Gut Liver.  2015 Jul;9(4):547-555. 10.5009/gnl15015.

Efficacy of Magnesium Trihydrate of Ursodeoxycholic Acid and Chenodeoxycholic Acid for Gallstone Dissolution: A Prospective Multicenter Trial

Affiliations
  • 1Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. hslee60@korea.ac.kr
  • 2Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.
  • 3Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea.
  • 4Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
  • 5Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.
  • 6Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
  • 7Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
  • 8Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.
  • 9Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
  • 10Department of Internal Medicine, Ajou University School of Medicine, Suwon, Korea.

Abstract

BACKGROUND/AIMS
Cholecystectomy is necessary for the treatment of symptomatic or complicated gallbladder (GB) stones, but oral litholysis with bile acids is an attractive alternative therapeutic option for asymptomatic or mildly symptomatic patients. This study was conducted to evaluate the efficacy of magnesium trihydrate of ursodeoxycholic acid (UDCA) and chenodeoxycholic acid (CDCA) on gallstone dissolution and to investigate improvements in gallstone-related symptoms.
METHODS
A prospective, multicenter, phase 4 clinical study to determine the efficacy of orally administered magnesium trihydrate of UDCA and CDCA was performed from January 2011 to June 2013. The inclusion criteria were GB stone diameter < or =15 mm, GB ejection fraction > or =50%, radiolucency on plain X-ray, and asymptomatic/mildly symptomatic patients. The patients were prescribed one capsule of magnesium trihydrate of UDCA and CDCA at breakfast and two capsules at bedtime for 6 months. The dissolution rate, response rate, and change in symptom score were evaluated.
RESULTS
A total of 237 subjects were enrolled, and 195 subjects completed the treatment. The dissolution rate was 45.1% and the response rate was 47.2% (92/195) after 6 months of administration of magnesium trihydrate of UDCA and CDCA. Only the stone diameter was significantly associated with the response rate. Both the symptom score and the number of patients with symptoms significantly decreased regardless of stone dissolution. Adverse events necessitating discontinuation of the drug, surgery, or endoscopic management occurred in 2.5% (6/237) of patients.
CONCLUSIONS
Magnesium trihydrate of UDCA and CDCA is a well-tolerated bile acid that showed similar efficacy for gallstone dissolution and improvement of gallstone-related symptoms as that shown in previous studies.

Keyword

Gallstones; Dissolution; Ursodeoxycholic acid; Chenodeoxycholic acid
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