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Original article
Randomised controlled trial of mesalazine in IBS
  1. Giovanni Barbara1,
  2. Cesare Cremon1,
  3. Vito Annese2,
  4. Guido Basilisco3,
  5. Franco Bazzoli4,
  6. Massimo Bellini5,
  7. Antonio Benedetti6,
  8. Luigi Benini7,
  9. Fabrizio Bossa8,
  10. Paola Buldrini9,
  11. Michele Cicala10,
  12. Rosario Cuomo11,
  13. Bastianello Germanà12,
  14. Paola Molteni13,
  15. Matteo Neri14,
  16. Marcello Rodi15,
  17. Alfredo Saggioro16,
  18. Maria Lia Scribano17,
  19. Maurizio Vecchi18,
  20. Giorgio Zoli19,
  21. Roberto Corinaldesi1,
  22. Vincenzo Stanghellini1
  1. 1Department of Medical and Surgical Sciences, Centre for Applied Biomedical Research, University of Bologna, Bologna, Italy
  2. 2Division of Gastroenterology SOD2, University Hospital Careggi, Florence, Italy
  3. 3Gastroenterology Unit, Ospedale Maggiore, Policlinico, Milan, Italy
  4. 4Gastroenterology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
  5. 5Gastroenterology Unit, Department of Gastroenterology, University of Pisa, Pisa, Italy
  6. 6Department of Gastroenterology and Hepatology, Università Politecnica delle Marche, Ancona, Italy
  7. 7Gastroenterology Unit, University of Verona, Verona, Italy
  8. 8Division of Gastroenterology, Casa Sollievo Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy
  9. 9Gastroenterology Unit of Comacchio/Lagosanto, Ferrara, Italy
  10. 10Gastroenterology Unit, University Campus Bio-Medico of Rome, Rome, Italy
  11. 11Digestive Motility Diseases, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy
  12. 12Gastroenterology Unit, S. Martino Hospital, Belluno, Italy
  13. 13Gastroenterology Unit, Department of Clinical Science, "L. Sacco" University Hospital, Milan, Italy
  14. 14Department of Medicine and Aging Sciences and CESI, G. D'Annunzio University and Foundation, Chieti, Italy
  15. 15Gastroenterology Unit, St. Andrea Hospital, Vercelli, Italy
  16. 16Department of Digestive Diseases, Hepatology and Clinical Nutrition, Dell'Angelo Hospital, Venice, Italy
  17. 17Division of Gastroenterology, AO San Camillo Forlanini, Rome, Italy
  18. 18Gastroenterology and Digestive Endoscopy Unit, IRCCS Policlinico San Donato, San Donato Milanese, Italy
  19. 19Santissima Annunziata Hospital, Cento, Italy
  1. Correspondence to Dr Giovanni Barbara, Department of Medical and Surgical Sciences, St. Orsola-Malpighi Hospital—Building # 5, Via Massarenti, Bologna 9-I-40138, Italy; giovanni.barbara{at}unibo.it

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.

  • IRRITABLE BOWEL SYNDROME
  • CLINICAL TRIALS
  • INFLAMMATORY CELLS
  • ABDOMINAL PAIN
  • GUT INFLAMMATION

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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