Advantages，Challenges，and Implementation Pathways of Natural Experiments in Evaluating the Efficacy of Traditional Chinese Medicine

LIU Rihe; LIU Tingxiu; LIU Kai; SUN Yuan; ZHANG Xiaohan; LIU Jianping; LIU Zhaolan

doi:10.13288/j.11-2166/r.2026.14.005

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Advantages，Challenges，and Implementation Pathways of Natural Experiments in Evaluating the Efficacy of Traditional Chinese Medicine

更新时间：2026-07-17

- Advantages，Challenges，and Implementation Pathways of Natural Experiments in Evaluating the Efficacy of Traditional Chinese Medicine
  增强出版
- Journal of Traditional Chinese Medicine Vol. 67, Issue 14, Pages: 1491-1496(2026)
- 作者机构：
  
  1.北京中医药大学循证医学中心，北京市朝阳区北三环东路11号，100029
  2.成都中医药大学附属医院循证医学中心
  3.四川省中医药循证医学中心
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2026.14.005
  CLC：
- Received：25 November 2025，
  
  Revised：2026-06-06，
  
  Accepted：29 April 2026，
  
  Online First：15 July 2026，
  
  Published：17 July 2026
- 稿件说明：
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刘日荷,刘庭秀,刘凯等.自然实验在中医药疗效评价中的优势、挑战及实施路径[J].中医杂志,2026,67(14):1491-1496.

LIU Rihe,LIU Tingxiu,LIU Kai,et al.Advantages，Challenges，and Implementation Pathways of Natural Experiments in Evaluating the Efficacy of Traditional Chinese Medicine[J].Journal of Traditional Chinese Medicine,2026,67(14):1491-1496.
刘日荷,刘庭秀,刘凯等.自然实验在中医药疗效评价中的优势、挑战及实施路径[J].中医杂志,2026,67(14):1491-1496. DOI： 10.13288/j.11-2166/r.2026.14.005.

LIU Rihe,LIU Tingxiu,LIU Kai,et al.Advantages，Challenges，and Implementation Pathways of Natural Experiments in Evaluating the Efficacy of Traditional Chinese Medicine[J].Journal of Traditional Chinese Medicine,2026,67(14):1491-1496. DOI： 10.13288/j.11-2166/r.2026.14.005.

摘要

自然实验是一种基于真实世界研究的因果推断研究设计，其核心思路在于利用由外部因素所引发的、近似随机化的暴露变异，评估干预措施或暴露因素对结局的影响，尤其适用于无法实施随机对照试验（RCT）或存在伦理限制的研究情景，并兼具因果推断能力与较好的外部真实性。总结自然实验的定义、基本特征与研究现状；提出自然实验在中医药疗效评价中的适用场景，如政策实施或变更评价、医院内部医疗实践差异评价、地区或机构间资源禀赋差异评价；认为设计路径包括从中医药临床或政策问题出发、系统收集研究数据、对数据进行统计建模与效应分析、结合临床实际对效应值进行解读等；并进一步讨论自然实验策略应用于中医药疗效评价的优势与挑战。

Abstract

A natural experiment is a causal inference study design grounded in real-world research. Its core concept is to use quasi-random variation in exposure generated by external factors to evaluate the effects of interventions or exposures on outcomes. It is particularly suitable for research settings in which randomized controlled trials （RCTs） are infeasible or ethically constrained， and it combines causal inference capacity with relatively strong external validity. This article provides an overview of the definition， key features， and current application status of natural experiments， and proposes the application scenarios for applying natural experiment strategies to the evaluation of therapeutic effects in traditional Chinese medicine （TCM）， including policy implementation or policy change evaluation， assessment of variations in clinical practice within hospitals， and evaluation of differences in resource allocation across regions or institutions. The design pathway includes starting from clinical or policy-related TCM questions， systematically collecting relevant data， performing statistical modeling and effect estimation， and interpreting effect estimates in the context of clinical practice. It further analyzes the advantages and challenges of using natural experiments in TCM.

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