A double-blind placebo controlled trial of fluoxetine in fibromyalgia

Scand J Rheumatol. 1994;23(5):255-9. doi: 10.3109/03009749409103725.

Abstract

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anxiety
  • Depression / etiology
  • Depression / prevention & control
  • Double-Blind Method
  • Female
  • Fibromyalgia / drug therapy*
  • Fibromyalgia / physiopathology
  • Fluoxetine / adverse effects
  • Fluoxetine / therapeutic use*
  • Humans
  • Middle Aged
  • Pain Measurement
  • Psychiatric Status Rating Scales

Substances

  • Fluoxetine