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Berberine

Berberine is a natural plant alkaloid known for its beneficial effects on metabolic health. It improves lipid profiles, regulates blood glucose, and reduces inflammation. Berberine functions as an AMPK activator, enhancing insulin sensitivity and glucose uptake. Additionally, it acts as a natural inhibitor of PCSK9, which helps lower cholesterol levels by increasing LDL receptor availability on liver cells. Studies have shown its efficacy in managing conditions like type 2 diabetes and dyslipidemia.

Berberine has shown diverse therapeutic potential, particularly its significant impact on metabolic and cardiovascular health. A systematic review and meta-analysis demonstrated that berberine, both alone and in combination with other nutraceuticals, effectively reduces total cholesterol (TC), low-density lipoproteins (LDL), and triglycerides (TG) while raising high-density lipoproteins (HDL). Specifically, berberine combined with red yeast rice and Silybum marianum showed more pronounced effects on lipid profiles, suggesting its potent role in managing hyperlipidemia and related disorders (J Diet Suppl. 2024).

Another meta-analysis focused on cardiovascular diseases found berberine to significantly reduce inflammatory markers such as C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), which are critical in managing conditions like metabolic syndrome and atherosclerosis (Phytother Res. 2023, Pharm Biol. 2023). Furthermore, clinical trials have highlighted berberine’s efficacy in improving glycemic control in type 2 diabetes patients (BMC Endocr Disord. 2023, Eur Rev Med Pharmacol Sci. 2023) and those with prediabetes. Studies also revealed berberine’s potential in reducing body weight, insulin resistance, and improving lipid profiles, emphasizing its multifaceted benefits for metabolic health (Clin Nutr ESPEN. 2020, Oxid Med Cell Longev. 2021).

PUBLICATIONS

  1. Impact of Berberine or Berberine Combination Products on Lipoprotein, Triglyceride and Biological Safety Marker Concentrations in Patients with Hyperlipidemia: A Systematic Review and Meta-Analysis.
          • J Diet Suppl. 2024;21(2):242-259.
          • Design: Systematic review and meta-analysis of randomized controlled trials (RCTs) assessing 8-18 weeks of berberine therapy on lipid concentrations.
          • Summary: Berberine-containing products significantly reduced total cholesterol (TC), low-density lipoproteins (LDL), and triglycerides (TG) while raising high-density lipoproteins (HDL). Products with berberine alone had less robust effects on TC, LDL, and HDL, but TG effects were similar. Combination therapies with red yeast rice or Silybum marianum showed more significant reductions in TC and LDL.
  2. Efficacy and Safety of Berberine for Premature Ventricular Contractions: A Meta-Analysis and Systematic Review of Randomized Controlled Trials.
          • Pharm Biol. 2023 Dec;61(1):1474-1483.
          • Design: Meta-analysis and systematic review of RCTs assessing the efficacy and safety of berberine for premature ventricular contractions (PVCs).
          • Summary: Berberine combined with antiarrhythmic drugs (AD) had a higher effective rate for treating PVCs compared to AD alone, with no significant increase in adverse reactions. Berberine alone showed no significant difference in effective rate but had a lower incidence of adverse reactions and recurrence rate compared to AD.
  3. Effects of Berberine and Barberry on Selected Inflammatory Biomarkers in Adults: A Systematic Review and Dose-Response Meta-Analysis of Randomized Clinical Trials.
          • Phytother Res. 2023 Dec;37(12):5541-5557.
          • Design: Systematic review and dose-response meta-analysis of RCTs assessing the effects of berberine/barberry on inflammatory biomarkers.
          • Summary: Berberine supplementation significantly mitigated levels of interleukin 6 (IL-6), tumor necrosis factor-α (TNF-α), and C-reactive protein (CRP). The dose-dependent effect showed significant lowering of IL-6 and TNF-α levels with doses less than 1000 mg/day and intervention durations of less than 5 weeks.
  4. Efficacy and Safety of HIMABERB® Berberine on Glycemic Control in Patients with Prediabetes: Double-Blind, Placebo-Controlled, and Randomized Pilot Trial.
