Double-blind placebo-controlled study of mesalamine in post-infective irritable bowel syndrome – a pilot study
Abstract
OBJECTIVE: Post-infective irritable bowel syndrome (PI-IBS) is characterized by continuing symptoms of irritable bowel syndrome, typically diarrhea-predominant, following an episode of acute gastroenteritis. There is often an increase in sub-epithelial inflammatory and neuroendocrine cells on colonic mucosal biopsy. Mesalamine is an anti-inflammatory agent, effective in the treatment of inflammatory bowel disease. The goal of this study was to compare mesalamine to placebo on symptoms and quality-of-life (QOL) in PI-IBS. MATERIAL AND METHODS: Twenty patients who developed diarrhea-predominant IBS after gastroenteritis were randomized to receive mesalamine (Asacol®) 1.6 gm b.i.d. or placebo for 12 weeks in a double-blind placebo-controlled study. QOL was assessed using the IBS-QOL questionnaire. Stool frequency, stool consistency, urgency, severity of abdominal pain, severity of bloating, and global-improvement scale were recorded in daily diaries for 7 days at baseline and every 4 weeks. Data were analyzed by comparing the change from baseline to last follow-up. RESULTS: One patient withdrew after randomization; data were incomplete in two patients. Thus, data were analyzed from 17 patients (11 men and 6 women, median age: 27 years, range 22-45 years). Mesalamine was not associated with significant improvement in global symptoms, abdominal pain, bloating, stool urgency, frequency, or consistency (all p ≥ 0.11) or QOL (p ≥ 0.16). CONCLUSIONS: There was no significant improvement in global symptoms or overall QOL with mesalamine in patients with PI-IBS.
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A small, double-blind, randomized study of 20 IBS patients showed that mesalamine 2.4 g/day for 8 wk failed to show improvement in IBS symptoms despite a reduction in the number of total immune cells in colonic biopsies and improvement in general well-being.
“A small, double-blind, randomized study of 20 IBS patients showed that mesalamine 2.4 g/day for 8 wk failed to show improvement in IBS symptoms despite a reduction in the number of total immune cells in colonic biopsies and improvement in general well-being (45, 177).”
From Intestinal microbiota and immune function in the pathogenesis of irritable bowel syndrome (2013) · cites this paper as [177]
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- Authors
- Tuteja, A. K., Fang, J. C., Al-Suqi, M., Stoddard, G. J., & Hale, D. C.
- Affiliations
- University of Utah (US)
- George E. Wahlen Department of VA Medical Center (US)
- Corresponding author
- Tuteja, Ashok K.
- Venue
- Scandinavian Journal of Gastroenterology
- Publisher
- Informa UK Limited
- Published
- 2012-07-12
- Volume
- 47
- Issue
- 10
- Pages
- 1159-1164
- ISSN
- 0036-5521 (ISSN-L)
- 1502-7708
- OpenAlex
- W2077139557
- Cited by
- 41
- References
- 33
- Citations by year
- 2024: 1 · 2023: 3 · 2022: 5 · 2021: 2 · 2019: 2 · 2018: 4 · 2017: 3 · 2016: 5 · 2015: 4 · 2014: 6 · 2013: 5 · 2012: 1
- FWCI
- 4.97
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Scandinavian Journal of Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Health Sciences › Medicine › Epidemiology › Microscopic Colitis
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Keywords
- 5-aminosalicylic acid, anti-inflammatory therapy, acute gastroenteritis, diarrhea-predominant irritable bowel syndrome, quality of life, abdominal pain, bloating, colonic mucosal inflammation
- MeSH terms
- Acute Disease, Adult, Anti-Inflammatory Agents, Non-Steroidal, Biopsy, Diarrhea, Double-Blind Method, Female, Gastroenteritis, Humans, Intestinal Mucosa, Male, Pain Measurement, Pilot Projects, Quality of Life, Surveys and Questionnaires, Severity of Illness Index, Abdominal Pain, Treatment Outcome, Mesalamine, Irritable Bowel Syndrome
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