Diseases of the Colon & Rectum

, Volume 41, Issue 1, pp 93–97 | Cite as

Comparison of oral with rectal mesalazine in the treatment of ulcerative proctitis

  • P. Gionchetti
  • F. Rizzello
  • A. Venturi
  • M. Ferretti
  • C. Brignola
  • M. Miglioli
  • M. Campieri
Original Contributions


PURPOSE: The aim of our study was to compare the efficacy and safety of oral mesalazine with mesalazine suppositories in patients with active ulcerative proctitis. PATIENTS AND METHODS: A four-week, randomized, single-blind trial was performed in 58 patients with active, histologically confirmed ulcerative proctitis (≤15 cm) to evaluate the efficacy and safety of oral 800-mg mesalazine tablets taken three times per day (n=29) compared with 400 mg of mesalazine suppositories administered three times per day (n=29). Patients were evaluated at study entry and after two and four weeks. Efficacy evaluations included a disease activity index, which represents a score with four variables: stools frequency, rectal bleeding, mucosal appearance, and physician's assessment of disease severity. Histologic activity was also assessed at study entry and after two and four weeks in accordance with the criteria by Truelove and Richard. Safety assessment included clinical laboratory parameters and adverse event reports. RESULTS: There were no significant differences with regard to baseline comparisons of demographics and severity between the two treatment groups. Improvement in mean disease activity index score was significantly greater with suppositories compared with oral mesalazine, both at two-week and four-week visits (mean disease activity index scores at baseline, two, and four weeks: suppositories = 7.7, 2.59, and 1.48; tablets = 7.42, 5.72, and 3.48, respectively (P<0.001)). The rate of histologic remission was significantly greater with suppositories compared with tablets both at two and four weeks (P<0.01). There were no significant differences in adverse events or clinical laboratory results between treatment groups. CONCLUSIONS: Results of this study indicate that treatment with mesalazine suppositories produces earlier and significantly better results than oral mesalazine in the treatment of active ulcerative proctitis.

Key words

Mesalazine suppositories Mesalazine tablets Ulcerative proctitis Topical treatment 


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  1. 1.
    Sutherland LR, Martin F, Greer S,et al. 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis and proctitis. Gastroenterology 1987;92:1894–8.Google Scholar
  2. 2.
    Campieri M, Gionchetti P, Belluzzi A,et al. Optimum dosage of 5-aminosalicylic acid as rectal enemas in patients with active ulcerative colitis. Gut 1991;32:929–31.Google Scholar
  3. 3.
    Van Hogezand RA, van Hees PA, van Gorp JP,et al. Double-blind comparison of 5-aminosalicylic and acetyl-5-aminosalicylic acid suppositories in patients with idiopathic proctitis. Aliment Pharmacol Ther 1988;2:33–40.Google Scholar
  4. 4.
    Campieri M, Gionchetti P, Belluzzi A,et al. Topical treatment with 5-aminosalicylic acid in distal ulcerative colitis by using a new suppository preparation: a double blind placebo controlled trial. Int J Colorectal Dis 1990;5:79–81.Google Scholar
  5. 5.
    Vitti RA, Meyers F, Knight LC,et al. Quantitative distribution of radiolabeled 5-aminosalicylic acid enema in patients with left-sided ulcerative colitis. Dig Dis Sci 1989;34:1792–7.Google Scholar
  6. 6.
    Campieri M, Corbelli C, Gionchetti P,et al. Spread and distribution of 5-ASA colonic foam and 5-ASA enema in patients with ulcerative colitis. Dig Dis Sci 1992;37:1890–7.Google Scholar
  7. 7.
    Williams CN, Haber G, Aquino JA. Double blind, placebo-controlled evaluation of 5-ASA suppositories in active distal proctitis and measurement of extent of spread using 99 Tc-labeled 5-ASA suppositories. Dig Dis Sci 1987;32:71S-5S.Google Scholar
  8. 8.
    Campieri M, Gionchetti P, Belluzzi A,et al. 5-Aminosalicylic acid as enemas or suppositories in distal ulcerative colitis? J Clin Gastroenterol 1988;10:406–9.Google Scholar
  9. 9.
    Campieri M, De Franchis R, Bianchi Porro G,et al. Mesalazine(5-aminosalicylic acid) suppositories in the treatment of ulcerative proctitis or distal proctosigmoiditis: a randomized controlled trial. Scand J Gastroenterol 1990;25:663–8.Google Scholar
  10. 10.
    Kam L, Cohen H, Dooley C,et al. A comparison of mesalamine and oral sulfasalazine for treatment of active distal ulcerative colitis in adults. Am J Gastroenterol 1996;91:1338–42.Google Scholar
  11. 11.
    The Rowasa Study Group. A double-blind comparison of oralversus rectal mesalamineversus combination therapy in the treatment of distal ulcerative colitis. Gastroenterology 1995;108:A909.Google Scholar
  12. 12.
    Truelove SC, Richard WC. Biopsy studies in ulcerative colitis. BMJ 1956;i:1315–7.Google Scholar
  13. 13.
    Sninsky C, Cort D, Shanahan F,et al. Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis: a multicenter study. Ann Intern Med 1990;115:350–5.Google Scholar
  14. 14.
    Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid in the treatment of active ulcerative colitis. N Engl Med 1987;317:1625–9.Google Scholar
  15. 15.
    Miglioli M, Bianchi-Porro G, Brunetti G,et al. Oraldelayed release mesalazine in the treatment of mild ulcerative colitis: a dose-ranging study. Eur J Gastroentol Hepatol 1990;2:229–34.Google Scholar
  16. 16.
    Rijk MCM, van Schaik A, van Tongeren JH. Disposition of 5-aminosalicylic acid by 5-aminosalicylic acid-delivering compounds. Scand J Gastroenterol 1988;23:107–12.Google Scholar
  17. 17.
    Christensen LA, Fallinborg J, Abildgaard K,et al. Topical and systemic availability of 5-aminosalicylate: a comparisons of three controlled release preparations in man. Aliment Pharmacol Ther 1990;4:523–33.Google Scholar
  18. 18.
    Gionchetti P, Campieri M, Venturi A,et al. Systemic availability of 5-aminosalicylic acid: comparison of delayed release and an azo-bond preparation. Aliment Pharmacol Ther 1996;10:601–5.Google Scholar
  19. 19.
    Jacobsen BA, Abildgaard K, Rasmussen HH,et al. Availability of mesalazine(5-aminosalicylic acid) from enemas and suppositories during steady-state conditions. Scand J Gastroenterol 1991;26:374–8.Google Scholar

Copyright information

© American Society of Colon and Rectal Surgeons 1998

Authors and Affiliations

  • P. Gionchetti
    • 1
  • F. Rizzello
    • 1
  • A. Venturi
    • 1
  • M. Ferretti
    • 1
  • C. Brignola
    • 1
  • M. Miglioli
    • 1
  • M. Campieri
    • 1
  1. 1.From the Dipartimento di Medicina Interna e GastroenterologiaUniversità di BolognaBolognaItaly

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