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

针灸改善稳定型心绞痛症状的随机对照试验（AIMS-A）的可行性测试

• 批准号: 9794136
• 负责人: HOLLI A DEVON
• 金额: $ 19.99万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-26 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9794136
• 关键词: Academic Medical Centers; Acupuncture Therapy; Address; Adult; American; American Heart Association; Analgesics; Area; Atrial Fibrillation; Biological Markers; Chest Pain; Chinese People; Chinese Traditional Medicine; Complementary therapies; Control Groups; Coronary; Data; Diagnosis; Disease; Down-Regulation; Elements; Emotional Stress; Exertion; Goals; Guidelines; Health education; Heart Arrest; Heart Diseases; Heart failure; Hospitals; Hour; Hyperalgesia; IL8 gene; Immune; Inflammatory; Interleukin-1 beta; Interleukin-10; Interleukin-18; Interleukin-2; Interleukin-6; Location; McGill Pain Scale; Measures; Medical; Modeling; Myocardial Infarction; Myocardial Ischemia; Obstruction; Outcome; Outcome Measure; Pain; Participant; Patient Care; Patient-Focused Outcomes; Patients; Pattern; Persistent pain; Pharmaceutical Preparations; Physiological; Population; Pre-Post Tests; Prevalence; Process; Prospective Studies; Protocols documentation; Psyche structure; Public Health; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Reporting; Research; Science; Standardization; Statistical Methods; Symptoms; TNF gene; Testing; Time; Treatment Protocols; Woman; Work; associated symptom; attentional control; care outcomes; conventional therapy; cytokine; disability; experience; experimental group; functional status; group intervention; health related quality of life; impaired functional status; improved; innovation; interest; macrophage; men; mortality; novel; pain reduction; pain score; pain symptom; recruit; relating to nervous system; retention rate; satisfaction; statistics; symptom management; symptom treatment; symptomatic improvement

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.

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 测试针灸治疗的可行性和初步效率，用于稳定心绞痛患者 计算效应大小，用于测试前和测试后疼痛，相关符号， 炎症生物标志物，功能状态和HRQOL。六十九名患者有IHD和 经历稳定心绞痛的症状将从学术医学中心招募。那些有一个 确认的稳定心绞痛的诊断，并通过药物治疗至少6个月，将是随机的 分配给针灸或注意力控制组。针灸组的参与者将获得 标准化的中医（TCM）点处方。针灸将被施用2次 每周5周，共10次治疗。注意力控制小组将查看与无生气有关的健康 5周以上的教育视频等于针灸组的10小时治疗。完成后 在研究中，注意力控制组将与干预相同的针灸方案提供 团体。 McGill疼痛问卷和美国心脏协会（AHA）心绞痛将用于 测量疼痛位置，强度，质量，模式和相关符号。西雅图心绞痛问卷 - 7将用于测量疼痛，功能状态和HRQOL以外的其他症状。参与者将完成 心绞痛疼痛的度量（与现在的疼痛相比，平均疼痛，最严重的疼痛和过去24小时的疼痛最小） 和每次针灸治疗之前的AHA心绞痛对数。将测量平均疼痛和“疼痛” 每次处理后。招聘，保留，数据完成和患者的结果指标 可接受性将在研究结束时衡量。可行性，定义为招聘和保留 利率> 75％，可接受性（> 80％可接受）将使用描述性统计数据进行分析。效应大小将 计算有关测试前和测试后疼痛，症状和HRQOL的差异。疼痛的结果变量， 症状，功能状态和HRQOL将使用混合回归模型进行分析，以确定是否存在 如果效应大小很大，则是针灸的重大好处。症状管理对于减少至关重要 残疾和心绞痛患者的HRQOL。

项目成果

Feasibility and preliminary efficacy of acupuncture for angina in an underserved diverse population.

• DOI: 10.1177/09645284211055754
• 发表时间: 2022-04
• 期刊: Acupuncture in medicine : journal of the British Medical Acupuncture Society
• 作者: DeVon HA;Uwizeye G;Cai HY;Shroff AR;Briller JE;Ardati A;Hoppensteadt D;Rountree L;Schlaeger JM
• 通讯作者: Schlaeger JM

Acupuncture as an adjunctive therapy for stable angina.

• DOI: 10.1177/0964528420905841
• 发表时间: 2020-08
• 期刊: Acupuncture in medicine : journal of the British Medical Acupuncture Society
• 作者: DeVon HA;Schlaeger JM;Briller JE
• 通讯作者: Briller JE

Adverse Pregnancy Outcomes and Downstream Risk of Coronary Microvascular Disease.

不良妊娠结局和冠状动脉微血管疾病的下游风险。

• DOI: 10.1089/jwh.2019.8218
• 发表时间: 2020
• 期刊: Journal of women's health (2002)
• 作者: DeVon,HolliA;Schlaeger,JudithM
• 通讯作者: Schlaeger,JudithM