Evidence map›Paper›PMID 32882428›Full record

SynthesisClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2021

Change in MRI-PDFF and Histologic Response in Patients With Nonalcoholic Steatohepatitis: A Systematic Review and Meta-Analysis.

Jonathan G Stine, Nagambika Munaganuru, Abbey Barnard, Jennifer L Wang, Kellee Kaulback, Curtis K Argo, Siddarth Singh, Kathryn J Fowler, Claude B Sirlin, Rohit Loomba

2 registry-linked trialsOpen access · bronzeAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 144 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
144citing papers in PubMed, 10 pooled it
14.8field-weighted citation impact, top 1% 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.

NCT06334666 naenrolling by invitationnot on this mapstarted 2024, after this paper: background citation

The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With Metabolic-associated Steatotic Liver Disease: a Randomized-controlled Trial

TypeinterventionalSponsorMahidol UniversityRan2024 to 2026Enrolled86ConditionsDaily Step Count, MASLD, BMI, Metabolic SyndromeArmsEncourage using pedometer
NCT06826807 naenrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Hepatic Elastography-Enhanced Lifestyle Modification in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Controlled Trial

TypeinterventionalSponsorMahidol UniversityRan2025 to 2027Enrolled92ConditionsTransient Elastography, MASLD, BMI, Metabolic SyndromeArmsRegular monitoring with transient elastography
3 · Its place in the literature

Who cites it

144 citing papers in PubMed, 10 syntheses or guidelines pooled it, 250 citations in OpenAlex.

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  17. Exercise training improves serum biomarkers of liver fibroinflammation in patients with metabolic dysfunction-associated steatohepatitis.Liver international : official journal of the International Association for the Study of the Liver · 2024
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84 more citing papers are in PubMed but not listed here.

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

10 authors at 5 institutions in 1 country.

Jonathan G StineDivision of Gastroenterology and Hepatology, Department of Medicine, Milton S. Hershey Medical Center, Pennsylvania State University College of Medicine, Hershey, Pennsylvania; Department of Public Health Sciences, Milton S. Hershey Medical Center, Pennsylvania State University College of Medicine, Hershey, Pennsylvania; Liver Center, Milton S. Hershey Medical Center, Pennsylvania State University College of Medicine, Hershey, Pennsylvania; Cancer Institute, Milton S. Hershey Medical Center, Pennsylvania State University College of Medicine, Hershey, Pennsylvania.
Nagambika MunaganuruDepartment of Medicine, University of California, San Diego, La Jolla, California.
Abbey BarnardDivision of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego, La Jolla, California.
Jennifer L WangDivision of Gastroenterology and Hepatology, Department of Medicine, University of Chicago, Chicago, Illinois.
Kellee KaulbackPenn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.
Curtis K ArgoDivision of Gastroenterology and Hepatology, Department of Medicine, University of Virginia, Charlottesville, Virginia.
Siddarth SinghDivision of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego, La Jolla, California.
Kathryn J FowlerLiver Imaging Group, Department of Radiology, University of California, San Diego, La Jolla, California.
Claude B SirlinLiver Imaging Group, Department of Radiology, University of California, San Diego, La Jolla, California.
Rohit LoombaDivision of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego, La Jolla, California; Division of Epidemiology, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California; NAFLD Research Center, University of California, San Diego, La Jolla, California. Electronic address: roloomba@ucsd.edu.
University of California San Diego · USPenn State Milton S. Hershey Medical Center · USPennsylvania State University · USUniversity of Chicago · USUniversity of Virginia · US

