Trial reportJournal of Crohn's & colitis2017
Budesonide Multimatrix Is Efficacious for Mesalamine-refractory, Mild to Moderate Ulcerative Colitis: A Randomised, Placebo-controlled Trial.
Trial report in Journal of Crohn's & colitis, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 32 papers, 5 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
32 citing papers in PubMed, 5 syntheses or guidelines pooled it, 73 citations in OpenAlex.
- Definition of mild to moderate ulcerative colitis in clinical trials: A systematic literature review.United European gastroenterology journal · 2022Pooled it
- Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020Pooled it
- Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020Pooled it
- Comparative assessment of budesonide-MMX and mesalamine in active, mild-to-moderate ulcerative colitis: A systematic review and network meta-analysis.British journal of clinical pharmacology · 2019Pooled it
- Comparative safety of systemic and low-bioavailability steroids in inflammatory bowel disease: Systematic review and network meta-analysis.British journal of clinical pharmacology · 2018Pooled it
- Effects of Spirulina supplementation in patients with ulcerative colitis: a double-blind, placebo-controlled randomized trial.BMC complementary medicine and therapies · 2024Trial
- Efficacy and safety of prolonged release budesonide granules in mesalazine-refractory ulcerative colitis: A multi-centre Phase IIa study (TOPICAL-1).United European gastroenterology journal · 2020Trial
- Efficacy and Safety of Oral Prednisolone and Budesonide MMX for Outpatient Induction Therapy in Active Ulcerative Colitis: A Multicenter Retrospective Cohort Study.Journal of clinical medicine · 2026Article
- Ulcerative colitis: signaling pathways, therapeutic targets and interventional strategies.Signal transduction and targeted therapy · 2026Review
- Qijiao Shengbai capsule ameliorates ulcerative colitis in mice by modulating gut microbiota and protecting the intestinal barrier, associated with suppression of the TLR4/MyD88/NF-κB pathway.Frontiers in microbiology · 2026Article
- From guidelines to evidence-based practice - A German perspective on mesalazine as first-line therapy for mild-to-moderate ulcerative colitis.Zeitschrift fur Gastroenterologie · 2025Review
- Optimizing 5-aminosalicylate for moderate ulcerative colitis: expert recommendations from the Asia-Pacific, Middle East, and Africa Inflammatory Bowel Disease Coalition.Intestinal research · 2025Review
- Drug Optimization in Patients with Mild-to-Moderate Ulcerative Colitis: A Global Survey.Journal of clinical medicine · 2024Article
- Multifunctional nanoparticle-mediated combining therapy for human diseases.Signal transduction and targeted therapy · 2024Review
- Treatment of Patients with Mild to Moderate Ulcerative Colitis: A Middle East Expert Consensus.Journal of clinical medicine · 2023Review
- Assessment of the effectiveness of Budesonide MMXPrzeglad gastroenterologiczny · 2023Article
- Efficacy and safety of oral beclomethasone dipropionate and budesonide MMXTherapeutic advances in gastroenterology · 2023Article
- Guidelines for the management of ulcerative colitis. Recommendations of the Polish Society of Gastroenterology and the Polish National Consultant in Gastroenterology.Przeglad gastroenterologiczny · 2023Article
- An Update on Current Pharmacotherapeutic Options for the Treatment of Ulcerative Colitis.Journal of clinical medicine · 2022Review
- A review of the therapeutic management of ulcerative colitis.Therapeutic advances in gastroenterology · 2022Review
Corrections and comments
- Erratum issued
Authors and funding
10 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsSafety and efficacy of budesonide multimatrix, an oral extended-release second-generation corticosteroid designed for targeted delivery throughout the colon, were examined for induction of remission in patients with mild to moderate ulcerative colitis refractory to baseline mesalamine therapy.
methodsA randomised, double-blind, placebo-controlled, multicentre trial evaluated efficacy and safety of budesonide multimatrix for induction of remission [ulcerative colitis disease activity index score ≥ 4 and ≤ 10] in 510 adults randomised to once-daily oral budesonide multimatrix 9 mg or placebo for 8 weeks. Patients continued baseline treatment with oral mesalamine ≥ 2.4 g/day.
resultsCombined clinical and endoscopic remission at Week 8 was achieved by 13.0% and 7.5% of patients receiving budesonide multimatrix [n = 230] or placebo [n = 228], respectively, in the modified intention-to-treat population [p = 0.049]. Clinical remission [ulcerative colitis disease activity index rectal bleeding and stool frequency subscale scores of 0] was similar in both groups [p = 0.70]. More patients receiving budesonide multimatrix vs placebo achieved endoscopic remission [ulcerative colitis disease activity index mucosal appearance subscale score of 0; 20.0% vs 12.3%; p = 0.02] and histological healing [27.0% vs 17.5%; p = 0.02]. Adverse event rates were similar [budesonide multimatrix, 31.8%; placebo, 27.1%]. Mean morning cortisol concentrations decreased at Weeks 2, 4, and 8 with budesonide multimatrix but remained within the normal range.
conclusionBudesonide multimatrix was safe and efficacious for inducing clinical and endoscopic remission for mild to moderate ulcerative colitis refractory to oral mesalamine therapy.
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.