A randomized, double-blind crossover trial of fluoxetine & amitriptyline in the treatment of fibromyalgia (FM)
November 16, 1996
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.
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