborn infants with cardiorespiratory or neurological depression that may be due to intrauterine exposure to opioid. Given concerns about the safety of naloxone in this context, it may be appropriate to limit its use to randomised controlled trials that aim to resolve these uncertainties.

Plain-language summary: We found nine completed trials that compared giving to newborn babies, whose mothers had received opioids during labour, either naloxone or a placebo ('dummy drug'). These trials were conducted more than 30 years ago and they were generally very small including only about 300 infants in total. Most of the trials did not use reliable methods consistently. Evidence is up-to-date as of February 2018. The trials reported the effects of naloxone on the baby's breathing but did not assess the effect on the need for babies to be cared for in a neonatal unit (separated from their mother), whether they needed help with breathing, or on breastfeeding success. None of the trials assessed long-term development. We did not find any trials including babies born to mothers who had used opioids (whether prescribed or non-prescribed) during pregnancy. The available evidence was not sufficient to determine whether giving naloxone to babies whose mothers received opioids during birth was helpful or harmful.
Abstract: We found no RCT and thus no available data for evaluation of the primary outcome (mortality) nor secondary outcomes or adverse effects. Therefore, we conducted no statistical analysis. A total of 73 observational studies reported on various clinically relevant outcomes following catheter removal or catheter retention. Most of these excluded, observational studies reported a beneficial effect of catheter removal in patients with candidaemia. None of the observational studies reported results in favour of retaining a catheter. However, the observational studies were very heterogeneous with regards to population, pathogens and interventions. Furthermore, they suffered from confounding by indication and an overall high risk of bias. As a consequence, we are not able to provide recommendations or to draw firm conclusions because of the difficulties involved in interpreting the results of these observational studies (very low quality of evidence, GRADE - Grades of Recommendation, Assessment, Development and Evaluation Working Group). Despite indications from observational studies in favour of early catheter removal, we found no eligible RCTs or quasi-RCTs to support these practices and therefore could draw no firm conclusions. At this stage, RCTs have provided no evidence to support the benefit of early or late catheter removal for survival or other important outcomes among patients with candidaemia; no evidence with regards to assessment of harm or benefit with prompt central venous catheter removal and subsequent re-insertion of new catheters to continue treatment; and no evidence on optimal timing of insertion of a new central venous catheter.

Plain-language summary: We found no clinical trials with a randomized controlled design that evaluated this topic and measured the number of deaths or any of our secondary outcomes. We identified 73 observational studies that delivered descriptive data on catheter management and survival in people with bloodstream infections caused by Candida. We identified no randomized controlled trials for statistical analyses and assessments. Therefore, we can present no results on the effect of catheter removal on survival when Candida is found in the bloodstream. A total of 73 observational studies reported relevant outcomes after the catheter was removed or was kept in place. In all, 40 studies reported a beneficial effect of catheter removal in patients with candidaemia, and 34 presented results showing no clear differences between groups. No studies reported results in favour of retaining the catheter. We found no reports on the harmful effects of removing a catheter and re-inserting a new catheter. No randomized controlled trials met the inclusion criteria. Consequently, we cannot assess the quality of evidence.
Abstract: We included three RCTs (n=277) with 24-28 weeks follow-up. Three combinations of minerals were investigated: potassium-magnesium, calcium-magnesium, and calcium-potassium. One trial investigated combinations of calcium-magnesium and of calcium-potassium, and for each found a statistically non-significant increase in both SBP and DBP. All three trials investigated the potassium-magnesium combination. None of the trials provided mortality or morbidity data. The potassium-magnesium combination compared to control resulted in statistically non-significant reductions in both SBP (mean difference = -4.6 mmHg, 95% CI: -9.9 to 0.7) and DBP (mean difference = -3.8 mmHg, 95% CI: -9.5 to 1.8), although the results were heterogeneous (I2=68% and 85% for SBP and DBP respectively). A sensitivity analysis using alternative reported values which accounted for missing data had very little effect on DBP but resulted in a larger, statistically significant reduction in SBP (mean difference = -5.8 mmHg, 95% CI: -10.5 to -1.0). The quality of the trials was not well reported. We found no robust evidence that supplements of any combination of potassium, magnesium or calcium reduce mortality, morbidity or BP in adults. More trials are needed to investigate whether the combination of potassium & magnesium is effective.

