Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia
Francesco Di Pierro,1 Pietro Putignano,2 Tarcisio Ferrara,3 Carmela Raiola,4 Giuliana Rapacioli,5 Nicola Villanova6 1Scientific Department, Velleja Research, Milan, Italy; 2Outpatient Diabetic Clinic, University Hospital San Gerardo, Monza, Italy; 3District 63, Cava de’ Tirreni-Costa d&...
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oai:doaj.org-article:00dc716845f146ea9f628f35637121aa2021-12-02T04:02:55ZRetrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia1179-1438https://doaj.org/article/00dc716845f146ea9f628f35637121aa2016-12-01T00:00:00Zhttps://www.dovepress.com/retrospective-analysis-of-the-effects-of-a-highly-standardized-mixture-peer-reviewed-article-CPAAhttps://doaj.org/toc/1179-1438Francesco Di Pierro,1 Pietro Putignano,2 Tarcisio Ferrara,3 Carmela Raiola,4 Giuliana Rapacioli,5 Nicola Villanova6 1Scientific Department, Velleja Research, Milan, Italy; 2Outpatient Diabetic Clinic, University Hospital San Gerardo, Monza, Italy; 3District 63, Cava de’ Tirreni-Costa d’Amalfi, Salerno, Italy; 4Outpatient Clinic “Ordine di Malta”, Naples, Italy; 5AIOR, Piacenza, Italy; 6Metabolic Disorders, S. Orsola Malpighi Hospital, Bologna, Italy Background: Berberis aristata, because of its berberine content, and Monascus purpureus fermented 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.Aim: 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. Conclusion: 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. Keywords: berberine, Berberol®K, silymarin, P-glycoprotein, cholesterol, triglycerides, Monascus purpureus, Monakopure™-K20Di Pierro FPutignano PFerrara TRaiola CRapacioli GVillanova NDove Medical PressarticleberberineBerberol®KsilymarinP-glycoproteincholesteroltriglyceridesMonascus purpureusMonakopure™-K20.Therapeutics. PharmacologyRM1-950ENClinical Pharmacology: Advances and Applications, Vol Volume 9, Pp 1-7 (2016) |
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berberine Berberol®K silymarin P-glycoprotein cholesterol triglycerides Monascus purpureus Monakopure™-K20. Therapeutics. Pharmacology RM1-950 |
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berberine Berberol®K silymarin P-glycoprotein cholesterol triglycerides Monascus purpureus Monakopure™-K20. Therapeutics. Pharmacology RM1-950 Di Pierro F Putignano P Ferrara T Raiola C Rapacioli G Villanova N Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia |
description |
Francesco Di Pierro,1 Pietro Putignano,2 Tarcisio Ferrara,3 Carmela Raiola,4 Giuliana Rapacioli,5 Nicola Villanova6 1Scientific Department, Velleja Research, Milan, Italy; 2Outpatient Diabetic Clinic, University Hospital San Gerardo, Monza, Italy; 3District 63, Cava de’ Tirreni-Costa d’Amalfi, Salerno, Italy; 4Outpatient Clinic “Ordine di Malta”, Naples, Italy; 5AIOR, Piacenza, Italy; 6Metabolic Disorders, S. Orsola Malpighi Hospital, Bologna, Italy Background: Berberis aristata, because of its berberine content, and Monascus purpureus fermented 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.Aim: 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. Conclusion: 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. Keywords: berberine, Berberol®K, silymarin, P-glycoprotein, cholesterol, triglycerides, Monascus purpureus, Monakopure™-K20 |
format |
article |
author |
Di Pierro F Putignano P Ferrara T Raiola C Rapacioli G Villanova N |
author_facet |
Di Pierro F Putignano P Ferrara T Raiola C Rapacioli G Villanova N |
author_sort |
Di Pierro F |
title |
Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia |
title_short |
Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia |
title_full |
Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia |
title_fullStr |
Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia |
title_full_unstemmed |
Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia |
title_sort |
retrospective analysis of the effects of a highly standardized mixture of berberis aristata, silybum marianum, and monacolins k and ka in patients with dyslipidemia |
publisher |
Dove Medical Press |
publishDate |
2016 |
url |
https://doaj.org/article/00dc716845f146ea9f628f35637121aa |
work_keys_str_mv |
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