Prophylactic mesalamine treatment decreases postoperative recurrence of Crohn's disease

Gastroenterology. 1995 Aug;109(2):404-13. doi: 10.1016/0016-5085(95)90327-5.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aminosalicylic Acids / adverse effects
  • Aminosalicylic Acids / therapeutic use*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Combined Modality Therapy
  • Confidence Intervals
  • Crohn Disease / prevention & control
  • Crohn Disease / surgery*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Mesalamine
  • Pancreatitis / chemically induced
  • Patient Compliance
  • Recurrence
  • Risk Factors


  • Aminosalicylic Acids
  • Anti-Inflammatory Agents, Non-Steroidal
  • Mesalamine