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Pamela Maffioli - One of the best experts on this subject based on the ideXlab platform.
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efficacy of Berberis aristata compared to metformin in improving glycemic control and insulin resistance in patients with type 2 diabetes mellitus
Journal of Food and Nutrition Research, 2020Co-Authors: Giuseppe Derosa, Angela Dangelo, G Gaudio, Pamela MaffioliAbstract:Aim: the study was aimed to evaluate the action of a combination of an extract of Berberis aristata/Silybum marianum compared to metformin in a sample of Caucasian type 2 diabetic patients not taking anti-diabetic drugs. Methods: we enrolled 109 type 2 diabetic patients and randomized them to take Berberis aristata/Silybum marianum 588/108 mg or metformin for 6 months, in a double-blind, randomized, controlled, clinical trial. Results: glycated hemoglobin was similarly reduced by both Berberis aristata/Silybum marianum and metformin (p < 0.05 vs baseline, for both treatments), without significant differences between the two treatments. The same trend was recorded for FPG (p < 0.05 vs baseline, for both treatments), and PPG (p < 0.01 vs baseline, for both treatments). Both treatment reduced FPI and HOMA-IR (p < 0.05 vs baseline), without any differences between the two arms. Both Berberis aristata/Silybum marianum and metformin improved TC, LDL-C and Tg compared to baseline (p < 0.05 for both); however, Berberis aristata/Silybum marianum better improved these parameters compared to metformin (p < 0.05 for all). Conclusions: Berberis aristata/Silybum marianum can be a valid alternative to metformin in patients not well controlled by diet.
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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
International Journal of Molecular Sciences, 2017Co-Authors: Giuseppe Derosa, Davide Romano, Angela Dangelo, Pamela MaffioliAbstract: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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the role of a fixed Berberis aristata silybum marianum combination in the treatment of type 1 diabetes mellitus
Clinical Nutrition, 2016Co-Authors: Giuseppe Derosa, Angela Dangelo, Pamela MaffioliAbstract:Summary Aim To evaluate if the addition of Berberis aristata/Silybum marianum (Berberol®) leads to a reduction of insulin dose and to an improvement of glycemic control in patients with type 1 diabetes mellitus. Material and methods 85 type 1 diabetic patients were enrolled and randomized to take placebo or B. aristata/S. marianum 588/105 mg, 1 tablet at lunch and 1 tablet at dinner, for six months. We evaluated if there was a reduction of insulin dose necessary to reach an adequate glycemic control. We also evaluated at the study start, and after 6 months: body mass index (BMI), glycated hemoglobin, fasting plasma glucose (FPG), post-prandial glucose (PPG), lipid profile. Results We observed a reduction of total insulin consumption in B. aristata/S. marianum, both compared to baseline and to placebo. Regarding insulin administration at meals, we recorded that the group treated with B. aristata/S. marianum used less insulin at meals, and at bedtime. Glycated hemoglobin decreased with B. aristata/S. marianum compared to baseline, but not compared to placebo. There was a decrease of FPG, and PPG with B. aristata/S. marianum both compared to baseline and to placebo. Regarding lipid profile, we recorded a decrease of total cholesterol, triglycerides, and LDL-cholesterol and an increase of HDL-cholesterol with B. aristata/S. marianum, both compared to baseline and to placebo. Conclusions The addition of B. aristata/S. marianum to insulin therapy in patients with type 1 diabetes mellitus leads to a reduction of the insulin dose necessary to have an adequate glycemic control.
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Berberis aristata combined with silybum marianum on lipid profile in patients not tolerating statins at high doses
Atherosclerosis, 2015Co-Authors: Giuseppe Derosa, Davide Romano, Angela Dangelo, Pamela MaffioliAbstract:Abstract Aim 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.
