Table 10Placebo-controlled trials of drugs for HIV-associated neuropathic pain

Author, year
(Quality)
Drug, doseN
Duration
Design
Main results
Kieburtz 1998126
(Fair)
Amitriptyline96
10 weeks
Parallel
No difference from placebo in pain score
Moderate or better relief:
23/46 amitriptyline (50%)
24/50 placebo (48%)
P=0.84
Shlay 1998127
(Fair)
Amitriptyline126
14 weeks
Parallel
No difference from placebo in pain score
Moderate or better relief:
27/61 amitriptyline (44%)
27/60 placebo (45%)
P=0.81
Simpson 2000129
(Fair)
Lamotrigine42
14 weeks
Parallel
Intent-to-treat analysis: No difference between treatment groups in pain score (P=0.65)

Per protocol analysis (29 of 42 patients):
Decrease in average pain score with lamotrigine
Significant difference only in the subgroup exposed to neurotoxic antiretrovirals
Simpson 2003128
(Fair)
Lamotrigine227
11 weeks
Parallel
Among patients receiving neurotoxic antiretroviral treatment:
At least moderate improvement:
53/62 lamotrigine (85%)
30/30 placebo (100%)
Marked improvement:
29/62 lamotrigine (46.8%)
4/30 placebo (13.3%)
P<0.05

No difference between treatment groups in subgroup not receiving neurotoxic antiretrovirals
Hahn 2004125
(Fair)
Gabapentin26
5 weeks
Parallel
Both groups improved from baseline; decrease in pain was significant in gabapentin group but not placebo (−44.1%; P<0.05 vs. −29.8%; P=0.646)

Comparison of change from baseline in pain score (ANCOVA) did not show a significant difference between groups

Response not reported
Simpson 2010130
(Fair)
Pregabalin302
14 weeks
Parallel
No difference between groups in pain score (difference −0.25, P=0.39)
No difference between groups in 30% and 50% responder rates

From: Results

Cover of Drug Class Review: Neuropathic Pain
Drug Class Review: Neuropathic Pain: Final Update 1 Report [Internet].
Selph S, Carson S, Fu R, et al.
Portland (OR): Oregon Health & Science University; 2011 Jun.
Copyright © 2011 by Oregon Health & Science University.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.