title: Berberis aristata combined with Silybum marianum on lipid profile in patients not tolerating statins at high doses.
abstract: OBJECTIVE
  To evaluate the effects of Berberis aristata combined with Silybum marianum in dyslipidemic patients intolerant to statins at high doses.
  
  
  METHODS
  137 euglycemic, dyslipidemic subjects, with previous adverse events to statins at high doses, were enrolled. Statins were stopped for 1 month (run-in), then they were re-introduced at the half of the previously taken dose. At randomization, patients tolerating the half dose of statin, were assigned to add placebo or B. aristata/S. marianum 588/105 mg, 1 tablet during the lunch and 1 tablet during the dinner, for six months. We evaluated lipid profile and safety parameters variation at randomization, and after 3, and 6 months.
  
  
  RESULTS
  B. aristata/S. marianum reduced fasting plasma glucose (-9 mg/dl), insulin (-0.7 μU/ml), and HOMA-index (-0.35) levels compared to baseline and also to placebo. Lipid profile did not significantly change after 6 months since the reduction of statin dosage and the introduction of B. aristata/S. marianum, while it worsened in the placebo group both compared to placebo and with active treatment (+23.4 mg/dl for total cholesterol, +19.6 mg/dl for LDL-cholesterol, +23.1 mg/dl for triglycerides with placebo compared to B. aristata/S. marianum). We did not record any variations of safety parameters in nether of groups.
  
  
  CONCLUSIONS
  B. aristata/S. marianum can be considered as addition to statins in patients not tolerating high dose of these drugs.
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*; D002784:Cholesterol / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D050171:Dyslipidemias / Q000188:drug therapy*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D020944:Silybum marianum / Q000737:chemistry*; D063806:Myalgia / Q000097:blood; D010936:Plant Extracts / Q000737:chemistry*; D013997:Time Factors; D014280:Triglycerides / Q000097:blood
chemical_list: D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008055:Lipids; D010936:Plant Extracts; D014280:Triglycerides; D002784:Cholesterol
keywords: Berberis aristata and Silybum marianum; Dyslipidemia; Lipid profile; Myalgia; Statins