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Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial.
Arthritis Rheum. 2007 Apr; 56(4):1336-44.AR

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 >or=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.

Authors+Show Affiliations

University of Cincinnati College of Medicine, Cincinnati, Ohio 45219, and Newton-Wellesley Hospital, Newton, MA, USA. Lesley.Arnold@uc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

17393438

Citation

Arnold, Lesley M., et al. "Gabapentin in the Treatment of Fibromyalgia: a Randomized, Double-blind, Placebo-controlled, Multicenter Trial." Arthritis and Rheumatism, vol. 56, no. 4, 2007, pp. 1336-44.
Arnold LM, Goldenberg DL, Stanford SB, et al. Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007;56(4):1336-44.
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., & Hudson, J. I. (2007). Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis and Rheumatism, 56(4), 1336-44.
Arnold LM, et al. Gabapentin in the Treatment of Fibromyalgia: a Randomized, Double-blind, Placebo-controlled, Multicenter Trial. Arthritis Rheum. 2007;56(4):1336-44. PubMed PMID: 17393438.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. AU - Arnold,Lesley M, AU - Goldenberg,Don L, AU - Stanford,Sharon B, AU - Lalonde,Justine K, AU - Sandhu,H S, AU - Keck,Paul E,Jr AU - Welge,Jeffrey A, AU - Bishop,Fred, AU - Stanford,Kevin E, AU - Hess,Evelyn V, AU - Hudson,James I, PY - 2007/3/30/pubmed PY - 2007/5/11/medline PY - 2007/3/30/entrez SP - 1336 EP - 44 JF - Arthritis and rheumatism JO - Arthritis Rheum. VL - 56 IS - 4 N2 - 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 >or=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. SN - 0004-3591 UR - https://www.unboundmedicine.com/medline/citation/17393438/Gabapentin_in_the_treatment_of_fibromyalgia:_a_randomized_double_blind_placebo_controlled_multicenter_trial_ L2 - https://doi.org/10.1002/art.22457 DB - PRIME DP - Unbound Medicine ER -