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Related Experiment Videos

Methotrexate for primary biliary cirrhosis.

Y Gong1, C Gluud

  • 1Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Dept. 7102, Blegdamsvej 9, H:S Rigshospitalet, Copenhagen, Denmark, DK-2100. ygong@ctu.rh.dk

The Cochrane Database of Systematic Reviews
|July 22, 2005
PubMed
Summary
This summary is machine-generated.

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Methotrexate (MTX) treatment for primary biliary cirrhosis (PBC) showed no significant benefits but increased mortality. MTX is not recommended for PBC outside of clinical trials due to potential harm.

Area of Science:

  • Hepatology
  • Immunology
  • Clinical Trials

Background:

  • Primary biliary cirrhosis (PBC) is a chronic liver disease.
  • Methotrexate (MTX), an immunosuppressive drug, has been used for PBC.
  • Previous studies showed heterogeneous responses to MTX in PBC patients.

Purpose of the Study:

  • To evaluate the efficacy and safety of methotrexate for primary biliary cirrhosis.
  • To assess the beneficial and harmful effects of MTX in PBC patients.

Main Methods:

  • Systematic review of randomized clinical trials (RCTs) comparing MTX with placebo or other drugs.
  • Searched multiple databases including Cochrane Hepato-Biliary Group Register, Cochrane Central Register, MEDLINE, and EMBASE.
  • Included RCTs regardless of blinding, language, or publication status; analyzed data using random-effects and fixed-effect models.

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Main Results:

  • Five RCTs with 457 patients were included.
  • Methotrexate did not show significant effects on pruritus, fatigue, liver complications, biochemistry, histology, or adverse events.
  • A significant reduction in pruritus score, serum alkaline phosphatases, and plasma immunoglobulin M was observed with MTX.

Conclusions:

  • Methotrexate demonstrated an increased mortality risk in patients with primary biliary cirrhosis.
  • MTX is not recommended for treating PBC outside of controlled randomized trials due to safety concerns.