title: Berberis aristata/Silybum marianum fixed combination (Berberol(®)) effects on lipid profile in dyslipidemic patients intolerant to statins at high dosages: a randomized, placebo-controlled, clinical trial.
abstract: OBJECTIVE
  to evaluate the efficacy of Berberis aristata/Silybum marianum (Berberol(®)) in a sample of dyslipidemic patients intolerant to statins at high dosages in a randomized, double blind, placebo-controlled clinical trial.
  
  
  METHODS
  we enrolled 175 euglycemic, dyslipidemic subjects, intolerant to statins at high dosages. During the run-in period, statins were stopped for 1 month, then they were re-introduced at the half of the previously taken dose. After that, patients were randomized to placebo or Berberol(®), 1 tablet during the lunch and 1 tablet during the dinner, for 6 months. Anthropometric, metabolic and inflammatory parameters were assessed at randomization, at 3 and 6 months.
  
  
  RESULTS
  fasting plasma glucose, insulin, and HOMA-index levels were reduced by Berberol(®), but not by placebo; moreover they were lower than the ones recorded with placebo. Total cholesterol, LDL-C, triglycerides, and myeloperoxidase did not change after 6 months since the reduction of statin dosage and the introduction of Berberol(®), while they increased in the placebo group, and were higher compared to the ones obtained with active treatment. No patients had serious adverse events in both groups.
  
  
  CONCLUSIONS
  our study displays the rationale of the combination of Berberol(®) and a reduced dosage of statin for the treatment of hyperlipidemia in patients intolerant to statins at high dosage.
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy ; Center for the Study of Endocrine-Metabolic Pathophysiology and Clinical Research, University of Pavia, Pavia, Italy . Electronic address: giuseppe.derosa@unipv.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Derosa
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Romano
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: D'Angelo
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy ; PhD School in Experimental Medicine, University of Pavia, Pavia, Italy.
authors.forename: Pamela
authors.initials: P
authors.lastname: Maffioli
mesh_terms: D000328:Adult; D000368:Aged; D028142:Berberis / Q000737:chemistry*; D001786:Blood Glucose / Q000378:metabolism; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000188:drug therapy*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D020944:Silybum marianum / Q000737:chemistry*; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008055:Lipids; D010936:Plant Extracts
keywords: Berberis aristata and Silybum marianum; Dyslipidemia; Lipid profile; Myalgia; Statins