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Treatment of Type 2 Diabetes and Dyslipidemia with the Natural Plant Alkaloid Berberine
Abstract
Context: Berberine, a natural plant alkaloid, is usually used as an antibiotic drug. The potential glucose-lowering effect of berberine was noted when it was used for diarrhea in diabetic patients. In vitro and in vivo studies have then showed its effects on hyperglycemia and dyslipidemia. Objective: The objective of the study was to evaluate the efficacy and safety of berberine in the treatment of type 2 diabetic patients with dyslipidemia. Design: One hundred sixteen patients with type 2 diabetes and dyslipidemia were randomly allocated to receive berberine (1.0 g daily) and the placebo for 3 months. The primary outcomes were changes in plasma glucose and serum lipid concentrations. Glucose disposal rate (GDR) was measured using a hyperinsulinemic euglycemic clamp to assess insulin sensitivity. Results: In the berberine group, fasting and postload plasma glucose decreased from 7.0 ± 0.8 to 5.6 ± 0.9 and from 12.0 ± 2.7 to 8.9 ± 2.8 mm/liter, HbA1c from 7.5 ± 1.0% to 6.6 ± 0.7%, triglyceride from 2.51 ± 2.04 to 1.61 ± 1.10 mm/liter, total cholesterol from 5.31 ± 0.98 to 4.35 ± 0.96 mm/liter, and low-density lipoprotein-cholesterol from 3.23 ± 0.81 to 2.55 ± 0.77 mm/liter, with all parameters differing from placebo significantly (P < 0.0001, P < 0.0001, P < 0.0001, P = 0.001, P < 0.0001, and P <0.0001, respectively). The glucose disposal rate was increased after berberine treatment (P = 0.037), although no significant change was found between berberine and placebo groups (P = 0.063). Mild to moderate constipation was observed in five participants in the berberine group. Conclusions: Berberine is effective and safe in the treatment of type 2 diabetes and dyslipidemia.
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“Two cases of liver function abnormalities were reported in one study in the berberine group,(29) although two studies reported no increase or a decrease in liver transaminases with berberine.(32, 34)”
From Overall and sex-specific effect of berberine for dyslipidemia: systematic review and meta-analysis of placebo-controlled trials (2022) · cites this paper as [32]
In the citing paper
“Further analysis suggested that this was likely due to most participants in this subgroup having normal blood glucose levels, as berberine does not significantly affect normal values for these indicators (Zhang et al., 2008; An et al., 2014; Wang et al., 2016b).”
From Efficacy and safety of berberine on the components of metabolic syndrome: a systematic review and meta-analysis of randomized placebo-controlled trials (2025) · cites this paper as Zhang et al., 2008
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“0 g/day/person for 3 months is effective and safe in the treatment of type 2 diabetes and dyslipidemia [15].”
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“Two trials of berberine in subjects newly diagnosed with type 2 diabetes (49,50) revealed favorable effects on plasma glucose, lipids, and HbA1c, although neither plasma berberine levels nor AMPK activation were assessed.”
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“Zhang et al. (2008) studied the antidiabetic properties of berberine (1000 mg daily for 3 months) and it was concluded that berberine is safe to be employed in humans, with the exception that it produced mild to moderate constipation in some individuals as compared to a placebo control group.”
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“The high dose of berberine (63mg/kg) can decrease left ventricular end-diastolic pressure, improve [-dp/dt(max)], decurtate left ventricular relax time constant quantity and decrease [Ca2+]i level in diastole heart failure rat models (Zhang et al., 2008b).”
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Berberine Improves Glucose Metabolism in Diabetic Rats by Inhibition of Hepatic Gluconeogenesis
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“[9], three from the placebo group and one from the berberine group due to losing followup.”
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“Although numerous clinical studies have demonstrated its strong effects in the treatment of DM[67-69], there was few studies at this stage about the usage of BBR in DKD patients.”
