Pregabalin in the treatment of post-traumatic peripheral neuropathic pain: a
randomized double-blind trial.
Author(s): van Seventer R, Bach FW, Toth CC, Serpell M, Temple J, Murphy TK, Nimour M.
Affiliation(s): Pain Clinic, Amphia Hospital, Breda, The Netherlands.
Publication date & source: 2010, Eur J Neurol. , 17(8):1082-9
BACKGROUND: Pregabalin is effective in the treatment of peripheral and central
neuropathic pain. This study evaluated pregabalin in the treatment of
post-traumatic peripheral neuropathic pain (including post-surgical).
METHODS: Patients with a pain score >or=4 (0-10 scale) were randomized and
treated with either flexible-dose pregabalin 150-600 mg/day (n = 127) or placebo
(n = 127) in an 8-week double-blind treatment period preceded by a 2-week placebo
RESULTS: Pregabalin was associated with a significantly greater improvement in
the mean end-point pain score vs. placebo; mean treatment difference was -0.62
(95% CI -1.09 to -0.15) (P = 0.01). The average pregabalin dose at end-point was
approximately 326 mg/day. Pregabalin was also associated with significant
improvements from baseline in pain-related sleep interference, and the Medical
Outcomes Study sleep scale sleep problems index and sleep disturbance subscale
(all P < 0.001). In the all-patient group (ITT), pregabalin was associated with a
statistically significant improvement in the Hospital Anxiety and Depression
Scale anxiety subscale (P < 0.05). In total, 29% of patients had moderate/severe
baseline anxiety; treatment with pregabalin in this subset did not significantly
improve anxiety. More patients reported global improvement at end-point with
pregabalin than with placebo (68% vs. 43%; overall P < 0.01). Adverse events led
to discontinuation of 20% of patients from pregabalin and 7% from placebo. Mild
or moderate dizziness and somnolence were the most common adverse events in the
CONCLUSION: Flexible-dose pregabalin 150-600 mg/day was effective in relieving
neuropathic pain, improving disturbed sleep, improving overall patient status,
and was generally well tolerated in patients with post-traumatic peripheral