Acu/Moxa for Peripheral Neuropathy in Pts with HIV

描述（由申请人提供）：本提案将测试使用传统中医（TCM）方法，针灸/艾灸（Acu/艾草），以减轻HIV/AIDS患者远端对称性周围神经病变（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。公认的引起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。治疗与DSP相关的疼痛的处方，如非麻醉性和麻醉性镇痛药，抗抑郁药和抗惊厥药，在很大程度上是无效的。因此，非侵入性Acu/艾草治疗可作为一种有价值的替代疗法，与传统的医疗干预来管理DSP。到目前为止，已经有五个发表的研究使用针灸周围神经病变的人与艾滋病毒/艾滋病。然而，他们表现出几个缺陷，缺乏科学的严谨性，以充分评估治疗。尽管缺乏设计良好的随机，对照，盲法研究针灸DSP在艾滋病毒，有大量的信息针灸对神经系统的生理作用。此外，没有研究检查针灸（艾蒿）用于DSP。在中医学中，针灸与艾灸相辅相成，形成一种治疗模式。该方案将为设计更大规模的临床试验奠定可行性和基础。 拟定的可行性研究是一项样本量有限、随机化、设盲（受试者和评价者）、假针灸/安慰剂灸（Sham Acu/Placebo艾草）对照临床试验。本初步研究的受试者为50名诊断为DSP的HIV感染男性和女性。将受试者随机分配至两种实验干预条件之一：条件1，受试者接受Acu/艾草治疗，条件2（对照组），受试者接受假Acu/安慰剂艾草。 条件1和条件2中的所有受试者将在15周内参加16个计划的疗程，使用相同的仪器，并提交其每日症状日记进行分析。将有六周的每周两次治疗，并在第9、11和15周进行三次随访。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来自每日症状日记和问卷的数据进行分析，以确定基线时、每周两次治疗6周后以及无治疗随访2、4和8周后症状减轻时间模式的组间差异。此外，探索性分析将评估一项针对HIV/AIDS相关DSP的CAM临床试验的后勤工作，以准备一项更大规模的临床试验。 根据RFA-AT-05-004，研究者将评价Acu/艾草在减轻与HIV/AIDS相关的DSP症状和治疗副作用方面的作用。还将检查症状减轻对生活质量的影响。此外，该应用程序来自一个拥有NIH艾滋病研究中心（CFAR）和支持社区网络的机构。

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.