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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
Phytomedicine, 2015Co-Authors: Giuseppe Derosa, Davide Romano, Angela Dangelo, Pamela MaffioliAbstract:Abstract Aim to evaluate the efficacy of Berberis aristata/Silybum marianum (Berberol®) in a sample of dyslipidemic patients intolerant to statins at high dosages in a randomized, double blind, placebo-controlled clinical trial. Methods we enrolled 175 euglycemic, dyslipidemic subjects, intolerant to statins at high dosages. During the run-in period, statins were stopped for 1 month, then they were re-introduced at the half of the previously taken dose. After that, patients were randomized to placebo or Berberol®, 1 tablet during the lunch and 1 tablet during the dinner, for 6 months. Anthropometric, metabolic and inflammatory parameters were assessed at randomization, at 3 and 6 months. Results fasting plasma glucose, insulin, and HOMA-index levels were reduced by Berberol®, but not by placebo; moreover they were lower than the ones recorded with placebo. Total cholesterol, LDL-C, triglycerides, and myeloperoxidase did not change after 6 months since the reduction of statin dosage and the introduction of Berberol®, while they increased in the placebo group, and were higher compared to the ones obtained with active treatment. No patients had serious adverse events in both groups. Conclusions our study displays the rationale of the combination of Berberol® and a reduced dosage of statin for the treatment of hyperlipidemia in patients intolerant to statins at high dosage.
Giuseppe Derosa - One of the best experts on this subject based on the ideXlab platform.
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efficacy of Berberis aristata compared to metformin in improving glycemic control and insulin resistance in patients with type 2 diabetes mellitus
Journal of Food and Nutrition Research, 2020Co-Authors: Giuseppe Derosa, Angela Dangelo, G Gaudio, Pamela MaffioliAbstract:Aim: the study was aimed to evaluate the action of a combination of an extract of Berberis aristata/Silybum marianum compared to metformin in a sample of Caucasian type 2 diabetic patients not taking anti-diabetic drugs. Methods: we enrolled 109 type 2 diabetic patients and randomized them to take Berberis aristata/Silybum marianum 588/108 mg or metformin for 6 months, in a double-blind, randomized, controlled, clinical trial. Results: glycated hemoglobin was similarly reduced by both Berberis aristata/Silybum marianum and metformin (p < 0.05 vs baseline, for both treatments), without significant differences between the two treatments. The same trend was recorded for FPG (p < 0.05 vs baseline, for both treatments), and PPG (p < 0.01 vs baseline, for both treatments). Both treatment reduced FPI and HOMA-IR (p < 0.05 vs baseline), without any differences between the two arms. Both Berberis aristata/Silybum marianum and metformin improved TC, LDL-C and Tg compared to baseline (p < 0.05 for both); however, Berberis aristata/Silybum marianum better improved these parameters compared to metformin (p < 0.05 for all). Conclusions: Berberis aristata/Silybum marianum can be a valid alternative to metformin in patients not well controlled by diet.
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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
International Journal of Molecular Sciences, 2017Co-Authors: Giuseppe Derosa, Davide Romano, Angela Dangelo, Pamela MaffioliAbstract: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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the role of a fixed Berberis aristata silybum marianum combination in the treatment of type 1 diabetes mellitus
Clinical Nutrition, 2016Co-Authors: Giuseppe Derosa, Angela Dangelo, Pamela MaffioliAbstract:Summary Aim To evaluate if the addition of Berberis aristata/Silybum marianum (Berberol®) leads to a reduction of insulin dose and to an improvement of glycemic control in patients with type 1 diabetes mellitus. Material and methods 85 type 1 diabetic patients were enrolled and randomized to take placebo or B. aristata/S. marianum 588/105 mg, 1 tablet at lunch and 1 tablet at dinner, for six months. We evaluated if there was a reduction of insulin dose necessary to reach an adequate glycemic control. We also evaluated at the study start, and after 6 months: body mass index (BMI), glycated hemoglobin, fasting plasma glucose (FPG), post-prandial glucose (PPG), lipid profile. Results We observed a reduction of total insulin consumption in B. aristata/S. marianum, both compared to baseline and to placebo. Regarding insulin administration at meals, we recorded that the group treated with B. aristata/S. marianum used less insulin at meals, and at bedtime. Glycated hemoglobin decreased with B. aristata/S. marianum compared to baseline, but not compared to placebo. There was a decrease of FPG, and PPG with B. aristata/S. marianum both compared to baseline and to placebo. Regarding lipid profile, we recorded a decrease of total cholesterol, triglycerides, and LDL-cholesterol and an increase of HDL-cholesterol with B. aristata/S. marianum, both compared to baseline and to placebo. Conclusions The addition of B. aristata/S. marianum to insulin therapy in patients with type 1 diabetes mellitus leads to a reduction of the insulin dose necessary to have an adequate glycemic control.
