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Ursodeoxycholic acid and methotrexate for primary sclerosing cholangitis: a pilot study
K D Lindor1, R A Jorgensen, M L Anderson
1Division of Gastroenterology and Internal Medicine, Mayo Foundation, Rochester, Minnesota, USA.
The American Journal of Gastroenterology
|March 1, 1996
Summary
This study found that combining ursodeoxycholic acid (UDCA) with methotrexate (MTX) for primary sclerosing cholangitis (PSC) did not improve liver biochemistries and was associated with toxicity. The combination therapy showed no benefit over UDCA alone.
Area of Science:
- Hepatology and Gastroenterology
- Clinical Pharmacology
- Autoimmune Diseases
Background:
- Primary sclerosing cholangitis (PSC) is a chronic liver disease with limited treatment options.
- Ursodeoxycholic acid (UDCA) and methotrexate (MTX) are being evaluated for PSC treatment.
- A combination therapy of UDCA and MTX was investigated in a pilot study.
Purpose of the Study:
- To assess the safety and estimate the efficacy of combined UDCA and MTX treatment over two years in PSC patients.
- To compare the combination therapy's outcomes with UDCA monotherapy.
Main Methods:
- A prospective pilot study involving 19 PSC patients receiving UDCA and MTX.
- A concurrent control group of 10 PSC patients received UDCA alone.
- Patients were compared at baseline for age, sex, liver biochemistries, and histological stage.
Main Results:
- Five patients on UDCA/MTX combination withdrew due to adverse events or disease progression.
- MTX was discontinued in five additional patients due to toxicity (hair loss, pulmonary issues).
- No significant improvement in fatigue, itching, or liver biochemistries was observed with the UDCA/MTX combination compared to UDCA alone.
Conclusions:
- The combination of MTX with UDCA in PSC patients was associated with toxicity.
- This pilot study found no evidence to support the use of MTX in combination with UDCA for PSC treatment.
- Further research may be needed to explore alternative therapeutic strategies for PSC.