Use of mesalazine slow release suppositories 1 g three times per week to maintain remission of ulcerative proctitis: A randomised double blind placebo controlled multicentre study

Abstract

Background - Daily administration of rectal formulations of mesalazine is effective in preventing relapse of ulcerative proctitis. Maintenance of remission with lower doses would be an advantage. Aim - The efficacy of mesalazine suppositories (Pentasa) 1 g three times a week ν placebo to maintain remission in patients with cryptogenetic proctitis was studied. Methods - Ninety five patients with cryptogenetic proctitis were randomised within two weeks of remission to receive for one year or until relapse three suppositories per week of either Pentasa (n = 48) or placebo (n = 47). In the case of a relapse, the patients received one suppository/day. Results - It was found that 25 of 48 subjects ν 18 of 47 remained in remission in the mesalazine and placebo groups respectively. The relapse rate was lower in the mesalazine group for the following time intervals: 0-90 days (19% ν 38%, p = 0.035), 0-180 days (29% ν 54%, p = 0.017), 0-270 days (38% ν 60%, p = 0.031), and 0-365 days (48% ν 62%, p = 0.18). Treatment of relapse with one suppository/day induced remission in 11 of 18 and 2 of 26 patients in the mesalazine and placebo groups respectively (p = 0.001). Overall, 61% ν 28% patients remained in the protocol and were in remission at one year (p = 0.001). Tolerance was good. Conclusion - Mesalazine suppositories 1 g three times a week are effective for preventing relapses of cryptogenetic proctitis. Increasing the dose to 1 g/day is effective in a high proportion of subjects who relapsed.