安慰剂反应率对临床试验结果的影响：对患有重度抑郁症的儿童和青少年使用抗抑郁药的系统评价和荟萃分析。
The Impact of Placebo Response Rates on Clinical Trial Outcome: A Systematic Review and Meta-Analysis of Antidepressants in Children and Adolescents with Major Depressive Disorder.
作者信息
Li Yanfei, Huang Jihan, He Yingchun, Yang Juan, Lv Yinghua, Liu Hongxia, Liang Liyu, Li Huafang, Zheng Qingshan, Li Lujin
机构信息
Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Shanghai Mental Health Center, Shanghai, China.
出版信息
J Child Adolesc Psychopharmacol. 2019 Nov;29(9):712-720. doi: 10.1089/cap.2019.0022. Epub 2019 Aug 1.
The high placebo response rate may hamper the discovery of antidepressants in children and adolescents with major depressive disorder (MDD). The aim of the study was to clarify the relationship between the placebo response rate and clinical trial outcomes of the use of antidepressants in children and adolescents, and distinguish main factors responsible to placebo response rate. The PubMed and Cochrane Library databases were searched for double-blind randomized placebo-controlled trials of the new-generation antidepressants for the acute treatment of MDD in children and adolescents. The response rate differences (RDs) between placebo group and treatment group under different level of placebo response rate were pooled by random-effects meta-analysis. The classification thresholds for low, medium, and high placebo response rate were set at <40%, 40%-50%, and ≥50%, respectively. Predictors of placebo response rate were explored using meta-regression. The analysis included 18 trials with 4365 participants. This study found that the lower the placebo response rate, the greater the efficacy differences between antidepressants and placebo. In the high, moderate, and low placebo response rate subgroups, the response RDs (95% CI) between antidepressants and placebo were 8 (1-14)%, 10 (2-17)%, and 21 (9-32)%, respectively. The meta-regression showed that the number of study sites was the factor most associated with placebo response rate, and that response rate increased 3% with every additional 10 study sites. The clinical outcome was related to the placebo response rates in the clinical trials of antidepressants in children and adolescents with MDD. The efficacy differences between antidepressants and placebo will be maximized when placebo response rates are reduced. The number of study sites was the factor most associated with the placebo response rates.
高安慰剂反应率可能会阻碍重度抑郁症（MDD）儿童和青少年抗抑郁药物的研发。本研究的目的是阐明安慰剂反应率与儿童和青少年使用抗抑郁药物临床试验结果之间的关系，并区分导致安慰剂反应率的主要因素。在PubMed和Cochrane图书馆数据库中检索了关于新一代抗抑郁药物用于儿童和青少年MDD急性治疗的双盲随机安慰剂对照试验。通过随机效应荟萃分析汇总了不同安慰剂反应率水平下安慰剂组和治疗组之间的反应率差异（RDs）。低、中、高安慰剂反应率的分类阈值分别设定为<40%、40%-50%和≥50%。使用荟萃回归探索安慰剂反应率的预测因素。该分析纳入了18项试验，共4365名参与者。本研究发现，安慰剂反应率越低，抗抑郁药物与安慰剂之间的疗效差异越大。在高、中、低安慰剂反应率亚组中，抗抑郁药物与安慰剂之间的反应RDs（95%CI）分别为8（1-14）%、10（2-17）%和21（9-32）%。荟萃回归显示，研究地点的数量是与安慰剂反应率最相关的因素，每增加10个研究地点，反应率就会增加3%。在患有MDD的儿童和青少年抗抑郁药物临床试验中，临床结果与安慰剂反应率相关。当安慰剂反应率降低时，抗抑郁药物与安慰剂之间的疗效差异将最大化。研究地点的数量是与安慰剂反应率最相关的因素。
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