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 intra
venous [i.v.] injection of 2 mg tropisetron, in the second cohort 24 FMS pa
tients were treated with 2 mg i.v. bolus injection tropisetron daily for fi
ve days. Pain intensity was measured with the visual analog scale and the p
ainscore; pain at the tenderpoints and control points [dolorimeter] was eva
luated as well as 17 ancillary symptoms before and after treatment; further
more, pain intensity was followed up by means of a patient diary, until pai
n recurrence.
Results: Even with a single i.v. injection of 2 mg tropisetron a significan
t pain reduction as well as an enhancement of the pain threshold provable b
y dolorimetry could be achieved; however, this lasted only a few days. Thre
e out of these 18 patients did not respond at all to therapy. If 2 mg tropi
setron were applied daily for five days, 23 of 24 patients showed a pain re
duction, which lasted for two weeks to two months in 20 of these patients.
Two patients stopped filling in the pain diary. Twelve ancillary symptoms s
uch as sleep disturbances, fatigue, morning stiffness, and others, were als
o significantly improved by the latter treatment. In the global assessment
16 out of 24 patients showed a significant improvement and seven showed a s
light 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 the
rapeutic effect on fibromyalgia symptoms. The results achieved are now bein
g evaluated in a randomized, placebo-controlled, double-blind trial.