The researchers conducted a preliminary trial of high-dose ursodeoxycholic acid (UDCA) in primary sclerosing cholangitis (PSC) patients.
They reported their findings in the October issue of Gastroenterology.
UDCA is used for the treatment of cholestatic liver diseases, including primary biliary cirrhosis (PBC). However, standard doses of UDCA (8-15 mg/kg daily) have been shown to be ineffective in the treatment of PSC.
A total of 26 patients with PSC were randomized to high-dose (20 mg/kg daily) UDCA or placebo.
Cholangiography and liver biopsy were performed at entry and after 2 years.
| Further studies are needed to establish long-term survival.
| Gastroenterology |
Symptoms, clinical signs, and liver biochemical tests were recorded at 3 monthly intervals.
The researchers found that high-dose UDCA did not influence symptoms. However, there was a significant improvement in liver biochemistry (serum alkaline phosphatase and γ-glutamyl transferase). There was also a significant reduction in progression in cholangiographic appearances and liver fibrosis, as assessed by disease staging.
In the treatment group, a significant increase in total bile acids and saturation with UDCA >70% confirmed patient compliance.
The researchers reported no significant side-effects.
Author Stephen A. Mitchell, of the Oxford Radcliffe Hospital, Oxford, England, concluded on behalf of his team, "High-dose UDCA may be of clinical benefit in PSC.
"However, trials with a larger number of participants and of longer duration are required.
"This is so it can be established whether the effect of high-dose UDCA on liver biochemistry, histology, and cholangiography in patients with PSC is translated into improved long-term survival."