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Efficacy and safety of tauroursodeoxycholic acid in the treatment of liver cirrhosis: A double-blind randomized controlled trial

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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.

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Authors and Affiliations

  1. Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China

    Xiao-li Pan  (潘晓莉), Li Zhao  (赵 莉), Liang Li  (李 靓), Ai-hua Li  (李爱华), Jin Ye  (叶 进), Ling Yang  (杨 玲), Ke-shu Xu  (徐可树) & Xiao-hua Hou  (侯晓华)

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  1. Xiao-li Pan  (潘晓莉)
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  2. Li Zhao  (赵 莉)
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  3. Liang Li  (李 靓)
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  4. Ai-hua Li  (李爱华)
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  5. Jin Ye  (叶 进)
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  6. Ling Yang  (杨 玲)
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  7. Ke-shu Xu  (徐可树)
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  8. Xiao-hua Hou  (侯晓华)
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Correspondence to Jin Ye  (叶 进).

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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

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  • DOI: https://doi.org/10.1007/s11596-013-1095-x

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