A RANDOMIZED, DOUBLE-BLIND CROSSOVER TRIAL OF FLUOXETINE AND AMITRIPTYLINE IN THE TREATMENT OF FIBROMYALGIA

Objective. To study the effect of fluoxetine (FL) and amitriptyline (A M), alone and in combination, in patients with fibromyalgia (FM). Meth ods. Nineteen patients with FM completed a randomized, double-blind cr ossover study, which consisted of 4 6-week trials of FL (20 mg), AM (2 5 mg), a combination of FL and AM, or placebo. Patients were evaluated on the first and last day of each trial period. Outcome measures incl uded a tender point score, the Fibromyalgia Impact Questionnaire (FIQ) , the Beck Depression Inventory (BDI) scale, and visual analog scales (VAS) for global well-being (1 completed by the physican and 1 by the patient), pain, sleep trouble, fatigue, and feeling refreshed upon awa kening. Results. Both FL and AM were associated with significantly imp roved scores on the FIQ and on the VAS for pain, global well-being, an d sleep disturbances. When combined, the 2 treatments worked better th an either medication alone. Similar, but nonsignificant, improvement o ccurred in the BDI scale, the physician global VAS, and the VAS for fa tigue and feeling refreshed upon awakening. Trends were less clear for the tender point score. Conclusion. Both FL and AM are effective trea tments for FM, and they work better in combination than either medicat ion alone.