Ursodeoxycholic acid and prednisolone versus ursodeoxycholic acid and placebo in the treatment of early stages of primary biliary cirrhosis

Journal of Hepatology

Volumn 25, Issue 1, 1996, Pages 49-57

  Leuschner, Maria ^a   Güldütuna, Sükrettin ^a   You, Tiangeng ^a   Hübner, Klaus ^a   Bhatti, Susan ^a   Leuschner, Ulrich ^a  

^a GOETHE UNIVERSITY   (Germany)

Author keywords

Glucocorticoids; Liver histology; Primary biliary cirrhosis; Ursodeoxycholic acid

Indexed keywords

PREDNISOLONE; URSODEOXYCHOLIC ACID;

ADULT; AGED; ARTICLE; BILIARY CIRRHOSIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECT; DRUG EFFICACY; FEMALE; HUMAN; LIVER BIOPSY; LIVER FUNCTION; MALE; PRIORITY JOURNAL;

EID: 0030198972     PISSN: 01688278     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0168-8278(96)80327-8     Document Type: Article

References (34)

1. David R, Kurtz W, Strohm WD, Leuschner U. Die Wirkung von Ursodesoxycholsäure bei chronischen Leberkrankheiten. Eine Pilotstudie (abstr.). Z Gastroenterol. 23:1985;420.
2. Leuschner U, Fischer H, Kurtz W, Güldütuna S, Hübner K, Hellstem A, Gatzen M, Leuschner M. Ursodeoxycholic acid in primary biliary cirrhosis: results of a controlled double blind trial. Gastroenterology. 97:1989;1268-1274.
3. Poupon RE, Balkau B, Eschwège E, Poupon R. A multicenter, controlled trial of ursodiol for the treatment of primary biliary cirrhosis. N Engl J Med. 324:1991;1548-1554.
4. Hadziyannis SJ, Hadziyannis ES, Lianidou E, Markis A. Paumgartner G, Stiehl A, Gerok W. Long-term treatment of primary biliary cirrhosis with ursodeoxycholic acid: the third year of a controlled trial. Bile Acids as Therapeutic Agents. From Basic Science to Clinical Practice. 1991;287-296 Kluwer, Dordrecht, Boston, London.
5. Oka H, Toda G, Ikeda Y, Hashimoto N, Hasumura Y, Kamimura T, Ohta Y, Tsuji T, Hattori N, Namihisa T, Nishioka M, Ito K, Sasaki H, Kakumu S, Kuroki T, Fugisawa K, Nakanuma Y. A multi-center double-blind controlled trial of ursodeoxycholic acid for primary biliary cirrhosis. Gastroenterol Jpn. 25:1990;774-780.
6. Battezzati PM, Podda M, Bianchi FB, Naccarato R, Orlandi F, Surrenti C, Pagliaro L, Manenti F. Ursodeoxycholic acid for symptomatic primary biliary cirrhosis. Preliminary analysis of a double-blind multicenter trial. J Hepatol. 17:1993;332-338.
7. Hwang S-J, Chan C-Y, Lee S-D, Wu J-C, Tsay S-H, Lo K-J. Ursodeoxycholic acid in the treatment of primary biliary cirrhosis: A short-term, randomized, double-blind controlled, cross-over study with long-term follow up. J Gastroenterol Hepatol. 8:1993;217-223.
8. Turner IB, Myscor M, Mitchinson HC, Bennet MK, Burt AD, James OFW. A two-year controlled trial examining the effectiveness of ursodeoxycholic acid in primary biliary cirrhosis. J Gastroenterol Hepatol. 9:1994;162-168.
9. Poupon RE, Poupon R, Balkau B. Ursodiol for the long-term treatment of primary biliary cirrhosis. N Engl J Med. 330:1994;1342-1347.
10. Lindor KD, Dickson ER, Baldus WP, Jorgensen RA, Ludwig J, Murtough PA, Harrison JM, Wiesner RH, Anderson ML, Lange SM, LeSage G, Rossi SS, Hofmann HF. Ursodeoxycholic acid in the treatment of primary biliary cirrhosis. Gastroenterology. 106:1994;1284-1290.
11. Heathcote EJ, Cauch-Dudek K, Walker V, Walker V, Bailey R, Blendis LM, Ghent CN, Michieletti P, Minuk GY, Pappas Scully LJ, Steinbrecher UP, Sutherland LR, Williams CN, Witt-Sullivan H, Worobetz LJ, Milner RA, Wanless IR. The Canadian multicenter double-blind randomized controlled trial of ursodeoxycholic acid in primary biliary cirrhosis. Hepatology. 19:1994;1149-1156.
12. Combes B, Carithers RL, Maddrey WC, Munoz SJ, McDonald HF, Garcia-Tsao G, Boyer JL, Luketi V, Schiffman ML, Peters MG, White H, Zetterman R, Markin R. Paumgartner G, Stiehl A, Gerok W. A randomized, double-blind, placebo-controlled trial of ursodeoxycholic acid in primary biliary cirrhosis. Bile Acids and the Hepatobiliary System. 1993;289-291 Kluwer, Dordrecht, Boston, London.
13. Leuschner U, Güldütuna S, Imhof M, Hübner K, Benjaminov A, Leuschner M. Effects of ursodeoxycholic acid after 4 to 12 years of therapy in early and late stages of primary biliary cirrhosis. J Hepatol. 21:1994;624-633.
14. Raedsch R, Stiehl A, Walker S, Rudi J, Schlenker T, Gertlis C, Kommerel LB, Klein R, Berg P, Scherrmann JH. Paumgartner G, Stiehl A, Gerok W. Controlled study on the effects of a combined ursodeoxycholic acid plus colchicine treatment in primary biliary cirrhosis. Bile Acids and the Hepatobiliary System. 1993;303-309 Kluwer, Dordrecht, Boston, London.
