Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.
Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA; Brain Research Institute, University of California, Los Angeles, Los Angeles, CA, USA; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA.
Alcohol. 2024 Nov;120:194-203. doi: 10.1016/j.alcohol.2024.06.007. Epub 2024 Jul 5.
Refining clinical trial methodology has become increasingly important as study design is shown to influence treatment efficacy. To maximize the efficiency of randomized clinical trials (RCTs), researchers aim to establish standardized practices. The goal of this systematic review is to describe methodological practices of clinical trials for alcohol use disorder (AUD) over the past 40 years. To achieve this goal, a PubMed search was conducted in April 2023 for RCTs on AUD medications published between July 2018 through April 2023. Resulting studies were combined with a previous search from 1985 through 2018. Inclusion criteria for the RCT studies were: (1) a randomized controlled trial, (2) double or single blinded, (3) placebo or active control condition, (4) alcohol use as the primary endpoint, (5) 4 or more weeks of treatment, and (6) 12 or more weeks of follow-up. In total, methodological data from 139 RCTs representing 19 medications and spanning the past four decades were summarized. Results indicated that the most common medications tested were naltrexone (k = 42), acamprosate (k = 24), and baclofen (k = 11). On average, participants were 74% male and consumed 226 drinks per month pre-randomization. The median length of treatment was 12 weeks (IQR = 12-16; min = 4 max = 52) and the median follow-up duration was 12.5 weeks (IQR: 12-26; min = 7 max = 104). There were two broad domains of outcomes (i.e., abstinence and heavy drinking), with most studies featuring outcomes from both domains (k = 87; 63%). Reporting practices were summarized by decade, revealing an increased enrollment of females, better reporting of race and ethnicity data, and less studies requiring pre-trial abstinence. This review summarizes the current state of the literature on randomized clinical trials for AUD including effect sizes for individual studies and summaries of key methodological features across this representative set of clinical trials.
随着研究设计被证明会影响治疗效果，精炼临床试验方法变得越来越重要。为了使随机临床试验 (RCT) 的效率最大化，研究人员旨在建立标准化的实践。本系统评价的目的是描述过去 40 年来酒精使用障碍 (AUD) 的临床试验方法学实践。为了实现这一目标，我们于 2023 年 4 月在 PubMed 上对 2018 年 7 月至 2023 年 4 月期间发表的 AUD 药物 RCT 进行了检索。将检索到的研究与 1985 年至 2018 年的先前检索结果相结合。RCT 研究的纳入标准为：(1) 随机对照试验，(2) 双盲或单盲，(3) 安慰剂或阳性对照，(4) 酒精使用为主要终点，(5) 4 周以上的治疗，和 (6) 12 周以上的随访。总共总结了过去 40 年 19 种药物的 139 项 RCT 的方法学数据。结果表明，测试的最常见药物是纳曲酮 (k=42)、安非他酮 (k=24) 和巴氯芬 (k=11)。参与者平均 74%为男性，随机分组前每月饮酒 226 杯。治疗的中位数长度为 12 周 (IQR=12-16；min=4 max=52)，随访中位数时间为 12.5 周 (IQR：12-26；min=7 max=104)。结果有两个广泛的领域 (即，戒酒和重度饮酒)，大多数研究都有这两个领域的结果 (k=87；63%)。按十年总结报告实践，发现女性的入组人数增加，种族和民族数据的报告更好，需要试验前戒酒的研究更少。本综述总结了目前关于 AUD 的随机临床试验文献，包括个体研究的效应大小以及这组代表性临床试验的关键方法学特征的总结。
