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) 死亡率显着下降了 32.7%，但 稳定型心绞痛没有减少。稳定型心绞痛定义为在劳累时或劳累时出现可预测的胸痛。 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部分阻塞。 变化并带来严重的终生后果，包括心力衰竭、心房颤动、再梗塞、 近 900 万美国人患有稳定型心绞痛，心脏病现在是最主要的疾病。 全球范围内的残疾调整疾病与多种症状、功能受损有关。 健康相关生活质量 (HRQoL) 下降。这项随机对照试验的目的是 检验针灸治疗稳定型心绞痛患者的可行性和初步疗效， 计算测试前和测试后疼痛、相关症状的组间差异的效应大小， 炎症生物标志物、功能状态和 HRQoL 69 名因 IHD 住院的患者 稳定型心绞痛症状将从学术医疗中心招募。 确诊为稳定型心绞痛，并接受至少 6 个月的药物治疗，将被随机分组 分配到针灸组或注意力对照组的参与者将收到一份报告。 规范中医穴位处方2次。 每周进行 5 周，总共 10 次治疗；注意力对照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灸组 10 小时的治疗完成后。 在研究中，注意力对照组将接受与干预组相同的针灸方案 麦吉尔疼痛问卷和美国心脏协会 (AHA) 心绞痛日志将用于 测量疼痛位置、强度、性质、模式和相关症状。 7 将用于测量除疼痛之外的症状、功能状态和 HRQoL 参与者将完成。 心绞痛的测量（平均疼痛比较；现在的疼痛、最严重的疼痛和过去 24 小时内最轻的疼痛） 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”。 每次治疗后的招募、保留、数据完成和患者的结果测量。 可行性将在研究结束时进行衡量，定义为招募和保留。 将使用描述性统计数据分析比率 >75% 和可接受性（>80% 可接受）。 计算测试前和测试后疼痛、症状和 HRQoL 的差异。 将使用混合回归模型分析症状、功能状态和 HRQoL，以确定是否存在 如果效果很大，那么针灸的好处就很明显，症状管理对于减少症状至关重要。 残疾并改善心绞痛患者的 HRQoL。

项目成果

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。

• 发表时间: 2020
• 作者: DeVon, Holli A;Schlaeger, Judith M
• 通讯作者: Schlaeger, Judith M

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

在服务不足的多元化人群中针灸治疗心绞痛的可行性和初步疗效。

• 发表时间: 2022-04
• 作者: DeVon, Holli A;Uwizeye, Glorieuse;Cai, Hui Yan;Shroff, Adhir R;Briller, Joan E;Ardati, Amer;Hoppensteadt, Debra;Rountree, Lauren;Schlaeger, Judith M
• 通讯作者: Schlaeger, Judith M

Acupuncture as an adjunctive therapy for stable angina.

针灸作为稳定型心绞痛的辅助治疗。

• 发表时间: 2020
• 作者: DeVon, Holli A;Schlaeger, Judith M;Briller, Joan E
• 通讯作者: Briller, Joan E

Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial.

针灸改善稳定型心绞痛症状：随机对照试验方案。

• 发表时间: 2019-07-29
• 影响因子: 1.7
• 作者: Schlaeger, Judith;Cai, Hui Yan;Steffen, Alana D;Angulo, Veronica;Shroff, Adhir R;Briller, Joan E;Hoppensteadt, Debra;Uwizeye, Glorieuse;Pauls, Heather A;Takayama, Miho;Yajima, Hiroyoshi;Takakura, Nobuari;DeVon, Holli A
• 通讯作者: DeVon, Holli A