          • BMC Endocr Disord. 2023 Sep 7;23(1):190.
          • Design: Double-blind, placebo-controlled, and randomized pilot trial evaluating the effect of HIMABERB® berberine on glycemic control in individuals with prediabetes.
          • Summary: HIMABERB® berberine significantly reduced fasting plasma glucose (FPG), fasting insulin (FI), 2-hour oral glucose tolerance test (2h-OGTT), HbA1c, and homeostatic model assessment-insulin resistance (HOMA-IR) levels over 12 weeks compared to placebo, with no severe adverse effects detected.
  5. Berberine Phospholipid Exerts a Positive Effect on the Glycemic Profile of Overweight Subjects with Impaired Fasting Blood Glucose (IFG): A Randomized Double-Blind Placebo-Controlled Clinical Trial.
          • Eur Rev Med Pharmacol Sci. 2023 Jul;27(14):6718-6727.
          • Design: Randomized double-blind placebo-controlled clinical trial evaluating the effect of Berberine Phytosome™ on the metabolic profile of overweight subjects with impaired fasting blood glucose (IFG).
          • Summary: After two months of treatment, Berberine Phytosome™ significantly improved glycemia, total cholesterol, total cholesterol/HDL ratio, triglycerides, insulin, ApoB/ApoA ratio, visceral adipose tissue (VAT), and fat mass compared to placebo, with no adverse events reported.
  6. Overall and Sex-Specific Effect of Berberine for the Treatment of Dyslipidemia in Adults: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.
          • Drugs. 2023 Apr;83(5):403-427.
          • Design: Systematic review and meta-analysis of randomized placebo-controlled trials evaluating the efficacy and safety of berberine for dyslipidemia treatment with consideration of potential sex disparity.
          • Summary: Berberine reduced LDL cholesterol, total cholesterol, triglycerides, and apolipoprotein B. It increased HDL cholesterol, with a more significant effect in women compared to men. No serious adverse events were reported, but gastrointestinal issues were more common in the berberine group.
  7. Efficacy and safety of berberine for several cardiovascular diseases: A systematic review and meta-analysis of randomized controlled trials.
          • Phytomedicine. 2023 Apr;112:154716.
          • Design: Systematic review and meta-analysis of RCTs evaluating the efficacy and safety of berberine for cardiovascular diseases.
          • Summary: Berberine alone significantly reduced hs-CRP, IL-6, TNF-α, and NIHSS scores. When combined with statins, berberine improved TC, TG, LDL-C, and several other cardiovascular markers compared to statins alone, without increasing adverse reactions.
  8. Preventive Effect of Berberine on Postoperative Atrial Fibrillation.
          • Circ Arrhythm Electrophysiol. 2022 Oct;15(10):e011160.
          • Design: Randomized, double-blind, placebo-controlled trial assessing the impact of berberine on postoperative atrial fibrillation (POAF) in patients undergoing coronary artery bypass grafting.
          • Summary: Berberine treatment reduced POAF incidence, POAF burden, and serum inflammatory biomarkers levels. It significantly decreased lipopolysaccharide, CRP, and IL-6 levels without increasing perioperative mortality and morbidity.
  9. A network meta-analysis on the comparative effect of nutraceuticals on lipid profile in adults.
          • Pharmacol Res. 2022 Sep;183:106402.
          • Design: Network meta-analysis of randomized trials evaluating the comparative efficacy of different nutraceuticals on lipid profiles.
          • Summary: Berberine was found effective in lowering LDL-C and total cholesterol (TC) compared to placebo. The study suggests that berberine, along with other nutraceuticals like bergamot and red yeast rice, significantly improves lipid profiles.
  10. Efficacy and Underlying Mechanism of Berberine Against Atherosclerosis: A Meta-Analysis in Preclinical Animal Studies.
          • J Cardiovasc Pharmacol. 2022 Sep;80(3):476-488.
          • Design: Meta-analysis of preclinical animal studies evaluating the effects and mechanisms of berberine against atherosclerosis.