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“Recently, it was found that berberine was effective and safe in the treatment of type 2 diabetic patients with dyslipidemia (Yin et al., 2008b; Zhang et al., 2008).”
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Berberine-induced bioactive metabolites of the gut microbiota improve energy metabolism
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“In this study, berberine was effective in significantly lowering the biochemical parameters associated with diabetes with minor adverse effects, such as constipation (Y. Zhang et al., 2008).”
BackgroundEffects and mechanisms of berberine in diabetes treatment
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“Another confirmation that berberine is effective and safe in the treatment of type 2 diabetes and dyslipidemia came from a study [71] where 116 patients with type 2 diabetes and dyslipidemia were randomly allocated to receive berberine (1.”
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“Recent studies have shown that BBR decreases hyperglycemia, alleviates insulin resistance and inhibits lipid synthesis possibly via the activation of adenosine monophosphate-activated protein kinase (AMPK) [15–17].”
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“The efficacy and safety of berberine in the treatment of type 2 diabetes have been reported [53,54], which reinforces the anti-AD potential of berberine.”
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“%) in glycated hemoglobin (HBA1c), postprandial blood glucose, fasting blood glucose and plasma triglycerides were recorded in persons treated with berberine (Zhang et al., 2008).”
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“BBR bioavailability is usually less than 1% [21,22], the rapid biotransformation also accounts for the low plasma concentrations [10,23].”
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“In addition, a randomized, double-blind, placebo-controlled and multiple-center trial [3] showed that treatment with berberine (0.”
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Lipid-lowering effect of berberine in human subjects and rats
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“) when compared to other berberine trials (Kong et al. 2008; Yin et al. 2008; Zhang et al. 2008).”
BackgroundResultInfluentialBerberine Modulates Gut Microbiota and Reduces Insulin Resistance via the TLR4 Signaling Pathway
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“Low-dose berberine has also been proven to have beneficial effects for T2DM and dyslipidemia with few side effects [13, 14].”
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“Li’s group performed a randomized, double-blind, placebo controlled trial in four centers to evaluate the efficacy and safety of berberine in the treatment of DM and dyslipidemia, demonstrating that berberine is effective and safe in the treatment of type 2 DM and dyslipidemia [43].”
MethodBerberine promotes the recruitment and activation of brown adipose tissue in mice and humans
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“In addition, berberine, a natural plant alkaloid, is not only effective in lowering lipids and in the treatment of type 2 diabetes [13], but it also upregulates the number and function of circulating endothelial progenitor cells (EPCs), leading to increased nitric oxide production and endothelial function [14].”
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“Gastrointestinal symptoms such as diarrhea, constipation, flatulence and abdominal pain were the main reported side effects of BBR treatment in human subjects [191, 192].”
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“2008 [15] Randomized, double-blind, placebocontrolled and multiple-center trial 58/52 Newly diagnosed 51 ± 9/51 ± 10 Berberine/ placebo 0.”
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Modulating the Microbiota as a Therapeutic Intervention for Type 2 Diabetes
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Berberine is an insulin secretagogue targeting the KCNH6 potassium channel
Zhao, M., Lü, J., Li, S., Wang, H., Cao, X., Li, Q., Shi, T., Matsunaga, K., Chen, C., Huang, H., et al. (2021) · Nature Communications · doi:10.1038/s41467-021-25952-2 · Cited by 124
Self-citationBerberine as a promising anti-diabetic nephropathy drug: An analysis of its effects and mechanisms
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“In addition to evidence from animal models and cultured cells, the anti-inflammatory effect of berberine has also been identified in clinical studies (Zhang et al., 2008).”
BackgroundQin, X., Guo, B.-S., Wan, B., Fang, L., Lü, L., Wu, L., Zang, Y. Q., & Zhang, J. Z. (2010) · The Journal of Immunology · doi:10.4049/jimmunol.0903853 · Cited by 122
“The finding related to the IL-6–reducing effect of BBR is consistent with other reports that BBR treatment results in decreased expression of IL-6 in macrophages (44) and that reduced serum IL-6 levels were found in individuals treated with BBR in controlled clinical trials (36).”
