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Pathogenetic aspects of responsiveness to ondansetron 5-hydroxytryptamine type 3 receptor antagonist) in patients with primary fibromyalgia (FM) syndrome–a preliminary study

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OBJECTIVE: To study the efficacy of 5-hydroxytryptamine type 3

receptor (5-HT-3R) antagonist (ondansetron) vs paracetamol in

primary fibromyalgia (FM) syndrome.

METHODS: A double blind,

crossover, latin square study of 21 patients with FM. Visual

analog scale (VAS) and body drawings were used to record pain

intensity. Functional symptoms were determined for using a

Likert-type self-developed protocol. Quantitative dolorimetry

was applied to assess the number of painful tender points and

the average pain threshold. Serum serotonin levels were

measured by a commercial ELISA.

RESULTS: A marked improvement

in pain intensity measured by VAS (p < 0.005), pain score (p

< 0.05), tender points (p < 0.05), and average pain threshold

(p < 0.01) was obtained with ondansetron, whereas no

improvement was seen with paracetamol. After ondansetron

treatment, there was also significant reduction in both

functional symptoms (p < 0.01) and headache intensity (p <

0.05). In patients who did not respond to ondansetron there

was higher baseline pain intensity measured by VAS (p < 0.05)

and pain score (p < 0.01), and a lower pain threshold (p <

0.05) compared to those who did respond well. In the

responsive group, no significant differences were seen in the

serotonin level before and after therapy. Whereas a

significant increase in serum serotonin concentration (p <

0.01) was observed in nonresponders after ondansetron


CONCLUSION: Ondansetron appears to be an effective

drug in about 50% of patients with FM. There may be 2 subsets

of patients with FM that differ clinically and

pathogenetically with regard to the disturbance in the

5-HT-3R system.

Hrycaj P, Stratz T, Mennet P, Muller W

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