Randomized Controlled Trial
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World J Gastroenterol. Sep 14, 2014; 20(34): 12283-12291
Published online Sep 14, 2014. doi: 10.3748/wjg.v20.i34.12283
Otilonium bromide in irritable bowel syndrome: A dose-ranging randomized double-blind placebo-controlled trial
Danuta Chmielewska-Wilkoń, Giorgio Reggiardo, Colin Gerard Egan
Danuta Chmielewska-Wilkoń, Department of Gastrointestinal Endoscopy, Gabinet Endoskopii Przewodu Pokarmowego, Szewska, 31-009 Krakow, Poland
Giorgio Reggiardo, Medi Service, World Trade Center, 16149 Genoa, Italy
Colin Gerard Egan, Primula Multimedia SRL, 56121 Pisa, Italy
Author contributions: Chmielewska-Wilkoń D designed the trial and recruited the patients; Reggiardo G performed statistical analysis; Egan CG performed data analysis, prepared tables and figures and wrote the manuscript; all authors critically revised the final version of the manuscript.
Supported by Menarini Group, Florence, Italy
Correspondence to: Colin Gerard Egan, PhD, Primula Multimedia SRL, Via G. Ravizza 22/b Ospedaletto, 56121 Pisa, Italy. cegan@primulaedizioni.it
Telephone: +39-50-9656242 Fax: +39-50-3163810
Received: February 10, 2014
Revised: April 29, 2014
Accepted: June 2, 2014
Published online: September 14, 2014
Processing time: 220 Days and 2 Hours
Core Tip

Core tip: Although previous trials have confirmed the efficacy of a single dose of otilonium bromide (OB) on well-defined endpoints in patients with irritable bowel syndrome (IBS), no study has specifically defined the optimal dosage of OB on standard IBS efficacy measures in a controlled cross-over design. Findings from this dose-ranging study demonstrate that OB at 40 and 80 mg can improve both individual and global clinical IBS symptoms compared to placebo over 4 wk. All doses of OB were well tolerated compared to placebo. Future long-term controlled trials on global efficacy measures will help reinforce findings from the present trial.