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

  1. Lesley M. Arnold1,‡,*,
  2. Don L. Goldenberg2,
  3. Sharon B. Stanford1,
  4. Justine K. Lalonde3,†,
  5. H. S. Sandhu2,
  6. Paul E. Keck Jr.1,§,
  7. Jeffrey A. Welge1,
  8. Fred Bishop1,
  9. Kevin E. Stanford1,
  10. Evelyn V. Hess1,
  11. James I. Hudson3

Article first published online: 28 MAR 2007

DOI: 10.1002/art.22457

Issue

Arthritis & Rheumatism

Arthritis & Rheumatism

Volume 56, Issue 4, pages 1336–1344, April 2007

Additional Information

How to Cite

Arnold, L. M., Goldenberg, D. L., Stanford, S. B., Lalonde, J. K., Sandhu, H. S., Keck, P. E., Welge, J. A., Bishop, F., Stanford, K. E., Hess, E. V. and Hudson, J. I. (2007), Gabapentin in the treatment of fibromyalgia: A randomized, double-blind, placebo-controlled, multicenter trial. Arthritis & Rheumatism, 56: 1336–1344. doi: 10.1002/art.22457

Author Information

  1. 1

    University of Cincinnati College of Medicine, Cincinnati, Ohio

  2. 2

    Newton-Wellesley Hospital, Newton, Massachusetts, and Tufts University School of Medicine, Boston, Massachusetts

  3. 3

    McLean Hospital, Belmont, Massachusetts, and Harvard Medical School, Boston, Massachusetts

  1. †

    AstraZeneca Pharmaceuticals, Zug, Switzerland

  1. ‡

    Dr. Arnold has received consulting fees from Eli Lilly (more than $10,000) and from Pfizer, Cypress Bioscience, Wyeth Pharmaceuticals, Sanofi-Aventis, Boehringer Ingelheim, Sepracor, Forest Laboratories, Allergan, and Vivus (less than $10,000 each). She also has received research support from Eli Lilly, Pfizer, Cypress Bioscience, Wyeth Pharmaceuticals, Sanofi-Aventis, and Boehringer Ingelheim.

  2. §

    Dr. Keck has received consulting fees (less than $10,000) from or is a member of the scientific advisory boards of Abbott, AstraZeneca Pharmaceuticals, Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, and Pfizer. He is a principal or coinvestigator on research studies sponsored by Abbott, the American Diabetes Association, AstraZeneca Pharmaceuticals, Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, Janssen Pharmaceutica, the National Institute of Mental Health, the National Institute of Drug Abuse, Pfizer, the Stanley Medical Research Institute, and UCB.

*University of Cincinnati Medical Arts Building, 222 Piedmont Avenue, Suite 8200, Cincinnati, OH 45219

Publication History

  1. Issue published online: 28 MAR 2007
  2. Article first published online: 28 MAR 2007
  3. Manuscript Accepted: 19 DEC 2006
  4. Manuscript Received: 29 AUG 2006

Funded by

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases. Grant Number: N01-AR-2-2264

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Abstract

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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