Effect of Berberine on Cardiovascular Disease Risk Factors: A Mechanistic Randomized Controlled Trial.

2021-07-26
Nutrients 13(8)
- Jie V Zhao
- Wai-Fung Yeung
- Yap-Hang Chan
- Dana Vackova
- June Y Y Leung
- Dennis K M Ip
- Jiaxi Zhao
- Wai-Kwan Ho
- Hung-Fat Tse
- Catherine Mary Schooling

PubMed: 34444711
DOI: 10.3390/nu13082550

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 84
Population: 84 eligible Chinese men with hyperlipidemia
Methods: randomized, double-blind, placebo-controlled, parallel trial; berberine (500 mg orally, twice a day) or placebo for 12 weeks
Blinding: Double-blind
Duration: 12 weeks
Funding: Unclear

Rigorous Journal

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.

Research Insights

Berberine→Increased Testosterone Level
berberine...possibly increased testosterone
Effect
Neutral
Effect size
Small
Dose
500 mg orally, twice a day
Berberine→Reduced Blood Cholesterol
berberine lowered total cholesterol...larger reductions in total cholesterol (-0.39 mmol/L, 95% confidence interval (CI) -0.70 to -0.08)
Effect
Beneficial
Effect size
Small
Dose
500 mg orally, twice a day
Berberine→Reduced Blood Pressure
Changes in...blood pressure...after the intervention did not differ between the berberine and placebo groups
Effect
Neutral
Effect size
Small
Dose
500 mg orally, twice a day
Berberine→Reduced Body Mass Index
Changes in...body mass index...after the intervention did not differ between the berberine and placebo groups
Effect
Neutral
Effect size
Small
Dose
500 mg orally, twice a day
Berberine→Reduced High-Density Lipoprotein Cholesterol Level
larger reductions in...high-density lipoprotein cholesterol (-0.07 mmol/L, 95% CI -0.13 to -0.01)
Effect
Harmful
Effect size
Small
Dose
500 mg orally, twice a day
Berberine→Reduced Low-Density Lipoprotein Level
berberine lowered total cholesterol and possibly low-density lipoprotein-cholesterol (LDL-c)
Effect
Neutral
Effect size
Small
Dose
500 mg orally, twice a day
Berberine→Reduced Thromboxane A2 Level
Changes in...thromboxane A2...after the intervention did not differ between the berberine and placebo groups
Effect
Neutral
Effect size
Small
Dose
500 mg orally, twice a day
Berberine→Reduced Triglyceride Levels
Changes in triglycerides...after the intervention did not differ between the berberine and placebo groups
Effect
Neutral
Effect size
Small
Dose
500 mg orally, twice a day
Berberine→Reduced Waist-to-Height Ratio
Changes in...waist-hip ratio after the intervention did not differ between the berberine and placebo groups
Effect
Neutral
Effect size
Small
Dose
500 mg orally, twice a day

Adverse Events Reported

Berberine→Overall tolerability
No serious adverse event was reported.
Finding
Reported