Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

针灸和放松疗法对胃肠道症状和艾滋病毒药物依从性的影响

基本信息

批准号：
7490608
负责人：
Bei-Hung Chang
金额：
$ 14.3万
依托单位：
BOSTON UNIVERSITY MEDICAL CAMPUS
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-30 至 2011-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7490608
关键词：
AIDS/HIV problem Abdominal Pain Acupuncture Points Acupuncture procedure Adherence Adverse effects Anesthesia procedures Area Audiotape Blinded Chemotherapy-Oncologic Procedure Chinese Traditional Medicine Chronic Clinical Clinical Medicine Combined Modality Therapy Complement Complex Condition Daily Data Depth Diarrhea Disease Drug Costs Enrollment Equation Feces Frequencies Gases HIV HIV Seropositivity Hand Health education Healthcare High Prevalence Highly Active Antiretroviral Therapy Home environment Individual Instruction Intervention Intervention Studies Intervention Trial Lead Life Literature Measures Medical Methods Modeling Music Nature Nausea and Vomiting Neurologic Numbers Operative Surgical Procedures Outcome Measure Outcome Study Outpatients Oxygen Consumption Participant Patient Self-Report Patients Personal Satisfaction Pharmaceutical Preparations Pharmacy facility Physiological Protease Inhibitor Quality of life Questionnaires Randomized Randomized Controlled Trials Range Rate Records Recruitment Activity Relaxation Reporting Research Research Design Research Personnel Rest Self-Administered Severities Shame Signs and Symptoms Symptoms Techniques Testing Therapeutic Effect Treatment Protocols Upper arm Visit Week base body-mind cohort cost day design diaries experience fighting follow-up gastrointestinal gastrointestinal symptom improved interest medication compliance member pill response sound treatment effect

项目摘要

DESCRIPTION (provided by applicant): HIV/AIDS has become a chronic and manageable condition due to the use of combination therapy introduced in the mid-1990's. Despite this pharmacological advancement, people living with HIV/AIDS (PLWA) continue to experience a wide range of symptoms associated with clinical manifestations of HIV disease, related opportunistic conditions, and side effects from medications. Gastrointestinal symptoms are particularly prevalent and are often the side effect of the combination therapies. Due to the high prevalence of digestive side effects, adherence to the combination therapy is a great concern. The efficacy of acupuncture and the relaxation response (RR) in managing various prevalent symptoms among PLWA has been demonstrated in other studies and yet their use either alone or in combination on improving medication adherence through symptom reduction remain unexplored. We propose to recruit 80 PLWA for a 4-arm, single blinded, parallel randomized controlled trial to evaluate the individual and combined effects of acupuncture and the RR on reducing digestive symptoms, increasing medication adherence, and improving quality of life for PLWA. We will also explore the mechanism of acupuncture and the RR through oxygen consumption reduction. Enrolled patients will listen to tapes while receiving acupuncture treatment. We will use a 2x2 study design with 2 types of acupuncture points (symptom specific vs. sham) and 2 types of audiotapes (RR vs. control). Treatment will be provided twice weekly for 4 weeks and once weekly for another 4 weeks on an out-patient basis. The study outcomes are digestive symptom severity rating, medication adherence, and quality of life measures. Participants will use daily diaries to record symptom severity, as well as the number of combination-therapy pills taken each day at baseline and during the study period. Adherence will also be assessed from pharmacy refill records. Quality of Life questionnaires will be administered at baseline and upon the completion of the study. Oxygen consumption will be measured during the last treatment. Study outcome measures will be administrated again at the 6-month follow-up. We will use both the generalized estimating equation approach and random effects model to analyze the diary data. Our proposed study can contribute to the improvement of the well-being of PLWA and help to understand the mechanism of the therapeutic effects of these two remedies.

描述（由申请人提供）：由于 20 世纪 90 年代中期引入的联合疗法的使用，艾滋病毒/艾滋病已成为一种慢性且可控制的疾病。尽管药理学取得了这一进步，艾滋病毒/艾滋病患者 (PLWA) 仍然会经历与艾滋病毒临床表现、相关机会性病症和药物副作用相关的各种症状。胃肠道症状尤其普遍，并且通常是联合疗法的副作用。由于消化道副作用的发生率很高，坚持联合治疗是一个很大的问题。针灸和放松反应（RR）在治疗 PLWA 中各种常见症状方面的功效已在其他研究中得到证实，但它们单独或组合使用以通过减轻症状来提高药物依从性仍有待探索。我们建议招募 80 名 PLWA 进行一项 4 组、单盲、平行随机对照试验，以评估针灸和 RR 对减轻 PLWA 消化症状、提高药物依从性和改善生活质量的个体和组合效果。我们还将探讨针灸和通过减少耗氧量进行RR的机制。登记的患者将在接受针灸治疗时听录音带。我们将使用 2x2 研究设计，其中包括 2 种类型的针灸点（特定症状与假治疗）和 2 种录音带（RR 与对照）。治疗将在门诊每周两次，持续 4 周，每周一次，持续 4 周。研究结果是消化症状严重程度评级、药物依从性和生活质量衡量。参与者将使用每日日记来记录症状的严重程度，以及基线和研究期间每天服用的联合治疗药物的数量。还将根据药房补充记录评估依从性。将在基线和研究完成后进行生活质量调查问卷。将在最后一次治疗期间测量耗氧量。研究结果测量将在 6 个月的随访中再次进行。我们将使用广义估计方程方法和随机效应模型来分析日记数据。我们提出的研究有助于改善 PLWA 的福祉，并有助于了解这两种疗法的治疗作用机制。