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Abstract
Objective: As in a prospective, randomized, placebo-controlled, multicenter, double-blind trial in fibromyalgia [FMS] a significant reduction of pain especially, but of other symptoms as well, could be gained after 10 days of peroral daily treatment with 5 mg tropisetron, the question was evaluated as to whether quicker and better effects could be achieved with intravenous application of 2 mg tropisetron daily for a limited period of time.
Methods: In the first cohort, 18 FMS patients received a single bolus intravenous [i.v.] injection of 2 mg tropisetron, in the second cohort 24 FMS patients were treated with 2 mg i.v. bolus injection tropisetron daily for five days. Pain intensity was measured with the visual analog scale and the painscore; pain at the tenderpoints and control points [dolorimeter] was evaluated as well as 17 ancillary symptoms before and after treatment; furthermore, pain intensity was followed up by means of a patient diary, until pain recurrence.
Results: Even with a single i.v. injection of 2 mg tropisetron a significant pain reduction as well as an enhancement of the pain threshold provable by dolorimetry could be achieved; however, this lasted only a few days. Three out of these 18 patients did not respond at all to therapy. If 2 mg tropisetron were applied daily for five days, 23 of 24 patients showed a pain reduction, which lasted for two weeks to two months in 20 of these patients. Two patients stopped fillling in the pain diary. Twelve ancillary symptoms such as sleep disturbances, fatigue, morning stiffness, and others, were also significantly improved by the latter treatment. In the global assessment 16 out of 24 patients showed a significant improvement and seven showed a slight improvement of their disease. There was only one patient who did not experience any improvement. Tolerability was good.
Conclusion: Intravenous injection of 2 mg of the 5-HT3 receptor antagonist tropisetron once daily for five days can often produce a longer-lasting therapeutic effect on fibromyalgia symptoms. The results achieved are now being evaluated in a randomized, placebo-controlled, double-blind trial.
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