A Mechanistic Randomized Controlled Trial on the Cardiovascular Effect of Berberine
Status:
Completed
Trial end date:
2020-11-01
Target enrollment:
Participant gender:
Summary
Berberine is extracted from Coptis (Huanglian) and Phellodendron Chinese (Huangbai), to make
into berberine tablets.1 Recent studies have shown that berberine has beneficial effects on
cardiovascular disease (CVD) risk factors,1,2 such as lowering the risk of hyperlipidemia,
diabetes, and hypertension.1 In a comprehensive systematic review and meta-analysis of 27
randomized controlled trials (RCTs), berberine effectively reduced low density lipoprotein
cholesterol (LDL-c) (-0.65 mmol/L, 95% confidence interval (CI) -0.75 to -0.56),
triglycerides (TG) (-0.39 mmol/L, 95% CI -0.59 to -0.19), total cholesterol (TC) (-0.66
mmol/L, 95% CI -1.02 to -0.31) and increased high density lipoprotein cholesterol (HDL-c)
(0.07mmol/L, 95% CI 0.04 to 0.1).1 Notably, no serious adverse event has been reported in
these trials,1 suggesting a good tolerability of berberine. The mechanism by which berberine
exerts a protective role in atherosclerosis is unclear. Protoberberines have been identified
as a new inhibitor of AKR1C3, an enzyme responsible for the regulation of steroid hormone
action.3 The investigators propose to examine the effects of berberine on a set of
well-established CVD risk factors including lipids, systolic and diastolic blood pressure,
coagulation factors, adiposity, fasting glucose, insulin, and liver function, as well as to
examine potential mediation via testosterone and/or sex hormone binding globulin using a
mechanistic, randomized, double-blind, placebo-controlled trial in Chinese men with
hyperlipidemia.