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

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electroacupuncture, which uses tiny electrical currents through acupuncture needles, might help lower high blood pressure. It tests various types of electroacupuncture, including combinations aimed at reducing stress responses or inflammation, and a control version that mimics treatment without active effects. Individuals with mild to moderate high blood pressure, whether on medication or not, might be suitable participants. The trial lasts eight weeks, with weekly sessions. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for managing high blood pressure.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that electroacupuncture (EA) is generally well-tolerated by people with high blood pressure. Studies have found that using electroacupuncture to manage blood pressure is safe and usually doesn't cause serious side effects.

For the type of electroacupuncture that targets the nervous system, research indicates it effectively lowers blood pressure and is well-accepted by patients, with no major safety concerns. Similarly, the anti-inflammatory electroacupuncture method, which helps reduce blood pressure by decreasing chronic inflammation, also appears safe, with no significant negative effects reported.

Researchers have studied these treatments both separately and together, and no major safety issues have emerged in the research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about electroacupuncture for high blood pressure because it offers a unique, non-drug approach that might complement or enhance current treatments like medications and lifestyle changes. This method involves using electrical stimulation at acupuncture points to target the body's nervous and inflammatory systems. The Sympathoinhibitory EA (SI-EA) focuses on reducing the activity of the sympathetic nervous system, potentially lowering blood pressure. Meanwhile, the Anti-inflammatory EA (AI-EA) aims to reduce inflammation, which can also impact blood pressure levels. This innovative technique could provide a new, holistic option for managing high blood pressure without the side effects often associated with traditional medications.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Studies have shown that electroacupuncture can help lower blood pressure in individuals with hypertension. This trial will provide participants with various electroacupuncture treatments, including Sympathoinhibitory EA (SI-EA), Anti-inflammatory EA (AI-EA), and a combination of both (cEA). Research indicates that combining acupuncture with blood pressure medication reduces blood pressure more effectively than medication alone. One study found that electroacupuncture might lower blood pressure by increasing vagus nerve activity, which helps control heart rate and blood pressure. Overall, evidence suggests that electroacupuncture treatments, like those tested in this trial, may effectively manage high blood pressure. ^{6 7 8 9 10}

Who Is on the Research Team?

Shaista Malik, MD, PhD, MPH

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6614319/

Acupuncture therapy for essential hypertension: a network ... The results of the network meta-analysis showed that there was no significant clinical or statistic difference in systolic blood pressure (SBP) change ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352906722002093

Effect of electroacupuncture combined with rehabilitation ... Many studies reported the application of electroacupuncture combined with rehabilitation training (EART) compared with CRT in controlling hypertension.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5963739/

Efficacy and Safety of Acupuncture for Essential ... Pooled results demonstrate that acupuncture plus anti-hypertensive drugs is better than anti-hypertensive drugs alone at reducing systolic and diastolic blood ...

4. advrehab.org advrehab.org/Effect-of-electroacupuncture-on-blood-pressure-and-quality-of-life-in-patients-with-primary-hypertension-a-randomised-controlled-trial,125,55858,1,1.html

Effect of electroacupuncture on blood pressure and quality ... The findings suggest that acupuncture may lower the BP and HR by increasing vagal nerve activity in cases with mild to moderate HTN. When the patient has a ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00932139

Effect of Electro-Acupuncture on Blood Pressure The purpose of this study is to prove: (1) hypertensive response at rest and provoked by stress are decreased by EA; (2) The mechanisms of EA that reduces ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10262041/

Sympathoinhibitory electroacupuncture (EA) interacts ... Anti-inflammatory EA (AI-EA) treatment slows down the advancement of high blood pressure primarily through the alleviation of chronic inflammation. On the ...

7. researchgate.net researchgate.net/publication/371509959_Sympathoinhibitory_electroacupuncture_EA_interacts_positively_with_anti-inflammatory_EA_alleviating_blood_pressure_in_hypertensive_rats

Sympathoinhibitory electroacupuncture (EA) interacts ... Sympathoinhibitory electroacupuncture (EA) interacts positively with anti-inflammatory EA alleviating blood pressure in hypertensive rats.

8. journals.lww.com journals.lww.com/md-journal/fulltext/2022/11110/effectiveness_and_safety_of_electroacupuncture_for.66.aspx

Effectiveness and safety of electroacupuncture for... This review aims to assess the efficacy and safety of EA in AS treatment at home and abroad to provide evidence-based medicine for clinical practice.

9. e-century.us e-century.us/files/ajtr/14/1/ajtr0137585.pdf

ajtr0137585.pdf Accordingly, this study explores the clinical efficacy and safety of electro-acupuncture (EA) combined with beraprost sodium (BPS) and α-lipoic acid (α-LA) in ...

10. frontiersin.org frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2023.1207137/full

Electroacupuncture relieves portal hypertension by ... Electroacupuncture relieves portal hypertension by improving vascular angiogenesis and linking gut microbiota in bile duct ligation rats.