Efficacy and neural mechanism of acupuncture for essential hypertension: Study protocol for a randomized clinical trial

BACKGROUND: Hypertension is a major risk factor for cardiovascular diseases. Acupuncture has been used to control blood pressure in clinical, however, the high-quality clinical evidence is insufficient and the underlying mechanisms remain unclear. OBJECTIVES: This study aims to evaluate the efficacy of electroacupuncture for patients with essential hypertension (EH) compared with sham electroacupuncture and explore the neural mechanism. STUDY DESIGN AND METHODS: his is an 8-week, parallel-grouped, randomized clinical trial. A total of 66 patients diagnosed with EH are randomly assigned (1:1) to receive either the electroacupuncture or sham electroacupuncture treatment 3 sessions per week for 4 weeks. The primary outcome is the mean systolic blood pressure change at week 4 from the baseline measurement. The independent sample t-test will be used to compare the differences between two groups. The secondary outcomes include the change in mean diastolic blood pressure, the proportion of patients with controlled blood pressure (< 140/90 mm Hg), and quality of life. The outcome variables are measured at baseline, week 2, week 4 and week 8. Functional magnetic resonance imaging scans, pulse rate variability acquisition, and image-based photoplethysmography recording are performed at baseline and the end of the intervention period to explore acupuncture-related neuroplasticity changes. Correlation analyses are performed to investigate the relationships between the neural changes and clinical symptoms. Adverse events during the trial are monitored. TRIAL REGISTRATION: Chinese Clinical Trials Registry, the number is: ChiCTR2400082315 (https://www.chictr.org.cn/showproj.html?proj=223840).