title: A multicenter, randomized, double-blind trial comparing the efficacy and safety of TUDCA and UDCA in Chinese patients with primary biliary cholangitis.
abstract: OBJECTIVE
  Tauroursodeoxycholic acid (TUDCA) is a taurine conjugated form of ursodeoxycholic acid (UDCA) with higher hydrophility. To further evaluate the efficacy and safety of TUDCA for primary biliary cholangitis (PBC), we performed this study on Chinese patients.
  
  
  METHODS
  199 PBC patients were randomly assigned to either 250 mg TUDCA plus UDCA placebo or 250 mg UDCA plus TUDCA placebo, 3 times per day for 24 weeks. The primary endpoint was defined as percentage of patients achieving serum alkaline phosphatase (ALP) reduction of more than 25% from baseline.
  
  
  RESULTS
  At week 24, 75.97% of patients in the TUDCA group and 80.88% of patients in the UDCA group achieved a serum ALP reduction of more than 25% from baseline (P = 0.453). The percentage of patients with serum ALP levels declined more than 40% following 24 weeks of treatment was 55.81% in the TUDCA group and 52.94% in the UDCA group (P = 0.699). Both groups showed similar improvement in serum levels of ALP, aspartate aminotransferase, and total bilirubin (P > 0.05). The proportion of patients with pruritus/scratch increased from 1.43% to 10.00% in UDCA group, while there's no change in TUDCA group (P = 0.023). Both drugs were well tolerated, with comparable adverse event rates between the 2 groups.
  
  
  CONCLUSIONS
  TUDCA is safe and as efficacious as UDCA for the treatment of PBC, and may be better to relieve symptoms than UDCA.
authors.affiliation: Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Gastroenterology Department, Renji Hospital, Shanghai Jiao Tong University, Shanghai Department of Gastroenterology, Xijing Hospital, Fourth Military Medical University, Xi'an Clinical Research Center for Autoimmune Liver Disease, Beijing You-an Hospital Capital Medical University, Beijing Department of Infectious Diseases, Huaxi Hospital, Chengdu Department of Infectious Diseases, Zhejiang University 1st Affiliated Hospital, Hangzhou Department of Comprehensive Treatment II, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai Department of Gastroenterology and Hepatology, Chinese People's Liberation Army General Hospital, Beijing Department of Infectious Diseases, Ruijin Hospital, Shanghai Hepatology Department, Nanfang Hospital, Southern Medical University, Guangzhou Liver Fibrosis Noninvasive Diagnosis and Treatment Center, 302 Military Hospital, Beijing Department of Infectious Diseases, Sun Yat-Sen University 3rd Affiliated Hospital, Guangzhou Liver Disease Center, Beijing Ditan Hospital, Capital Medial University, Beijing Department of Gastroenterology and Hepatology, Zhongshan Hospital, Fudan University Shanghai Public Health Center, Shanghai Department of Infectious Disease, Peking University First Hospital, Beijing Department of Infectious Diseases, Changzheng Hospital, Second Military Medical University, Shanghai Department of Infectious Diseases, Hangzhou Sixth People's Hospital, Hangzhou Department of Gastroenterology, The 1st Affiliated Hospital of Kunming Medical University, Kunming, China Department of Infectious Diseases, The Third People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Hepatology Unit, Peking University People's Hospital, Beijing Department of Infectious Diseases, Shanghai Huashan Hospital Department of Infectious Diseases, 85th PLA Hospital, Shanghai Department of Gastroenterology, First Affiliated Hospital, Sun Yat-sen University, Guangzhou Institute and Department of Infectious Diseases, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Department of Biostatistics, Peking University First Hospital, Beijing, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Ma
authors.forename: Minde
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authors.lastname: Zeng
authors.forename: Ying
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authors.lastname: Han
authors.forename: Huiping
authors.initials: H
authors.lastname: Yan
authors.forename: Hong
authors.initials: H
authors.lastname: Tang
authors.forename: Jifang
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authors.lastname: Sheng
authors.forename: Heping
authors.initials: H
authors.lastname: Hu
authors.forename: Liufang
authors.initials: L
authors.lastname: Cheng
authors.forename: Qing
authors.initials: Q
authors.lastname: Xie
authors.forename: Youfu
authors.initials: Y
authors.lastname: Zhu
authors.forename: Guofeng
authors.initials: G
authors.lastname: Chen
authors.forename: Zhiliang
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authors.lastname: Gao
authors.forename: Wen
authors.initials: W
authors.lastname: Xie
authors.forename: Jiyao
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authors.lastname: Wang
authors.forename: Shanming
authors.initials: S
authors.lastname: Wu
authors.forename: Guiqiang
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authors.lastname: Wang
authors.forename: Xiaohui
authors.initials: X
authors.lastname: Miao
authors.forename: Xiaoqing
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authors.lastname: Fu
authors.forename: Liping
authors.initials: L
authors.lastname: Duan
authors.forename: Jie
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authors.lastname: Xu
authors.forename: Lai
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authors.lastname: Wei
authors.forename: Guangfeng
authors.initials: G
authors.lastname: Shi
authors.forename: Chengwei
authors.initials: C
authors.lastname: Chen
authors.forename: Minhu
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authors.lastname: Chen
authors.forename: Qin
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authors.lastname: Ning
authors.forename: Chen
authors.initials: C
authors.lastname: Yao
authors.forename: Jidong
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authors.lastname: Jia
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D002681:China; D002756:Cholagogues and Choleretics / Q000627:therapeutic use*; D002761:Cholangitis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013655:Taurochenodeoxycholic Acid / Q000627:therapeutic use*; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
chemical_list: D002756:Cholagogues and Choleretics; D013655:Taurochenodeoxycholic Acid; C031655:ursodoxicoltaurine; D014580:Ursodeoxycholic Acid; D000469:Alkaline Phosphatase