Evidence map›Paper›PMID 28419124›Full record

Trial reportPloS one2017

A randomised controlled trial of losartan as an anti-fibrotic agent in non-alcoholic steatohepatitis.

Stuart McPherson, Nina Wilkinson, Dina Tiniakos, Jennifer Wilkinson, Alastair D Burt, Elaine McColl, Deborah D Stocken, Nick Steen, Jane Barnes, Nicola Goudie and 5 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
3.6field-weighted citation impact, top 7% 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

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 53 citations in OpenAlex.

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  13. Treatments for NAFLD: State of Art.International journal of molecular sciences · 2021
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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

15 authors at 5 institutions in 4 countries.

Stuart McPhersonInstitute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.ORCID http://orcid.org/0000-0002-5638-2453
Nina WilkinsonInstitute of Health and Society, Faculty of Medical Sciences, Newcastle University, Newcastle-upon-Tyne, United Kingdom.
Dina TiniakosInstitute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.
Jennifer WilkinsonNewcastle Clinical Trials Unit, Faculty of Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.
Alastair D BurtFaculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.
Elaine McCollInstitute of Health and Society, Faculty of Medical Sciences, Newcastle University, Newcastle-upon-Tyne, United Kingdom.
Deborah D StockenInstitute of Health and Society, Faculty of Medical Sciences, Newcastle University, Newcastle-upon-Tyne, United Kingdom.
Nick SteenInstitute of Health and Society, Faculty of Medical Sciences, Newcastle University, Newcastle-upon-Tyne, United Kingdom.
Jane BarnesNewcastle Clinical Trials Unit, Faculty of Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.
Nicola GoudieNewcastle Clinical Trials Unit, Faculty of Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.
Stephen StewartDepartment of Gastroenterology, Mater Misericordiae University Hospital, Dublin, Ireland.
Yvonne BuryMedical School, National & Kapodistrian University of Athens, Athens, Greece.
Derek MannInstitute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.
Quentin M AnsteeInstitute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.
Christopher P DayInstitute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.
Newcastle University · GBFreeman Hospital · GBNational and Kapodistrian University of Athens · GRMater Misericordiae University Hospital · IEThe University of Adelaide · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNon-alcoholic fatty liver disease (NAFLD) is a common liver disease worldwide. Experimental and small clinical trials have demonstrated that angiotensin II blockers (ARB) may be anti-fibrotic in the liver. The aim of this randomised controlled trial was to assess whether treatment with Losartan for 96 weeks slowed, halted or reversed the progression of fibrosis in patients with non-alcoholic steatohepatitis (NASH).

methodsDouble-blind randomised-controlled trial of Losartan 50 mg once a day versus placebo for 96 weeks in patients with histological evidence of NASH. The primary outcome for the study was change in histological fibrosis stage from pre-treatment to end-of-treatment.

resultsThe study planned to recruit 214 patients. However, recruitment was slower than expected, and after 45 patients were randomised (median age 55; 56% male; 60% diabetic; median fibrosis stage 2), enrolment was suspended. Thirty-two patients (15 losartan and 17 placebo) completed follow up period: one patient (6.7%) treated with losartan and 4 patients (23.5%) in the placebo group were "responders" (lower fibrosis stage at follow up compared with baseline). The major reason for slow recruitment was that 39% of potentially eligible patients were already taking an ARB or angiotensin converting enzyme inhibitor (ACEI), and 15% were taking other prohibited medications.

conclusionsDue to the widespread use of ACEI and ARB in patients with NASH this trial failed to recruit sufficient patients to determine whether losartan has anti-fibrotic effects in the liver.

trial registrationISRCTN 57849521.

Indexed as

AdultAgedAngiotensin II Type 1 Receptor BlockersDouble-Blind MethodDrug Administration ScheduleFemaleFibrosisHumansLiverLiver CirrhosisLosartanMaleMiddle AgedNon-alcoholic Fatty Liver DiseaseTreatment OutcomeYoung AdultAngiotensin II Type 1 Receptor BlockersLosartan

Identifiers

PMID28419124
PMCPMC5395178
OpenAlexW2605795744

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.