Acupuncture for High Blood Pressure

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Shaista Malik, MD, PhD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Irvine

Must not be taking: Antihypertensives

Disqualifiers: Pregnancy, Coronary disease, Severe hypertension, others

No Placebo Group

Approved in 3 Jurisdictions

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.

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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.

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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.

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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

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Susan Samueli Integrative Health Institute Irvine, CA

Susan Samueli Integrative Health Institute Costa Mesa, CA

University of California, Irvine, Health Sciences Medical Center Orange, CA

Who Is Running the Clinical Trial?

University of California, Irvine Lead Sponsor

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] Electrical stimulation of four specific acupuncture points (Liver 3, Stomach 36, Large Intestine 11, and the Groove for Lowering Blood Pressure) was examined in order to determine the effect of this stimulation on diastolic blood pressure in 10 subjects with diastolic hypertension. Subjects were randomly divided into two groups: (1) an Acu-ES group, which received electrical stimulation applied to the four antihypertensive acupuncture points, and (2) a Sham-ES group, which received electrical stimulation applied to non-acupuncture-point areas. A repeated-measures analysis of variance revealed a significant, immediate poststimulation reduction of diastolic blood pressure for the Acu-Es group versus the Sham-ES group. Further studies are needed to determine whether there are other acupuncture points, stimulation characteristics, or modalities that can enhance this treatment effect and whether the treatment effect can last for a clinically significant period of time.

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] Hypertension is a common risk factor for cardiovascular disease. Transcutaneous electrical acupoint stimulation (TEAS) may be effective for hypertension, but the evidence remains limited. The aim of this study is to evaluate the effectiveness and safety of the smart phone-based TEAS as adjunctive therapy for hypertension.

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

The effect of transcutaneous electric nerve stimulation in patients with therapy-resistant hypertension. [2019] Afferent nerve stimulation, such as acupuncture and transcutaneous electric nerve stimulation (TENS), has shown a blood pressure reduction in both animal and man. In the present open and non-controlled study we investigated the effect on 24-h ambulatory blood pressure of low frequency TENS in a group of hypertensive subjects who do not respond properly to pharmacological treatment.

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

Effects of electrical stimulation of acupuncture points on blood pressure. [2022] Arterial hypertension is considered a major contributor to coronary arterial disease. The purpose of the study was to investigate the effects of Hans electrical stimulation of acupuncture points on blood pressure.

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] High-normal blood pressure (BP) is associated with increased all-cause, cardiovascular mortality and frequently progresses to hypertension. Transcutaneous electrical acupoint stimulation (TEAS) might be a non-pharmaceutical therapy option to control BP. This trial aims to determine the effectiveness and safety of TEAS combined with lifestyle modification for high-normal BP.

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

Home-based transcutaneous electrical acupoint stimulation for hypertension: a randomized controlled pilot trial. [2023] The aim of this trial was to evaluate the feasibility and effect of home-based transcutaneous electrical acupoint stimulation (TEAS) in patients with hypertension. In this randomized pilot trial, patients with hypertension were randomly assigned to the TEAS group or the usual care group. Participants in the usual care group were instructed to continue taking their antihypertensive drugs and received education on lifestyle modifications. In addition, participants in the TEAS group received 4 weekly sessions of noninvasive acupoint stimulation for 12 weeks at home. The primary outcome was the change in office systolic blood pressure at week 12 from baseline. Withdrawal from the study and adverse events associated with TEAS were also recorded. Sixty patients were randomized, with 30 patients in the TEAS group, of whom 1 was lost at week 36, and 30 patients in the usual care group, of whom 3 were lost by week 12. The reduction in systolic blood pressure at week 12 was greater in the TEAS group (-8.53 mm Hg; 95% CI [-13.37, -3.70 mm Hg]) than in the usual care group (-1.70 mm Hg; 95% CI [-4.29, -0.89 mm Hg]), with a between-group difference of -6.83 mm Hg (95% CI, [-12.23, -1.43 mm Hg]; P = 0.014). No TEAS-related adverse events occurred. In conclusion, home-based TEAS added to usual care for patients with hypertension was acceptable and safe and may be a potential treatment option. A larger randomized controlled trial of this intervention is warranted.