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Berberis aristata combined with silybum marianum on lipid profile in patients not tolerating statins at high doses
Atherosclerosis, 2015Co-Authors: Giuseppe Derosa, Davide Romano, Angela Dangelo, Pamela MaffioliAbstract:Abstract Aim 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.
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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
Phytomedicine, 2015Co-Authors: Giuseppe Derosa, Davide Romano, Angela Dangelo, Pamela MaffioliAbstract:Abstract Aim to evaluate the efficacy of Berberis aristata/Silybum marianum (Berberol®) in a sample of dyslipidemic patients intolerant to statins at high dosages in a randomized, double blind, placebo-controlled clinical trial. Methods we enrolled 175 euglycemic, dyslipidemic subjects, intolerant to statins at high dosages. During the run-in period, statins were stopped for 1 month, then they were re-introduced at the half of the previously taken dose. After that, patients were randomized to placebo or Berberol®, 1 tablet during the lunch and 1 tablet during the dinner, for 6 months. Anthropometric, metabolic and inflammatory parameters were assessed at randomization, at 3 and 6 months. Results fasting plasma glucose, insulin, and HOMA-index levels were reduced by Berberol®, but not by placebo; moreover they were lower than the ones recorded with placebo. Total cholesterol, LDL-C, triglycerides, and myeloperoxidase did not change after 6 months since the reduction of statin dosage and the introduction of Berberol®, while they increased in the placebo group, and were higher compared to the ones obtained with active treatment. No patients had serious adverse events in both groups. Conclusions our study displays the rationale of the combination of Berberol® and a reduced dosage of statin for the treatment of hyperlipidemia in patients intolerant to statins at high dosage.
Davide Romano - One of the best experts on this subject based on the ideXlab platform.
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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
International Journal of Molecular Sciences, 2017Co-Authors: Giuseppe Derosa, Davide Romano, Angela Dangelo, Pamela MaffioliAbstract: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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Berberis aristata combined with silybum marianum on lipid profile in patients not tolerating statins at high doses
Atherosclerosis, 2015Co-Authors: Giuseppe Derosa, Davide Romano, Angela Dangelo, Pamela MaffioliAbstract:Abstract Aim 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.
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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
Phytomedicine, 2015Co-Authors: Giuseppe Derosa, Davide Romano, Angela Dangelo, Pamela MaffioliAbstract:Abstract Aim to evaluate the efficacy of Berberis aristata/Silybum marianum (Berberol®) in a sample of dyslipidemic patients intolerant to statins at high dosages in a randomized, double blind, placebo-controlled clinical trial. Methods we enrolled 175 euglycemic, dyslipidemic subjects, intolerant to statins at high dosages. During the run-in period, statins were stopped for 1 month, then they were re-introduced at the half of the previously taken dose. After that, patients were randomized to placebo or Berberol®, 1 tablet during the lunch and 1 tablet during the dinner, for 6 months. Anthropometric, metabolic and inflammatory parameters were assessed at randomization, at 3 and 6 months. Results fasting plasma glucose, insulin, and HOMA-index levels were reduced by Berberol®, but not by placebo; moreover they were lower than the ones recorded with placebo. Total cholesterol, LDL-C, triglycerides, and myeloperoxidase did not change after 6 months since the reduction of statin dosage and the introduction of Berberol®, while they increased in the placebo group, and were higher compared to the ones obtained with active treatment. No patients had serious adverse events in both groups. Conclusions our study displays the rationale of the combination of Berberol® and a reduced dosage of statin for the treatment of hyperlipidemia in patients intolerant to statins at high dosage.
