Controlled trial of oral 5-aminosalicylic acid for the prevention of early relapse in Crohn's disease.
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.
de Franchis
R
R
Istituto di Medicina Interna Università di Milano, V Divisione di Medicina, IRCCS Ospedale Policlinico, Italy.
Omodei
P
P
Ranzi
T
T
Brignola
C
C
Rocca
R
R
Prada
A
A
Pera
A
A
Vecchi
M
M
Del Piano
M
M
Ferrara
A
A
Belloli
C
C
Piodi
L
L
Framarin
L
L
Astegiano
M
M
Riccioli
F A
FA
Meucci
G
G
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
D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine