Testosterone treatment of men with alcoholic cirrhosis: A double-blind study

Authors

  • Christian Gluud M.D.

    Corresponding author
    1. Medical Department, Division of Hepatology, Department of Pathology and Department of Clinical Physiology and Nuclear Medicine, Hvidovre University Hospital, University of Copenhagen, Copenhagen, Denmark
    2. Medical Department B, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark
    3. Medical Department of Gastroenterology B, Fredriksberg Hospital, University of Copenhagen, Copenhagen, Denmark
    4. Medical Department A, Division of Hepatology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
    5. Medical Department II, Kommunehospitalet, University of Copenhagen, Copenhagen, Denmark
    6. Hormone Department, Statens Seruminstitut, University of Copenhagen, Copenhagen, Denmark
    7. Statistical Research Unit, Danish Medical and Social Science Research Councils, University of Copenhagen, Copenhagen, Denmark
    • Medical Department C, Herlev University Hospital, DK-2730, Copenhagen, Denmark
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  • Members of the Copenhagen Study Group for Liver Diseases are: Principal investigator—Christian Gluud (Hvidovre University Hospital). Planning and steering committee—Christian Gluud, Finn Hardt and Erik Juhl (Hvidovre University Hospital). Pathology—Per Chris–toffersen and Hemming Poulsen (Hvidovre University Hospital). Hormone analysis—Paul Bennett and Svend G. Johnsen (Statens Seruminstitut). Statistical analysis—Gert Nielsen (Statistical Research Unit, Danish Medical and Social Science Research Councils). Clinical investigators—Olav Bonnevie, Jan Eriksen, Christian Gluud, Finn Hardt, Kurt Iversen, Erik Juhl, Bodil B. Knudsen, Nils Milman, Leo Ranek, Thorkild I.A. Sørensen, Henrik F. Thomsen, Åge C. Thomsen, Niels Tygstrup, Per Wantzin and Kjeld Winkler.

Abstract

A double-blind, placebo-controlled multicenter trial was conducted to determine the efficacy of oral testosterone treatment (200 mg three times daily) in men with alcoholic cirrhosis. By skewed randomization (3:2), 134 patients received testosterone and 87 placebo. Patients were followed from 8 to 62 months (median = 28 months). In the testosterone group, 33 patients died (25%; 95% confidence limits = 18 to 33%) as compared to 18 (21%; 95% confidence limits = 13 to 31%) in the placebo group. Taking age and significant prognostic variables into consideration, this corresponds with a relative mortality risk of 1.17 (95% confidence limits = 0.65 to 2.15) in the testosterone group vs. the placebo group. Testosterone treatment did not significantly affect liver biochemistry, prevalence of complications to cirrhosis or causes of death. Patients treated with testosterone developed significantly (p < 0.05) higher serum testosterone and blood hemoglobin concentrations and significantly (p < 0.05) lower plasma IgM concentrations as compared to the placebo group. The prevalence of gynecomastia decreased significantly (p < 0.05) in the testosterone group as compared to the placebo group. We conclude that oral testosterone treatment has no beneficial effect on survival and liver biochemistry in men with alcoholic cirrhosis, and adverse effects cannot be excluded.

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