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A multi-center double-blind controlled trial of ursodeoxycholic acid for primary biliary cirrhosis

Gastroenterologia Japonica volume 25, pages 774–780 (1990)Cite this article

Summary

A multi-center double-blind controlled trial of ursodeoxycholic acid (UDCA) for treatment of primary biliary cirrhosis (PBC) was carried out. Twenty two and 23 patients were treated with 600mg/day UDCA and placebo, respectively, for 24 weeks. In UDCA - treated patients, fall of serum aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and gamma glutamyltranspeptidase activities started within 4 weeks after start of the trial and continued throughout the trial period. The serum IgM level fell in 7 UDCA-treated patients examined but not in 10 placebo-treated patients examined. Serum bilirubin concentration showed no significant change at the end of the study in either of UDCA- and placebotreated group of patients. There was no significant difference between these two groups with respect to the frequency of improvement of pruritus. In UDCA-treated patients, serum bile acid composition changed markedly, though its concentation showed no significant change. The percentage of total bile acid which ursodeoxycholic acid took up increased, whereas those which cholic acid, chenodeoxycholic acid and deoxycholic acid took up were decreased.

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Affiliations

  1. First Department of Internal Medicine, Faculty of Medicine, University of Tokyo, 3-1Hongo 7-chome, Bunkyoku, 113, Tokyo, Japan

    Hiroshi Oka, Gotaro Toda M.D., Yusei Ikeda & Naoaki Hashimoto

  2. Second Department of Internal Medicine, Tokyo Medical and Dental University School of Medicine, 113, Tokyo

    Yasushi Hasumura

  3. Third Department of Internal Medicine, Niigata University School of Medicine, 951, Niigata

    Tomoteru Kamimura

  4. Third Department of Internal Medicine, Ehime University School of Medicine, 791-02, Ehime

    Yasuyuki Ohta

  5. First Department of Internal Medicine, Okayama University Medical School, 700, Okayama

    Takao Tsuji

  6. First Department of Internal Medicine, Kanazawa University School of Medicine, 920, Ishikawa

    Nobu Hattori

  7. Department of Medicine, Juntendo University School of Medicine, 113, Tokyo

    Toshihiko Namihisa

  8. Department of Internal Medicine, Kagawa Medical School, 761-07, Kagawa

    Mikio Nishioka

  9. First Department of Internal Medicine, Kochi Medical School, 781-51, Kochi

    Ken’ichi Ito

  10. Third Department of Internal Medicine, Faculty of Medicine, Toyama Medical and PharmaceuticalUniversity, 930-01, Toyama

    Hiroshi Sasaki

  11. Third Department of Internal Medicine, Nagoya University School of Medicine, 466, Nagoya

    Shin’ichi Kakumu

  12. Third Department of Internal Medicine, Osaka City University Medical School, 545, Osaka

    Tetsuo Kuroki

  13. First Department of Internal Medicine, The Jikei University School of Medicine, 105, Tokyo

    Kiyoshi Fujisawa

  14. Second Department of Pathology, Kanazawa University School of Medicine, 920, Ishikawa, Japan

    Yasuo Nakanuma

Authors
  1. Hiroshi Oka
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  2. Gotaro Toda M.D.
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  3. Yusei Ikeda
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  4. Naoaki Hashimoto
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  5. Yasushi Hasumura
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  6. Tomoteru Kamimura
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  7. Yasuyuki Ohta
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  8. Takao Tsuji
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  9. Nobu Hattori
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  10. Toshihiko Namihisa
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  11. Mikio Nishioka
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  12. Ken’ichi Ito
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  13. Hiroshi Sasaki
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  14. Shin’ichi Kakumu
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  15. Tetsuo Kuroki
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  16. Kiyoshi Fujisawa
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  17. Yasuo Nakanuma
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Additional information

This work was supported in part by a grant from the Japanese Ministry of Public Health and Welfare. We express thanks to the following physicians for referring their patients for inclusion in this study: Mamoru Hohzumi (Tokyo Koseinenkin Hospital, Tokyo), Toshihiro Azuma (First Department of Internal Medicine, Okayama University Medical School, Okayama), Takafumi Ichida (Third Department of Internal Medicine, Niigata University School of Medicine, Niigata), Tadao Unuma (Mitsui Memorial Hospital, Tokyo), Masashi Unoura (First Department of Internal Medicine, Kanazawa University School of Medicine, Kanazawa) and others. We are also indebted to a moderator, Prof. Fujio Nakagawa (Department of Pharmacy, Faculty of Medicine, University of Tokyo, Tokyo).

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Oka, H., Toda, G., Ikeda, Y. et al. A multi-center double-blind controlled trial of ursodeoxycholic acid for primary biliary cirrhosis. Gastroenterol Jpn 25, 774–780 (1990). https://doi.org/10.1007/BF02779195

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  • DOI: https://doi.org/10.1007/BF02779195

Key words

  • cholestasis
  • double-blind controlled trial
  • primary biliary cirrhosis
  • ursodeoxycholic acid