ACUPUNCTURE AND AMITRIPTYLINE FOR PAIN DUE TO HIV-RELATED PERIPHERAL NEUROPATHY - A RANDOMIZED CONTROLLED TRIAL

Context.-Peripheral neuropathy is common in persons infected with the human immunodeficiency virus (HIV) but few data on symptomatic treatme nt are available. Objective.-To evaluate the efficacy of a standardize d acupuncture regimen (SAR) and amitriptyline hydrochloride for the re lief of pain due to HIV-related peripheral neuropathy in HIV-infected patients. Design.-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, amitriptyl ine, or the combination compared with placebo, (2) a modified double-b lind design of an SAR vs control points, or (3) a double-blind design of amitriptyline vs placebo. Setting.-Terry Beirn Community Programs f or Clinical Research on AIDS (HIV primary care providers) in 10 US cit ies. Patients.-Patients with HIV-associated, symptomatic, lower-extrem ity peripheral neuropathy. Of 250 patients enrolled, 239 were in the a cupuncture comparison (125 in the factorial option and 114 in the SAR option vs control points option), and 136 patients were in the amitrip tyline comparison (125 in the factorial option and 11 in amitriptyline option vs placebo option). Interventions.-Standarized acupuncture reg imen vs control points, amitriptyline (75 mg/d) vs placebo, or both fo r 14 weeks. Main Outcome Measure.-Changes in mean pain scores at 6 and 14 weeks, using a pain scale ranging from 0.0 (no pain) to 1.75 (extr emely intense), recorded daily. Results.-Patients in all 4 groups show ed reduction in mean pain scores at 6 and 14 weeks compared with basel ine values. For both the acupuncture and amitriptyline comparisons, ch anges in pain score were not significantly different between the 2 gro ups. At 6 weeks, the estimated difference in pain reduction for patien ts in the SAR group compared with those in the control points group (a negative value indicates a greater reduction for the ''active'' treat ment) was 0.01 (95% confidence interval [CI], -0.11 to 0.12; P=.88) an d for patients in the amitriptyline group vs those in the placebo grou p was -0.07 (95% CI, -0.22 to 0.08; P = .38). At 14 weeks, the differe nce for those in the SAR group compared with those in the control poin ts group was -0.08 (95% CI, -0.21 to 0.06; P = .26) and for amitriptyl ine compared with placebo was 0.00 (95% CI, -0.18 to 0.19; P = .99). C onclusions.-In this study, neither acupuncture nor amitriptyline was m ore effective than placebo in relieving pain caused by HIV-related per ipheral neuropathy.