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Researchers find high-dose therapy for liver disease not effective
Date:8/28/2009

ROCHESTER, Minn. -- A national team of researchers led by scientists at Mayo Clinic has found that a common treatment for primary sclerosing cholangitis, a chronic liver disease, is not helpful for patients, according to a study published this month in the journal Hepatology.

Primary sclerosing cholangitis (PSC) is a disease of the bile ducts. In this case, the term "cholangitis" refers to inflammation of the bile ducts, while "sclerosing" describes the hardening and scarring of the bile ducts that result from chronic inflammation.

"Primary sclerosing cholangitis is a serious liver disease lacking an effective medical therapy," says Keith Lindor, M.D., Mayo Clinic gastroenterologist and the study's lead researcher. "Some studies have shown that the use of ursodeoxycholic acid, a naturally occurring bile acid, may be a potential solution for patients. Our research, however, showed long-term use of this treatment in high dosages is not suitable for patients."

In this six-year, multicenter trial, 150 patients were enrolled in the study to determine the effectiveness of ursodeoxycholic acid (UDCA) in treatment of PSC. Seventy-six patients were treated with higher doses (28 to 30 mg/kg/day) of UDCA and 74 patients were given a placebo. Serious adverse events were more common in the UDCA group than the placebo group, which prompted researchers to halt the study. UDCA has been thought to be a possible treatment solution for PSC patients, but this trial indicates that the drug, used at this higher dose, is not helpful.

"All of us were surprised that the higher doses of UDCA did not help; in fact, the risk of developing even more liver problems increased with the higher dosages," says Dr. Li
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Contact: Amy Tieder
tieder.amy@mayo.edu
507-293-0969
Mayo Clinic
Source:Eurekalert

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