Acupuncture Therapy and Hypertension

University of California Irvine (UCI)

Status: Enrolling

Conditions: Mild to Moderate Hypertension

Treatments: Other: electroacupuncture

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05530512

19992222

R01AT011306 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will be either on or off hypertensive medications. The course last for 8 weeks and the frequency is once a week.

Full description

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 age. 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, 39 participants have been enrolled in the study.

Enrollment: 72 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects from 45 to 75 years of age
2. Clinically diagnosed with mild to moderate hypertension and ON or OFF medication (Office SBP > 140 mmHg and < 160 mmHg Or ABPM average SBP > 130 mmHg and < 145 mmHg), and
3. No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study.

Exclusion criteria

1. Subjects will be excluded if pregnant or nursing.
2. 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.
3. Those with known sensitivity to any topical preparations or strong reactions to medical dressings and skin tapes also will be excluded.
4. Inability our or unwillingness of individual to give written informed consent.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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72 participants in 4 patient groups

Anti-inflammatory EA (AI-EA)

Experimental group

Description:

Anti-inflammatory electroacupuncture therapy

Treatment:

Other: electroacupuncture

Sympathoinhibitory EA (SI-EA)

Experimental group

Description:

sympatho-inhibitory electroacupuncture therapy

Treatment:

Other: electroacupuncture

Combined EA (cEA)

Experimental group

Description:

combination of SI-EA and AI-EA

Treatment:

Other: electroacupuncture

Control EA (Sham-EA)

Experimental group

Description:

Sham electroacupuncture

Treatment:

Other: electroacupuncture