What side effects are associated with this type of intervention?

Common treatments for high blood pressure include medications such as hydrochlorothiazide, atenolol, and verapamil. Hydrochlorothiazide, a diuretic, can cause side effects like electrolyte imbalance, dehydration, and increased blood sugar levels. Atenolol, a beta-blocker, may lead to fatigue, cold extremities, and bradycardia. Verapamil, a calcium channel blocker, can cause constipation, dizziness, and swelling of the ankles. Acupuncture, which is being studied for its potential to reduce blood pressure by modulating the autonomic nervous system, generally has fewer side effects, with occasional reports of minor bruising or soreness at needle insertion sites.

What prior FDA approvals exist?

FDA-approved treatments for high blood pressure include a variety of drug classes such as ACE inhibitors (e.g., lisinopril), angiotensin II receptor blockers (e.g., losartan), calcium channel blockers (e.g., amlodipine), and beta-blockers (e.g., metoprolol). These medications primarily work by different mechanisms to reduce blood pressure, such as vasodilation, reducing heart rate, or decreasing blood volume. While these drugs do not directly mimic the autonomic modulation seen with acupuncture, they achieve similar outcomes in blood pressure reduction through pharmacological means.

What other types of research exist?

Promising novel alternatives to acupuncture for high blood pressure patients include: 1) Transcutaneous Trigeminal Nerve Stimulation (TTNS), which has shown potential in modulating the autonomic nervous system; 2) Dietary Approaches to Stop Hypertension (DASH) diet, which is effective in reducing blood pressure through dietary modifications; 3) Pharmacologic options like fludrocortisone, midodrine, and droxidopa, which can manage symptoms of autonomic dysfunction and improve blood pressure control. Patients should discuss these options with their healthcare provider to determine the best individualized treatment plan.

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Other

Acupuncture for High Blood Pressure

N/A

Recruiting

Led By Shaista Malik

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study.

Must not have

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

Subjects will be excluded if on anti-hypertensive medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 4.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a treatment involving small electrical currents through needles to help people with mild to moderate high blood pressure who are not taking medication. The treatment aims to reduce stress and inflammation, which can help lower blood pressure.

Who is the study for?

This trial is for people aged 50-75 with mild to moderate high blood pressure who aren't taking any hypertension medication. Participants should have a stable ECG without signs of ischemia. Pregnant or nursing individuals, those sensitive to topical preparations, on anti-hypertensive drugs, or with certain heart conditions and severe illnesses are excluded.

What is being tested?

The study tests if electroacupuncture can lower blood pressure in patients not using hypertension meds. It's an 8-week course with sessions once weekly, aiming to see how effective this therapy is for controlling high blood pressure without medication.

What are the potential side effects?

Potential side effects may include minor bruising at needle sites, light-headedness after treatment, rare allergic reactions to needles or materials used during acupuncture, and discomfort during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have high blood pressure but am not taking medication for it.

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My heart's electrical activity is normal, with no signs of blockage.

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I have high blood pressure but am not taking medication for it.

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I am between 50 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have heart disease, severe high blood pressure, or other serious health issues.

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I am not taking any blood pressure medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 4.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 4.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in sympathetic and parasympathetic nervous systems

Secondary study objectives

Change in biomarkers like cytokines

Other study objectives

Change in blood pressure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Sympathoinhibitory EA (SI-EA)Experimental Treatment1 Intervention

sympatho-inhibitory electroacupuncture therapy

Group II: Control EA (Sham-EA)Experimental Treatment1 Intervention

Sham electroacupuncture

Group III: Combined EA (cEA)Experimental Treatment1 Intervention

combination of SI-EA and AI-EA

Group IV: Anti-inflammatory EA (AI-EA)Experimental Treatment1 Intervention

Anti-inflammatory electroacupuncture therapy

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include medications such as ACE inhibitors, beta-blockers, diuretics, and calcium channel blockers, as well as non-pharmacologic interventions like lifestyle changes and acupuncture. ACE inhibitors work by blocking the formation of a hormone that narrows blood vessels, beta-blockers reduce heart rate and the heart's output of blood, diuretics help the kidneys remove excess sodium and water, and calcium channel blockers relax blood vessels by preventing calcium from entering cells of the heart and blood vessel walls. Acupuncture, as studied in trials, may reduce blood pressure by modulating the autonomic nervous system, leading to vasodilation and subsequent blood pressure reduction. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and manage their condition more effectively.