Cardio-Cerebral Protective Effect of Moxibustion On Phlegm-Dampness Type Hypertension: A Study Protocol of a Randomized Clinical Trial

Abstract

Ling Cheng, Ning Bai，Lulu Cao，Liang zheng, Huangan Wu，Ruiping Wang，Chen Zhao，Yunli Shen，Haiyin Zhao，Gang Li，Bing Yang，Qinghui Yang，Yan Xing，Jianhong Cao，Yixing Wang，Lin Xu，Junjie Yan，Jie Cao, and Yiyang Guo

Introduction Hypertension is associated with a high rate of disability and mortality, and leads to a substantial socio-economic burden. Moxibustion is an external treatment in traditional Chinese medicine, which was used to treat mild to moderate hypertension in individuals with phlegm-dampness constitution, and had acupoint specificity. However, a standard large-scale randomized clinical trial to verify its effectiveness is still needed. This study is proposed to examine the clinical effectiveness and potential cardio-protective benefits of moxibustion at home as a treatment for individuals with phlegm-dampness hypertension.

Methods and Design This study is a multi-center, randomized, controlled trial. A total of 120 patients with mild to moderate hypertension and phlegm-dampness constitution will be recruited and randomly assigned in a 1:1 ratio to the treatment group (acupoint: Zusanli, ST36) or the control group (acupoint: Xuanzhong, GB39). All patients will receive 12 weeks of treatment and a 12-week follow-up period. The primary outcome measure is the change in morning systolic blood pressure from baseline to week 12. The secondary outcome measures include blood pressure-related indicators (morning diastolic blood pressure, average systolic blood pressure, average diastolic blood pressure, nighttime systolic blood pressure, nighttime diastolic blood pressure, blood pressure circadian rhythm) and short-term blood pressure variability coefficient, all of which will be measured by 24-hour ambulatory blood pressure monitoring. Additionally, cardiac-related indicators measured by 24-hour Holter monitoring, metabolic disorder-related indicators, liver and kidney function indicators, transformed scores of the TCM phlegm-dampness constitution scale, and the Montreal Cognitive Assessment (MoCA) will also be evaluated.

Conclusion This multi-center, randomized, controlled clinical trial will provide evidence on the clinical treatment effectiveness and potential cardio-protective benefits of moxibustion at home as a treatment for individuals with phlegm-dampness type hypertension.