Double-blind placebo-controlled study of mesalamine in post-infective irritable bowel syndrome--a pilot study

Scand J Gastroenterol. 2012 Oct;47(10):1159-64. doi: 10.3109/00365521.2012.694903. Epub 2012 Jul 12.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Abdominal Pain* / etiology
  • Abdominal Pain* / physiopathology
  • Acute Disease
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Biopsy
  • Diarrhea* / etiology
  • Diarrhea* / physiopathology
  • Double-Blind Method
  • Female
  • Gastroenteritis / complications*
  • Humans
  • Intestinal Mucosa / pathology
  • Irritable Bowel Syndrome* / drug therapy
  • Irritable Bowel Syndrome* / etiology
  • Irritable Bowel Syndrome* / pathology
  • Irritable Bowel Syndrome* / physiopathology
  • Irritable Bowel Syndrome* / psychology
  • Male
  • Mesalamine / administration & dosage*
  • Pain Measurement
  • Pilot Projects
  • Quality of Life*
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal
  • Mesalamine