Acupuncture for Angina

(EASE Trial)

Overseen By Peter Cabezas

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Steroids, Prescription analgesics

Disqualifiers: Pregnancy, Physical limitations, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 5 weeks

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if acupuncture can reduce pain in individuals with stable angina, a condition causing chest pain or discomfort. Participants will either receive acupuncture treatments or watch non-pain-related TED Talks for an equal duration. The goal is to assess whether acupuncture improves pain, quality of life, and health outcomes for those with persistent angina. Individuals who have experienced stable angina for at least a month and have weekly symptoms may be suitable for this study. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance pain management strategies for stable angina.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use steroid or prescription pain medications.

What prior data suggests that this acupuncture protocol is safe for angina patients?

Research has shown that acupuncture is generally safe for treating chest pain related to angina. Several studies have found positive results with few side effects. For example, acupuncture alone effectively reduced the frequency of angina attacks. Another study found that acupuncture improved angina symptoms and heart function when combined with medication.

Reports suggest that patients tolerate acupuncture well. Used alongside standard angina treatments, it has shown more benefits than medication alone. These studies did not report any serious side effects, indicating that acupuncture is a promising option for safely managing angina symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using acupuncture for angina because it offers a non-drug alternative that targets the body's energy pathways, known as meridians, to potentially improve heart health. Unlike standard treatments such as nitrates, beta-blockers, or calcium channel blockers, acupuncture does not rely on medication, which means it could reduce the risk of side effects associated with pharmaceuticals. Additionally, acupuncture's unique approach of using specific needle placements might help alleviate chest pain by promoting relaxation and improving blood flow, providing a holistic option that complements conventional angina treatments.

What evidence suggests that acupuncture is effective for reducing pain in angina?

Research shows that acupuncture, which participants in this trial may receive, can help reduce chest pain caused by heart problems, known as angina. Some studies have found that acupuncture alone lowers the number of angina attacks. Other research highlights its benefits in easing symptoms and improving the quality of life for people with angina. Acupuncture has also proven more effective than standard heart treatments alone. Overall, the evidence supports acupuncture as a promising option for managing angina symptoms. ^{2 3 5 6 7}

Who Is on the Research Team?

Holli A. DeVon, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 21 with stable angina or chest pain syndrome, treated medically for at least a month and experiencing symptoms weekly. It's not suitable for those who don't meet these criteria.

Inclusion Criteria

I have been on medication for my condition for at least 1 month.

I am at least 21 years old.

I have had stable chest pain for at least 1 month.

Exclusion Criteria

I do not have autoimmune diseases or COPD.

I am currently taking steroid or prescription pain medications.

Pregnancy as some acupuncture points included in the protocol are contraindicated in pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either acupuncture or view TED talks as part of the control group, with sessions occurring twice weekly for 5 weeks.

5 weeks

10 sessions (in-person for acupuncture, virtual for control)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of pain and angina symptoms.

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture

Trial Overview

The study tests if a specific acupuncture protocol can reduce pain in stable angina patients versus an attention control group watching educational videos. Participants will receive either ten acupuncture sessions or watch videos over five weeks.

How Is the Trial Designed?

Group I: Acupuncture Experimental Treatment 1 Intervention

Participants in the acupuncture group will receive a standardized Traditional Chinese Medicine (TCM) point prescription. Acupuncture will be administered 2 times per week for 5 weeks for a total of 10 treatments.

Group II: Attention Control Group Active Control 1 Intervention

The attention control group will view non-pain related TED talk videos over 5 weeks approximately equal to 10 hours of treatment for the acupuncture group.

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

Approved in United States as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Approved in European Union as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression

Approved in China as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

In a 20-week clinical trial with 404 participants suffering from chronic stable angina, acupuncture targeting the disease-affected meridian (DAM) significantly reduced the frequency of angina attacks compared to sham acupuncture, non-affected meridian acupuncture, and no acupuncture at all.

The results showed that participants receiving DAM acupuncture experienced a greater reduction in angina attacks, with a difference of 5.63 attacks compared to the waitlist group, indicating that acupuncture can be an effective adjunctive treatment alongside standard antianginal therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture as Adjunctive Therapy for Chronic Stable Angina: A Randomized Clinical Trial. Zhao, L., Li, D., Zheng, H., et al.[2022]

Acupuncture has been shown to have a clear therapeutic effect on stable angina pectoris, with 225 clinical studies reviewed over the past 20 years supporting its efficacy.

The most commonly used acupoints for treatment include PC6, BL15, and RN17, which work through neural regulation mechanisms to relieve angina symptoms and improve heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of acupoint selection and prescription rules of acupuncture for treatment of stable angina pectoris based on a Traditional Chinese Medicine inheritance calculation platform: A systematic review. Yang, K., Zhang, L., Li, B., et al.[2023]

Acupuncture combined with anti-angina medications significantly reduced the number of patients experiencing ineffective angina relief and showed better ECG improvement compared to anti-angina medications alone, based on a review of 25 trials involving 2,058 patients.