15. Podda M, Almasio P, Battezzati PM, Crosignani A. Paumgartner G, Stiehl A, Gerok W. Long-term effect of the administration of ursodeoxycholic acid alone or with colchicine in patients with primary biliary cirrhosis. A double-blind multicenter study. Bile acids and the hepatobiliary system. 1993;310-315 Kluwer, Dordrecht, Boston, London.
16. Shibata J, Fujiyama S, Honda Y, Sato T. Combination therapy with ursodeoxycholic acid and colchicine for primary biliary cirrhosis. J Gastroenterol Hepatol. 7:1992;277-282.
17. Schaffner F. Ursodeoxycholic acid (U) + colchicine (C) for treatment of primary biliary cirrhosis (PBC) (abstr.). Hepatology. 14:1991;62A.
18. Kaplan MM. The therapeutic effects of ursodiol and methotrexate are additive and well tolerated in primary biliary cirrhosis (abstr.). Hepatology. 16:1992;92A.
19. Buscher H-P, Zietzschmann Y, Gerok W. Positive responses to methotrexate and ursodeoxycholic acid in patients with primary biliary cirrhosis responding insufficiently to ursodeoxycholic acid alone. J Hepatol. 18:1993;9-14.
20. Van Steenbergen W, Sciot R, van Eyken P, Desmet V, Fevery J. Van Berge Henegouwen GP, van Hoek B, de Groote J, Matern S. Methotrexate alone or in combination with ursodeoxycholic acid as possible treatment in primary biliary cirrhosis. Cholestatic Liver Diseases. New Strategies for Prevention and Treatment of Hepatobiliary and Cholestatic Liver Diseases. 1994;246-254 Kluwer, Dordrecht, Boston, London.
21. Wolfhagen FHJ, van Buuren HR, Schalm SW. Combined treatment with ursodeoxycholic acid and prednisolone in primary biliary cirrhosis. Neth J Med. 44:1994;84-90.
22. Van Buuren HR, Wolfhagen FHJ, Schalm SW. Van Berge Henegouwen GP, van Hoek B, de Groote J, Matern S. Treatment with ursodeoxycholic acid, as monotherapy and in combination with other agents, in primary biliary cirrhosis. Cholestatic Liver Diseases. New Strategies for Prevention and Treatment of Hepatobiliary and Cholestatic Liver Diseases. 1994;236-245 Kluwer, Dordrecht, Boston, London.
23. Mitchison HC, Palmer JM, Bassendine MF, Watson AJ, Record CO, James OFW. A controlled trial of prednisolone treatment in primary biliary cirrhosis. Three-year results. J Hepatol. 15:1992;336-344.
24. Güldütuna S, You T, Kurts W, Leuschner U. High performance liquid chromatographic determination of free and conjugated bile acids in serum, liver biopsies, bile, gastric juice and feces by fluorescence labeling. Clin Chim Acta. 214:1993;195-207.
25. Weibel ER. Selection of the best method in stereology. J Microsc. 100:1974;261-269.
26. Weibel ER, Kistler GS, Scherle WF. Practical stereological methods for morphometric cytology. J Cell Biol. 30:1966;23-39.
27. Mitchison HC, Bassendine MF, Malcolm AJ, Watson AJ, Record CO, James OFW. A pilot, double-blind, controlled one year trial of prednisolone treatment in primary biliary cirrhosis: hepatic improvement but greater bone loss. Hepatology. 10:1989;420-429.
28. Floreani A, Chiaramonte M, Giannini S, Malvasi L, Lodetti MG, Castrignano R, Giacomo A, Angelo AD, Naccarato R. Longitudinal study on osteodystrophy in primary biliary cirrhosis (PBC) and a pilot study on calcitonin treatment. J Hepatol. 12:1991;217-223.
29. Guañabens N, Parés A, del Rio L, Roca M, Gómez R, Muñoz J, Rodés J. Sodium fluoride prevents bone loss in primary biliary cirrhosis. J Hepatol. 15:1992;345-349.
30. Camisasca M, Crosignani A, Battezzati PM, Albisetti W, Grandinetti G, Pietrogrande L, Biffi A, Zuin M, Podda M. Parenteral calcitonin for metabolic bone disease associated with primary biliary cirrhosis. Hepatology. 20:1994;633-637.
31. Stiehl A, Rudolph G, Raedsch R, Möller B, Hopf U, Cotterer E, Bircher J, Fölsch U, Klaus J, Endele R, Senu M. Ursodeoxycholic acid-induced changes of plasma and urinary bile acids in patients with primary biliary cirrhosis. Hepatology. 12:1990;492-497.
32. Poupon RE, Chrétien Y, Poupon R, Paumgartner G. Serum bile acids in primary biliary cirrhosis: effect of ursodeoxycholic acid therapy. Hepatology. 17:1993;599-604.
33. Roda E, Mazzella G, Bazzoli F, Villanova N, Minutello A, Simoni P, Rouchi M, Pozzi C, Festi D, Aldini R, Roda A. Effect of ursodeoxycholic acid administration on biliary lipid secretion in primary biliary cirrhosis. Dig Dis Sci. 34:1989;52S-58S.
34. Batta AK, Salen G, Mirchandani R, Tint GS, Shefer S, Batta M, Abroon BSJ, O'Brien CB, Senior JR. Effect of long-term treatment with ursodiol on clinical and biochemical features and biliary bile acid metabolism in patients with primary biliary cirrhosis. Am J Gastroenterol. 88:1993;691-700.