Evidence map›Paper›PMID 39744921›Full record

Trial reportAlimentary pharmacology & therapeutics2025

Lubiprostone Reduces Fat Content on MRI-PDFF in Patients With MASLD: A 48-Week Randomised Controlled Trial.

Mohamed El-Kassas, Hala Mostafa, Wessam Abdellatif, Sohier Shoman, Gamal Esmat, Mayur Brahmania, Hongqun Liu, Samuel S Lee

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05768334 (Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT05768334 phase3completednot on this map

Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease

TypeinterventionalSponsorHelwan UniversityRan2020 to 2023Enrolled116ConditionsNAFLDArmsLubiprostone 24Mcg Oral twice daily
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

8 authors.

Mohamed El-KassasEndemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.
Hala MostafaEndemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.
Wessam AbdellatifRadiology Department, National Hepatology & Tropical Medicine Research Institute (NHTMRI), Cairo, Egypt.
Sohier ShomanGastroenterology and Hepatology Department, National Hepatology & Tropical Medicine Research Institute (NHTMRI), Cairo, Egypt.
Gamal EsmatHepatology and Endemic Medicine Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
Mayur BrahmaniaLiver Unit, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.ORCID https://orcid.org/0000-0002-4671-1479
Hongqun LiuLiver Unit, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.ORCID https://orcid.org/0000-0002-6805-5177
Samuel S LeeLiver Unit, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.ORCID https://orcid.org/0000-0003-4431-272X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsThe laxative lubiprostone has been shown to decrease intestinal permeability. We aimed to assess the safety and efficacy of lubiprostone administered for 48 weeks in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). APPROACH AND

resultsA randomised placebo-controlled trial was conducted in a specialised MASLD outpatient clinic at the National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt. The recruited patients had radiological evidence of MASLD along with other criteria for diagnosis. Eligible patients were randomly assigned to receive either placebo or lubiprostone 24 μg orally twice daily for 48 weeks. The liver fat content was quantified by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF). Between November 2020 and February 2023, 176 patients were screened, of whom 116 were eligible. Fifty-nine patients were randomised to receive placebo, while 57 patients were randomised to receive lubiprostone. Due mostly to patient dropout (i.e., loss to follow-up), complete data were available for 40 patients in each group. Compared with placebo group, 48-week lubiprostone treatment significantly reduced fat quantity (p = 0.04). Despite a significant reduction in body weight in the control group, no significant difference was found between both groups regarding fibrosis score by transient elastography or in serum ALT levels. One patient in the lubiprostone group developed severe diarrhoea requiring treatment stoppage. No other serious adverse events occurred.

conclusionLubiprostone was well tolerated and reduced liver fat content as measured by MRI-PDFF in patients with MASLD over 48 weeks. Lubiprostone appears promising to treat MASLD and warrants more extensive studies to confirm such efficacy.

trial registrationClinicalTrials.gov identifier: NCT05768334.

Indexed as

Fatty LiverLaxativesLubiprostoneAdultDouble-Blind MethodFemaleHumansLiverMagnetic Resonance ImagingMaleMiddle AgedTreatment OutcomeLaxativesLubiprostonelubiprostonemagnetic resonance imaging estimated proton density fat fractionmetabolic dysfunction‐associated steatotic liver diseaserandomised placebo‐controlled trial

Identifiers

PMID39744921
PMCPMC11754939

What Socratic 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 Socratic graph.