Document Detail

Effect of mesalazine on mucosal immune biomarkers in irritable bowel syndrome: a randomized controlled proof-of-concept study.
MedLine Citation:
PMID:  19438846     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Intestinal immune infiltration contributes to symptoms in patients with irritable bowel syndrome (IBS).
AIM: To assesses the effect of mesalazine (mesalamine) on mucosal immune cells in patients with IBS, through a pilot study.
METHODS: A randomized, double-blind, placebo-controlled trial in 20 patients with IBS in tertiary care setting. Patients were randomized to receive placebo or 800 mg mesalazine three times daily for 8 weeks. The primary endpoint was a significant reduction in total colonic immune cells on biopsies obtained at the end of treatment compared to baseline. Secondary endpoints included effects on subsets of immune cells, inflammatory mediators and symptom severity. Intention-to-treat analysis was performed.
RESULTS: Mesalazine markedly reduced immune cells as compared with placebo (P = 0.0082); this effect was ascribed to a marked inhibition of mast cells (P = 0.0014). Mesalazine significantly increased general well-being (P = 0.038), but had no significant effects on abdominal pain (P = 0.084), bloating (P = 0.177) or bowel habits. No serious drug-related adverse events were reported during the study.
CONCLUSIONS: Mesalazine is an effective and safe approach to reduce mast cell infiltration and may improve general well-being in patients with IBS. These results support the hypothesis that immune mechanisms represent potential therapeutic targets in IBS.
R Corinaldesi; V Stanghellini; C Cremon; L Gargano; R F Cogliandro; R De Giorgio; G Bartesaghi; B Canovi; G Barbara
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-05-12
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  30     ISSN:  1365-2036     ISO Abbreviation:  Aliment. Pharmacol. Ther.     Publication Date:  2009 Aug 
Date Detail:
Created Date:  2009-07-23     Completed Date:  2010-02-22     Revised Date:  2011-08-05    
Medline Journal Info:
Nlm Unique ID:  8707234     Medline TA:  Aliment Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  245-52     Citation Subset:  IM    
Department of Clinical Medicine and Center for Applied Biomedical Research, University of Bologna, Bologna, Italy.
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MeSH Terms
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
Biological Markers / metabolism
Double-Blind Method
Intestinal Mucosa / metabolism*,  pathology
Irritable Bowel Syndrome / drug therapy*,  pathology
Mesalamine / therapeutic use*
Middle Aged
Pilot Projects
Treatment Outcome
Young Adult
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Biological Markers; 89-57-6/Mesalamine
Comment In:
Aliment Pharmacol Ther. 2011 Jul;34(2):259-60   [PMID:  21679211 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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