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.

抽象的 尽管自1999年以来，缺血性心脏病（IHD）死亡率下降了32.7％，但患病率的流行 稳定的心绞痛没有改善。稳定的心绞痛定义为劳累或下方的可预测的胸痛 精神或情感压力。稳定的心绞痛表示冠状动脉流或微血管的部分目标 变化并带来很大的终生后果，包括心力衰竭，心房颤动，重新孔， 和心脏骤停。近900万美国人患有稳定的心绞痛，心脏病现在是领先的 全球残疾调整的疾病。稳定的Anina与多种症状有关，功能受损 地位，降低与健康相关的生活质量（HRQOL）。这项随机对照试验的目的是 测试针灸稳定心绞痛/胸痛综合征对疼痛和症状控制的效率 相关的生活质量，医疗保健利用，Promis测量了患者的健康结果，并描述了 针灸治疗的持续时间和安慰剂作用长达12周。一百十二例患者 用IHD住院并经历稳定心绞痛的症状，将从2个学术医学中招募 中心。那些确认稳定心绞痛的人，每周至少出现一次症状， 并通过药物治疗至少1个月，将随机分配给针灸或注意力 对照组。针灸组的参与者将获得标准化的中药 （TCM）点处方。针灸将每周2次服用5周，总计10周 治疗。注意控制小组将在大约5周内观看无生病的TED谈话视频 等于针灸组的10小时治疗。然后，参与者将与研究会面 工作人员回答与视频有关的问题。研究完成后，注意力控制组将是 提供与干预组相同的针灸方案。麦吉尔痛苦问卷 美国心脏协会（AHA）心绞痛将用于测量疼痛位置，强度，质量， 模式和相关症状。 Froelicher的医疗保健利用问卷REV。将习惯 评估医疗保健使用。西雅图心绞痛调查表7将用于测量以外的其他症状 疼痛，功能状态和HRQOL。 Promis-29V2将评估患者报告的健康结果。 参与者将完成心绞痛疼痛的测量（现在疼痛，最严重的疼痛和自上次课程以来）和 每次针灸治疗之前的AHA心绞痛。每次治疗后都会测量疼痛。 研究人员将每周联系参与者长达12周，或直到疼痛恢复到基线以评估 心绞痛攻击的频率和严重性。疼痛，症状，功能状态的结果变量， 将使用混合回归模型分析医疗保健利用，HRQOL和PROMIS健康结果 症状管理对于减少残疾和改善至关重要 患有心绞痛的人的健康成果。