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Thirteen studies were included in this review. All studies used a crossover design and were of high quality. Spirometry performed at the end of the study period and after the administration of treatment (post-bronchodilator) showed a slight but significant increase in FEV1 and FVC when compared to placebo (WMD 0.14 L; ...
This review has shown that regular use for at least seven days of inhaled beta-2 medicines that relieve airways obstruction and can also improve the symptoms associated with chronic obstructive pulmonary disease (COPD) in most patients but not all. Patients are far more likely to prefer treatment with these type of med...
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. T...
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...
We included 25 RCTs involving 7259 participants including 977 (13.5%) men and 6282 (86.5%) women. Mean age reported ranged from 52.6 to 71 years, and range of age of included participants was 23 to 85 years. The trials reported 27 comparisons and included participants who had survived breast cancer (17 trials), colorec...
The quality of evidence is generally low to very low. Most studies did not evaluate dietary interventions for key review outcomes, particularly mortality and morbidity. However, a few study outcomes with moderate-certainty evidence focused on dietary intake and physical measurements. Included studies compared dietary i...
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, ...
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 result...
Seven studies with a total of 225 participants met the inclusion criteria for this review. All seven studies compared the effects of a cognitive training intervention to a control intervention at the end of treatment periods lasting four to eight weeks. Six studies included people with PD living in the community. These...
We found seven studies that randomly allocated a total of 225 participants to cognitive training or to a control group. Treatment lasted from four to eight weeks. All the cognitive training interventions were delivered by computer. The control groups received either no intervention or a control intervention such as lan...
We identified seven randomised controlled trials involving 542 breast cancer patients undergoing or having recently undergone chemotherapy. All studies were conducted and published in China. We did not pool the results because few studies were identified and no more than two used the same intervention. All were of low ...
The purpose of this systematic review was to evaluate the effectiveness and safety of CMH in alleviating chemotherapy-induced short term side effects for women either undergoing chemotherapy or having recently undergone chemotherapy. Short term side effects are those that occur during the course of the treatment and ge...
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 t...
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 combinatio...
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...
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 di...
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 ...
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 marke...
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 the...
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 adv...
Primary outcome measure: one cross-over trial including 18 participants showed after four weeks, 2 (95% confidence interval (CI) 0.9 to 3.1) points more improvement on an 11-point disability scale with plasma exchange (10 exchanges over four weeks) than with sham exchange. Rapid deterioration after plasma exchange occu...
We found two randomised controlled trials. Both studies compared plasma exchange with sham exchange (in which blood was removed and returned but not exchanged). One trial aimed to compare four weeks' plasma exchange with sham exchange. The 18 participants received both treatments, being randomised to either treatment i...
We included three trials with 3851 participants. All three were cluster-RCTs. Two of the trials were of complex, single-component, non-pharmacological interventions and one trial was a feasibility trial of a complex, multicomponent, non-pharmacological intervention. Risk of bias ratings were mixed across the three tria...
The evidence is current to February 2019. We found three studies that included 3851 participants. Two studies took place in the US and one study in the UK. One study tested whether delirium could be prevented by calculating how much fluid an older person in a care home needs each day and ensuring hydration was maintain...
We identified 15 studies described in 27 articles that met our inclusion criteria. These 15 included studies randomised a total of 3062 participants (PAAP vs no PAAP: 2602 participants; PAAP plus education vs education alone: 460 participants). Ten studies (eight PAAP vs no PAAP; two PAAP plus education vs education al...
We searched for studies up to September 2016. We found 15 studies that provided the information we were looking for in conducting this review. A total of 3062 people had taken part in these studies; 2602 people took part in 11 studies looking at PAAP versus no PAAP, and 460 people were included in four studies looking ...
We included 25 studies (6293 participants) in this review. All included studies specified inguinal hernias, and two studies reported that femoral hernias were included. Mesh repair probably reduces the risk of hernia recurrence compared to non-mesh repair (21 studies, 5575 participants; RR 0.46, 95% CI 0.26 to 0.80, I2...
In this update of a review originally published in 2001, we included a total of 25 studies (with a total of 6293 people) undertaken in a number of different countries. A variety of outcomes were assessed, including return of the hernia after initial repair (hernia recurrence), a variety of complications including pain,...
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 1...
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.
The search for the original version of the review identified 635 unique references. We found 31 references (which reported on 30 studies) in full text after inspection of titles and abstracts, but we excluded them all as they did not meet the inclusion criteria. However, we have included a comprehensive narrative accou...
We searched for randomised controlled trials (trials where treatment is allocated to women in a random manner) and well-designed non-randomised studies that compared different treatments in women aged 18 years or older with biopsy-confirmed Paget's disease of the vulva. We searched scientific databases and contacted ex...
Four studies randomising 163 people could be included in the review. It is not clear if brief family intervention reduces the utilisation of health services by patients, as most results are equivocal at long term and only one study reported data for the primary outcomes of interest of hospital admission (n = 30, 1 RCT,...
This review investigates the effects of brief family intervention for people with schizophrenia, compared to standard or usual care. A search of the Cochrane Schizophrenia Group's trial register was carried out in July 2012. Four randomised studies, with a total of 163 participants were included. Results were limited, ...
We included two studies (involving 141 women - with data from 124 women). We considered both studies as being at high risk of bias. Meta-analysis was not possible because the included studies examined different interventions (both in comparison with standard care) and reported on few, but different, outcomes. One study...
In our study we assessed the different techniques used for resealing the waters. We aimed to compare the survival of babies affected with this condition before and after birth and look at the rates of complications in both the babies and mothers. We searched for trials (30 May 2016) and found two studies that compared ...
We included two RCTs (with a total of 789 participants) comparing LMWH with 5-FU infusion and placebo. However, we did not perform a meta-analysis because of significant heterogeneity between these studies. One study found a significant beneficial effect of LMWH with 5-FU in reducing postoperative PVR compared to place...
