International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.
Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
BMJ Open. 2022 Jul 28;12(7):e058172. doi: 10.1136/bmjopen-2021-058172.
Hypertension is a common risk factor for cardiovascular disease. Transcutaneous electrical acupoint stimulation (TEAS) may be effective for hypertension, but the evidence remains limited. The aim of this study is to evaluate the effectiveness and safety of the smart phone-based TEAS as adjunctive therapy for hypertension.
This study is a 52-week cluster randomised controlled trial with 1600 hypertension patients in 32 community health service centres. Patients who meet the inclusion criteria will be randomised into usual care group or TEAS group in a 1:1 ratio. All patients will be provided with usual care as recommended by the guidelines. In addition to this, patients in the TEAS group will receive non-invasive acupoint electrical stimulation for 30 min at home, 4 times weekly for 12 weeks. The primary outcome will be the mean difference in the changes in office systolic blood pressure from baseline to 12 weeks between TEAS and usual care groups. Secondary outcomes will include the change of mean diastolic blood pressure, proportion of patients with controlled blood pressure (blood pressure <140/90 mm Hg), proportion of patients taking antihypertensive drugs, change in number of antihypertensive drugs and changes in 12-item Short-Form. Tertiary outcomes will include change in body mass index, change in waist circumference, physical activity and medication adherence. Safety outcomes will be any serious adverse events and clinical events.
This study has been approved by ethics committee of Beijing University of Chinese Medicine (No. 2020BZHYLL0104). Written informed consent will be obtained from all patients before randomisation. Trial results will be disseminated in peer-reviewed publications.
ChiCTR2000039400.
高血压是心血管疾病的常见危险因素。经皮穴位电刺激（TEAS）可能对高血压有效，但证据仍然有限。本研究旨在评估基于智能手机的 TEAS 作为高血压辅助治疗的有效性和安全性。
这是一项为期 52 周的集群随机对照试验，共有 32 个社区卫生服务中心的 1600 名高血压患者参与。符合纳入标准的患者将以 1:1 的比例随机分为常规护理组或 TEAS 组。所有患者将按照指南建议接受常规护理。此外，TEAS 组的患者将在家中接受非侵入性穴位电刺激 30 分钟，每周 4 次，共 12 周。主要结局将是 TEAS 组和常规护理组从基线到 12 周时办公室收缩压变化的平均值差异。次要结局将包括平均舒张压变化、血压控制（血压<140/90mmHg）的患者比例、服用降压药物的患者比例、降压药物数量的变化以及 12 项简明健康调查问卷的变化。次要结局将包括体重指数变化、腰围变化、身体活动和药物依从性变化。安全性结局将包括任何严重不良事件和临床事件。
本研究已获得北京中医药大学伦理委员会的批准（编号：2020BZHYLL0104）。所有患者在随机分组前将获得书面知情同意。试验结果将在同行评议的出版物中公布。
ChiCTR2000039400。
