Strategies for overcoming enrollment challenges of patients in control group in randomized controlled trials of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20250108.501
- Author:
Tian-Tian ZHOU
1
;
Jia-Xin ZUO
1
;
Hong WANG
1
;
Xing LIAO
2
;
Jing HU
1
Author Information
1. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University/Beijing Institute of Traditional Chinese Medicine/Beijing Evidence-based Chinese Medicine Center Beijing 100010, China.
2. Center for Evidence-based Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
- Publication Type:Journal Article
- Keywords:
control group;
enrollment challenge;
randomized controlled trial;
traditional Chinese medicine
- MeSH:
Humans;
Medicine, Chinese Traditional/methods*;
Randomized Controlled Trials as Topic/methods*;
Research Design;
Patient Selection;
Drugs, Chinese Herbal/therapeutic use*;
Control Groups
- From:
China Journal of Chinese Materia Medica
2025;50(7):1980-1986
- CountryChina
- Language:Chinese
-
Abstract:
Randomized controlled trial(RCT) is considered to represent the gold standard for evaluating the efficacy of interventions and has been widely used to evaluate the clinical efficacy of traditional Chinese medicine(TCM). However, there are unique challenges in implementing RCT in TCM. Patients seeking TCM treatment often have preferences for TCM due to the unsatisfactory therapeutic effect of western medicine, their personal intolerance, and their rejection of certain drugs, medical devices, or surgery. Patients are generally reluctant to be randomly assigned to a group, making it challenging to enroll patients in the control group of western medicine during the implementation of RCT in TCM. This has become a prominent problem restricting the implementation of RCT in TCM and needs to be solved urgently. Therefore, this paper introduced commonly used research designs used in solving the problem of enrolling patients in control group during the implementation of RCT in TCM, including Zelen design, partially randomized patient preference trial(PRPP), single-arm objective performance criteria(OPC), cohort studies, single-arm clinical trials using real world data(RWD) alone as the external control group, and the design method based on RWD-augmented control group samples in RCT. The paper outlined the definitions and principles of these methods, evaluated their advantages, disadvantages, and applicable scenarios, and explored their applications in the TCM field, so as to offer insights for solving the difficulty in enrolling patients in the control group during the implementation of RCT in TCM.
