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Indexed/Abstracted in: CAB, EMBASE, PubMed/MEDLINE, Scopus, Emerging Sources Citation Index
Online ISSN 1827-1642
Luciano PELLEGRINI 1, 2, Gianni BELCARO 1, 2, Mark DUGALL 1, 2, Marcello CORSI 1, 2, Roberta LUZZI 1, 2, Masayuki HOSOI 1, 2
1 Irvine3 Labs, Chieti, Italy; 2 Department of Medical and Biotechnological Sciences, D’Annunzio University, Pescara, Italy
BACKGROUND: The aim of this registry study was to evaluate Robuvit® (French oak wood extract) supplementation in the evolution of moderate functional hepatic failure (MTHF) due to alcohol. Recent studies have indicated the protective effect of oak wood (QR) extracts on liver injury. This registry included patients with MTHF characterized by: decreased albumin levels; increased total bilirubin, altered hepatic functions enzymes, increased oxidative stress, negative viral hepatitis markers.
METHODS: The two groups resulted divided into a best management (BM) group and a comparative group (BM + Robuvit®): 23 Robuvit® patients and 21 comparable controls completed the 12-week registry. At inclusion, blood parameters in the two groups were comparable.
RESULTS: During the observation period, the increase in albumin levels was significantly (P<0.05 at 6 weeks) faster and higher in the Robuvit® group in comparison with controls. The decrease in ALT-SGPT and AST-ASAT were significantly more important in the supplement group (P<0.05 at 6 and 12 weeks). Alkaline phosphatase was significantly lower at 6 and 12 weeks in Robuvit® patients; (Robuvit® group’s values were significantly better; P<0.05). Total bilirubin improved more in Robuvit® subjects at 6 weeks. Results were statistically significant in comparison with controls (P<0.05). Also, direct bilirubin values were higher in the Robuvit® group at 6 and 12 weeks (P<0.05). Gamma GT values were normalized at 6 and 12 weeks in the Robuvit® group. There was a less important decrease in controls (P<0.05) without normalization at 12 weeks. Plasma free radicals, high at inclusion, showed a more significant decrease in Robuvit® subjects (at 6 and 12 weeks), with normalization at 12 weeks. Persisting high values in controls were observed even at 12 weeks (P<0.05). Erythrocytes sedimentation rate (ESR) decreased in both groups with a more important decrease in the Robuvit® group (P<0.05). Hepatitis markers were negative when repeated at 6 and 12 weeks.
CONCLUSIONS: In conclusion, observations from this pilot, supplement registry study indicate a significant protective activity of the supplementation with Robuvit®, associated with a very good safety profile, in patients with temporary alcoholic hepatic failure. The activity of Robuvit® seems to be mediated by its anti-inflammatory activity associated to its important action on oxidative stress.