Methodological Issues in the Design，Evaluation，and Reporting of Randomized Controlled Trials with "Pattern Dominating Disease"
10.13288/j.11-2166/r.2026.14.006
- VernacularTitle:“以证统病”随机对照试验研究设计、评价与报告方法学问题探讨
- Author:
Lu WANG
1
;
Jiajia WANG
1
;
Yingying ZHANG
2
;
Xufei LUO
3
;
Yaolong CHEN
4
;
Jiansheng LI
1
Author Information
1. Lung Disease Diagnosis and Treatment，The First Affiliated Hospital of Henan University of Chinese Medicine，Zhengzhou， 450003
2. Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province Education Ministry of P.R.China/Henan Key Laboratory of Chinese Medicine for Respiratory Diseases，Henan University of Chinese Medicine
3. School of Chinese Medicine，Hong Kong Baptist University
4. Research Unit of Evidence-Based Evaluation and Guidelines，Chinese Academy of Medical Sciences，School of Basic Medical Sciences，Lanzhou University
- Publication Type:Journal Article
- Keywords:
syndrome dominating disease;
randomized controlled trial;
research design;
methodology
- From:
Journal of Traditional Chinese Medicine
2026;67(14):1497-1502
- CountryChina
- Language:Chinese
-
Abstract:
This study explores methodological issues in the design， evaluation， and reporting of randomized controlled trials （RCTs） under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design， the screening of research participants， the standardization of syndrome differentiation， the balance between intervention individualization and standardization， the integration of multi-dimensional outcome measures， and the limitations of existing evaluation and reporting tools when applied to this type of research， along with corresponding recommendations and future perspectives. Regarding research design， it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs， in order to innovate the design format of RCTs. Meanwhile， criteria for participant screening， TCM syndrome differentiation， and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization， and a multidimensional assessment system encompassing TCM syndromes， disease-specific outcomes， and patient-reported outcomes should be established. For risk of bias assessment and research reporting， it is recommended，to develop specialized assessment and reporting tools based on existing instruments， in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design， risk-of-bias assessment， and reporting quality assessment of RCTs based on the "syndrome dominating disease" model， with a particular focus on methodological optimization， data integration， and enhancement of research quality.
