Abstract
BACKGROUND: Traditional Chinese Medicine (TCM) is widely used to treat heart failure (HF). Syndrome differentiation is a unique and crucial component in TCM practice for guiding disease diagnosis and treatment strategies as well as clinical research. The major bottlenecks in TCM syndrome differentiation are the diversity of the syndrome differentiation criteria and the broad spectrum of syndrome patterns, hindering evidence-based studies for clinical research. In the present study, we aim to develop an evidence-based questionnaire for the diagnosis of HF and establish a definitive set of criteria for syndrome differentiation. METHODS: We designed a TCM syndrome differentiation questionnaire for heart failure (SDQHF) based on the "TCM expert consensus for diagnosis and treatment of heart failure" (expert consensus), literature review, and various clinical guidelines. To test the reliability and efficiency of the questionnaire, we performed a large-scale multiple-center clinical trial with the recruitment of 661 HF patients. Cronbach's alpha was used to assess the internal consistency of the SDQHF. Content validity was conducted through expert review. Principal component analysis (PCA) was applied to evaluate the construct validity. We constructed a proposed model for syndrome differentiation for HF based on the PCA results. Tongue analysis was performed to verify the accuracy of syndromes derived from the proposed model and the expert consensus. An evidence-based practical questionnaire for TCM syndrome differentiation patients was developed and validated with the data from 661 HF patients. RESULTS: The syndrome differentiation criteria were constructed with five syndrome elements (qi-deficiency, yang-deficiency, yin-deficiency, blood stasis, and phlegm retention). The results revealed good convergent and discriminant validity, satisfactory internal consistency, and feasibility. The significant discoveries include: (1) A total of 91% of the derived TCM syndromes from the proposed model matched with the characterized tongue images of the syndrome patterns; (2) Qi Deficiency Syndrome is the dominant syndrome pattern for HF patients, followed by Yang-Qi Deficiency Syndrome and Qi-yin deficiency Syndrome, and finally, Yin-Yang Dual Deficiency Syndrome; (3) The majority of the HF patients had the combination of Blood Stasis and Phlegm Retention Syndromes; (4) The "Yin-Yang Dual Deficiency" Syndrome was a valid syndrome for HF, suggesting that this syndrome pattern should be included in the criteria for syndrome differentiation; and (5) Through the validation of the expert consensus, several recommendations were proposed to improve the accuracy of syndrome differentiation of HF. CONCLUSIONS: The proposed SDQHF and the criteria could be a reliable and valid tool for syndrome differentiation of heart failure with high accuracy. It is recommended to use the proposed model for evidence-based study on Chinese Medicine to diagnose and treat HF. TRIAL REGISTRATION NUMBER: The trial was registered at the Chinese Clinical Trial Registry, http://www.chictr.org.cn . (Registration No.: ChiCTR1900021929); Date: 2019-03-16.