title: Pilot study on the additive effects of berberine and oral type 2 diabetes agents for patients with suboptimal glycemic control.
abstract: BACKGROUND
  Suboptimal glycemic control is a common situation in diabetes, regardless of the wide range of drugs available to reach glycemic targets. Basic research in diabetes is endeavoring to identify new actives working as insulin savers, use of which could delay the introduction of injectable insulin or reduce the insulin dose needed. Commonly available as a nutraceutical, berberine is a potential candidate.
  
  
  RESULTS
  Because its low oral bioavailability can be overcome by P-glycoprotein inhibitors like herbal polyphenols, we have tested the nutraceutical combination of Berberis aristata extract and Silybum marianum extract (Berberol(®)) in type 2 diabetes in terms of its additive effect when combined with a conventional oral regimen for patients with suboptimal glycemic control. After 90 days of treatment, the nutraceutical association had a positive effect on glycemic and lipid parameters, significantly reducing glycosylated hemoglobin, basal insulin, homeostatic model assessment of insulin resistance, total and low-density lipoprotein cholesterol, and triglycerides. A relevant effect was also observed in terms of liver function by measuring aspartate transaminase and alanine transaminase. The product had a good safety profile, with distinctive gastrointestinal side effects likely due to its acarbose-like action.
  
  
  CONCLUSIONS
  Although further studies should be carried out to confirm our data, Berberol could be considered a good candidate as an adjunctive treatment option in diabetes, especially in patients with suboptimal glycemic control.
authors.affiliation: Scientific Department, Velleja Research, Milano.
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Pierro
authors.forename: Nicola
authors.initials: N
authors.lastname: Villanova
authors.forename: Federica
authors.initials: F
authors.lastname: Agostini
authors.forename: Rebecca
authors.initials: R
authors.lastname: Marzocchi
authors.forename: Valentina
authors.initials: V
authors.lastname: Soverini
authors.forename: Giulio
authors.initials: G
authors.lastname: Marchesini