The two studies included in this review looked at using LMWH with 5-FU during retinal detachment repair to see if there was an effect of reducing PVR levels after surgery. One study focused on patients who are considered at high-risk of developing PVR after surgery because of pre-existing ocular features, and found ben...
In this updated analysis, we included nine trials (N = 1070 infants) comparing prophylactic ibuprofen (IV or oral) with placebo/no intervention or indomethacin. Ibuprofen (IV or oral) probably decreases the risk of PDA on day 3 or 4 (typical RR 0.39, 95% CI 0.31 to 0.48; typical RD -0.26, 95% CI -0.31 to -0.21; NNTB 4,...
More than 1000 infants have been enrolled in trials of ibuprofen for prevention of a PDA; most studies were of small sample size. Prophylactic use of ibuprofen reduces the incidence of patent ductus arteriosus (PDA), the need for rescue treatment with other medications, or the need for surgical closure. Adverse effects...
We included eight small trials involving a total of 282 participants with chronic osteomyelitis. Data were available from 248 participants. Most participants were male with post-traumatic osteomyelitis, usually affecting the tibia and femur, where recorded. The antibiotic regimens, duration of treatment and follow-up v...
We included eight small randomised trials involving 282 people. The trials presented results for a total of 248 people with chronic osteomyelitis. Post-traumatic bone infections were the most frequent type. Surgical removal of the infected tissue (debridement) before starting on antibiotic therapy was mentioned as part...
Seven studies (581 participants) met our inclusion criteria. Trials had an intervention length of 6 weeks to 12 months and follow-up length of 6 to 12 months. The comparison group in all trials was usual care (without any form of structured exercise training or advice) or a no-exercise comparator. The mean age of parti...
The evidence is current to 2 October 2017. We included seven studies that randomly allocated a total of 581 participants with stable angina to either receive cardiac rehabilitation or no exercise control. We identified that there are no ongoing randomised studies. The average age of participants ranged from 50 to 66 ye...
We identified one new study with 100 participants for the pooled analysis. We identified two additional reports of a study using an enriched enrolment randomised withdrawal (EERW) design that included participants from earlier randomised controlled trials and an open-label study. Because this study used the same partic...
We searched scientific databases for studies that looked at the effects of milnacipran in adults with fibromyalgia who had moderate or severe pain. The treatment had to last at least eight weeks. The evidence is current to May 2015. We identified six studies that satisfied the inclusion criteria, including one new stud...
We included eleven randomised clinical trials with 1664 participants who were mostly at low anaesthetic risk, low frequency of co-morbidities, low risk of conversion to open surgery, and low risk of infectious complications. None of the trials had low risk of bias. We found no statistically significant differences betw...
This meta-analysis of eleven randomised clinical trials could not find sufficient evidence to support or refute the use of antibiotic prophylaxis to reduce surgical site infection or global infections in patients with low anaesthetic risk, low co-morbidities, and low-risk of conversion to open surgery, and undergoing e...
Two completed and one ongoing clinical trial met the inclusion criteria. One trial (34 patients randomised) examined the effects of H pylori eradication on levodopa absorption and motor symptoms and found significant improvements in both. The ongoing trial has similar objectives and aims to recruit 100 patients. The ot...
We used clinical trials to see if treatment of H pylori-positive Parkinson's disease patients with antibiotics improved the absorption of levodopa and improved their motor symptoms. Only two completed trials were found from our searching. We did not pool these as they had different objectives and used different outcome...
We included 13 trials in this review. Eight studies reported data on the Bayley Scales of Infant Development (BSID) in 2134 participants. We combined the data in a meta-analysis to assess the effect on development as measured by the Mental Development Index (MDI) and Psychomotor Development Index (PDI). There was no si...
The review authors searched the medical literature for studies that evaluated mental and motor development in infants and children randomly assigned to receive either zinc supplements or a 'placebo' (fake) supplement. We found 13 relevant studies. Eight studies measured development using the Mental Development Index an...
This review update added three new studies including 419 participants to the review. In total, we identified eight RCTs, most of which were at low risk of bias, involving 1669 participants with mild to moderate asthma. We included three paediatric (n = 422) and five adult (n = 1247) studies; six were parallel-group tri...
This review update added three new studies including 419 participants to the review. We performed the most recent searches in March 2016. In total, we found eight studies involving 1669 people with mild or moderate asthma. Three were conducted in children, and five in adults. These studies provided participants with an...
We included six RCTs with a total of 248 participants; none of the trials were determined to have overall low risk of bias. We found 12 ongoing trials, from which we were unable to retrieve any data. Only two trials provided data on mortality, and one was a zero event study; thus the meta-analysis showed no statistical...
In the present Cochrane systematic review, we set out to assess the benefits and harms of fibrinogen concentrate in patients with bleeding. We searched the databases to August 2013, we identified six randomized trials in cardiac and elective surgical settings that compared fibrinogen concentrate (248 participants) with...
Four trials involving 91 infants were included. No difference was detected between intravenous doxapram or methylxanthine in the incidence of failed treatment within 48 hours [typical relative risk 0.91, 95% confidence interval (95% CI) 0.45, 1.85] . Only one trial reported results at 7 days and there was no difference...
The review of four small trials found that there was no large difference between the drugs in the short term. There is not enough evidence to exclude a small difference in benefit, long term effects or a difference in less common adverse effects. More research is needed into the long term and adverse effects of these d...
Nineteen studies enrolling approximately 5000 preterm and/or LBW infants met inclusion criteria. No new trials were identified in May 2013. When all studies were combined, a significant reduction in sepsis was noted (typical risk ratio (RR) 0.85, 95% confidence interval (CI) 0.74 to 0.98; typical risk difference (RD) -...
To date, approximately 5000 infants have been enrolled in studies conducted to evaluate the effects of prophylactic use of intravenous immunoglobulin on neonatal outcomes. Intravenous administration of immunoglobulin results in a 3% reduction in blood-borne infection and a 4% reduction in serious infection. Intravenous...
