Berberine Extract
CLINICAL STUDIES ON THE FOLLOWING INGREDIENTS:
Efficacy and Safety of Berberine Alone for Several Metabolic Disorders: A Systematic Review and Meta-Analysis of Randomized Clinical Trials
Abstract
Objective: To evaluate the therapeutic effect and safety of berberine alone on metabolic diseases through a systematic review and meta-analysis of randomized controlled trials (RCTs).
Setting: Pertinent studies were identified using PubMed, GeenMedical, Cochrane Library, and China National Knowledge Infrastructure (CNKI) databases up to April 2021. Standardized Mean Differences (SMD) were pooled using a random-effects model.
Results: Results of 18 RCTs showed significant improvements in several metabolic parameters following berberine supplementation. Specifically, berberine led to a significant reduction in triglyceride levels (TG) (SMD: 0.94; 95%CI: 0.49,1.38; p = 0.00), total cholesterol (TC) (SMD: 1.06; 95%CI: 0.64, 1.48; p = 0.00), and low-density lipoprotein (LDL) (SMD: 1.77; 95%CI: 1.11,2.44; p = 0.00). Additionally, berberine supplementation resulted in a significant increase in high-density lipoprotein (HDL) (SMD: -1.59; 95%CI: −2.32, −0.85; p = 0.00), and a reduction in homeostasis model assessment-insulin resistance (HOMA-IR) (SMD: 1.25; 95%CI: 0.25,2.24; p = 0.01) and fasting plasma glucose (FPG) (SMD: 0.65; 95%CI: 0.28,1.03; p = 0.00).
Conclusion: Berberine supplementation significantly improves metabolic parameters related to obesity, hyperlipidemia, insulin resistance, and type II diabetes, and may have a role in preventing diabetic encephalopathy.
Source: Ye, Y., Liu, X., Wu, N., Han, Y., Wang, J., Yu, Y., & Chen, Q. (2021). Efficacy and Safety of Berberine Alone for Several Metabolic Disorders: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Frontiers in Pharmacology, 12, 653887.
Effect of Berberine on Cardiovascular Disease Risk Factors: A Mechanistic Randomized Controlled Trial
Abstract
Objective: To assess berberine's impact on cardiovascular disease (CVD) risk factors and potential pathways via testosterone in hyperlipidemic men.
Methods: A randomized, double-blind, placebo-controlled trial was conducted in Hong Kong. 84 Chinese men with hyperlipidemia received berberine (500 mg orally, twice a day) or a placebo for 12 weeks. CVD risk factors (lipids, thromboxane A2, blood pressure, BMI, WHR) and testosterone were evaluated.
Results: Berberine significantly lowered total cholesterol (-0.39 mmol/L) and HDL-cholesterol (-0.07 mmol/L) at 12 weeks. The results indicate that berberine lowered total cholesterol, possibly LDL-c, and potentially raised testosterone. There were no significant adverse events reported.
Conclusion: Berberine holds promise for lowering cholesterol and potentially increasing testosterone in men, suggesting sex-specific effects. Further pathway exploration is warranted.
Source: Zhao, J. V., Yeung, W.-F., Chan, Y.-H., Vackova, D., Leung, J. Y. Y., Ip, D. K. M., ... & Schooling, C. M. (2021). Effect of Berberine on Cardiovascular Disease Risk Factors: A Mechanistic Randomized Controlled Trial. Nutrients, 13(8), 2550.
The Effect of Berberine on Metabolic Profiles in Type 2 Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Abstract
Objective: To evaluate the efficacy and safety of berberine in the treatment of patients with type 2 diabetes mellitus (T2DM) by examining its effects on glycemic control, insulin resistance, lipid profiles, and inflammation.
Methods: A systematic review and meta-analysis of randomized controlled trials (RCTs) from eight databases (PubMed, Embase, Web of Science, Cochrane Library, CNKI, SinoMed, Wanfang Database, and Chinese VIP Information) up to April 2021. Data were extracted on glycemic metabolism, insulin resistance, lipid profiles, inflammation factors, and safety outcomes.
