Abstract:
BACKGROUND:The objective of this research was to evaluate data from a randomized clinical trial that tested injectable diacetylmorphine (DAM) and oral methadone (MMT) for substitution treatment, using a multi-domain dichotomous index, with a Bayesian approach. METHODS:Sixty two long-term, socially-excluded heroin injectors, not benefiting from available treatments were randomized to receive either DAM or MMT for 9 months in Granada, Spain. Completers were 44 and data at the end of the study period was obtained for 50. Participants were determined to be responders or non responders using a multi-domain outcome index accounting for their physical and mental health and psychosocial integration, used in a previous trial. Data was analyzed with Bayesian methods, using information from a similar study conducted in The Netherlands to select a priori distributions. On adding the data from the present study to update the a priori information, the distribution of the difference in response rates were obtained and used to build credibility intervals and relevant probability computations. RESULTS:In the experimental group (n = 27), the rate of responders to treatment was 70.4% (95% CI 53.287.6), and in the control group (n = 23), it was 34.8% (95% CI 15.354.3). The probability of success in the experimental group using the a posteriori distributions was higher after a proper sensitivity analysis. Almost the whole distribution of the rates difference (the one for diacetylmorphine minus methadone) was located to the right of the zero, indicating the superiority of the experimental treatment. CONCLUSION:The present analysis suggests a clinical superiority of injectable diacetylmorphine compared to oral methadone in the treatment of severely affected heroin injectors not benefiting sufficiently from the available treatments. TRIAL REGISTRATION:Current Controlled Trials ISRCTN52023186.
journal_name
Trialsjournal_title
Trialsauthors
Perea-Milla E,Ayçaguer LC,Cerdà JC,Saiz FG,Rivas-Ruiz F,Danet A,Vallecillo MR,Oviedo-Joekes Edoi
10.1186/1745-6215-10-70subject
Has Abstractpub_date
2009-08-14 00:00:00pages
70issn
1745-6215pii
1745-6215-10-70journal_volume
10pub_type
杂志文章,随机对照试验相关文献
Trials文献大全abstract:BACKGROUND:Sharing interim results by the Data Safety Monitoring Board (DSMB) with non-DSMB members is an issue that can affect trial integrity. It is unclear what should be shared. This study assesses the views of professionals to understand what interim information should be shared at interim, with whom and why. MET...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2655-y
更新日期:2018-05-21 00:00:00
abstract::In ageing men testosterone levels decline, while cognitive function, muscle and bone mass, sexual hair growth, libido and sexual activity decline and the risk of cardiovascular diseases increase. We set up a double-blind, randomized placebo-controlled trial to investigate the effects of testosterone supplementation on...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-7-24
更新日期:2006-08-03 00:00:00
abstract:BACKGROUND:Previous studies have shown that acupuncture and electroacupuncture (EA) are effective in the treatment of patients with low back pain. However, there is little evidence to support the use of one intervention over the other. The aim of this study is to compare the effect of acupuncture and electroacupuncture...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0850-7
更新日期:2015-10-15 00:00:00
abstract:BACKGROUND:Active surveillance (AS) is the disease management option of choice for low-risk prostate cancer. Despite this, men with low-risk prostate cancer (LRPC) find management decisions distressing and confusing. We developed Navigate, an online decision aid to help men and their partners make management decisions ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04986-9
更新日期:2021-01-11 00:00:00
abstract:BACKGROUND:Overt chronic metabolic acidosis in patients with chronic kidney disease develops after a drop of glomerular filtration rate to less than approximately 25 mL/min/1.73 m2. The pathogenic mechanism seems to be a lack of tubular bicarbonate production, which in healthy individuals neutralizes the acid net produ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-196
更新日期:2013-07-04 00:00:00
abstract::Data sharing from clinical trials is one way of promoting fair and transparent conduct of clinical trials. It would maximise the use of data and permit the exploration of additional hypotheses. On the other hand, the quality of secondary analyses cannot always be ascertained, and it may be unfair to investigators who ...
