GEM/cochrane-simplification huggingface dataset:
Abstract: Eighty studies were identified. Fifty-eight were excluded for various reasons, usually as there was no prospective trial design with randomised treatment allocation. Of the 21 included studies 13 provided data on survival, 7 on tumour response, 16 on measures of QOL or psychological outcomes, or prevalence of chemotherapy-related adverse effects and 12 on side effects of mistletoe treatment; overall comprising 3484 randomised cancer patients. Interventions evaluated were 5 preparations of mistletoe extracts from 5 manufacturers and one commercially not available preparation. The general reporting of RCTs was poor. Of the 13 trials investigating survival, 6 showed some evidence of a benefit, but none of them was of high methodological quality. The results of two trials in patients with melanoma and head and neck cancer gave some evidence that the used mistletoe extracts are not effective for improving survival. Of the 16 trials investigating the efficacy of mistletoe extracts for either improving QOL, psychological measures, performance index, symptom scales or the reduction of adverse effects of chemotherapy, 14 showed some evidence of a benefit, but only 2 of them including breast cancer patients during chemotherapy were of higher methodological quality. Data on side effects indicated that, depending on the dose, mistletoe extracts were usually well tolerated and had few side effects. The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak. Nevertheless, there is some evidence that mistletoe extracts may offer benefits on measures of QOL during chemotherapy for breast cancer, but these results need replication. Overall, more high quality, independent clinical research is needed to truly assess the safety and effectiveness of mistletoe extracts. Patients receiving mistletoe therapy should be encouraged to take part in future trails.

Plain-language summary: The review found that there was not enough evidence to reach clear conclusions about the effects on any of these outcomes and it is therefore not clear to what extent the application of mistletoe extracts translates into improved symptom control, enhanced tumour response or prolonged survival. Adverse effects of mistletoe extracts were reported, but appeared to be dose-dependent and primarily confined to reactions at injection site and mild, transient flu-like symptoms. In the absence of good quality, independent trials, decisions about whether mistletoe extracts are likely to be beneficial for a particular problem should rely on expert judgement and practical considerations.
Abstract: Eleven RCTs were identified involving 1067 participants; 568 were randomly allocated to an exercise intervention and 499 to a usual care control group. The majority of participants received treatment for breast cancer (73%). Due to the nature of the intervention, it was not possible to blind the participants or personnel delivering the intervention. The risk of detection bias was either high or unclear in some cases, whilst most other domains were rated as low risk. The included studies were of moderate to very low-certainty evidence. Pooled data demonstrated that exercise training may have little or no difference on physical fitness (VO2 max) compared to usual care (mean difference (MD) 0.05 L/min-1, 95% confidence interval (CI) -0.03 to 0.13; I2 = 0%; 2 studies, 381 participants; low-certainty evidence). Included studies also showed in terms of adverse effects (safety), that it may be of benefit to exercise (8 studies, 507 participants; low-certainty evidence). Furthermore, exercise training probably made little or no difference on HRQoL (EORTC global health status subscale) compared to usual care (MD 2.29, 95% CI -1.06 to 5.65; I2 = 0%; 3 studies, 472 participants; moderate-certainty evidence). However, exercise training probably reduces fatigue (multidimensional fatigue inventory) compared to usual care (MD -1.05, 95% CI -1.83 to -0.28; I2 = 0%; 3 studies, 449 participants moderate-certainty evidence). No studies reported postoperative outcomes. The findings should be interpreted with caution in view of the low number of studies, the overall low-certainty of the combined evidence, and the variation in included cancer types (mainly people with breast cancer), treatments, exercise interventions, and outcomes. Exercise training may, or may not, confer modest benefit on physical fitness and HRQoL. Limited evidence suggests that exercise training is probably not harmful and probably reduces fatigue. These findings highlight the need for more RCTs, particularly in the neoadjuvant setting.

