TY - JOUR T1 - Effect of ondansetron, a 5-HT<sub>3</sub> receptor antagonist, on fatigue in chronic hepatitis C: a randomised, double blind, placebo controlled study JF - Gut JO - Gut SP - 1169 LP - 1173 DO - 10.1136/gut.2004.055251 VL - 54 IS - 8 AU - T Piche AU - G Vanbiervliet AU - F Cherikh AU - Z Antoun AU - P M Huet AU - E Gelsi AU - J-F Demarquay AU - F-X Caroli-Bosc AU - S Benzaken AU - M-C Rigault AU - C Renou AU - P Rampal AU - A Tran Y1 - 2005/08/01 UR - http://gut.bmj.com/content/54/8/1169.abstract N2 - Background and aims: There are no available effective therapies for fatigue associated with chronic hepatitis C (CHC). The serotonin antagonist ondansetron has been shown to be effective in the chronic fatigue syndrome. In this randomised, placebo controlled, double blind trial, we investigated the effect of orally administered ondansetron on fatigue in CHC. Methods: Thirty six patients with CHC were included if fatigue was their predominant symptom and they scored more than 4 on a visual analogue scale (0–10). During the study, fatigue and depression were measured on days 0, 15, 30, and 60 using a validated self report questionnaire (fatigue impact scale and Beck depression inventory). Patients were randomised to receive ondansetron tablets 4 mg twice daily or placebo for one month followed by an additional four weeks of observation. Results: Fatigue score was 85.4 (28.2) and 98.2 (26.9) in the ondansetron and placebo groups, respectively (NS). Ondansetron significantly reduced the fatigue score with more than 30% improvement on day 15 (57.1 (38.9); p&lt;0.01), day 30 (54.5 (37.6); p&lt;0.01), and day 60 (60.8 (37.3); p&lt;0.01) whereas placebo did not. Overall, the reduction in fatigue was significantly higher with ondansetron compared with placebo (ANOVA for repeated measurements) for the whole follow up period (p = 0.03) or for the treatment period only (p = 0.04). Ondansetron also significantly reduced depression scores. Conclusions: The 5-hydroxytryptamine receptor type 3 antagonist ondansetron had a significant positive effect on fatigue in CHC. These observations support the concept that fatigue involves serotoninergic pathways and may encourage further evaluations of the efficacy of ondansetron on fatigue in chronic liver diseases. ER -