Trial reportGut2016
A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D).
Trial report in Gut, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01316718 (Efficacy and Mode of Action of Mesalazine in the Treatment of Diarrhoea-predominant Irritable Bowel Syndrome), which is not on this map. Cited by 34 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy and Mode of Action of Mesalazine in the Treatment of Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D).
Who cites it
34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 91 citations in OpenAlex.
- Randomised clinical trial and meta-analysis: mesalazine treatment in irritable bowel syndrome-effects on gastrointestinal symptoms and rectal biomarkers of immune activity.Alimentary pharmacology & therapeutics · 2022Pooled it
- Pooled it
- Rome Foundation Working Team Report on Post-Infection Irritable Bowel Syndrome.Gastroenterology · 2019Guideline
- Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence.Alimentary pharmacology & therapeutics · 2017Trial
- Review
- Irritable bowel syndrome management: current insights.Singapore medical journal · 2026Article
- Mesalazine vs. IBS-D: Examining its impact on patient symptoms & stool calprotectin levels: A randomized double-blind, placebo-controlled trial.Caspian journal of internal medicine · 2025Article
- Therapeutic Potential of Palmitoylethanolamide in Gastrointestinal Disorders.Antioxidants (Basel, Switzerland) · 2024Review
- Emerging role of the gut microbiome in post-infectious irritable bowel syndrome: A literature review.World journal of gastroenterology · 2023Review
- Review
- Review
- Immune activation in irritable bowel syndrome: what is the evidence?Nature reviews. Immunology · 2022Review
- Mast cell mediation of visceral sensation and permeability in irritable bowel syndrome.Neurogastroenterology and motility · 2022Review
- Functional bowel disorders with diarrhoea: Clinical guidelines of the United European Gastroenterology and European Society for Neurogastroenterology and Motility.United European gastroenterology journal · 2022Review
- Postinfection Irritable Bowel Syndrome.Gut and liver · 2022Review
- Post-infection Irritable Bowel Syndrome.Gastroenterology clinics of North America · 2021Review
- Colonic Gene Expression and Fecal Microbiota in Diarrhea-predominant Irritable Bowel Syndrome: Increased Toll-like Receptor 4 but Minimal Inflammation and no Response to Mesalazine.Journal of neurogastroenterology and motility · 2021Article
- Twitter debate: controversies in functional gastrointestinal disorders.Frontline gastroenterology · 2020Article
- Post-infectious IBS: Defining its clinical features and prognosis using an internet-based survey.United European gastroenterology journal · 2018Article
- New treatments and therapeutic targets for IBS and other functional bowel disorders.Nature reviews. Gastroenterology & hepatology · 2018Review
Corrections and comments
- Commented on by
- Commented on by
Authors and funding
13 authors at 6 institutions in 1 country.
Funding
Abstract
introductionImmune activation has been reported in the mucosa of IBS patients with diarrhoea (IBS-D), and some small studies have suggested that mesalazine may reduce symptoms. We performed a double-blind, randomised placebo-controlled trial of 2 g mesalazine twice daily versus placebo for 3 months in patients with Rome III criteria IBS-D. Primary outcome was daily average stool frequency during weeks 11-12; secondary outcomes were abdominal pain, stool consistency, urgency and satisfactory relief of IBS symptoms.
methodsParticipants were randomised after a 2-week baseline stool diary. All participants completed a 12-week stool diary and at the end of each week recorded the presence of 'satisfactory relief of IBS symptoms'.
results136 patients with IBS-D (82 women, 54 men) were randomised, 10 patients withdrew from each group. Analysis by intention to treat showed the daily average stool frequency during weeks 11 and 12 were mean (SD), 2.8 (1.2) in mesalazine and 2.7 (1.9) in the placebo group with no significant group difference, (95% CI) 0.1 (-0.33 to 0.53), p=0.66. Mesalazine did not improve abdominal pain, stool consistency nor percentage with satisfactory relief compared with placebo during the last two-weeks follow-up.
conclusionsThis study does not support any clinically meaningful benefit or harm of mesalazine compared with placebo in unselected patients with IBS-D. More precise subtyping based on underlying disease mechanisms is needed to allow more effective targeting of treatment in IBS. TRIAL REGISTRATION NUMBER: NCT01316718.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.