Effects of a Combination of Berberis aristata, Silybum marianum and Monacolin on Lipid Profile in Subjects at Low Cardiovascular Risk; A Double-Blind, Randomized, Placebo-Controlled Trial.

Giuseppe Derosa,Angela D'Angelo,Davide Romano,Pamela Maffioli

doi:10.3390/ijms18020343

Abstract

The aim of this study was to evaluate the efficacy and safety of an anti-hypercholesterolemic agent containing Berberis aristata, Silybum marianum and monacolin K and KA in a sample of Caucasian patients at low cardiovascular risk according to Framingham score. The primary outcome was to evaluate the effects of this nutraceutical combination on lipid profile; the secondary outcome was to evaluate the effect on some inflammatory markers, in particular high sensitivity C-reactive protein and tumor necrosis factor-α interleukin-6. One hundred and forty-three patients were randomized to placebo or Berberol® K, once a day, during the dinner, for 3 months, in a randomized, double-blind, placebo-controlled trial. We recorded a significant reduction of fasting plasma glucose with Berberol® K compared to placebo (−12.2%, p < 0.05). Moreover, we recorded an increase of fasting plasma insulin with Berberol® K both compared to baseline and to placebo (+9.9%, p < 0.05). Accordingly, the homeostasis model assessment (HOMA) index obtained after treatment with Berberol® K was lower than the one in the placebo group (−2.8%, p < 0.05). No variations of lipid profile were observed with placebo, while there was a significant decrease of total cholesterol (−20.5%, p < 0.05), triglycerides (−17.7%, p < 0.05), and low density lipoprotein (LDL) cholestero (−27.8%, p < 0.05) with Berberol® K, compared to placebo. There was a decrease of high sensitivity C-reactive protein (−30.8%, p < 0.05), and interleukin-6 (−25.0%, p < 0.05), with Berberol® K compared to placebo. In conclusion, combining different hypocholesterolemic nutraceutical agents such as Berberis aristata, Silybum marianum and monacolin K and KA could be effective and safe to obtain a reduction of lipid profile and an improvement of inflammatory parameters.

Highlights

Cardiovascular disease, and in particular coronary heart disease (CHD), is the main cause of mortality in developed countries [1]
We tested the anti-hyperlipidemic effect of a combination of Berberis aristata combined with Silybum marianum, and monacolins K and KA, obtaining a low density lipoprotein (LDL)-C reduction of about 31.6% compared to baseline
When we previously tested a nutraceutical combination of monacolins + Coenzime-Q10, instead, we observed a reduction in total cholesterol and low density lipoprotein cholesterol (LDL-C) of about 22%, but no effects on high density lipoprotein-cholesterol (HDL-C) and Tg were recorded [13]

Summary

Introduction

Cardiovascular disease, and in particular coronary heart disease (CHD), is the main cause of mortality in developed countries [1]. Cholesterol, and in particular low density lipoprotein (LDL) cholesterol, plays a main role: usually, atherosclerosis begins with an endothelial damage caused by high blood pressure, smoke, or high cholesterol. At this stage, LDL cholesterol enters the wall of the artery, and this causes white blood cells to stream in to digest the LDL. The most used hypocholesterolemic agents are statins, or 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors They are effective in reducing cholesterol [2], but they have some potential adverse effects, including muscle pain with creatine phosphokinase (CPK) elevation, fatigue and weakness, and liver transaminases increase [3]. The combination of Berberis aristata 588 mg and Silybum marianum 105 mg largely proved to be effective and safe [6,7,8]

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