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 稳定型心绞痛并未减少。稳定性心绞痛的定义是运动时或运动后可预见的胸痛。 精神或情绪上的压力。稳定性心绞痛表示冠状动脉血流或微血管部分阻塞。 改变并伴随着实质性的终生后果，包括心力衰竭、心房颤动、再梗塞， 和心脏骤停。近900万美国人患有稳定型心绞痛，心脏病现在是主要的 全球残疾调整疾病。稳定性心绞痛与多种症状、功能受损有关 健康状况恶化，健康相关生活质量下降。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及初步疗效 计算测试前和测试后疼痛、相关症状 炎性生物标记物、功能状态和HRQL。69名因IHD住院的患者和 有稳定型心绞痛症状的患者将从学术医学中心招募。那些拥有 确诊为稳定型心绞痛，并接受至少6个月的药物治疗，将是随机的。 分配到针刺组或注意对照组。针刺组的参与者将获得 规范中医穴位处方。将进行2次针灸治疗 每周治疗5周，共10次治疗。注意控制组将观察与疼痛无关的健康状况 超过5周的教育视频相当于针刺组10个小时的治疗时间。完工后 在这项研究中，注意控制组将被提供与干预相同的针灸方案 一群人。麦吉尔疼痛问卷和美国心脏协会(AHA)心绞痛日志将用于 测量疼痛的部位、强度、质量、类型和相关症状。西雅图心绞痛调查问卷- 7将用于衡量疼痛、功能状态和HRQL以外的症状。参赛者将完成 心绞痛的衡量标准(与平均疼痛相比；现在疼痛、最严重疼痛和过去24小时内最轻疼痛) 并于每次针刺治疗前进行AHA心绞痛日志检查。将测量平均疼痛和“立即疼痛” 每次治疗后。招募、保留、完成数据和患者的结果衡量标准 可接受性将在研究结束时进行衡量。可行性，定义为招聘和留住 评级&gt；75%和可接受性(&gt；80%可接受)将使用描述性统计进行分析。效果大小将 计算测试前和测试后疼痛、症状和HRQL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HRQL，以确定是否存在 如果效果很大，针灸的好处是显著的。症状管理是减少 心绞痛患者的残疾和改善的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.