Evidence map›Paper›PMID 41625336›Full record

ArticleFrontiers in pharmacology2025

Economic value and clinical association of a supervised lifestyle-improving program for MASLD.

Maurizio Polignano, Antonella Bianco, Davide Guido, Pietro Trisolini, Isabella Franco, Caterina Bonfiglio, Gianluigi Giannelli

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06026293 (Retrospective and Prospective Study Aimed At the Pharmacoeconomic Evaluation of the Cost/effectiveness Ratio of Physical Exercise on the Prognosis of Non-alcoholic Fatty Liver Disease), which is not on this map. Not yet cited in PubMed.

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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.

NCT06026293 completednot on this map

Retrospective and Prospective Study Aimed At the Pharmacoeconomic Evaluation of the Cost/effectiveness Ratio of Physical Exercise on the Prognosis of Non-alcoholic Fatty Liver Disease (NAFLD)

TypeobservationalSponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisRan2023 to 2024Enrolled58ConditionsNon-Alcoholic Fatty Liver Disease
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Maurizio PolignanoClinical Trial Unit - National Institute of Gastroenterology - I.R.C.C.S "Saverio de Bellis", Castellana Grotte, Italy.
Antonella Bianco *Laboratory of Movement & Wellness - National Institute of Gastroenterology - I.R.C.C.S "Saverio de Bellis", Castellana Grotte, Italy.
Davide GuidoUOS Data Science, National Institute of Gastroenterology - I.R.C.C.S "Saverio de Bellis", Castellana Grotte, Italy.
Pietro TrisoliniHospital Pharmacy, National Institute of Gastroenterology - I.R.C.C.S "Saverio de Bellis", Castellana Grotte, Italy.
Isabella FrancoLaboratory of Movement & Wellness - National Institute of Gastroenterology - I.R.C.C.S "Saverio de Bellis", Castellana Grotte, Italy.
Caterina BonfiglioUOS Data Science, National Institute of Gastroenterology - I.R.C.C.S "Saverio de Bellis", Castellana Grotte, Italy.
Gianluigi GiannelliScientific Direction, National Institute of Gastroenterology - I.R.C.C.S "Saverio de Bellis", Castellana Grotte, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) is both common and, in some cases, a progressive condition. Emerging pharmacological options have shown promise in select patient sub-groups (e.g., resmetirom for MASH with fibrosis; GLP-1 receptor agonists for obesity/diabetes with metabolic benefits), but structured lifestyle programs remain foundational in routine care. Objective: This study evaluates the cost-utility analysis of a multidisciplinary, kinesiology-supervised lifestyle-improving program for patients with MASLD, supported by clinical evidence. Methods: We analyzed 27 adults with MASLD, a cohort established from an initial group of 43 subjects, who participated in a structured program of supervised exercise and dietary counseling. Health-related quality of life (SF-36 mapped to EQ-5D) and associated clinical markers, including hepatic steatosis (ultrasound), blood pressure, and serum aminotransferases, were evaluated at baseline and after the program. A cost-utility analysis was conducted from the healthcare system's perspective, estimating the incremental cost-effectiveness ratios (ICERs and €/QALY) with deterministic and probabilistic sensitivity analyses. Pharmaceutical expenditures and projected disease progression costs were also explored using administrative data and literature-based models. Results: Health-related quality of life improved after the program, with a quality-adjusted life year (QALY) gain of 0.081 (95% CI: 0.001-0.161). The base-case ICER was €17,778/QALY. The probability of cost-effectiveness was 71% at €25,000/QALY, 84% at €30,000/QALY, and 95% at €40,000/QALY. Ultrasound steatosis showed a distributional shift toward lower grades with an unchanged median (Wilcoxon p = 0.007). Systolic/diastolic blood pressure decreased by -5.6/-3.7 mmHg (p = 0.05 and p = 0.03), and AST/ALT declined (both p < 0.01). At the 2-year follow-up, 55.6% of patients reported maintaining regular physical activity. Outpatient pharmaceutical expenditures showed a decline from €74 to €50 per patient/year between 2018 and 2021, with reduced variability across patients. However, this trend did not reach statistical significance in mixed-effects analyses (p = 0.06). Conclusion: In this pre-post observational study, the supervised program was associated with favorable cost-utility outcomes and distributional improvements in selected clinical markers. These findings support the program's potential value in routine care and warrant confirmation in controlled studies. Clinical Trial Registration: https://clinicaltrials.gov/expert-search?term, identifier NCT06026293.

Indexed as

cost–utility analysislifestyle programmetabolic dysfunction-associated steatotic liver diseasequality of lifesupervised exercise

Identifiers

PMID41625336
PMCPMC12856267

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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.