journal_title:Trials
pub_type: 信件
doi:10.1186/s13063-017-1816-8
更新日期:2017-02-14 00:00:00
abstract:BACKGROUND:There is a high prevalence of pain and post-traumatic symptoms among refugees and feasible interventions to manage these are needed. However, knowledge about the effect of physiotherapy and psychological group interventions among refugees is scarce. Our aim is to determine whether two different interventions...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3919-x
更新日期:2019-12-27 00:00:00
abstract:BACKGROUND:Obesity represents a major public health problem and is the fifth leading risk factor for mortality. Morbid obesity is associated with chronic systemic inflammation which increases the risk of comorbidities. Bariatric surgery (BS) is considered an effective intervention for obese patients. However, BS is ass...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2844-8
更新日期:2018-10-31 00:00:00
abstract:BACKGROUND:Neointimal hyperplasia plays a pivotal role in the pathogenesis of in-stent restenosis in patients undergoing percutaneous coronary interventions. Drug-eluting balloons are a promising tool to prevent restenosis after coronary angioplasty. Moreover, an increased knowledge of the pathophysiology of restenosis...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-13-55
更新日期:2012-05-06 00:00:00
abstract:BACKGROUND:Acute kidney allograft rejection is a major cause for declining graft function and has a negative impact on the long-term graft survival. The majority (90%) of acute rejections are T-cell mediated and, therefore, the anti-rejection therapy targets T-cell-mediated mechanisms of the rejection process. However,...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-13-199
更新日期:2012-10-26 00:00:00
abstract:BACKGROUND:Delirium is a highly prevalent and morbid syndrome in intensive care units (ICUs). Changing the stressful environment within the ICU via music may be an effective and a scalable way to reduce the burden of delirium. METHODS/DESIGN:The Decreasing Delirium through Music (DDM) study is a three-arm, single-blin...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-2324-6
更新日期:2017-11-29 00:00:00
abstract:BACKGROUND:The purpose of clinical trials of acupuncture is to help clinicians and patients make decisions about treatment. Yet this is not straightforward: some trials report acupuncture to be superior to sham (placebo) acupuncture while others show evidence that acupuncture is superior to usual care but not sham, and...
journal_title:Trials
pub_type: 杂志文章,meta分析
doi:10.1186/1745-6215-11-90
更新日期:2010-09-28 00:00:00
abstract::Tuberculosis (TB) remains a major killer amongst the infectious diseases. Current treatment involves a four-drug regimen for at least 6 months. New drugs and regimens are required to shorten treatment duration, reduce toxicity and combat drug resistance, but the optimal methodology to define the critical path for nove...
journal_title:Trials
pub_type: 杂志文章,meta分析,评审
doi:10.1186/s13063-015-1050-1
更新日期:2015-11-14 00:00:00
abstract::An amendment to this paper has been published and can be accessed via the original article. ...
journal_title:Trials
pub_type: 杂志文章,已发布勘误
doi:10.1186/s13063-020-04504-x
更新日期:2020-06-16 00:00:00
abstract:BACKGROUND:The physical and mental health of college students tends to continuously decline around the world. Since they are in a significant transition period which presents opportunities and challenges in health promotion, it is important to improve their health in this period. As a traditional Chinese exercise form ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-422
更新日期:2013-12-05 00:00:00
abstract:BACKGROUND:It is expected that in 2020 more than 17,000 cases of colorectal cancer will be diagnosed in The Netherlands. To date, patients are included in a surgeon-led follow-up programme whose main focus is recurrence detection. However, patients often experience multiple physical and psychosocial problems. Currently...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-0798-7
更新日期:2015-06-26 00:00:00
abstract:BACKGROUND:Chronic musculoskeletal pain (MSP) affects more than 40% of adults aged 50 years and older and is the leading cause of disability in the USA. Older adults with chronic MSP are at risk for analgesic-related side effects, long-term opioid use, and functional decline. Recognizing the burden of chronic MSP, redu...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04552-3
更新日期:2020-07-06 00:00:00
abstract:BACKGROUND:Immunologic derangement may be the critical pathophysiologic mechanism in sepsis, and immunotherapy might be a potential new treatment. Si-ni-tang (SNT), an ancient Chinese herbal formula documented in Shanghan Lun, has been used for treating severe sepsis for thousands of years. Research shows that it may h...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3646-3
