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European Journal of Clinical Pharmacology

, Volume 40, Issue 5, pp 473–476 | Cite as

Effects of ursodeoxycholic acid (UDCA) on serum liver damage indices in patients with chronic active hepatitis

A double-blind controlled study
  • E. Rolandi
  • R. Franceschini
  • A. Cataldi
  • V. Cicchetti
  • L. Carati
  • T. Barreca
Originals

Summary

The effects of ursodeoxycholic acid (UDCA, 450 mg daily) in patients with histologically proven chronic active hepatitis (CAH) have been evaluated in a randomized, double-blind, placebo-controlled study. Twenty-six patients with serum alanine aminotransferase (ALT) values at least twice the normal upper limit in two of three pre-treatment tests received UDCA or a placebo for twelve weeks.

In all UDCA-treated patients, serum aspartate aminotransferase (AST), ALT, gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase (AP) fell significantly after 4 weeks of treatment. There was a further decrease at the end of therapy, as well as a small but significant fall in total serum bilirubin. Conversely, 4 weeks aftersuspension of therapy, serum enzyme levels had increased, reaching values not much lower than those recorded before treatment. Total serum protein, albumin and γ-globulin did not change after UDCA treatment. In the placebo group no significant variation in the test results were found.

The results indicate that UDCA therapy in CAH, as has been observed in primary biliary cirrhosis and primary sclerosing cholangitis, is able to improve several indices of liver damage, without producing any toxic adverse effects.

Key words

Ursodeoxycholic acid chronic active hepatitis liver damage liver function tests side effects 

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References

  1. 1.
    Danzinger RG, Hofmann AF, Schoenfield LJ, Thistle JL (1972) Dissolution of cholesterol gallstones by chenodeoxycholic acid. N Engl J Med 286: 1–8Google Scholar
  2. 2.
    Makino I, Shinozaki K, Yoshino K, Nakagawa S (1975) Dissolution of cholesterol gallstones by ursodeoxycholic acid. Jpn J Gastroenterol 72: 690–702Google Scholar
  3. 3.
    Leuschner U, Reber E, Erb W (1977) Treatment of patients with gallstones with chenodeoxycholic acid. Dtsch Med Wochenschr 102: 156–160Google Scholar
  4. 4.
    Miyazaki K, Nakayama F, Koga F, Koga A (1984) Effect of chenodeoxycholic and ursodeoxycholic acids on isolated adult human hepatocytes. Dig Dis Sci 29: 1123–1130Google Scholar
  5. 5.
    Schölmerich J, Becher MS, Schmidt K, Schubert R, Kremer B, Felhaus S, Gerok W (1984) Influence of hydroxylation and conjugation of bile salts on their membrane-damaging properties. Studies on isolated hepatocytes and lipid membrane vesicles. Hepatology 4: 661–666Google Scholar
  6. 6.
    Leuschner U, Leuschner M, Hubner K (1981) Gallstone dissolution in patients with chronic active hepatitis (Abstr). Gastroenterol 80: 1208Google Scholar
  7. 7.
    Del Vecchio Blanco C, Caporaso N, Gentile S, Rinaldi M, Pucci R (1982) Safe use of ursodeoxycholic acid in the treatment of dyspeptic symptoms in patients with chronic active hepatitis: a double-blind controlled trial. J Int Med Res 10: 278–282Google Scholar
  8. 8.
    Hatoff DE, Hardison WGM (1981) Bile acids modify alkaline phosphatase induction and bile secretion pressure after bile duct obstruction in the rat. Gastroenterol 80: 666–672Google Scholar
  9. 9.
    Miyai K, Toyota N, Jones HM, Gochman N (1982) Protective effects of ursodeoxycholic acid against cholestatic and hepatotoxic effects of lithocholic acid (Abstr). Hepatology 2: 706Google Scholar
  10. 10.
    Hofmann AF (1984) Medical treatment of cholesterol gallstones by bile desaturating agents. Hepatology 4 [Suppl]: 199–208Google Scholar
  11. 11.
    Koga Y (1987) Anti-cholestatic and cytoprotective properties of ursodeoxycholic acid. Studies in vivo and in vitro. Acta Hepatol Jap 28: 1597–1604Google Scholar
  12. 12.
    Leuschner U, Fischer H, Kurtz W, Guldutuna S, Hubner K, Hellstern A, Gatzen M, Leuschner M (1989) Ursodeoxycholic acid in primary biliary cirrhosis: results of a controlled double-blind trial. Gastroenterol 97: 1268–1274Google Scholar
  13. 13.
    Fisher MM, Paradine ME (1986) Influence of ursodeoxycholic acid (UDCA) on biochemical parameters in cholestatic liver disease (Abstr). Gastroenterol 90: 1725Google Scholar
  14. 14.
    Poupon R, Chretien Y, Poupon RE, Ballet F, Calmus Y, Darnis F (1987) Is ursodeoxycholic acid an effective treatment for primary biliary cirrhosis? Lancet I: 834–836Google Scholar
  15. 15.
    Bateson MC, Ross PE, Diffey BL (1989) Ursodeoxycholic acid in primary biliary cirrhosis. Lancet I: 898–899Google Scholar
  16. 16.
    Leuschner U, Leuschner M, Sieratzki J, Kurtz W, Hubner K (1985) Gallstone dissolution with ursodeoxycholic acid in patients with chronic active hepatitis and two years follow-up. A pilot study. Dig Dis Sci 30: 642–649Google Scholar
  17. 17.
    Podda M, Ghezzi C, Battezzati PM, Bertolini E, Crosignani A, Petroni ML, Zuin M (1988) Ursodeoxycholic acid for chronic liver diseases. J Clin Gastroenterol 10: S25-S32Google Scholar
  18. 18.
    Bellentani S, Tabarroni G, Barchi T, Ferretti I, Fratti N, Villa E, Manenti F (1989) Effect of ursodeoxycholic acid treatment on alanine aminotransferase and γ-glutamyltranspeptidase serum levels in patients with hypertransaminasemia. Results from a double-blind controlled trial. J Hepatol 8: 7–12Google Scholar
  19. 19.
    Podda M, Ghezzi C, Battezzati PM, Crosignani A, Zuin M, Roda A (1990) Effects of ursodeoxycholic acid and taurine on serum liver enzymes and bile acids in chronic hepatitis. Gastroenterol 98: 1044–1050Google Scholar
  20. 20.
    Attili AF, Angelico M, Cantafora A, Alvaro D, Capocaccia L (1986) Bile-acid-induced liver toxicity: relation to the hydrophobic-hydrophilic balance of bile acids. Med Hypotheses 19: 57–68Google Scholar
  21. 21.
    Hofmann AF, Popper H (1989) Ursodeoxycholic acid for primary biliary cirrhosis. Lancet II: 398–399Google Scholar
  22. 22.
    Editorial (1989): Gallstones, bile acids, and the liver. Lancet II: 249–251Google Scholar

Copyright information

© Springer-Verlag 1991

Authors and Affiliations

  • E. Rolandi
    • 1
  • R. Franceschini
    • 1
  • A. Cataldi
    • 1
  • V. Cicchetti
    • 2
  • L. Carati
    • 2
  • T. Barreca
    • 1
  1. 1.Department of Internal MedicineUniversity of GenoaGenoaItaly
  2. 2.Medical DepartmentZambon GroupMilanItaly

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