          • Summary: Berberine significantly decreased plaque area, plaque macrophage content, and levels of TC, TG, LDL, and inflammatory cytokines in animal models. These findings indicate berberine’s potential as a promising drug for treating atherosclerosis by regulating lipid metabolism, inflammation, and plaque composition.
  11. The effects of berberine on inflammatory markers in Chinese patients with metabolic syndrome and related disorders: a meta-analysis of randomized controlled trials.
          • Inflammopharmacology. 2022 Jun;30(3):1063-1077.
          • Design: Meta-analysis of randomized controlled trials (RCTs) assessing the effects of berberine on inflammatory markers in metabolic syndrome.
          • Summary: Berberine significantly reduced C-reactive protein (CRP), tumor necrosis factor-α (TNF-α), and interleukin 6 (IL-6) levels among patients with metabolic syndrome. However, it did not affect interleukin 1β (IL-1β) levels.
  12. Combined berberine and probiotic treatment as an effective regimen for improving postprandial hyperlipidemia in type 2 diabetes patients: a double-blinded placebo-controlled randomized study.
          • Gut Microbes. 2022 Jan-Dec;14(1):2003176.
          • Design: Double-blinded placebo-controlled randomized study evaluating the combined effect of berberine and probiotics on postprandial hyperlipidemia in type 2 diabetes patients.
          • Summary: The combination of berberine and probiotics significantly improved postprandial total cholesterol (pTC) and low-density lipoprotein cholesterol (pLDLc) levels compared to berberine or probiotics alone. The effect was linked to changes in fecal Bifidobacterium breve levels.
  13. The Effect of Berberine on Metabolic Profiles in Type 2 Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
          • Oxid Med Cell Longev. 2021 Dec 15;2021:2074610.
          • Design: Systematic review and meta-analysis of RCTs examining the effects of berberine on metabolic profiles in type 2 diabetic patients.
          • Summary: Berberine significantly reduced glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), and 2-hour postprandial blood glucose (2hPG) levels. It also improved insulin resistance and lipid profiles, with reductions in triglycerides (TG), total cholesterol (TC), and low-density lipoprotein (LDL) levels, and an increase in high-density lipoprotein (HDL) levels.
  14. Berberine Phospholipid Is an Effective Insulin Sensitizer and Improves Metabolic and Hormonal Disorders in Women with Polycystic Ovary Syndrome: A One-Group Pretest-Post-Test Explanatory Study.
          • Nutrients. 2021 Oct 19;13(10):3665.
          • Design: One-group pretest-post-test explanatory study evaluating the effects of berberine on insulin sensitivity and metabolic and hormonal disorders in women with polycystic ovary syndrome (PCOS).
          • Summary: Berberine supplementation significantly decreased insulin resistance, inflammatory markers (CRP, TNF-α), triglycerides, testosterone, body mass index (BMI), visceral adipose tissue (VAT), fat mass, and acne scores. It also increased sex hormone-binding globulin (SHBG) levels without significant adverse effects.
  15. Effectiveness and safety of Bifidobacterium and berberine in human hyperglycemia and their regulatory effect on the gut microbiota: a multi-center, double-blind, randomized, parallel-controlled study.
          • Genome Med. 2021 Aug 9;13(1):125.
          • Design: Multi-center, double-blind, randomized, parallel-controlled study evaluating the effects of berberine and Bifidobacterium on hyperglycemia and gut microbiota regulation.
          • Summary: Berberine and Bifidobacterium treatment significantly reduced fasting plasma glucose (FPG) and 2-hour postprandial plasma glucose levels. The combination also lowered HbA1c levels and altered gut microbiota composition, enhancing the hypoglycemic effect of berberine.
  16. Effect of Berberine on Cardiovascular Disease Risk Factors: A Mechanistic Randomized Controlled Trial.
          • Nutrients. 2021 Jul 26;13(8):2550.
          • Design: Randomized, double-blind, placebo-controlled trial assessing the effects of berberine on cardiovascular disease risk factors in men.
          • Summary: Berberine significantly reduced total cholesterol and possibly low-density lipoprotein cholesterol (LDL-c) levels. It also showed a potential increase in testosterone levels. No serious adverse events were reported.
