Systematic Review and Meta-Analysis: Placebo Response in Randomized Controlled Trials of Tourette Disorder Medications.

IF 9.2 1区医学 Q1 PEDIATRICS Journal of the American Academy of Child and Adolescent Psychiatry Pub Date : 2024-11-02 DOI:10.1016/j.jaac.2024.10.011

Pedro Macul Ferreira de Barros, Luis C Farhat, Emily Behling, Madeeha Nasir, Angeli Landeros-Weisenberger, Michael H Bloch

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Abstract

Objective: To examine the magnitude of placebo response in randomized controlled trials (RCTs) of medications for Tourette disorder (TD).

Method: We searched CENTRAL, Embase, PubMed, PsycInfo, Web of Science, WHO ICTRP and ClinicalTrials.gov to identify placebo-controlled RCTs assessing pharmacological interventions for TD. Standardized mean change (SMC) and standardized mean difference were calculated for within-group (placebo, drug) and between-group (drug-placebo) change in tics. Data were pooled in random-effects meta-analysis. Meta-regressions were performed to identify study-level characteristics that could be differentially associated with placebo, drug, and drug-placebo response.

Results: We identified 13,775 records and included 50 RCTs involving 1,566 participants in the placebo meta-analysis. Placebo response was medium-to-large (SMC -0.62; 95% confidence interval [CI] -0.75 to -0.5; I² 76%; τ² 0.14). There were several factors associated with larger placebo responses (e.g., non-US RCT; industry sponsorship; number of centers and participants). However, there was a moderate-to-high correlation between placebo and drug response (ρ 0.66, 95% CI 0.47, 0.79), and factors associated with larger placebo response were also generally associated with larger drug responses. Also, there was not a significant correlation between placebo response and drug-placebo differences (ρ -0.05, 95% CI -0.32, 0.22), and factors associated with larger placebo response generally did not interfere in drug-placebo differences.

Conclusion: The magnitude of placebo response in TD may be large, but similar to that in other child psychiatry conditions. Clinical-researchers may manipulate study-level factors to diminish placebo response (for example, carefully selecting study sites and keeping them at the minimum feasibility). However, drug-placebo differences may not increase since drug response will likely diminish as well.

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系统回顾和元分析：妥瑞症药物随机对照试验中的安慰剂反应。

目的：研究治疗妥瑞症的随机对照试验（RCT）中安慰剂反应的程度：研究治疗妥瑞症（TD）药物的随机对照试验（RCT）中安慰剂反应的程度：我们检索了 CENTRAL、Embase、PubMed、PsycInfo、Web of Science、WHO ICTRP 和 ClinicalTrials.gov，以确定评估 TD 药物干预的安慰剂对照 RCT。计算了组内（安慰剂、药物）和组间（药物-安慰剂）抽搐变化的标准化平均变化（SMC）和标准化平均差。在随机效应荟萃分析中对数据进行了汇总。我们还进行了元回归分析，以确定与安慰剂、药物和药物-安慰剂反应相关的研究水平特征：我们确定了 13,775 条记录，并在安慰剂荟萃分析中纳入了 50 项 RCT，涉及 1,566 名参与者。安慰剂反应为中至大反应（SMC -0.62；95% 置信区间 [CI] -0.75 至 -0.5；I2 76%；τ2 0.14）。有几个因素与较大的安慰剂反应有关（例如，非美国 RCT；行业赞助；中心和参与者数量）。然而，安慰剂和药物反应之间存在中高相关性（ρ 0.66，95% CI 0.47，0.79），与较大安慰剂反应相关的因素通常也与较大药物反应相关。此外，安慰剂反应与药物-安慰剂差异之间没有明显的相关性（ρ -0.05，95% CI -0.32，0.22），与较大安慰剂反应相关的因素一般不会干扰药物-安慰剂差异：结论：TD的安慰剂反应幅度可能较大，但与其他儿童精神病学疾病的安慰剂反应类似。临床研究人员可能会操纵研究层面的因素来减少安慰剂反应（例如，精心选择研究地点并将其保持在最低可行性水平）。然而，药物与安慰剂之间的差异可能不会增加，因为药物反应可能也会减少。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of the American Academy of Child and Adolescent Psychiatry 医学-精神病学

CiteScore

21.00

自引率

1.50%

发文量

1383

审稿时长

53 days

期刊介绍： The Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP) is dedicated to advancing the field of child and adolescent psychiatry through the publication of original research and papers of theoretical, scientific, and clinical significance. Our primary focus is on the mental health of children, adolescents, and families. We welcome unpublished manuscripts that explore various perspectives, ranging from genetic, epidemiological, neurobiological, and psychopathological research, to cognitive, behavioral, psychodynamic, and other psychotherapeutic investigations. We also encourage submissions that delve into parent-child, interpersonal, and family research, as well as clinical and empirical studies conducted in inpatient, outpatient, consultation-liaison, and school-based settings. In addition to publishing research, we aim to promote the well-being of children and families by featuring scholarly papers on topics such as health policy, legislation, advocacy, culture, society, and service provision in relation to mental health. At JAACAP, we strive to foster collaboration and dialogue among researchers, clinicians, and policy-makers in order to enhance our understanding and approach to child and adolescent mental health.

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