Randomized double-blind placebo-controlled study to evaluate the effect of long-acting mesalamine on postinfectious irritable bowel syndrome with diarrhea

Neurogastroenterol Motil. 2024 Oct;36(10):e14889. doi: 10.1111/nmo.14889. Epub 2024 Aug 5.

Abstract

Background: A subset of patients with irritable bowel syndrome (IBS) develop their symptoms after gastroenteritis, referred to as postinfectious IBS (PI-IBS). PI-IBS is associated with low-grade intestinal inflammation. Previous studies have evaluated mesalamine, an anti-inflammatory drug, in patients with IBS. We evaluated the efficacy of long-acting mesalamine in patients with PI-IBS.

Methods: Sixty-one patients who developed diarrhea-predominant IBS (IBS-D) after gastroenteritis were randomized to receive either 2.4 g of long-acting mesalamine or placebo daily for 8-weeks. The symptoms assessed were abdominal pain, bloating, stool frequency, stool consistency, severity of diarrhea and constipation, satisfaction with bowel habits, and IBS affecting or interfering with life. Quality-of-life (QOL) was assessed using the IBS-QOL questionnaire. The prespecified primary outcome variable was the overall bowel symptom score (BSS) after 8-weeks of treatment. Effect sizes were expressed as standardized mean differences (Cohen's d).

Results: Fifty-four patients completed the 8-week treatment (n = 28 mesalamine, n = 26 placebo), 49 (91%) were male, and age range 23-71 years (mean ± SD 43 ± 13). Mesalamine demonstrated superior efficacy compared to placebo on the primary outcome variable, overall BSS (Cohen's d = 0.57, p = 0.042). Mesalamine was also superior for the secondary outcome of how much IBS affects your life in general (d = 0.72, p = 0.01). For the secondary outcomes of IBS symptoms, 7 of the 7 symptoms had trends of mesalamine superiority. For the secondary outcomes of IBS-QOL subscales, 8 of 9 had trends of mesalamine superiority.

Conclusion: In patients with PI-IBS, long-acting mesalamine demonstrated to be effective in reducing IBS symptoms and improving QOL.

Keywords: diarrhea; irritable bowel syndrome; mesalamine.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal* / therapeutic use
  • Delayed-Action Preparations
  • Diarrhea* / drug therapy
  • Diarrhea* / etiology
  • Double-Blind Method
  • Female
  • Gastroenteritis / complications
  • Gastroenteritis / drug therapy
  • Humans
  • Irritable Bowel Syndrome* / complications
  • Irritable Bowel Syndrome* / drug therapy
  • Male
  • Mesalamine* / administration & dosage
  • Mesalamine* / therapeutic use
  • Middle Aged
  • Quality of Life*
  • Treatment Outcome
  • Young Adult

Substances

  • Mesalamine
  • Anti-Inflammatory Agents, Non-Steroidal
  • Delayed-Action Preparations