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


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.
Division of Gastroenterology, University of Utah, School of Medicine, 30 N 1900 E, Salt Lake City, UT 84132, USA. Ashok.Tuteja@hsc.utah.edu
Ashok K
AK
Tuteja
John C
JC
Fang
Manal
M
Al-Suqi
Gregory J
GJ
Stoddard
Devon C
DC
Hale
D015746:Abdominal Pain / Q000209:etiology / Q000503:physiopathology; D000208:Acute Disease; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D001706:Biopsy; D003967:Diarrhea / Q000209:etiology / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005759:Gastroenteritis / Q000150:complications*; D006801:Humans; D007413:Intestinal Mucosa / Q000473:pathology; D043183:Irritable Bowel Syndrome / Q000188:drug therapy / Q000209:etiology / Q000473:pathology / Q000503:physiopathology / Q000523:psychology; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage*; D010147:Pain Measurement; D010865:Pilot Projects; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine