A controlled trial of ondansetron in the pruritus of cholestasis

Aliment Pharmacol Ther. 2005 Apr 15;21(8):1041-5. doi: 10.1111/j.1365-2036.2005.02430.x.


Background: In patients with pruritus of cholestasis, response to conventional drug treatment may be unsatisfactory. Activation of 5-hydroxytryptamine receptors on dermal sensory nerve-endings plays a role in the perception of pruritus. The 5-hydroxytryptamine(3) receptor antagonist, ondansetron, has been used in the treatment of pruritus of cholestasis, but there are few controlled data.

Aim: To determine whether ondansetron is effective in treating the pruritus of cholestasis.

Methods: A total of 19 patients with resistant pruritus were randomized, double blind, to receive either ondansetron 8 mg or placebo as a single intravenous bolus, followed by oral ondansetron 8 mg or placebo twice daily for 5 days. Patients' perception of pruritus was recorded hourly using a visual analogue scale, and scratching activity measured by means of a piezo-electric crystal attached to the fingernail.

Results: Mean pruritus score using visual analogue scale and scratching activity were reduced on the first treatment day compared with baseline in both the ondansetron and placebo groups (P < 0.05), but there were no significant differences in mean pruritus perception or scratching activity between the two groups.

Conclusion: Ondansetron was of no benefit in this group of pruritic patients during short-term treatment.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antipruritics / adverse effects
  • Antipruritics / therapeutic use*
  • Cholestasis / complications*
  • Female
  • Humans
  • Liver Cirrhosis, Biliary / complications
  • Male
  • Middle Aged
  • Ondansetron / adverse effects
  • Ondansetron / therapeutic use*
  • Pruritus / drug therapy*
  • Pruritus / etiology
  • Treatment Outcome


  • Antipruritics
  • Ondansetron