Eight studies are now included in this review. When any dose omega-3 (E-EPA or EPA) is compared with placebo, small short trials suggest that the need for neuroleptics appears to be reduced for people allocated omega-3 supplementation (n=30, 1 RCT, RR 0.73 CI 0.54 to 1.00) and mental state may improve (n=30, 1 RCT, RR ...
The majority of the trials compared two different types of omega 3 fatty acids, EPA (usually as E-EPA) and DHA with placebo, in people with schizophrenia who are stable on antipsychotic medication. Some of these trials show some improvement in general functioning and in mental state but not to a statistically significa...
We included 16 studies assessing a median of 54 RCTs (range: 2 to 362). Twelve studies compared protocols to published reports and four compared trial registry entries to published reports. In two studies, eligibility criteria differed between the protocol and publication in 19% and 100% RCTs. In one study, 16% (9/58) ...
The non-reporting of a piece of research and the selective reporting of only some of its findings has been identified as a problem for research studies such as randomised trials and systematic reviews of these. If the decision about what to report and what to keep unpublished is based on the results obtained in the tri...
The review includes seven trials; five on aspects of lifestyle changes (eg, diet, physical exercise) and two on treatment with a weight reduction drug 'orlistat'. In total, 373 participants were enrolled, and the duration of the trials ranged from 1 month to 1 year. Only one trial on lifestyle programme was judged to b...
We performed this systematic review to investigate the beneficial and harmful effects of weight reduction with different measures for NAFLD patients, but we could not find firm evidence. Five trials on lifestyle programme and two trials on orlistat were obtained, and all but one had high risk of bias. There seemed to b...
We included five randomised clinical trials with 265 participants. All trials were prospective, double-blind, placebo-controlled randomised controlled trials on the effects of positive pressure therapy on vertigo complaints in Ménière's disease. Overall, the risk of bias varied: three out of five studies were at low ri...
In this review, we included five randomised controlled trials, with a total of 265 participants. All participants had Ménière's disease and their ages ranged from 19 to 74 years. In all of the studies positive pressure therapy was compared with a placebo device. For our primary outcome, control of vertigo, we could not...
Eight trials involving 3417 people were included. AA may help patients to accept treatment and keep patients in treatment more than alternative treatments, though the evidence for this is from one small study that combined AA with other interventions and should not be regarded as conclusive. Other studies reported simi...
The available experimental studies did not demonstrate the effectiveness of AA or other 12-step approaches in reducing alcohol use and achieving abstinence compared with other treatments, but there were some limitations with these studies. Furthermore, many different interventions were often compared in the same study ...
We identified 12 studies (667 participants) and two new ongoing studies for inclusion. Six RCTs were newly included at this update and important non-randomised cohort studies have also been published. Some important studies remain unpublished and not all published studies provide complete outcome data. Primary outcome ...
We found 12 studies of corticosteroid treatment in DMD, involving a total of 667 randomised boys; two other studies are ongoing. Among the 12 completed studies, the treatments were: a corticosteroid versus inactive medicine (placebo) (in nine trials); daily versus weekend-only prednisone (in one trial); and deflazacort...
We included 28 trials, involving 5855 participants, comparing stroke unit care with an alternative service. More-organised care was consistently associated with improved outcomes. Twenty-one trials (3994 participants) compared stroke unit care with care provided in general wards. Stroke unit care showed reductions in t...
This review of 28 trials, involving 5855 participants, showed that patients who receive this care are more likely to survive their stroke, return home and become independent in looking after themselves. A variety of different types of stroke unit have been developed. The best results appear to come from those which are...
Six trials with a total of 556 people were included. These trials were all placebo-controlled and double-blind, but of variable quality. They used different homeopathic treatments which precluded quantitative pooling of results for the primary outcome. Standardised treatments in these trials are unlikely to represent c...
The review of trials found that the type of homeopathy varied between the studies, that the study designs used in the trials were varied and that no strong evidence existed that usual forms of homeopathy for asthma are effective. There has been only a limited attempt to measure a 'package of care' effect (i.e., the eff...
Seven studies are now included in this review. For the comparison of physical healthcare advice versus standard care we identified six studies (total n = 964) of limited quality. For measures of quality of life one trial found no difference (n = 54, 1 RCT, MD Lehman scale 0.20, CI -0.47 to 0.87, very low quality of evi...
Based on an electronic search carried out in 2012, this review now includes seven studies that randomised a total of 1113 people with serious mental illness. Six studies compared general physical health advice with standard care, one compared advice on healthy living with artistic techniques such as sketching and potte...
Cabergoline has been compared with bromocriptine in five randomised, double-blind, parallel group studies including 1071 patients. Only one of the phase II studies was medium term (36 weeks), the others all being short term (12 -15 weeks). The non-significant difference in off time reduction produced by cabergoline com...
Cabergoline has been compared with the older agonist bromocriptine in five studies including 1071 patients. Only one of the smaller studies was medium term (36 weeks), the others all being short term (12 -15 weeks). The time patients spent in the immobile off state was reduced with both agonists but slightly more by ca...
Of the 3032 records identified, 10 studies were included in this review. Effect of ITN cost on ownership: Four studies including 4566 households and another study comprising 424 participants evaluated the effect of ITN price on ownership. These studies suggest that providing free ITNs probably increases ITN ownership w...
The studies included in this review took place in Africa and India. In five of the studies, people were either given insecticide-treated bednets free, or could buy them at a subsidized price or full market price. In the other five studies, people were educated about how to use the bednets properly, for instance through...
Four studies involving 127,891 men and 9342 women were included in this review. Only one study included women. Results for men and women were analysed separately. Three to five years after screening there was no significant difference in all-cause mortality between screened and unscreened groups for men or women (men, ...
This review identified four controlled trials involving 127,891 men and 9342 women who were randomly assigned to aortic aneurysm screening using ultrasound or no screening. Only one trial included women. Two of the trials were conducted in the UK, one in Denmark and one in Australia. The results provide evidence of a b...
