GEM/cochrane-simplification huggingface dataset:
Abstract: Five studies, 212 participants, were included. PAN showed improvement of symptoms (RR 1.35; 95% CI 1.01 to 1.79), of the amount and duration of sedative medication and of psychomotor function (WMD -8.71; 95% CI -13.71 to -3.71). At one hour post intervention, no significant differences were found for depression (WMD -2.40; 95% CI -8.70 to 3.89) and anxiety (WMD -3.70; 95% CI -10.53 to 3.12). None of the included studies reported any significant adverse effects of any treatment. Results indicate that PAN may be an effective treatment of the mild to moderate alcoholic withdrawal state. The rapidity of the therapeutic effect of PAN therapy coupled with the minimal sedative requirements, may enable patients to enter the psychological treatment phase more quickly than those on sedative regimens, accelerating the patients recovery. Our review does not provide strong evidence due to the small sample sizes of the included trials. Neither does the review indicate any causes for concern that PAN is more harmful than the benzodiazepines. Clinicians wishing to use PAN may initially wish to do so within trial settings.  Further high quality trials should be done to confirm these findings and to investigate whether the PAN therapy has fewer adverse effects than other treatments for the alcohol withdrawal states. Studies to investigate the possible cost-effectiveness of PAN by reducing costly hospital admissions and decreasing post administration supervision also need to be performed.

Plain-language summary: This review assessed the effects of psychotropic analgesic nitrous oxide (PAN) in treating alcohol withdrawal. All trials were conducted in in-patient settings although PAN is also administered in outpatient settings. The review found that PAN is as effective as sedatives for managing mild to moderate alcohol withdrawal states. Nonetheless, it does not provide strong evidence in favour of the benefits or harms of using PAN over sedatives in managing acute alcohol withdrawal. Further high quality trials should be done before these findings can be confirmed.
Abstract: We identified two trials (of high risk of bias) involving 152 patients randomised to gastrojejunostomy (80 patients) and no gastrojejunostomy (72 patients). In both trials, patients were found to be unresectable during exploratory laparotomy. Most of the patients also underwent biliary-enteric drainage. There was no evidence of difference in the overall survival (HR 1.02; 95% CI 0.84 to 1.25), peri-operative mortality or morbidity, quality of life, or hospital stay (MD 0.97 days; 95%CI -0.18 to 2.12) between the two groups. The proportion of patients who developed long-term gastric outlet obstruction was significantly lower in the prophylactic gastrojejunostomy group (2/80; 2.5%) compared with no gastrojejunostomy group (20/72; 27.8%) (RR 0.10; 95%CI 0.03 to 0.37). The operating time was significantly longer in the gastrojejunostomy group compared with no gastrojejunostomy group (MD 45.00 minutes; 95%CI 21.39 to 68.61). Routine prophylactic gastrojejunostomy is indicated in patients with unresectable periampullary cancer undergoing exploratory laparotomy (with or without hepaticojejunostomy).

