Acupuncture for Chronic Nausea in Pts with HIV: A RCT

描述(由申请者提供)：这项提案将测试一种传统中医方法-针灸的使用，以减轻HIV阳性患者慢性恶心的严重程度。恶心是HIV疾病的常见症状。尽管由于新的药物鸡尾酒，与艾滋病毒/艾滋病相关的OLL已经减少，但这些药物中的许多都有恶心的副作用。在这一群体中，针对恶心开出的止吐药通常无效。针灸在作为常规药物干预的辅助疗法来管理慢性恶心方面表现出了希望。在亚洲国家，针灸已被广泛用于治疗各种胃肠道疾病。到目前为止，只有1篇发表的报告使用针灸来治疗艾滋病毒/艾滋病患者的Gl症状，包括恶心，然而这项研究缺乏严谨性。尽管缺乏关于针灸治疗HIV患者恶心的精心设计的研究，但有大量关于针灸对胃肠道系统的生理影响的信息。从文献中获得的信息、研究团队的临床经验和我们的初步研究为进行针灸治疗艾滋病毒/艾滋病患者慢性恶心的严格对照临床试验提供了坚实的基础。该研究是一项随机、盲法(受试者和评估者)、假针灸对照临床试验。在拟议的实验中，受试者将是159名艾滋病毒感染的男性和女性，他们有3个月或更长时间的慢性恶心病史，表现出2次或更多恶心发作的证据，和/或在为期2周的预期基线症状日记中报告持续2小时或更长时间(每天)。将受试者随机分为3个条件：条件1，受试者接受标准针灸；条件2，受试者根据中医诊断和穴位处方接受个体化针灸；条件3，(对照组)，受试者接受假针灸。所有受试者将参加为期24周的16次预定会议；由诊断针灸医生进行评估(对治疗任务视而不见)；提交症状日记。在第12、16和24周，将有4周的每周两次治疗疗程、4次每周治疗疗程和3次随访疗程。所有情况在持续时间上都是相同的，并由受过中医培训的有执照的针灸医生进行治疗。来自每日患者日记和病例报告表的数据将用混合模型方差分析，以确定在基线、每周两次治疗4周、每周一次治疗4周和未治疗16周随访后症状缓解时间模式的组间差异。将使用多个二级相依比较的F Crit的Bonferroni调整。对“有效完成者”的二次分析将使用混合模型分析，将基线恶心严重程度作为连续协变量输入。身体症状检查表和不良事件报告中的安全指数的组间差异将与Fisher‘s精确检验和Wilcoxon符号秩法进行比较。初步研究结果和数据分析目标表明，每组53名受试者需要确保80%的功率和1%的I型错误率，以及16%的自然减员和20%的安慰剂效应。

DESCRIPTION (provided by applicant): This proposal will test the use of a Traditional Chinese Medicine (TCM) approach, acupuncture, to reduce the severity of chronic nausea among HIV positive individuals. Nausea is a common symptom with HIV disease. Although Ols associated with HIV/AIDS have decreased due to new drug cocktails, many of these drugs have nausea as a side effect. Anti-emetics prescribed for nausea are commonly ineffective in this group. Acupuncture shows promise in serving as an adjunctive therapy with conventional medical interventions to manage chronic nausea. In Asian countries, acupuncture has been widely used to treat various gastrointestinal (Gl) disorders. To date, there is only 1 published report using acupuncture for the management of Gl symptoms inclusive of nausea in persons with HIV/AIDS, however this study lacked rigor. Despite the paucity of well-designed studies on acupuncture for nausea in HIV, there is substantial information regarding the physiological effects of acupuncture on the gastrointestinal system. The information obtained from the literature, the clinical experiences of the research team and our preliminary studies provide a strong foundation to conduct a rigorous controlled, clinical trial of acupuncture for the management of chronic nausea in persons with HIV/AIDS. The proposed study is a randomized, blinded (subject and evaluator), sham acupuncture controlled clinical trial. The subjects in the proposed experiment will be 159 men and women with HIV infection who have a history of chronic nausea for 3 months or greater and show evidence of 2 or more episodes of nausea and/or report a duration of 2 hours or greater (per day) in 2-week prospective baseline symptom diaries. Subjects will be randomized to 1 of 3 conditions: Condition 1, subjects receive Standard acupuncture; Condition 2, subjects receive Individualized acupuncture based on TCM Diagnosis and point prescription; Condition 3, (Control Group), subjects receive Sham acupuncture. All subjects will attend 16 scheduled sessions over 24 weeks; assessed by a diagnostic acupuncturist (blinded to treatment assignments); submit symptom diaries. There will be 4 weeks of twice weekly treatment sessions, 4 weekly treatment sessions and 3 follow-up sessions at weeks 12, 16 and 24. All conditions will be identical in duration and be administered by licensed acupuncturists trained in TCM. Data from daily patient diaries and case report forms will be analyzed with mixed model analysis of variance for the between-group difference in the temporal pattern of symptom reduction measured at baseline, after 4 weeks of twice weekly treatment, after 4 weeks of once-weekly treatment, and after 16 weeks of non-treatment follow-up. Bonferroni adjustment of F crit for multiple secondary dependent comparisons will be used. Secondary analysis of 'valid completers' will use mixed model analysis with baseline nausea severity entered as a continuous covariate. Group differences in safety indices from physical symptom checklists and adverse event reports will be compared with Fisher's Exact test and Wilcoxon signed rank methods. Pilot study results and data analytic objectives indicate the need for 53 subjects per group to ensure 80% power < 1% Type I error rate, and 16% attrition, 20% placebo effect.