The Solomon Four-Group Design：Key Considerations in Design and Statistical Analysis and Their Significance in Clinical Trials of Traditional Chinese Medicine
10.13288/j.11-2166/r.2025.16.005
- VernacularTitle: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
- Author:
Wenqian ZHANG
1
;
Yufei LI
1
;
Tong LIN
2
;
Xintong WEI
3
;
Yingjie WANG
3
;
Jianping LIU
1
;
Ying ZHANG
1
Author Information
1. Centre for Evidence-Based Chinese Medicine， Beijing University of Chinese Medicine，Beijing，100029
2. Guang'anmen Hospital，China Academy of Chinese Medical Sciences
3. Changchun University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
Solomon four-group design;
traditional Chinese medicine clinical research;
experimental design;
statistical analysis
- From:
Journal of Traditional Chinese Medicine
2025;66(16):1649-1655
- CountryChina
- Language:Chinese
-
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.
