Acupuncture for High Blood Pressure

Recruiting at 2 trial locations

Overseen By Ashwini Erande

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Antihypertensives

Disqualifiers: Pregnancy, Coronary disease, Severe hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Participants cannot be on any anti-hypertensive medications to join this trial.

What data supports the effectiveness of the treatment Electroacupuncture for high blood pressure?

Research shows that electrical stimulation of specific acupuncture points can significantly reduce diastolic blood pressure in people with high blood pressure. Additionally, transcutaneous electrical nerve stimulation (TENS) has been shown to lower blood pressure in individuals who do not respond well to medication. ^{1 2 3 4 5}

Is acupuncture safe for treating high blood pressure?

Research shows that transcutaneous electrical acupoint stimulation (TEAS), a form of acupuncture, is generally safe for treating high blood pressure, with no related adverse events reported in studies. ^{1 2 3 5 6}

How does the treatment Electroacupuncture differ from other treatments for high blood pressure?

Electroacupuncture (EA) is unique because it combines traditional acupuncture with electrical stimulation, which may help lower blood pressure by targeting specific acupuncture points. Unlike standard drug treatments, EA is a non-pharmaceutical option that uses electrical currents to stimulate nerves and potentially reduce blood pressure. ^{1 2 3 4 5}

Research Team

Shaista Malik, MD, PhD, MPH

Principal Investigator

University of California, Irvine

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

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

I am not taking any blood pressure medications.

Subjects will be excluded if pregnant or nursing

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acupuncture therapy once a week for 8 weeks to reduce blood pressure

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for changes in sympathetic and parasympathetic nervous systems, biomarkers, and blood pressure

4.5 years

Treatment Details

Interventions

• Electroacupuncture

Trial Overview 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.

Participant Groups

Group I: Sympathoinhibitory EA (SI-EA) Experimental Treatment 1 Intervention

sympatho-inhibitory electroacupuncture therapy

Group II: Control EA (Sham-EA) Experimental Treatment 1 Intervention

Sham electroacupuncture

Group III: Combined EA (cEA) Experimental Treatment 1 Intervention

combination of SI-EA and AI-EA

Group IV: Anti-inflammatory EA (AI-EA) Experimental Treatment 1 Intervention

Anti-inflammatory electroacupuncture therapy

Electroacupuncture is already approved in China, United States, European Union for the following indications:

Approved in China as Electroacupuncture for:

• Pain relief
• Chronic pain
• Muscle spasms
• Paralysis
• Neurological diseases

Approved in United States as Electroacupuncture for:

• Pain management
• Chronic pain disorders
• Nausea and vomiting

Approved in European Union as Electroacupuncture for:

• Pain relief
• Chronic pain
• Rheumatoid arthritis

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

Electrical stimulation of specific acupuncture points significantly reduced diastolic blood pressure in 10 subjects with diastolic hypertension, compared to a sham stimulation group.

The study suggests that acupuncture point stimulation could be an effective intervention for managing diastolic hypertension, but further research is needed to explore optimal techniques and long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of acupuncture-point stimulation on diastolic blood pressure in hypertensive subjects: a preliminary study. Williams, T., Mueller, K., Cornwall, MW.[2019]

This study will evaluate the effectiveness and safety of smartphone-based transcutaneous electrical acupoint stimulation (TEAS) as an adjunctive therapy for hypertension in a large cohort of 1600 patients over 52 weeks.

Patients in the TEAS group will receive non-invasive electrical stimulation at home for 30 minutes, four times a week for 12 weeks, with the primary outcome being the change in systolic blood pressure compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smart phone-based transcutaneous electrical acupoint stimulation as adjunctive therapy for hypertension (STAT-H trial): protocol for a cluster randomised controlled trial. Tu, JF., Kang, SB., Wang, LQ., et al.[2022]

In a study involving 12 hypertensive patients who did not respond well to medication, low-frequency TENS treatment for 30 minutes twice daily over 4 weeks resulted in a significant reduction in blood pressure, with systolic pressure decreasing by 6.3 mm Hg and diastolic pressure by 3.7 mm Hg.

The blood pressure-lowering effects of TENS persisted for at least one week after the treatment ended, suggesting that TENS may provide a beneficial alternative for managing hypertension in patients unresponsive to traditional pharmacological therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcutaneous electric nerve stimulation in patients with therapy-resistant hypertension. Jacobsson, F., Himmelmann, A., Bergbrant, A., et al.[2019]

Hans electrical stimulation of acupuncture points significantly reduced systolic blood pressure in subjects over a 5-week treatment period, with systolic levels dropping from 117.8 mm Hg to 110.1 mm Hg (P < .05).

Diastolic blood pressure did not show significant changes, indicating that while the treatment may effectively lower systolic pressure, it does not have the same impact on diastolic pressure in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of electrical stimulation of acupuncture points on blood pressure. Zhang, J., Ng, D., Sau, A.[2022]

This clinical trial will assess the effectiveness and safety of transcutaneous electrical acupoint stimulation (TEAS) combined with lifestyle modifications in 60 participants with high-normal blood pressure over 12 weeks.

The primary outcome will focus on changes in mean systolic blood pressure, while secondary outcomes will evaluate diastolic blood pressure, progression to hypertension, quality of life, and other health metrics, providing a comprehensive view of TEAS's potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial. Wang, Y., Shi, GX., Tian, ZX., et al.[2022]

In a pilot trial involving 60 patients with hypertension, home-based transcutaneous electrical acupoint stimulation (TEAS) significantly reduced systolic blood pressure by an average of 8.53 mm Hg after 12 weeks, compared to only 1.70 mm Hg in the usual care group.

TEAS was found to be safe, with no adverse events reported, suggesting it could be a viable addition to standard hypertension treatment, warranting further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based transcutaneous electrical acupoint stimulation for hypertension: a randomized controlled pilot trial. Tu, JF., Wang, LQ., Liu, JH., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of acupuncture-point stimulation on diastolic blood pressure in hypertensive subjects: a preliminary study. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Smart phone-based transcutaneous electrical acupoint stimulation as adjunctive therapy for hypertension (STAT-H trial): protocol for a cluster randomised controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The effect of transcutaneous electric nerve stimulation in patients with therapy-resistant hypertension. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of electrical stimulation of acupuncture points on blood pressure. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Home-based transcutaneous electrical acupoint stimulation for hypertension: a randomized controlled pilot trial. [2023]