Trial reportGut2005
Combined oral and enema treatment with Pentasa (mesalazine) is superior to oral therapy alone in patients with extensive mild/moderate active ulcerative colitis: a randomised, double blind, placebo controlled study.
Trial report in Gut, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 71 papers, 8 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
71 citing papers in PubMed, 8 syntheses or guidelines pooled it, 364 citations in OpenAlex.
- Management of paediatric ulcerative colitis, part 1: Ambulatory care-An updated evidence-based consensus guideline from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition and the European Crohn's and Colitis Organisation.Journal of pediatric gastroenterology and nutrition · 2025Guideline
- Saudi consensus guidance for the diagnosis and management of inflammatory bowel disease in children and adolescents.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2025Guideline
- Definition of mild to moderate ulcerative colitis in clinical trials: A systematic literature review.United European gastroenterology journal · 2022Pooled it
- Ulcerative Colitis-Diagnostic and Therapeutic Algorithms.Deutsches Arzteblatt international · 2020Pooled it
- Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis.The Cochrane database of systematic reviews · 2017Pooled it
- Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis.Journal of Crohn's & colitis · 2016Pooled it
- Rectal 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2012Pooled it
- Meta-analysis of the placebo response in ulcerative colitis.Digestive diseases and sciences · 2008Pooled it
- [Clinical efficacy of porcine pulmonary surfactant combined with budesonide suspension intratracheal instillation in the treatment of neonatal meconium aspiration syndrome].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2016Trial
- A multicenter, randomized study to evaluate the efficacy and safety of mesalamine suppositories 1 g at bedtime and 500 mg Twice daily in patients with active mild-to-moderate ulcerative proctitis.Digestive diseases and sciences · 2011Trial
- Self-assembled nanoparticles from Xiexin Decoction attenuate ulcerative colitis by targeting VDAC1-Mediated NLRP3 inflammasome activation.Materials today. Bio · 2026Article
- Optimised mesalazine therapy reduces ulcerative colitis recurrence across the mild-to-moderate disease spectrum: the IMPACT study.Frontiers in gastroenterology (Lausanne, Switzerland) · 2026Article
- A practical approach to positioning therapies in ulcerative colitis.Journal of the Canadian Association of Gastroenterology · 2025Article
- Optimizing 5-aminosalicylate for moderate ulcerative colitis: expert recommendations from the Asia-Pacific, Middle East, and Africa Inflammatory Bowel Disease Coalition.Intestinal research · 2025Review
- Endoplasmic Reticular Stress and Pathogenesis of Experimental Colitis: Mechanism of Action of 5-Amino Salicylic Acid.Medical principles and practice : international journal of the Kuwait University, Health Science Centre · 2025Article
- Common Mistakes in Managing Patients with Inflammatory Bowel Disease.Journal of clinical medicine · 2024Review
- Drug Optimization in Patients with Mild-to-Moderate Ulcerative Colitis: A Global Survey.Journal of clinical medicine · 2024Article
- An In Vitro Study Evaluating the Safety of Mesalazine on Human Nasoepithelial Cells.International journal of molecular sciences · 2024Article
- Treatment of Patients with Mild to Moderate Ulcerative Colitis: A Middle East Expert Consensus.Journal of clinical medicine · 2023Review
- Clinical Background Factors as Predictors of the Efficacy of 5-Aminosalicylic Acid Suppositories in Patients with Ulcerative Colitis.Inflammatory intestinal diseases · 2023Article
11 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 10 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsOral aminosalicylates are well established in the treatment of active mild/moderate ulcerative colitis (UC) when the disease is extensive (that is, beyond the splenic flexure). The majority of clinical symptoms relate to disease activity in the distal part of the colon and therefore this study was designed to investigate if adding a mesalazine enema to oral mesalazine has additional benefit for patients with extensive mild/moderate active UC.
methodsA randomised double blind study was performed in 127 ambulatory patients. All received 4 g/day (twice daily dosing) oral mesalazine for eight weeks. During the initial four weeks, they additionally received an enema at bedtime containing 1 g of mesalazine or placebo. Disease activity was assessed using the ulcerative colitis disease activity index, with clinical and endoscopic signs at four and eight weeks.
resultsRemission was obtained in 44% (95% confidence interval (CI) 31%, 58%) of the mesalazine enema group (Me) and in 34% (95% CI 21%, 49%) of the placebo enema group (Pl) at four weeks (p = 0.31) and in 64% (95% CI 50%, 76%) of the Me group versus 43% (95% CI 28%, 58%) of the Pl group at eight weeks (p = 0.03). Improvement was obtained in 89% (95% CI 78%, 96%) of the Me group versus 62% (95% CI 46%, 75%) of the Pl group at four weeks (p = 0.0008) and in 86% (95% CI 75%, 94%) of the Me group versus 68% (95% CI 53%, 81%) of the Pl group at eight weeks (p = 0.026).
conclusionIn patients with extensive mild/moderate active UC, the combination therapy is superior to oral therapy. It is safe, well accepted, and may be regarded as firstline treatment.
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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.