Evidence map›Paper›PMID 36180756›Full record

SynthesisDigestive diseases and sciences2023

Efficacy and Safety of Bezafibrate Alone or in Combination with Ursodeoxycholic Acid in Primary Biliary Cholangitis: Systematic Review and Meta-Analysis.

Nidah Shabbir Khakoo, Shahnaz Sultan, John M Reynolds, Cynthia Levy

Abstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Digestive diseases and sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
2.6field-weighted citation impact, top 9% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Treatment Goals for Primary Biliary Cholangitis, an Australian Perspective.Journal of gastroenterology and hepatology · 2026
    Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. The treatment of primary biliary cholangitis: from shadow to light.Therapeutic advances in gastroenterology · 2024
    Review
  11. Pharmaceuticals (Basel, Switzerland) · 2023
    Review
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

4 authors at 2 institutions in 1 country.

Nidah Shabbir KhakooDepartment of Internal Medicine, University of Miami School of Medicine, Miami, FL, USA.
Shahnaz SultanDepartment of Gastroenterology and Hepatology, University of Minnesota and Minneapolis Veterans Affairs Medical Center, Minneapolis, MN, USA.
John M ReynoldsDepartment of Health Informatics, Calder Memorial Library, University of Miami Miller School of Medicine, Miami, FL, USA.
Cynthia LevyDivision of Digestive Health and Liver Diseases, University of Miami School of Medicine, 1500 NW 12th Avenue, Suite 1101, Miami, FL, 33136, USA. clevy@med.miami.edu.ORCID http://orcid.org/0000-0001-5498-6037
University of Miami · USUniversity of Minnesota Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBezafibrate (BZF) alone or in combination with ursodeoxycholic acid (UDCA) has been used to slow disease progression in patients with primary biliary cholangitis (PBC). We performed a systematic review and meta-analysis to assess the efficacy and harms of BZF monotherapy or combination therapy.

methodsWe performed a systematic search of PubMed, EMBASE, Cochrane Library, Scopus, ClinicalTrials.gov, and WHO ICTRP from inception until January 2020, for randomized controlled clinical trials assessing BZF + UDCA versus UDCA monotherapy or BZF monotherapy versus UDCA monotherapy in PBC patients. Additionally, we systematically evaluated data on harms using seven observational studies. Pooled effect estimates were calculated for the outcomes of interest. The certainty of evidence was assessed using GRADE (Grading of Recommendations Assessment, Development and Evaluation).

resultsWe identified 7 randomized controlled trials with a total of 279 participants. Comparing BZF + UDCA to UDCA alone, a clinically significant improvement was observed in serum ALP with a mean difference (MD) of - 159.04 U/L (95% CI - 186.45 to - 131.62) and a reduction in gamma-glutamyltransferase (GGT) (MD - 106.94 IU/L; 95% CI - 151.99 to - 61.89), but not in total bilirubin (TB) or IgM levels. A statistically significant reduction in ALP levels was also noticed with BZF monotherapy compared to UDCA monotherapy. The effect of BZF + UDCA versus UDCA on mortality remains unclear. Across 5 observational studies including 106 patients, one death was reported due to advanced liver disease in an incomplete responder getting treatment with BZF + UDCA. Analysis of observational studies demonstrated improvement in pruritus intensity with BZF.

conclusionsUse of BZF alone or in combination with UDCA improved liver biochemistries in patients with PBC, but its effect on mortality, liver-related complications or quality of life remains unknown.

Indexed as

Liver Cirrhosis, BiliaryUrsodeoxycholic AcidBezafibrateCholagogues and CholereticsDrug Therapy, CombinationHumansQuality of LifeBezafibrateCholagogues and CholereticsUrsodeoxycholic AcidBezafibrateMeta-analysisPrimary biliary cholangitisTreatmentUrsodeoxycholic acid

Identifiers

PMID36180756
OpenAlexW4298125372

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.