Fluoxetine, Amitriptyline, or Both for Fibromyalgia

Previous placebo-controlled trials of amitriptyline and fluoxetine for treatment of fibromyalgia have yielded mixed results. This randomized, double-blind, crossover study examined the effects of these two agents, both alone and in combination.

Each patient had four six-week trials (separated by two-week "washout" periods) of 20 mg fluoxetine plus placebo, 25 mg amitriptyline plus placebo, both, or double placebo. Although only 19 of 31 patients completed the study, completers and dropouts had similar characteristics.

For each of four major end points (a validated fibromyalgia questionnaire, and patient ratings of pain, sleep, and global well-being), single-drug therapy with either fluoxetine or amitriptyline was significantly better than pla…