Key result
Acupuncture trial evaluates feasibility, pain, and quality of life in stable angina.
Why the study?
Acupuncture has demonstrated analgesic effects in Chinese patients with stable angina, but testing is needed in American patients, who vary in healthcare systems and other salient variables.
Does a 10-session, 5-week acupuncture treatment protocol improve anginal pain and quality of life in adults with stable angina not controlled by guideline-directed medical management?
RCT (n=69)
Open-label
1:1 permuted block, stratified by biological sex
No
Does a 10-session, 5-week acupuncture treatment protocol improve anginal pain and quality of life in adults with stable angina not controlled by guideline-directed medical management?
This protocol outlines a feasibility study to evaluate a 10-session acupuncture treatment protocol as a complementary therapy for symptom management in American patients with stable angina.
Acupuncture remains investigational for refractory stable angina; this RCT protocol leaves open its feasibility and efficacy in US patients.
Background Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for these analgesic effects is the downregulation of M1 macrophages, interleukin 1 beta, interleukin-6, interleukin-18, and tumor necrosis factor alpha. Objective This study aims to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in health care systems and other salient variables. Methods We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized traditional Chinese medicine point prescription. The attention control group will view non–pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. The primary outcomes are anginal pain and quality of life. Results This study has been funded over 2 years by the National Institutes of Health, National Institute for Nursing Research. We are currently recruiting and expect to have initial results by December 2020. Conclusions We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a proinflammatory state and hyperalgesia caused by multiple neural and immune processes not always relieved with medication. International Registered Report Identifier (IRRID) DERR1-10.2196/14705
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Schlaeger et al. (2019) conducted an RCT in Stable angina (n=69). Acupuncture vs. Attention control (health education videos) was evaluated on Feasibility, anginal pain, and quality of life. Acupuncture will be evaluated in a 69-patient randomized controlled trial to determine its feasibility and effect on pain and quality of life in patients with stable angina.
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