Application of comprehensive evaluation methods in the clinical efficacy evaluation of traditional Chinese medicine: a narrative review

Background and Objective: Clinical effect is necessary for the inheritance and development of traditional Chinese medicine (TCM). The conventional single primary outcome evaluation method is difficult to reflect the advantages of multi-target and multi-dimensional treatment of TCM. The comprehensive evaluation method can combine multiple dimensional outcomes such as Western medicine-related outcomes, TCM-related syndromes, and patient report outcomes into a single-dimensional comprehensive outcome, which can reflect the advantages of the multi-dimensional efficacy of TCM, and has been gradually applied to the clinical efficacy of TCM in recent years. In this study, we aimed to introduce comprehensive evaluation methods and guide TCM researchers use these methods correctly, then provide methodological aid for the comprehensive and objective evaluation of true clinical effect of TCM. Methods: We searched the primary Chinese and English electronic databases systematically [PubMed, CENTRAL, China National Knowledge Infrastructure (CNKI), Wanfang, and VIP] and collected randomized controlled trials (RCTs), non-RCTs, or follow-up or secondary analysis of the original trials data until June 30, 2021. Key Content and Findings: In this study, we introduced seven comprehensive evaluation methods commonly used in the field of TCM, we compared the advantages and disadvantages of these methods and their specific implementation in clinical efficacy evaluation, and demonstrated the application of each evaluation method with examples. We also gave some suggestions for applying comprehensive evaluation methods. Conclusions: The development of comprehensive evaluation methods will provide new research ideas for the evaluation of clinical efficacy of TCM. This article introduces several commonly used comprehensive evaluation methods in the field of TCM, in order to guide the appropriate selection and use for TCM clinical researchers.