Acupuncture for Chronic Nausea in Pts with HIV: A RCT

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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.