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


CONCLUSIONS
Lidocaine 5% gel is a safe but ineffective agent in the treatment of pain in HIV-associated DSP.
Estanislao
Lydia
L
Department of Neurology and Clinical Neurophysiology, Mount Sinai Medical Center, New York, NY 10029, USA.
Carter
Kay
K
McArthur
Justin
J
Olney
Richard
R
Simpson
David
D
D000779:Anesthetics, Local / Q000008:administration & dosage / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy*; D011115:Polyneuropathies / Q000188:drug therapy*; D016896:Treatment Outcome
D000779:Anesthetics, Local; D008012:Lidocaine