Bile acid therapy versus placebo before and after extracorporeal shock wave lithotripsy of gallbladder stones. The East-Danish Gallstone Study Group.

AIM

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.

PATIENTS AND METHODS

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 3 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 6-month double-blind therapy with bile acids or placebo.

RESULTS

Ninety-nine patients completed 3 weeks of pre-ESWL treatment. There was no statistically significant difference in fragmentation rate between the two groups. After 6 months of post-ESWL therapy, 12 of 49 patients (24%) had cleared the fragments from their gallbladder with bile acids compared with five of 50 patients (10%) who had placebo therapy (P = 0.10). There was no significant difference in the occurrence of pain between groups. The figures were no better in patients with a single stone < or = 20 mm in diameter.

CONCLUSION

Extracorporeal shock wave lithotripsy with or without adjuvant bile acid therapy does not seem to be an attractive therapy for patients with uncomplicated symptomatic gallstone disease.