Plain-language summary: We identified two trials (of high risk of bias or systematic error) involving 152 patients randomised to gastrojejunostomy (80) and no gastrojejunostomy (72). In both studies, patients were found to be unresectable during operations aimed at surgical removal i.e. the stomach was opened to remove the cancer but the cancer could not be removed. There was no evidence of any difference in the overall survival, surgical complications, quality of life, or hospital stay between the two groups. The proportion of patients who developed long-term stomach outflow obstruction was significantly lower in the prophylactic gastrojejunostomy group (2.5%) compared with no gastrojejunostomy group (27.8%). The operating time was significantly longer in the gastrojejunostomy group compared with no gastrojejunostomy group by about 45 minutes. Routine prophylactic gastrojejunostomy is indicated in patients with unresectable periampullary cancer undergoing open operation of the stomach. There is no information available currently about the necessity for prophylactic gastrojejunostomy in patients with periampullary cancer diagnosed to be unresectable by investigations such as scans. Further trials of low risk of bias are necessary to assess the role of prophylactic gastrojejunostomy in patients with unresectable periampullary cancer.
Abstract: Seven eligible studies were identified from a total of 2314 references. One new study with 600 patients was added to the original review. Four trials compared IABP to standard treatment and three to other percutaneous left assist devices (LVAD). Data from a total of 790 patients with acute myocardial infarction and cardiogenic shock were included in the updated meta-analysis: 406 patients were treated with IABP and 384 patients served as controls; 339 patients were treated without assisting devices and 45 patients with other LVAD. The HR for all-cause 30-day mortality of 0.95 (95% CI 0.76 to 1.19) provided no evidence for a survival benefit. Different non-fatal cardiovascular events were reported in five trials. During hospitalisation, 11 and 4 out of 364 patients from the intervention groups suffered from reinfarction or stroke, respectively. Altogether 5 out of 363 patients from the control group suffered from reinfarction or stroke. Reocclusion was treated with subsequent re-revascularization in 6 out of 352 patients from the intervention group and 13 out of 353 patients of the control group. The high incidence of complications such as moderate and severe bleeding or infection in the control groups has to be attributed to interventions with other LVAD. Possible reasons for bias were more frequent in small studies with high cross-over rates, early stopping and the inclusion of patients with IABP at randomisation. Available evidence suggests that IABP may have a beneficial effect on some haemodynamic parameters. However, this did not result in survival benefits so there is no convincing randomised data to support the use of IABP in infarct-related cardiogenic shock.

Plain-language summary: In contrast to the previous version of this review, this update now includes data from one large and six small randomised controlled trials. It allows more definitive conclusions about the potential beneficial or harmful clinical effects of IABP support beyond its immediate haemodynamic effects. Complications such as moderate and severe bleeding were more frequently observed in patients treated with more invasive devices than IABP. Small randomised trials suffered from inadequate power to address deaths and harmful effects of IABP and were biased by frequent cross-over to the more aggressive strategy, early stopping of the trial, or the inclusion of patients with IABP at randomisation. It is most noteworthy that a recently conducted and published large randomised trial showed no evidence for survival benefits of IABP support in patients with infarct-related cardiogenic shock treated by percutaneous coronary intervention (PCI). On the basis of these data, IABP support is no longer strongly recommended by the European Society of Cardiology (ESC) guidelines for treatment of patients with infarct-related cardiogenic shock. Rather, IABP use is based on the personal experience and decision of the physician and the particular circumstances of individual patients.
Abstract: Nineteen randomised trials on banding ligation versus non-selective beta-blockers for primary prevention in oesophageal varices were included. Most trials specified that only patients with large or high-risk oesophageal varices were included. Bias control was unclear in most trials. In total, 176 of 731 (24%) of the patients randomised to banding ligation and 177 of 773 (23%) of patients randomised to non-selective beta-blockers died. The difference was not statistically significant in a random-effects meta-analysis (RR 1.09; 95% CI 0.92 to 1.30; I2 = 0%). There was no evidence of bias or small study effects in regression analysis (Egger's test P = 0.997). Trial sequential analysis showed that the heterogeneity-adjusted low-bias trial relative risk estimate required an information size of 3211 patients, that none of the interventions showed superiority, and that the limits of futility have not been reached. When all trials were included, banding ligation reduced upper gastrointestinal bleeding and variceal bleeding compared with non-selective beta-blockers (RR 0.69; 95% CI 0.52 to 0.91; I2 = 19% and RR 0.67; 95% CI 0.46 to 0.98; I2 = 31% respectively). The beneficial effect of banding ligation on bleeding was not confirmed in subgroup analyses of trials with adequate randomisation or full paper articles. Bleeding-related mortality was not different in the two intervention arms (29/567 (5.1%) versus 37/585 (6.3%); RR 0.85; 95% CI 0.53 to 1.39; I2 = 0%). Both interventions were associated with adverse events. This review found a beneficial effect of banding ligation on primary prevention of upper gastrointestinal bleeding in patient with oesophageal varices. The effect on bleeding did not reduce mortality. Additional evidence is needed to determine whether our results reflect that non-selective beta-blockers have other beneficial effects than on bleeding.

