针刺治疗原发性高血压疗效的临床研究：随机对照试验方案

A Clinical Study on the Efficacy of Acupuncture Treatment in Essential Hypertension: Protocol for Randomized Controlled Trial.

作者信息

Hao Xiaomin, Zhang Lili, Gong Yu, Wang Jun, Qin Weilan, Zhang Xudong, Guo Qiulei, Xu Meng, Lv Taotao, Guo Yan, Liu Yu, Liu Jipeng, Yue Bingnan, Liu Qingguo

机构信息

Department of Acupuncture and Moxibustion, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.

National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.

出版信息

JMIR Res Protoc. 2025 May 23;14:e71850. doi: 10.2196/71850.

DOI:10.2196/71850

PMID:40409751

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12144478/

Abstract

BACKGROUND

Primary hypertension represents a significant global public health issue and is a major risk factor for severe cardiovascular disease complications. Previous research has indicated that acupuncture, as a relatively safe therapeutic approach, effectively reduces blood pressure and alleviates clinical symptoms.

OBJECTIVE

This study aims to assess the clinical efficacy and safety of the "HuoXueSanFeng" acupuncture technique in patients with essential hypertension.

METHODS

This investigation is designed as a multicenter, randomized, single-blind, sham-controlled clinical trial. A total of 228 participants with essential hypertension will be recruited from 5 tertiary hospitals in China. Participants will be randomly allocated to either the acupuncture group or the sham acupuncture group in a 1:1 ratio. Each participant will undergo treatment 3 times per week over a 6-week period, amounting to 18 sessions in total. Follow-up assessments will be conducted at 1, 2, and 4 weeks post treatment. The primary outcome measures include 24-hour ambulatory blood pressure and immediate in-office blood pressure readings. Secondary outcome measures included the Dizziness Handicap Inventory, the Headache Impact Test-6, and the Pittsburgh Sleep Quality Index. In addition, any adverse events will be documented throughout the study to assess safety.

RESULTS

This study was registered with the China Clinical Trial Registration Center on May 23, 2024. Data collection commenced in July 2024 and is anticipated to conclude in June 2025. Currently, the study is in the data collection phase, with 27 participants recruited, and data analysis has yet to be conducted. The findings of this study are expected to be submitted for publication in November 2025.

CONCLUSIONS

The outcomes of this study are anticipated to further elucidate the benefits of acupuncture in reducing blood pressure and to provide more robust evidence for the treatment of essential hypertension using the "HuoXueSanFeng" acupuncture method.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2400084696; https://www.chictr.org.cn/showprojEN.html?proj=229194.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71850.

摘要

背景

原发性高血压是一个重大的全球公共卫生问题，是严重心血管疾病并发症的主要危险因素。先前的研究表明，针灸作为一种相对安全的治疗方法，能有效降低血压并缓解临床症状。

目的

本研究旨在评估“活血散风”针刺技术对原发性高血压患者的临床疗效和安全性。

方法

本研究设计为一项多中心、随机、单盲、假针刺对照临床试验。将从中国5家三级医院招募228名原发性高血压参与者。参与者将按1:1的比例随机分配到针刺组或假针刺组。每位参与者将在6周内每周接受3次治疗，共18次。治疗后1周、2周和4周进行随访评估。主要结局指标包括24小时动态血压和即时诊室血压读数。次要结局指标包括头晕残障量表、头痛影响测试-6和匹兹堡睡眠质量指数。此外，在整个研究过程中记录任何不良事件以评估安全性。