title: Randomised controlled trial of mesalazine in IBS.
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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  ClincialTrials.gov number, NCT00626288.
authors.affiliation: Department of Medical and Surgical Sciences, Centre for Applied Biomedical Research, University of Bologna, Bologna, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Barbara
authors.affiliation: Department of Medical and Surgical Sciences, Centre for Applied Biomedical Research, University of Bologna, Bologna, Italy.
authors.forename: Cesare
authors.initials: C
authors.lastname: Cremon
authors.affiliation: Division of Gastroenterology SOD2, University Hospital Careggi, Florence, Italy.
authors.forename: Vito
authors.initials: V
authors.lastname: Annese
authors.affiliation: Gastroenterology Unit, Ospedale Maggiore, Policlinico, Milan, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Basilisco
authors.affiliation: Gastroenterology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Bazzoli
authors.affiliation: Gastroenterology Unit, Department of Gastroenterology, University of Pisa, Pisa, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Bellini
authors.affiliation: Department of Gastroenterology and Hepatology, Università Politecnica delle Marche, Ancona, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Benedetti
authors.affiliation: Gastroenterology Unit, University of Verona, Verona, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Benini
authors.affiliation: Division of Gastroenterology, Casa Sollievo Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Bossa
authors.affiliation: Gastroenterology Unit of Comacchio/Lagosanto, Ferrara, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Buldrini
authors.affiliation: Gastroenterology Unit, University Campus Bio-Medico of Rome, Rome, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Cicala
authors.affiliation: Digestive Motility Diseases, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy.
authors.forename: Rosario
authors.initials: R
authors.lastname: Cuomo
authors.affiliation: Gastroenterology Unit, S. Martino Hospital, Belluno, Italy.
authors.forename: Bastianello
authors.initials: B
authors.lastname: Germanà
authors.affiliation: Gastroenterology Unit, Department of Clinical Science, "L. Sacco" University Hospital, Milan, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Molteni
authors.affiliation: Department of Medicine and Aging Sciences and CESI, G. D'Annunzio University and Foundation, Chieti, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Neri
authors.affiliation: Gastroenterology Unit, St. Andrea Hospital, Vercelli, Italy.
authors.forename: Marcello
authors.initials: M
authors.lastname: Rodi
authors.affiliation: Department of Digestive Diseases, Hepatology and Clinical Nutrition, Dell'Angelo Hospital, Venice, Italy.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Saggioro
authors.affiliation: Division of Gastroenterology, AO San Camillo Forlanini, Rome, Italy.
authors.forename: Maria Lia
authors.initials: ML
authors.lastname: Scribano
authors.affiliation: Gastroenterology and Digestive Endoscopy Unit, IRCCS Policlinico San Donato, San Donato Milanese, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Vecchi
authors.affiliation: Santissima Annunziata Hospital, Cento, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Zoli
authors.affiliation: Department of Medical and Surgical Sciences, Centre for Applied Biomedical Research, University of Bologna, Bologna, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Corinaldesi
authors.affiliation: Department of Medical and Surgical Sciences, Centre for Applied Biomedical Research, University of Bologna, Bologna, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Stanghellini
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use*; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine
keywords: ABDOMINAL PAIN; CLINICAL TRIALS; GUT INFLAMMATION; INFLAMMATORY CELLS; IRRITABLE BOWEL SYNDROME