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 Jr., 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.
LESLIE J. SCHOENFIELD, JOHN M. LACHIN, RICHARD A. BAUM, ROBERT L. HABIG, RUSSELL F. HANSON, THEODORE HERSH, 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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