Problems and strategies of clinical efficacy evaluation of Traditional Chinese Medicine in the new era

ABSTRACT

Traditional Chinese medicine (TCM) has been widely used to prevent and treat Coronavirus Disease 2019 (COVID-19). In the absence of any miracle drug or vaccine, TCM was applied to all stages of the COVID-19 prevention and treatment for the first time and played a significant role. In addition to the first-line clinical treatment for the COVID-19, TCM scholars have also carried out various types of clinical research to evaluate the efficacy and safety of TCM. However, the lack of high-quality research evidence has led to TCM not being included in the list of treatment options recommended by the World Health Organization (WHO), which makes it difficult to provide references for TCM treatment protocols for the prevention and treatment of the COVID-19 for other countries, which significantly limits its promotion and internationalization. Evidence-based medicine has been operative in the TCM research field for more than 20 years. How best to combine the methods of evidence-based medicine with the characteristics and advantages of TCM so that the effect of TCM can be "clarified and understood" has always been a big challenge. The emergence of COVID-19 has highlighted the importance of this issue. Based on the concept of evidence-based medicine, this paper has elicited the shortcomings of TCM clinical research and efficacy evaluation during the COVID-19, such as design flaws, replicated research, insufficient professional involvement and lack of information sharing. It discusses the strategies of TCM clinical research on new emergent diseases in the new era from the aspects of research design and implementation. It is worth emphasizing that in future research, we should pay attention to the individualized efficacy evaluation of TCM, introduce the design concept of the master protocol platform, strengthen the overall planning of clinical research resources, retain the involvement of professionals, and establish a data-sharing mechanism. It is necessary to promote the integration of evidence-based norms and TCM differentiation and treatment, provide new ideas for clinical efficacy evaluation of TCM, enhance the ability of TCM clinical evidence to support decision-making, promote the development of the TCM industry and present TCM to the world. At the same time, we suggest that in response to the challenge of emerging infectious diseases, we should strengthen the clinical research into integrated Traditional Chinese and Western medicine, quickly collect high-quality research evidence, formulate evidence-based emergency intervention protocols, and build a more scientifically coordinated Traditional Chinese and Western medicine treatment system. In the meantime, we need to pay attention to multi-disciplinary and multi-knowledge integration, combined with modern science and technology such as big data and artificial intelligence, build a new paradigm of clinical research into traditional Chinese medicine, and improve the level and efficiency of TCM clinical research. © 2022, Science Press. All right reserved.