For this update, we identified two additional studies, for a total of five eligible trials that enrolled 166 infants. The methodological quality of these studies ranged from low to high risk of bias. Three studies were performed in resource-limited settings, where iNO and high-frequency ventilation were not available a...
We identified five studies that evaluated effects of sildenafil: three studies that compared sildenafil with placebo (no sildenafil); one that compared sildenafil with other medication (magnesium sulphate); and one that used sildenafil in combination with another medicine (nitric oxide). These studies included 166 newb...
We included six studies involving 462 participants with chronic peripheral neuropathic pain (442 completers (251 male), mean ages 52 to 63 years). The included studies recruited 403 participants from China and 59 from the UK. Most studies included a small sample size (fewer than 50 participants per treatment arm) and a...
We conducted a search for relevant clinical trials in February 2017. We included six studies of manual acupuncture: one compared acupuncture with sham acupuncture; three investigated acupuncture combined with other active treatments compared with other active treatments alone; two compared acupuncture alone compared wi...
We included 10 RCTs involving a total of 844 participants. The primary outcome was overall incidence of parastomal herniation. Secondary outcomes were rate of reoperation at 12 months, operative time, postoperative length of hospital stay, stoma-related infections, mesh-related infections, quality of life, and rehospit...
Following our data search in January 2018, we included 10 trials with a total of 844 participants, which we assessed using the standard Cochrane Review protocol. The trials compared the incidence of hernia development around a stoma between a group having a mesh placement at the time of stoma formation and a control gr...
Fourteen randomised controlled trials comparing exercise against no exercise in type 2 diabetes were identified involving 377 participants. Trials ranged from eight weeks to twelve months duration. Compared with the control, the exercise intervention significantly improved glycaemic control as indicated by a decrease i...
This review found that exercise improves blood sugar control and that this effect is evident even without weight loss. Furthermore, exercise decreases body fat content, thus the failure to lose weight with exercise programmes is probably explained by the conversion of fat to muscle. Exercise improved the body's reactio...
We included two randomised controlled trials that involved a total of 147 adult outpatients with acute sinusitis confirmed by radiology or nasal endoscopy who were assigned to Cyclamen europaeum nasal spray or placebo study arms for up to 15 days. The risk of selection and detection bias was unclear, as allocation conc...
We included two studies involving 147 adults with acute sinusitis. Participants were randomly allocated to receive Cyclamen europaeum delivered as an intranasal spray or a non-active substance for up to 15 days. Pharmaceutical companies funded both studies. We wanted to find out the proportion of participants whose sym...
We included two RCTs involving 3375 women. Tamoxifen after surgery for DCIS reduced recurrence of both ipsilateral (same side) DCIS (HR 0.75; 95% CI 0.61 to 0.92) and contralateral (opposite side) DCIS (RR 0.50; 95% CI 0.28 to 0.87). There was a trend towards decreased ipsilateral invasive cancer (HR 0.79; 95% CI 0.62 ...
Our findings are based on two large studies with 3375 participants and should be applicable to most women having treatment for DCIS. Overall tamoxifen did reduce the number of future cancers or DCIS in either breast. However, women taking tamoxifen did not live longer than those who did not take it. A total of 15 women...
Seven studies, involving 632 DME eyes were included. Four examined the effectiveness of intravitreal triamcinolone acetate injection (IVTA), three examined intravitreal steroids implantation (fluocinolone acetonide implant (FAI) or dexamethasone drug delivery system (DDS)). Two trials were at low risk of bias, one was ...
This systematic review included seven randomized clinical trials involving 632 eyes from five countries evaluating the effectiveness and safety of intravitreal steroids for treating DME. Two trials were at low risk of bias, one was at median risk of bias, two were at high risk of bias, and the remaining two had an uncl...
The electronic search yielded 8746 records. We included 12 RCTs (3885 participants) comparing usual care with the following interventions: commonly used drugs (four studies); sedation regimens (four studies); physical therapy or cognitive therapy, or both (one study); environmental interventions (two studies); and prev...
We included 12 randomized controlled trials (3885 participants) in our review. The studies included adults aged 48 to 70 years from surgical and medical ICUs. The studies compared different drugs (three studies) various approaches to sedation (five studies), physical or cognitive therapy or both (one study), noise and ...
A total of five studies including 868 participants met the inclusion criteria for this review. The five studies included in this review reported the value of drain fluid amylase at different thresholds and different postoperative days. The sensitivities and specificities were variable; the sensitivities ranged between ...
We performed a thorough literature search for studies reporting the accuracy of drain fluid amylase in identifying pancreatic leaks. We included studies reported up to 20 February 2017. We identified five studies reporting information on 868 people who underwent pancreatic resections for cancer and non-cancerous growth...
We included 64 studies (78 references) and 4547 participants in this review, and classified 12 additional studies as ongoing. A further 12 studies await classification, as we were unable to obtain the full texts. Most of the studies were conducted in high altitude mountain areas, while the rest used low pressure (hypob...
The evidence is current to January 2017. We included 64 studies related to six different types of drugs recommended for HAI prevention. Most of the studies were conducted in high altitude mountain areas, while the rest used low pressure (hypobaric) chambers to simulate altitude exposure. The participants' ages ranged b...
Our searches identified six randomised, double-blind studies involving 292 participants in suitably characterised fibromyalgia. The mean age of participants was between 39 and 50 years, and 89% to 100% were women. The initial pain intensity was around 7/10 on a 0 to 10 pain scale, indicating severe pain. NSAIDs tested ...
We searched for clinical trials in which NSAIDs were used to treat symptoms of fibromyalgia in adults. The latest search was in January 2017. Six studies satisfied the inclusion criteria, randomising 292 participants to treatment with NSAID or placebo. NSAIDs tested were etoricoxib 90 mg daily, ibuprofen 2400 mg daily,...
