[Integrated evidence chain: a new strategy and methodology for effectiveness e valuation of traditional Chinese medicines].

The evaluation of the effectiveness of traditional Chinese medicine(TCM) has long been a "bottleneck" issue that restricts the healthy development and internationalization of TCM. This article systematically analyzes the differences in diagnostic and treatment principles, material composition, new drug development pathways, efficacy cognition, and evaluation methodology between Chinese and Western medicine from the underlying logic of medical perspective. On this basis, it integrates the evidence elements of clinical experience, experimental research, and clinical trials, and for the first time proposes and establishes a new strategy and methodology for the evaluation of the effectiveness of TCM: the integrated evidence chain-based effectiveness evaluation of traditional Chinese medicine(iEC-Eff), forming an integrated evaluation and confirmation model of "clinical experience-experimental research-clinical trial" for the effectiveness of TCM. Preliminary application research shows that this method can scientifically enhance the evaluation level of the effectiveness of TCM, especially for classic prescriptions that have been passed down for thousands of years, have a good reputation, and are commonly used in clinical practice today, making the level of efficacy evidence more objectively reflect their clinical value and status. It breaks through the limitation of the current TCM efficacy evaluation that takes RCT as the only "gold standard", providing a new strategy and method with originality, strategy, and leadership for solving the problem of TCM efficacy evaluation. It provides a new tool with operability for establishing a TCM registration review evidence system that combines TCM theory, human experience, and clinical trials. The iEC-Eff can be used for the efficacy evaluation of classic prescriptions in TCM, the development of new TCM drugs, and the re-evaluation of the effectiveness of TCM after listing, and can also be used as a reference for the selection of TCM varieties in the national medical insurance drug catalog and the national essential drug catalog.