Improved maintenance of remission in ulcerative colitis by balsalazide 4 g/day compared with 2 g/day

Aliment Pharmacol Ther. 1992 Aug;6(4):479-85. doi: 10.1111/j.1365-2036.1992.tb00561.x.

Abstract

The efficacy of two doses of balsalazide for the maintenance of remission in patients with ulcerative colitis was compared in a double-blind multicentre trial. Sixty-five patients received a 2 g daily dose, and 68 a 4 g dose. The patient groups were similar at entry for sex, age, and disease distribution. Clinical assessment was carried out at 3-monthly intervals, with sigmoidoscopy, rectal biopsy, and blood tests on entry and at 26 and 52 weeks. Clinical relapse over twelve months was significantly less common on the 4 g dose (36%), than on the 2 g dose (55%), P less than 0.01. There were eight withdrawals on 2 g daily and 13 on 4 g daily, six and nine respectively being mainly due to gastrointestinal intolerance. It is concluded that balsalazide is a well-tolerated drug, and is effective for the maintenance of remission in patients with ulcerative colitis, the optimal dose being greater than 2 g daily.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Aminosalicylic Acids / administration & dosage*
  • Aminosalicylic Acids / adverse effects
  • Aminosalicylic Acids / pharmacokinetics
  • Colitis, Ulcerative / drug therapy*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Male
  • Mesalamine
  • Middle Aged
  • Phenylhydrazines
  • Sulfasalazine / adverse effects

Substances

  • Aminosalicylic Acids
  • Phenylhydrazines
  • Sulfasalazine
  • Mesalamine
  • balsalazide