Effect of Electro-Acupuncture on Blood Pressure

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

Detailed Description
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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.

Official Title
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Neural Mechanism of the Effect of Acupuncture on Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Procedure: Electro-acupuncture control
* Procedure: Electro-acupuncture test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 39 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two different formulated sets of acupoints will be used as EA intervention in the treatment of hypertension.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electro-acupuncture control<br>Blood pressure will be recorded before and after each EA treatment for 8 weeks. The course is a once a week 8-week treatment. Intervention is the Electro-acupuncture control treatment. | Procedure: Electro-acupuncture control<br>* First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.<br>* Other names: Hypertension;Procedure: Electro-acupuncture test<br>* First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.<br>* Other names: Hypertension;|
| Experimental: Electro-acupuncture test<br>Blood pressure will be recorded before and after each EA treatment for 8 weeks. The course is a once a week 8-week treatment. Intervention is the active Electro-acupuncture treatment. | Procedure: Electro-acupuncture control<br>* First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.<br>* Other names: Hypertension;Procedure: Electro-acupuncture test<br>* First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.<br>* Other names: Hypertension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | evaluation of systolic and diastolic blood pressures changes | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | evaluation of heart rate change | 8 weeks | 
| plasma catecholamine | evaluation of plasma catecholamine (ng/ml) change | 8 weeks | 
| plasma renin | evaluation of plasma renin (ng/ml.hr) change | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, blood pressure, mild to moderate hypertension