Grodin Erica N, Donato Suzanna, Du Han, Green ReJoyce, Bujarski Spencer, Ray Lara A
Department of Psychology, University of California, 502 Portola Plaza, Los Angeles, California 90095 USA.
Department of Psychiatry and Biobehavioral Sciences. University of California, 757 Westwood Plaza #4, Los Angeles, CA 90095 USA.
Alcohol Alcohol. 2022 Sep 10;57(5):589-594. doi: 10.1093/alcalc/agac004.
To test whether two critical design features, inclusion criteria of required pre-trial abstinence and pre-trial alcohol use disorder (AUD) diagnosis, predict the likelihood of detecting treatment effects in AUD pharmacotherapy trials.
This secondary data analysis used data collected from a literature review to identify randomized controlled pharmacotherapy trials for AUD. Treatment outcomes were selected into abstinence and no heavy drinking. Target effect sizes were calculated for each outcome and a meta-regression was conducted to test the effects of required pre-trial abstinence, required pre-trial AUD diagnosis, and their interaction on effect sizes. A sub-analysis was conducted on trials, which included FDA-approved medications for AUD.
In total, 118 studies testing 19 medications representing 21,032 treated participants were included in the meta-regression analysis. There was no significant effect of either predictor on abstinence or no heavy drinking outcomes in the full analysis or in the sub-study of FDA-approved medications.
By examining these design features in a quantitative, rather than qualitative, fashion the present study advances the literature and shows that requiring AUD diagnosis or requiring pre-trial abstinence do not impact the likelihood of a significant medication effect in the trial.
检验两个关键设计特征，即所需的试验前戒酒纳入标准和试验前酒精使用障碍（AUD）诊断，是否能预测在AUD药物治疗试验中检测到治疗效果的可能性。
这项二次数据分析使用了从文献综述中收集的数据，以确定AUD的随机对照药物治疗试验。治疗结果分为戒酒和无重度饮酒。计算每个结果的目标效应大小，并进行元回归以检验所需的试验前戒酒、所需的试验前AUD诊断及其相互作用对效应大小的影响。对包括FDA批准的AUD药物的试验进行了亚分析。
元回归分析总共纳入了118项测试19种药物的研究，涉及21,032名接受治疗的参与者。在全面分析或FDA批准药物的子研究中，两种预测因素对戒酒或无重度饮酒结果均无显著影响。
通过以定量而非定性的方式研究这些设计特征，本研究推进了文献研究，并表明要求进行AUD诊断或要求试验前戒酒不会影响试验中药物显著疗效的可能性。
