[Bile acid therapy vs. placebo before and after extracorporeal shock wave lithotripsy of gallbladder stones]

Abstract

The aims of the project were to study the effects of bile acid therapy on the fragmentation rate of cholesterol gallbladder stones by extracorporeal shock wave lithotripsy (ESWL) and on the clearance of fragments after ESWL. One hundred and two patients with biliary pain, between one and five radiolucent gallbladder stones, and a gallbladder with a patent cystic duct were randomized to three weeks of double-blind treatment with bile acids (ursodeoxycholic acid 500 mg and chenodeoxycholic acid 500 mg per day) or placebo before ESWL. After successful fragmentation by ESWL (largest fragment (< or = 5 mm) the patients were re-randomized to six months double-blind therapy with bile acids or placebo. The endpoint of pre-ESWL bile acid/placebo therapy was the proportion of patients having a successful fragmentation after < or = 3 sessions of ESWL. After post-ESWL bile acid/placebo therapy success was defined as a gallbladder cleared of fragments. Ninety-nine patients carried out three weeks of pre-ESWL treatment. There was no statistically significant difference in fragmentation rate between the two groups. After six months of post-ESWL therapy, 12 of 49 patients (24%) receiving bile acids had cleared the fragments from their gallbladder compared to 5 out of 50 patients (10%) who received placebo (p = 0.10). There was no significant difference in the occurrence of pain between the two groups. In conclusion, ESWL with or without adjuvant bile acid does not seem to be an attractive therapy for patients with uncomplicated symptomatic gallstone disease.