Acupuncture Therapy and Hypertension

Study Overview
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Brief Summary
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Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will not be on hypertensive medications. The course last for 8 weeks and the frequency is once a week.

Detailed Description
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Improvement in BP control rates would lead to one of the largest impacts in improving life expectancy and the quality of life for over 100 million people in the United States and 1 billion people worldwide with immediate and measurable results. In the United States, 80% of patients with HTN are treated, but BP is controlled in only half of these individuals, with control worsening with increasing age1,2. The reasons for inadequate treatment and BP control are complex, but one reason for this therapeutic misalignment may be an incomplete understanding of the mechanisms underlying the development and progression of HTN. The aging process leads to dysfunction of the ANS, resulting in neuroendocrine abnormalities and chronic low-grade inflammation. The investigators have previously shown that electroacupuncture (EA) at four targeted acupoints, can decrease sympathetic activity [sympathoinhibitory (SI)], approaching levels close to those present prior to onset of HTN and may address this unmet need in HTN management. The investigators are now testing and have preliminary evidence that EA at two additional acupoints (SP6-7) increases parasympathetic activation, thereby decreasing circulating and tissue inflammatory biomarkers [thus anti-inflammatory (AI)] and when combined with SI-EA can improve measures of vascular health including endothelial function and arterial stiffness in preclinical model with overall greater reduction in BP. Together these combined six acupoints, when simultaneously activated by EA may restore optimal autonomic control of the immune system and target an important mechanistic pathway not addressed by BP-lowering pharmacotherapy alone. To date, 12 participants have been enrolled in the study.

Official Title
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Acupuncture Therapy in Non Medicated Hypertensive Patients

Conditions
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Mild to Moderate Hypertension

Intervention / Treatment
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* Other: electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects from 50 to 75 years of age Clinically diagnosed with mild to moderate hypertension and NOT on medication (Office SBP > 140 mmHg and < 160 mmHg Or ABPM average SBP > 130 mmHg and < 145 mmHg), and No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study. Exclusion Criteria: Subjects will be excluded if on anti-hypertensive medications. Subjects will be excluded if pregnant or nursing. Subjects will be excluded if they have coronary disease (by history or on ECG screening), 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 neuropathy or severe hypertension (BP >170 mmHg systolic or >110 mmHg diastolic), or any other physical or psychological illness. Those with known sensitivity to any topical preparations or strong reactions to medical dressings and skin tapes also will be excluded. Inability our or unwillingness of individual to give written informed consent.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 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: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: two by two factorial design for a 4 arm study.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-inflammatory EA (AI-EA)<br>Anti-inflammatory electroacupuncture therapy | Other: electroacupuncture<br>* acupuncture needling and stimulation are applied for 30 min<br>* Other names: acupuncture;|
| Experimental: Sympathoinhibitory EA (SI-EA)<br>sympatho-inhibitory electroacupuncture therapy | Other: electroacupuncture<br>* acupuncture needling and stimulation are applied for 30 min<br>* Other names: acupuncture;|
| Experimental: Combined EA (cEA)<br>combination of SI-EA and AI-EA | Other: electroacupuncture<br>* acupuncture needling and stimulation are applied for 30 min<br>* Other names: acupuncture;|
| Experimental: Control EA (Sham-EA)<br>Sham electroacupuncture | Other: electroacupuncture<br>* acupuncture needling and stimulation are applied for 30 min<br>* Other names: acupuncture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sympathetic and parasympathetic nervous systems | Heart rate variability and its component will be evaluated with EKG. | through study completion, an average of 4.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biomarkers like cytokines | Plasma will be measured for inflammatory markers with ELISA kits. | through study completion, an average of 4.5 years |