Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 28, 2025
Date Accepted: Apr 18, 2025
Efficacy of acupuncture treatment for essential hypertension: a randomized controlled clinical trial study protocol
ABSTRACT
Background:
Background:Primary hypertension is a significant global public health concern and one of the major risk factors for fatal complications of cardiovascular disease. Previous studies have demonstrated that acupuncture, as a relatively safe treatment modality, is effective in lowering blood pressure and improving clinical symptoms.
Objective:
Objective:The primary objective of this study is to evaluate the clinical efficacy and safety of the "HuoXue SanFeng" acupuncture method in patients with essential hypertension.
Methods:
Methods:This study is a multicenter, randomized, single-blind, sham-controlled clinical trial in which 228 subjects with essential hypertension will be recruited from five tertiary hospitals in China. Subjects will be randomly assigned to either the acupuncture or sham acupuncture group in a 1:1 ratio. Each participant will receive treatment three times per week for six weeks, totaling 18 sessions, with follow-up visits scheduled at weeks 1, 2, and 4 post-treatment.Primary outcome measures included 24-hour ambulatory blood pressure and in-office immediate blood pressure. Secondary outcome measures included dizziness handicap inventory (DHI), Headache Impact Test-6 (HIT-6), and Pittsburgh sleep quality index(PSQI), and any adverse events will be recorded throughout the study to evaluate safety.
Results:
Results:This study was registered in China Clinical Trial Registration Center on May 23rd, 2024. Data collection began in July 2024 and is expected to end in June 2025. At present, the data of this experiment is in the collection stage, 27 subjects have been recruited, and the data has not been analyzed. The experimental results are expected to be submitted and published in November 2025.
Conclusions:
Conclusions:The results of this study will further clarify the advantages of acupuncture in lowering blood pressure and provide more reliable evidence for the treatment of essential hypertension using the "HuoXueSanFeng" acupuncture method. Clinical Trial: Dear Editor: We are pleased to submit our original research paper entitled "Efficacy of Acupuncture Treatment for Essential Hypertension: A Randomized Controlled Clinical Trial Study Protocol" for consideration for publication in JMIR Research Protocols. Essential hypertension is a major risk factor for cardiovascular disease complications and a significant public health issue. Previous studies have demonstrated that acupuncture can safely lower blood pressure and improve clinical symptoms. Our study aims to evaluate the antihypertensive efficacy and safety of the "activating blood and dispersing wind" acupuncture method in patients with essential hypertension. We believe our work holds significant scientific value. This manuscript is an original work of the authors and is not under consideration elsewhere. All authors have agreed to submit it to JMIR Research Protocols. We appreciate your careful handling of our manuscript. Best regards, Xiaomin Hao
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