Efficacy and safety of berberine for dyslipidaemias: A systematic review and meta-analysis of randomized clinical trials

Abstract

Background: In recent years, berberine has become widely used as an effective alternative to treat dyslipidaemias; much clinical evidence has emerged. It is important to systematically and critically evaluate the existing evidence.

Purpose: This study aims to evaluate the efficacy and safety of berberine in patients with dyslipidaemias.

Study design: A systematic review and meta-analysis of randomized clinical trials.

Methods: Five electronic databases were searched up to Apr 15, 2018 to identify randomized controlled trials (RCTs) of berberine in treatment of dyslipidaemias. The outcomes were lipid profile parameters and adverse events. Study selection, data collection, risk of bias assessment, data analyses and interpretations were conducted according to the Cochrane handbook.

Results: Sixteen trials with total of 2147 participants were judged to be eligible and were included in the meta-analysis. The included trials were assessed to be of high clinical heterogeneity. The methodological quality of the majority of the trials was generally low in terms of random sequence generation, allocation concealment, blinding and incomplete outcome data. Thus, selection bias, performance bias, detection bias, attrition bias and confounding bias might exist. Meta-analysis showed that berberine significantly reduced levels of total cholesterol (TC) (MD = -0.47 mmol/l 95% CI [-0.64, -0.31], p < 0.00001), low-density lipoprotein cholesterol (LDL-C) (MD =-0.38 mmol/l 95% CI [-0.53, -0.22], p < 0.00001) and triglycerides (TG) (MD = -0.28 mmol/l 95% CI [-0.46, -0.10], p = 0.002). Berberine also increased the level of high-density lipoprotein cholesterol (HDL-C) when used alone (MD = 0.08 mmol/l 95% CI [0.03, 0.12], p = 0.001). No significant differences were found between groups in terms of incidence of adverse events (RR = 0.64 95% CI [0.31, 1.30], p = 0.22). No severe adverse effects were reported in either group.

Conclusion: Berberine improves lipid profiles in dyslipidaemias with satisfactory safety. Nevertheless, these findings should be interpreted with caution because of the high clinical heterogeneity and high risk of bias in the included trials. Rigorous clinical trials should be carried out to provide more reliable evidence.

Keywords: Berberine; CAD; CAS; Dyslipidaemias; HDL-C; IGT; ITT; LDL-C; LLDs; Lipid profile; Meta-analysis; RCTs; Randomized controlled trial; Systematic review; T2DM; TC; TG; carotid atherosclerosis; coronary artery disease ITT, intention-to-treat; high-density lipoprotein cholesterol; impaired glucose tolerance; intention-to-treat; lipid-lowering drugs; low-density lipoprotein cholesterol; randomized controlled trials; total cholesterol; triglycerides; type 2 diabetes mellitus.