ursodeoxycholic acid

UDCA fails to improve mortality in primary biliary cholangitis

ursodeoxycholic acidApril 13, 2016

BARCELONA — The use of ursodeoxycholic acid for primary biliary cholangitis failed to reduce all-cause mortality, according to results of a systematic review presented at the International Liver Congress 2016.

“Based on current evidence, the treatment of primary biliary cholangitis with ursodeoxycholic acid can neither be supported nor rejected,” Jelena Nincevic, MD, of the clinic of gastroenterology and hepatology at the Clinical Center of Serbia, said during her presentation.

Nincevic and colleagues conducted a systematic review of studies and clinical trials that used ursodeoxycholic acid (UDCA) for the treatment of primary biliary cholangitis (PBC), to determine if UDCA had any impact on all-cause mortality, liver transplantation and other variables.

The researchers identified 1,846 studies, of which 16 were clinical trials encompassing 1,476 patients. Fourteen trials compared the use of UDCA and placebo (n = 1,198) and two compared UDCA vs. no intervention (n = 278).

A total of 12 clinical trials used in the review included high-risk bias, according to Nincevic.

Meta-analysis and sub-group analysis of all-cause mortality or liver transplantation yielded a risk ratio of 0.96 (95% CI, 0.74-1.25) between the UDCA-treated group and controls.

“[Overall], there was no significant effect of ursodeoxycholic acid on all-cause mortality,” Nincevic said during her presentation.

The number of serious adverse events were similar between the groups, indicating there were no drastic changes in occurrence of serious adverse events with UDCA use. In addition, there were no differences in non-serious adverse events and any impact on quality of life could not be determined as data was not available, Nincevic noted.

In a meta-analysis of pruritus incidence, there were 309 reports of pruritus in the controls vs. 321 in the UDCA-treated patients. The risk ratio was 0.96 (95% CI, 0.84-1.09), suggesting UDCA does not improve the rate of pruritus, a common adverse event in PBC.

“[Overall], there was no effect on mortality, mortality and liver transplantation and adverse events, no effect on liver transplantation, symptoms and liver-related morbidity,” Nincevic said.

However, there was evidence UDCA use improved bilirubin and plasma alkaline phosphatase slightly, according to Nincevic’s presentation. – by Melinda Stevens


Nincevic J. Joint Workshop: EASL-CHBG. Presented at: International Liver Congress; April 13-17, 2016; Barcelona.

Disclosure: Nincevic reports no relevant financial disclosures.

Editors’ Note: This item was updated due to an error in identifying primary biliary cholangitis and primary sclerosing cholangitis as equivalent diseases. We apologize for this confusion.

1 Comment

  1. Juanita McCracken on September 19, 2016 at 12:58 am

    Ursodiol is the only medication I take for liver disease. It cost a lot. Should I just quit it according to these placebo effect? My liver enzymes have become normal with my Paleo Diet.

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