Controlled trial of oral 5-aminosalicylic acid for the prevention of early relapse in Crohn's disease

R. De Franchis, P. Omodei, T. Ranzi, C. Brignola, R. Rocca, A. Prada, A. Pera, M. Vecchi, M. Del Piano, A. Ferrara, C. Bellolij, L. Piodi, L. Framarin, M. Astegiano, F. A. Riccioli, G. Meucci

Research output: Contribution to journalArticlepeer-review


Background: Recent data indicate that: 5-aminosalicylic acid (5-ASA) is most effective in preventing relapse of Crohn's disease in patients with a short duration of remission before enrolment. Aim: To evaluate the efficacy of oral 5-ASA treatment, started immediately after achieving steroid-induced remission, in preventing clinical relapses of Crohn's disease. Methods: Patients with active Crohn's disease, achieving remission on steroids, were randomized to oral 5-ASA 3 g/day or placebo, while steroids were tapered over 6 weeks. The trial was terminated after interim analysis showed a slightly higher relapse rate in the 5-ASA group, and the calculated probability of seeing a statistically significant difference by completing the study was minimal. Results: Final analysis included 117 patients (58 taking 5-ASA and 59 taking placebo; follow-up 9.2 ± 6.5 months). Cumulative relapse rates at 6 and 12 months were 34% and 58% in 5-ASA patients and 31% and 52% in placebo patients, respectively (rate difference + 0.095; 95% CI = -0.085 to + 0.274). Subgroups analysis showed that 5-ASA was equally ineffective in patients with ileal, colonic or ileocolonic disease. Conclusions: Contrary to previous results, in our study early introduction of treatment with oral 5-ASA did not prevent relapse in Crohn's disease patients treated with steroids to induce remission.

Original languageEnglish
Pages (from-to)845-852
Number of pages8
JournalAlimentary Pharmacology and Therapeutics
Issue number5
Publication statusPublished - 1997

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)


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