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Berberis aristata silybum marianum fixed combination on lipid profile and insulin secretion in dyslipidemic patients
Expert Opinion on Biological Therapy, 2013Co-Authors: Giuseppe Derosa, Aldo Bonaventura, Lucio Bianchi, Davide Romano, Elena Fogari, Angela Dangelo, Pamela MaffioliAbstract:Background: Relatively large number of dietary supplements and nutraceuticals have been studied for their supposed or demonstrated ability to reduce cholesterolemia in humans. Objectives: The aim of this study was to evaluate the efficacy as antihypercholesterolemic and insulin-sensitizing agent of a combination of Berberis aristata/Silybum marianum extract (Berberol®) in a sample of dyslipidemic patients. A total of 102 dyslipidemic subjects were enrolled. After a 6 months run-in period of diet and physical activity, the patients were randomized to placebo or Berberis aristata/Silybum marianum extract 588 mg/105 mg, twice a day for 3 months. Berberis aristata/Silybum marianum and placebo were then interrupted for 2 months (washout period), and then restarted for further 3 months. Anthropometric and metabolic parameters were assessed; moreover, all patients underwent a glucagon stimulation test. Results: Berberis aristata/Silybum marianum reduced total cholesterol, triglycerides and low-density lipoprotei...
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effects of Berberis aristata silybum marianum association on metabolic parameters and adipocytokines in overweight dyslipidemic patients
Journal of Biological Regulators and Homeostatic Agents, 2013Co-Authors: Giuseppe Derosa, Aldo Bonaventura, Lucio Bianchi, Davide Romano, A D' Angelo, Elena Fogari, Pamela MaffioliAbstract:Nutraceuticals and functional foods have attracted considerable interest as potential alternative therapies for treatment of different cardiovascular disorders and insulin resistance. We evaluated the efficacy of a combination of Berberis aristata/Silybum Marianum extract (Berberol®) in a sample of overweight, dyslipidemic patients at low cardiovascular risk. We enrolled 105 Caucasian, euglycemic, overweight, dyslipidemic patients, of either sex. At baseline all patients underwent a 6 months run-in period during which they followed an adequate diet and practiced physical activity. At the end of the run-in period, patients were randomised to take placebo or a combination of Berberis aristata/Silybum marianum, 1 tablet during the lunch and 1 tablet during the dinner, for three months, in a double-blind, placebo-controlled design. Berberis aristata/Silybum marianum and placebo were then interrupted for 2 months (wash-out period), and all patients continued with only diet and physical activity. At the end of the wash-out period, patients re-started Berberis aristata/Silybum marianum or placebo twice a day for further 3 months. We evaluated during the run-in period, at randomisation, before and after the wash-out period these parameters: body weight and BMI, fasting plasma glucose, lipid profile, insulin resistance, retinol binding protein-4 (RBP-4), adiponectin (ADN), resistin. Total cholesterol, LDL-C, and Tg decreased, and HDL-C increase after 3 months of Berberis aristata/Silybum marianum, both compared to baseline and placebo. Berberis aristata/Silybum marianum decreased fasting plasma insulin, and HOMA-IR, both compared to baseline and to placebo. Moreover, there was a decrease of RBP-4, and resistin, and an increase of ADN after 3 months of Berberis aristata/Silybum marianum. All these positive effects disappeared after the wash-out period, and re-appeared after the re-introduction of the drug. We observed a significant correlation between HOMA-index decrease and resistin, and RBP-4 decrease, and between HOMA-index decrease and ADN increase in Berberis aristata/Silybum marianum group, but not in placebo group. Berberis aristata/Silybum marianum fixed combination seems to be safe and effective in improving lipid profile, but also in improving insulin resistance and adipocytokines levels.
Angela Dangelo - One of the best experts on this subject based on the ideXlab platform.
