Current Status and Reflections on Key Technologies and Methods for Clinical Research Design and Evaluation of Traditional Chinese Medicine in Spleen and Stomach Diseases
10.13288/j.11-2166/r.2026.05.007
- VernacularTitle:中医脾胃病临床研究设计及评价关键技术的研究现状与思考
- Author:
Fang LU
1
;
Ping WANG
2
;
Liqun BIAN
2
;
Lin LYU
2
;
Mengli XIAO
3
;
Tai ZHANG
2
;
Xudong TANG
2
Author Information
1. Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing,100091
2. Institute of Spleen and Stomach Diseases,Xiyuan Hospital,China Academy of Chinese Medical Sciences
3. The First Affiliated Hospital of Guangzhou University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
spleen and stomach disorders;
clinical research design;
efficacy evaluation techniques;
data management platform
- From:
Journal of Traditional Chinese Medicine
2026;67(5):498-503
- CountryChina
- Language:Chinese
-
Abstract:
Clinical trials represent a pivotal stage in the development of pharmaceutical drugs. Nevertheless, given the unique characteristics of traditional Chinese medicine (TCM) and the diagnostic and treatment principle of syndrome differentiation and treatment in TCM, the clinical evaluation techniques and methods that can comprehensively reflect the characteristics of TCM and are tailored to its specificities are still in need of refinement and innovation. This paper systematically summarizes the key techniques and methods for designing and evaluating the clinical research on the treatment of the spleen and stomach diseases with TCM from three aspects including clinical research design, evaluation, and platform construction, compares domestic and international research landscapes, and proposes for future directions. It is suggested that a multidimensional evaluation system integrating modern medicine and TCM theory should be established, and further innovation is needed in TCM research design and methodologies, leveraging intelligent devices and technologies powered by next-generation information technology to transform clinical data into high-quality TCM evidence. Moreover, standardized and shared platforms for TCM clinical data should be accelerated, so as to provide references for the design, implementation, and evaluation of future clinical research on the treatment of the spleen and stomach diseases with TCM.