Effect of Electro-Acupuncture on Blood Pressure

Официальное название

Neural Mechanism of the Effect of Acupuncture on Hypertension

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура Electro-acupuncture control
  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.
• Процедура Electro-acupuncture test
  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. At end of 8-week treatment, 24 hours blood pressure and heart rate will be measured.

Первичные конечные точки

• blood pressure [Срок оценки: 8 weeks]

Вторичные конечные точки (3)

• Heart rate [Срок оценки: 8 weeks]
• plasma catecholamine [Срок оценки: 8 weeks]
• plasma renin [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Susan Samueli Integrative Health Institute — Irvine
• UCIMedical Center — Orange

Публикации

• 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. PMID 26392838

Идентификаторы

NCT: NCT00932139 · 1999-2222

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