Efficacy and tolerability of intravenous tropisetron in the treatment of fibromyalgia

Scand J Rheumatol. 2004;33(4):267-70. doi: 10.1080/03009740410005818.


Objective: To determine the efficacy of a serotonin receptor (5-HT(3)) antagonist in the treatment of fibromyalgia (FM) in a prospective, randomized, double-blind, placebo-controlled, multicentre trial.

Methods: Twenty-one female patients (age 21-63 years) with FM according to the American College of Rheumatology classification criteria for FM were assigned randomly to either a placebo group or to receive a daily intravenous bolus injection of 5 mg tropisetron for 5 days.

Results: In patients receiving tropisetron, the visual analogue scale (VAS) score for pain decreased by 28.9 compared with a decrease of 6.8 in the placebo group [probability (p)=0.063; effect size: 0.794]. Similar results were obtained using a body diagram pain score as a secondary efficacy parameter: mean pain reduction was 27.2 in the tropisetron group, versus 2.8 in the placebo group (p=0.038; effect size: 0.902).

Conclusion: 5-HT(3) receptor antagonists provide significant pain relief for a group of FM patients.

Publication types

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

MeSH terms

  • Adult
  • Double-Blind Method
  • Female
  • Fibromyalgia / drug therapy*
  • Humans
  • Indoles / administration & dosage
  • Indoles / adverse effects
  • Indoles / therapeutic use*
  • Middle Aged
  • Pain / drug therapy*
  • Pain / etiology*
  • Placebos
  • Serotonin Antagonists / administration & dosage
  • Serotonin Antagonists / adverse effects
  • Serotonin Antagonists / therapeutic use*
  • Tropisetron


  • Indoles
  • Placebos
  • Serotonin Antagonists
  • Tropisetron