title: Efficacy of Magnesium Trihydrate of Ursodeoxycholic Acid and Chenodeoxycholic Acid for Gallstone Dissolution: A Prospective Multicenter Trial.
abstract: OBJECTIVE
  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 ≤15 mm, GB ejection fraction ≥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.
authors.affiliation: Department of Internal Medicine, Korea University College of Medicine, Korea.
authors.forename: Jong Jin
authors.initials: JJ
authors.lastname: Hyun
authors.affiliation: Department of Internal Medicine, Korea University College of Medicine, Korea.
authors.forename: Hong Sik
authors.initials: HS
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Korea University College of Medicine, Korea.
authors.forename: Chang Duck
authors.initials: CD
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.
authors.forename: Seok Ho
authors.initials: SH
authors.lastname: Dong
authors.affiliation: Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea.
authors.forename: Seung-Ok
authors.initials: SO
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Ji Kon
authors.initials: JK
authors.lastname: Ryu
authors.affiliation: Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.
authors.forename: Don Haeng
authors.initials: DH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.
authors.forename: Seok
authors.initials: S
authors.lastname: Jeong
authors.affiliation: Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
authors.forename: Tae Nyeun
authors.initials: TN
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: Jin
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: Dong Hee
authors.initials: DH
authors.lastname: Koh
authors.affiliation: Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.
authors.forename: Eun Taek
authors.initials: ET
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: In-Seok
authors.initials: IS
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Byung Moo
authors.initials: BM
authors.lastname: Yoo
authors.affiliation: Department of Internal Medicine, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Jin Hong
authors.initials: JH
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000863:Antacids / Q000008:administration & dosage*; D002635:Chenodeoxycholic Acid / Q000008:administration & dosage*; D002756:Cholagogues and Choleretics / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D042882:Gallstones / Q000188:drug therapy*; D006801:Humans; D008276:Magnesium Hydroxide / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D012995:Solubility / Q000187:drug effects; D014580:Ursodeoxycholic Acid / Q000008:administration & dosage*
chemical_list: D000863:Antacids; D002756:Cholagogues and Choleretics; D004338:Drug Combinations; D002635:Chenodeoxycholic Acid; D014580:Ursodeoxycholic Acid; D008276:Magnesium Hydroxide
keywords: Chenodeoxycholic acid; Dissolution; Gallstones; Ursodeoxycholic acid