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

BackgroundPrimary 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 bloo...

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Main Authors: Xiaomin Hao, Lili Zhang, Yu Gong, Jun Wang, Weilan Qin, Xudong Zhang, Qiulei Guo, Meng Xu, Taotao Lv, Yan Guo, Yu Liu, Jipeng Liu, Bingnan Yue, Qingguo Liu
Format: Article
Language:English
Published: JMIR Publications 2025-05-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2025/1/e71850
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author Xiaomin Hao
Lili Zhang
Yu Gong
Jun Wang
Weilan Qin
Xudong Zhang
Qiulei Guo
Meng Xu
Taotao Lv
Yan Guo
Yu Liu
Jipeng Liu
Bingnan Yue
Qingguo Liu
author_facet Xiaomin Hao
Lili Zhang
Yu Gong
Jun Wang
Weilan Qin
Xudong Zhang
Qiulei Guo
Meng Xu
Taotao Lv
Yan Guo
Yu Liu
Jipeng Liu
Bingnan Yue
Qingguo Liu
author_sort Xiaomin Hao
collection DOAJ
description BackgroundPrimary 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. ObjectiveThis study aims to assess the clinical efficacy and safety of the “HuoXueSanFeng” acupuncture technique in patients with essential hypertension. MethodsThis 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. ResultsThis 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. ConclusionsThe 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 RegistrationChinese Clinical Trial Registry ChiCTR2400084696; https://www.chictr.org.cn/showprojEN.html?proj=229194 International Registered Report Identifier (IRRID)DERR1-10.2196/71850
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spelling doaj-art-cdf89f2583674b9cad10a62ee82bd1ca2025-08-20T03:53:52ZengJMIR PublicationsJMIR Research Protocols1929-07482025-05-0114e7185010.2196/71850A Clinical Study on the Efficacy of Acupuncture Treatment in Essential Hypertension: Protocol for Randomized Controlled TrialXiaomin Haohttps://orcid.org/0009-0004-8790-7832Lili Zhanghttps://orcid.org/0000-0003-0935-4991Yu Gonghttps://orcid.org/0000-0002-3794-8562Jun Wanghttps://orcid.org/0000-0001-5626-5700Weilan Qinhttps://orcid.org/0000-0002-6339-193XXudong Zhanghttps://orcid.org/0000-0003-1025-1631Qiulei Guohttps://orcid.org/0000-0002-6262-1983Meng Xuhttps://orcid.org/0000-0003-3070-0123Taotao Lvhttps://orcid.org/0000-0002-8874-7592Yan Guohttps://orcid.org/0000-0002-4379-3982Yu Liuhttps://orcid.org/0009-0002-9673-2689Jipeng Liuhttps://orcid.org/0009-0004-5217-9169Bingnan Yuehttps://orcid.org/0009-0004-6750-9626Qingguo Liuhttps://orcid.org/0000-0003-4271-1639 BackgroundPrimary 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. ObjectiveThis study aims to assess the clinical efficacy and safety of the “HuoXueSanFeng” acupuncture technique in patients with essential hypertension. MethodsThis 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. ResultsThis 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. ConclusionsThe 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 RegistrationChinese Clinical Trial Registry ChiCTR2400084696; https://www.chictr.org.cn/showprojEN.html?proj=229194 International Registered Report Identifier (IRRID)DERR1-10.2196/71850https://www.researchprotocols.org/2025/1/e71850
spellingShingle Xiaomin Hao
Lili Zhang
Yu Gong
Jun Wang
Weilan Qin
Xudong Zhang
Qiulei Guo
Meng Xu
Taotao Lv
Yan Guo
Yu Liu
Jipeng Liu
Bingnan Yue
Qingguo Liu
A Clinical Study on the Efficacy of Acupuncture Treatment in Essential Hypertension: Protocol for Randomized Controlled Trial
JMIR Research Protocols
title A Clinical Study on the Efficacy of Acupuncture Treatment in Essential Hypertension: Protocol for Randomized Controlled Trial
title_full A Clinical Study on the Efficacy of Acupuncture Treatment in Essential Hypertension: Protocol for Randomized Controlled Trial
title_fullStr A Clinical Study on the Efficacy of Acupuncture Treatment in Essential Hypertension: Protocol for Randomized Controlled Trial
title_full_unstemmed A Clinical Study on the Efficacy of Acupuncture Treatment in Essential Hypertension: Protocol for Randomized Controlled Trial
title_short A Clinical Study on the Efficacy of Acupuncture Treatment in Essential Hypertension: Protocol for Randomized Controlled Trial
title_sort clinical study on the efficacy of acupuncture treatment in essential hypertension protocol for randomized controlled trial
url https://www.researchprotocols.org/2025/1/e71850
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