ORIGINAL ARTICLE   

Minerva Gastroenterology 2022 December;68(4):434-41

DOI: 10.23736/S2724-5985.22.03201-6

Copyright © 2022 EDIZIONI MINERVA MEDICA

language: English

Effects of Robuvit® on the progression of non-alcoholic fatty liver disease

Gianni BELCARO ¹ ✉, David M. COX ¹, M. Rosaria CESARONE ¹, Giuseppe GIZZI ¹, Luciano PELLEGRINI ¹, Claudia SCIPIONE ¹, Valeria SCIPIONE ¹, Mark DUGALL ¹, Shu HU ¹, Marcello CORSI ¹, Beatrice FERAGALLI ², Roberto COTELLESE ^{2, 3}

¹ Irvine3 Labs, San Valentino Vascular Screening Project and IA-PSS (International Agency for Pharma-Standard Supplements) Pescara, Italy; ² Dept.SMO-Biotec, Chieti University, Italy; ³ Outpatients Vascular Surgery, School of General Surgery, Ch-Pe University, Pescara, Italy

BACKGROUND: The aim of this study was to evaluate the effects of Robuvit^® in preventing the progression of chronic hepatitis (CH) in non-alcoholic fatty liver disease (NAFLD) which encompasses the entire spectrum of fatty liver disease, from isolated steatosis to non-alcoholic steatohepatitis (NASH).
METHODS: One group of patients followed the Standard management (SM) and were assigned as controls while the supplementation group followed the SM and additionally took 2 Robuvit® capsules daily for 3 months (200 mg/day).
RESULTS: 34 subjects with NAFLD were included in the study. The two groups completing 90 days were comparable at baseline with 18 being supplemented with Robuvit^® and 16 in the control group. The tolerability was very good, and no side effects were observed with the supplement. Fasting glucose levels were significantly lower after 3 months with Robuvit^® (P<0.05) compared to controls. The increased serum aspartate aminotransferase levels (AST), considered the key metabolic value in these patients, decreased significantly with Robuvit® (P<0.05) compared to controls. Serum alanine aminotransferase levels (ALT) also decreased significantly with the supplement compared to controls (P<0.05). Platelet count and albumin levels improved significantly with Robuvit® (P<0.05) in comparison to standard management. No other significant changes were observed. The APRI score (the AST/platelet ratio index) was also decreased with the supplementation compared to controls (P<0.05). A high APRI score provides an estimate of the possibility of the liver to develop fibrosis and eventually cirrhosis. After Robuvit® supplementation, the ultrasound characterization showed a significant decrease in the size of the liver in association with a lower echogenicity, which represents less fibrotic changes due to collagen accumulation.
CONCLUSIONS: Robuvit® improved liver function in NAFLD and prevented progression to liver fibrosis by improving hepatic metabolism in a relatively short period of time. Numerous people are affected by NAFLD, many of them with subclinical symptoms. But to date, there are no specific, definite treatment options. Prolonged evaluations of Robuvit® in a larger group of subjects is suggested.

KEY WORDS: Non-alcoholic fatty liver disease; Hepatitis, chronic; Robuvit®