Clinical and endosonographic effect of ciprofloxacin on the treatment of perianal fistulae in Crohn's disease with infliximab: a double-blind placebo-controlled study
Authors: West, R. L.1; Woude, C. J.1; Hansen, B. E.1; Felt-Bersma, R. J. F.1; Tilburg, A. J. P.2; Drapers, J. A. G.3; Kuipers, E. J.1
Source: Alimentary Pharmacology & Therapeutics, Volume 20, Numbers 11-12, December 2004 , pp. 1329-1336(8)
Publisher: Blackwell Publishing
Abstract:
Summary Background : Ciprofloxacin is effective in perianal Crohn's disease but after treatment discontinuation symptoms reoccur. Infliximab is effective but requires maintenance therapy. Aim : To evaluate the effect of combined ciprofloxacin and infliximab in perianal Crohn's disease. Methods : A double-blind placebo-controlled study was conducted. Patients were randomly assigned to receive 500-mg ciprofloxacin twice daily or a placebo for 12 weeks. All patients received 5-mg/kg infliximab in week 6, 8 and 12 and were followed for 18 weeks. Primary end-point was clinical response, defined as a 50% or greater reduction from baseline in the number of draining fistulae. Secondary end-points were the change in Perianal Disease Activity Index and hydrogen peroxide enhanced three-dimensional endoanal ultrasonography findings. Analysis was by intention-to-treat. Results : Twenty-four patients were included but two discontinued treatment. At week 18, response was 73% (eight of 11) in the ciprofloxacin group and 39% (five of 13) in the placebo group (P = 0.12). Using logistic regression analysis patients treated with ciprofloxacin tended to respond better (OR = 2.37, CI: 0.94-5.98, P = 0.07). The Perianal Disease Activity Index score only improved (P = 0.008) in the ciprofloxacin group. Three-dimensional endoanal ultrasonography improved in three patients with a clinical response. Conclusions : A combination of ciprofloxacin and infliximab tended to be more effective than infliximab alone.Document Type: Research article
DOI: 10.1111/j.1365-2036.2004.02247.x
Affiliations: 1: Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam 2: Department of Internal Medicine, St Franciscus Gasthuis, Rotterdam 3: Department of Internal Medicine, Ziekenhuis Walcheren, Vlissingen, The Netherlands

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