Effects of Acupuncture on Symptoms of Stable Angina: A Randomized Controlled Trial

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Abstract Despite a notable 32.7% decline in mortality from ischemic heart disease (IHD) since 1999, the prevalence of stable angina has not decreased. Stable angina is defined as predictable chest pain on exertion or under mental or emotional stress. Stable angina signifies partial obstruction of coronary flow or microvascular changes and comes with substantial lifetime consequences including heart failure, atrial fibrillation, reinfarction, and cardiac arrest. Nearly 9 million Americans have stable angina and heart disease is now the leading disability-adjusted disease globally. Stable angina is associated with multiple symptoms, impaired functional status, and reduced health-related quality of life (HRQoL). The aims of this randomized controlled trial are to test the efficacy of acupuncture for stable angina/chest pain syndrome on pain and symptom control, health- related quality of life, healthcare utilization, PROMIS measured patient health outcomes and to describe the duration of the acupuncture treatment and placebo effects for up to 12 weeks. One hundred twelve patients hospitalized with IHD and experiencing symptoms of stable angina will be recruited from 2 academic medical centers. Those with a confirmed diagnosis of stable angina, experiencing symptoms at least once per week, and treated with medical therapy for at least 1 month, will be randomly assigned to acupuncture or an attention control group. 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. The attention control group will view non-pain related TED Talk videos over 5 weeks approximately equal to the 10 hours of treatment for the acupuncture group. The participants will then meet with research staff to answer questions related to the videos. Upon completion of the study, the attention control group will be offered the same acupuncture protocol as the intervention group at no charge. The McGill Pain Questionnaire and the American Heart Association (AHA) Angina Log will be used to measure pain location, intensity, quality, pattern and associated symptoms. Froelicher’s Healthcare Utilization Questionnaire-Rev. will be used to assess healthcare use. The Seattle Angina Questionnaire-7 will be used to measure symptoms other than pain, functional status, and HRQoL. The PROMIS-29v2 will assess patient-reported health outcomes. Participants will complete measures of anginal pain (pain now, worst pain, & pain since the last session) and the AHA Angina Log before each acupuncture treatment. Pain will be measured after each treatment. Research staff will contact participants weekly for up to 12 weeks or until pain returns to baseline to assess the frequency and severity of anginal attacks. The outcome variables of pain, symptoms, functional status, healthcare utilization, HRQoL, and PROMIS health outcomes will be analyzed using mixed regression models to determine the efficacy of acupuncture. Symptom management is critical for reducing disability and improving health outcomes for those with angina.