Ursodeoxycholic acid alone or with chenodeoxycholic acid for dissolution of cholesterol gallstones: a randomized multicentre trial. The British-Italian Gallstone Study group.
Level 2 - randomized trial
Individual multicenter randomized controlled trial
PubMed 11136285 · doi:10.1046/j.1365-2036.2001.00853.x
What was done
A multicenter randomized controlled trial across six centers in England and Italy evaluated 154 symptomatic patients with radiolucent cholesterol gallstones (≤ 15 mm) in functioning gallbladders. Patients were randomized to receive either combination therapy of chenodeoxycholic acid plus ursodeoxycholic acid (5 mg/kg/day each) or ursodeoxycholic acid monotherapy (10 mg/kg/day). Gallstone dissolution was assessed every 6 months via oral cholecystography and ultrasonography for up to 24 months.
What was found
Both regimens reduced biliary pain frequency with no significant differences in side effects or dropout rates. Complete gallstone dissolution on an intention-to-treat basis at 24 months was 28% for ursodeoxycholic acid alone and 30% for combination therapy. Mean dissolution rates were 47% vs. 44% at 6 months and 59% vs. 59% at 12 months for monotherapy versus combination therapy, respectively.
Why it matters
Despite biological rationale suggesting complementary mechanisms, combining chenodeoxycholic acid with ursodeoxycholic acid provides no clinical advantage in dissolution efficacy, complete clearance, or symptom relief over ursodeoxycholic acid monotherapy.
Limits
The abstract does not report exact p-values, confidence intervals, or specific numerical rates of adverse events and dropouts. Findings are limited to radiolucent stones ≤ 15 mm in functioning gallbladders and cannot be generalized to larger or calcified gallstones.
Cited by
- supports Gallstones can be dissolved using bile salts.