Double-blind withdrawal trial of azathioprine as maintenance treatment for Crohn's disease

Lancet. 1978 Nov 4;2(8097):955-7. doi: 10.1016/s0140-6736(78)92524-2.

Abstract

51 patients with Crohn's disease who were in good health while taking azathiprine, 2 mg/kg body-weight/day, for at least six months were allocated either to a group in which azathioprine was continued or to one in which a control tablet was substituted. The trial lasted one year unless relapse recurred earlier. The cumulative probability of relapse was nil at six months and 5% (+/-5 S.D.) at a year among those on azathioprine, compared with 25% (+/-9 S.D.) at six months and 41% (+/-11 S.D.) at a year among those in the control group (P less than 0.01). 1 patient in whom azathioprine was continued died of pancytopenia in the fourth month of the trial. Azathioprine is potentially toxic but appears to reduce the relapse-rate in Crohn's disease.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Azathioprine / administration & dosage*
  • Azathioprine / toxicity
  • Clinical Trials as Topic
  • Crohn Disease / drug therapy*
  • Double-Blind Method
  • Drug Evaluation
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Placebos
  • Recurrence
  • Remission, Spontaneous
  • Substance Withdrawal Syndrome / epidemiology*
  • Time Factors

Substances

  • Placebos
  • Azathioprine