Efficacy of Magnesium Trihydrate of Ursodeoxycholic Acid and Chenodeoxycholic Acid for Gallstone Dissolution: A Prospective Multicenter Trial
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 tr...
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| Published in | Gut and Liver Vol. 9; no. 4; pp. 547 - 555 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Korea (South)
The Editorial Office of Gut and Liver
01.07.2015
Gut and Liver Gastroenterology Council for Gut and Liver 거트앤리버 소화기연관학회협의회 |
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| Online Access | Get full text |
| ISSN | 1976-2283 2005-1212 |
| DOI | 10.5009/gnl15015 |
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| Abstract | 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.
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.
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.
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. |
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| AbstractList | Background/AimsCholecystectomy 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.Conclusion : sMagnesium 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. 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 ≤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. KCI Citation Count: 6 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. 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. 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. 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. |
| Author | Seung Ok Lee Tae Nyeun Kim Hong Sik Lee Byung Moo Yoo Don Haeng Lee Jin Lee Seok Jeong Chang Duck Kim In Seok Lee Seok Ho Dong Jong Jin Hyun Ji Kon Ryu Eun Taek Park Jin Hong Kim Dong Hee Koh |
| AuthorAffiliation | Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea Department of Internal Medicine, Ajou University School of Medicine, Suwon, Korea |
| AuthorAffiliation_xml | – name: Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea – name: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea – name: Department of Internal Medicine, Ajou University School of Medicine, Suwon, Korea – name: Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea – name: Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea – name: Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea – name: Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea – name: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea – name: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea – name: Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea |
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| Copyright | Copyright © 2015 by The Korean Society of Gastroenterology, the Korean Society of Gastrointestinal Endoscopy, the Korean Society of Neurogastroenterology and Motility, Korean College of Helicobacter and Upper Gastrointestinal Research, Korean Association for the Study of Intestinal Diseases, the Korean Association for the Study of the Liver, Korean Pancreatobiliary Association, and Korean Society of Gastrointestinal Cancer. 2015 |
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| Keywords | Gallstones Chenodeoxycholic acid Dissolution Ursodeoxycholic acid |
| Language | English |
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| Snippet | Cholecystectomy is necessary for the treatment of symptomatic or complicated gallbladder (GB) stones, but oral litholysis with bile acids is an attractive... Background/AimsCholecystectomy is necessary for the treatment of symptomatic or complicated gallbladder (GB) stones, but oral litholysis with bile acids is an... Background/Aims: Cholecystectomy is necessary for the treatment of symptomatic or complicated gallbladder (GB) stones, but oral litholysis with bile acids is... |
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| SubjectTerms | Adult Aged Antacids Antacids - administration & dosage Chenodeoxycholic Acid Chenodeoxycholic Acid - administration & dosage Cholagogues and Choleretics Cholagogues and Choleretics - administration & dosage Diseases of the digestive system. Gastroenterology dissolution Drug Administration Schedule Drug Combinations Female Gallstones Gallstones - drug therapy Humans Magnesium Hydroxide Magnesium Hydroxide - administration & dosage Male Middle Aged Original Original Article Prospective Studies RC799-869 Severity of Illness Index Solubility Solubility - drug effects Ursodeoxycholic Acid Ursodeoxycholic Acid - administration & dosage 내과학 |
| Title | Efficacy of Magnesium Trihydrate of Ursodeoxycholic Acid and Chenodeoxycholic Acid for Gallstone Dissolution: A Prospective Multicenter Trial |
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