Feasibility Testing of a Randomized Controlled Trial of Acupuncture to Improve Symptoms for Stable Angina (AIMS-A)

摘要

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 feasibility and preliminary efficacy of acupuncture therapy for patients with stable angina and to compute effect sizes for between group differences in pre and post-test pain, associated symptoms, inflammatory biomarkers, functional status, and HRQoL. Sixty-nine patients hospitalized with IHD and experiencing symptoms of stable angina will be recruited from an academic medical center. Those with a confirmed diagnosis of stable angina, and treated with medical therapy for at least 6 months, will be randomly assigned to the acupuncture or 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 health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Upon completion of the study, the attention control group will be offered the same acupuncture protocol as the intervention group. 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. The Seattle Angina Questionnaire- 7 will be used to measure symptoms other than pain, functional status, and HRQoL. Participants will complete measures of anginal pain (average pain compared to; pain now, worst pain, & least pain in the past 24 hours) and the AHA Angina Log before each acupuncture treatment. Average pain and “pain now” will be measured after each treatment. Outcome measures for recruitment, retention, completion of data, and patient acceptability will be measured at the conclusion of the study. Feasibility, defined as recruitment and retention rates >75%, and acceptability (>80% acceptable) will be analyzed using descriptive statistics. Effect sizes will be computed for differences in pre and post-test pain, symptoms, and HRQoL. The outcome variables of pain, symptoms, functional status, and HRQoL will be analyzed using mixed regression models to determine if there are significant benefits of acupuncture if effect sizes are large. Symptom management is critical for reducing disability and improving HRQoL for those with angina.