title: Treatment of pruritus in chronic liver disease with the 5-hydroxytryptamine receptor type 3 antagonist ondansetron: a randomized, placebo-controlled, double-blind cross-over trial.
abstract: BACKGROUND
  Recently, the serotonin antagonist ondansetron has been reported to have a positive effect on cholestasis-associated pruritus.
  
  
  OBJECTIVE
  To study the effect of orally administered ondansetron on pruritus in chronic liver disease in a randomized, placebo-controlled, double-blind, cross-over study.
  
  
  METHODS
  Subjective severity of pruritus was assessed using a visual analogue scale (VAS) recorded four times daily by the patients. After a one week pretreatment baseline period the patients were randomized to receive ondansetron tablets 8 mg tds or placebo tablets tds for one week. Following a one week wash-out period patients were switched to the other treatment for one week. The study was ended by an additional follow-up week without medication. For each day peak VAS values were determined and the mean value of the last five days of each week was calculated and referred to as the composite peak VAS score.
  
  
  RESULTS
  We observed a significant but moderate reduction of the composite peak VAS score of 1.34 points (CI(95%): 0.12-2.56; P=0.033) during treatment with ondansetron as compared to placebo (treatment effect). In addition, a period effect was observed: a reduction of composite peak VAS score by 1.26 points (C1(95%): 0.04-2.48; P=0.044) was seen in the second treatment period as compared to the first period, irrespective of the kind of treatment. Although under treatment with ondansetron a significant improvement of itching as assessed by the VAS score was demonstrated, this treatment was not preferred over placebo by the patients.
  
  
  CONCLUSIONS
  The 5-hydroxytryptamine receptor type 3 antagonist ondansetron has a small, but significant positive effect on pruritus in chronic liver disease as compared to placebo.
authors.affiliation: Universitätsklinik für Innere Medizin IV, Klinische Abteilung Gastroenterologie und Hepatologie, Vienna, Austria. christian.muller@akh-wien.ac.at
authors.forename: C
authors.initials: C
authors.lastname: Müller
authors.forename: S
authors.initials: S
authors.lastname: Pongratz
authors.forename: J
authors.initials: J
authors.lastname: Pidlich
authors.forename: E
authors.initials: E
authors.lastname: Penner
authors.forename: A
authors.initials: A
authors.lastname: Kaider
authors.forename: M
authors.initials: M
authors.lastname: Schemper
authors.forename: M
authors.initials: M
authors.lastname: Raderer
authors.forename: W
authors.initials: W
authors.lastname: Scheithauer
authors.forename: P
authors.initials: P
authors.lastname: Ferenci
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008107:Liver Diseases / Q000150:complications*; D008297:Male; D008875:Middle Aged; D017294:Ondansetron / Q000008:administration & dosage / Q000627:therapeutic use*; D010147:Pain Measurement; D011537:Pruritus / Q000150:complications / Q000188:drug therapy*; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D012702:Serotonin Antagonists; D017294:Ondansetron