Electro-Acupuncture for High Blood Pressure

Recruiting at 2 trial locations

Overseen By Shaista Malik, MD, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Severe coronary disease, Diabetes, Psychological illness, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

160 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients with high blood pressure can participate with or without antihypertensive medication, suggesting you may not need to stop them.

What data supports the effectiveness of the treatment Electro-Acupuncture 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, acupuncture combined with antihypertensive medications has been found to significantly lower blood pressure. ^{1 2 3 4 5}

Is electro-acupuncture generally safe for humans?

A systematic review of electro-acupuncture (EA) found that while adverse events (unwanted side effects) are reported, the safety of EA is less well documented compared to traditional acupuncture. Further studies are needed to better understand its safety profile. ^{1 3 5 6 7}

How does the Electro-Acupuncture treatment for high blood pressure differ from other treatments?

Electro-Acupuncture (EA) is unique because it combines traditional acupuncture with electrical stimulation at specific points on the body, which may help lower blood pressure without the use of medication. This approach is different from standard drug treatments as it uses electrical currents to potentially achieve blood pressure reduction. ^{1 3 5 7 8}

What is the purpose of this trial?

Based on previous published research in animals and human, the investigators hypothesize that electroacupuncture (EA) will have a positive effect on hypertension.

Research Team

Shaista Malik, MD, PhD, MPH

Principal Investigator

University of California, Irvine

LiFang Xie, PhD, LAc

Principal Investigator

University of California, Irvine

Liang-Wu Fu, MD, PhD

Principal Investigator

University of California, Irvine

Eligibility Criteria

This trial is for adults with high blood pressure, which can be with or without current medication. It's also open to those with mild heart disease but no serious ECG changes. However, it's not for pregnant women, individuals with severe heart issues like ongoing chest pain, peripheral vascular disease, certain ECG abnormalities, orthopedic conditions, skin sensitivities to tapes/dressings, very low blood pressure-related arrhythmias or uncontrolled diabetes and psychological conditions.

Inclusion Criteria

I have mild heart disease with no significant changes in my resting ECG.

I have high blood pressure, with or without medication.

Exclusion Criteria

You have a specific heart condition that shows up on an ECG test.

I have severe heart disease with constant chest pain.

I have heart rhythm problems with low blood pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive electro-acupuncture treatment once a week for 8 weeks to evaluate its effect on blood pressure and other cardiovascular parameters.

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Electro-acupuncture control
• Electro-acupuncture test

Trial Overview The study is testing whether electro-acupuncture (EA) can help lower high blood pressure. Participants will receive either the test EA treatment or a control version of EA. The hypothesis is that EA could have beneficial effects on hypertension based on earlier research in animals and humans.

Participant Groups

Group I: Electro-acupuncture test Experimental Treatment 2 Interventions

Blood pressure will be recorded before and after each EA treatment for 8 weeks. The course is a once a week 8-week treatment. Intervention is the active Electro-acupuncture treatment.

Group II: Electro-acupuncture control Experimental Treatment 2 Interventions

Blood pressure will be recorded before and after each EA treatment for 8 weeks. The course is a once a week 8-week treatment. Intervention is the Electro-acupuncture control treatment.

Electro-acupuncture test is already approved in China, United States for the following indications:

Approved in China as Electro-acupuncture for:

• Hypertension

Approved in United States as Electro-acupuncture for:

• Hypertension (investigational)

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Findings from Research

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]

Acupuncture does not show significant improvement in systolic or diastolic blood pressure compared to sham acupuncture in patients not on antihypertensive medications, based on a review of 4 randomized controlled trials involving 386 participants.

However, acupuncture may significantly lower blood pressure in patients who are already taking antihypertensive medications, suggesting it could be a beneficial adjunct treatment for those individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for essential hypertension: a meta-analysis of randomized sham-controlled clinical trials. Li, DZ., Zhou, Y., Yang, YN., et al.[2022]

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]

Acupuncture has been found to significantly lower both systolic and diastolic blood pressure in patients with grade 1 hypertension, showing a mean decrease of 3.62 mmHg and 3.12 mmHg respectively, based on a meta-analysis of 10 randomized controlled trials involving 1196 patients.

The treatment demonstrated a favorable efficacy compared to placebo and lifestyle interventions, with a relative risk of response at 2.12, and a low incidence of adverse effects, suggesting it is a safe option for managing mild hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between acupuncture and grade 1 hypertension: A systematic review and meta-analysis. Zhang, M., Zhu, Y., Wang, J., et al.[2022]

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]

A systematic review of 37 studies on electroacupuncture (EA) identified various adverse events (AEs), with common issues including pallor, skin pigmentation, and vertigo, highlighting the need for awareness of these potential side effects in clinical practice.

While most patients (62%) fully recovered from AEs related to EA, there were serious incidents reported, including three deaths, indicating that although EA can be beneficial, it carries risks that require careful monitoring and reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to electroacupuncture: a systematic review of single case studies and case series. Park, JH., Lee, JH., Lee, S., et al.[2021]

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]

A randomized controlled trial involving 60 patients with stage 1 hypertension will assess the effects of transcutaneous electrical acupoint stimulation (TEAS) on blood pressure over 12 weeks, with participants receiving treatment 4 times a week.

The primary outcome will measure changes in mean systolic blood pressure, while secondary outcomes will include diastolic blood pressure, quality of life, body mass index, and physical activity, aiming to provide evidence for the efficacy and safety of TEAS in hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial. Tian, ZX., Liu, CZ., Qi, YS., et al.[2021]

References

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

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

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

Acupuncture for essential hypertension: a meta-analysis of randomized sham-controlled clinical trials. [2022]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Association between acupuncture and grade 1 hypertension: A systematic review and meta-analysis. [2022]

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

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

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

Adverse events related to electroacupuncture: a systematic review of single case studies and case series. [2021]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial. [2021]