Journal of Nutraceuticals and Food Science

Effects of Nutraceutical Epatrex on Hamaguchi Score in Subjects with Non-Alcoholic Fatty Liver Disease: A Statistical Modeling Analysis

Background: Epatrex is a nutraceutical compound for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD). It is formulated as a three-layer tablet containing Lactobacillus casei (LC-XCAL), silymarin/silybin and chromium picolinate. The safety and efficacy of Epatrex vs. placebo have already been investigated in the REVEAL clinical trial. The results of the REVEAL study clearly demonstrated that the investigated nutraceutical was safe. Nevertheless, no clear differences of Epatrex over placebo with respect to blood markers of hepatic inflammation could be detected, suggesting that alternative biomarkers might be evaluated for a more comprehensive understanding of Epatrex’s effects. To date, Epatrex effects have not been evaluated in relation to Ultrasound (US) imaging-based biomarkers, such as the score introduced by Hamaguchi for the assessment of liver steatosis.

Objectives: In the present study, we used the REVEAL study data to conduct statistical analyses. Assuming that the Hamaguchi score might be more sensitive than blood markers in detecting changes in liver steatosis, the objectives of our analyses were to i) assess Epatrex effects on the Hamaguchi score endpoint and ii) investigate the impact of study design as well as patient-speci ic characteristics known to potentially affect placebo response. The results of these analyses indicate that the Hamaguchi score is sensitive to treatment period, alcohol consumption and patient waist circumference.

Conclusions: Our indings provide insights on how to improve clinical trial design and represent a irst step toward a mechanistic understanding of Epatrex effects.

Author(s): Alessia Baretta1*, Chiara Nicolo1, Stefania Murzilli2, Arianna Vanelli2* and Roberta Bursi3

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