PS-C31-9: A RANDOMISED TRIAL OF THE TRADITIONAL CHINESE MEDICINE (TCM) CONSTITUTION-BASED DIETARY REGIME IN GRADE 1 HYPERTENSIVE PATIENTS: RATIONALE AND DESIGN

Abstract

Background and Objective: Cardiovascular disease (CVD) represents enormous challenges to population health. Body constitution, from the perspective of traditional Chinese medicine (TCM), differentiates how individuals feel and behave, and ultimately affects how different bodies respond to dietary intake. We hypothesise that the TCM constitution-based dietary intervention would be an effective approach to achieving favourable clinical and TCM-related outcomes when compared to usual care alone among the Chinese grade 1 hypertensive patients. Design and method: This is a parallel-group, randomised trial (registered as ChiCTR2000034749; http://www.chictr.org.cn). Participants consist of 274 primary care adults, aged 35 years or older, with uncomplicated grade 1 hypertension and at low risk of cardiovascular and renal events. Participants will be randomly assigned to either control or intervention group with a 1:1 allocation as per computer-generated random numbers. Permuted blocks of random sizes will be used. Subjects in the invention group will receive an on-site constitution assessment based on physical signs, personality, body symptoms, and the susceptibility to environmental changes. This will be conducted by the attending TCM practitioners trained in a prior session to improve the inter-rater reliability. A colour-printed constitution-specific brochure will be provided onsite. Health education materials will be made available to patients by courier service thereafter. All participants receive routine care provided by the ‘family doctor team’ in the context of the national basic public health service delivery. Measurements will be undertaken at three time-points, i.e., at baseline, at 6- and 12-month follow-ups. At each follow-up interview, subjects in the intervention group will be questioned about the constitution types of their own, and a full awareness of the constitution profile will be seen as an adherence to the protocol. Results and outcome evaluation: The primary outcome of the study is the difference between the two arms in the proportion of participants who had optimal control of blood pressure at 12 months. A point estimate of 25% inferiority in effectiveness would be acceptable assuming a gain that is considered to be clinically relevant. The secondary outcome measures include differences in the profile of clinical parameters and TCM symptoms between the two arms. Conclusions: We believe that this study offers new insights for cardiovascular health management through TCM constitution-based strategies in primary care settings to target those who need continuous attention in dietary modifications. The findings may advance our knowledge of the practical contribution of complementary and alternative medicine in the prevention and control of CVD.