Six studies were included in this review (3256 children, 4 to 17 years of age). Two studies were published as conference abstracts only. Ciclesonide was compared to budesonide and fluticasone. Ciclesonide compared to budesonide (dose ratio 1:2): asthma symptoms and adverse effect were similar in both groups. Pooled res...
We found six studies comparing ciclesonide with either budesonide or fluticasone in 3256 children (aged four to 17 years) with chronic asthma. After three months of treatment with ciclesonide compared to budesonide or fluticasone, no relevant differences could be found on asthma symptoms, exacerbations or side effects....
Twelve trials met the inclusion criteria. Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E2C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E2V) 5 mg. These contraceptives resulted in lower rates of early study d...
In January and February 2013, we did computer searches to find randomized trials of combination injectable contraceptives. We included studies that compared a CIC with another birth control method. The other method could be another injectable contraceptive, either combined or having only a progestin. The CIC could also...
We included only one small trial (60 participants randomised) which overall was judged to be at low risk of bias. The study examined two doses of menaquinone (vitamin K2) over 3 months in healthy participants aged 40 to 65 years. The primary focus of the trial was to examine the effects of menaquinone (subtype MK7) on ...
We searched scientific databases for randomised controlled trials (clinical trials where people are allocated at random to one of two or more treatments) looking at the effects of vitamin K supplementation in healthy adults or those at high risk of developing CVD. We did not include people who already had CVD (e.g. hea...
We included 72 RCTs. The included trials studied the effects of 32 drugs belonging to different pharmacological groups. Only two trials mentioned the primary outcome of morbidity and mortality related to the haemodynamic response to tracheal intubation. Of the secondary outcomes, 40 of the included trials observed arrh...
We included adult patients aged 18 years and above undergoing elective surgery in the operating room setting. We found that the effects of drugs on the stress response was the subject of 72 studies. The investigators used 32 drugs. Promising results were seen in the reduction of arrhythmias with intravenous injections ...
We included five trials that recruited 14,624 women, with data analysed for 14,185 women. All trials had adequate allocation concealment, but none had adequate blinding of participants, staff or outcome assessors. Overall and apart from lack of blinding, the risk of bias for the included trials was considered to be low...
It is used in pregnancy to study blood circulation in the baby, uterus and placenta. Using it in high-risk pregnancies, where there is concern about the baby's condition, shows benefits. However, its value as a screening tool in all pregnancies needs to be assessed as there is a possibility of unnecessary interventions...
Ten trials, involving 361 participants, satisfied the inclusion criteria. All the trials were randomised; two had a parallel design while the remainder had a cross-over design. Although some individual studies reported a beneficial effect of pancreatic enzyme over placebo in improving pain, incidence of steatorrhoea an...
This practice is based on studies which have shown the benefit of pancreatic enzymes on various outcomes such as abdominal pain, weight loss, analgesic use, fatty stools and quality of life. However, a collective conclusion about the role of pancreatic enzymes in chronic pancreatitis patients needs to be established fr...
Thirty two studies were identified, of which four met the inclusion criteria. One of these had been reported in the original Cochrane review. Since then, three other studies have been reported. One large study, comparing atropine, hyoscine hydrobromide and hyoscine butylbromide, showed no difference between the treatme...
The aim of this review is to find out which treatment, if any, is best. Only four of 32 reports identified met the inclusion criteria for this review; none showed a convincing benefit of any single drug over any others. Some treatments may be worth trying but staff should watch carefully for any side effects of the tre...
We included 14 studies involving 1469 participants with acute middle third clavicle fractures. All studies included adults, with the overall range from 17 to 70 years. Of the studies that reported gender, men were over-represented. Ten studies compared plate fixation with sling or figure-of-eight bandage, or both, and ...
We searched medical databases up to December 2017 and included 14 studies involving 1469 participants with displaced or angulated middle third clavicle fractures. All participants were adults, ranging in age from 17 to 70 years, and there were more men than women. Ten studies compared plate fixation with conservative i...
We identified 10 trials with a total of 1730 participants randomised, and one ongoing trial. Six trials investigated the provision of fruit and vegetables, and four trials examined advice to increase fruit and vegetable consumption.The ongoing trial is examining the provision of an avocado-rich diet.The number and type...
This review assessed the effectiveness of increasing fruit and vegetable consumption as a single intervention without the influence of other dietary patterns or other lifestyle modifications in healthy adults and those at high risk of CVD for the prevention of CVD. We found 10 trials involving 1730 participants in whic...
74% of patients had FIGO stage IIIB LACC. Treatment outcome was significantly better for patients receiving the combined treatment (Figures 4 to 6). The pooled data analysis yielded a significantly higher complete response rate (relative risk (RR) 0.56; 95% confidence interval (CI) 0.39 to 0.79; p < 0.001), a significa...
In several clinical studies it was found that the respons of these tumours to radiotherapy was improved by adding hyperthermia. Hyperthermia is a type of cancer treatment in which body tissue is exposed to high temperatures (i.e. around 42 to 43 degrees Celcius during one hour) to damage and kill cancer cells.. This te...
We included four trials involving 94 participants in this review. There was a significant improvement in activity of daily living (mean difference (MD) 13.20 points on the 'Capacidad funcional' (functional capacity) subscale of the Brazilian-Portuguese version of the SF-36; 95% confidence interval (CI) 8.36 to 18.04; P...
This review of four trials, which included 94 participants, found there is not enough evidence to decide if water-based exercises may reduce disability after stroke. There is a lack of hard evidence for water-based exercises after stroke. More research is therefore needed.
Ten randomised trials were included, involving 3944 adults with predominantly SUI, randomised to receive duloxetine or placebo and/ or PFMT. All arms in individual trials were comparable for various baseline characteristics. Treatment duration was between three weeks and 12 weeks. Duloxetine was significantly better th...
The trials reviewed compared duloxetine against dummy placebo tablets and also pelvic floor muscle training in women with predominantly stress urinary incontinence. Duloxetine reduced the frequency of episodes of incontinence and improved quality of life scores. However, it had little impact on the numbers cured and co...
