Efficacy and tolerability of intravenous tropisetron in the treatment of fibromyalgia.
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).


CONCLUSIONS
5-HT(3) receptor antagonists provide significant pain relief for a group of FM patients.
Späth
M
M
Friedrich-Baur-Institute, University of Munich, D-80336 München, Germany. michael.spaeth@lrz.uni-muenchen.de
Stratz
T
T
Neeck
G
G
Kötter
I
I
Hammel
B
B
Amberger
C C
CC
Haus
U
U
Färber
L
L
Pongratz
D
D
Müller
W
W
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy*; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000209:etiology*; D010919:Placebos; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077526:Tropisetron
D007211:Indoles; D010919:Placebos; D012702:Serotonin Antagonists; D000077526:Tropisetron