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efficacy of Berberis aristata compared to metformin in improving glycemic control and insulin resistance in patients with type 2 diabetes mellitus
Journal of Food and Nutrition Research, 2020Co-Authors: Giuseppe Derosa, Angela Dangelo, G Gaudio, Pamela MaffioliAbstract:Aim: the study was aimed to evaluate the action of a combination of an extract of Berberis aristata/Silybum marianum compared to metformin in a sample of Caucasian type 2 diabetic patients not taking anti-diabetic drugs. Methods: we enrolled 109 type 2 diabetic patients and randomized them to take Berberis aristata/Silybum marianum 588/108 mg or metformin for 6 months, in a double-blind, randomized, controlled, clinical trial. Results: glycated hemoglobin was similarly reduced by both Berberis aristata/Silybum marianum and metformin (p < 0.05 vs baseline, for both treatments), without significant differences between the two treatments. The same trend was recorded for FPG (p < 0.05 vs baseline, for both treatments), and PPG (p < 0.01 vs baseline, for both treatments). Both treatment reduced FPI and HOMA-IR (p < 0.05 vs baseline), without any differences between the two arms. Both Berberis aristata/Silybum marianum and metformin improved TC, LDL-C and Tg compared to baseline (p < 0.05 for both); however, Berberis aristata/Silybum marianum better improved these parameters compared to metformin (p < 0.05 for all). Conclusions: Berberis aristata/Silybum marianum can be a valid alternative to metformin in patients not well controlled by diet.
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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
International Journal of Molecular Sciences, 2017Co-Authors: Giuseppe Derosa, Davide Romano, Angela Dangelo, Pamela MaffioliAbstract: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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the role of a fixed Berberis aristata silybum marianum combination in the treatment of type 1 diabetes mellitus
Clinical Nutrition, 2016Co-Authors: Giuseppe Derosa, Angela Dangelo, Pamela MaffioliAbstract:Summary Aim To evaluate if the addition of Berberis aristata/Silybum marianum (Berberol®) leads to a reduction of insulin dose and to an improvement of glycemic control in patients with type 1 diabetes mellitus. Material and methods 85 type 1 diabetic patients were enrolled and randomized to take placebo or B. aristata/S. marianum 588/105 mg, 1 tablet at lunch and 1 tablet at dinner, for six months. We evaluated if there was a reduction of insulin dose necessary to reach an adequate glycemic control. We also evaluated at the study start, and after 6 months: body mass index (BMI), glycated hemoglobin, fasting plasma glucose (FPG), post-prandial glucose (PPG), lipid profile. Results We observed a reduction of total insulin consumption in B. aristata/S. marianum, both compared to baseline and to placebo. Regarding insulin administration at meals, we recorded that the group treated with B. aristata/S. marianum used less insulin at meals, and at bedtime. Glycated hemoglobin decreased with B. aristata/S. marianum compared to baseline, but not compared to placebo. There was a decrease of FPG, and PPG with B. aristata/S. marianum both compared to baseline and to placebo. Regarding lipid profile, we recorded a decrease of total cholesterol, triglycerides, and LDL-cholesterol and an increase of HDL-cholesterol with B. aristata/S. marianum, both compared to baseline and to placebo. Conclusions The addition of B. aristata/S. marianum to insulin therapy in patients with type 1 diabetes mellitus leads to a reduction of the insulin dose necessary to have an adequate glycemic control.
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Berberis aristata combined with silybum marianum on lipid profile in patients not tolerating statins at high doses
Atherosclerosis, 2015Co-Authors: Giuseppe Derosa, Davide Romano, Angela Dangelo, Pamela MaffioliAbstract:Abstract Aim 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.
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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
Phytomedicine, 2015Co-Authors: Giuseppe Derosa, Davide Romano, Angela Dangelo, Pamela MaffioliAbstract:Abstract Aim to evaluate the efficacy of Berberis aristata/Silybum marianum (Berberol®) in a sample of dyslipidemic patients intolerant to statins at high dosages in a randomized, double blind, placebo-controlled clinical trial. Methods we enrolled 175 euglycemic, dyslipidemic subjects, intolerant to statins at high dosages. During the run-in period, statins were stopped for 1 month, then they were re-introduced at the half of the previously taken dose. After that, patients were randomized to placebo or Berberol®, 1 tablet during the lunch and 1 tablet during the dinner, for 6 months. Anthropometric, metabolic and inflammatory parameters were assessed at randomization, at 3 and 6 months. Results fasting plasma glucose, insulin, and HOMA-index levels were reduced by Berberol®, but not by placebo; moreover they were lower than the ones recorded with placebo. Total cholesterol, LDL-C, triglycerides, and myeloperoxidase did not change after 6 months since the reduction of statin dosage and the introduction of Berberol®, while they increased in the placebo group, and were higher compared to the ones obtained with active treatment. No patients had serious adverse events in both groups. Conclusions our study displays the rationale of the combination of Berberol® and a reduced dosage of statin for the treatment of hyperlipidemia in patients intolerant to statins at high dosage.
