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

针灸对稳定型心绞痛症状的影响：一项随机对照试验

• 批准号: 10588045
• 负责人: HOLLI A DEVON
• 金额: $ 78.59万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10588045
• 关键词: Academic Medical Centers; Acupuncture Points; Acupuncture Therapy; Address; Adult; American; American Heart Association; Analgesics; Area; Arrhythmia; Atrial Fibrillation; Autonomic nervous system; Black Populations; Blood Vessels; Brain Stem; Cardiac; Cardiology; Cardiovascular system; Charge; Chest Pain; Chinese; Chinese Traditional Medicine; Clinic; Complementary therapies; Control Groups; Coronary; Data; Diagnosis; Dimensions; Disease; Elements; Emotional Stress; Enrollment; Exercise; Exertion; Frequencies; Goals; Guidelines; Health; Healthcare; Heart Arrest; Heart Diseases; Heart Rate; Heart failure; Hospitalization; Hospitals; Hour; Hyperalgesia; Immune; Infarction; Inflammatory; Integrative Therapy; Ischemia; Location; McGill Pain Scale; Measures; Mediating; Medical; Menopausal Status; Minority Groups; Modeling; Myocardial Infarction; Myocardial Ischemia; Obstruction; Outcome; Outcome Measure; Pain; Pain intensity; Participant; Patient Care; Patient-Focused Outcomes; Patients; Pattern; Persistent pain; Pharmaceutical Preparations; Pharmacotherapy; Physiological; Pilot Projects; Placebo Effect; Population; Prevalence; Process; Prospective Studies; Protocols documentation; Psyche structure; Qualifying; Quality of life; Questionnaires; Randomized; Randomized, Controlled Trials; Recording of previous events; Reporting; Research; Science; Severities; Standardization; Statistical Methods; Symptoms; Syndrome; Testing; Treatment Protocols; United States; Woman; Work; associated symptom; attentional control; blood pressure reduction; care outcomes; disability; efficacy evaluation; efficacy testing; experience; experimental group; functional status; group intervention; health assessment; health care service utilization; health inequalities; health related quality of life; health service use; impaired functional status; improved; innovation; men; mortality; neural; novel; pain reduction; pain symptom; primary outcome; recruit; secondary outcome; sex; social disparities; symptom management; symptom treatment; symptomatic improvement; treatment effect; treatment group; video session

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.

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 测试针灸治疗稳定型心绞痛/胸痛综合征对疼痛和症状控制的疗效， 相关的生活质量，医疗保健利用，PROMIS测量患者的健康结果，并描述 针灸治疗和安慰剂效应的持续时间长达12周。112名患者 因IHD住院并出现稳定型心绞痛症状的患者将从2名学术医学研究人员中招募 中心.确诊为稳定型心绞痛，每周至少出现一次症状的患者， 并接受药物治疗至少1个月，将被随机分配到针灸或关注 对照组针灸组的参与者将接受标准化的传统中药 (TCM)穴位处方针灸将每周进行2次，持续5周，共10次 治疗。注意力控制组将在大约5周内观看与疼痛无关的TED演讲视频 相当于针刺组治疗10小时。与会者将与研究 工作人员回答与视频有关的问题。研究完成后，注意力控制组将 免费提供与干预组相同的针灸方案。的麦吉尔疼痛问卷 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。Froelicher的《医疗保健利用指南-修订版》将用于 评估医疗保健使用。西雅图心绞痛问卷-7将用于测量除 疼痛、功能状态和HRQoL。PROMIS-29 v2将评估患者报告的健康结局。 参与者将完成心绞痛的测量（现在的疼痛，最严重的疼痛和自上次会议以来的疼痛）， 每次针灸治疗前的AHA心绞痛日志。每次治疗后将测量疼痛。 研究人员将每周联系参与者，持续长达12周或直到疼痛恢复到基线，以评估 心绞痛发作的频率和严重程度。结果变量包括疼痛、症状、功能状态， 将使用混合回归模型分析医疗保健利用、HRQoL和PROMIS健康结局 来确定针灸的疗效症状管理对于减少残疾和改善 心绞痛患者的健康状况。