Evidence map›Paper›PMID 28535810›Full record

Trial reportTrials2017

Fibrates for the treatment of cholestatic itch (FITCH): study protocol for a randomized controlled trial.

Ruth Bolier, Elsemieke S de Vries, Albert Parés, Jeltje Helder, E Marleen Kemper, Koos Zwinderman, Ronald P Oude Elferink, Ulrich Beuers, Netherlands Association for the Study of the Liver (NASL) Cholestatic Liver Diseases Study Group

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02701166 (The Effect of Bezafibrate on Cholestatic Itch), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
2.5field-weighted citation impact, top 11% 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.

NCT02701166 phase3unknown statusnot on this map

The Effect of Bezafibrate on Cholestatic Itch

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2016 to 2018Enrolled84ConditionsPrimary Biliary Cholangitis, Primary Sclerosing Cholangitis, Secondary Sclerosing CholangitisArmsBezafibrate, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Cholestatic pruritus: Emerging mechanisms and therapeutics.Journal of the American Academy of Dermatology · 2019
    Pooled it
  3. [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
    Pooled it
  4. Treatment Goals for Primary Biliary Cholangitis, an Australian Perspective.Journal of gastroenterology and hepatology · 2026
    Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Current understanding of primary biliary cholangitis.Clinical and molecular hepatology · 2021
    Review
  10. The Simple Cholestatic Complaints Score is a valid and quick patient-reported outcome measure in primary sclerosing cholangitis.Liver international : official journal of the International Association for the Study of the Liver · 2020
    Article
  11. Review
  12. Review
  13. 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

9 authors at 2 institutions in 2 countries.

Ruth BolierTytgat Institute for Liver and Intestinal Research, Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. a.r.bolier@amc.uva.nl.ORCID 0000-0002-3039-0594
Elsemieke S de VriesTytgat Institute for Liver and Intestinal Research, Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Albert ParésLiver Unit, Hospital Clínic, IDIBAPS, CIBERehd, Department of Medicine, University of Barcelona, Barcelona, Spain.
Jeltje HelderTytgat Institute for Liver and Intestinal Research, Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
E Marleen KemperDepartment of pharmacy, Academic Medical Center, Amsterdam, The Netherlands.
Koos ZwindermanDepartment of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, Amsterdam, The Netherlands.
Ronald P Oude ElferinkTytgat Institute for Liver and Intestinal Research, Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Ulrich BeuersTytgat Institute for Liver and Intestinal Research, Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Netherlands Association for the Study of the Liver (NASL) Cholestatic Liver Diseases Study Group
Amsterdam UMC Location University of Amsterdam · NLHospital Clínic de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPruritus (itch) is a frequent, burdensome and difficult-to-treat symptom in patients with cholestasis. Fibrates are currently under investigation for the treatment of primary biliary cholangitis in patients with a suboptimal response to ursodeoxycholic acid. Moreover, there is empirical evidence for a possible antipruritic effect. We aim to prove this in a randomized controlled trial, including patients with cholestatic liver diseases other than primary biliary cholangitis that are accompanied by pruritus.

methodsA multicenter investigator-initiated, double-blind, randomized placebo-controlled trial to evaluate the effect of bezafibrate on cholestatic pruritus in 84 adult patients with primary biliary cholangitis or primary/secondary sclerosing cholangitis. Primary outcome is the proportion of patients with a reduction of itch intensity of 50% or more (measured on a Visual Analog Scale) after 21 days of treatment with bezafibrate 400 mg qid or placebo. Secondary outcomes include the effect of bezafibrate on a five-dimensional itch score, liver disease-specific quality of life, serum liver tests and autotaxin activity. Safety will be evaluated through serum parameters for kidney function and rhabdomyolysis as well as precise recording of (serious) adverse events. We provide a schematic overview of the study protocol and describe the methods used to recruit and randomize patients, collect and handle data and perform statistical analyses. DISCUSSION: Given its favorable safety profile and anticholestatic properties, bezafibrate may become the new first-line treatment option for treating cholestatic pruritus.

trial registrationNetherlands Trial Register, ID: NCT02701166 . Registered on 2 March 2016; Netherlands Trial Register, ID: NTR5436 . Registered on 3 August 2015.

Indexed as

AntipruriticsBezafibrateCholangitis, SclerosingClinical ProtocolsDouble-Blind MethodHumansLiver Cirrhosis, BiliaryNetherlandsPruritusResearch DesignSpainTime FactorsTreatment OutcomeAntipruriticsBezafibrateBezafibrateItchPrimary biliary cholangitisPrimary sclerosing cholangitisPruritusSecondary sclerosing cholangitis

Identifiers

PMID28535810
PMCPMC5442649
OpenAlexW2619280077

What OpenQuestion holds

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Registered trials

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.