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Clinical Trial
. 2025 Jun 6;26(12):5427.
doi: 10.3390/ijms26125427.

Therapeutic Efficacy of Silymarin, Vitamin E, and Essential Phospholipid Combination Therapy on Hepatic Steatosis, Fibrosis, and Metabolic Parameters in MASLD Patients: A Prospective Clinical Study

Dan-Ionuț Gheonea  1 , Cristina Tocia  2   3 , Victor-Mihai Sacerdoțianu  1 , Alexandra-Georgiana Bocioagă  1   4 , Irina-Paula Doica  1   4 , Nicolae Cătălin Manea  5 , Adina Turcu-Știolică  6 , Carmen-Nicoleta Oancea  4 , Eugen Dumitru  2   3   7   8
Affiliations
Clinical Trial

Therapeutic Efficacy of Silymarin, Vitamin E, and Essential Phospholipid Combination Therapy on Hepatic Steatosis, Fibrosis, and Metabolic Parameters in MASLD Patients: A Prospective Clinical Study

Dan-Ionuț Gheonea et al. Int J Mol Sci. .

Abstract

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most prevalent chronic liver disease globally, and current estimates indicate an increase in incidence and prevalence in the general population. The design of the prospective study was to evaluate the response of patients with MASLD to an original formula consisting of silymarin, vitamin E, and essential phospholipids. In total, 200 patients were initially enrolled in the study and a total of 190 who participated in all four visits were included in our analysis. During the visits, liver function tests, lipid profiles, blood glucose level, fibrosis, and steatosis values and grades were assessed. From baseline, visit 0, to month 6th, visit III, a statistically significant difference (p-value < 0.0001) was observed in the reduction in ALT, AST, GGT, ALP, TG, total cholesterol, and blood glucose levels. There was a significant decrease in the fibrosis value from the first visit to the last visit (p = 0.002). Even though administered separately, silymarin, essential phospholipids, and vitamin E have established their efficacy in MASLD, this study demonstrates that their combination produces an indubitable effect on liver steatosis, even in a short cure of 6 months, and it can be proposed due to it having no adverse effects on patients with MASLD.

Keywords: MASLD; VCTE; silymarin.

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Conflict of interest statement

The authors declare no conflicts of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Flowchart of the patients included in the study.
Figure 2
Figure 2
A reduction in BMI was observed after 6 months of treatment (BMI1, visit I vs. BMI3, visit III). ****, p < 0.0001.
Figure 3
Figure 3
Reduction in ALT was observed after 6 months of treatment (ALT1, visit I vs. ALT3, visit III). ****, p < 0.0001.
Figure 4
Figure 4
Reduction in AST was observed after 6 months of treatment (AST1, visit I vs. AST3, visit III). ****, p < 0.0001.
Figure 5
Figure 5
Reduction in GGT was observed after 6 months of treatment (GGT1, visit I vs. GGT3, visit III). ****, p < 0.0001.
Figure 6
Figure 6
Reduction in ALP was observed after 6 months of treatment (ALP1, visit I vs. ALP3, visit III). *, p < 0.05.
Figure 7
Figure 7
A reduction in TG was observed after 6 months of treatment (TG1, visit I vs. TG3, visit III). ****, p < 0.0001.
Figure 8
Figure 8
A reduction in TC was observed after 6 months of treatment (TC1, visit I vs. TC3, visit III). ****, p < 0.0001.
Figure 9
Figure 9
Reduction in blood glucose (BG) was observed after 6 months of treatment (BG1, visit I vs. BG3, visit III). ****, p < 0.0001.
Figure 10
Figure 10
Evolution of fibrosis—VCTE_LSM values from visit I (VCTE_LSM1) to visit III (VCTE_LSM3). The dashed lines represent individual patient trajectories, showing how each patient’s VCTE_LSM value changed over time. The arrow emphasizes the magnitude of the decrease in stiffness (the mean), suggesting an improvement in liver fibrosis over the course of the study.
Figure 11
Figure 11
Evolution of steatosis—VCTE_CAP values from visit I (CAP1) to visit III (CAP3). The dashed lines represent individual patient trajectories, showing how each patient’s CAP value changed over time. The arrow emphasizes the magnitude of the decrease in steatosis levels (the mean), suggesting an improvement in liver steatosis over the course of the study. It directly visualizes whether the change was significant and in which direction.
Figure 12
Figure 12
Alluvial diagram to connect fibrosis improvement with steatosis improvement. 1/2/3 = one-/two-/three-stage improvement, 0 = no change in steatosis/fibrosis stage, −1/−2 = worsening by one stage/two stages.
Figure 13
Figure 13
Partial correlation plot. The circles indicate Spearman’s rho coefficient (white color indicates a positive correlation, black color indicates a negative correlation, dimension of the circle indicates the magnitude of the correlation). diffLSM, the difference between liver stiffness measurement (LSM) in visit III and visit I; diffCAP, the difference between controlled attenuation parameter (CAP) in visit III and visit I.
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