Skip to main content
PMC home page
Gut logoLink to Gut
. 1998 Feb;42(2):195–199. 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 1, M Foucault 1, J Rambaud 1
PMCID: PMC1727004  PMID: 9536943

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. 



Keywords: inflammatory bowel disease; mesalazine; 5-aminosalicylic acid; topical treatments; proctitis

Full Text

The Full Text of this article is available as a PDF (115.8 KB).

Figure 1 .

Figure 1

Open in a new tab

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

Open in a new tab

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. 


Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Andreoli A., Spinella S., Levenstein S., Prantera C. 5-ASA enema versus oral sulphasalazine in maintaining remission in ulcerative colitis. Ital J Gastroenterol. 1994 Apr;26(3):121–125. [PubMed] [Google Scholar]
  2. Biddle W. L., Miner P. B., Jr Long-term use of mesalamine enemas to induce remission in ulcerative colitis. Gastroenterology. 1990 Jul;99(1):113–118. doi: 10.1016/0016-5085(90)91237-z. [DOI] [PubMed] [Google Scholar]
  3. D'Arienzo A., Panarese A., D'Armiento F. P., Lancia C., Quattrone P., Giannattasio F., Boscaino A., Mazzacca G. 5-Aminosalicylic acid suppositories in the maintenance of remission in idiopathic proctitis or proctosigmoiditis: a double-blind placebo-controlled clinical trial. Am J Gastroenterol. 1990 Sep;85(9):1079–1082. [PubMed] [Google Scholar]
  4. Freedman L. S. Tables of the number of patients required in clinical trials using the logrank test. Stat Med. 1982 Apr-Jun;1(2):121–129. doi: 10.1002/sim.4780010204. [DOI] [PubMed] [Google Scholar]
  5. Guarino J., Chatzinoff M., Berk T., Friedman L. S. 5-Aminosalicylic acid enemas in refractory distal ulcerative colitis: long-term results. Am J Gastroenterol. 1987 Aug;82(8):732–737. [PubMed] [Google Scholar]
  6. Hanauer S. B. Inflammatory bowel disease. N Engl J Med. 1996 Mar 28;334(13):841–848. doi: 10.1056/NEJM199603283341307. [DOI] [PubMed] [Google Scholar]
  7. Mantzaris G. J., Hatzis A., Petraki K., Spiliadi C., Triantaphyllou G. Intermittent therapy with high-dose 5-aminosalicylic acid enemas maintains remission in ulcerative proctitis and proctosigmoiditis. Dis Colon Rectum. 1994 Jan;37(1):58–62. doi: 10.1007/BF02047216. [DOI] [PubMed] [Google Scholar]
  8. Ngô Y., Gélinet J. M., Ivanovic A., Kac J., Schénowitz G., Vilotte J., Rambaud J. C. Efficacité d'une application quotidienne d'un suppositoire de mésalazine (Pentasa) à libération progressive, dans le traitement des poussées de rectite ulcéro-hémorragique. Essai randomisé en double aveugle contre placebo. Gastroenterol Clin Biol. 1992;16(10):782–786. [PubMed] [Google Scholar]
  9. d'Albasio G., Trallori G., Ghetti A., Milla M., Nucci A., Pacini F., Morettini A. Intermittent therapy with high-dose 5-aminosalicylic acid enemas for maintaining remission in ulcerative proctosigmoiditis. Dis Colon Rectum. 1990 May;33(5):394–397. doi: 10.1007/BF02156265. [DOI] [PubMed] [Google Scholar]

Articles from Gut are provided here courtesy of BMJ Publishing Group

RESOURCES