Using patient-reported outcomes in clinical studies for cardiovascular diseases of Traditional Chinese medicine worldwide: a cross-sectional study.

Abstract

Background and purpose: Cardiovascular diseases (CVD) represent a major global health challenge. Clinical research is increasingly leveraging patient perspectives to evaluate the efficacy of Traditional Chinese Medicine (TCM) in treating these conditions. This study reviews and summarizes the application and characteristics of Patient-reported outcomes (PROs) in TCM for CVD, the overarching goal is to provide a resource that can guide potential research directions for PROs endpoints in future TCM CVD clinical research.

Methods: We searched clinical studies of TCM for CVD from the World Health Organization International Clinical Trials Registry Platform registered between January 1, 2010, and February 22, 2025. The outcome types, whether PRO measures (PROMs) explicitly mentioned, study design, clinical study phases,age, gender, and geographic region were analyzed. We classified the studies that explicitly specified PROs into 15 categories based on the International Classification of Diseases-11 (ICD-11),and compared their PROMs with the Core Outcome Measures in Effectiveness Trials (COMET).

Results: A total of 636 TCM CVD studies were included, of which 394 employed PROs. However, 103 studies did not specify the PROMs utilized, including 33 that involved TCM syndrome scores. None of the most frequently used PROMs were TCM-specific. The most frequently studied disease categories - chronic coronary heart diseases and heart failure - employed PROMs that were basically aligned with COMET recommendations. In contrast, other disease categories were not aligned with COMET.

Conclusion: In TCM clinical research on CVD, PROs have been commonly adopted as outcome measures, with usage steadily increasing. However, the application of TCM-specific PROMs remains limited, revealing a significant gap. PROMs recommended by COMET should be further investigated across a broader range of CVD categories. Furthermore, there is an urgent need for patient-centered research on TCM syndrome scores, highlighting the importance of developing robust, standardized TCM-specific PROMs tailored to this field.