  17. Effectiveness and Safety of Novel Nutraceutical Formulation Added to Ezetimibe in Statin-Intolerant Hypercholesterolemic Subjects with Moderate-to-High Cardiovascular Risk.
          • J Med Food. 2021 Jan;24(1):59-66.
          • Design: Open-label randomized study evaluating the effectiveness and safety of a nutraceutical compound combined with ezetimibe in statin-intolerant hypercholesterolemic subjects.
          • Summary: The nutraceutical combination significantly reduced total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-c) levels compared to ezetimibe alone, without significant adverse effects. Improvements in triglycerides and high-density lipoprotein cholesterol (HDL-c) levels were not observed.
  18. The effect of berberine supplementation on obesity parameters, inflammation and liver function enzymes: A systematic review and meta-analysis of randomized controlled trials.
          • Clin Nutr ESPEN. 2020 Aug;38:43-49.
          • Design: Systematic review and meta-analysis of RCTs examining the effects of berberine on obesity parameters, inflammation, and liver function enzymes.
          • Summary: Berberine significantly reduced body weight, body mass index (BMI), waist circumference (WC), and C-reactive protein (CRP) levels. However, it did not significantly affect liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
  19. Efficacy of Nutraceutical Combination of Monacolin K, Berberine, and Silymarin on Lipid Profile and PCSK9 Plasma Level in a Cohort of Hypercholesterolemic Patients.
          • J Med Food. 2020 Jun;23(6):658-666.
          • Design: Study evaluating the effects of a nutraceutical combination containing Monacolin K, berberine, and silymarin on lipid profile and PCSK9 plasma levels in hypercholesterolemic patients.
          • Summary: The nutraceutical combination significantly reduced low-density lipoprotein cholesterol (LDL-c) and PCSK9 levels. It also improved the cholesterol loading capacity (CLC) and reduced foam cell generation, suggesting an antiatherogenic effect.
  20. A nutraceutical combination reduces left ventricular mass in subjects with metabolic syndrome and left ventricular hypertrophy: A multicenter, randomized, double-blind, placebo-controlled trial.
          • Clin Nutr. 2020 May;39(5):1379-1384.
          • Design: Multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy of a nutraceutical combination of berberine, red yeast rice extract, and policosanol (Armolipid Plus™) in reducing left ventricular mass (LVM) in patients with metabolic syndrome (MS) and left ventricular hypertrophy (LVH).
          • Summary: Treatment with Armolipid Plus™ for 24 weeks significantly reduced LVM in subjects with MS and LVH, compared to placebo, and improved lipid profiles. The study suggests this nutraceutical combination could be an effective strategy to reduce cardiovascular risk in these patients.
  21. Berberine and Dyslipidemia: Different Applications and Biopharmaceutical Formulations Without Statin-Like Molecules-A Meta-Analysis.
          • J Med Food. 2020 Feb;23(2):101-113.
          • Design: Meta-analysis of studies evaluating the efficacy of berberine alone or in combination with silymarin on dyslipidemia.
          • Summary: Berberine formulations significantly reduced total cholesterol (TC) and low-density lipoprotein (LDL) cholesterol levels. The combination with silymarin was particularly effective, possibly due to increased bioavailability. The study highlights berberine’s potential in managing dyslipidemia, especially when combined with other compounds like silymarin.
  22. The Effects of a New Generation of Nutraceutical Compounds on Lipid Profile and Glycaemia in Subjects with Pre-hypertension.
          • High Blood Press Cardiovasc Prev. 2019 Aug;26(4):345-350.
          • Design: Randomized study evaluating the effects of a new-generation nutraceutical compound containing red yeast rice, berberine, Coenzyme Q10, folic acid, and chrome on lipid profile and glycemia in subjects with pre-hypertension.
          • Summary: The nutraceutical compound significantly improved total cholesterol, LDL cholesterol, triglycerides, and glucose levels. HDL cholesterol levels increased only in the treatment group. The study indicates that this nutraceutical formulation is safe and effective in improving lipid and glucose profiles in subjects with pre-hypertension.
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