Geha Mental Health Center, Petah Tikva, Israel.
Tel-Aviv University, Israel.
J Atten Disord. 2020 Feb;24(3):425-433. doi: 10.1177/1087054718780328. Epub 2018 Jun 21.
Several ADHD pharmacological trials reported high placebo response (PR) rates. This study aims to characterize the PR in adult ADHD. : A retrospective cohort analysis of the placebo arm (140 adults with ADHD, 18-55 yrs, M:F 46.4%-53.6%) of a 6-week randomized, multicenter, double-blind metadoxine study, using Conners' Adult ADHD Rating Scale (CAARS) and the Adult ADHD Self-Report Scale (ASRS), was conducted. : Pre-post changes in placebo-treated adults were significant for both the CAARS and ASRS, (2.9, 404.5) = 61.2, < .00001, (2.8, 383.0) = 43.1, < .00001, respectively. Less than half of the participants had a PR which began early in treatment and persisted; almost 50% had a variable, inconsistent PR. : In the current sample, PR in adult ADHD was prominent on both symptom scales and the investigator-rater instrument. Therefore, using investigator ratings as a primary endpoint does not necessarily attenuate PR. Of note, about half of the PR is variable, suggesting unreliable determination of efficacy.
几项 ADHD 药物治疗试验报告称，安慰剂的反应率很高。本研究旨在描述成人 ADHD 的安慰剂反应。：这是一项回顾性队列分析，纳入了一项为期 6 周的随机、多中心、双盲美金刚研究的安慰剂组（140 名成人 ADHD 患者，18-55 岁，男女比例为 46.4%-53.6%），使用 Conners' 成人 ADHD 评定量表（CAARS）和成人 ADHD 自评量表（ASRS）。：安慰剂治疗的成年人在 CAARS 和 ASRS 上的前后变化均有显著差异，（2.9，404.5）=61.2， <.00001，（2.8，383.0）=43.1， <.00001，分别。不到一半的参与者有早期开始并持续的安慰剂反应；近 50%的参与者有变化不定、不一致的安慰剂反应。：在当前样本中，成人 ADHD 的两种症状量表和研究者评定量表都显示出明显的安慰剂反应。因此，使用研究者评分作为主要终点并不能减轻安慰剂反应。值得注意的是，大约一半的安慰剂反应是可变的，这表明疗效的确定不可靠。