Plain-language summary: The overall quality (certainty) of the evidence was moderate to very low for all of the outcomes, mainly because of the small number of studies and low number of participants, as well as study limitations. The findings of this review should be interpreted with caution due to the overall low-certainty of the evidence, variation in cancer types and treatments, exercise interventions, and outcomes measured. We are moderately certain that exercise training during adjuvant treatment (chemotherapy or radiotherapy treatment after surgery) reduces fatigue. This is a new area of research, and more information is needed to help us understand whether exercise benefits people undergoing cancer treatment. Future studies should also concentrate on people with a new diagnosis of cancer who have chemotherapy or radiotherapy prior to surgery (known as neoadjuvant treatment), to tell us whether exercise training prior to surgery is important.
Abstract: We included four randomized trials involving 200 participants. Owing to small numbers of studies and participants, it was not possible to combine data for all outcomes. Two trials reported 28-day mortality, and one trial reported hospital mortality; in the third trial, the number of deaths stated did not match the quoted mortality rates. The pooled risk ratio (95% confidence interval) for 28-day mortality associated with HVHF was 0.89 (0.60 to 1.32, two trials, 146 participants, low-quality evidence). One study (137 participants, low-quality evidence) reported length of stay in the ICU. Two trials (170 participants, low-quality evidence) reported organ dysfunction, but we could not pool results owing to reporting differences. Three studies (189 participants, low-quality evidence) reported on haemodynamic changes, but we could not pool results owing to reporting differences. Investigators reported no adverse events. Overall, the included studies had low risk of bias. Investigators reported no adverse effects of HVHF (low-quality evidence). The results of this meta-analysis show that very few studies have been conducted to investigate the use of HVHF in critically ill patients with severe sepsis or septic shock (four studies, 201 participants, low-quality evidence). Researchers should consider additional randomized controlled trials that are large and multi-centred and have clinically relevant outcome measures. The cost-effectiveness of HVHF should also be studied..

Plain-language summary: This review is current until December 2015. We included four trials involving 205 participants. All four studies assessed effects of HVHF compared with the current standard haemofiltration and included participants with severe sepsis or septic shock who had been admitted to an ICU. Three of the four studies were very small (fewer than 20 participants enrolled in each study). The maximum time that participants were followed up after inclusion in any of the studies was 28 days. Two studies received financial support from pharmaceutical companies, and one study received support from a health research organization. Key results Outcome data were limited - two trials reported death rates at 28 days and one reported death rates in hospital; in the fourth study, the number of deaths stated did not match the quoted mortality rates. One study reported length of stay in the ICU, and one provided data on organ dysfunction. Investigators described no complications. No clear evidence showed any benefit of HVHF in critically ill patients with severe sepsis or septic shock. Quality of evidence Evidence is insufficient to support the routine use of high-volume haemofiltration in patients with severe sepsis or septic shock. Studies included in this review reported relatively small numbers of participants and measured different outcomes; therefore, we judged the quality of evidence with respect to the impact of HVHF as low. Larger trials, carried out at many centres, are required for full assessment of clinically relevant outcomes and for evaluation of cost versus benefit.
Abstract: One randomised controlled trial with a total of 100 male participants was included in the review. The trial compared hand-assisted laparoscopic repair with EVAR and provided results for in-hospital mortality, operative time, length of hospital stay and lower limb ischaemia. The included study did not report on the other pre-planned outcomes of this review. No in-hospital deaths occurred in the study. Hand-associated laparoscopic repair was associated with a longer operative time (MD 53.00 minutes, 95% CI 36.49 to 69.51) than EVAR. The incidence of lower limb ischaemia was similar between the two treatment groups (risk ratio (RR) 0.50, 95% confidence interval (CI) 0.05 to 5.34). The mean length of hospital stay was 4.2 days and 3.4 days in the hand-assisted laparoscopic repair and EVAR groups respectively but standard deviations were not reported and therefore it was not possible to independently test the statistical significance of this result. The quality of evidence was downgraded for imprecision due to the inclusion of one small study; and wide confidence intervals and indirectness due to the study including male participants only. No study compared laparoscopic repair (total or hand-assisted) with open surgical repair or total laparoscopic surgical repair with EVAR. There is insufficient evidence to draw any conclusions about effectiveness and safety of laparoscopic (total and hand-assisted) surgical repair of AAA versus open surgical repair or EVAR, because only one small randomised trial was eligible for inclusion in this review. High-quality randomised controlled trials are needed.

Plain-language summary: One randomised controlled trial (current until August 2016), studying 100 male participants and comparing hand-assisted laparoscopic repair with EVAR, was included in this review. No in-hospital deaths occurred during the study. The trial showed that hand-assisted laparoscopic repair took longer to perform than EVAR but there was no difference in the number of patients with reduced blood flow to the leg following either treatment. At present, there is a lack of randomised controlled trials examining the comparative effectiveness and safety of laparoscopic repair of AAA. The quality of the available evidence was imprecise due to the inclusion of one small study and wide confidence intervals; and indirect because the study includes male participants only. Further research is required before conclusions can be made.
Abstract: Two randomised controlled trials were identified, both were conducted in patients with yellow oleander poisoning. One trial investigated the effect of MDAC on mortality, the relative risk (RR) was 0.31 (95% confidence interval (CI) 0.12 to 0.83) indicating a beneficial effect. The second study found a beneficial effect of anti-digoxin Fab antitoxin on the presence of cardiac dysrhythmias at two hours post-administration; the RR was 0.60 (95% CI 0.44 to 0.81). Other benefits were also noted in both studies and serious adverse effects were minimal. Studies assessing the effect of antidotes on other cardenolides were not identified. One ongoing study investigating the activated charcoal for acute yellow oleander self-poisoning was also identified. There is some evidence to suggest that MDAC and anti-digoxin Fab antitoxin may be effective treatments for yellow oleander poisoning. However, the efficacy and indications of these interventions for the treatment of acute digitalis poisoning is uncertain due to the lack of good quality controlled clinical trials. Given pharmacokinetic differences between individual cardenolides, the effect of antidotes administered to patients with yellow oleander poisoning cannot be readily translated to those of other cardenolides. Unfortunately cost limits the use of antidotes such as anti-digoxin Fab antitoxin in developing countries where cardenolide poisonings are frequent. More research is required using relatively cheap antidotes which may also be effective.

