Abstract
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.
Highlights
Cardiovascular disease (CVD) is a major contributor to the global burden of morbidity and mortality, with higher incidence and mortality rates in men than in women [1,2], and a corresponding need for, possibly sex-specific, innovations in prevention and treatment.Recently, development of new therapeutics for CVD prevention and treatment focusing on addressing lipid and inflammatory pathways has encountered repeated expensive failures, which has discouraged investment [3].Berberine, an isoquinoline plant alkaloid [4], is widely used in traditional Chinese and Ayurvedic medicine [5]
The trial was conducted following the requirement of International Council for Harmonisation (ICH) Good Clinical Practice (GCP) standards, and reported according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines
Our findings extend the current evidence by assessing the effect of berberine in men only, including the effect on testosterone
Summary
Cardiovascular disease (CVD) is a major contributor to the global burden of morbidity and mortality, with higher incidence and mortality rates in men than in women [1,2], and a corresponding need for, possibly sex-specific, innovations in prevention and treatment. An isoquinoline plant alkaloid [4], is widely used in traditional Chinese and Ayurvedic medicine [5]. Berberine is highly concentrated in the roots, rhizomes and stem bark of several plants, such as Coptis (Huanglian), Rhizoma coptidis and Hydrastis canadensis (goldenseal) [9]. Berberine is extracted from Coptis (Huanglian) and Phellodendron Chinese (Huangbai), to make into compound berberine tablets, currently used in clinical practice for digestive diseases [8]. Berberine is widely used as a nutrient supplement in the US
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