Acupuncture for Chronic Nausea in Pts with HIV: A RCT

描述（由申请人提供）：该提案将测试使用传统中医（TCM）方法，针灸，以减少HIV阳性个体慢性恶心的严重程度。恶心是艾滋病的常见症状。虽然与艾滋病毒/艾滋病有关的OLS由于新的药物鸡尾酒而减少，但这些药物中的许多药物都有恶心的副作用。用于治疗恶心的止吐药在这组患者中通常无效。针灸显示出作为一种与传统医疗干预措施相结合的治疗慢性恶心的前景。在亚洲国家，针灸已被广泛用于治疗各种胃肠道（GI）疾病。迄今为止，只有1篇发表的报告使用针灸治疗HIV/AIDS患者的胃肠道症状（包括恶心），但该研究缺乏严谨性。尽管针灸治疗艾滋病患者恶心的设计良好的研究很少，但关于针灸对胃肠道系统的生理作用有大量的信息。从文献中获得的信息，研究小组的临床经验和我们的初步研究提供了一个坚实的基础，进行严格的控制，针灸治疗慢性恶心的HIV/AIDS患者的临床试验。拟定研究是一项随机、设盲（受试者和评价者）、假针灸对照临床试验。拟定实验中的受试者将是159名HIV感染的男性和女性，他们有3个月或更长时间的慢性恶心史，并在2周前瞻性基线症状日记中显示2次或更多次恶心发作的证据和/或报告持续时间为2小时或更长（每天）。受试者将被随机分配至3种条件之一：条件1，受试者接受标准针灸;条件2，受试者接受基于中医诊断和穴位处方的个体化针灸;条件3，（对照组），受试者接受假针灸。所有受试者将在24周内参加16个计划的疗程;由诊断性针灸师（对治疗分配设盲）进行评估;提交症状日记。将有4周的每周两次治疗，4周的每周一次治疗和3次随访（第12、16和24周）。所有条件将是相同的持续时间和管理由持牌针灸师在中医训练。将采用混合模型方差分析对每日患者日记和病例报告表中的数据进行分析，以确定基线时、每周两次治疗4周后、每周一次治疗4周后和16周非治疗随访后测量的症状减轻时间模式的组间差异。将使用Bonferroni校正的F crit进行多重次要依赖性比较。“有效完成者”的次要分析将使用混合模型分析，基线恶心严重程度作为连续协变量输入。将采用Fisher精确检验和Wilcoxon符号秩方法比较来自身体症状检查表和不良事件报告的安全性指数的组间差异。初步研究结果和数据分析目标表明，每组需要53名受试者，以确保80%的把握度< 1%的I型错误率，16%的损耗，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.