Plain-language summary: Two randomised controlled trials were identified; both were conducted in patients with yellow oleander poisoning. One trial investigated the effect of MDAC on mortality, the relative risk (RR) was 0.31 (95% confidence interval (CI) 0.12 to 0.83) indicating a beneficial effect. The second study found a beneficial effect of anti-digoxin Fab antitoxin on the presence of cardiac dysrhythmias at two hours post-administration; the RR was 0.60 (95% CI 0.44 to 0.81). Other benefits were also noted in both studies and serious adverse effects were minimal. Studies assessing the effect of antidotes on other cardenolides were not identified. One ongoing study investigating the activated charcoal for acute yellow oleander self-poisoning was also identified. There is some evidence to suggest that MDAC and anti-digoxin Fab antitoxin may be effective treatments for yellow oleander poisoning. However, the efficacy and indications of these interventions for the treatment of acute digitalis poisoning is uncertain due to the lack of good quality controlled clinical trials. Given pharmacokinetic differences between individual cardenolides, the effect of antidotes administered to patients with yellow oleander poisoning cannot be readily translated to those of other cardenolides. Unfortunately cost limits the use of antidotes such as anti-digoxin Fab antitoxin in developing countries where cardenolide poisonings are frequent. More research is required using relatively cheap antidotes which may also be effective.
Abstract: Only one study fulfilled the criteria (Amato 1988). 20 full term babies requiring exchange transfusion for hemolytic jaundice due to ABO incompatibility were randomly allocated to receive single or double volume exchange transfusion. Base line characteristics of both groups were similar with regards to birth weight 3260 (SD 390) g vs. 3350 SD (410) g, gestational age 39 (SD 1) week vs. 40 (SD 0.8) week, immediate pre exchange bilirubin level 199 (SD 33) micromol/L vs. 216 (SD 55) micromol/L. Both groups were treated equally apart from the volume of blood used for exchange transfusion. Total bilirubin levels immediately after exchange transfusion were not significantly different in either group. No long term neurodevelopmental outcome was examined in this study. There was insufficient evidence to support or refute the use of single volume exchange transfusion as opposed to double volume exchange transfusion in jaundiced newborns. A change from the current practice of double volume exchange transfusions for severe jaundice in newborns infant, cannot be recommended on current evidence.

Plain-language summary: This review was undertaken to examine if single volume (removal of blood equivalent to the blood volume of the baby) is as effective as double volume (removal of twice blood volume of the baby) in reducing the brain damage and bilirubin levels in newborn infants with severe jaundice. Only one randomised trial fulfilled the criteria for inclusion in the analysis. This study compared single and double volume exchange transfusion in jaundice due to ABO hemolytic jaundice. The study found no significant difference in bilirubin levels following exchange. This study did not look at any long term neurodevelopmental outcome (brain damage). Based on the available data, there is insufficient evidence to support or refute the use of single volume exchange transfusion as opposed to double volume exchange transfusion in jaundiced newborns.
Abstract: Twelve trials involving 844 participants were included. One trial tested two comparisons. Quality assessment revealed a poor level of methodological rigour in many studies, particularly with regard to concealment of allocation and the lack of assessor blinding. Open surgical treatment compared with non-surgical treatment (6 trials, 536 participants) was associated with a statistically significant lower risk of rerupture (risk ratio (RR) 0.41, 95% confidence interval (CI) 0.21 to 0.77), but a higher risk of other complications including infection (RR 4.89, 95% CI 1.09 to 21.91), adhesions and disturbed skin sensibility (numbness). Functional status including sporting activity was variably and often incompletely reported, including frequent use of non standardised outcome measures, and the results were inconclusive. Open surgical repair compared with percutaneous repair (4 trials, 174 participants) was associated with a higher risk of infection (RR 9.32, 95% CI 1.77 to 49.16). These figures should be interpreted with caution because of the small numbers involved. Similarly, no definitive conclusions could be made regarding different tendon repair techniques (3 trials, 147 participants). Open surgical treatment of acute Achilles tendon ruptures significantly reduces the risk of rerupture compared with non-surgical treatment, but produces significantly higher risks of other complications, including wound infection. The latter may be reduced by performing surgery percutaneously.

