Ursodeoxycholic acid exerts no beneficial effect in patients with symptomatic gallstones awaiting cholecystectomy

• Published in: Hepatology (Baltimore, Md.) Vol. 43; no. 6; pp. 1276 - 1283
• Main Authors: Venneman, Niels G., Besselink, Marc G.H., Keulemans, Yolande C.A., vanBerge‐Henegouwen, Gerard P., Boermeester, Marja A., Broeders, Ivo A.M.J., Go, Peter M.N.Y.H., van Erpecum, Karel J.
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01-06-2006; Wiley
• Subjects: Administration, Oral; Adolescent; Adult; Aged; Biological and medical sciences; Cholecystectomy, Laparoscopic - methods; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Gallbladder Emptying - drug effects; Gallstones - diagnosis; Gallstones - drug therapy; Gallstones - surgery; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Liver, biliary tract, pancreas, portal circulation, spleen; Liver. Biliary tract. Portal circulation. Exocrine pancreas; Male; Medical sciences; Middle Aged; Multivariate Analysis; Other diseases. Semiology; Preoperative Care - methods; Probability; Reference Values; Risk Assessment; Severity of Illness Index; Statistics, Nonparametric; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the digestive system; Treatment Outcome; Ursodeoxycholic Acid - administration & dosage; Cholecystectomy; Human; Treatment; Surgery; Bile acid; Gastroenterology; Digestive diseases; Gallbladder; Biliary tract disease; Cholelithiasis; Ursodeoxycholic acid
• ISSN: 0270-9139; 1527-3350
• DOI: 10.1002/hep.21182

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.)