A randomized controlled trial of 5% lidocaine gel for HIV-associated distal symmetric polyneuropathy

被引:48
作者
Estanislao, L
Carter, K
McArthur, J
Olney, R
Simpson, D
机构
[1] Mt Sinai Med Ctr, Dept Neurol & Clin Neurophysiol, New York, NY 10029 USA
[2] Johns Hopkins Univ Hosp, Dept Neurol, Baltimore, MD 21205 USA
[3] Univ Calif San Francisco, Dept Neurol, San Francisco, CA 94143 USA
关键词
HIV; randomized controlled trial; pain; neuropathy;
D O I
10.1097/00126334-200412150-00010
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Objective: To investigate the analgesic efficacy and safety of 5% lidocaine gel in painful HIV-associated distal sensory polyneuropathy (DSP). Background: Painful DSP, the most common neurologic complication in HIV infection, is difficult to treat. Lidocaine 5% gel was effective in alleviating neuropathic pain in an open-label study of HIV DSP. Methods: In a double-blind, placebo-controlled, crossover, multi-center study, 64 subjects were randomized to receive 5% lidocaine or vehicle gel for 2 weeks (phase A). A washout period of 2 weeks was followed by a crossover to the alternate agent for another 2 weeks (phase B). The primary outcome was difference in average pain scores (Gracely pain scale) between the 2 groups during the second week of each treatment period. Secondary outcomes included differential effect of the first treatment, difference in global pain relief and pain response by neurotoxin exposure. Results: The baseline pain scores of the 2 groups were similar. The average pain scores during the second week of each phase of the lidocaine gel group did not differ from those of the placebo group (phase A: lidocaine 1.09, placebo 1.15; phase B: lidocaine 1.16, placebo 1.10). There also was no difference noted in secondary outcomes. The pain responses of lidocaine gel-treated subjects with current exposure to neurotoxic antiretrovirals (1.18) did not differ compared with those without (1.10) (P = 0.358). There were no significant adverse effects. Conclusion: Lidocaine 5% gel is a safe but ineffective agent in the treatment of pain in HIV-associated DSP.
引用
收藏
页码:1584 / 1586
页数:3
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