Gastroenterology

Gastroenterology

Volume 109, Issue 2, August 1995, Pages 404-413
Gastroenterology

Alimentary tract
Prophylactic mesalamine treatment decreases postoperative recurrence of Crohn's disease,☆☆

https://doi.org/10.1016/0016-5085(95)90327-5Get rights and content

Abstract

Background & Aims: Recurrence of Crohn's disease frequently occurs after surgery. A randomized controlled trial was performed to determine if mesalamine is effective in decreasing the risk of recurrent Crohn's disease after surgical resection is performed. Methods: One hundred sixty-three patients who underwent a surgical resection and had no evidence of residual disease were randomized to a treatment group (1.5 g mesalamine twice a day) or a placebo control group within 8 weeks of surgery. The follow-up period was a maximum of 72 months. Results: The symptomatic recurrence rate (symptoms plus endoscopic and/or radiological confirmation of disease) in the treatment group was 31% (27 of 87) compared with 41% (31 of 76) in the control group (P = 0.031). The relative risk of developing recurrent disease was 0.628 (90% confidence interval, 0.40-0.97) for those in the treatment group (P = 0.039; one-tail test) using an intention-to-treat analysis and 0.532 (90% confidence interval, 0.32-0.87) using an efficacy analysis. The endoscopic and radiological rate of recurrence was also significantly decreased with relative risks of 0.654 (90% confidence interval, 0.47-0.91) in the effectiveness analysis and 0.635 (90% confidence interval, 0.44-0.91) in the efficacy analysis. There was only one serious side effect (pancreatitis) in subjects in the treatment group. Conclusions: Mesalamine (3.0 g/day) is effective in decreasing the risk of recurrence of Crohn's disease after surgical resection is performed.

References (45)

  • MR Lock et al.

    Recurrence and reoperation for Crohn's disease

    N Engl J Med

    (1981)
  • JE Lennard Jones et al.

    Prognosis after resection of chronic regional ileitis

    Gut

    (1967)
  • J Hellers

    Crohn's disease in Stockholm county 1955–1974: a study of epidemiology

    Acta Chir Scand Suppl

    (1979)
  • K Nygaard et al.

    Crohn's disease: recurrence after surgical treatment

    Scand J Gastroenterol

    (1977)
  • R Karesen et al.

    Crohn's disease: long-term results of surgical treatment

    Scand J Gastroenterol

    (1981)
  • AJ Greenstein et al.

    Reoperation and recurrence in Crohn's colitis and ileocolitis: crude and cumulative rates

    N Engl J Med

    (1975)
  • RS McLeod et al.

    The release profile of a controlled release preparation of 5-aminosalicylic acid (RowasaR I) in humans

    Dis Colon Rectum

    (1990)
  • Ho V, Blair JE, Cohen Z, McLeod RS. The release profile of SalofalkR 750 mg tablets. Can J Gastroenterol (in...
  • MC Cook et al.

    An analysis of the reliability of detection and diagnostic value of various pathological features in Crohn's disease and ulcerative colitis

    Gut

    (1973)
  • BC Morson

    Histopathology of Crohn's disease

  • RH Marshak et al.

    Ulcerative and granulomatous colitis

    J Mt Sinai Hosp

    (1966)
  • RH Marshak

    Granulomatous disease of the intestinal tract (Crohn's disease)

    Radiology

    (1973)
  • Cited by (249)

    • Post-operative recurrence in Crohn's disease: Critical analysis of potential risk factors. An update

      2015, Surgeon
      Citation Excerpt :

      The objective is therefore to assess whether there is an effective pharmacological prophylaxis. Several randomized trials have shown that mesalamine is effective not only in reducing the incidence of POR, but also mitigating the severity of the lesions.4,15,43,94–97 In a study, involving 110 patients who underwent bowel resection for CD and who were randomly divided into 2 groups (group A: patients treated with mesalamine −2.4 g/die-; Group B: untreated patients), Caprilli et al. reported significantly lower recurrence rates at 6, 12 and 24 months in the group of treated patients (P = 0.002).

    View all citing articles on Scopus

    Supported by a grant from the Ontario Ministry of Health and by Interfalk Canada, Mount Sinai Hospital, and the Mayo Research Foundation.

    ☆☆

    Presented at the annual meeting of the American Gastroenterological Association in New Orleans, Louisiana, May 1994.

    View full text