Methotrexate for maintenance of remission in Crohn's disease
Bibliographic record
Abstract
BACKGROUND: Safe and effective long-term treatments that reduce the need for corticosteroids are needed for Crohn's disease. Although purine antimetabolites are moderately effective for maintenance of remission patients often relapse despite treatment with these agents. Methotrexate may provide a safe and effective alternative to more expensive maintenance treatment with TNF-alpha antagonists. OBJECTIVES: To conduct a systematic review of randomized trials examining the efficacy and safety of methotrexate for maintenance of remission in Crohn's disease. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials (CENTRAL) Issue 2, 2009, PUBMED (1966 to April 2009), EMBASE (1984 to April 2009), DDW abstracts (1980 to 2008) and the Cochrane IBD/FBD Specialized Trials Register were searched. Study references and review papers were also searched for additional trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared methotrexate to placebo or any other active intervention for maintenance of remission in Crohn's disease were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of methodological quality of included studies were independently performed by each author. The main outcome measure was the proportion of patients maintaining clinical remission as defined by the studies and expressed as a percentage of the total number of patients randomized (intention to treat analysis). Pooled odds ratios and 95% confidence intervals were calculated for dichotomous outcomes. MAIN RESULTS: Three studies were included in the review. A pooled analysis (n = 98) including one high quality trail (n = 76) showed that intramuscular methotrexate (15 mg/week) was significantly more effective than placebo for maintenance of remission in Crohn's disease (OR 3.11; 95% CI 1.31 to 7.41; P = 0.01). The number needed to treat to prevent one relapse was 4. A pooled analysis of two small studies (n = 50) showed no difference between methotrexate and 6-MP for maintenance of remission (OR 2.63; 95% CI 0.74 to 9.37; P = 0.14). Adverse events were generally mild in nature and resolved upon discontinuation or with folic acid supplementation. Common adverse events included nausea and vomiting, symptoms of a cold, abdominal pain, headache, joint pain or arthralgia, and fatigue. AUTHORS' CONCLUSIONS: Intramuscular methotrexate at a dose of 15 mg/week is safe and effective for maintenance of remission in Crohn's disease. Oral methotrexate (12.5 to 15 mg/week) does not appear to be effective for maintenance of remission in Crohn's disease.
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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 | 0.012 | 0.029 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.005 |
| Bibliometrics | 0.006 | 0.004 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
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".