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

Author(s): Lucidarme D, Marteau P, Foucault M, Vautrin B, Filoche B

Affiliation(s): Hopital Saint-Philibert, Lomme, France.

Publication date & source: 1997-04, Aliment Pharmacol Ther., 11(2):335-40.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

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.

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