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Scand. J. Rheumatol. · Jan 2004
Randomized Controlled Trial Multicenter Study Clinical TrialEfficacy and tolerability of intravenous tropisetron in the treatment of fibromyalgia.
- M Späth, T Stratz, G Neeck, I Kötter, B Hammel, C C Amberger, U Haus, L Färber, D Pongratz, and W Müller.
- Friedrich-Baur-Institute, University of Munich, D-80336 München, Germany. michael.spaeth@lrz.uni-muenchen.de
- Scand. J. Rheumatol. 2004 Jan 1;33(4):267-70.
ObjectiveTo 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.MethodsTwenty-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.ResultsIn 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).Conclusion5-HT(3) receptor antagonists provide significant pain relief for a group of FM patients.
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