title: Controlled trial of oral 5-aminosalicylic acid for the prevention of early relapse in Crohn's disease.
abstract: 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 enrollment.
  
  
  OBJECTIVE
  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.
authors.affiliation: Istituto di Medicina Interna Università di Milano, V Divisione di Medicina, IRCCS Ospedale Policlinico, Italy.
authors.forename: R
authors.initials: R
authors.lastname: de Franchis
authors.forename: P
authors.initials: P
authors.lastname: Omodei
authors.forename: T
authors.initials: T
authors.lastname: Ranzi
authors.forename: C
authors.initials: C
authors.lastname: Brignola
authors.forename: R
authors.initials: R
authors.lastname: Rocca
authors.forename: A
authors.initials: A
authors.lastname: Prada
authors.forename: A
authors.initials: A
authors.lastname: Pera
authors.forename: M
authors.initials: M
authors.lastname: Vecchi
authors.forename: M
authors.initials: M
authors.lastname: Del Piano
authors.forename: A
authors.initials: A
authors.lastname: Ferrara
authors.forename: C
authors.initials: C
authors.lastname: Belloli
authors.forename: L
authors.initials: L
authors.lastname: Piodi
authors.forename: L
authors.initials: L
authors.lastname: Framarin
authors.forename: M
authors.initials: M
authors.lastname: Astegiano
authors.forename: F A
authors.initials: FA
authors.lastname: Riccioli
authors.forename: G
authors.initials: G
authors.lastname: Meucci
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D003424:Crohn Disease / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use*; D008875:Middle Aged; D055502:Secondary Prevention; D017211:Treatment Failure
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine