title: Robuvit® (French oak wood extract) in the management of functional, temporary hepatic damage. A registry, pilot study.
abstract: OBJECTIVE
  The aim of this registry study was to evaluate the evolution of moderate functional hepatic failure (MTHF) using a proprietary new oak wood supplement (Robuvit®) extracted from Quercus Robur. Recent studies have indicated the protective effect of oak wood extracts on liver injury. Quercus wood extracts have shown hepatoprotective effect on initial induced liver-injury.
  
  
  METHODS
  This registry included a total of 75 patients with MTHF characterized by: decreased albumin levels; increased total bilirubin, altered hepatic functions enzymes, increased oxidative stress, negative viral hepatitis markers.
  
  
  RESULTS
  The two groups (best management in comparison with best management+ Robuvit®) were comparable: 32 Robuvit® patients and 29 comparable controls) completed the 12-week registry. At inclusion, the blood parameter values in the two groups were comparable. At the end of the supplementation period, the increase in albumin levels was significantly (P<0.05 at 12 weeks) faster and higher in the Robuvit® group. The decrease in ALT-SGPT and AST-ASAT was significant in the supplement group (P<0.05 at 4 and 12 weeks); the tests were normalized at 4 and 12 weeks. Controls remained out of the normal range for more than 12 weeks. Alkaline phosphatase was normalized at 4 and 12 weeks in Robuvit® patients; they were decreased, but not normalized in controls at 4 weeks (Robuvit® group's values were significantly better; P<0.05). Values were normalized in controls (significantly higher in comparison with Robuvit®; P<0.05) at 12 weeks. Total bilirubin was normalized in Robuvit® subjects at 4 and 12 weeks. Results were significantly better in comparison with controls (P<0.05). Direct bilirubin values increased more in the Robuvit® group at 4 and 12 weeks (P<0.05). Gamma GT values were normalized at 4 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 increased at inclusion showed a significant decrease in Robuvit® subject (at 4 and 12 weeks) with normalization at 12 weeks. Persisting, elevated values in controls were observed even at 12 weeks (P<0.05). ESR and CRP decreased in both groups with a more important decrease in the Robuvit® group (P<0.05). Hepatitis markers were negative when repeated at 4 and 12 weeks.
  
  
  CONCLUSIONS
  Data from this pilot, supplement registry study indicate a significant protective activity of Robuvit®, associated with a very good safety profile, in patients with temporary hepatic failure. The activity of Robuvit® seems to be mediated by its anti-inflammatory activity.
authors.affiliation: Department of Biomedical Sciences, Irvine3 Labs, Chieti-Pescara University, Spoltore, Pescara, Italy - cardres@abol.it.
authors.forename: G
authors.initials: G
authors.lastname: Belcaro
authors.forename: G
authors.initials: G
authors.lastname: Gizzi
authors.forename: S
authors.initials: S
authors.lastname: Hu
authors.forename: M
authors.initials: M
authors.lastname: Dugall
authors.forename: L
authors.initials: L
authors.lastname: Pellegrini
authors.forename: U
authors.initials: U
authors.lastname: Cornelli
authors.forename: M R
authors.initials: MR
authors.lastname: Cesarone
authors.forename: M
authors.initials: M
authors.lastname: Trignani
authors.forename: C
authors.initials: C
authors.lastname: Maione
mesh_terms: D000328:Adult; D001663:Bilirubin / Q000097:blood; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D047348:Hydrolyzable Tannins / Q000627:therapeutic use*; D017093:Liver Failure / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D018384:Oxidative Stress; D008517:Phytotherapy / Q000379:methods*; D010865:Pilot Projects; D010936:Plant Extracts / Q000627:therapeutic use*; D029963:Quercus / Q000737:chemistry*; D012042:Registries; D012709:Serum Albumin / Q000378:metabolism
chemical_list: D047348:Hydrolyzable Tannins; D010936:Plant Extracts; C588251:Robuvit; D012709:Serum Albumin; D001663:Bilirubin