Results: Forty-six trials were included. Meta-analysis showed significant reductions in glycosylated hemoglobin (HbA1c) (MD = −0.73; 95% CI (−0.97, −0.51)), fasting plasma glucose (FPG) (MD = −0.86, 95% CI (−1.10, −0.62)), and 2-hour postprandial blood glucose (2hPG) (MD = −1.26, 95% CI (−1.64, −0.89)). Improved insulin resistance was indicated by reductions in fasting blood insulin (FINS) (MD = −2.05, 95% CI (−2.62, −1.48)), homeostasis model assessment-insulin resistance (HOMA-IR) (MD = −0.71, 95% CI (−1.03, −0.39)), and body mass index (BMI) (MD = −1.07, 95% CI (−1.76, −0.37)). Lipid profiles were ameliorated with reductions in triglyceride (TG) (MD = −0.5, 95% CI (−0.61, −0.39)), total cholesterol (TC) (MD = 0.64, 95% CI (−0.78, −0.49)), and low-density lipoprotein (LDL) (MD = 0.86, 95% CI (−1.06, −0.65)), and increased high-density lipoprotein (HDL) (MD = 0.17, 95% CI (0.09, 0.25)). Berberine also improved inflammation factors.
Conclusion: Strong evidence supports the clinical efficacy and safety of berberine in treating T2DM, especially as an adjunctive therapy, potentially guiding targeted clinical use and the development of medications.
Source: Guo, J., Chen, H., Zhang, X., Lou, W., Zhang, P., Qiu, Y., ... & Liu, W. J. (2021). The Effect of Berberine on Metabolic Profiles in Type 2 Diabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Evidence-Based Complementary and Alternative Medicine, 2021.
Study on the Effect of Berberine, Myoinositol, and Metformin in Women with Polycystic Ovary Syndrome: A Prospective Randomised Study
Abstract
Objective: To compare the effects of berberine, metformin, and myoinositol on clinical, metabolic, hormonal, and lipid parameters in women with polycystic ovary syndrome (PCOS).
Methods: Women with PCOS were randomly assigned to receive either berberine hydrochloride 500 mg twice daily, metformin hydrochloride 500 mg twice daily, or myoinositol 1000 mg twice daily for three months. Clinical (weight, waist circumference, waist-to-hip ratio, BMI), metabolic (fasting blood sugar, serum fasting insulin, FBS/FI ratio), hormonal (serum total testosterone [TT], serum sex hormone-binding globulin [SHBG], free androgen index), and lipid profile parameters were assessed.
Results: All three groups showed significant improvements in weight, BMI, waist circumference, waist-hip ratio, FBS, FI and fasting glucose/insulin ratio, total testosterone, free androgen index (FAI), SHBG, total cholesterol, triglycerides, LDL, VLDL, and HDL after three months of treatment (p<0.0001). Berberine showed greater differences in clinical, hormonal, and lipid parameters compared to metformin and myoinositol, while myoinositol showed greater improvement in carbohydrate metabolic parameters.
Conclusion: Metformin improves all parameters in PCOS women. Berberine may have greater potential to reduce cardiovascular disease risk in PCOS patients due to its effect on body composition, lipid profile, and improvement in hormone status. Myoinositol improves endocrine parameters and insulin sensitivity, making it a potential first-line option in PCOS patients with insulin resistance but without prediabetes or diabetes.
Source: Mishra, N., & Verma, R., & Jadaun, P. (2022). Study on the Effect of Berberine, Myoinositol, and Metformin in Women with Polycystic Ovary Syndrome: A Prospective Randomised Study. Cureus 14(2), e22755.
Berberine as a Potential Anticancer Agent: A Comprehensive Review
Abstract
Objective: To consolidate salient information concerning the promising anticancer activity of berberine (BBR), a bioactive agent with remarkable health benefits.
