LESLIE J. SCHOENFIELD, M.D., Ph.D; JOHN M. LACHIN, Sc.D.; RICHARD A. BAUM, M.D.; ROBERT L. HABIG, Ph.D.; RUSSELL F. HANSON, M.D.; THEODORE HERSH, M.D.; N. C. HIGHTOWER, M.D.; ALAN F. HOFMANN, M.D.; ELLIOT C. LASSER, M.D.; JAY W. MARKS, M.D.; HAGOP MEKHJIAN, M.D.; RONALD OKUN, M.D.; ROBERT A. SCHAEFER, M.D.; LAWRENCE SHAW; ROGER D. SOLOWAY, M.D.; JOHNSON L. THISTLE, M.D.; FRED B. THOMAS, M.D.; MALCOLM P. TYOR, M.D.
A double-masked study was conducted to determine the efficacy and safety of randomly allocated chenodiol (chenodeoxycholic acid, 750 mg/d or 350 mg/d) or placebo administered for 2 years to 916 patients for dissolution of radiolucent gallstones. There was confirmed complete dissolution in 13.5% of patients (750 mg/d), 5.2% (375 mg/d), and 0.8% (placebo), p < 0.0001. Partial (over 50%) or complete dissolution (by validated roentgenographic metrology) occurred in 40.8% (750 mg/d), 23.6% (375 mg/d), and 11.0% (placebo), p < 0.0001. Dissolution occurred more frequently in women, thin patients, or patients with small or floating gallstones or serum cholesterol ≥ 227 mg/dL. Clinically significant hepatotoxicity occurred in 3% of patients (750 mg/d), 0.4% (375 mg/d), and 0.4% (placebo), p < 0.007, and always was reversible biochemically. Elevations of 10% or more of serum cholesterol, mostly low-density lipoproteins, occurred in 85.2% of patients (750 mg/d), 82.8% (375 mg/d), and 67.0% (placebo), p < 0.001. Chenodiol, 750 mg/d for up to 2 years, is appropriate therapy for dissolution of gallstones in selected patients who are informed of the risks and benefits.
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SCHOENFIELD LJ, LACHIN JM, BAUM RA, HABIG RL, HANSON RF, HERSH T, et al. Chenodiol (Chenodeoxycholic Acid) for Dissolution of Gallstones: The National Cooperative Gallstone Study: A Controlled Trial of Efficacy and Safety. Ann Intern Med. 1981;95:257-282. doi: 10.7326/0003-4819-95-3-257
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Published: Ann Intern Med. 1981;95(3):257-282.
Biliary Disorders, Gastroenterology/Hepatology, Prevention/Screening.
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