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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine if a standardized 12-point acupuncture protocol will reduce pain in participants with stable angina. This study addresses the critical need to reduce persistent pain for angina. The investigators long-term goal is symptom management for diverse women and men with angina, targeting additional angina burden borne of social disadvantage Participants will be randomized to a 10-acupuncture session protocol, two treatments per week for five weeks, or an attention control group. Participants will view designated, non-pain related Technology, Entertainment, Design Talks equal to the time spent receiving acupuncture (\~7.5-10 hrs.). The investigators will test the efficacy of acupuncture for stable angina/chest pain syndrome to reduce pain and symptoms, improve health-related quality of life, reduce healthcare utilization and and improve patient related health outcomes.

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 data supports the effectiveness of acupuncture treatment for angina?

Research shows that acupuncture can effectively relieve symptoms of angina (chest pain due to heart issues) and improve the effects of nitroglycerine, a common angina medication. It has been found to be almost as effective as conventional drugs, with the added benefit of fewer side effects. ^{1 2 3 4 5}

Is acupuncture generally safe for humans?

Acupuncture is generally considered safe, but it can have some risks. Serious side effects like organ injuries and infections are rare, while minor issues like dizziness or local reactions are more common. It's important to ensure that the acupuncturist is well-trained to minimize these risks. ^{6 7 8 9 10}

How does acupuncture treatment for angina differ from other treatments?

Acupuncture for angina is unique because it uses specific points on the body to relieve symptoms without the side effects common in conventional drugs like nitroglycerine or propranolol. It can be used alone or alongside other treatments to enhance their effects and reduce the need for medication, offering a natural alternative with fewer adverse reactions. ^{1 2 3 11 12}

Research Team

Holli A. DeVon, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of acupuncture for angina pectoris: a systematic review of randomized controlled trials. [2021]

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

Acupuncture therapy for the treatment of stable angina pectoris: An updated meta-analysis of randomized controlled trials. [2019]

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

Treating angina pectoris by acupuncture therapy. [2019]

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

Acupuncture in angina pectoris: does acupuncture have a specific effect? [2021]

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

Acupuncture as Adjunctive Therapy for Chronic Stable Angina: A Randomized Clinical Trial. [2022]

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

Safety of Acupuncture: Overview of Systematic Reviews. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Acupuncture-related adverse events: a systematic review of the Chinese literature. [2022]

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

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. [2021]

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

Meta-analysis of acupuncture therapy for the treatment of stable angina pectoris. [2020]

11. United States 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. [2023]

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

Acupuncture as an Adjunctive Treatment for Angina Due to Coronary Artery Disease: A Meta-Analysis. [2020]