Sm. Madsen et al., An open-labeled, randomized study comparing systemic interferon-alpha-2A and prednisolone enemas in the treatment of left-sided ulcerative colitis, AM J GASTRO, 96(6), 2001, pp. 1807-1815
OBJECTIVE: The aim of this study was to compare the treatment efficacies of
subcutaneous interferon-alpha -2A (IFN-alpha -2A) injections versus predni
solone enemas in active left-sided ulcerative colitis in an open-labeled, r
andomized study.
METHODS: Sixteen ulcerative colitis patients received IFN-alpha -2A subcuta
neously (dosage: first wk, 9 MIU three times weekly [t.i.w.]; second wk, 6
MIU t.i.w.; wk 3-12, 3 MIU t.i.w.), and 16 received prednisolone enemas for
30 days (100 ml once daily, 0.25 mg of prednisolone/ml). The Powell-Tuck I
ndex, Inflammatory Bowel Disease Questionnaire (IBDQ) score, and rectal his
tological activities were assessed before and after treatment. Thirteen pat
ients in the IFN-alpha -2A group and all 16 in the prednisolone enema group
completed the treatment.
RESULTS: IFN-alpha -2A treatment showed significant improvements in the Pow
ell-Tuck Index (p = 0.0002), IBDQ score (p = 0.002), and rectal histologica
l activity scores (p = 0.02). In the enema group, significant improvements
were found in the Powell-Tuck Index (p = 0.0009), whereas no significant im
provements were detected in the IBDQ scores (p = 0.055) or rectal histologi
cal scores (p = 0.052). There were no differences between scores of the two
groups either before or after treatment. Only moderate side effects from t
he IFN-alpha -2A treatment were seen during the first 2-4 wk of treatment.
CONCLUSION: IFN-alpha -2A treatment resulted in significant depression of t
he disease activity as reflected by the Powell-Tuck Index, IBDQ score, and
histological disease activity scoring. The preliminary trial thus suggests
that IFN-alpha -2A may be effective in the treatment of active left-sided u
lcerative colitis. Larger, randomized trials are, however, warranted to con
firm this finding, owing to possible type II errors in group comparisons. (
C) 2001 by Am. Coll. of Gastroenterology.