Effectiveness of fluoxetine associated with cyclobenzaprine in the treatment of fibromyalgia: Twelve-months-follow up results

The aim of the study was to evaluate the long-term effectiveness (twelve months) of fluoxetine associated with cyclobenzaprine vs cyclobenzaprine in the treatment of fibromyalgia. Between September 1991 and December 1992 thirty-four females with fibromyalgia (ACR 1990) were randomly assigned to 2 groups: group A (16 patients) was treated with fluoxetine (20 mg/day over 3 months and 20 mg e.o.d. over the next 9 months) and cyclobenzaprine (10 mg/day); group B (18 patients) with cyclobenzaprine (10 mg/day). Basally and every 3 months patient self-assessment of pain (SP), number of painful tender points (Tp+), tender points index (TPI) and articular morning stiffness (MS) were evaluated. After 12-month-therapy the following changes (mean ± SEM) between basal and final parameters were observed: Group A (fluoxetine + cyclobenzaprine): SP: 2.50 ± 0.13 vs 0.50 ± 0.13 (p < 0.005), TP+: 13.94 ± 0.30 vs 3.56 ± 0.35 (p < 0.001), TPI: 44.00 ± 0.69 vs 7.38 ± 0.98 (p < 0.001 ), MS: 76.56 ± 2.84 vs 16.88 ± 2.32 (p < 0.001); Group B (cyclobenzaprine): SP: 2.43 ± 0.14 vs 1.36 ± 0.50 (p < 0.05), TP+: 13.93 ± 0.30 vs 9.43 (p < 0.005), TPI: 44.86 ± 0.88 vs 26.21 ± 0.97 (p < 0.05), MS: 73.57 ± 3.57 vs 46.43 ± 3.72 (p < 0.01 ). The comparison between the two groups showed a greater effectiveness, statistically significant, of the treatment with fluoxetine associated with cyclobenzaprine compared with cyclobenzaprine alone. On the basis of these preliminary data the authors conclude that the association of fluoxetine and cyclobenzaprine shows a good efficacy in the long-term treatment of fibromyalgia: double-blind, placebo controlled studies are necessary to confirm these results.