Funding

Yeast Genetics and Stress Response Genes-BiomedicalP42ES010337 · NIEHS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TUKEY, ROBERT H · 2000 to 2022
$69.8M
Pediatric Trials in Non-Alcoholic Steatohepatitis (NASH)U01DK061734 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI ROHIT LOOMBA · 2002 to 2026
$24.4M
San Diego Digestive Diseases Research CenterP30DK120515 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Bernd G. Schnabl · 2019 to 2026
$10.8M
HIV MASLD Clinical Research Network (HCRN)R01DK121378 · NIDDK · INDIANA UNIVERSITY INDIANAPOLIS · PI NAGA P CHALASANI, ROHIT LOOMBA · 2020 to 2026
$8.7M
Inactivation of Hepatic Stellate Cells During Reversal of Liver FibrosisR01DK099205 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BRENNER, DAVID A., KISSELEVA, TATIANA · 2014 to 2025
$4.8M
The Role of Portal Fibroblasts in Cholestatic Liver FibrosisR01DK101737 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KISSELEVA, TATIANA · 2014 to 2025
$3.8M
Novel IL-23 inhibitor for the treatment of alcohol associated liver diseaseU01AA029019 · NIAAA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KISSELEVA, TATIANA, LOOMBA, ROHIT · 2020 to 2024
$3.7M
Epigenetic Regulation of Alcoholic Liver FibrosisU01AA018663 · NIAAA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI KISSELEVA, TATIANA, MANN, DEREK · 2010 to 2019
$3.7M
QUS Technology for Diagnosis and Grading of Hepatic Steatosis in NAFLDR01DK106419 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LOOMBA, ROHIT, SIRLIN, CLAUDE B · 2015 to 2019
$3.4M
The role of IL-17 signaling in alcohol-induced HCCR01AA028550 · NIAAA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BRENNER, DAVID A., KISSELEVA, TATIANA · 2021 to 2025
$2.3M
The Role of IL-17 in Alcoholic Liver Disease and CancerU01AA022614 · NIAAA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KARIN, MICHAEL, KISSELEVA, TATIANA · 2014 to 2018
$1.8M
Non-invasive screening of diabetics for advanced fibrosis due to NAFLDR01DK124318 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LOOMBA, ROHIT · 2020 to 2022
$1.7M
NIAAA NIH HHS R01 AA028550NIAAA NIH HHS U01 AA018663NIAAA NIH HHS U01 AA022614NIAAA NIH HHS U01 AA029019NIDDK NIH HHS L30 DK118601NIDDK NIH HHS P30 DK120515NIDDK NIH HHS R01 DK099205NIDDK NIH HHS R01 DK101737NIDDK NIH HHS R01 DK106419NIDDK NIH HHS R01 DK111866NIDDK NIH HHS R01 DK121378NIDDK NIH HHS R01 DK124318NIDDK NIH HHS R56 DK088837NIDDK NIH HHS U01 DK061734NIEHS NIH HHS P42 ES010337
6 · The paper itself

Abstract

BACKGROUND &

aimsMagnetic resonance imaging proton density fat fraction (MRI-PDFF) offers promise as a non-invasive biomarker of treatment response in early-phase nonalcoholic steatohepatitis (NASH) trials. We performed a systematic review to quantify the association between a ≥ 30% reduction in MRI-PDFF and histologic response in NASH.

methodsWe searched the Cochrane Library, Embase, Medline and trial registries through May 2020 for early-phase clinical trials that incorporated MRI-PDFF and examined histologic response following intervention in adults with NASH. Subjects were classified as MRI-PDFF responders (relative decline in liver fat ≥30%) or non-responders (relative decline in liver fat <30%). MRI-PDFF responders versus non-responders were compared. Primary outcome was histologic response defined as a 2-point improvement in NAFLD Activity Score with at least 1-point improvement in lobular inflammation or ballooning. Secondary outcome was NASH resolution. Proportions and random effects odds ratios (OR) with corresponding 95% confidence intervals (CI) were calculated.

resultsSeven studies met inclusion criteria, comprising 346 subjects (median age 51 years; 59% female; 46% with diabetes). MRI-PDFF responders were significantly more likely to have a histologic response (51% vs 14%, P < .001; OR 6.98, 95% CI 2.38-20.43, P < .001) and NASH resolution (41% vs 7%, P < .001; OR 5.45, 95% CI 1.53-19.46, P = .009) compared to non-responders.

conclusionsThis meta-analysis demonstrates that a ≥30% relative decline in MRI-PDFF is associated with higher odds of histologic response and NASH resolution. These results support the use of MRI-PDFF in non-invasive monitoring of treatment response in early-phase NASH clinical trials and provide helpful data for sample-size estimation for histology-based assessment.

Indexed as

Non-alcoholic Fatty Liver DiseaseAdultBiomarkersFemaleHumansLiverMagnetic Resonance ImagingMaleMiddle AgedProtonsBiomarkersProtonsClinical TrialHistologyLiver BiopsySteatohepatitisSteatosis

Identifiers

PMID32882428
PMCPMC7914285
OpenAlexW3082261340

What OpenQuestion holds

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Read underepoch 390

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.