Methods: A comprehensive review of literature regarding the sources, extraction methods, pharmacokinetic and pharmacodynamic profiles, and proposed mechanisms of action associated with BBR's anticancer potential.
Results: BBR exhibits therapeutic efficacy in several cancers, including colon, breast, pancreatic, liver, oral, bone, cutaneous, prostate, intestine, and thyroid cancers. BBR prevents cancer cell proliferation by inducing apoptosis, controlling the cell cycle, and promoting autophagy. BBR also hinders tumor cell invasion and metastasis by down-regulating metastasis-related proteins. BBR is beneficial in early cancer stages by lowering epithelial-mesenchymal transition protein expression.
Conclusion: BBR shows promising anticancer potential and may be a valuable candidate in treating different types of cancers. The comprehensive knowledge summarized in this review provides a baseline for researchers and drug developers.
Source: Rauf, A., Abu-Izneid, T., Khalil, A. A., Imran, M., Shah, Z. A., Emran, T. B., ... & Gondal, T. A. (2021). Berberine as a Potential Anticancer Agent: A Comprehensive Review. Molecules, 26(24), 7736.
Berberine pharmacology and the gut microbiota: A hidden therapeutic link
Abstract
Objective: To scrutinize evidence suggesting the gut microbiota as targets for the multifunctional role of berberine, a natural isoquinoline alkaloid found in many medicinal plants, and to show that structural and numerical changes in the gut microbiota under pathological conditions are reversed by berberine.
Methods: Examination of existing evidence linking the gut microbiota to the polypharmacology of berberine, using examples in pharmacokinetics, obesity, hyperlipidaemia, diabetes, cancer, and inflammatory disease conditions.
Results: Berberine's effects in ameliorating intestinal inflammation, including direct antibacterial action against Escherichia coli and Clostridium difficile, are linked to structural and numerical changes in the gut microbiota. Berberine may have promising effects as an antimicrobial agent.
Conclusion: Berberine is a multifunctional natural product with diverse therapeutic applications, and its organoprotective effects could be linked to its impact on the gut microbiota.
Source: Habtemariam, S. (2020). Berberine pharmacology and the gut microbiota: A hidden therapeutic link. Pharmacological Research, 155, 104722.
Effect of Berberine on Cardiovascular Disease Risk Factors: A Mechanistic Randomized Controlled Trial
Abstract
Objective: To assess the effect of berberine on cardiovascular disease (CVD) risk factors and its potential pathway via testosterone in men with hyperlipidemia.
Methods: A randomized, double-blind, placebo-controlled trial was conducted in Hong Kong with 84 Chinese men with hyperlipidemia. Participants received berberine (500 mg orally, twice a day) or placebo for 12 weeks. CVD risk factors (lipids, thromboxane A2, blood pressure, BMI, WHR) and testosterone were assessed at baseline, and 8 and 12 weeks after intervention.
Results: Men taking berberine had larger reductions in total cholesterol (-0.39 mmol/L, 95% CI -0.70 to -0.08) and HDL-cholesterol (-0.07 mmol/L, 95% CI -0.13 to -0.01) after 12 weeks. Berberine lowered total cholesterol, possibly LDL-c, and may have increased testosterone, considering changes after 8 and 12 weeks. No serious adverse events were reported.
Conclusion: Berberine is a promising treatment for lowering cholesterol and may increase testosterone in men, suggesting sex-specific effects.
Source: Zhao, J. V., Yeung, W.-F., Chan, Y.-H., Vackova, D., Leung, J. Y. Y., Ip, D. K. M., ... & Schooling, C. M. (2021). Effect of Berberine on Cardiovascular Disease Risk Factors: A Mechanistic Randomized Controlled Trial. Nutrients, 13(8), 2550.
