Ursodeoxycholic acid is a safe medical therapy for primary biliary cirrhosis, but its effect on liver histology remains uncertain.
Budesonide is a glucocorticoid with high receptor activity and high first-pass metabolism in liver.
Dr Rautiainen and colleagues from Finland evaluated the combination of budesonide and ursodeoxycholic acid on liver histology compared with ursodeoxycholic acid alone.
The investigative team conducted a 3 year prospective, randomized, open multicenter study.
The team randomized patients with primary biliary cirrhosis (n = 77), at stages I to III into 2 treatment arms.
The first treatment arm (n = 41) received budesonide 6 mg/d and ursodeoxycholic acid 15 mg/kg/d and the second (n = 36) received ursodeoxycholic acid 15mg/kg/d.
The investigators assessed liver histology at the beginning and at the end of the study.
The researchers undertook liver function tests and determined glucose and cortisol values every 4 months.
Paired liver biopsy specimens were available from 69 patients.
The research team found that the stage improved 22% in the first group but deteriorated 20% in the second group.
|A mild systemic glucocorticoid effect from budesonide was evident in the combination group|
Fibrosis decreased 25% in group 1 but increased 70% in group 2 whilst serum III procollagen decreased significantly in group 1.
The team observed that inflammation decreased in both groups, 34% in group 1, but only 10% in group 2.
In addition, the research team noted that serum liver enzymes decreased significantly in both treatment arms.
Bilirubin values rose in the second group but stayed stable in the first group.
Finally, the researchers also reported that a mild systemic glucocorticoid effect from budesonide was evident after 2 years.
Dr Rautiainen’s team concludes, “Budesonide combined with ursodeoxycholic acid improved liver histology, whereas the effect of ursodeoxycholic acid alone was mainly on laboratory values.”