CHICAGO — A bile acid thought to decrease biliary pain and acute cholecystitis in patients with gallstones exerted no beneficial effects in Dutch patients who were awaiting cholecystectomy, Niels Venneman, M.D., reported at the annual Digestive Disease Week.
Dr. Venneman of University Medical Center Utrecht, the Netherlands, presented results of a randomized, double-blind, placebo-controlled trial of ursodeoxycholic acid, also called ursodiol.
He and his coworkers randomized 177 symptomatic gallstone patients scheduled for elective cholecystectomy to receive either ursodiol or placebo. Only 23 of 89 patients (26%) receiving ursodiol remained free of biliary colic while waiting for surgery (mean, 90 days), whereas 29 of 88 patients (33%) receiving placebo stayed colic free.
“Clearly, [ursodiol] does not protect against biliary colics,” Dr. Venneman said. The drug also had no effect on analgesic intake or episodes of nonsevere biliary pain, he added. However, patients who had fewer than three biliary colic episodes in the year before the study were significantly more likely to remain colic free while waiting for surgery than were patients with three or more preoperative colic episodes.
At baseline, 126 patients underwent ultrasonographic studies of gallbladder motility. Among those patients, the likelihood of remaining colic free was comparable in strong and weak contractors (minimal gallbladder volume less than or equal to 6 mL and greater than 6 mL, respectively).
The study may have had a selection bias, in that patients waiting to be operated on are likely sicker, one attendee commented after the presentation. Dr. Venneman agreed, saying, “We had a highly symptomatic group.”
Results of the current study contradicted a Japanese study, which found that ursodiol therapy was associated with a reduced risk of biliary pain after 10 years' follow-up of patients with gallstones (Hepatology 1999;30:6–13).
The foundation Maag Lever Darm Stichting in Nieuwegein, the Netherlands, funded Dr. Venneman's study.