Abstract
The ethical review of TCM (traditional Chinese medicine) clinical research in China is highly consistent with that of Western medicine, but it lacks the characteristics and culture of TCM. Compared with modern medicine, TCM has its own characteristics, such as the theory of Yin-Yang and the five elements, the treatment of syndrome differentiation, and the compatibility of prescriptions. These characteristics determine the ethical particularity of TCM clinical research. This article discusses the challenges in the ethical review of TCM clinical research, such as scientific design, efficacy evaluation, risk assessment, informed consent, and placebo use. We propose opportunities and difficulties in the ethical review of TCM clinical research and provide some relevant suggestions.
Highlights
Evidence-Based Complementary and Alternative Medicine ethical principles are the foundation of Traditional Chinese medicine (TCM) ethical review, and special attention to the scientificity of the research design, efficacy evaluation, risk assessment, informed consent, and placebo use should be paid due to the characteristics of TCM
Scientific validity determines the value of the research for society. e challenges in scientific validity include the particularity of TCM theory, quality control of Chinese herbal medicine, and methods for efficacy evaluation
Based on the four diagnostic methods of TCM and syndrome differentiation, the patients were treated with Chinese medicine, acupuncture, massage, cupping, and Qigong. e “syndrome” in “syndrome differentiation” refers to the conditions of pulse, tongue, body and spirit, complexion, and other related symptoms presented by the patients, which reflect the cause, nature, and stage of the disease
Summary
Some ethics committee members believe that the duty of the ethical review is only to review ethically and not scientifically. E challenges in scientific validity include the particularity of TCM theory, quality control of Chinese herbal medicine, and methods for efficacy evaluation. In the fourth chapter of guiding principles for “Clinical Research of New Chinese Materia Medica (Trial)” issued by China in 2002, the methods for efficacy evaluation of the syndromes and symptoms in clinical trials of CHM were discussed [29]. Liu et al [31] drew lessons from the thought of evaluating athletes’ skills in sports competitions and proposed a new strategy from evaluating “doctor” to evaluating “prescription,” which combined clinical epidemiology and evidence-based medicine with syndrome differentiation. e evaluation process should adhere to the basic principles of control, adopt the appropriate design methods, such as RCT and cohort study, and select the suitable method according to the research purpose combining the “full sample, mixed big data” and “sampling, precise small data” in RWS. e evaluation results first recommend the appropriate “doctor”, rather than a certain “prescription” to treat a certain disease. e comprehensive curative effect of the “representative team” is used to reflect the clinical effectiveness of syndrome differentiation in treating certain diseases. e ideas and strategies of this study break through the conventional clinical evaluation method and open a new way for the clinical efficacy evaluation of TCM individualized diagnosis and treatment
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