Abstract | BACKGROUND & AIMS: METHODS: Methods included three monthly symptom assessment and liver function tests and liver biopsy and gastroscopy at baseline, after 2 years, and after 4-6 years. RESULTS: Patients randomized to methotrexate had, compared with patients randomized to placebo, (1) significantly lower on-treatment serum alkaline phosphatase, gamma-glutamyltransferase, immunoglobulin (Ig) M, IgG, and (after 24 months) aspartate aminotransferase and alanine aminotransferase levels (P < 0.02-0.001 by analysis of covariance to adjust for baseline differences); (2) a nonsignificant trend toward lower on-treatment pruritus scores; (3) similar on-treatment Knodell inflammatory scores but nonsignificant trends toward lower Knodell fibrosis score and less ductopenia; (4) a trend toward greater increases in serum bilirubin level and Mayo score with time (both significant after 5 years of follow-up); and (5) a 2.9-fold (95% confidence interval, 0.85-10.25-fold) increase the rate of death or liver transplantation as a result of liver disease during or after the trial (P = 0.09) in a Cox multivariate regression analysis compared with patients randomized to placebo. CONCLUSIONS: These results do not support the clinical use of low-dose methotrexate in PBC.
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Authors | M T Hendrickse, E Rigney, M H Giaffer, I Soomro, D R Triger, J C Underwood, D Gleeson |
Journal | Gastroenterology
(Gastroenterology)
Vol. 117
Issue 2
Pg. 400-7
(Aug 1999)
ISSN: 0016-5085 [Print] United States |
PMID | 10419922
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Autoantibodies
- Alanine Transaminase
- Bilirubin
- Methotrexate
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Topics |
- Aged
- Alanine Transaminase
(blood)
- Autoantibodies
(blood)
- Bilirubin
(blood)
- Female
- Humans
- Liver Cirrhosis, Biliary
(drug therapy)
- Liver Transplantation
- Male
- Methotrexate
(adverse effects, therapeutic use)
- Middle Aged
- Mitochondria
(immunology)
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