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Clinical Trial
. 1998 Feb;42(2):195-9.
doi: 10.1136/gut.42.2.195.

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

P Marteau  1 , J Crand, M Foucault, J C Rambaud
Affiliations
Clinical Trial

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

P Marteau et al. Gut. 1998 Feb.

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 v 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 v 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% v 38%, p = 0.035), 0-180 days (29% v 54%, p = 0.017), 0-270 days (38% v 60%, p = 0.031), and 0-365 days (48% v 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% v 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.

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Figures

Figure 1
Figure 1
Flow chart of the numbers of patients studied at the different steps of the protocol comparing the efficacy of mesalazine and placebo suppositories to maintain remission of ulcerative proctitis over one year.
Figure 2
Figure 2
Time to relapse. Relapse was defined as occurrence of clinical symptoms with an increase in the endoscopy score ⩾1 when compared with the endoscopy score at entry, or occurrence of rectal bleeding more than twice in one day.
See this image and copyright information in PMC

Comment in

  • ACP J Club. 1998 Sep-Oct;129(2):43

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