601   Topical Application of Aspirin/Diethyl Ether in Treatment of Painful Distal Sensory Polyneuropathy in HIV-Positive Individuals: A Randomized, Double-Blind, Crossover Placebo-Controlled Study.

I. Cergnul*¹, J. Ernst¹, S. Blum², and J. Cadman¹.
¹Community Res. Initiative on AIDS (CRIA), New York, and²Bronx-Lebanon Hosp. Ctr., Bronx, NY.

Background:Persons with HIV frequently suffer from painful distal sensory polyneuropathy (DSP) of varying causes. Topical application of aspirin in diethyl ether (ASA/DE) has been shown to have a significant analgesic effect in postherpetic neuralgia with minimal blood levels of ASA. Because of the need to avoid drug interactions and side effects in already pharmacologically burdened HIV patients, we studied the effect of topical ASA/DE on HIV DSP.

Methods:A randomized, double-blind, crossover, placebo-controlled study with a three-day washout between two 14-day periods. 43 HIV-positive adults with painful DSP of grade 3—8 on the 0—10 scale of the Brief Pain Inventory (BPI) were randomized to 375 mg ASA/DE topically t.i.d. in one period and placebo in the other. BPI was self-administered on days 0, 7, 14, 24, and 31.

Results:Of the 43 patients enrolled, 31 completed both arms. Demographics and clinical characteristics of the 31 were: 55% male, median age 43, median years with HIV 10, median years with DSP 3, 90% had AIDS, median CD4 300. There was a 30% median improvement over baseline in the ASA-treated arm in both weekly summary BPI results. The ASA arm was also 30% improved over the placebo arm in all BPI results. The median scores of the best days on ASA were 30% better than baseline, and the median scores of the worst days were 25% better than baseline for the ASA group. All results were statistically significant at p < 0.001. Based on randomization, 19 received placebo and 12 received treatment, first. The temporal order of group assignment had no effect.

Conclusions:In every comparison made, topical ASA/DE resulted in significant clinical and statistical reduction of pain on the BPI with no observed side effects. The demographics of those who did and did not complete were remarkably similar. Furthermore, 8 of the 12 who did not complete the trial began with ASA/DE arm first, had significant improvement and dropped out because of return of symptoms during what proved to be the placebo phase.