However, acupuncture alone did not demonstrate any significant benefits over anti-angina medications alone, and the overall quality of the studies was low, indicating a need for more rigorous research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of acupuncture for angina pectoris: a systematic review of randomized controlled trials. Yu, C., Ji, K., Cao, H., et al.[2021]

A systematic review of 24 randomized controlled trials involving 1,916 patients found that acupuncture as an adjunctive treatment significantly increased the rate of marked effectiveness in managing angina due to coronary artery disease (CAD).

While acupuncture improved the markedly effective rate, it did not show a statistically significant difference in moderately effective rates compared to standard treatment alone, indicating that its primary benefit may be in enhancing treatment outcomes rather than providing a standalone solution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture as an Adjunctive Treatment for Angina Due to Coronary Artery Disease: A Meta-Analysis. Huang, X., Guo, S., Li, F., et al.[2020]

A systematic review of 115 Chinese-language articles identified 479 cases of adverse events related to acupuncture, with 14 reported deaths, highlighting significant safety concerns.

The most common adverse events included pneumothorax and infections, primarily resulting from improper techniques, indicating a need for improved monitoring and risk management in acupuncture practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: a systematic review of the Chinese literature. Zhang, J., Shang, H., Gao, X., et al.[2022]

Acupuncture has a relatively low risk of adverse events (AEs), with at least one AE occurring in about 9.31% of patients undergoing treatment, and serious adverse events (SAEs) being very rare at approximately 1.01 per 10,000 patients.

The most common minor AEs are mild reactions such as bleeding or pain at the needle site, which are often considered intended effects of acupuncture, highlighting the need for standardized assessment tools to differentiate between adverse reactions and therapeutic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. Bäumler, P., Zhang, W., Stübinger, T., et al.[2021]

Acupuncture significantly improved the relief of angina symptoms and showed better electrocardiographic outcomes compared to conventional drugs in a study of 640 patients across 8 randomized controlled trials.

While acupuncture did not significantly reduce the overall need for nitroglycerin compared to conventional treatments, it did lead to a notable decrease in nitroglycerin consumption and had no reported adverse effects, suggesting it is a safe alternative therapy for stable angina pectoris.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of acupuncture therapy for the treatment of stable angina pectoris. Zhang, Z., Chen, M., Zhang, L., et al.[2020]

In a study of 33 patients with stable angina pectoris, both genuine and sham acupuncture showed significant effects on improving symptoms, with notable improvements in exercise tolerance, anginal attack rate, and nitroglycerine consumption.

Patients who did not experience a decrease in skin temperature after acupuncture had a median improvement of 15% in exercise tolerance and a 67% reduction in anginal attacks, suggesting that acupuncture may provide additional benefits alongside standard pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture in angina pectoris: does acupuncture have a specific effect? Ballegaard, S., Meyer, CN., Trojaborg, W.[2021]

Acupuncture can lead to adverse events (AEs), including organ or tissue injuries, infections, local reactions, and other complications, with serious AEs being rare but potentially life-threatening, as highlighted by a review of 17 systematic reviews.

The overall methodological quality of the reviews on acupuncture AEs was mediocre, indicating a need for improved research standards and emphasizing the importance of patient safety and acupuncturist training in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. Chan, MWC., Wu, XY., Wu, JCY., et al.[2022]

In a study involving 1968 patients across three multicenter randomized controlled trials, only 3.76% experienced adverse events from acupuncture, indicating a low risk associated with this therapy.

The most common adverse events were minor, such as subcutaneous haematoma and needle site pain, and all but one patient recovered within two weeks, suggesting acupuncture is generally safe when performed by skilled practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Zhao, L., Zhang, FW., Li, Y., et al.[2021]

Acupuncture therapy, particularly at the PC 6 (Neiguan) point, has been shown to effectively relieve symptoms of acute angina pectoris and enhance the effects of nitroglycerine, with effectiveness rates between 80% to 96.2%, comparable to conventional drug treatments.

Unlike traditional anti-anginal medications, acupuncture has the advantage of minimal adverse side effects and does not interfere with other medications, making it a safe alternative or complementary treatment for patients with angina.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating angina pectoris by acupuncture therapy. Xu, L., Xu, H., Gao, W., et al.[2019]

Acupuncture, either alone or combined with medication, significantly improves anginal symptoms and electrocardiographic results in patients with stable angina pectoris, based on a meta-analysis of 12 randomized controlled trials involving 974 patients.

The combination of acupuncture and medication also reduces the need for nitroglycerin, suggesting that acupuncture can enhance the effectiveness of standard treatments without any reported adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture therapy for the treatment of stable angina pectoris: An updated meta-analysis of randomized controlled trials. Liu, Y., Meng, HY., Khurwolah, MR., et al.[2019]

Citations

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