Mesalazine Has No Effect on Mucosal Immune Biomarkers in Patients with Diarrhea-Dominant Irritable Bowel Syndrome Referred to Shariati Hospital: A Randomized Double-Blind, Placebo-Controlled Trial

BACKGROUND Intestinal mast cells may cause gastrointestinal symptoms in patients with diarrhea-dominant irritable bowel syndrome (IBS). The objective of this study was to determine the effect of mesalazine on the number of lamina propria mast cells and clinical manifestations of patients with diarrhea-dominant IBS referred to Shariati Hospital affiliated to Tehran University of Medical Sciences. METHODS This was a randomized placebo-controlled double-blind trial conducted on 49 patients with diarrhea-dominant IBS. The patients were randomly assigned to one of the experiment or control groups. The patients in experiment group took 2400 mg mesalazine daily in three divided doses for 8 weeks and the patient in control group took placebo on the same basis. Our first targeted outcome was an assigned downturn of mast cells number to the safe colonic baseline and the next one was a marked palliation of disease symptoms. Data were analyzed conforming intention-to-treat method. We used MANCOVA test to compare our both assigned outcomes in the two groups. We also compared the data with baseline values in both groups.All statistical tests were performed at the significance level of 0.05. RESULTS There was no significant difference between Mesalazine and placebo groups regarding the number of mast cells (p value=0.396), abdominal pain (p value=0.054), bloating (p value=0.365), defecation urgency (p value=0.212), and defecation frequency (p value=0.702). CONCLUSION Mesalazine had no significant effect either on the number of mast cells or on the severity of disease symptoms. This finding seems to be inconsistent with the hypothesis indicating immune mechanisms as potential therapeutic targets in IBS. The possible difference in this effect of Mesalazine should be evaluated in further studies among populations varying in race, ethnic, and geographical characteristics.