The Solomon Four-Group Design：Key Considerations in Design and Statistical Analysis and Their Significance in Clinical Trials of Traditional Chinese Medicine

ZHANG Wenqian; LI Yufei; LIN Tong; WEI Xintong; WANG Yingjie; LIU Jianping; ZHANG Ying

doi:10.13288/j.11-2166/r.2025.16.005

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The Solomon Four-Group Design：Key Considerations in Design and Statistical Analysis and Their Significance in Clinical Trials of Traditional Chinese Medicine

更新时间：2025-08-13

- The Solomon Four-Group Design：Key Considerations in Design and Statistical Analysis and Their Significance in Clinical Trials of Traditional Chinese Medicine
- Journal of Traditional Chinese Medicine Vol. 66, Issue 16, Pages: 1649-1655(2025)
- 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.中国中医科学院广安门医院
  3.长春中医药大学
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2025.16.005
  CLC：
- Received：16 February 2025，
  
  Revised：2025-04-17，
  
  Published：17 August 2025
- 稿件说明：
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张文倩,李宇飞,林潼等.所罗门四组设计和统计分析要点及其在中医药临床研究中的应用价值[J].中医杂志,2025,66(16):1649-1655.

ZHANG Wenqian,LI Yufei,LIN Tong,et al.The Solomon Four-Group Design：Key Considerations in Design and Statistical Analysis and Their Significance in Clinical Trials of Traditional Chinese Medicine[J].Journal of Traditional Chinese Medicine,2025,66(16):1649-1655.
张文倩,李宇飞,林潼等.所罗门四组设计和统计分析要点及其在中医药临床研究中的应用价值[J].中医杂志,2025,66(16):1649-1655. DOI： 10.13288/j.11-2166/r.2025.16.005.

ZHANG Wenqian,LI Yufei,LIN Tong,et al.The Solomon Four-Group Design：Key Considerations in Design and Statistical Analysis and Their Significance in Clinical Trials of Traditional Chinese Medicine[J].Journal of Traditional Chinese Medicine,2025,66(16):1649-1655. DOI： 10.13288/j.11-2166/r.2025.16.005.

摘要

所罗门四组设计作为提升临床研究内部效度的重要方法，可减少偏倚，控制霍桑效应及前测敏感化对研究结果的干扰，在复杂临床干预效果评估中具有独特优势。系统梳理所罗门四组设计的核心架构与统计分析要点，总结该设计在国内外临床研究领域中的应用，发掘其优点和局限性，并探讨其在中医药临床研究中的应用价值。认为所罗门四组设计在中医药临床研究中可帮助区分测试效应与干预效应，减少主观指标评价偏倚；同时针对所罗门四组设计的复杂性及中医药临床研究的特殊性，提出未来应聚焦于以心理量表、知识、态度、行为测量等作为评价终点的中医药临床研究，倡导加强跨学科协作，为中医药临床研究提供方法学新路径。

Abstract

The Solomon four-group design， a critical method for improving internal validity in clinical research， can reduce bias and control the interference of Hawthorne effects and pretest sensitization on research results， which offers unique advantages in evaluating complex intervention outcomes. This paper systematically outlined the core framework and key points of statistical analysis of the Solomon four-group design， summarized its applications in clinical research at home and abroad， explored its advantages and limitations， and discussed the potential value in traditional Chinese medicine （TCM） clinical trials. It is believed that the Solomon four-group design can help distinguish between testing effects and intervention effects in TCM clinical studies， and reduce the bias in the evaluation of subjective indicators. Meanwhile， given the complexity of the Solomon four-group design and the particularity of TCM clinical research， it is proposed that future TCM clinical studies should focus on using psychological scales， know-ledge， attitude， and behavior measurements， and other similat evaluations as endpoints. It also advocates strengthening interdisciplinary collaboration to provide new methodological paths for TCM clinical research.

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references

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