Efficacy and indications of ursodeoxycholic acid treatment for dissolving gallstones. A multicenter double-blind trial. Tokyo Cooperative Gallstone Study Group.
The cholelitholytic action of ursodeoxycholic acid (UDCA) was investigated by a double-blind clinical trial. The trial started with 151 subjects all confirmed by radiographic examination as having radiolucent gallstones in a functioning gallbladder. The subjects were divided into three groups receiving 600 mg/day of UDCA, 150 mg/day of UDCA, and placebo (lactose) per day, respectively. Seventy-nine cases were classed as dropouts or were excluded due to incomplete follow-up or inadequate patient selection, and the data on the remaining 72 cases were analyzed. After 6--12 mo of treatment, dissolution of decrease in size or number of stones occurred in 10 of the 29 cases in the 600 mg/day group (34.5%), 4 of 23 cases in the 150 mg/day group (17.4%), and 1 of 20 cases in the control group (5.0%). For those cases with noncalcified, less than 15 mm in diameter, and floating stones, efficacy increased to 83.3% in the 600 mg/day group. Lithogenic index of bile defined by Thomas and Hofmann became unsaturated after treatment in the 600 mg/day group. Neither diarrhea nor hepatic toxicity was noted. The results indicate that UDCA is a safe and effective litholytic agent.
D001646:Bile / Q000032:analysis; D002769:Cholelithiasis / Q000188:drug therapy*; D002784:Cholesterol / Q000032:analysis; D002986:Clinical Trials as Topic; D003840:Deoxycholic Acid / Q000031:analogs & derivatives*; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D010743:Phospholipids / Q000032:analysis; D013997:Time Factors; D014580:Ursodeoxycholic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D010743:Phospholipids; D003840:Deoxycholic Acid; D014580:Ursodeoxycholic Acid; D002784:Cholesterol