Acu/Moxa for Peripheral Neuropathy in Pts with HIV

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DESCRIPTION (provided by applicant): This proposal will test the use of a Traditional Chinese Medicine (TCM) approach, acupuncture/moxibustion (Acu/Moxa), to reduce the severity of pain associated with distal symmetric peripheral neuropathy (DSP) among persons with HIV/AIDS. DSP is the most frequent neurologic complication of HIV infection. The etiologies recognized to cause DSP include neurotoxic side effects of medications, advanced immunosuppression, and nutritional deficiency. Treatments prescribed to manage the pain associated with DSP, such as nonnarcotic and narcotic analgesics, antidepressants and anticonvulsants, are largely ineffective. Therefore, non-invasive Acu/Moxa treatment may serve as a valuable adjunctive therapy with conventional medical interventions to manage DSP. To date, there have been five published studies using acupuncture for peripheral neuropathy in persons with HIV/AIDS. However, they exhibited several flaws, and lacked the scientific rigor to adequately evaluate the treatment. Despite the paucity of well-designed randomized, controlled, blinded studies on acupuncture for DSP in HIV, there is substantial information regarding the physiological effects of acupuncture on the neurological system. Furthermore, no studies examined the use of acupuncture with moxibustion (artemisia vulgaris) for DSP. In TCM, acupuncture and moxibustion complement each other to form one mode of therapy. This proposal will establish the feasibility and provide foundation for designing a larger clinical trial. The proposed feasibility study is a sample-size-limited, randomized, blinded (subject and evaluator), sham acupuncture/placebo moxibustion (Sham Acu/Placebo Moxa) controlled clinical trial. The subjects in this pilot study will be 50 men and women with HIV infection who have a diagnosis of DSP. Subjects will be randomized to one of two experimental intervention conditions: Condition 1, subjects receive Acu/Moxa Treatment, and Condition 2, (Control Group), subjects receive Sham Acu/Placebo Moxa. All subjects in Conditions 1 & 2 will attend 16 scheduled sessions over 15 weeks, be administered the same instruments, and submit their daily symptom diaries for analysis. There will be six weeks of twice weekly treatment sessions, and three follow-up sessions at weeks 9, 11 and 15. All conditions will be identical in duration and be administered by licensed acupuncturists trained in TCM. Data from daily symptom diaries and questionnaires will be analyzed with mixed model analysis of variance for between-group difference in the temporal pattern of symptom reduction at baseline, after 6 weeks of twice weekly treatment, and after 2, 4, and 8 weeks of no-treatment follow-ups. In addition, exploratory analyses will assess the logistics of a CAM clinical trial for HIV/AIDS related DSP in preparation of a larger clinical trial. In response to RFA-AT-05-004, the investigators will evaluate the role of Acu/Moxa in reducing the symptoms of DSP related to HIV/AIDS and treatment side effects. The effects of symptom reduction on quality of life will also be examined. In addition, this application originates from an institution with a NIH Center for AIDS Research (CFAR) and a supportive community network.