BackgroundResultAntidiabetic claims of Tinospora cordifolia (Willd.) Miers: critical appraisal and role in therapy
Sharma, R., Amin, H., Galib, & Prajapati, P. (2015) · Asian Pacific Journal of Tropical Biomedicine · doi:10.1016/s2221-1691(15)30173-8 · Cited by 118
“Hypoglycaemic Decreases the blood glucose level and increases glucose tolerance [15]”
BackgroundEffect of berberine administration on metabolic syndrome, insulin sensitivity, and insulin secretion
Pérez-Rubio, K. G., González-Ortiz, M., Martínez-Abundis, E., Robles-Cervantes, J. A., & Espinel-Bermúdez, M. C. (2013) · Metabolic Syndrome and Related Disorders · doi:10.1089/met.2012.0183 · Cited by 113
“This was certainly due to an increment in insulin sensitivity and decrease in insulin secretion.(14,15) Similar findings regarding metabolic control have recently been published with the administration of berberine alone or in combination with other nutraceutical compounds.”
Gao, K., Yang, R., Zhang, J., Wang, Z., Jia, C., Zhang, F., Li, S., Wang, J., Murtaza, G., Xie, H., et al. (2018) · Pharmacological Research · doi:10.1016/j.phrs.2018.01.011 · Cited by 119
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“05).(19) One RCT revealed that Tangke soft capsules reduced the levels of HbAlc, FPG and 2hPG compared with baseline levels (P < .”
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“It has received increasing attention for a variety of metabolic benefits in recent years[24, 25].”
BackgroundTabeshpour, J., Imenshahidi, M., & Hosseinzadeh, H. (2017) · Europe PMC (PubMed Central) · doi:10.22038/ijbms.2017.8682 · Cited by 115
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“anti-microbial medicine, possesses an anti-hyperlipidemic potential [7, 8].”
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“, 2011), but also increasing insulin expression, β-cell regeneration, antioxidant enzyme activity, glucose uptake, while decreasing lipid peroxidation (Wang et al., 2009a; Zhang et al., 2008; Zhou et al., 2009) and cholesterol and triglyceride synthesis (Brusq et al.”
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Marazzi, G., Cacciotti, L., Pelliccia, F., Iaia, L., Volterrani, M., Caminiti, G., Sposato, B., Massaro, R., Grieco, F., & Rosano, G. (2011) · Advances in Therapy · doi:10.1007/s12325-011-0082-5 · Cited by 107
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Protective effect of berberine against LPS-induced injury in the intestine: a review
Izadparast, F., Riahi‐Zanjani, B., Yarmohammadi, F., Hayes, A. W., & Karimi, G. (2022) · Cell Cycle · doi:10.1080/15384101.2022.2100682 · Cited by 113
“Berberine has a diverse range of pharmacological actions, including anticancer [21–23], antidiabetic [24–26], antiobesity, anti-hyperlipidemic [25,27], cardio protective [25,28], and spatial memory improvement [25,29], immunosuppressive [30] properties, as well as antioxidant and anti-inflam matory activity [31,32].”
BackgroundBioactivities of berberine metabolites after transformation through CYP450 isoenzymes
Li, Y., Ren, G., Wang, Y.-X., Kong, W.-J., Yang, P., Wang, Y.-M., Li, Y.-H., Yi, H., Li, Z.-R., Song, D.-Q., et al. (2011) · Journal of Translational Medicine · doi:10.1186/1479-5876-9-62 · Cited by 109
“Clinical studies showed that oral administration of BBR caused significant reduction of blood cholesterol, triglyceride as well as glucose in patients with hyperlipidemia and type 2 diabetes [2,3,5-7], with no side-effects on liver, kidney and muscle [2,5].”
