Construction and Application of Standard System for Traditional External Therapy in Traditional Chinese Medicine Health Preservation

Abstract

Against the backdrop of a growing global burden of chronic non-communicable diseases and sub-health issues, traditional Chinese medicine (TCM) external therapies serve as core techniques for TCM health preservation. However, inconsistent operational norms and lack of quantitative parameters have resulted in high clinical heterogeneity, hindering their clinical application and international development. This study constructed a four-layer hierarchical standard system for TCM external therapies by integrating literature analysis and three rounds of Delphi expert consultation, and extracted 17 core quantitative operational parameters for cupping, scraping, moxibustion and other therapies. A multicenter stratified randomized controlled trial involving 384 participants was further conducted to validate the system. The subjects were divided into four groups: control group, standardized TCM external therapy group, therapy combined with TCM constitution conditioning group, and therapy combined with digital health management group. After 12 weeks of intervention and 12 weeks of follow-up, relevant biomarkers, clinical scales and safety indicators were assessed. The overall expert consensus rate of the standard system reached 83.2%. All intervention groups exhibited significant increases in BDNF levels and decreases in inflammatory factors, along with notable improvements in fatigue and sleep status. The combination of standardized therapy and constitution conditioning delivered the best therapeutic effect. Operation standardization was positively correlated with clinical efficacy and negatively correlated with adverse event incidence. All adverse reactions were mild, and participants maintained high treatment compliance. This standard system fills the gaps in existing industry specifications. Standardized TCM external therapies are effective and safe for intervening sub-health and mild chronic diseases. It is suggested to promote the implementation of this system, conduct in-depth mechanism research and accelerate its international popularization.