Eleven studies were eligible for this systematic review, with a total of 1817 people. Three studies included only people who experienced clinically relevant fatigue (Fatigue Severity Scale score ≥ 4 out of 7 or Multidimensional Fatigue Inventory total score > 48 out of 100), whereas all other studies did not select par...
We reviewed the medical literature up to April 2015, and found 11 studies that included a total of 1817 people. Nine studies investigated the effects of medication (i.e. levodopa-carbidopa, memantine, rasagiline, caffeine, methylphenidate, modafinil or doxepin) on fatigue. Two studies investigated the effects of exerci...
Twenty-five studies met the inclusion criteria, but only 23 studies contributed data to the review. These 23 trials recruited 18,587 women, with 17,842 women included in final analyses. There were no statistically significant differences between women who received calcium supplementation and those who did not in terms ...
In our review, regular intake of extra calcium tablets during pregnancy did not improve the number of preterm births or other infant outcomes, except for a slight increase in infant birthweight in the group of women who received calcium supplementation. Most studies included in this review were assessed as of low risk ...
We included 25 studies involving 4121 participants (2511 children and 1517 adults; 93 mixed population). Four studies were of high quality with no risk of bias, 14 of medium quality and seven of low quality, indicating a moderate risk of bias for the total analysis. Nine studies were performed in low-income countries a...
The evidence is current to February 2015. We identified 25 trials, including 4121 participants with acute bacterial meningitis of which seven were performed in adults (over 16 years old), two included both children and adults and the other were performed in children. In 22 studies the corticosteroid used was dexamethas...
The search identified 813 references on MEDLINE, 418 on EMBASE, 22 on CINAHL, 666 on PubMed, 291 on PsycINFO and 145 on CENTRAL. When all references were imported into EndNote and duplications were removed, 1348 references remained. Initial screening of titles and abstracts of these references revealed that 42 referenc...
We searched for randomised control trials (RCTs) that compared follow-up management strategies following LLETZ treatment for CIN. We checked 1348 titles and abstracts of potentially relevant references, but we identified no randomised controlled trials (RCTs) that met our inclusion criteria. We identified trials of int...
Ten of 31 studies identified were included (959 patients). Five studies with a low risk of bias examined azithromycin versus placebo and demonstrated consistent improvement in forced expiratory volume in one second over six months (mean difference at six months 3.97% (95% confidence interval 1.74% to 6.19%; n = 549, fr...
We have included ten randomised controlled trials with a total of 959 participants in this review. Eight of these trials compared azithromycin (a macrolide antibiotic) to placebo and two compared different doses of azithromycin. Four trials in children and adults (549 participants) showed significant improvements in lu...
Twelve studies (2146 participants) that compared 5-ASA to placebo were included. We did not identify any studies that compared sulphasalazine to placebo. Seven studies were judged to be at low risk of bias. The other studies were judged to have an unclear risk of bias for various items due to insufficient details to al...
We found 12 studies that included a total of 2146 participants. Eleven studies including 2014 adult participants compared oral 5-ASA to a placebo (i.e. inactive pills or tablets). One study including 132 children compared oral 5-ASA to a placebo. Eleven studies were conducted for 12 months and one study was conducted f...
We identified 33 randomised controlled trials, from 6 countries and in a range of settings. A total of 8244 patients was randomised and entered into studies. The most common interventions were question checklists and patient coaching. Most interventions were delivered immediately before the consultations. Commonly-occu...
We identified 33 randomised controlled trials involving 8244 patients from six countries, mainly the USA, in a range of clinical settings. Most interventions, which included written materials (for example, question prompt sheets) and coaching sessions, were delivered in the waiting room immediately before the consultat...
The updated search in June 2011 did not identify any new trials. One study is included in the review. This study assessed the effect of intraventricular gentamicin in a mixed population of neonates (69%) and older infants (31%) with gram-negative meningitis and ventriculitis. Mortality was statistically significantly h...
Only one trial was identified. In this trial enrolling infants with gram-negative meningitis and ventriculitis, the use of intraventricular antibiotics in addition to intravenous antibiotics resulted in a three-fold increased risk for mortality compared to standard treatment with intravenous antibiotics alone. Based on...
We included 11 studies in our synthesis, involving 267 participants (one study did not report the number of participants). Five more studies are awaiting classification and will be dealt with when we update the review. The quality of the evidence was mixed; of the 35 summary statements, we assessed 17 as ‘low’, 13 as ‘...
Our synthesis included 11 studies, involving around 267 participants; five more studies are awaiting classification. We identified several potential barriers and facilitators to the use of protocols. First, doctors used protocols only in certain circumstances; otherwise they preferred to wean using their own knowledge ...
There were 18 trials that were eligible for inclusion, five of these were still ongoing.Thirteen completed published trials (2331 participants) were included for analysis in the review. The original review contained nine trials (718 participants). This updated review includes six new trials (1818 participants).Two tria...
This review was undertaken to determine the best use of platelet transfusions for the prevention of bleeding in patients who have haematological disorders and are receiving intensive (myelosuppressive) chemotherapy or stem cell transplantation. The review aimed to look at three main topics. One, what is the evidence to...
We identified only one study for inclusion in this review. This study was a prospective, double-blind cross-over trial that compared the effect of systemic metronidazole with a placebo on odour in malignant wounds. Nine participants with a fungating wound and for whom the smell was troublesome were recruited and six of...
In March 2017 we searched for randomised controlled trials looking at the effects of systemic antibiotics on malignant wounds. We found only one trial, dating from 1984, which compared the effectiveness of the antibiotic metronidazole with a placebo (sugar pill) on six participants with malignant wounds resulting from ...
Thirty-five RCTs were included; 20 were published in English, seven in Japanese, five in Chinese and one each in Norwegian, Polish and German. There were only three trials of acupuncture for acute low-back pain. They did not justify firm conclusions, because of small sample sizes and low methodological quality of the s...
