A randomized, double-blind crossover trial of fluoxetine & amitriptyline in the treatment of fibromyalgia (FM)

OBJECTIVE: To study the effect of fluoxetine (FL) and amitriptyline (AM), alone and in combination, in patients with fibromyalgia (FM).

METHODS: Nineteen patients with FM completed a

randomized, double-blind crossover study, which consisted of 4

6-week trials of FL (20 mg), AM (25 mg), a combination of FL

and AM, or placebo. Patients were evaluated on the first and

last day of each trial period. Outcome measures included 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

physician and 1 by the patient), pain, sleep trouble,

fatigue, and feeling refreshed upon awakening.

RESULTS: Both

FL and AM were associated with significantly improved scores

on the FIQ and on the VAS for pain, global well-being, and

sleep disturbances. When combined, the 2 treatments worked

better than either medication alone. Similar, but

nonsignificant, improvement occurred in the BDI scale, the

physician global VAS, and the VAS for fatigue and feeling

refreshed upon awakening. Trends were less clear for the

tender point score.

CONCLUSION: Both FL and AM are effective

treatments for FM, and they work better in combination than

either medication alone.

Goldenberg D, Mayskiy M, Mossey C, Ruthazer R, Schmid C

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