Evidence map›Paper›PMID 25732417›Full record

Trial reportThe American journal of gastroenterology2015

A prospective randomized controlled study of long-term combination therapy using ursodeoxycholic acid and bezafibrate in patients with primary biliary cirrhosis and dyslipidemia.

Kenichi Hosonuma, Ken Sato, Yuichi Yamazaki, Masatoshi Yanagisawa, Hiroaki Hashizume, Norio Horiguchi, Satoru Kakizaki, Motoyasu Kusano, Masanobu Yamada

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The American journal of gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 9 pooled it
7.7field-weighted citation impact, top 2% 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

48 citing papers in PubMed, 9 syntheses or guidelines pooled it, 116 citations in OpenAlex.

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  6. [Ursodeoxycholic acid combined with bezafibrate in the treatment of refractory primary biliary cholangitis: a meta-analysis].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2019
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  13. New therapies for primary biliary cholangitis.Hepatology international · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 2 countries.

Kenichi HosonumaDepartment of Gastroenterology, Toho Hospital, Gunma, Japan.
Ken SatoDepartment of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Gunma, Japan.
Yuichi YamazakiDepartment of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Gunma, Japan.
Masatoshi YanagisawaDepartment of Gastroenterology, Heisei Hidaka Clinic, Gunma, Japan.
Hiroaki HashizumeDepartment of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Gunma, Japan.
Norio HoriguchiDepartment of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Gunma, Japan.
Satoru KakizakiDepartment of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Gunma, Japan.
Motoyasu KusanoDepartment of Endoscopy and Endoscopic Surgery, Gunma University Hospital, Gunma, Japan.
Masanobu YamadaDepartment of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Gunma, Japan.
Gunma University · JPSatou Hospital · JPYazaki (United States) · USSapporo Toho Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this study was to assess the long-term prognosis, efficacy, and safety of combination therapy using ursodeoxycholic acid (UDCA) and bezafibrate (BF) for primary biliary cirrhosis (PBC) patients exhibiting dyslipidemia.

methodsWe performed a prospective, randomized, controlled, multicenter study to compare the long-term clinical results between combination therapy and UDCA monotherapy for patients refractory to UDCA monotherapy. Twenty-seven consecutive PBC patients were enrolled.

resultsThe median treatment period in the UDCA and UDCA+BF groups was 107 and 110 months, respectively. The serum alkaline phosphatase (ALP) levels and the Mayo risk score in the combination therapy group (mean 290 IU/l and 0.91, respectively) were significantly lower than those in the UDCA monotherapy group (mean 461 IU/l and 1.42, respectively) at 8 years after the beginning of the study (P<0.05). The serum creatinine levels in the combination therapy group (mean 0.94 mg/dl) were significantly higher than those in the UDCA monotherapy group (mean 0.56 mg/dl) at 8 years after the beginning of the study (P<0.05). However, the survival rate was not significantly different between the groups. We observed dose reduction or discontinuation of the administration of BF, but not UDCA, due to renal dysfunction or muscle pain.

conclusionsLong-term combination therapy significantly improved the serum ALP levels and the Mayo risk score. However, the survival rate was not significantly different between the groups. In addition, long-term combination therapy significantly increased the serum creatinine levels. We should pay close attention to adverse events during this long-term combination therapy.

Indexed as

BezafibrateMyalgiaRenal InsufficiencyUrsodeoxycholic AcidAlkaline PhosphataseCholagogues and CholereticsCreatinineDose-Response Relationship, DrugDrug MonitoringDrug Therapy, CombinationDyslipidemiasFemaleHumansHypolipidemic AgentsLiver Cirrhosis, BiliaryMaleAlkaline PhosphataseBezafibrateCholagogues and CholereticsCreatinineHypolipidemic AgentsUrsodeoxycholic Acid

Identifiers

PMID25732417
OpenAlexW2085108629

What OpenQuestion holds

Textmetadata
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.