Trial reportInflammatory bowel diseases2012
One-year investigator-blind randomized multicenter trial comparing Asacol 2.4 g once daily with 800 mg three times daily for maintenance of remission in ulcerative colitis.
Trial report in Inflammatory bowel diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020Pooled it
- Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2016Pooled it
- Similar pharmacokinetics of three dosing regimens comprising two oral delayed-release mesalamine formulations in healthy adult volunteers: Randomised, open-label, parallel-group study.British journal of clinical pharmacology · 2021Trial
- Non-Adherence Rate to Oral Mesalamine in Ulcerative Colitis Patients: A Systematic Review with Meta-Analysis.Journal of personalized medicine · 2025Review
- Obstacles to Medication Adherence for Patients with Inflammatory Bowel Disease: A Qualitative Study in East China.Patient preference and adherence · 2024Article
- Treatment of Patients with Mild to Moderate Ulcerative Colitis: A Middle East Expert Consensus.Journal of clinical medicine · 2023Review
- Overcoming barriers to patient adherence: the case for developing innovative drug delivery systems.Nature reviews. Drug discovery · 2023Review
- Clinical and Mechanistic Characteristics of Current JAK Inhibitors in IBD.Inflammatory bowel diseases · 2021Article
- Adherence to Asacol once daily versus divided regimen for maintenance therapy in ulcerative colitis: a prospective, multicenter, randomized study.Intestinal research · 2019Article
- AGA Clinical Practice Guidelines on the Management of Mild-to-Moderate Ulcerative Colitis.Gastroenterology · 2019Review
- AGA Technical Review on the Management of Mild-to-Moderate Ulcerative Colitis.Gastroenterology · 2019Review
- Article
- Challenges in the Diagnosis and Management of Inflammatory Bowel Disease in the Elderly.Current treatment options in gastroenterology · 2015Article
- Long-term efficacy and safety of once-daily mesalazine granules for the treatment of active ulcerative colitis.Clinical and experimental gastroenterology · 2014Review
- Medication adherence and persistence in the treatment of Canadian ulcerative colitis patients: analyses with the RAMQ database.BMC gastroenterology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMesalazine (Asacol) is still widely prescribed in divided doses for ulcerative colitis (UC), despite evidence that adherence is improved by once-daily (OD) prescribing. We aimed to investigate whether OD Asacol was as effective as three times (TDS) daily dosing, and to evaluate the role of treatment adherence.
methodsAn investigator-blind randomized trial was undertaken comparing OD Asacol (three 800 mg tablets) versus one 800 mg TDS in maintenance of remission of UC over 1 year. The primary endpoint was relapse rate, and noninferiority would be concluded if the lower limit of the two-sided 95% confidence interval (CI) of the difference in proportions relapsing (TDS-OD) exceeded -10%. Adherence was measured by tablet counts and self-reported adherence. A subgroup of patients used a bottle cap that recorded all bottle opening events.
resultsIn all, 213 patients were randomized. In the intention-to-treat (ITT) population, relapse rates were 31% (95% CI 22%-40%) in the OD and 45% (95% CI 35%-54%) in the TDS group. Primary analysis confirmed the noninferiority of OD dosing. Two of the study populations, ITT and per-protocol (PP), showed potential superiority of OD dosing. All measures of adherence showed that it was significantly better in the OD group. Multivariate analysis, however, showed OD dosing was associated with lower relapse risk independently of adherence.
conclusionsOD dosing with Asacol 2.4 g is as safe and effective as TDS dosing, and secondary analysis confirmed significantly reduced relapse rates. The benefit, however, was clinically borderline and may relate in part to ease of adherence.
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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.