Plain-language summary: This review includes 19 randomised trials on banding ligation versus beta-blockers for patients with high-risk oesophageal varices and no history of bleeding. Bias control was unclear in most trials. There was no difference in mortality among the patients randomised to banding ligation compared with beta-blockers. The trials with adequate bias control based on the assessment of randomisation methods found no difference in bleeding rates. The trials with unclear randomisation methods found that banding ligation reduced bleeding. The effect of banding ligation was associated with the duration of follow-up and publication status of the trials. The results of trials with less than 20 months of follow-up found a better effect of banding ligation compared to trials with longer follow-up. Trials published in abstract form were more positive towards the effect of banding ligation than trials published as full paper articles. The combined evidence suggests that banding ligation and beta-blockers may be used as primary prophylaxis in oesophageal varices in adult patients. Additional evidence from trials with adequate bias control and sufficient follow-up is still needed to determine long-term effects.
Abstract: Four trials involving 132 people were included. Two studies compared nasal mask with the Oracle oral mask and showed no significant difference in compliance at one month (mean difference (MD) 0.17 hours per night, 95%CI 0.54 to 0.87). There were also no significant differences in any of the physiological parameters (e.g. AHI, arousal index, minimum oxygen saturation), Epworth Sleepiness Scale (ESS), or symptoms of OSA. A single study comparing nasal mask with nasal pillows showed a significant difference in compliance when expressed as the percentage of days used in favour of nasal pillows (nasal pillows mean 94.1± SD 8.3%; nasal mask 85.7 ± 23.5%, P = 0.02), however there were no significant differences in the mean daily use for all days or when use was greater than 0 minutes per day. Nasal pillows were also associated with fewer overall adverse effects (P < 0.001) and greater interface satisfaction (P = 0.001). One study comparing nasal mask with face mask showed that compliance was significantly greater with use of a nasal mask (MD 1.0 hour per night,95% CI 0.3 to 1.8). Nasal mask was also associated with significantly lower ESS scores and was the preferred interface in almost all patients. Due to the limited number of studies available comparing various interface types, the optimum form of CPAP delivery interface remains unclear. The results of our review suggest that nasal pillows or the Oracle oral mask may be useful alternatives when a patient is unable to tolerate conventional nasal masks. The face mask can not be recommended as a first line interface, but may be considered if nasal obstruction or dryness limits the use of a nasal mask. Further randomised studies comparing the different forms of CPAP delivery interface now available for the treatment of OSA, in larger groups of patients and for longer durations, are required.

Plain-language summary: This review compares the different interface options for CPAP in patients with OSA. Four trials involving 132 people were included. Two studies compared nasal masks with an oral mask called the Oracle, and there did not appear to any significant differences between the two in terms of compliance, sleep study recordings, sleepiness or other symptoms of OSA. One study assessing nasal masks versus nasal pillows (consisting of prongs that rest within the nostrils) showed that patients using the nasal pillows had fewer overall side effects and reported greater satisfaction. The nose mask performed better than the face mask (which covers both the nose and mouth) with one study showing greater compliance and less sleepiness, and was the preferred mask in almost all patients. The choice of interface for a particular person will need to be tailored to the individual. Further trials comparing the many interfaces for CPAP in the treatment of OSA are needed.
Abstract: Forty nine studies (12,067 patients) were identified. Thirty eight compared ACEi with placebo, four compared AIIRA with placebo and seven compared ACEi and AIIRA directly. There was no significant difference in the risk of all-cause mortality for ACEi versus placebo (RR 0.91, 95% CI 0.71 to 1.17) and AIIRA versus placebo (RR 0.99, 95% CI 0.85 to 1.17). A subgroup analysis of studies using full-dose ACEi versus studies using half or less than half the maximum tolerable dose of ACEi showed a significant reduction in the risk of all-cause mortality with the use of full-dose ACEi (RR 0.78, 95% CI 0.61 to 0.98). Baseline mortality rates were similar in the ACEi and AIIRA studies. The effects of ACEi and AIIRA on renal outcomes (ESKD, doubling of creatinine, prevention of progression of micro- to macroalbuminuria, remission of micro- to normoalbuminuria) were similarly beneficial. Reliable estimates of effect of ACEi versus AIIRA could not be obtained from the three studies in which they were compared directly because of their small sample size. Although the survival benefits of ACEi are known for patients with DKD, the relative effects on survival of ACEi with AIIRA are unknown due to the lack of adequate direct comparison studies. In placebo controlled studies, only ACEi (at the maximum tolerable dose, but not lower so-called renal doses) were found to significantly reduce the risk of all-cause mortality. Renal and toxicity profiles of these two classes of agents were not significantly different.

