Effect of Berberine on Cardiovascular Disease Risk Factors: A Mechanistic Randomized Controlled Trial
Open accessAbstract
Cardiovascular disease (CVD) is a major contributor to the global burden of disease. Berberine, a long-standing, widely used, traditional Chinese medicine, is thought to have beneficial effects on CVD risk factors and in women with polycystic ovary syndrome. The mechanisms and effects, specifically in men, possibly via testosterone, have not been examined previously. To assess the effect of berberine on CVD risk factors and any potential pathway via testosterone in men, we conducted a randomized, double-blind, placebo-controlled, parallel trial in Hong Kong. In total, 84 eligible Chinese men with hyperlipidemia were randomized to berberine (500 mg orally, twice a day) or placebo for 12 weeks. CVD risk factors (lipids, thromboxane A2, blood pressure, body mass index and waist–hip ratio) and testosterone were assessed at baseline, and 8 and 12 weeks after intervention. We compared changes in CVD risk factors and testosterone after 12 weeks of intervention using analysis of variance, and after 8 and 12 weeks using generalized estimating equations (GEE). Of the 84 men randomized, 80 men completed the trial. Men randomized to berberine had larger reductions in total cholesterol (−0.39 mmol/L, 95% confidence interval (CI) −0.70 to −0.08) and high-density lipoprotein cholesterol (−0.07 mmol/L, 95% CI −0.13 to −0.01) after 12 weeks. Considering changes after 8 and 12 weeks together, berberine lowered total cholesterol and possibly low-density lipoprotein-cholesterol (LDL-c), and possibly increased testosterone. Changes in triglycerides, thromboxane A2, blood pressure, body mass index and waist–hip ratio after the intervention did not differ between the berberine and placebo groups. No serious adverse event was reported. Berberine is a promising treatment for lowering cholesterol. Berberine did not lower testosterone but instead may increase testosterone in men, suggesting sex-specific effects of berberine. Exploring other pathways and assessing sex differences would be worthwhile, with relevance to drug repositioning and healthcare.
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In the authors' randomized controlled trial in Chinese men, berberine increased serum testosterone.
“In our randomized controlled trial in Chinese men, berberine increased serum testosterone, whereas trials in women with polycystic ovary syndrome (PCOS) showed berberine decreased testosterone concentrations.(16-18)”
From Overall and sex-specific effect of berberine for dyslipidemia: systematic review and meta-analysis of placebo-controlled trials (2022) · cites this paper as [16]
The Results report a statistically significant increase in testosterone when measurements at 8 and 12 weeks were analyzed together in the randomized trial of Chinese men. However, the Abstract and Conclusions describe the effect as a *possible* increase, so the unqualified claim is stronger than the paper's conclusion. (LLM, conf=0.85)
Experimental — accuracy not yet measuredBerberine increases testosterone in men, as shown in the authors' previous randomized controlled trial.
“As shown in our previous randomized controlled trial, berberine increases testosterone in men.(16)”
From Overall and sex-specific effect of berberine for dyslipidemia: systematic review and meta-analysis of placebo-controlled trials (2022) · cites this paper as [16]
The Results report a statistically significant increase in testosterone when the 8- and 12-week measurements were analyzed together. But the Conclusions describe the increase as only possible, and the trial enrolled Chinese men with hyperlipidemia. The claim states an unqualified effect in men. (LLM, conf=0.88)
Experimental — accuracy not yet measuredBerberine may affect sex hormones and therefore exert sex-specific effects.
“Berberine may also affect sex hormones, and therefore exert sex-specific effects.”
From Overall and sex-specific effect of berberine for dyslipidemia: systematic review and meta-analysis of placebo-controlled trials (2022) · cites this paper as [16]
Trials in women with PCOS showed berberine decreased testosterone concentrations.
“In our randomized controlled trial in Chinese men, berberine increased serum testosterone, whereas trials in women with polycystic ovary syndrome (PCOS) showed berberine decreased testosterone concentrations.(16-18)”
From Overall and sex-specific effect of berberine for dyslipidemia: systematic review and meta-analysis of placebo-controlled trials (2022) · cites this paper as [16]
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- Authors
- Zhao, J. V., Yeung, W.-F., Chan, Y.-H., Vackova, D., Leung, J. Y. Y., Ip, D. K. M., Zhao, J., Ho, W.-K., Tse, H.-F., & Schooling, C. M.
- Affiliations
- University of Hong Kong (HK)
- Queen Mary Hospital (CN)
- School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China
- Pok Oi Hospital (HK)
- City University of New York (US)
- Corresponding author
- Zhao, Jie V.
- Venue
- Nutrients
- Publisher
- MDPI AG
- Published
- 2021-07-26
- Volume
- 13
- Issue
- 8
- Pages
- 2550
- ISSN
- 2072-6643 (ISSN-L)
- PMC
- PMC8401658
- OpenAlex
- W3185720742
- Cited by
- 58
- References
- 44
- Citations by year
- 2026: 10 · 2025: 12 · 2024: 16 · 2023: 12 · 2022: 8
- FWCI
- 5.25
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Nutrients (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Health and Medical Research Fund (15162621)
- Topics
- Health Sciences › Medicine › Pharmacology › Berberine and alkaloids research
- Health Sciences › Medicine › Surgery › Natural Products and Biological Research
- Health Sciences › Medicine › Complementary and alternative medicine › Traditional Chinese Medicine Analysis
- Keywords
- berberine, cardiovascular risk factors, hyperlipidemia, testosterone, cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, thromboxane A2, blood pressure, body mass index, waist-to-hip ratio, sex differences, traditional Chinese medicine, drug repurposing, men
- MeSH terms
- Heart Disease Risk Factors, Adult, Anticholesteremic Agents, Berberine, Blood Pressure, Cholesterol, Double-Blind Method, Humans, Hyperlipidemias, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Testosterone, Thromboxane A2, Triglycerides, Body Mass Index, Waist-Hip Ratio
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