The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared with Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients, 1993-1997
Investigators: Judith Shlay, Bob Flaws, Kathryn Chaloner, Jeffrey Cohen, David Cohn, Marjorie Dehlinger, Shauna Hillman, Mitchell Max, Carol Mesard, Jill Ramser, Patricia Reichelderfer, Jack Rouff, Catherine Salveson, James Sampson, & Victoria Taylor

The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared with Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients was conducted between 1993 and 1997 at 11 units of the Terry Beirn Community Programs for the Clinical Research on AIDS. The study was conducted to evaluate the efficacy of a standardized acupuncture regime and amitriptyline hydrochloride for relief of pain due to HIV-related peripheral neuropathy. The study was a randomized, placebo-controlled, clinical trial that lasted 14 weeks. 250 HIV-infected patients with lower extremity peripheral neuropathy were randomly assigned to receive either amitriptyline or placebo capsules (once a day) and either acupuncture or needles placed in control points (once or twice a week) Patients were evaluated at baseline, 6 weeks, and 14 weeks. The primary outcome variables are changes in pain scores at weeks 6 and 14. Secondary outcome variables are discontinuation of study treatment, changes in the quality of life-physical functioning item at weeks 6 and 14, and changes in neurological summary scores at week 14. The dataset contains 91 variables collected from 250 patients.