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Berberis aristata silybum marianum fixed combination on lipid profile and insulin secretion in dyslipidemic patients
Expert Opinion on Biological Therapy, 2013Co-Authors: Giuseppe Derosa, Aldo Bonaventura, Lucio Bianchi, Davide Romano, Elena Fogari, Angela Dangelo, Pamela MaffioliAbstract:Background: Relatively large number of dietary supplements and nutraceuticals have been studied for their supposed or demonstrated ability to reduce cholesterolemia in humans. Objectives: The aim of this study was to evaluate the efficacy as antihypercholesterolemic and insulin-sensitizing agent of a combination of Berberis aristata/Silybum marianum extract (Berberol®) in a sample of dyslipidemic patients. A total of 102 dyslipidemic subjects were enrolled. After a 6 months run-in period of diet and physical activity, the patients were randomized to placebo or Berberis aristata/Silybum marianum extract 588 mg/105 mg, twice a day for 3 months. Berberis aristata/Silybum marianum and placebo were then interrupted for 2 months (washout period), and then restarted for further 3 months. Anthropometric and metabolic parameters were assessed; moreover, all patients underwent a glucagon stimulation test. Results: Berberis aristata/Silybum marianum reduced total cholesterol, triglycerides and low-density lipoprotei...
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effects of Berberis aristata silybum marianum association on metabolic parameters and adipocytokines in overweight dyslipidemic patients
Journal of Biological Regulators and Homeostatic Agents, 2013Co-Authors: Giuseppe Derosa, Aldo Bonaventura, Lucio Bianchi, Davide Romano, A D' Angelo, Elena Fogari, Pamela MaffioliAbstract:Nutraceuticals and functional foods have attracted considerable interest as potential alternative therapies for treatment of different cardiovascular disorders and insulin resistance. We evaluated the efficacy of a combination of Berberis aristata/Silybum Marianum extract (Berberol®) in a sample of overweight, dyslipidemic patients at low cardiovascular risk. We enrolled 105 Caucasian, euglycemic, overweight, dyslipidemic patients, of either sex. At baseline all patients underwent a 6 months run-in period during which they followed an adequate diet and practiced physical activity. At the end of the run-in period, patients were randomised to take placebo or a combination of Berberis aristata/Silybum marianum, 1 tablet during the lunch and 1 tablet during the dinner, for three months, in a double-blind, placebo-controlled design. Berberis aristata/Silybum marianum and placebo were then interrupted for 2 months (wash-out period), and all patients continued with only diet and physical activity. At the end of the wash-out period, patients re-started Berberis aristata/Silybum marianum or placebo twice a day for further 3 months. We evaluated during the run-in period, at randomisation, before and after the wash-out period these parameters: body weight and BMI, fasting plasma glucose, lipid profile, insulin resistance, retinol binding protein-4 (RBP-4), adiponectin (ADN), resistin. Total cholesterol, LDL-C, and Tg decreased, and HDL-C increase after 3 months of Berberis aristata/Silybum marianum, both compared to baseline and placebo. Berberis aristata/Silybum marianum decreased fasting plasma insulin, and HOMA-IR, both compared to baseline and to placebo. Moreover, there was a decrease of RBP-4, and resistin, and an increase of ADN after 3 months of Berberis aristata/Silybum marianum. All these positive effects disappeared after the wash-out period, and re-appeared after the re-introduction of the drug. We observed a significant correlation between HOMA-index decrease and resistin, and RBP-4 decrease, and between HOMA-index decrease and ADN increase in Berberis aristata/Silybum marianum group, but not in placebo group. Berberis aristata/Silybum marianum fixed combination seems to be safe and effective in improving lipid profile, but also in improving insulin resistance and adipocytokines levels.