Research Status and Design Ideas of Placebo Manipulation in Clinical Trial Design of Tuina

WANG Jingui; ZHANG Haining; FAN Shun; LI Yusheng; WANG Hongyi; BAO An; ZHANG Wei; LI Huanan

doi:10.13288/j.11-2166/r.2025.11.008

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Research Status and Design Ideas of Placebo Manipulation in Clinical Trial Design of Tuina

更新时间：2025-05-28

- Research Status and Design Ideas of Placebo Manipulation in Clinical Trial Design of Tuina
  增强出版
- Journal of Traditional Chinese Medicine Vol. 66, Issue 11, Pages: 1128-1132(2025)
- 作者机构：
  
  1.天津中医药大学第一附属医院/国家中医针灸临床医学研究中心，天津市南开区鞍山西道314号，300193
  2.国家中医药管理局推拿手法生物效应三级实验室
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2025.11.008
  CLC：
- Received：30 October 2024，
  
  Revised：2025-03-27，
  
  Published：02 June 2025
- 稿件说明：
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王金贵,张海宁,范顺等.推拿临床试验中安慰推拿手法的现状和设计思路[J].中医杂志,2025,66(11):1128-1132.

WANG Jingui,ZHANG Haining,FAN Shun,et al.Research Status and Design Ideas of Placebo Manipulation in Clinical Trial Design of Tuina[J].Journal of Traditional Chinese Medicine,2025,66(11):1128-1132.
王金贵,张海宁,范顺等.推拿临床试验中安慰推拿手法的现状和设计思路[J].中医杂志,2025,66(11):1128-1132. DOI： 10.13288/j.11-2166/r.2025.11.008.

WANG Jingui,ZHANG Haining,FAN Shun,et al.Research Status and Design Ideas of Placebo Manipulation in Clinical Trial Design of Tuina[J].Journal of Traditional Chinese Medicine,2025,66(11):1128-1132. DOI： 10.13288/j.11-2166/r.2025.11.008.

摘要

推拿临床试验中对照的合理设置是验证推拿疗法有效性的基础。梳理当前推拿临床试验中安慰推拿手法的研究现状，指出推拿临床试验中安慰推拿设置的必要性，分析安慰推拿手法设置的难点，认为安慰推拿尚存在安慰效应的影响、推拿手法多样化但缺乏标准化、公众对推拿认知度较高而实施盲法较困难等问题。总结脊柱整复手法、穴位按摩、小儿推拿三种类型推拿临床试验中安慰手法的研究设计，提出控制安慰效应、制定安慰推拿手法操作标准、确保盲法实施的严密性、应用新技术提高安慰推拿手法标准化和可盲性的四种安慰推拿手法设计思路，以期提升推拿临床试验设计的方法学质量，促进推拿临床试验设计的规范性和科学性。

Abstract

The rationale for the design of control groups in tuina clinical trial is the foundation for rigorously validating the effectiveness and safety of this therapy. This article reviewed the current state of the design of tuina placebo in control groups of clinical trials， pointed out the necessity of setting up tuina placebo in clinical trials of tuina， analyzed the challenges in implementing blinding of tuina manipulation， and concluded that tuina placebo is still challenged by the placebo effect， the diversification of tuina manipulation but the lack of standardization， and the difficulty of implementing blinding due to the high level of public awareness of tuina. This article also summarized the design of placebo manipulation in three types of clinical trials， including spinal manipulation， acupressure， and paediatric tuina， and proposed four strategies for designing placebo tuina manipulation-controlling placebo effects， developing operational standards for placebo tuina manipulation， ensuring the rigor of blinding implementation， and applying new technologies to enhance the standardization and blinding capacity of placebo tuina methods. So the article is aimed at improving the methodological quality of tuina clinical trial designs， and promoting the standardization and scientificity of tuina clinical trial design.

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references

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