title: A Double-Blind Placebo-controlled Trial of Ursodeoxycholic Acid in the Prevention of Gallstones during Weight Loss after Vertical Banded Gastroplasty.
abstract: One hundred and seven patients whose gallbladder was normal at the time of vertical banded gastroplasty (VBG) were considered for entry into a randomized placebo-controlled double-blind study to determine the effectiveness of ursodeoxycholic acid (UDCA) in preventing cholelithiasis during the period of weight loss. Twenty-one patients (20%) developed gallstones in the six-week period post-VBG and prior to randomization and were therefore excluded. Eighty-six patients were randomized at 6 weeks to active medication or placebo. Of these, 61 patients (71 %) completed the study. Twenty-five patients (29%) failed to complete the study because of incompliance, intolerance to the medication or pregnancy; 17 of these were in the active treatment group and eight were in the placebo group. None of the 27 patients treated with UDCA developed gallstones, whereas eight of 34 (24%) patients taking placebo developed gallstones. This difference was statistically significant (p = 0.0061). These results suggest that UDCA is fully effective in preventing gallstone formation following VBG in patients who follow the prescribed regimen.
authors.affiliation: Department of Medicine (Division of Gastroenterology), Dalhousie University and Victoria General Hospital, Halifax, Nova Scotia, B3H 4H7, Canada.
authors.initials: C
authors.lastname: Williams
authors.initials: R
authors.lastname: Gowan
authors.initials: BJ
authors.lastname: Perey