An open-labeled, randomized study comparing systemic interferon-α-2A and prednisolone enemas in the treatment of left-sided ulcerative colitis

SM Madsen, P Schlichting, B Davidsen… - Official journal of the …, 2001 - journals.lww.com
SM Madsen, P Schlichting, B Davidsen, OH Nielsen, B Federspiel, P Riis, P Munkholm
Official journal of the American College of Gastroenterology| ACG, 2001journals.lww.com
OBJECTIVE: The aim of this study was to compare the treatment efficacies of subcutaneous
interferon-α-2A (IFN-α-2A) injections versus prednisolone enemas in active left-sided
ulcerative colitis in an open-labeled, randomized study. METHODS: Sixteen ulcerative colitis
patients received IFN-α-2A subcutaneously (dosage: first wk, 9 MIU three times weekly [tiw];
second wk, 6 MIU tiw; wk 3–12, 3 MIU tiw), and 16 received prednisolone enemas for 30
days (100 ml once daily, 0.25 mg of prednisolone/ml). The Powell-Tuck Index, Inflammatory …
Abstract
OBJECTIVE:
The aim of this study was to compare the treatment efficacies of subcutaneous interferon-α-2A (IFN-α-2A) injections versus prednisolone enemas in active left-sided ulcerative colitis in an open-labeled, randomized study.
METHODS:
Sixteen ulcerative colitis patients received IFN-α-2A subcutaneously (dosage: first wk, 9 MIU three times weekly [tiw]; second wk, 6 MIU tiw; wk 3–12, 3 MIU tiw), and 16 received prednisolone enemas for 30 days (100 ml once daily, 0.25 mg of prednisolone/ml). The Powell-Tuck Index, Inflammatory Bowel Disease Questionnaire (IBDQ) score, and rectal histological activities were assessed before and after treatment. Thirteen patients in the IFN-α-2A group and all 16 in the prednisolone enema group completed the treatment.
RESULTS:
IFN-α-2A treatment showed significant improvements in the Powell-Tuck Index (p= 0.0002), IBDQ score (p= 0.002), and rectal histological activity scores (p= 0.02). In the enema group, significant improvements were found in the Powell-Tuck Index (p= 0.0009), whereas no significant improvements were detected in the IBDQ scores (p= 0.055) or rectal histological scores (p= 0.052). There were no differences between scores of the two groups either before or after treatment. Only moderate side effects from the IFN-α-2A treatment were seen during the first 2–4 wk of treatment.
CONCLUSION:
IFN-α-2A treatment resulted in significant depression of the disease activity as reflected by the Powell-Tuck Index, IBDQ score, and histological disease activity scoring. The preliminary trial thus suggests that IFN-α-2A may be effective in the treatment of active left-sided ulcerative colitis. Larger, randomized trials are, however, warranted to confirm this finding, owing to possible type II errors in group comparisons.
Lippincott Williams & Wilkins