Efficacy and tolerability of paroxetine in patients with fibromyalgia syndrome: a single-blind study

Abstract The efficacy and tolerability of paroxetine, a selective serotonin reuptake inhibitor, were evaluated in a 12-week, single-blind, randomized study. Forty outpatients with fibromyalgia syndrome (FMS) were allocated to receive paroxetine 20 mg once daily for 3 months (group A; n=20) or placebo once daily for 3 months (group B; n=20). The investigator's overall assessment of paroxetine's efficacy was much improved or improved in 68% of group A patients, slightly improved in 24%, and no change in 8%. Group A patients' overall assessment of paroxetine's efficacy was much improved or improved in 40%, slightly improved in 48%, and no change in 12%. The investigator's and group B patients' overall assessments of the placebo's efficacy were no change in 96% and 82% and slightly improved in 4% and 18%, respectively. The investigator's overall assessment of tolerability was very good or good in 82% of group A patients and very good or good in 98% of group B patients. The patients' overall assessment of tolerability was very good or good in 70% in group A and in 18% in group B. Based on the findings, paroxetine appeared to be effective and well tolerated in our group of patients with FMS. Key words: fibromyalgia, selective serotonin re-uptake inhibitors, paroxetine, efficacy, tolerability.