BackgroundSelf-citationWang, S., Ren, H., Zhong, H., Zhao, X., Li, C., Ma, J., Gu, X., Xue, Y., Huang, S., Yang, J., et al. (2021) · Gut Microbes · doi:10.1080/19490976.2021.2003176 · Cited by 110
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Berberine inhibits PTP1B activity and mimics insulin action
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Self-citationIqbal, M. J., Quispe, C., Javed, Z., Sadia, H., Qadri, Q. R., Raza, S., Salehi, B., Martins, N. A., Mohamed, Z. A., Mohammed, J. S., et al. (2021) · Frontiers in Molecular Biosciences · doi:10.3389/fmolb.2020.624494 · Cited by 106
“Pharmacokinetic profile of berberine has been reported in plenty of studies that it has low rate of absorption, especially when taken orally (Zhang et al., 2008; Alolga et al., 2016).”
BackgroundSarna, L. K., Wu, N., Hwang, S., Siow, Y. L., & Karmin, O. (2010) · Canadian Journal of Physiology and Pharmacology · doi:10.1139/y09-136 · Cited by 108
Berberine Inhibits Inflammatory Response and Ameliorates Insulin Resistance in Hepatocytes
Lou, T., Zhang, Z., Xi, Z., Liu, K., Li, L., Liu, B., & Huang, F. (2010) · Inflammation · doi:10.1007/s10753-010-9276-2 · Cited by 104
“modulation in sugar and lipid metabolic disorders [14].”
BackgroundProtective Effects of Berberine on Doxorubicin-Induced Hepatotoxicity in Mice
Zhao, X., Zhang, J., Tong, N., Chen, Y., & Luo, Y. (2012) · Biological and Pharmaceutical Bulletin · doi:10.1248/bpb.35.796 · Cited by 105
Berberine as a Promising Safe Anti-Cancer Agent- Is there a Role for Mitochondria?
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Self-citationBerberine and Its Study as an Antidiabetic Compound
Utami, A. R., Maksum, I. P., & Deawati, Y. (2023) · Biology · doi:10.3390/biology12070973 · Cited by 110
Metadata
- Authors
- Zhang, Y., Li, X., Zou, D., Liu, W., Yang, J., Zhu, N., Huo, L., Wang, M., Hong, J., Wu, P., Ren, G., & Ning, G.
- Affiliations
- Shanghai Jiao Tong University (CN)
- Second Military Medical University (CN)
- Department of Endocrinology (J.Y., G.R.), Min-Hang Hospital, Shanghai 201100, People’s Republic of China
- Corresponding author
- Ning, Guang
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2008-07-01
- Volume
- 93
- Issue
- 7
- Pages
- 2559-2565
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W1969395627
- Cited by
- 573
- References
- 23
- Citations by year
- 2026: 30 · 2025: 27 · 2024: 28 · 2023: 33 · 2022: 41 · 2021: 54 · 2020: 46 · 2019: 42 · 2018: 33 · 2017: 23 · 2016: 29 · 2015: 32 · 2014: 34 · 2013: 31 · 2012: 25
- FWCI
- 14.72
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Berberine and alkaloids research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Natural Antidiabetic Agents Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Metabolism, Diabetes, and Cancer
- Keywords
- berberine, type 2 diabetes, dyslipidemia, glucose-lowering effect, insulin sensitivity, glucose disposal rate, hyperinsulinemic-euglycemic clamp, HbA1c, serum lipids, triglycerides, LDL cholesterol, total cholesterol, plant alkaloids, constipation, drug safety, antidiabetic therapy, lipid-lowering therapy
- MeSH terms
- Adult, Aged, Berberine, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Glycated Hemoglobin, Humans, Insulin, Insulin Resistance, Cholesterol, LDL, Male, Middle Aged, Triglycerides, Dyslipidemias
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