Trial reportGut2001
Low dose balsalazide (1.5 g twice daily) and mesalazine (0.5 g three times daily) maintained remission of ulcerative colitis but high dose balsalazide (3.0 g twice daily) was superior in preventing relapses.
Trial report in Gut, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 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
26 citing papers in PubMed, 5 syntheses or guidelines pooled it, 113 citations in OpenAlex.
- Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020Pooled it
- Comparative efficacy and tolerability of pharmacological agents for management of mild to moderate ulcerative colitis: a systematic review and network meta-analyses.The lancet. Gastroenterology & hepatology · 2018Pooled it
- Histologic scoring indices for evaluation of disease activity in ulcerative colitis.The Cochrane database of systematic reviews · 2017Pooled it
- Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2016Pooled it
- Comparison of mesalazine and balsalazide in induction and maintenance of remission in patients with ulcerative colitis: a meta-analysis.Digestive diseases and sciences · 2009Pooled it
- Retarded release phosphatidylcholine benefits patients with chronic active ulcerative colitis.Gut · 2005Trial
- Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults with Mild to Moderate Ulcerative Colitis; A Placebo Randomized Controlled Trial.Life (Basel, Switzerland) · 2025Article
- CD45 inhibition in myeloid leukaemia cells sensitizes cellular responsiveness to chemotherapy.Annals of hematology · 2024Article
- Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults with Mild to Moderate Ulcerative Colitis: A Protocol for a Placebo Randomized Controlled Trial.Methods and protocols · 2023Article
- Molecules from American Ginseng Suppress Colitis through Nuclear Factor Erythroid-2-Related Factor 2.Nutrients · 2020Article
- Outcomes of a drug shortage requiring switching in patients with ulcerative colitis.World journal of gastrointestinal pathophysiology · 2020Article
- 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
- Synergic modulation of the inflammatory state of macrophages utilizing anti-oxidant and phosphatidylserine-containing polymer-lipid hybrid nanoparticles.MedChemComm · 2017Article
- Behavioural Effects of Using Sulfasalazine to Inhibit Glutamate Released by Cancer Cells: A Novel target for Cancer-Induced Depression.Scientific reports · 2017Article
- Looking for the best anti-colitis medicine: A comparative analysis of current and prospective compounds.Oncotarget · 2017Article
- Rectal budesonide and mesalamine formulations in active ulcerative proctosigmoiditis: efficacy, tolerance, and treatment approach.Clinical and experimental gastroenterology · 2016Review
- Nonsteroidal anti-inflammatory medications are cytostatic against human vestibular schwannomas.Translational research : the journal of laboratory and clinical medicine · 2015Article
- Pharmacological intervention based on fecal calprotectin levels in patients with ulcerative colitis at high risk of a relapse: A prospective, randomized, controlled study.United European gastroenterology journal · 2015Article
- Impact of pain on health-related quality of life in patients with inflammatory bowel disease.World journal of gastroenterology · 2010Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBalsalazide is a new 5-aminosalicylic acid (5-ASA) containing prodrug. Its efficacy in comparison with standard mesalazine therapy and the optimum dose for maintaining remission of ulcerative colitis are still unclear.
aimsTo compare the relapse preventing effect and safety profile of two doses of balsalazide and a standard dose of Eudragit coated mesalazine.
methodsA total of 133 patients with ulcerative colitis in remission were recruited to participate in a double blind, multicentre, randomised trial: 49 patients received balsalazide 1.5 g twice daily, 40 received balsalazide 3.0 g twice daily, and 44 received mesalazine 0.5 g three times daily. Efficacy assessments were clinical activity index (CAI) and endoscopic score according to Rachmilewitz, and a histological score. In addition, laboratory tests were performed and urinary excretion of 5-ASA and its metabolite N-Ac-5-ASA was analysed. The study lasted for 26 weeks.
resultsBalsalazide 3.0 g twice daily resulted in a significantly higher clinical remission rate (77.5%) than balsalazide 1.5 g twice daily (43.8%) and mesalazine 0.5 g three times daily (56.8%) (p=0.006). The respective times to relapse were 161 days, 131 days (p=0.003), and 144 days (NS). Accordingly, pairwise contrasts of the final endoscopic score demonstrated a significant difference (p=0.005) between the two balsalazide treatment groups while differences between either of these two groups and mesalazine were not statistically significant. Patients treated with balsalazide excreted less 5-ASA and N-Ac-5-ASA than patients receiving mesalazine but these differences were not statistically significant. Discontinuation of the trial because of adverse effects occurred in nine patients: three in the balsalazide 1.5 g twice daily group, two in the balsalazide 3.0 g twice daily group, and four in the mesalazine 0.5 g three times daily group. No clinically important new drug safety related findings were identified in this study.
conclusionsHigh dose balsalazide (3.0 g twice daily) was superior in maintaining remission in patients with ulcerative colitis compared with a low dose (1.5 g twice daily) or a standard dose of mesalazine (0.5 g three times daily). All three treatments were safe and well tolerated.
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.