The design of "dynamic-static evaluation by parallel groups within subpopulations" for clinical research of traditional Chinese medicine.

To more precisely evaluate the clinical efficacy of traditional Chinese medicine, we propose a novel study design called dynamic-static evaluation by parallel groups within subpopulations. The design includes 3 elements: subpopulations of patients based on TCM differentiation of syndrome and disease; parallel control groups inside or outside subpopulations; comprehensive evaluation for the combined effects of static and dynamic treatment. Using dry eye disease (disease-based syndromes), renal edema (syndrome-based diseases), and end-stage renal disease (method-based diseases and/or syndromes) as examples, we demonstrate potential applications of the design. Considering both characteristics of traditional Chinese medicine and modern research standards, the dynamic-static evaluation by parallel groups within subpopulations design provides a novel method for clinical research on traditional Chinese medicine. Please cite this article as: Zhang W, Huang N, Lai YS, Chen XL, Zhang WJ, Qiu MY, Lu XJ, Liu LY, Li CD, Gu J, Fang JQ. The design of "dynamic-static evaluation by parallel groups within subpopulations" for clinical research of traditional Chinese medicine. J Integr Med. 2026; Epub ahead of print.