Incorporating Traditional Chinese Medicine Syndrome Differentiation in Randomized Trials: Methodological Issues (Cochrane CAM Field Invited Commentary)

Abstract

Purpose: In traditional Chinese medicine (TCM) practice, decision on prescription is based on a process called Bian Zheng Lun Zhi (syndrome differentiation guided treatment decision). The syndrome differentiation process may not be recognized in conventional standards of randomized controlled trial (RCT), limiting the model validity and generalizability of results. Methods: This article discussed how syndrome differentiation, a classical TCM approach in diagnosis, can be incorporated into RCT design. Results: Four methodological solutions were proposed: (i) Lesson learnt from the design of patient reported outcome questionnaire can inform how TCM diagnosis instrument could be developed. A proper TCM diagnostic tool with sound psychometric properties can reduce variation in the syndrome differentiation process. (ii) Treatment strategies for a specific TCM diagnosis could be highly diversified. Delphi technique can inform the design of optimal treatment program by facilitating consensus among experts. (iii) Subgroup analysis is often needed in RCT recruiting patient with several TCM diagnosis. It is highlighted that investigators should consider whether the design, analysis and context of the trial are robust enough to support a reliable claim of subgroup effect associatedwith a particular TCMdiagnosis. (iv) Finally, we discussed alternative research and analysis approaches for handling misalignment of Western and TCM diagnoses, including the possibility of unifying TCM syndrome with Western phenotypes using latent class analysis. Conclusion: Further methodological advances are needed in the better alignment of classical TCM theories and diagnostic instrument development, aswell as in reducing bias during the expert consensus processes. Contact: Robin Ho, robinho@cuhk.edu.hk