title: Effect of ondansetron, a 5-HT3 receptor antagonist, on fatigue in chronic hepatitis C: a randomised, double blind, placebo controlled study.
abstract: OBJECTIVE
  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<0.01), day 30 (54.5 (37.6); p<0.01), and day 60 (60.8 (37.3); p<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.
authors: Department of Hepatogastroenterology, Chu de Nice, France. tpiche@fc.horus-medical.fr
authors: T
authors: T
authors: Piche
authors: G
authors: G
authors: Vanbiervliet
authors: F
authors: F
authors: Cherikh
authors: Z
authors: Z
authors: Antoun
authors: P M
authors: PM
authors: Huet
authors: E
authors: E
authors: Gelsi
authors: J-F
authors: JF
authors: Demarquay
authors: F-X
authors: FX
authors: Caroli-Bosc
authors: S
authors: S
authors: Benzaken
authors: M-C
authors: MC
authors: Rigault
authors: C
authors: C
authors: Renou
authors: P
authors: P
authors: Rampal
authors: A
authors: A
authors: Tran
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D003863:Depression / Q000188:drug therapy / Q000209:etiology; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017294:Ondansetron / Q000008:administration & dosage* / Q000009:adverse effects; D012702:Serotonin Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D012702:Serotonin Antagonists; D017294:Ondansetron