Plain-language summary: This review found no robust evidence to suggest that combinations of potassium, calcium or magnesium can reduce high blood pressure (BP) in adults. Only three trials assessing a total of 277 participants were found. The only combination assessed by all three trials was potassium and magnesium, demonstrating a statistically non-significant reduction in BP among people receiving this combination. One trial assessed both calcium & magnesium and calcium & potassium and found that neither combination had very much effect on BP. None of the trials were of high quality, so their results may not be reliable. Very few mild adverse effects were reported. These were of short duration and participants did not have to stop taking their treatment.
Abstract: We included one randomized controlled trial on pharmacological interventions with 95 participants. No studies were found for non-pharmacological interventions. Concerning the proportion of participants with seizure freedom, no significant differences were found for the comparisons of levetiracetam (LEV) versus lamotrigine (LTG) (risk ratio (RR) 1.20, 95% confidence interval (CI) 0.53 to 2.71), LEV versus phenobarbital (PB) (RR 1.01, 95% CI 0.47 to 2.19), or LTG versus PB (RR 0.84, 95% CI 0.35 to 2.02). It seemed that LEV could improve cognition and LTG could relieve depression, while PB and LTG could worsen cognition, and LEV and PB could worsen mood. Unclear risk of bias was found in allocation, blinding and selective reporting. We judged the quality of the evidence to be very low. This review does not provide sufficient evidence to support LEV, PB or LTG for the treatment of epilepsy in people with AD. Regarding efficacy and tolerability, no significant differences were found between LEV, PB and LTG. Large randomized controlled trials with a double-blind, parallel-group design are required to determine the efficacy and tolerability of treatment for epilepsy in people with AD.

Plain-language summary: We searched scientific databases for clinical trials comparing medication and non-medication-based treatments for epilepsy in people with Alzheimer's disease. We wanted to evaluate how well the treatment worked and if it had any side effects. We included and analyzed one randomized controlled trial (a clinical study where people are randomly put into one or two or more treatment groups) with 95 participants. Concerning the proportion of participants with seizure freedom, no significant differences were found between the antiepileptic drugs (levetiracetam versus lamotrigine, levetiracetam versus phenobarbital, and lamotrigine versus phenobarbital). It seemed that levetiracetam could improve cognition (thinking) and lamotrigine could relieve depression; while phenobarbital and lamotrigine could worsen cognition, and levetiracetam and phenobarbital could worsen mood. The quality of the evidence from the study was very low and results should be interpreted with caution. Large randomized controlled trials, which have a double-blind parallel-group design, are required to determine how effective and well tolerated treatments are for epilepsy in people with Alzheimer's disease. The evidence is current to July 2018.
Abstract: Eight studies involving 290 participants were included. Two trials examined the effects of captopril, the rest were single trials on single drugs. All comparisons were with placebo. The methodological quality of most trials was poor. Enalapril was associated with a small increase in the frequency of attacks per week (difference in means 0.8; 95% CI 0.43 to 1.17). The difference between the intervention groups on a subjective improvement score was non-significant.  There was a significant effect of buflomedil on the frequency of attacks per week (weighted mean difference (WMD) -8.8; 95% CI -17.55 to -0.09), but there was no evidence of effect on the severity score.  The proportion with fewer attacks was significantly higher on moxisylyte than on placebo (relative risk (RR) 4.33; 95% CI 1.36 to 13.81).  For captopril, beraprost, dazoxiben and ketanserin there was no evidence of an effect on the frequency, severity or duration of attacks.  Beraprost and moxisylyte gave significantly more adverse effects than placebo. Poor methodological quality, small sample sizes and the limited data available resulted in low precision of the statistical results and limited value of the overall results .The overall results show that there is no evidence for an effect of vasodilator drugs on primary Raynaud's phenomenon.

