Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial

Abstract

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

Acupuncture therapy for stable angina pectoris: a systematic review and meta-analysis

“…The quality of these outcomes was low and very low, thus, we could not come to a firm conclusion. Acupuncture has physiologic analgesic effects [41], and our study indicated that acupuncture on DAM could effectively improve SAP. Nevertheless, the mechanisms have not yet comprehensively explained.…”

Acupuncture as an adjunctive therapy for stable angina

“…We are currently pilot testing a standardized acupuncture prescription (Figure 1), similar to the protocol of Zhao et al, 9 in a diverse sample of Americans in our Acupuncture to Improve Symptoms for Angina (AIMS-A) study. 10…”

Acupuncture: Could it be a treatment for angina pectoris?

“…Nonetheless, in assessing the effects of acupuncture, undoubtedly, the major and yet unsolved problem is the placebo effect. 4,5 Even with the sham group, such a placebo effect cannot be ruled out; however, it may occur more frequently in patients who undergo the standard medical therapy alone. The study by Yang et al 5 involved patients who underwent the standard medical therapy.…”

“…2 Among such non-pharmacological treatments for angina pectoris, interest in acupuncture seems to be increasing recently, due to its efficacy. [4][5][6] Therefore, we focus on acupuncture as an additional treatment procedure for angina pectoris.…”

“…It has been shown that acupuncture regulates the autonomic nervous system and reduces sympathetic stimulation to the heart and vasculature by modulating the midbrain; endorphins and dynorphins are released, decreasing the production of norepinephrine and epinephrine. 4 Experimental and human evidence has shown that acupuncture prevents endothelial dysfunction 7 and inflammation, 4 increases blood flow, 8,9 protects myocardial reperfusion injury 10 and improves cardiac function. 11 Because of these favorable effects on the cardiovascular system, acupuncture may be effective against angina pectoris.…”