A double-blind placebo controlled trial of fluoxetine in fibromyalgia (FM)

42 women were randomized to receive either placebo or fluoxetine at

20 mgs per day. Inter and intra group differences in clinical

variables were evaluated after 3 and 6 weeks of treatment.

Except for self rated anxiety which improved in the placebo

treated group at 3 weeks, no differences between groups were

noted. For those receiving fluoxetine both AIMS Anxiety (4.0

baseline vs. 3.3, p = 0.04) and Depression scores (2.6

baseline vs. 1.9, p = 0.03) improved at 3 weeks; however,

improvement in the Beck Depression Scale did not reach

significance (11.8 vs. 9.4, p = 0.34). At 6 weeks, both AIMS

Depression (2.6 at baseline and 1.5 at 6 weeks, p = 0.03) and

Beck Depression Scales (11.8 at baseline vs. 8.3 at 6 weeks, p

= 0.04) showed improvement, as did sleep quality (9.6 vs. 7.6,

p = 0.03). But no other variable had a significant change from

baseline at either the 3 or 6 week point.

Our data do not suggest that fluoxetine improves the

signs and symptoms of fibromyalgia.

Wolfe F, Cathey MA, Hawley DJ

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