Plain-language summary: The review looked at the effectiveness of other drugs that can be taken by mouth. These were drugs that increase blood flow (vasodilators). The evidence from randomised controlled trials is limited. The review authors identified eight controlled studies. These were published between 1980 and 1996 and involved a total of 290 participants randomly assigned to the vasodilator drug or placebo. The length of treatment varied from two weeks to six months. Only two trials looked at the same drug, the angiotensin converting enzyme (ACE) inhibitor captopril so most of the findings were from single trials. Taking enalapril resulted in a small increase in the frequency of attacks in a week. Buflomedil reduced the frequency of attacks but without a clear effect on their severity. Moxisylyte (thymoxamine) also reduced attacks but both beraprost and moxisylyte produced more adverse effects than with placebo. For captopril, beraprost, dazoxiben and ketanserin there was no evidence of an effect on the frequency, severity or duration of attacks. The methodological quality of most trials was poor and they were small. The outcomes were subjective and were reported on scales that were not well described or validated. This makes the clinical importance of the results difficult to assess, especially if the placebo response is high.
Abstract: We included 5 RCTs involving a total of 103 participants; all of the trials used a within-participant design. The interventions and outcomes were too varied to be combined statistically. All trials used the pulsed dye laser for comparisons. None of the studies focused on participant satisfaction, which was one of our primary outcomes, but participant preference was evaluated in three of five studies. Participants preferred the pulsed dye laser to intense pulsed light based on the clinical effect. They marginally preferred the Neodymium:YAG (yttrium-aluminium-garnet) (Nd:YAG) laser to the pulsed dye laser due to shorter lasting purpura, and pulsed dye laser in conjunction with cooling was preferred to treatment with pulsed dye laser alone. All trials examined short-term efficacy of less than six months after treatments with the pulsed dye laser, intense pulsed light, and Nd:YAG laser. The pulsed dye laser was evaluated in all five trials. Depending upon the setting of the pulsed dye laser, this resulted in more than 25% reduction in redness. This was after 1 to 3 treatments for up to 4 to 6 months postoperatively in 50% to 100% of the participants. There was only one study each of intense pulsed light and Nd:YAG laser. Two trials had no occurrence of long-term adverse effects, i.e. six months after treatment. Three trials reported pigmentary alterations in 3% to 24% of the participants, with the highest percentage occurring in Chinese participants with darker skin types. In one study one participant experienced scarring of the skin caused by a too-high dose of the laser used. Short-term side-effects included pain, crusting, and blistering in the first two weeks after treatment. The pulsed dye laser leads to clinically relevant clearance of port-wine stains. A limited number of RCTs evaluated the efficacy from intense pulsed light and other laser types. High-quality RCTs are needed to assess individual efficacy from different lasers and light sources, as well as participant satisfaction.

