Shlay J C, Chaloner K, Max M B, Flaws B, Reichelderfer P, Wentworth D, Hillman S, Brizz B, Cohn D L
Denver Community Programs for Clinical Research on AIDS, Colo, USA.
JAMA. 1998 Nov 11;280(18):1590-5. doi: 10.1001/jama.280.18.1590.
Peripheral neuropathy is common in persons infected with the human immunodeficiency virus (HIV) but few data on symptomatic treatment are available.
To evaluate the efficacy of a standardized acupuncture regimen (SAR) and amitriptyline hydrochloride for the relief of pain due to HIV-related peripheral neuropathy in HIV-infected patients.
Randomized, placebo-controlled, multicenter clinical trial. Each site enrolled patients into 1 of the following 3 options: (1) a modified double-blind 2 x 2 factorial design of SAR, amitriptyline, or the combination compared with placebo, (2) a modified double-blind design of an SAR vs control points, or (3) a double-blind design of amitriptyline vs placebo.
Terry Beirn Community Programs for Clinical Research on AIDS (HIV primary care providers) in 10 US cities.
Patients with HIV-associated, symptomatic, lower-extremity peripheral neuropathy. Of 250 patients enrolled, 239 were in the acupuncture comparison (125 in the factorial option and 114 in the SAR option vs control points option), and 136 patients were in the amitriptyline comparison (125 in the factorial option and 11 in amitriptyline option vs placebo option).
Standardized acupuncture regimen vs control points, amitriptyline (75 mg/d) vs placebo, or both for 14 weeks.
Changes in mean pain scores at 6 and 14 weeks, using a pain scale ranging from 0.0 (no pain) to 1.75 (extremely intense), recorded daily.
Patients in all 4 groups showed reduction in mean pain scores at 6 and 14 weeks compared with baseline values. For both the acupuncture and amitriptyline comparisons, changes in pain score were not significantly different between the 2 groups. At 6 weeks, the estimated difference in pain reduction for patients in the SAR group compared with those in the control points group (a negative value indicates a greater reduction for the "active" treatment) was 0.01 (95% confidence interval [CI], -0.11 to 0.12; P=.88) and for patients in the amitriptyline group vs those in the placebo group was -0.07 (95% CI, -0.22 to 0.08; P=.38). At 14 weeks, the difference for those in the SAR group compared with those in the control points group was -0.08 (95% CI, -0.21 to 0.06; P=.26) and for amitriptyline compared with placebo was 0.00 (95% CI, -0.18 to 0.19; P=.99).
In this study, neither acupuncture nor amitriptyline was more effective than placebo in relieving pain caused by HIV-related peripheral neuropathy.
周围神经病变在感染人类免疫缺陷病毒（HIV）的人群中很常见，但关于症状治疗的数据很少。
评估标准化针刺方案（SAR）和盐酸阿米替林对缓解HIV感染患者中与HIV相关的周围神经病变所致疼痛的疗效。
随机、安慰剂对照、多中心临床试验。每个研究点将患者纳入以下3种选择之一：（1）SAR、阿米替林或两者联合与安慰剂比较的改良双盲2×2析因设计；（2）SAR与对照穴位比较的改良双盲设计；（3）阿米替林与安慰剂比较的双盲设计。
美国10个城市的特里·贝恩艾滋病临床研究社区项目（HIV初级保健提供者）。
患有HIV相关、有症状的下肢周围神经病变的患者。在250名入组患者中，239名参与针刺比较（125名在析因选项，114名在SAR选项与对照穴位选项），136名患者参与阿米替林比较（125名在析因选项，11名在阿米替林选项与安慰剂选项）。
标准化针刺方案与对照穴位、阿米替林（75mg/d）与安慰剂，或两者联合，持续14周。
使用范围从0.0（无疼痛）至1.75（极其剧烈）的疼痛量表，记录6周和14周时平均疼痛评分的变化，每日记录。
与基线值相比，所有4组患者在6周和14周时平均疼痛评分均降低。对于针刺和阿米替林比较，两组间疼痛评分变化无显著差异。在6周时，SAR组患者与对照穴位组患者相比，疼痛减轻的估计差异（负值表示“活性”治疗减轻更多）为0.01（95%置信区间[CI]，-0.11至0.12；P=0.88），阿米替林组患者与安慰剂组患者相比为-0.07（95%CI，-0.22至0.08；P=0.38）。在14周时，SAR组患者与对照穴位组患者相比的差异为-0.08（95%CI，-0.21至0.06；P=0.26），阿米替林与安慰剂相比为0.00（95%CI，-0.18至0.19；P=0.99）。
在本研究中，针刺和阿米替林在缓解HIV相关周围神经病变所致疼痛方面均不比安慰剂更有效。
