title: Retrospective analysis of the effects of a highly standardized mixture ofBerberis aristata,Silybum marianum, and monacolins K and KA in patients with dyslipidemia.
abstract: BACKGROUND
  Berberis aristata, because of its berberine content, andMonascus purpureusfermented rice, because of the presence of monacolins (naturally derived statins), are widely investigated food-grade ingredients used to formulate cholesterol-lowering supplements. Although they are extensively used, berberine is poorly absorbed and monacolins are poorly chemically characterized, not standardized, and possibly contaminated with toxic compounds. Silymarin is reported to enhance berberine absorption, while Monakopure™-K20 (MK-20) is a highly standardized red yeast rice containing monacolins K and KA in the ratio of 1:1 but not secondary monacolins, dehydromonacolins, or citrinin.
  
  
  OBJECTIVE
  The effects of a cholesterol-lowering supplement (Berberol®K) containing berberine, silymarin, and MK-20 (BSM) in patients with dyslipidemia were clinically analyzed.
  
  
  METHODS
  The clinical role of BSM in naïve and in statin-intolerant patients was retrospectively evaluated and the effects observed were compared with those obtained in patients without treatment or treated with lovastatin.
  
  
  RESULTS
  Total cholesterol, low density lipoprotein, and triglyceride levels were approximately 4%, 6%, and 11% lower, respectively, and the creatine phosphokinase increase was reduced in patients treated with BSM compared to those treated with lovastatin. Similar results were also obtained in statin-intolerant subjects where BSM was administered as add-on therapy to ezetimibe or fenofibrate.
  
  
  CONCLUSIONS
  BSM is a food supplement potentially useful 1) as a primary intervention in low-cardiovascular-risk subjects with dyslipidemia; 2) as add-on therapy in mildly statin-intolerant patients; and 3) in dyslipidemic patients with a negative perception of statins who prefer a treatment seen as natural.
authors.affiliation: Scientific Department, Velleja Research, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Pierro
authors.affiliation: Outpatient Diabetic Clinic, University Hospital San Gerardo, Monza, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Putignano
authors.affiliation: District 63, Cava de' Tirreni-Costa d'Amalfi, Salerno, Italy.
authors.forename: Tarcisio
authors.initials: T
authors.lastname: Ferrara
authors.affiliation: Outpatient Clinic "Ordine di Malta", Naples, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Raiola
authors.affiliation: AIOR, Piacenza, Italy.
authors.forename: Giuliana
authors.initials: G
authors.lastname: Rapacioli
authors.affiliation: Metabolic Disorders, S. Orsola Malpighi Hospital, Bologna, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Villanova
keywords: Berberol®K; Monakopure™-K20; Monascus purpureus; P-glycoprotein; berberine; cholesterol; silymarin; triglycerides