title: Effects of Berberis aristata/Silybum marianum association on metabolic parameters and adipocytokines in overweight dyslipidemic patients.
abstract: Nutraceuticals and functional foods have attracted considerable interest as potential alternative therapies for treatment of different cardiovascular disorders and insulin resistance. We evaluated the efficacy of a combination of Berberis Aristata/Silybum Marianum extract (Berberol®) in a sample of overweight, dyslipidemic patients at low cardiovascular risk. We enrolled 105 Caucasian, euglycemic, overweight, dyslipidemic patients, of either sex. At baseline all patients underwent a 6 months run-in period during which they followed an adequate diet and practiced physical activity. At the end of the run-in period, patients were randomised to take placebo or a combination of Berberis aristata/Silybum marianum, 1 tablet during the lunch and 1 tablet during the dinner, for three months, in a double-blind, placebo-controlled design. Berberis aristata/Silybum marianum and placebo were then interrupted for 2 months (wash-out period), and all patients continued with only diet and physical activity. At the end of the wash-out period, patients re-started Berberis aristata/Silybum marianum or placebo twice a day for further 3 months. We evaluated during the run-in period, at randomisation, before and after the wash-out period these parameters: body weight and BMI, fasting plasma glucose, lipid profile, insulin resistance, retinol binding protein-4 (RBP-4), adiponectin (ADN), resistin. Total cholesterol, LDL-C, and Tg decreased, and HDL-C increase after 3 months of Berberis aristata/Silybum marianum, both compared to baseline and placebo. Berberis aristata/Silybum marianum decreased fasting plasma insulin, and HOMA-IR, both compared to baseline and to placebo. Moreover, there was a decrease of RBP-4, and resistin, and an increase of ADN after 3 months of Berberis aristata/Silybum marianum. All these positive effects disappeared after the wash-out period, and re-appeared after the re-introduction of the drug. We observed a significant correlation between HOMA-index decrease and resistin, and RBP-4 decrease, and between HOMA-index decrease and ADN increase in Berberis aristata/Silybum marianum group, but not in placebo group. Berberis aristata/Silybum marianum fixed combination seems to be safe and effective in improving lipid profile, but also in improving insulin resistance and adipocytokines levels.
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Derosa
authors.forename: A
authors.initials: A
authors.lastname: Bonaventura
authors.forename: L
authors.initials: L
authors.lastname: Bianchi
authors.forename: D
authors.initials: D
authors.lastname: Romano
authors.forename: A
authors.initials: A
authors.lastname: D' Angelo
authors.forename: E
authors.initials: E
authors.lastname: Fogari
authors.forename: P
authors.initials: P
authors.lastname: Maffioli
mesh_terms: D054392:Adipokines / Q000097:blood*; D000328:Adult; D028142:Berberis; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000097:blood / Q000188:drug therapy / Q000378:metabolism*; D005260:Female; D006801:Humans; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D020944:Silybum marianum; D050177:Overweight / Q000097:blood / Q000188:drug therapy / Q000378:metabolism*; D010936:Plant Extracts / Q000008:administration & dosage*
chemical_list: D054392:Adipokines; D010936:Plant Extracts