安慰剂效应及临床试验中针刺安慰效应的设计思路  

Placebo Effect and the Design of Placebo Acupuncture in Clinical Trials

作　　者：张艳宏 艾艳珂[2] 杨金洪[1] 岗卫娟[1] 景向红[1] 刘保延[3] ZHANG Yanhong;AI Yanke;YANG Jinhong;GANG Weijuan;JING Xianghong;LIU Baoyan(Institute of Acupuncture and Moxibustion,China Academy of Chinese Medical Sciences,Beijing,100700;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;Traditional Chinese Medicine Data Center,China Academy of Chinese Medical Sciences)

机构地区：[1]中国中医科学院针灸研究所,北京市100700 [2]中国中医科学院中医临床基础医学研究所 [3]中国中医科学院中医药数据中心

出　　处：《中医杂志》2024年第9期904-908,共5页Journal of Traditional Chinese Medicine

基　　金：中国中医科学院针灸研究所基本科研业务费自主选题(ZZ202017017);国家中医药管理局全国名老中医药专家传承工作室建设项目。

摘　　要：临床研究通常以疗效为目的和导向,如何从治疗效果中厘清净效应和安慰效应是临床研究的重要问题。梳理安慰剂效应的涵义,认为临床中可能产生安慰剂效应的因素包括既往经验关联、患者期望、暗示、医患关系,并总结反安慰剂效应的特点、产生因素及对临床预后的影响。结合中医学特点,探讨设计能够体现安慰效应测量的针刺临床试验,试图对中医针刺疗效评价中的安慰剂效应做出更清晰的阐释。以原发性失眠症为例,设计前瞻性随机安慰剂对照试验,以观察和评价不同患者在同一医生诊治下针刺的治疗效果和安慰剂效应之间的关系,其组间比较有助于更好地区分不同情形下的临床效应。并尝试探讨安慰剂效应的反应人群,以及安慰剂在不同人群中的效应。Clinical research is usually aimed at and guided by therapeutic efficacy.Clarifying the placebo effect and the nocebo effect from treatment outcomes is an important issue in clinical research.This paper reviews the meaning of the placebo effect,suggesting that factors that may produce the placebo effect in clinical practice include past experience associations,patient expectations,suggestion,and doctor-patient relationships.It also summarizes the characteristics of the nocebo effect,its influencing factors,and its impact on clinical prognosis.Combining the characteristics of traditional Chinese medicine,this paper explores the design of acupuncture clinical trials that can reflect the measurement of the placebo effect,attempting to provide a clearer interpretation of the placebo effect in the evaluation of acupuncture efficacy in traditional Chinese medicine.Taking primary insomnia as an example,a prospective randomized placebo-controlled trial is designed to observe and evaluate the relationship between the treatment effects of acupuncture and the placebo effect in different patients under the treatment of the same doctor.Group comparisons will help better distinguish clinical effects in different situations.The authors also attempt to explore the responsive population to the placebo effect and the effects of placebos in different populations.

关 键 词：安慰剂 安慰效应 针刺 疗效评价 

分 类 号：R285[医药卫生—中药学]