Plain-language summary: None of the studies focused on participant satisfaction which was our primary outcome. Depending upon the setting of the pulsed dye laser, more than 25% lightening (i.e. by reduction in redness) of port-wine stains occurred. This was after 1 to 3 treatments for up to 4 to 6 months postoperatively in 50% to 100% of the participants of the trials. Substantial evidence is lacking for other laser types and intense pulsed light. Side-effects were rare in the included trials, but 3 trials reported pigmentary alterations in 3% to 24% of the participants, with the highest percentage occurring in Chinese participants with darker skin types. In one study one participant experienced scarring of the skin due to a too-high dose of the laser used. Short-term side-effects included pain, crusting, and blistering in the first two weeks after treatment. Two trials reported no occurrence of long-term adverse effects, i.e. six months after treatment.
Abstract: Twenty four studies, including 2147 participants, met the inclusion criteria. Comparing any dopamine agonist versus placebo, we found no differences for any of the outcomes considered: dropout (moderate quality of evidence), abstinence (low quality of evidence), severity of dependence (low quality of evidence), adverse events (moderate quality of evidence). This was also observed when single dopamine agonists were compared against placebo. Comparing amantadine versus antidepressants, we found low quality of evidence that antidepressants performed better for abstinence (RR 0.25, 95% CI 0.12 to 0.53) based on two studies with 44 participants. No differences were found for dropout or adverse events, for both moderate quality of evidence. The major flaws of the included studies concerned selection bias because most studies did not report information about sequence generation (80%) and allocation concealment methods (86%): half of the included studies were judged at unclear risk of performance bias and 62.5% at unclear risk of detection bias for what concerns subjective outcomes. Current evidence from RCTs does not support the use of dopamine agonists for treating cocaine misuse. This absence of evidence may leave to clinicians the alternative of balancing the possible benefits against the potential adverse effects of the treatment. Even the potential benefit of combining a dopamine agonist with a more potent psychosocial intervention, which was suggested by the previous Cochrane Review (Soares 2003), is not supported by the results of this Cochrane Review update.

Plain-language summary: We searched scientific databases and internet resources to identify randomised controlled trials (where participants are allocated at random to any dopamine agonist drug or placebo or another type of drug aimed to reduce use of cocaine. We also assessed dropout from treatment and frequency of side effects. We included adults of any gender, age or ethnicity. We included 24 studies with 2147 participants, who were all addicted to cocaine. Most were men (82.%)with an average age of 37 years. The mean duration of the included trials was seven weeks (range 1.5 to 16 weeks) Twenty-two studies were conducted in USA, one in Brazil and one in Spain; all but four were outpatients. The included trials studied the following drugs: amantadine, bromocriptine, L dopa/Carbidopa, pergolide, cabergoline hydergine, and pramipexole. All compared dopamine agonist versus placebo. Four studies compared amantidine versus antidepressants. No differences were found between the drugs and placebo for any of the outcomes considered: dropout (moderate quality of evidence), abstinence (low quality of evidence), severity of dependence (low quality of evidence), adverse events (moderate quality of evidence). Antidepressants was found to be better than the dopamine agonist amantidine for abstinence, but this was based on two studies with very few participants and low quality of evidence. There is no current evidence supporting the clinical use of dopamine agonist medications in the treatment of cocaine misuse. The evidence is current to 12 January 2015.
Abstract: Nine randomized, double-blind, placebo controlled trials meeting the inclusion criteria were identified. Eight trials enrolled healthy participants, and one was of subjects with age-associated memory impairment (AAMI). Only five of the identified trials had extractable information and were included in the analysis. Four studies investigated the effects of ginseng extract and one assessed the efficacy of ginseng compound HT008-1. All of these trials investigated the effects of ginseng on healthy participants. Pooling the data was impossible owing to heterogeneity in outcome measures, trial duration, and ginseng dosage. Results of the analysis suggested improvement of some aspects of cognitive function, behavior and quality of life. No serious adverse events associated with ginseng were found. Currently, there is a lack of convincing evidence to show a cognitive enhancing effect of Panax ginseng in healthy participants and no high quality evidence about its efficacy in patients with dementia. Randomized, double-blind, placebo-controlled, parallel group trials with large sample sizes are needed to further investigate the effect of ginseng on cognition in different populations, including dementia patients.

Plain-language summary: This review aimed to identify all double-blind and single-blind randomized, placebo-controlled trials assessing the effects of ginseng on cognitive function. Five trials investigating the effects of ginseng on healthy participants had extractable information for efficacy and were included in the review. Ginseng appeared to have some beneficial effects on cognition, behavior and quality of life. More rigorously designed studies are needed on this important issue.