Summary
No direct comparison of tauroursodeoxycholic acid (TUDCA) and ursodeoxycholic acid (UDCA) has yet been carried out in the treatment of liver cirrhosis in China. We designed a double-blind randomized trial to evaluate the potential therapeutic efficacy of TUDCA in liver cirrhosis, using UDCA as parallel control. The enrolled 23 patients with liver cirrhosis were randomly divided into TUDCA group (n=12) and UDCA group (n=11), and given TUDCA and UDCA respectively at the daily dose of 750 mg, in a randomly assigned sequence for a 6-month period. Clinical, biochemical and histological features, and liver ultrasonographic findings were evaluated before and after the study. According to the inclusion criteria, 18 patients were included in the final analysis, including 9 cases in both two groups. Serum ALT, AST and ALP levels in TUDCA group and AST levels in UDCA group were significantly reduced as compared with baseline (P<0.05). Serum albumin levels were significantly increased in both TUDCA and UDCA groups (P<0.05). Serum markers for liver fibrosis were slightly decreased with the difference being not significant in either group. Only one patient in TUDCA group had significantly histological relief. Both treatments were well tolerated and no patient complained of side effects. It is suggested that TUDCA therapy is safe and appears to be more effective than UDCA in the treatment of liver cirrhosis, particularly in the improvement of the biochemical expression. However, both drugs exert no effect on the serum markers for liver fibrosis during 6-month treatment.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
Kuiper EM, Hansen BE, Lesterhuis W, et al. The long-term effect of ursodeoxycholic acid on laboratory liver parameters in biochemically non-advanced primary biliary cirrhosis. Clin Res Hepatol Gastroenterol, 2011,35(1):29–33
Wang X, Shen S, Li N, et al. Effect of ursodeoxycholi acid on liver cirrhosis with hepatitis B. Zhong Nan Da Xue Xue Bao Yi Xue Ban (Chinese), 2010,35(2):171–175
Fischer S, Muller I, Zundt BZ, et al. Ursodeoxycholic acid decreases viscosity and sedimentable fractions of gallbladder bile in patients with cholesterol gallstones. Eur J Gastroenterol Hepatol, 2004,16(3):305–311
Rodriques CM, Kren BT, Steer CJ, et al. Tauroursodeoxycholate increases rat liver ursodeoxycholate levels and limits lithocholate formation better than ursodeoxycholate. Gastroenterology, 1995,109(2):564–572
Fickert P, Fuchsbichler A, Marschall HU, et al. Lithocholic acid feeding induces segmental bile duct obstruction and destructive cholangitis in mice. Am J Pathol, 2006,168(2):410–422
Invernizzi P, Setchell KDR, Crosignani A, et al. Differences in the metabolism and disposition of ursodeoxycholic acid and its taurine-conjugated species in patients with primary biliary cirrhosis. Hepatology, 1999,29(2):320–327
Crosignani A, Battezzati PM, Setchell KD, et al. Tauroursodeoxycholic acid for treatment of primary biliary cirrhosis. A dose-response study. Dig Dis Sci, 1996,41(4):809–815
Setchell KD, Rodrigues CM, Podda M, et al. Metabolism of orally administered tauroursodeoxycholic acid in patients with primary biliary cirrhosis. Gut, 1996,38(3):439–446
Boatright JH, Nickerson JM, Moring AG, et al. Bile acids in treatment of ocular disease. J Ocul Biol Dis Infor, 2009,2(3):149–159
Chinese Society of Infectious Diseases and Parasitoloy and Chinese Society of Hepatology of Chinese Medical Association. The programme of prevention and cure for viral hepatitis. Zhonggua Gan Zang Bing Za Zhi (Chinese), 2000,8(6):324–329
Wang TL, Liu X, Zhou YP. Inflammatory activity of chronic hepatitis and fibrosis scoring program. Zhong Hua Gan Zang Bing Za Zhi (Chinese), 1998,6(4):195–197
Caglieris S, Giannini E, Dardano G, et al. Tauroursodeoxycholic acid administration as adjuvant therapy in cirrhotic patients on transplantation waiting lists. Hepatogastroenterology, 2000,47(34):1045–1047
Úriz M, Sáez E, Prieto J, et al. Ursodeoxycholic acid is conjugated with taurine to promote secretin-stimulated biliary hydrocholeresis in the normal rat. PLos One, 2011,6(12):e28717
Ben Mosbah I, Alfany-Fernandez I, Martel C, et al. Endoplasmic reticulum stress inhibition protects steatotic and non-steatotic livers in partial hepatectomy under ischemia-reperfusion. Cell Death Dis, 2010,8(1):e52
Rodrigues CM, Sola S, Sharpe JC, et al. Tauroursodeoxycholic acid prevents Bax-induced membrane perturbation and cytochrome C release in isolated mitochondria. Biochemistry, 2003,42(10):3070–3080
Schoemaker MH, Conde de la Rosa L, Buist-Homan M, et al. Tauroursodeoxycholic acid protects rat hepatocytes from bile acid-induced apoptosis via activation of survival pathways. Hepatology, 2004,39(6):1563–1573
Terasaki S, Nakanuma Y, Oqino H, et al. Hepatocellular and biliary expression of HLA antigens in primary biliary cirrhosis before and after ursodeoxycholic acid therapy. Am J Gastroenterol, 1991,86(9):1194–1199
Liu L, Sakaquchi T, Cui X, et al. Liver regeneration enhanced by orally administered ursodesoxycholic acid is mediated by immunosuppression in partially hepatectomized rats. Am J Clin Med, 2002,30(1):119–126
Kuiper EM, Hansen BE, Lesterhuis W, et al. The long-term effect of ursodeoxycholic acid on laboratory liver parameters in biochemically non-advanced primary biliary cirrhosis. Clin Res Hepatol Gastroenterol, 2011,35(1):29–33
Dan W, Ling Y, Jinming H, et al. Tauroursodeoxycholic acid inhibits carbon tetrachloride-induced liver fibrosis in rats. Shi Jie Hua Ren Xiao Hua Za Zhi (Chinese), 2010,18(19):1979–1984
Colell A, Coll O, Garcia-Ruiz C, et al. Tauroursodeoxycholic acid protects hepatocytes from ethanol-fed rats against tumor necrosis factor-induced cell death by replenishing mitochondrial glutathione. Hepatology, 2001,34(5):964–971
Zhang LX, Liang TJ, Tan YR, et al. Protective effects of ursodeoxycholic acid against immune-mediated liver fibrosis in rats. Hepatogastroenterology, 2010,57(102–103):1196–1202
Voumvouraki A, Koulentaki M, Notas G, et al. Serum surrogate markers of liver fibrosis in primary biliary cirrhosis. Eur J Intern Med, 2011,22(1):77–83
Larghi A, Crosignani A, Battezzati PM, et al. Ursodeoxycholic and tauroursodeoxycholic acids for the treatment of primary biliary cirrhosis: a pilot crossover study. Aliment Pharmacol Ther, 1997,11(2):409–414
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Pan, Xl., Zhao, L., Li, L. et al. Efficacy and safety of tauroursodeoxycholic acid in the treatment of liver cirrhosis: A double-blind randomized controlled trial. J. Huazhong Univ. Sci. Technol. [Med. Sci.] 33, 189–194 (2013). https://doi.org/10.1007/s11596-013-1095-x
Received:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11596-013-1095-x