A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL OF ORAL CIPROFLOXACIN IN ACUTE ULCERATIVE-COLITIS

Objectives: The aim of this prospective, randomized, controlled trial was to evaluate the role of ciprofloxacin as an adjunct to corticoster oids in acute ulcerative colitis. Methods: Seventy consecutive patient s with mild (n = 37) or moderately active (n = 33) ulcerative colitis were randomized to receive oral ciprofloxacin (250 mg b.i.d., n = 34) or placebo (n = 36) for 14 days. In addition, they were given oral pre dnisolone (initial dose 20 or 40 mg for mild and moderately active ulc erative colitis, respectively) and rectal betamethasone enemas (2 g at night) for 7-9 weeks. All patients were receiving olsalazine (0.5 g t wice daily). At study entry, the groups were similar with respect to a ge, sex, extent, duration, and severity of disease, and previous treat ments. Patients were assessed clinically, endoscopically, and histolog ically before, at the end of the trial (day 14), and on completion of steroid treatment, or at any time worsening of symptoms or a complicat ion of ulcerative colitis occurred. Results: At the end of the study, 24 patients (70.5%) in the ciprofloxacin group and 26 patients (72%) i n the placebo group achieved remission (p > 0.1, Yates (2)(chi)). Ten patients in each group necessitated higher doses of oral (n = 12) or i ntravenous (n = 8) steroids. Of the latter patients, two underwent eme rgency colectomy without perioperative deaths. Clostridium difficile t oxin A was not detected in nonresponders to ciprofloxacin treatment. C onclusions: A short course of oral ciprofloxacin treatment does not se em to increase the proportion of patients with active ulcerative colit is going into remission.