A Prospective Randomized Controlled Trial of Intravenous Ciprofloxacin as an Adjunct to Corticosteroids in Acute, Severe Ulcerative Colitis

Abstract

BACKGROUND: The role of antibiotics in the treatment of ulcerative colitis is controversial. This study aims at assessing the therapeutic role of ciprofloxacin as an adjunct to corticosteroids in acute severe ulcerative colitis. METHODS: In this prospective, randomized, double-blind, placebo-controlled trial, 55 consecutive patients fulfilling the criteria of Truelove and Witts for severe ulcerative colitis were randomized on admission to the hospital to receive intravenously ciprofloxacin (400 mg b.i.d.) (n = 29) or placebo (n = 27). All patients received parenteral nutrition, intravenous hydrocortisone (100 mg q.i.d.) and hydrocortisone enemas (100 mg b.i.d.). Patients were assessed after 10 days of continuous treatment, or at any time a severe complication occurred. RESULTS: At study entry, there were no significant differences between treatment groups in any patient or disease-related parameter. Twenty-three of 29 patients (79.3%) treated with ciprofloxacin and 20 of 26 patients (77%) treated with placebo showed substantial improvement and were given oral steroids (P > 0.1). Six patients in each group did not improve (n = 10) or developed complications (n = 2). Nine of these 12 patients underwent emergency colectomy; three patients consented to receive intravenous cyclosporin but did not achieve remission of colitis and they underwent elective colectomy. There were no perioperative or late deaths. CONCLUSIONS: A short course of intravenous ciprofloxacin does not seem to augment the effect of corticosteroids for patients with acute, severe ulcerative colitis.