Berberine at sub-inhibitory concentration inhibits biofilm dispersal in Staphylococcus aureus
Abstract
Objective: To investigate the effect of berberine on biofilm development in Staphylococcus aureus NCTC8325 and explore the possible mechanism of berberine as it relates to drug resistance in this human pathogen.
Methods: Susceptibility tests were conducted to see how berberine inhibits growth of methicillin-sensitive S. aureus (MSSA), methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA) at different concentrations. S. aureus NCTC8325 was chosen as a model strain to further explore the berberine effect.
Results: The MIC of berberine for S. aureus NCTC8325 is 256 µg ml-1. Berberine below 32 µg ml-1 inhibits the dispersal of biofilm and stimulates clumping of cells of NCTC8325 in a concentration-dependent manner, while not showing obvious inhibition on the bacterial growth. The transcription of the key negative regulator of biofilm dispersal AgrA is decreased. Transcription of some genes involving synthesis of biofilm structure components, including polysaccharide intracellular adhesin (PIA), proteins and eDNA were also up-regulated, especially icaA for PIA synthesis. And consistently, PIA content was increased in cells exposed to berberine at 32 µg ml-1.
Conclusion: Berberine inhibition of biofilm dispersal depends on the Agr system.
Source: Zhang, C., Li, Z., Pan, Q., Fan, L., Pan, T., Zhu, F., ... & Zhao, L. (2022). Berberine at sub-inhibitory concentration inhibits biofilm dispersal in Staphylococcus aureus. Microbiology, 168(10).
The effect of berberine supplementation on obesity parameters, inflammation and liver function enzymes: A systematic review and meta-analysis of randomized controlled trials
Abstract
Objective: A systematic review and meta-analysis of randomized controlled trials (RCTs) to analyze the effects of berberine on anthropometric parameters, C-reactive protein (CRP), and liver enzymes.
Methods: Electronic databases (MEDLINE, EMBASE, Web of Science, Cochrane Library, PubMed, and Google Scholar) were searched for eligible studies published up to July 30, 2019. Data were pooled using the inverse variance method, with results expressed as mean difference with 95% Confidence Intervals (95% CI).
Results: Twelve studies were included. Berberine treatment significantly decreased body weight (WMD = -2.07 kg, 95% CI -3.09, -1.05, P < 0.001), body mass index (BMI) (WMD = -0.47 kg/m2, 95% CI -0.70, -0.23, P < p 0.001), waist circumference (WC) (WMD = -1.08 cm, 95% CI -1.97, -0.19, P = 0.018), and C-reactive protein (CRP) concentrations (WMD = -0.42 mg/L, 95% CI -0.82, -0.03, P = 0.034). Berberine intake did not significantly affect liver enzymes (ALT, AST).
Conclusion: Berberine intake is associated with a significant reduction of body weight, BMI, WC, and CRP levels, which may indirectly improve clinical symptoms in diseases with metabolic disorders. Berberine did not significantly affect ALT and AST levels.
Keywords: Berberine; Body mass index; Body weight; C-reactive protein; Liver enzymes; Meta-analysis.
Source: Asbaghi, O., Ghanbari, N., Shekari, M., Reiner, Ž., Amirani, E., Hallajzadeh, J., Mirsafaei, L., & Asemi, Z. (2020). The effect of berberine supplementation on obesity parameters, inflammation and liver function enzymes: A systematic review and meta-analysis of randomized controlled trials. Clinical Nutrition ESPEN, 38, 43-49.
References:
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8107691/pdf/fphar-12-653887.pdf
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8401658/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8696197/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8890747/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8658774/
- https://www.sciencedirect.com/science/article/abs/pii/S1043661820301493?casa_token=9HZEccotgjsAAAAA:zJ5jCv41Y86vIsqSIVEaqrWw0B8Ior6-hBoEZXf0DU28Au4J0pNMSCs8AH0sIhPqfj8QYmzCKRc
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8401658/
- https://pubmed.ncbi.nlm.nih.gov/36178801/
- https://pubmed.ncbi.nlm.nih.gov/32690176/