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A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D)

Lam, Ching; Tan, Wei; Leighton, Matthew; Hastings, Margaret; Lingaya, Melanie; Falcone, Yirga; Zhou, Xiaoying; Xu, Luting; Whorwell, Peter; Walls, Andrew; Zaitoun, Abed M.; Montgomery, Alan; Spiller, Robin C.

Authors

Ching Lam

WEI TAN Wei.Tan@nottingham.ac.uk
Medical Statistician

Matthew Leighton Matthew.Leighton@nottingham.ac.uk

Margaret Hastings

Melanie Lingaya

Yirga Falcone

Xiaoying Zhou

Luting Xu

Peter Whorwell

Andrew Walls

Abed M. Zaitoun

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director, nottingham Clinical Trials Unit

Robin C. Spiller



Abstract

Introduction: Immune activation has been reported in the mucosa of irritable bowel syndrome patients with diarrhoea (IBS-D) and some small studies have suggested that Mesalazine may reduce symptoms. We performed a double blind, randomised placebo controlled trial of 2g Mesalazine twice daily versus placebo for 3 months in Rome III criteria IBS-D patients. Primary outcome was daily average stool frequency during weeks 11-12; secondary outcomes were abdominal pain, stool consistency, urgency and satisfactory relief of IBS symptoms.
Methods: Participants were randomised after a 2-week baseline stool diary. All participants completed a 12-week stool diary and at the end of each week recorded the presence of “satisfactory relief of IBS symptoms”.
Results: 136 patients with IBS-D (82 F, 54 M) were randomised, 10 patients withdrew from each group. Analysis by intention to treat showed the daily average stool frequency during weeks 11 and 12 were mean (SD), 2.8 (1.2) in Mesalazine and 2.7 (1.9) in placebo group with no significant group difference (95% confidence interval) 0.1 (-0.33,0.53); p=0.66. Mesalazine did not improve abdominal pain, stool consistency nor percentage with satisfactory relief compared to placebo during the last 2 weeks follow up.
Conclusion: This study does not support any clinically meaningful benefit or harm of Mesalazine compared with placebo in unselected IBS with diarrhoea. More precise subtyping based on underlying disease mechanisms is needed to allow more effective targeting of treatment in IBS. (ClinicalTrials.gov number NCT01316718)

Journal Article Type Article
Publication Date Mar 12, 2015
Journal Gut
Print ISSN 0017-5749
Electronic ISSN 1468-3288
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 65
Issue 1
APA6 Citation Lam, C., Tan, W., Leighton, M., Hastings, M., Lingaya, M., Falcone, Y., …Spiller, R. C. (2015). A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D). Gut, 65(1), https://doi.org/10.1136/gutjnl-2015-309122
DOI https://doi.org/10.1136/gutjnl-2015-309122
Keywords irritable bowel syndrome, diarrhoea, 5-aminosalicylate acid
Publisher URL http://gut.bmj.com/content/65/1/91
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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