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Liver Failure and Liver Disease
Article first published online: 25 MAY 2006
Copyright © 2006 American Association for the Study of Liver Diseases
Volume 43, Issue 6, pages 1276–1283, June 2006
How to Cite
Venneman, N. G., Besselink, M. G.H., Keulemans, Y. C.A., vanBerge-Henegouwen, G. P., Boermeester, M. A., Broeders, I. A.M.J., Go, P. M.N.Y.H. and van Erpecum, K. J. (2006), Ursodeoxycholic acid exerts no beneficial effect in patients with symptomatic gallstones awaiting cholecystectomy. Hepatology, 43: 1276–1283. doi: 10.1002/hep.21182
NIH clinical trial registration no.: (NCT00161083).
Potential conflict of interest: Nothing to report.
Presented in part at the annual meeting of the American Gastroenterological Association (Chicago, 2005) and published as an abstract (Gastroenterology 2005;128:A79).
- Issue published online: 25 MAY 2006
- Article first published online: 25 MAY 2006
- Manuscript Accepted: 22 FEB 2006
- Manuscript Received: 17 NOV 2005
- “Dutch Digestive Foundation” (“Maag Lever Darm Stichting”). Grant Number: MLDS WS 00-08
- Netherlands Organization for Health Research and Development. Grant Number: ZonMw: 920-03-232
Ursodeoxycholic acid (UDCA) and impaired gallbladder motility purportedly reduce biliary pain and acute cholecystitis in patients with gallstones. However, the effect of UDCA in this setting has not been studied prospectively. This issue is important, as in several countries (including the Netherlands) scheduling problems result in long waiting periods for elective cholecystectomy. We conducted a randomized, double-blind, placebo-controlled trial on effects of UDCA in 177 highly symptomatic patients with gallstones scheduled for cholecystectomy. Patients were stratified for colic number in the preceding year (<3: 32 patients; ≥3: 145 patients). Baseline postprandial gallbladder motility was measured by ultrasound in 126 consenting patients. Twenty-three patients (26%) receiving UDCA and 29 (33%) receiving placebo remained colic-free during the waiting period (89 ± 4; median [range]: 75[4–365] days) before cholecystectomy (P = .3). Number of colics, non-severe biliary pain, and analgesics intake were comparable. A low number of prior colics was associated with a higher likelihood of remaining colic-free (59% vs. 23%, P < .001), without effects on the risk of complications. In patients evaluated for gallbladder motility, 57% were weak and 43% were strong contractors (minimal gallbladder volume > respectively ≤ 6 mL). Likelihood to remain colic-free was comparable in strong and weak contractors (31% vs. 33%). In weak contractors, UDCA decreased likelihood to remain colic-free (21% vs. 47%, P = .02). In the placebo group, 3 preoperative and 2 post-cholecystectomy complications occurred. In contrast, all 4 complications in the UDCA group occurred after cholecystectomy. In conclusion, UDCA does not reduce biliary symptoms in highly symptomatic patients. Early cholecystectomy is warranted in patients with symptomatic gallstones. (HEPATOLOGY 2006;43:1276–1283.)