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

摘要 尽管自1999年以来缺血性心脏病（IHD）的死亡率显著下降了32.7%，但 稳定型心绞痛没有减少。稳定型心绞痛的定义是可预测的胸痛在努力或不足 精神或情绪压力。稳定型心绞痛意味着冠状动脉血流或微血管的部分阻塞 改变并伴随着大量的终身后果，包括心力衰竭，心房颤动，再梗死， 和心脏骤停近900万美国人患有稳定型心绞痛，心脏病现在是主要疾病。 全球范围内的残疾调整疾病。稳定型心绞痛伴有多种症状， 健康相关生活质量（HRQoL）下降。这项随机对照试验的目的是 验证针刺治疗稳定型心绞痛的可行性和初步疗效， 计算测试前后疼痛，相关症状， 炎症生物标志物、功能状态和HRQoL。69例因IHD住院的患者， 将从学术医学中心招募经历稳定型心绞痛症状的患者。者 确诊为稳定型心绞痛，并接受药物治疗至少6个月，将随机 被分配到针灸或注意力控制组。针灸组的参与者将获得 规范化中医穴位处方。针灸将进行2次 每周5次，共10次治疗。注意力控制组将观察与疼痛无关的健康状况 5周以上的教育视频相当于针灸组的10小时治疗。完成后 注意力控制组将接受与干预组相同的针灸治疗。 组McGill疼痛问卷和美国心脏协会（AHA）心绞痛日志将用于 测量疼痛位置、强度、质量、模式和相关症状。西雅图心绞痛问卷- 7将用于测量疼痛、功能状态和HRQoL以外的症状。参与者将完成 心绞痛的测量（平均疼痛与;现在疼痛，最严重的疼痛，以及过去24小时内最小的疼痛相比） 以及每次针灸治疗前的AHA心绞痛日志。将测量平均疼痛和"现在疼痛" 每次治疗后。招募、保留、完成数据和患者的结局指标 可接受性将在研究结束时进行衡量。可行性，定义为征聘和保留 率> 75%和可接受性（> 80%可接受）将使用描述性统计进行分析。效应量将 计算测试前后疼痛、症状和HRQoL的差异。疼痛的结果变量， 将使用混合回归模型分析症状、功能状态和HRQoL，以确定 如果效果很大的话，针灸的好处是显着的。症状管理对于减少 残疾和改善心绞痛患者的HRQoL。

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.