Faerber, L. and Stratz, T. H. and Brueckle, W. and Spaeth, M. and Pongratz, D. and Lautenschlaeger, J. and Koetter, Ina and Zoeller, B. and Peter, Hans-Hartmut and Neeck, G. and Welzel, D. and Mueller, Wolfgang (2001) Short-term treatment of primary fibromyalgia with the 5-HT3-receptor antagonist tropisetron. Results of a randomized, double-blind, placebo-controlled multicenter trial in 418 patients. INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY RESEARCH, 21 (1). pp. 1-13. ISSN 0251-1649
Full text not available from this repository.Abstract
We investigated the efficacy and tolerability of short-term treatment with tropisetron, a selective, competitive 5-HT3-receptor antagonist in fibromyalgia. The trial was designed as a prospective, multicenter double-blind, parallel-group, dose-finding study. We randomly assigned 418 patients suffering from primary fibromyalgia to receive either placebo, 5 mg, 10 mg or 15 mg tropisetron once daily for 10 days. Clinical response was measured by changes in pain score, visual analog scale, tender point count and ancillary symptoms. Responders were prospectively defined as patients showing a 35% or higher reduction in pain score. Treatment with 5 mg tropisetron resulted in a significantly higher response rate (39.2%) than placebo (26.2%) (p <0.05). In the visual analog scale, the group administered 5 mg tropisetron showed a significant improvement (p <0.05) and the group administered 10 mg tropisetron showed a nonsignificant clinical benefit. The number of painful tender points was significantly reduced (p = 0.002) in the 5 mg tropisetron group, Regarding ancillary symptoms, the 5 mg tropisetron group showed a significant improvement (p <0.05) in sleep and dizziness. The patients' overall assessment of efficacy was significantly higher for 5 mg (p = 0.016) and 10 mg (p = 0.002) tropisetron than for placebo. The safety and tolerability of tropisetron was good; gastrointestinal tract symptoms were the most frequently reported adverse events. Short-term treatment of fibromyalgia patients with 5 mg tropisetron for 10 days proved to be efficacious and well tolerated. In this study a bell-shaped dose-response curve was seen.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | 5-HT3 RECEPTOR ANTAGONISTS; SUBSTANCE-P; SPINAL ANTINOCICEPTION; PRIMARY FIBROSITIS; CROSSOVER TRIAL; ICS 205-930; PAIN; AMITRIPTYLINE; SEROTONIN; RELEASE; |
| Subjects: | 600 Technology > 615 Pharmacy |
| Divisions: | Chemistry and Pharmacy > Institute of Pharmacy > Pharmacology and Toxicology (Prof. Schlossmann, formerly Prof. Seifert) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 01 Mar 2022 07:47 |
| Last Modified: | 01 Mar 2022 07:47 |
| URI: | https://pred.uni-regensburg.de/id/eprint/41883 |
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