Thirty-five RCTs covering 2861 patients were included in this systematic review. There is insufficient evidence to make any recommendations about acupuncture or dry-needling for acute low-back pain. For chronic low-back pain, results show that acupuncture is more effective for pain relief than no treatment or sham trea...
Ten studies, reporting data from 354 participants, were included in this review, the majority of which were carried out in a university dental hospital setting. The studies were published between 2005 and 2011 and were conducted in Europe and in Brazil. The age range of participants was from nine to 15 years, with an e...
This review of existing studies was carried out by the Cochrane Oral Health Group, and the evidence is current as of December 2012. In this review there are 10 studies published between 2005 and 2011 in which a total of 354 children were randomised to receive treatment with a distalising orthodontic appliance and compa...
We included one double-blind, double-dummy RCT comparing a quadriphasic oral contraceptive composed of dienogest and estradiol valerate with a monophasic oral contraceptive composed of levonorgestrel and ethinylestradiol. Contraceptive effectiveness, intracyclic bleeding and discontinuation due to side effects were sim...
We did a computer search for randomized controlled trials comparing four-phase birth control pills with one-phase birth control pills. We also wrote to researchers and makers of birth control pills to find other trials. Studies had to report on pregnancy, bleeding problems, side effects or stopping the use of pills. We...
We included 11 RCTs with a total of 428 participants 18 years of age or older with low to moderate myopia. These trials were conducted in the Czech Republic, Brazil, Italy, Iran, China, Korea, Mexico, Turkey, USA, and UK. Investigators of 10 out of 11 trials randomly assigned one eye of each participant to be treated w...
We identified 11 trials that enrolled 428 adult participants. These trials were conducted in various countries, including the Czech Republic, Brazil, Italy, Iran, China, Korea, Mexico, Turkey, USA, and UK. Ten out of 11 trials used a paired-eye design, in which one eye of each participant received LASEK and the other e...
Nine studies met the inclusion criteria: three compared supervision with no supervision, five compared enhanced supervision with routine supervision, and one study compared less intensive supervision with routine supervision. Most outcomes were scores relating to providers’ practice, knowledge and provider or user sati...
The studies in this review took place in nine countries in Africa, Asia and Latin America, in both rural and urban areas. Most of the studies looked at the supervision of health care professionals (including nurses, midwives, health officers and physicians), while two studies examined the effect of supervision on commu...
This second update of the review identified 19 additional eligible trials resulting in a total of 33 studies (2793 participants) that met the inclusion criteria. There was low quality evidence that sutures were significantly better than tissue adhesives for reducing the risk of wound breakdown (dehiscence; RR 3.35; 95%...
The researchers searched the medical literature up to March 2014, and identified 33 medical studies that investigated the use of tissue adhesives for closure of wounds. They compared tissue adhesive with another method of closure such as sutures, staples, tape, or another type of tissue adhesive. The main outcomes of i...
This review includes 38 studies, of which 34 studies examined survival following transportation by HEMS compared with GEMS for adults with major trauma. Four studies were of inter-facility transfer to a higher level trauma center by HEMS compared with GEMS. All studies were NRS; we found no RCTs. The primary outcome wa...
We searched the medical literature for clinical studies comparing the transport of adults who had major injuries by helicopter ambulance (HEMS) or ground ambulance (GEMS). The evidence is current to April 2015. We found 38 studies which included people from 12 countries around the world. Researchers wanted to find out ...
Sixteen studies involving 1063 participants were identified. The risk of bias for fifteen studies was high and along with imprecision and possible publication bias, this lowered our confidence in the results. There was low quality evidence that Tong-xi-luo reduced the rates of angiographic restenosis (RR 0.16, 95% CI 0...
Study characteristics: We included sixteen randomised controlled trials (1063 participants) comparing Tong-xin-luo capsules plus conventional treatment with placebo plus/or conventional treatment (literature search date: though June 2014). All studies were undertaken in China. The sample size was from 50 to 178 and the...
We included 10 studies (12 trial reports) from which 5041 women contributed data for the primary outcome. The overall risk of bias was low. When comparing prophylactic intravenous (IV) antibiotic administration in women undergoing cesarean delivery, there was a reduction in composite maternal infectious morbidity (risk...
This review of randomized controlled studies looked at the different timing options for administration of prophylactic antibiotics to prevent infectious complications in women undergoing cesarean delivery. We compared preoperative administration to administration after the cord had been clamped. The review includes 10 ...
No randomised controlled trials or controlled clinical trials were identified for the original review or this update. We summarised the results of five observational studies (including one with two reports) in the Discussion section of this review. In the absence of randomised controlled trials or controlled clinical ...
This review did not find any high quality randomised controlled trials that examined the effectiveness of such multidisciplinary care, either when originally published in 2009 or for the update in 2011. The evidence from low quality studies suggests that such care may improve some aspects of quality of life, reduce the...
We identified no placebo-controlled comparisons of beta-2 agonists. Three studies permitted comparison of ipratropium to an inhaled beta-2 agonist. These studies included a total of 103 patients. The beta2-agonists used were: fenoterol and metaproterenol. One study was a parallel group trial of regular therapy for seve...
These days the drugs of the latter type that are used for acute COPD are salbutamol and terbutaline, but neither of these drugs have been used in the only studies that we could find. We found only three small studies. Overall, both types of drug showed a small but worthwhile effect. There was no difference between them...
Seventeen RCTs (1806 participants) were included. Five RCTs compared acupuncture versus sham acupuncture. The risk of bias in these studies was low. We found no evidence of an improvement with acupuncture relative to sham (placebo) acupuncture for symptom severity (SMD -0.11, 95% CI -0.35 to 0.13; 4 RCTs; 281 patients)...
This review included 17 randomized controlled trials (RCTs) including a total of 1806 participants. Five RCTs (411 participants) compared acupuncture to sham acupuncture for the treatment of IBS. Sham acupuncture is a procedure in which the patient believes he or she is receiving true acupuncture. However, in sham acup...
