Acu/Moxa for Peripheral Neuropathy in Pts with HIV

描述（由申请人提供）：该提案将测试使用中医（TCM）方法，针灸/艾灸（Acu/Moxa），以减轻艾滋病毒/艾滋病患者远端对称周围神经病变（DSP）相关疼痛的严重程度。DSP是HIV感染最常见的神经系统并发症。引起DSP的病因包括药物的神经毒性副作用、晚期免疫抑制和营养缺乏。用于控制与DSP相关的疼痛的治疗方法，如非麻醉性和麻醉性镇痛药、抗抑郁药和抗惊厥药，大多无效。因此，无创Acu/Moxa治疗可以作为一种有价值的辅助治疗，与传统的医疗干预来管理DSP。迄今为止，已有五篇已发表的研究使用针灸治疗艾滋病毒/艾滋病患者的周围神经病变。然而，他们表现出了一些缺陷，并且缺乏充分评估治疗的科学严谨性。尽管缺乏精心设计的随机、对照、盲法研究，但关于针灸对神经系统的生理影响有大量信息。此外，尚无研究考察针刺结合艾草治疗DSP的效果。在中医中，针灸与针灸相辅相成，形成一种治疗方式。该建议将为设计更大规模的临床试验奠定可行性和基础。

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.