Efficacy and tolerance of mesalazine suppositories vs. hydrocortisone foam in proctitis

Aliment Pharmacol Ther. 1997 Apr;11(2):335-40. doi: 10.1046/j.1365-2036.1997.126297000.x.

Abstract

Background: Topical treatments with steroids or mesalazine are the most effective treatments for idiopathic proctitis.

Aim: To compare the efficacy and tolerance of mesalazine suppositories vs. hydrocortisone acetate foam in the treatment of acute proctitis.

Patients and methods: 242 patients with active idiopathic proctitis were randomized to receive once daily either one Pentasa suppository (mesalazine 1 g) or 100 mg hydrocortisone (Colofoam) for 14-21 days (until remission). Disease activity and tolerance of the treatments were assessed using a daily questionnaire, by physician assessment, and endoscopy score.

Results: Both treatments induced a significant reduction in disease activity. Mesalazine suppositories were significantly more effective than hydrocortisone on rectal blood loss (P = 0.002) and mucus (P = 0.02) parameters, and on the degree of the decrease in endoscopy score (P = 0.02). No significant difference was observed between treatments concerning histology or tolerance.

Conclusion: Mesalazine suppositories were as well-tolerated as hydrocortisone foam, but were more effective for some parameters of disease activity.

Publication types

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

MeSH terms

  • Acute Disease
  • Administration, Topical
  • Adult
  • Aminosalicylic Acids / administration & dosage*
  • Aminosalicylic Acids / adverse effects
  • Aminosalicylic Acids / therapeutic use
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Female
  • Humans
  • Hydrocortisone
  • Male
  • Mesalamine
  • Proctitis / drug therapy*
  • Proctoscopy
  • Suppositories

Substances

  • Aminosalicylic Acids
  • Anti-Inflammatory Agents
  • Anti-Inflammatory Agents, Non-Steroidal
  • Suppositories
  • Mesalamine
  • Hydrocortisone