Twelve trials were included. They were of variable quality. Limited asthma education did not reduce hospitalisation for asthma (weighted mean difference -0.03 average hospitalisations per person per year, 95% confidence interval -0.09 to 0.03). There was no significant effect on doctor visits, lung function and medicat...
Using a systematic approach, the medical literature was searched thoroughly to find reliable studies that looked at the effects of improving patients' knowledge about asthma, but which did not attempt to improve practical self-management skills. The results of the studies were combined to see if patient education desig...
We identified 12 randomised controlled trials that meet the criteria for the review. Six were ongoing trials, four had been completed and two had been terminated early. Six studies with a total of 9849 participants provided data for this review. The trials evaluated the following: daily oral tenofovir disoproxil fumara...
This review evaluated the effects of giving people at high risk for HIV infection drugs to prevent infection (called antiretroviral pre-exposure prophylaxis, or PrEP). We found six randomised controlled trials that assessed the effects of oral tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) versus placebo;...
Ten trials, involving 6533 women, were included in this review, five trials were rated high quality. For the majority of trials, the antioxidant assessed was combined vitamin C and E therapy. There was no significant difference between antioxidant and control groups for the relative risk (RR) of pre-eclampsia (RR 0.73,...
The review covered 10 trials, involving 6533 women, and looked at several antioxidants. Overall the review found no reduction in pre-eclampsia, high blood pressure or preterm birth with the use of antioxidant supplements. When antioxidants were assessed separately, there were insufficient data to be clear about whether...
We included eight reviews in this overview: five Cochrane Reviews (33 included trials) and three non-Cochrane reviews (11 included trials). Three reviews (all Cochrane Reviews) scored low risk across all the ROBIS domains in Phase 2 and low risk of bias overall. The remaining five reviews scored high risk on Domain 4 o...
We identified five Cochrane Reviews and three non-Cochrane reviews. The reviews varied in how many trials they included and the number of participants within trials. The quality of both the reviews and trials varied. We found moderate-quality evidence that three types of strategies probably help to reduce antibiotic pr...
The search identified 20 studies (1615 infants). Most were small, single-centre, prospective cohort studies conducted in neonatal units in high- or middle-income countries since the late 1990s. Risk of bias in the included studies was generally low with independent assessment of index and reference tests. Most studies ...
We found 20 studies that assessed the accuracy of measuring the blood level of CRP to diagnose infections in newborn infants. These studies were similar enough to justify a combined analysis of their findings. The combined analysis indicated that a positive CRP test correctly identified infants with infection about six...
We included one RCT (a total of 50 participants, 25 in both the intervention and comparator group). The intervention focused on laparoscopic adjustable gastric banding surgery, which was compared to a control group receiving a multi component lifestyle programme. The participating population consisted of Australian ado...
We found one randomised controlled trial with a total of 50 participants (25 in both the intervention and comparator group) and a follow-up of two years. The surgery used was 'laparoscopic adjustable gastric banding' (gastric band placed around the entrance of the stomach by means of keyhole surgery). The control group...
A total of 31 trials, involving 12,587 participants, across a range of clinical specialities (e.g. surgery, critical care) met the eligibility criteria. The trial interventions were split fairly equally with regard to the haemoglobin concentration used to define the restrictive transfusion group. About half of them use...
We examined the results of RCTs that randomly allocated participants to one of two groups. In one group, trial participants received blood at lower blood counts. In the other group, trial participants received blood at higher blood counts. The data are current up to May 2016. We identified a total of 31 relevant trials...
Three placebo-controlled studies with a total of 263 participants (age range 0.8 to 61 years old, 122 males and 141 females, with variable lengths of study duration) were included in the review. We found high-quality evidence except for response to skin lesions which was judged to be low quality due to the risk of attr...
The review included three studies with 263 people with tuberous sclerosis complex aged between 0.8 and 61 years of age. However, one study involved five people with sporadic lymphangioleiomyomatosis (without tuberous sclerosis complex) which we could not remove from the analysis. Studies compared rapamycin or rapalogs ...
Twenty-four trials involving 4422 participants were reviewed. Most examined symptomatic women only. Only seven trials analysed results by intention to treat; we re-analysed the remainder. Compared with placebo, clindamycin showed a lower rate of treatment failure (relative risk (RR) 0.25, 95% confidence interval (CI) 0...
This review evaluated the effectiveness and adverse effects of antimicrobial agents used to treat BV in non-pregnant women. Twenty-four trials involving 4422 women were reviewed. With regard to less treatment failure, clindamycin was superior to placebo but comparable to metronidazole, irrespective of the dose regimen....
We included one RCT of 100 participants with ocular burns that were randomised to treatment with AMT and medical therapy or medical therapy alone. A subset of patients (n = 68) who were treated within the first seven days of the injury met the inclusion criteria and were included in the analysis. The remaining 32 eyes ...
The historical use of amniotic membrane transplantation (AMT) to treat eye burns during the acute phase has re-emerged in recent years, although its precise effects on the healing process have not been proven by randomised controlled trials (RCTs). One RCT conducted in India included a subset of patients who fulfilled ...
Nine trials were included in the review, involving 1384 randomised participants. Studies varied in risk of bias, although two studies were identified as being at high risk of selection bias because of problems with concealment of allocation. All studies were from primary care in the United Kingdom and thus comparabilit...
In this review we found nine studies involving counselling in primary care for 1384 participants. There were some problems with the methods in some studies. The evidence suggested that counselling is better than usual general practitioner care in improving mental health outcomes in the short term, although the advantag...
Of 241 records retrieved by the search, 17 trials conducted between 1961 and 2011, involving 2252 participants with follow-up from six weeks to two years, were included. Homogenous data demonstrated that instances of relapse were significantly higher in people receiving any intermittent drug treatment in the long term ...
This review assesses different intermittent drug techniques compared with maintenance treatment in people with schizophrenia or related disorders. Seventeen studies with 2252 participants compared intermittent drug techniques with standard maintenance on medication. Relapse was significantly higher in people receiving ...