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

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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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