Evidence map›Paper›PMID 27893675›Full record

Trial reportMedicine2016

A multicenter, randomized, double-blind trial comparing the efficacy and safety of TUDCA and UDCA in Chinese patients with primary biliary cholangitis.

Hong Ma, Minde Zeng, Ying Han, Huiping Yan, Hong Tang, Jifang Sheng, Heping Hu, Liufang Cheng, Qing Xie, Youfu Zhu and 17 more

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Article
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  5. Routes of Albumin Overload Toxicity in Renal Tubular Epithelial Cells.International journal of molecular sciences · 2023
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  11. Review
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  20. [Risk factors and therapeutic strategies for primary biliary cholangitis patients with poor prognosis].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2017
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 1 institution in 1 country.

Hong MaLiver 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.
Minde Zeng
Ying Han
Huiping Yan
Hong Tang
Jifang Sheng
Heping Hu
Liufang Cheng
Qing Xie
Youfu Zhu
Guofeng Chen
Zhiliang Gao
Wen Xie
Jiyao Wang
Shanming Wu
Guiqiang Wang
Xiaohui Miao
Xiaoqing Fu
Liping Duan
Jie Xu
Lai Wei
Guangfeng Shi
Chengwei Chen
Minhu Chen
Qin Ning
Chen Yao
Jidong Jia
Beijing YouAn Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTauroursodeoxycholic 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.

methods199 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.

resultsAt 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.

conclusionsTUDCA is safe and as efficacious as UDCA for the treatment of PBC, and may be better to relieve symptoms than UDCA.

Indexed as

AdolescentAdultAgedAlkaline PhosphataseChinaCholagogues and CholereticsCholangitisDouble-Blind MethodFemaleHumansMaleMiddle AgedTaurochenodeoxycholic AcidTreatment OutcomeUrsodeoxycholic AcidAlkaline PhosphataseCholagogues and CholereticsTaurochenodeoxycholic AcidUrsodeoxycholic Acidursodoxicoltaurine

Identifiers

PMID27893675
PMCPMC5134868
OpenAlexW2551543014

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.