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

Derosa, Giuseppe; Romano, Davide; D’Angelo, Angela; Maffioli, Pamela

doi:10.1016/j.phymed.2014.11.018

Cited by 28 publications

(29 citation statements)

References 36 publications

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“…Despite the better effects on lipid profile, we did not observe a major incidence of adverse events, in line with our previous studies [6,7,8], confirming the good tolerability of this nutraceutical combination.…”

Section: Discussionsupporting

confidence: 92%

“…Our research group already demonstrated that Berberis aristata combined with Silybum marianum were well-tolerated and effective in reducing cholesterolemia and estimated risk of cardiovascular disease [6,7,8]. Regarding the effect on glycemia and insulin, the reductions of glycemia, and the increase of insulinemia that we recorded were similar to our previous studies on Berberis aristata/Silybum marianum [6,7], suggesting a neutral effect of monacolin on these parameters.…”

Section: Discussionsupporting

confidence: 87%

“…To avoid statins’ side effects, often physicians consider the use of hypocholesterolemic nutraceutical agents in subjects at low cardiovascular risk [4,5]. Among nutraceuticals, the combination of Berberis aristata 588 mg and Silybum marianum 105 mg largely proved to be effective and safe [6,7,8]. …”

Section: Introductionmentioning

confidence: 99%

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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

Derosa

D’Angelo

Romano

et al. 2017

IJMS

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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.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 87%

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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

Derosa

D’Angelo

Romano

et al. 2017

IJMS

View full text Add to dashboard Cite

show abstract

“…High serum lipid and lipoprotein levels, particularly hypercholesterolemia, elevate the risk of cardiovascular diseases, fatty liver, carcinogenesis, peripheral vascular disease, and atherosclerosis in human (Derosa, Romano, D'Angelo, & Maffioli, ; Heidarian & Rafieian‐Kopaei, ). There are many new synthetic oral antihyperlipidemic drugs, but they have adverse side effects such as myopathy, increase in hepatic aminotransferases, and rhabdomyolysis condition (Heidarian & Rafieian‐Kopaei, ).…”

Section: Effect On Lipid Profilementioning

confidence: 99%

“…S. marianum inhibited cholesterol acyltransferase activity, decreased cholesterol absorption and lipoprotein biosynthesis, and improved B. aristata oral bioavailability and also had a synergic effect with this plant. Therefore, the combination of silymarin and B. aristata can reduce dosage of statin and their side effects in the treatment of hyperlipidemia (Derosa et al, ). Administration of 105 mg of S. marianum in combination with B. aristata twice a day for 3 months decreased TC, TG, and LDL‐C contents and enhanced HDL‐C level in dyslipidemic patients.…”

Section: Hepatoprotective and Antioxidant Effects Of S Marianummentioning

confidence: 99%

Silybum marianum (milk thistle) and its main constituent, silymarin, as a potential therapeutic plant in metabolic syndrome: A review

Tajmohammadi

Razavi

Hosseinzadeh

2018

Phytotherapy Research

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Metabolic syndrome describes a complex metabolic risk factors including obesity, hypertension, dyslipidemia, and diabetes. This syndrome is diagnosed by medical conditions such as weight gain, high blood pressure, high blood glucose, and disturbance in lipid profile. Metabolic syndrome has become as an important and increasing global health problem, so finding potentially novel solutions with less adverse effects is favorable for health problems. Herbal therapy plays an important role for treatment of different diseases. Silybum marianum is a plant that is used for centuries as a herbal treatment in liver and biliary tract diseases. Silymarin is the main component of S. marianum and derived from fruits and seeds of S. marianum (milk thistle). S. marianum has been found to exhibit antioxidant, lipid-lowering, antihypertensive, antidiabetic, antiatherosclerotic, anti-obesity, and hepatoprotective effects. Therefore, the aim of this review is to summarize different animal and human studies regarding the effect of S. marianum in metabolic syndrome and to identify the underlying mechanisms of action.

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Berberine and barberry (Berberis vulgaris): A clinical review

Imenshahidi

Hosseinzadeh

2019

Phytotherapy Research

244

134

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Barberry (Berberis vulgaris L.) has different medicinal applications in folk medicine of Iran. Berberine, an alkaloid constituent of this plant, is present in the roots, rhizomes, stem, and bark of B. vulgaris and many other plants. There have been many clinical trials conducted that suggested a wide range of therapeutic applications. Here, we investigated the clinical uses of berberine and B. vulgaris in the treatment of different diseases in humans. An extensive search in electronic databases (PubMed, Scopus, Embase, Web of Sciences and Science Direct) was used to identify the clinical trials on B. vulgaris and berberine. Lipid‐lowering and insulin‐resistance improving actions are the most studied properties of berberine in numerous randomized clinical trials. There are also clinical trials regarding cardiovascular, anticancer, gastrointestinal, CNS, endocrine, and so on. Berberine has very low toxicity in usual doses and reveals clinical benefits without major side effects. Only mild gastrointestinal reactions may occur in some patients. The purpose of this review is to provide a summary concerning the clinical trials conducted on berberine to improve the clinical application of this nutraceutical in different diseases. In this review article, we used 77 clinical studies on human subjects.

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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

Cited by 28 publications

References 36 publications

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

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

Silybum marianum (milk thistle) and its main constituent, silymarin, as a potential therapeutic plant in metabolic syndrome: A review

Berberine and barberry (Berberis vulgaris): A clinical review

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