A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D)
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...
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BMJ Publishing Group
2015
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| Online Access: | https://eprints.nottingham.ac.uk/40150/ |
| _version_ | 1848795995574370304 |
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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 Zaitoun, Abed M. Montgomery, Alan Spiller, Robin C. |
| author_facet | 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. |
| author_sort | Lam, Ching |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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) |
| first_indexed | 2025-11-14T19:40:57Z |
| format | Article |
| id | nottingham-40150 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:40:57Z |
| publishDate | 2015 |
| publisher | BMJ Publishing Group |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-401502020-05-04T17:04:46Z https://eprints.nottingham.ac.uk/40150/ 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. 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) BMJ Publishing Group 2015-03-12 Article PeerReviewed 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 and Spiller, Robin 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). pp. 91-99. ISSN 1468-3288 irritable bowel syndrome diarrhoea 5-aminosalicylate acid http://gut.bmj.com/content/65/1/91 doi:10.1136/gutjnl-2015-309122 doi:10.1136/gutjnl-2015-309122 |
| spellingShingle | irritable bowel syndrome diarrhoea 5-aminosalicylate acid 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. A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D) |
| title | A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D) |
| title_full | A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D) |
| title_fullStr | A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D) |
| title_full_unstemmed | A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D) |
| title_short | A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D) |
| title_sort | mechanistic multi-centre, parallel group, randomised placebo controlled trial of mesalazine for treatment of irritable bowel syndrome with diarrhoea (ibs-d) |
| topic | irritable bowel syndrome diarrhoea 5-aminosalicylate acid |
| url | https://eprints.nottingham.ac.uk/40150/ https://eprints.nottingham.ac.uk/40150/ https://eprints.nottingham.ac.uk/40150/ |