WCG Analgesic Solutions, Wayland, MA, United States of America.
University of Maryland, School of Nursing & School of Medicine, Baltimore, MD, United States of America.
Contemp Clin Trials. 2021 Aug;107:106503. doi: 10.1016/j.cct.2021.106503. Epub 2021 Jul 6.
The desire to reduce high placebo response rates in clinical trials is a popular concept. However, few studies have rigorously examined the effectiveness of methods to control for placebo responses that are relevant to randomized controlled trials. The primary objective of this review was to evaluate the effect of experimental placebo manipulations in randomized controlled trials (RCTs). We critically reviewed studies designed to manipulate placebo responses including positive expectations regarding the effectiveness of the placebo treatment, manipulating the time spent with subjects, and training study staff and subjects to accurately report symptom severity. These efforts have generally resulted in reduced placebo response and improved discrimination between drug and placebo. Interventions that neutralize staff and subject expectations and improve the ability of subjects to accurately report symptom severity have shown the most promise. Reduction of the placebo response has the potential to accelerate the development of new therapeutics.
减少临床试验中高安慰剂反应率的愿望是一个流行的概念。然而，很少有研究严格检查控制与随机对照试验相关的安慰剂反应的方法的有效性。本综述的主要目的是评估随机对照试验（RCT）中实验性安慰剂操作的效果。我们批判性地回顾了旨在操纵安慰剂反应的研究，包括对安慰剂治疗效果的积极期望、操纵与受试者在一起的时间，以及培训研究人员和受试者准确报告症状严重程度。这些努力通常导致安慰剂反应减少，药物和安慰剂之间的区分度提高。中和工作人员和受试者期望并提高受试者准确报告症状严重程度的能力的干预措施显示出最大的希望。降低安慰剂反应有可能加速新疗法的开发。
