Budesonide for maintenance of remission in Crohn's disease
Bibliographic record
Abstract
OBJECTIVES: The primary objective was to precisely derive an estimate of the efficacy of oral budesonide for the maintenance of remission in Crohn's disease. SEARCH STRATEGY: Medline 1966-September 2000 was searched using the text and key words "oral budesonide", "Crohn's disease", "Crohn disease", and "inflammatory bowel disease". Proceedings from the American Gastroenterology Association conference (1980-1998) were hand searched. Additionally, the Cochrane Controlled Trials Register and the Inflammatory Bowel Disease Review Group Trials Registers were also searched. The manufacturer of oral budesonide was also contacted, as were some of the local trialists involved in the oral budesonide trials. Relevant articles were retrieved, and their reference lists were also reviewed. SELECTION CRITERIA: Randomized controlled trials of oral budesonide in which patients at entry were in remission with a Crohn's Disease Activity Index (CDAI) <= 150, and had disease restricted to the ileum and colon. DATA COLLECTION AND ANALYSIS: The primary outcome was the relative risk (RR) of relapse (and 95% confidence interval [CI]) during the 12 months of treatment, as defined by the number of patients who relapsed, and the number of patients who entered the trial. The numbers needed to treat were also derived. MAIN RESULTS: Three randomized controlled trials of oral budesonide (controlled ileal release preparation) 6 mg/day, 3mg/day and placebo for a one year period were included in the analysis. Budesonide 6 mg/day was not effective at preventing relapse of Crohn's disease over the 12 months of treatment. The relative risk of relapse was 0.89 (95% CI: 0.71-1.13) comparing budesonide 6 mg/day and placebo. Similar results were also observed in the comparison of budesonide 6 mg/day with budesonide 3 mg/day; the relative risk of relapse was 0.89 (95% CI: 0.70-1.11). The 3 mg/day dose was similarly found to be ineffective at preventing relapse during the 12 months of treatment; the relative risk of relapse was 1.00 (95% CI: 0.80-1.24). The results of the analysis of relative risk of relapse were supported by the analysis of withdrawal due to treatment failure. The relative risks for withdrawal due to treatment failure for budesonide 6 mg/day compared with placebo was 0.85 (95% CI: 0.65-1.10), for budesonide 3 mg/day compared with placebo was 0.94 (95% CI: 0.73-1.20), and for budesonide 6 mg/day compared with budesonide 3 mg/day was 0.89 (95% CI: 0.68-1.17). REVIEWER'S CONCLUSIONS: Oral budesonide therapy at 6 mg/day is not effective in preventing relapses of Crohn's disease.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.017 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.007 | 0.003 |
| Bibliometrics | 0.004 | 0.003 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".