K. Ewe et al., Low-dose budesonide treatment for prevention of postoperative recurrence of Crohn's disease: a multicentre randomized placebo-controlled trial, EUR J GASTR, 11(3), 1999, pp. 277-282
Objective Endoscopic recurrence of Crohn's disease frequently occurs within
weeks after 'curative' operation. Treatment with 3 x 1 mg oral pH-modified
release budesonide was tried to prevent postoperative recurrence
Design A multicentre randomized double-blind placebo-controlled trial of 1
year duration was performed.
Setting Departments of surgery, endoscopy and pathology of three university
hospitals participated in the trial.
Patients Patients with Crohn's disease who underwent ileal and/or colonic r
esection and whose anastomosis was accessible to colonoscopy were admitted
to the study, Of the 88 randomized patients, 83 patients were included in t
he efficacy analysis (budesonide n = 43, placebo n = 40). Treatment was sta
rted within 2 weeks after surgery.
Interventions Colonoscopy was performed 3 and 12 months postoperatively. Th
e anastomosis and the adjacent bowel were evaluated by endoscopy and histol
ogy, For follow-up of the clinical course of the disease the Crohn's diseas
e activity index (CDAI) was used.
Main outcome measures The primary outcome variable was recurrence of Crohn'
s disease based on endoscopic findings. Secondary efficacy variables were h
istology scores, CDAI, time-to-failure and global judgement of wellbeing of
the patient.
Results The recurrence rate after 1 year (endoscopic and/ or clinical) was
57% (20/35) in the budesonide group and 70% (19/27) in the placebo group (n
.s.). Mean time-to-failure was 196 days under budesonide and 154 days under
placebo (n.s.). Median CDAI (relapse 19% vs. 28%) and global patients' jud
gement at the end of treatment (bad 5% vs. 15%) was slightly in favour of b
udesonide. One patient in each group discontinued the trial because of adve
rse events. Potentially steroid-related side effects were reported more fre
quently in the placebo than in the budesonide group (32% vs. 17%) (n.s,).
Summary and conclusion Although the effect of budesonide was altogether pos
itive in almost all variables studied in this trial (e.g. endoscopic and hi
stopathological score, time-to-failure, CDAI, patients' global judgement an
d rate of side effects), this increase in efficacy was small and the power
for detecting differences versus placebo was too low to be statistically si
gnificant. According to these results, low-dose oral budesonide cannot be r
ecommended to be used for the prevention of postoperative relapse in Crohn'
s disease. Eur J Gastroenterol Hepatol 11:277-282 (C) 1999 Lippincott Willi
ams & Wilkins.