经皮穴位电刺激治疗 1 期高血压：一项随机对照初步试验研究方案。
Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial.
机构信息
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.
Nanyuan Community Health Service Center, Fengtai District, Beijing, China.
出版信息
Trials. 2020 Jun 22;21(1):558. doi: 10.1186/s13063-020-04493-x.
BACKGROUND
Hypertension is a major pathogenic factor of cardiovascular diseases. Insufficient blood pressure control rate and sub-optimal medication adherence remain challenges for effective management of hypertension. Transcutaneous electrical acupoint stimulation (TEAS) has been used to treat various diseases, including hypertension, but the scientific evidence for its benefit remains insufficient. Therefore, we will perform a randomized, controlled clinical trial in patients with stage 1 hypertension to evaluate the effect of TEAS.
METHODS/DESIGN: The study will be a two-arm parallel, randomized controlled trial. Sixty patients with stage 1 hypertension will be randomly assigned to the TEAS group and the control group in a 1:1 ratio. The participants in the TEAS group will receive non-invasive acupoint electrical stimulation for 30 min at four acupoints in the upper and lower extremities at home, 4 times weekly for 12 weeks for a total of 48 sessions. Participants in the control group will not receive any form of acupoint stimulation. All participants in both groups will receive lifestyle education on how to control high blood pressure, including diet, weight control, and exercise. The primary outcome measure will be the change of the mean systolic blood pressure from baseline to 12 weeks. Secondary outcomes include the change of mean diastolic blood pressure, quality of life, body mass index, and physical activity level.
DISCUSSION
This pilot, randomized, controlled trial will explore the feasibility of TEAS. It will also provide potential clinical evidence for the efficacy and safety of TEAS in the treatment of patients with stage 1 hypertension. The results of this study will be published in peer-reviewed journals. Furthermore, this pilot trial as the precursor of a large scale randomized controlled trial will inform the sample size of the subsequent trial.
TRIAL REGISTRATION
Chinese clinical trial registry, ChiCTR1900025042, Registered on 8 August 2019 (http://www.chictr.org.cn/showproj.aspx?proj=41496).
背景
高血压是心血管疾病的主要致病因素。血压控制率不足和药物依从性不理想仍然是有效管理高血压的挑战。经皮穴位电刺激（TEAS）已被用于治疗各种疾病，包括高血压，但科学证据仍不足。因此，我们将在 1 级高血压患者中进行一项随机对照临床试验，以评估 TEAS 的疗效。
方法/设计：本研究将采用 2 臂平行、随机对照临床试验。将 60 例 1 级高血压患者以 1:1 的比例随机分为 TEAS 组和对照组。TEAS 组的参与者将在家中接受非侵入性穴位电刺激，在上肢和下肢的四个穴位各刺激 30 分钟，每周 4 次，共 12 周，共 48 次。对照组的参与者将不接受任何形式的穴位刺激。两组参与者都将接受控制高血压的生活方式教育，包括饮食、体重控制和运动。主要结局指标是从基线到 12 周时平均收缩压的变化。次要结局指标包括平均舒张压的变化、生活质量、体重指数和身体活动水平。
讨论
这项先导、随机、对照试验将探索 TEAS 的可行性。它还将为 TEAS 治疗 1 级高血压患者的疗效和安全性提供潜在的临床证据。研究结果将发表在同行评议的期刊上。此外，这项先导试验作为后续大规模随机对照试验的前导试验，将为后续试验的样本量提供信息。
试验注册
中国临床试验注册中心，ChiCTR1900025042，注册于 2019 年 8 月 8 日（http://www.chictr.org.cn/showproj.aspx?proj=41496）。
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