Clinical trial NCT00932139: Effect of Electro-Acupuncture on Blood Pressure
Official title: Neural Mechanism of the Effect of Acupuncture on Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
blood pressure
mild to moderate hypertension
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2009-07-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two different formulated sets of acupoints will be used as EA intervention in the treatment of hypertension.
Primary purpose: TREATMENT

Brief summary: Based on previous published research in animals and human, the investigators hypothesize that electroacupuncture (EA) will have a positive effect on hypertension.

Detailed description: The purpose of this study is to prove: (1) hypertensive response at rest and provoked by stress are decreased by EA; (2) The mechanisms of EA that reduces elevated blood pressure. EA inhibits the sympathetic nervous system, decreases blood pressure and reduces the oxygen demand. Our prior data in animals shows that improvements in cardiovascular function during myocardial ischemia, reflex hypertension and sustained hypertension are mediated by an EA-induced sensory neural reflex originating in somatic nerves to reduce sympathetic nerve activity. The specific aims of the present study will allow us to better understand and modulate the sympathetic nervous discharge activity that can cause hypertension during normal activity and stress in humans. The potential clinical application is the therapeutic value of EA in patients with hypertension.

Furthermore, the study will also investigate gender differences in the blood pressure lowering effect of EA. In particular in middle-aged hypertensive women and men.

Eligibility criteria: Inclusion Criteria:

* Patients with mild coronary disease, and no significant ECG change reflecting ischemia at rest.
* Patients with high blood pressure with or without antihypertensive medication.

Exclusion Criteria:

* Pregnant or nursing women
* Individuals with severe coronary disease (continuous angina)
* Conduction abnormalities on ECG consistent with left bundle branch block
* Cardiac arrhythmias associated with low blood pressure (90 mmHg)
* Peripheral vascular disease
* Orthopedic disease
* Diabetic or psychological illness that could interfere with safe performance of exercise of psychophysiological stress testing
* Those with known sensitivity to topical preparations or strong reactions to medical dressings and skin tapes

Primary outcomes:
measure: blood pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Heart rate
timeFrame: 8 weeks
measure: plasma catecholamine
timeFrame: 8 weeks
measure: plasma renin
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Susan Samueli Integrative Health Institute
state: California
city: Orange
country: United States
facility: UCIMedical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Shaista Malik, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Liang-Wu Fu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: LiFang Xie, PhD, LAc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li P, Tjen-A-Looi SC, Cheng L, Liu D, Painovich J, Vinjamury S, Longhurst JC. Long-Lasting Reduction of Blood Pressure by Electroacupuncture in Patients with Hypertension: Randomized Controlled Trial. Med Acupunct. 2015 Aug 1;27(4):253-266. doi: 10.1089/acu.2015.1106.