Plain-language summary: However studies have focused on kidney protection rather than over mortality. The aim of this review was to assess the benefits and harms or ACEI and AIIRA therapy in patients with DKD. Fifty studies (13,215 patients) were identified comparing ACEi to placebo, AIIRA to placebo and ACEi to AIIRA. The risk of death from any cause was not significantly reduced with the use of ACEi versus placebo, AIIRA versus placebo or ACEi versus AIIRA. However when we looked at the studies which used the maximum dose tolerated of ACEi rather than the lower, so-called renal doses, there was a significant reduction in the risk of death due to any cause. We were unable to determine which drug provides better protection due to the lack of head-to-head trials.
Abstract: Three crossover studies (Korner 1978; Tuck 1982; Jirapaet 1993) were identified that compared a form of kinesthetic stimulation to control for the treatment of apnea of prematurity. No study reported a clinically important reduction (> 50%) in apnea. Using a lower threshold (> 25%), Korner 1978 reported less apnea and bradycardia in infants while on an oscillating water bed. Tuck 1982 demonstrated a reduction in frequency of apneas (> 12 seconds) associated with bradycardia (< 100 bpm), apneas associated with hypoxia (TcP02 < 50 mmHg), and apneas requiring stimulation in infants on a rocking bed. Individual patient data were not available from the author to determine if there was an important reduction in clinical apnea. No outcome could be extracted from the study using a 'vertical pulsating stimulus' by Jirapaet 1993 that was consistent with the definition of clinically important apnea. Jirapaet 1993 reported no infants required resuscitation or ventilation. Adverse events such as death, intraventricular hemorrhage and neurodevelopmental disability were not reported. There is insufficient evidence to recommend kinesthetic stimulation as treatment for clinically significant apnea of prematurity. Previous reviews have suggested that kinesthetic stimulation is not effective at preventing apnea of prematurity (Henderson-Smart 2005) and is not as effective as theophylline at treating clinically significant apnea of prematurity (Osborn 2005).

Plain-language summary: Three controlled studies have used different gentle rocking motions (irregularly oscillating water beds, regularly rocking bed trays or a vertical pulsating stimulus) to reduce the occurrence of apnea in a total of 49 babies. However, there was no clinically useful reduction of periods of apnea, although only a small number of infants were studied. Shorter breathing pauses were reported to be reduced by one study but it is not thought to be clinically important. No harm has reported to be done to the preterm infants with these interventions.
Abstract: Only one trial with only eight participants met all the inclusion criteria and provided the primary outcome measure for this review. In this trial, four participants treated with neurotrophin-3 had more improvement after six months on the Neuropathy Impairment Score, mean difference -9.50 (95% CI -13.77 to -5.23), than those four treated with placebo. Small trials of exercise training, creatine monohydrate, orthoses and purified bovine brain ganglioside injections (Cronassial) showed no significant benefit in people with genetically undefined CMT1 or CMT2. Small trials of exercise, creatine, purified brain gangliosides, and orthoses have been performed. None showed significant benefit. A very small trial of neurotrophin-3 showed possible minor benefit which needs to be replicated in a larger trial. None of the two trials were large enough to detect moderate benefit or harm. Larger RCTs are needed for any form of pharmacological intervention as well as as for any form of physical intervention. Outcome measures should include a validated composite scale such as the Charcot-Marie-Tooth neuropathy scale.

