Traditional Chinese medicine (TCM) emphasizes syndrome differentiation and treatment, whereas commonly used evidence-based efficacy evaluation approaches are not aligned with TCM’s individualized diagnostic and therapeutic paradigm. “Average-based” assessments that ignore individual differences not only cannot accurately reflect the true efficacy of TCM interventions but also fail to guide TCM clinical practice. Accordingly, this review systematically summarizes commonly used methods for capturing the heterogeneity of treatment effect and proposes their potential applications in TCM clinical research, aiming to provide efficacy evaluation approaches that better accord with TCM’s diagnostic and therapeutic characteristics and, in turn, to furnish high-quality quantitative evidence for TCM clinical practice.
