International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Chaoyang District, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.
Nanyuan Community Health Service Center, Fengtai District, Beijing, China.
Trials. 2021 Feb 15;22(1):140. doi: 10.1186/s13063-021-05039-5.
High-normal blood pressure (BP) is associated with increased all-cause, cardiovascular mortality and frequently progresses to hypertension. Transcutaneous electrical acupoint stimulation (TEAS) might be a non-pharmaceutical therapy option to control BP. This trial aims to determine the effectiveness and safety of TEAS combined with lifestyle modification for high-normal BP.
METHODS/DESIGN: This prospective, randomized, and parallel clinical trial will be conducted in a community service center in China. Sixty participants with high-normal BP will be randomly allocated to receive TEAS plus lifestyle modification (intervention group) or lifestyle modification alone (control group) in a 1:1 ratio. In addition to lifestyle modification, the intervention group will receive TEAS at four acupoints for 30 min, 4 times weekly for 12 weeks for a total of 48 sessions at home. The control group will receive same lifestyle modification but no TEAS. The primary outcome will be the change in mean systolic blood pressure at 12 weeks from the baseline measurement. Secondary outcomes include the change of mean diastolic blood pressure, proportion of subjects with progression to hypertension, quality of life, body mass index, and waist circumference. Adverse events during the trial will be monitored.
This trial will explore the feasibility and provide potential evidence for the effectiveness and safety of TEAS plus lifestyle modification for high-normal BP. Furthermore, this pilot trial is being undertaken to determine the feasibility of a full scale definitive randomized controlled trial. The results of this study will be published in a peer-reviewed journal.
Chinese Clinical Trial Registry, ChiCTR 1900024982 . Registered on August 6, 2019.
正常高值血压（BP）与全因、心血管死亡率增加有关，且常进展为高血压。经皮穴位电刺激（TEAS）可能是一种控制血压的非药物治疗选择。本试验旨在确定 TEAS 联合生活方式改变对正常高值血压的有效性和安全性。
方法/设计：这是一项在中国社区服务中心进行的前瞻性、随机、平行临床试验。将 60 名正常高值血压患者随机分为 TEAS 联合生活方式改变组（干预组）和单纯生活方式改变组（对照组），1:1 比例。除生活方式改变外，干预组将在家中接受 4 个穴位的 TEAS，每次 30 分钟，每周 4 次，共 48 次。对照组将接受相同的生活方式改变，但不进行 TEAS。主要结局为从基线测量到 12 周时平均收缩压的变化。次要结局包括平均舒张压变化、进展为高血压的受试者比例、生活质量、体重指数和腰围。试验期间将监测不良事件。
本试验将探索 TEAS 联合生活方式改变对正常高值血压的可行性，并提供潜在的有效性和安全性证据。此外，这项先导试验旨在确定一项全面的、确定性的随机对照试验的可行性。该研究的结果将发表在同行评议的期刊上。
中国临床试验注册中心，ChiCTR1900024982 。注册于 2019 年 8 月 6 日。
