Randomised controlled trial of mesalazine in IBS

Giovanni Barbara, Cesare Cremon, Vito Annese, Guido Basilisco, Franco Bazzoli, Massimo Bellini, Antonio Benedetti, Luigi Benini, Fabrizio Bossa, Paola Buldrini, Michele Cicala, Rosario Cuomo, Bastianello Germanà, Paola Molteni, Matteo Neri, Marcello Rodi, Alfredo Saggioro, Maria Lia Scribano, Maurizio Vecchi, Giorgio Zoli & 2 others Roberto Corinaldesi, Vincenzo Stanghellini

Research output: Contribution to journalArticle

56 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)82-90
Number of pages9
JournalGut
Volume65
Issue number1
DOIs
Publication statusPublished - Jan 1 2016

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Mesalamine
Randomized Controlled Trials
Placebos
Therapeutics
Abdominal Pain
Inflammation
Safety

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Barbara, G., Cremon, C., Annese, V., Basilisco, G., Bazzoli, F., Bellini, M., ... Stanghellini, V. (2016). Randomised controlled trial of mesalazine in IBS. Gut, 65(1), 82-90. https://doi.org/10.1136/gutjnl-2014-308188

Randomised controlled trial of mesalazine in IBS. / Barbara, Giovanni; Cremon, Cesare; Annese, Vito; Basilisco, Guido; Bazzoli, Franco; Bellini, Massimo; Benedetti, Antonio; Benini, Luigi; Bossa, Fabrizio; Buldrini, Paola; Cicala, Michele; Cuomo, Rosario; Germanà, Bastianello; Molteni, Paola; Neri, Matteo; Rodi, Marcello; Saggioro, Alfredo; Scribano, Maria Lia; Vecchi, Maurizio; Zoli, Giorgio; Corinaldesi, Roberto; Stanghellini, Vincenzo.

In: Gut, Vol. 65, No. 1, 01.01.2016, p. 82-90.

Research output: Contribution to journalArticle

Barbara, G, Cremon, C, Annese, V, Basilisco, G, Bazzoli, F, Bellini, M, Benedetti, A, Benini, L, Bossa, F, Buldrini, P, Cicala, M, Cuomo, R, Germanà, B, Molteni, P, Neri, M, Rodi, M, Saggioro, A, Scribano, ML, Vecchi, M, Zoli, G, Corinaldesi, R & Stanghellini, V 2016, 'Randomised controlled trial of mesalazine in IBS', Gut, vol. 65, no. 1, pp. 82-90. https://doi.org/10.1136/gutjnl-2014-308188
Barbara G, Cremon C, Annese V, Basilisco G, Bazzoli F, Bellini M et al. Randomised controlled trial of mesalazine in IBS. Gut. 2016 Jan 1;65(1):82-90. https://doi.org/10.1136/gutjnl-2014-308188
Barbara, Giovanni ; Cremon, Cesare ; Annese, Vito ; Basilisco, Guido ; Bazzoli, Franco ; Bellini, Massimo ; Benedetti, Antonio ; Benini, Luigi ; Bossa, Fabrizio ; Buldrini, Paola ; Cicala, Michele ; Cuomo, Rosario ; Germanà, Bastianello ; Molteni, Paola ; Neri, Matteo ; Rodi, Marcello ; Saggioro, Alfredo ; Scribano, Maria Lia ; Vecchi, Maurizio ; Zoli, Giorgio ; Corinaldesi, Roberto ; Stanghellini, Vincenzo. / Randomised controlled trial of mesalazine in IBS. In: Gut. 2016 ; Vol. 65, No. 1. pp. 82-90.
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AU - Barbara, Giovanni

AU - Cremon, Cesare

AU - Annese, Vito

AU - Basilisco, Guido

AU - Bazzoli, Franco

AU - Bellini, Massimo

AU - Benedetti, Antonio

AU - Benini, Luigi

AU - Bossa, Fabrizio

AU - Buldrini, Paola

AU - Cicala, Michele

AU - Cuomo, Rosario

AU - Germanà, Bastianello

AU - Molteni, Paola

AU - Neri, Matteo

AU - Rodi, Marcello

AU - Saggioro, Alfredo

AU - Scribano, Maria Lia

AU - Vecchi, Maurizio

AU - Zoli, Giorgio

AU - Corinaldesi, Roberto

AU - Stanghellini, Vincenzo

PY - 2016/1/1

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N2 - 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.

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.

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