title: Berberis aristata/Silybum marianum fixed combination on lipid profile and insulin secretion in dyslipidemic patients.
abstract: BACKGROUND
  Relatively large number of dietary supplements and nutraceuticals have been studied for their supposed or demonstrated ability to reduce cholesterolemia in humans.
  
  
  OBJECTIVE
  The aim of this study was to evaluate the efficacy as antihypercholesterolemic and insulin-sensitizing agent of a combination of Berberis aristata/Silybum marianum extract (Berberol®) in a sample of dyslipidemic patients. A total of 102 dyslipidemic subjects were enrolled. After a 6 months run-in period of diet and physical activity, the patients were randomized to placebo or Berberis aristata/Silybum marianum extract 588 mg/105 mg, twice a day for 3 months. Berberis aristata/Silybum marianum and placebo were then interrupted for 2 months (washout period), and then restarted for further 3 months. Anthropometric and metabolic parameters were assessed; moreover, all patients underwent a glucagon stimulation test.
  
  
  RESULTS
  Berberis aristata/Silybum marianum reduced total cholesterol, triglycerides and low-density lipoprotein cholesterol and increased high-density lipoprotein cholesterol after 3 months from randomization and compared to placebo group. When Berberis aristata/Silybum marianum was interrupted, lipid profile worsened, and it improved again when nutraceutical combination was reintroduced. During the glucagon stimulation test, a higher increase of C-peptide levels and a lower increase in glycemia after the test with Berberis aristata/Silybum marianum compared to placebo, to baseline and to randomization were recorded. No patients had serious adverse events in both groups.
  
  
  CONCLUSIONS
  Berberis aristata/Silybum marianum is effective and safe in improving lipid profile and insulin secretion in euglycemic dyslipidemic patients.
authors: University of Pavia, Department of Internal Medicine and Therapeutics, Fondazione IRCCS Policlinico S. Matteo , P.le C. Golgi, 2 Pavia, 27100 , Italy +39 0382 526217 ; +39 0382 526259 ; giuseppe.derosa@unipv.it.
authors: Giuseppe
authors: G
authors: Derosa
authors: Aldo
authors: A
authors: Bonaventura
authors: Lucio
authors: L
authors: Bianchi
authors: Davide
authors: D
authors: Romano
authors: Angela
authors: A
authors: D'Angelo
authors: Elena
authors: E
authors: Fogari
authors: Pamela
authors: P
authors: Maffioli
mesh_terms: D000328:Adult; D000886:Anthropometry; D028142:Berberis; D001642:Bicycling; D001786:Blood Glucose / Q000032:analysis; D003131:Combined Modality Therapy; D004038:Diet, Reducing; D019587:Dietary Supplements; D004311:Double-Blind Method; D004338:Drug Combinations; D050171:Dyslipidemias / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy* / Q000503:physiopathology / Q000628:therapy; D005081:Exercise Therapy; D005260:Female; D005934:Glucagon; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007328:Insulin / Q000378:metabolism*; D000078790:Insulin Secretion; D008055:Lipids / Q000097:blood*; D008074:Lipoproteins / Q000097:blood; D008297:Male; D008875:Middle Aged; D020944:Silybum marianum; D050177:Overweight / Q000097:blood / Q000178:diet therapy / Q000628:therapy; D008517:Phytotherapy; D028321:Plant Preparations / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D004338:Drug Combinations; D000960:Hypolipidemic Agents; D007328:Insulin; D008055:Lipids; D008074:Lipoproteins; D028321:Plant Preparations; D005934:Glucagon