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.