Ursodeoxycholic acid

First-line disease-modifying therapy for primary biliary cholangitis per EASL 2017 and AASLD 2018. Dose 13–15 mg/kg/day in 1–4 divided doses. Lowers alkaline phosphatase and bilirubin, slows fibrosis progression, and improves transplant-free survival. Biochemical response is assessed at 12 months. Non-responders may receive obeticholic acid or fibrates per EASL.

ICD-10: K74.3 · ICD-11: DB96.1

Medical litholysis is reserved for a narrow group of patients with symptomatic cholesterol stones and contraindications to surgery. Conditions: radiolucent stones smaller than 10 mm occupying less than half the gallbladder, with preserved gallbladder function. Dose 10–15 mg/kg at bedtime for 6–24 months. Complete dissolution in 30–60 %, with 5-year recurrence of 30–50 %. Cholecystectomy remains standard for symptomatic stones.

ICD-10: K80 · ICD-11: DC11

Guidelines (RCOG 2022, SOGC) recommend ursodeoxycholic acid in intrahepatic cholestasis of pregnancy as a symptomatic option for marked pruritus. Its effect on itching in the largest RCT, PITCHES (Lancet 2019, n=605), is small, and a drop in maternal bile acids and ALT reflects only a surrogate biochemical shift, not a clinical outcome. Evidence on fetal outcomes diverges: PITCHES did not reduce the composite perinatal outcome, and the authors proposed reconsidering routine use. The IPD meta-analysis by Ovadia (2021) found a benefit signal on the composite outcome in the RCT subgroup, though not on stillbirth alone. Clinicians discuss a possible niche in severe cholestasis, when bile acids reach 100 micromol/L or higher. Clinicians individualize the decision alongside monitoring and delivery timing.

ICD-10: O26.6 · ICD-11: JA65.0