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Gabapentin in the treatment of Fibromyalgia: A randomized, double-blind, placebo-controlled, multicenter trial

  [ 401 votes ]   [ Discuss This Article ]
By LM Arnold, et al. • • March 30, 2007

[Note: gabapentin may currently be prescribed to help control certain types of epileptic seizures by decreasing abnormal excitement in the brain. It may also be prescribed to relieve post-shingles nerve pain by changing the way the body senses pain. For more information, see "NIH Issues Statement Highlighting Gabapentin's Potential as Effective Treatment for Fibromyalgia Pain, Sleep, and Fatigue."]

Journal: Arthritis & Rheumatism. 2007 Mar 28;56(4):1336-1344 [E-publication ahead of print]

Authors and affiliation: Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, Welge JA, Bishop F, Stanford KE, Hess EV, Hudson JI. University of Cincinnati College of Medicine, Cincinnati, Ohio.

PMID: 17393438

Objective: To assess the efficacy and safety of gabapentin in patients with Fibromyalgia.

Methods: A 12-week, randomized, double-blind study was designed to compare gabapentin (1,200-2,400 mg/day) (n = 75 patients) with placebo (n = 75 patients) for efficacy and safety in treating pain associated with fibromyalgia. The primary outcome measure was the Brief Pain Inventory (BPI) average pain severity score (range 0-10, where 0 = no pain and 10 = pain as bad as you can imagine). Response to treatment was defined as a reduction of >/=30% in this score. The primary analysis of efficacy for continuous variables was a longitudinal analysis of the intent-to-treat sample, with treatment-by-time interaction as the measure of effect.

Results: Gabapentin-treated patients displayed a significantly greater improvement in the BPI average pain severity score (P = 0.015; estimated difference between groups at week 12 = -0.92 [95% confidence interval -1.75, -0.71]). A significantly greater proportion of gabapentin-treated patients compared with placebo-treated patients achieved response at end point (51% versus 31%; P = 0.014). Gabapentin compared with placebo also significantly improved the BPI average pain interference score, the Fibromyalgia Impact Questionnaire total score, the Clinical Global Impression of Severity, the Patient Global Impression of Improvement, the Medical Outcomes Study (MOS) Sleep Problems Index, and the MOS Short Form 36 vitality score, but not the mean tender point pain threshold or the Montgomery Asberg Depression Rating Scale. Gabapentin was generally well tolerated.

Conclusion: Gabapentin (1,200-2,400 mg/day) is safe and efficacious for the treatment of pain and other symptoms associated with Fibromyalgia.

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