A randomized, double-blind, placebo-controlled trial of duloxetine
in the treatment of women with fibromyalgia with or without major depressive disorder


ABSTRACT

This was a 12-week, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, in 354 female patients with primary fibromyalgia, with or without current major depressive disorder. Patients (90% Caucasian; mean age, 49.6 years; 26% with current major depressive disorder) received duloxetine 60mg once daily (QD) (N=118), duloxetine 60mg twice daily (BID) (N=116), or placebo (N=120). The primary outcome was the Brief Pain Inventory average pain severity score. Response to treatment was defined as >/=30% reduction in this score. Compared with placebo, both duloxetine-treated groups improved significantly more (P<0.001) on the Brief Pain Inventory average pain severity score. A significantly higher percentage of duloxetine-treated patients had a decrease of >/=30% in this score (duloxetine 60mg QD (55%; P<0.001); duloxetine 60mg BID (54%; P=0.002); placebo (33%)). The treatment effect of duloxetine on pain reduction was independent of the effect on mood and the presence of major depressive disorder. Compared with patients on placebo, patients treated with duloxetine 60mg QD or duloxetine 60mg BID had significantly greater improvement in remaining Brief Pain Inventory pain severity and interference scores, Fibromyalgia Impact Questionnaire, Clinical Global Impression of Severity, Patient Global Impression of Improvement, and several quality-of-life measures. Both doses of duloxetine were safely administered and well tolerated. In conclusion, both duloxetine 60mg QD and duloxetine 60mg BID were effective and safe in the treatment of fibromyalgia in female patients with or without major depressive disorder.



SOURCE:-
Arnold LM, Rosen A, Pritchett YL, D'Souza DN,
Goldstein DJ, Iyengar S, Wernicke JF.
Women's Health Research Program,
Department of Psychiatry,
University of Cincinnati College of Medicine,
Medical Arts Building, 222 Piedmont Ave, Suite 8200,
Cincinnati, OH 45219, USA.
Pain. 2005 Dec;119(1-3):5-15.