Short report: comparison of two doses of balsalazide in maintaining ulcerative colitis in remission over 12 months

Aliment Pharmacol Ther. 1992 Oct;6(5):647-52. doi: 10.1111/j.1365-2036.1992.tb00578.x.


In a four-centre prospective double-blind trial, 108 patients with ulcerative colitis in remission were randomized to receive balsalazide in doses of 3 g or 6 g/day for 12 months. The patients were assessed at 3-monthly intervals clinically, sigmoidoscopically and with routine haematology and biochemistry. Remission rates of 77% (3 g/day) and 68% (6 g/day) at 12 months were not significantly different. Intolerance reactions leading to withdrawal from the study occurred in only 9 patients (8%), all occurring in the first 7 weeks of the study. Balsalazide is therefore both highly effective in maintaining remission in ulcerative colitis and well tolerated in both conventional and high dosage (the latter equivalent to 5.5 g/day of sulphasalazine). In this study no distinct advantage in maintenance of remission has been found for the higher dose of balsalazide.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Aminosalicylic Acids / adverse effects
  • Aminosalicylic Acids / therapeutic use*
  • Colitis, Ulcerative / drug therapy*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Male
  • Mesalamine
  • Middle Aged
  • Phenylhydrazines
  • Prospective Studies
  • Time Factors


  • Aminosalicylic Acids
  • Phenylhydrazines
  • Mesalamine
  • balsalazide