RT Journal Article
SR Electronic
T1 Randomised controlled trial of mesalazine in IBS
JF Gut
JO Gut
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP 82
OP 90
DO 10.1136/gutjnl-2014-308188
VO 65
IS 1
A1 Giovanni Barbara
A1 Cesare Cremon
A1 Vito Annese
A1 Guido Basilisco
A1 Franco Bazzoli
A1 Massimo Bellini
A1 Antonio Benedetti
A1 Luigi Benini
A1 Fabrizio Bossa
A1 Paola Buldrini
A1 Michele Cicala
A1 Rosario Cuomo
A1 Bastianello Germanà
A1 Paola Molteni
A1 Matteo Neri
A1 Marcello Rodi
A1 Alfredo Saggioro
A1 Maria Lia Scribano
A1 Maurizio Vecchi
A1 Giorgio Zoli
A1 Roberto Corinaldesi
A1 Vincenzo Stanghellini
YR 2016
UL http://gut.bmj.com/content/65/1/82.abstract
AB Objective Low-grade intestinal inflammation plays a role in the pathophysiology of IBS. In this trial, we aimed at evaluating the efficacy and safety of mesalazine in patients with IBS.Design We conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo-controlled trial in patients with Rome III confirmed IBS. Patients were randomly assigned to either mesalazine, 800 mg, or placebo, three times daily for 12 weeks, and were followed for additional 12 weeks. The primary efficacy endpoint was satisfactory relief of abdominal pain/discomfort for at least half of the weeks of the treatment period. The key secondary endpoint was satisfactory relief of overall IBS symptoms. Supportive analyses were also performed classifying as responders patients with a percentage of affirmative answers of at least 75% or >75% of time.Results A total of 185 patients with IBS were enrolled from 21 centres. For the primary endpoint, the responder patients were 68.6% in the mesalazine group versus 67.4% in the placebo group (p=0.870; 95% CI −12.8 to 15.1). In explorative analyses, with the 75% rule or >75% rule, the percentage of responders was greater in the mesalazine group with a difference over placebo of 11.6% (p=0.115; 95% CI −2.7% to 26.0%) and 5.9% (p=0.404; 95% CI −7.8% to 19.4%), respectively, although these differences were not significant. For the key secondary endpoint, overall symptoms improved in the mesalazine group and reached a significant difference of 15.1% versus placebo (p=0.032; 95% CI 1.5% to 28.7%) with the >75% rule.Conclusions Mesalazine treatment was not superior than placebo on the study primary endpoint. However, a subgroup of patients with IBS showed a sustained therapy response and benefits from a mesalazine therapy.Trial registration number ClincialTrials.gov number, NCT00626288.