Berberis aristata/Silybum marianum fixed combination on lipid profile and insulin secretion in dyslipidemic patients. (November 2013)

• Record Type: Journal Article
• Authors: Derosa, Giuseppe; Bonaventura, Aldo; Bianchi, Lucio; Romano, Davide; D'Angelo, Angela; Fogari, Elena; Maffioli, Pamela
• Is Part Of: Expert opinion on biological therapy. Volume 13:Number 11(2013:Nov.)
• Page Start: 1495
• Page End: 1506
• Publication Date: 2013-11
• Subjects: Gene therapy -- Periodicals; Protein drugs -- Periodicals; Peptide drugs -- Periodicals; Immunotherapy -- Periodicals; Drug delivery systems -- Periodicals; 615.5
• DOI: 10.1517/14712598.2013.832751
• Languages: English
• ISSNs: 1471-2598

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p> <bold> <italic>Background:</italic> </bold> Relatively large number of dietary supplements and nutraceuticals have been studied for their supposed or demonstrated ability to reduce cholesterolemia in humans.</p> <p> <bold> <italic>Objectives:</italic> </bold> The aim of this study was to evaluate the efficacy as antihypercholesterolemic and insulin-sensitizing agent of a combination of <italic>Berberis aristata</italic>/<italic>Silybum marianum</italic> 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 <italic>Berberis aristata/Silybum marianum</italic> extract 588 mg/105 mg, twice a day for 3 months. <italic>Berberis aristata/Silybum marianum</italic> 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.</p> <p> <bold> <italic>Results:</italic> </bold> <italic>Berberis aristata/Silybum marianum</italic> 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 <italic>Berberis aristata/Silybum marianum</italic> 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 <italic>Berberis aristata/Silybum marianum</italic> compared to placebo, to baseline and to randomization were recorded. No patients had serious adverse events in both groups.</p> <p> <bold> <italic>Conclusion: </italic> </bold> <italic>Berberis aristata/Silybum marianum</italic> is effective and safe in improving lipid profile and insulin secretion in euglycemic dyslipidemic patients.</p> </abstract>