更新日期:2019-08-28 00:00:00
abstract:BACKGROUND:Fimasartan is the ninth angiotensin receptor blocker to be developed. However, it has not yet been evaluated for reno-protective effects in hypertensive diabetic chronic kidney disease (CKD). The target blood pressure (BP) for hypertensive diabetic CKD is also a controversial topic. This trial was designed t...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-2375-8
更新日期:2017-12-29 00:00:00
abstract:BACKGROUND:The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame. Despite an increase in research into the benefits of exercise in people with multiple sclerosis (PwMS), no trial has reported detailed data on effective recruitment strategies for large-sc...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0996-3
更新日期:2015-10-15 00:00:00
abstract:BACKGROUND:Recent clinical observations have reported the potential benefit of vagus nerve stimulation (VNS) as an adjunctive therapy for pediatric epilepsy. Preliminary evidence suggests that VNS treatment is effective for seizure reduction and mental development in young participants between 3 and 6 years of age who ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-3087-4
更新日期:2019-01-14 00:00:00
abstract:BACKGROUND:Equine-assisted therapy is more often practiced with children and adolescents than with the elderly, although individuals in the second half of life could also profit from it. This group, from the age of 50, is characterised by increasing emotional, social, health-related and cognitive changes; a critical li...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04784-3
更新日期:2020-10-15 00:00:00
abstract:BACKGROUND:Severe thrombocytopenia should be corrected by prophylactic platelet transfusion prior to central venous catheter (CVC) insertion, according to national and international guidelines. Even though correction is thought to prevent bleeding complications, evidence supporting the routine administration of prophyl...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2480-3
更新日期:2018-02-20 00:00:00
abstract:BACKGROUND:For the last decade continuous efforts have been made to translate regenerative cell therapy protocols in the cardiovascular field from 'bench to bedside'. Successful clinical introduction, supporting safety, and feasibility of this new therapeutic approach, led to the initiation of the German, Phase III, mu...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-13-99
更新日期:2012-07-02 00:00:00
abstract:BACKGROUND:Parkinson's Disease is a degenerative neurological condition that causes movement problems and other distressing symptoms. People with Parkinson's disease gradually lose their independence and strain is placed on family members. A multidisciplinary approach to rehabilitation for people with Parkinson's is re...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-250
更新日期:2011-11-23 00:00:00
abstract:BACKGROUND:Patient-ventilator asynchrony is a common problem in mechanically ventilated patients with acute respiratory failure. It is assumed that asynchronies worsen lung function and prolong the duration of mechanical ventilation (MV). Neurally Adjusted Ventilatory Assist (NAVA) is a novel approach to MV based on ne...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1625-5
更新日期:2016-10-13 00:00:00
abstract:BACKGROUND:Surgical microvascular decompression (MVD) is the curative treatment for hemifacial spasm (HFS). Monitoring MVD by recording the lateral spread response (LSR) intraoperatively can predict a successful clinical outcome. However, the rate of the LSR varies between trials, and the reason for this variation is u...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-13-160
更新日期:2012-09-08 00:00:00
abstract:BACKGROUND:Incisional hernia is a frequent complication in abdominal surgery. This article describes the development of a prospective randomized clinical trial designed to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia. METHODS/DE...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-13-14
更新日期:2012-02-07 00:00:00
abstract:BACKGROUND:Oxygen is a life-saving, essential medicine that is important for the treatment of many common childhood conditions. Improved oxygen systems can reduce childhood pneumonia mortality substantially. However, providing oxygen to children is challenging, especially in small hospitals with weak infrastructure and...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-2241-8
更新日期:2017-10-27 00:00:00
abstract:BACKGROUND:There has been a recent steep growth in platelet-rich plasma (PRP) use for musculoskeletal conditions, but findings from high quality clinical trial data are lacking in the literature. Here, we describe the statistical analysis plan (SAP) for the Platelet-rich plasma in Achilles Tendon Healing 2 (PATH-2) tri...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2840-z
更新日期:2018-08-29 00:00:00