Ursodeoxycholic acid alone or with chenodeoxycholic acid for dissolution of cholesterol gallstones: a randomized multicentre trial

Background: Combination therapy using ursodeoxycholic acid plus chenodeoxyc holic acid has been advocated for dissolution of cholesterol gallstones bec ause the two bile acids have complementary effects on biliary lipid metabol ism and cholesterol solubilization. Aim: To compare the clinical efficacy of combination therapy with ursodeoxy cholic acid monotherapy. Patients and methods: A total of 154 symptomatic patients with radiolucent stones (less than or equal to 15 mm) in functioning gallbladders were enrol led from six centres in England and Italy. They were randomized to either a combination of chenodeoxycholic acid plus ursodeoxycholic acid (5 mg.day/k g each) or to ursodeoxycholic acid alone (10 mg.day/kg). Dissolution was as sessed by 6-monthly oral cholecystography and ultrasonography for up to 24 months. Results: Both regimens reduced the frequency of biliary pain and there was no significant difference between them in terms of side-effects or dropout rate. Complete gallstone dissolution on an intention-to-treat basis was sim ilar at all time intervals. At 24 months this was 28% with ursodeoxycholic acid alone and 30% with combination therapy. The mean dissolution rates at 6 and 12 months were 47% and 59% with ursodeoxycholic acid, and 44% and 59% with combination therapy, respectively. Conclusion: There is no substantial difference in the efficacy of combined ursodeoxycholic acid and chenodeoxycholic acid and that of ursodeoxycholic acid alone in terms of gallstone dissolution rate, complete gallstone disso lution, or relief of biliary pain.