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Ursodeoxycholic acid (UDCA) is a safe medical therapy for primary biliary cirr hosis (PBC), but its effect on liver histology remains uncertain. Budesonide is a glucocorticoid with high receptor activity and high first-pass metabolism in liver.We evaluated the combination of budesonide and UDCA on liver histology and compared this with UDCA alone in a 3 year prospective, randomized, open multice nter study. Patients with PBC (n = 77), at stages I to III, were randomized into 2 treatment arms, A (n = 41): budesonide 6 mg/d and UDCA 15 mg/kg/d and B (n = 36): UDCA 15mg/kg/d. Liver histology was assessed at the beginning and at the en d of the study. Liver function tests and glucose and cortisol values were determ ined every 4 months. Paired liver biopsy specimens were available from 69 patien ts (A = 37 and B = 32). Stage improved 22%in group A but deteriorated 20%in gr oup B (P = .009). Fibrosis decreased 25%in group A but increased 70%in group B (P = .000 9). S-PIIINP decreased significantly in group A.Inflammation decreas ed in both groups, 34%in group A(P=.02), but only 10%in group B (P = NS). Seru m liver enzymes decreased significantly in both treatment arms. Bilirubin values rose in group B but stayed stable in group A (A/B P = .002).A mild systemic glu cocorticoid effect from budesonide was evident after 2 years. In conclusion, bud esonide combined with UDCA improved liver histology, whereas the effect of UDCA alone was mainly on laboratory values. Studies with longer follow-up using a co mbination of budesonide and UDCA arewarranted to confirm safety and effects.
Ursodeoxycholic acid (UDCA) is a safe medical therapy for primary biliary cirrhosis (PBC), but its effect on liver histology remains uncertain. Budesonide is a glucocorticoid with high receptor activity and high first-pass metabolism in liver. Weigh the combination of budesonide and UDCA on liver histology and rather this with UDCA alone in a 3 year prospective, randomized, open multicent study. Patients with PBC (n = 77), at stages I to III, were randomized into 2 treatment arms, A (n = 41): budesonide 6 mg / d and UDCA 15 mg / kg / d and B (n = 36): UDCA 15 mg / kg / d. Liver histology was assessed at the beginning and at the en d of the study. Liver function tests and glucose and cortisol values were determined for each 4 months. Paired liver biopsy specimens were available from 69 patien ts (A = 37 and B = 32). Stage improved 22% in group A but deteriorated 20% in gr oup B (P = .009). Fibrosis decreased 25% in group A but increased 70% in group B (P = .000 9). S-PIIINP decreased signifi cantly in group A. Inflammation decreas ed in both groups, 34% in group A (P = .02), but only 10% in group B (P = NS). Bilirubin values rose in group B but stayed stable in group A (A / BP = .002). A mild systemic glu cocorticoid effect from budesonide was evident after 2 years. In conclusion, bud esonide combined with UDCA improved liver histology, but the effect of UDCA alone was mainly on laboratory values. Studies with longer follow-up using a co mbination of budesonide and UDCA are warranted to confirm safety and effects.