Examination of Clinical Trials in Traditional Chinese Medicine: Enhancement of the Ethical Processes

Zhang Yanqiang; Tan Suyono*, Ulina Karo-karo

Abstract: There is a current rise in published clinical trials relating to traditional Chinese medicine (CTM). However, the opposite execution of clinical trial registration (CTR), ethical review (ER), and informed consent (IC) relating to TCM trials are not elucidated. The current study aimed to examine CTR, ER, and IC in TCM clinical trials. TCM clinical trials selected from ten high-standard Chinese journals published in 2016 formed the study sample. Data relating to CTR, ER, and IC associated with the respective publications were obtained for further interpretation; these were acquired through two researchers’ independent reviews of the chosen papers. Six hundred fifty-nine clinical trials fulfilled the study’s inclusion criteria and were subject to analysis. Data of CTR, ER, and IC were evident in 9 (1.4%), 156 (23.7%), and 502 (72.6%) articles, respectively, and were poorly implemented. In particular, CTR and ER of TCM clinical trials should be assiduously considered by scientists, physicians, and journal editors. Education on related methodology should be made more robust.

FULL TEXT PDF 1-5 ] DOI: 10.30566/ijo-bs/2021.special.05

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