Plain-language summary: There have been few trials of treatment for Charcot-Marie Tooth disease. One very small trial of the nerve growth promoting factor, neurotrophin-3, showed possible benefit but needs to be replicated. Trials of exercise, orthosis, creatine and ganglioside injections have been done but did not show significant benefit. These were all too small to identify moderate benefit or harm. Trials of vitamin C for the commonest type of Charcot-Marie Tooth disease are in progress.
Abstract: Sixteen studies (enrolling 809 children) were identified. Risk of bias assessment indicated that study quality was poor or poorly reported with only four and five studies respectively reporting adequate allocation concealment or blinding of study participants and investigators. Treatment with rhGH (28 IU/m²/wk) compared with placebo or no specific therapy resulted in a significant increase in height standard deviation score (HSDS) at one year (8 studies, 391 children: MD 0.82, 95% CI 0.56 to 1.07), and a significant increase in height velocity at six months (2 studies, 27 children: MD 2.85 cm/6 mo, 95% CI 2.22 to 3.48) and one year (7 studies, 287 children: MD 3.88 cm/y, 95% CI 3.32 to 4.44). Height velocity, though reduced, remained significantly greater than untreated children during the second year of therapy (1 study, 82 children: MD 2.30 cm/y, 95% CI 1.39 to 3.21). Compared to the 14 IU/m²/wk group, there was a 1.18 cm/y increase in height velocity in the 28 IU/m²/wk group (3 studies, 150 children: 1.18 cm/y, 95% CI 0.52 to 1.84) . The frequency of reported side effects of rhGH was generally similar to that of the control group. One year of 28 IU/m²/wk rhGH in children with CKD resulted in a 3.88 cm increase in height velocity above that of untreated patients. Studies were too short to determine if continuing treatment resulted in an increase in final adult height.

Plain-language summary: This review of 16 studies enrolling 809 children found that rhGH increased height in children with CKD by about 4 cm after 1 year and by a further 2 cm after 2 years of treatment compared with no treatment. The frequency of reported side effects of rhGH was generally similar to that of the control group.
Abstract: Two randomised controlled studies were eligible for inclusion in the review. Both studies were of moderate quality and used active control comparisons (another type of meditation, relaxation, biofeedback). Anti-anxiety drugs were used as standard treatment. The duration of trials ranged from 3 months (12 weeks) to 18 weeks. In one study transcendental meditation showed a reduction in anxiety symptoms and electromyography score comparable with electromyography-biofeedback and relaxation therapy. Another study compared Kundalini Yoga (KY), with Relaxation/Mindfulness Meditation. The Yale-Brown Obsessive Compulsive Scale showed no statistically significant difference between groups. The overall dropout rate in both studies was high (33-44%). Neither study reported on adverse effects of meditation. The small number of studies included in this review do not permit any conclusions to be drawn on the effectiveness of meditation therapy for anxiety disorders. Transcendental meditation is comparable with other kinds of relaxation therapies in reducing anxiety, and Kundalini Yoga did not show significant effectiveness in treating obsessive-compulsive disorders compared with Relaxation/Meditation. Drop out rates appear to be high, and adverse effects of meditation have not been reported. More trials are needed.

Plain-language summary: Although meditation therapy is widely used in many anxiety-related conditions there is still a lack of studies in anxiety disorder patients. The small number of studies included in this review do not permit any conclusions to be drawn on the effectiveness of meditation therapy for anxiety disorders. Transcendental meditation is comparable with other kinds of relaxation therapies in reducing anxiety, and Kundalini Yoga did not show significant effectiveness in treating obsessive-compulsive disorders compared with Relaxation/Meditation. Drop out rates appear to be high, and adverse effects of meditation have not been reported. More trials are needed.