Acu/Moxa for Peripheral Neuropathy in Pts with HIV

描述(由申请人提供)：这项建议将测试使用一种传统的中医方法，针灸(针灸/艾灸)，以减轻与远端对称性周围神经病(DSP)相关的疼痛严重程度的艾滋病毒/艾滋病患者。DSP是HIV感染最常见的神经系统并发症。公认的引起DSP的原因包括药物的神经毒性副作用、晚期免疫抑制和营养不足。用于治疗与DSP相关的疼痛的处方治疗，如非麻醉性和麻醉性止痛药、抗抑郁药和抗惊厥药，大多无效。因此，非侵入性针灸疗法可作为常规药物干预的一种有价值的辅助治疗方法。到目前为止，已经发表了五项使用针灸治疗艾滋病毒/艾滋病患者周围神经病变的研究。然而，他们表现出了几个缺陷，并且缺乏足够的科学严谨性来充分评估治疗。尽管缺乏设计良好的随机、对照、盲法针灸治疗HIV中的DSP的研究，但有大量关于针灸对神经系统的生理影响的信息。此外，还没有研究研究针灸(艾灸)对DSP的治疗作用。在中医中，针灸相辅相成，形成一种治疗模式。该方案为设计更大规模的临床试验奠定了可行性和基础。 建议的可行性研究是一项样本量有限、随机、盲法(受试者和评估者)、假针灸/安慰剂艾灸(假针灸/安慰剂艾灸)对照的临床试验。这项初步研究的对象将是50名感染艾滋病毒的男性和女性，他们被诊断为DSP。受试者将被随机分成两种实验干预条件之一：条件1，受试者接受针灸治疗，条件2(对照组)，受试者接受假针灸/安慰剂艾灸。 条件1和条件2的所有受试者将在15周内参加16次预定的会议，使用相同的仪器，并提交他们的每日症状日记以供分析。为期六周的每周两次治疗，以及在第9、11和15周的三次后续治疗。所有情况都将持续相同的时间，并由受过中医培训的有执照的针灸医生进行治疗。 来自每日症状日记和问卷的数据将在基线、每周两次治疗6周以及非治疗2周、4周和8周随访后用混合模型方差分析组间症状缓解时间模式的差异。此外，探索性分析将评估针对艾滋病毒/艾滋病相关数字信号处理器的CAM临床试验的后勤，以准备一项更大的临床试验。 作为对RFA-AT-05-004的回应，研究人员将评估Acu/Moxa在减少与艾滋病毒/艾滋病相关的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，这一申请来自一家拥有美国国立卫生研究院艾滋病研究中心(CFAR)和支持性社区网络的机构。

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.