Trial reportThe American journal of gastroenterology2015
Oral prolonged release beclomethasone dipropionate and prednisone in the treatment of active ulcerative colitis: results from a double-blind, randomized, parallel group study.
Trial report in The American journal of gastroenterology, 2015. 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 24 papers, 2 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
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.
- 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
- Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis.PloS one · 2016Pooled it
- Efficacy of Beclomethasone Dipropionate in Lowering Fecal Calprotectin Levels in Patients with Ulcerative Colitis in Clinical Remission and at Risk of Relapse: The Becalcu Randomized, Controlled Trial.Digestive diseases (Basel, Switzerland) · 2024Trial
- Direct inhibition of the TXNIP-NLRP3-GSDMD pathway reduces pyroptosis in colonocytes and alleviates ulcerative colitis in mice by the small compound PEITC.Acta pharmacologica Sinica · 2025Article
- The continuing value of mesalazine as first-line therapy for patients with moderately active ulcerative colitis.Frontiers in gastroenterology (Lausanne, Switzerland) · 2024Article
- Oral beclomethasone dipropionate as an add-on therapy and response prediction in Korean patients with ulcerative colitis.The Korean journal of internal medicine · 2022Article
- Oral beclomethasone dipropionate is an effective treatment for immune checkpoint inhibitor induced colitis.Journal for immunotherapy of cancer · 2022Article
- Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α.The Korean journal of internal medicine · 2022Review
- An Update on Current Pharmacotherapeutic Options for the Treatment of Ulcerative Colitis.Journal of clinical medicine · 2022Review
- Inflammatory Bowel Disease Management during the COVID-19 Pandemic: A Literature Review.Middle East journal of digestive diseases · 2022Review
- A review of the therapeutic management of ulcerative colitis.Therapeutic advances in gastroenterology · 2022Review
- [Treatment of Inflammatory Bowel Disease in Elderly Patients - What Are Different and What Should We Know?]The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2021Review
- Flower extract ofIranian journal of basic medical sciences · 2021Article
- Review article: prevention, diagnosis and management of COVID-19 in the IBD patient.Alimentary pharmacology & therapeutics · 2020Review
- Ulcerative Colitis: Current and Emerging Treatment Strategies.Journal of clinical medicine · 2019Review
- Article
- Beclomethasone dipropionate in microscopic colitis: Results of an exploratory open-label multicentre study (COLCO).United European gastroenterology journal · 2019Observational
- Mucosal healing in inflammatory bowel disease: Expanding horizon.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2019Review
- AGA Technical Review on the Management of Mild-to-Moderate Ulcerative Colitis.Gastroenterology · 2019Review
- AGA Clinical Practice Guidelines on the Management of Mild-to-Moderate Ulcerative Colitis.Gastroenterology · 2019Review
Corrections and comments
- Erratum issued
Authors and funding
12 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesDouble-blind study comparing efficacy and safety of the topically acting corticosteroid beclomethasone dipropionate (BDP) to prednisone (PD) in patients with active, mild-to-moderate ulcerative colitis (UC).
methodsOverall, 282 patients were randomized to receive BDP-prolonged release tablets 5 mg once daily for 4 weeks and then every other day for an additional 4 weeks or oral PD 40 mg once daily for the initial 2 weeks tapered of 10 mg every 2 weeks during the 8-week study period. Efficacy end point was the non-inferiority of BDP vs. PD in terms of Disease Activity Index (DAI) score <3 or reduction by at least 3 points for patients with a baseline DAI ≥7 at week 4. Safety end point was the proportion of patients with steroid-related adverse events (AEs) and cortisol <150 nmol/l at week 4.
resultsDAI response rates at week 4 were 64.6% and 66.2% with BDP and PD, respectively, demonstrating non-inferiority of BDP vs. PD (delta: -1.56; 95% confidence interval (CI) -13.00-9.88, P=0.78). Patients with steroid-related AEs and cortisol <150 nmol/l at week 4 were 38.7% in the BDP group and 46.9% in the PD group (P=0.17 between groups). No safety signals were observed in both the groups.
conclusionsBDP was non-inferior to PD in the treatment of active UC, with a good safety profile in both the groups.
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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.