Plain-language summary: Twelve trials including 794 participants acute Achilles tendon rupture were included. The majority of participants were male, and the average ages of the study populations were between 36 to 41 years. Many of the trials had flawed methods that undermined the reliability of their results. Open surgical treatment compared with non-surgical treatment (6 studies, 502 participants) was associated with a lower risk of rerupture, but a higher risk of other complications such as infection, adhesions and disturbed skin sensibility (numbness and tingling). There were insufficient and inconclusive data on function and sporting activities. Percutaneous repair (involving stab incisions through which the repair suture is passed through without direct exposure of the tendon) compared with open repair (4 studies, 174 participants) was associated with a lower risk of infection. These figures should be interpreted with caution because of the small numbers involved. Similarly, no definitive conclusions could be made regarding different tendon repair techniques (3 studies, 141 participants).
Abstract: We have included seven trials, involving 1396 women. Three trials (1030 women) were good quality. Magnesium sulphate was associated with a reduction in maternal death (seven trials;1396 women; risk ratio (RR) 0.59, 95% confidence interval (CI) 0.38 to 0.92) and recurrence of seizures (seven trials;1390 women; RR 0.43, 95% CI 0.33 to 0.55) compared to diazepam. There were no clear differences in other measures of maternal morbidity. There was no clear difference in perinatal mortality (four trials; 788 infants; RR 1.04, 95% CI 0.81 to 1.34) or neonatal mortality (four trials; 759 infants; RR 1.18, 95% CI 0.75 to 1.84). In the magnesium sulphate group, fewer liveborn babies had an Apgar score less than seven at one minute (two trials; 597 babies; RR 0.75, 95% CI 0.65 to 0.87) or at five minutes (RR 0.70, 95% CI 0.54 to 0.90), and fewer appeared to need intubation at the place of birth (two trials; 591 infants; RR 0.67, 95% CI 0.45 to 1.00). There was no difference in admission to a special care nursery (four trials; 834 infants; RR 0.91, 95% CI 0.79 to 1.05), but fewer babies in the magnesium sulphate group had a length of stay more than seven days (three trials 631 babies; RR 0.66, 95% CI 0.46 to 0.96). Magnesium sulphate for women with eclampsia reduces the risk ratio of maternal death and of recurrence of seizures, compared with diazepam.

Plain-language summary: Our review of seven randomised trials, involving 1396 women, found that intravenous or intramuscular magnesium sulphate was substantially better than intravenous diazepam in reducing the risk of maternal death and of having further seizures. Treatment was for 24 hours unless there was an indication to continue for longer. Diazepam infusion was titrated against the level of sedation, with the aim of keeping the woman drowsy but rousable.  Use of magnesium sulphate requires monitoring of respiration rate, tendon reflexes and urine output to avoid adverse effects. Fewer babies had low Apgar scores at birth with magnesium sulphate than with diazepam and, although admissions to a special care nursery were similar, fewer babies in the magnesium sulphate group had a length of stay of more than seven days. In other Cochrane reviews, magnesium sulphate was also substantially better than other drugs (phenytoin and lytic cocktail).
Abstract: We found three studies for inclusion in the review. One recruited males with a biopsy-proven diagnosis of non-metastatic prostate cancer who were not receiving chemotherapy and had elected to receive external-beam radiation therapy; the second study recruited community-living participants who were aged 55 years and older; the third study recruited university students. These studies included subgroups with anxiety and depression as defined by symptom scores and provided data separately for those subgroups. As this included only 25 people with anxiety and 17 with depression and 20 more with either anxiety or depression, but which was not specified, the results could only be reported narratively. They show no evidence that Reiki is either beneficial or harmful in this population. The risk of bias for the included studies was generally rated as unclear or high for most domains, which reduces the certainty of the evidence. There is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.

Plain-language summary: We found three studies for inclusion in the review. One recruited males with a biopsy-proven diagnosis of prostate cancer who were not receiving chemotherapy and had elected to receive external-beam radiation therapy; the second study recruited community-living participants who were aged 55 years and older; the third study recruited university students.These studies included people with anxiety or depression or both, and reported their results separately. This included only 25 people with anxiety, 17 with depression and 20 more with either anxiety or depression but which was not specified. The search is up to date as of 4 November 2014. Very few people with anxiety or depression or both have been included in randomised studies. This means there is insufficient evidence to make any comment about the usefulness of Reiki for the treatment of anxiety and depression. At best, the quality of the evidence is moderate which, on top of a dearth of evidence, weakens the findings further.