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A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D)

INTRODUCTION: Immune activation has been reported in the mucosa of IBS 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 2 g mesalazine twice daily versus placebo for 3 month...

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Autores principales: Lam, Ching, Tan, Wei, Leighton, Matthew, Hastings, Margaret, Lingaya, Melanie, Falcone, Yirga, Zhou, Xiaoying, Xu, Luting, Whorwell, Peter, Walls, Andrew F, Zaitoun, Abed, Montgomery, Alan, Spiller, Robin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4717357/
https://www.ncbi.nlm.nih.gov/pubmed/25765462
http://dx.doi.org/10.1136/gutjnl-2015-309122
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author Lam, Ching
Tan, Wei
Leighton, Matthew
Hastings, Margaret
Lingaya, Melanie
Falcone, Yirga
Zhou, Xiaoying
Xu, Luting
Whorwell, Peter
Walls, Andrew F
Zaitoun, Abed
Montgomery, Alan
Spiller, Robin
author_facet Lam, Ching
Tan, Wei
Leighton, Matthew
Hastings, Margaret
Lingaya, Melanie
Falcone, Yirga
Zhou, Xiaoying
Xu, Luting
Whorwell, Peter
Walls, Andrew F
Zaitoun, Abed
Montgomery, Alan
Spiller, Robin
author_sort Lam, Ching
collection PubMed
description INTRODUCTION: Immune activation has been reported in the mucosa of IBS 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 2 g mesalazine twice daily versus placebo for 3 months in patients with Rome III criteria IBS-D. 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 women, 54 men) 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 the placebo group with no significant group difference, (95% CI) 0.1 (−0.33 to 0.53), p=0.66. Mesalazine did not improve abdominal pain, stool consistency nor percentage with satisfactory relief compared with placebo during the last two-weeks follow-up. CONCLUSIONS: This study does not support any clinically meaningful benefit or harm of mesalazine compared with placebo in unselected patients with IBS-D. More precise subtyping based on underlying disease mechanisms is needed to allow more effective targeting of treatment in IBS. TRIAL REGISTRATION NUMBER: NCT01316718.
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spelling pubmed-47173572016-01-28 A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D) Lam, Ching Tan, Wei Leighton, Matthew Hastings, Margaret Lingaya, Melanie Falcone, Yirga Zhou, Xiaoying Xu, Luting Whorwell, Peter Walls, Andrew F Zaitoun, Abed Montgomery, Alan Spiller, Robin Gut Neurogastroenterology INTRODUCTION: Immune activation has been reported in the mucosa of IBS 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 2 g mesalazine twice daily versus placebo for 3 months in patients with Rome III criteria IBS-D. 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 women, 54 men) 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 the placebo group with no significant group difference, (95% CI) 0.1 (−0.33 to 0.53), p=0.66. Mesalazine did not improve abdominal pain, stool consistency nor percentage with satisfactory relief compared with placebo during the last two-weeks follow-up. CONCLUSIONS: This study does not support any clinically meaningful benefit or harm of mesalazine compared with placebo in unselected patients with IBS-D. More precise subtyping based on underlying disease mechanisms is needed to allow more effective targeting of treatment in IBS. TRIAL REGISTRATION NUMBER: NCT01316718. BMJ Publishing Group 2016-01 2015-03-12 /pmc/articles/PMC4717357/ /pubmed/25765462 http://dx.doi.org/10.1136/gutjnl-2015-309122 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
spellingShingle Neurogastroenterology
Lam, Ching
Tan, Wei
Leighton, Matthew
Hastings, Margaret
Lingaya, Melanie
Falcone, Yirga
Zhou, Xiaoying
Xu, Luting
Whorwell, Peter
Walls, Andrew F
Zaitoun, Abed
Montgomery, Alan
Spiller, Robin
A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D)
title A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D)
title_full A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D)
title_fullStr A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D)
title_full_unstemmed A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D)
title_short A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D)
title_sort mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of ibs with diarrhoea (ibs-d)
topic Neurogastroenterology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4717357/
https://www.ncbi.nlm.nih.gov/pubmed/25765462
http://dx.doi.org/10.1136/gutjnl-2015-309122
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