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.
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No serious adverse events associated with berberine were identified in this review.
“Consistent with previous systematic reviews, we did not identify any serious adverse events associated with berberine.(8, 10)”
From Overall and sex-specific effect of berberine for dyslipidemia: systematic review and meta-analysis of placebo-controlled trials (2022) · cites this paper as [10]
Prior reviews of berberine have limitations including that they included studies that did not make comparisons to placebo, compared berberine to diverse controls, assessed extracts from the barberry plant, or defined the intervention as combination nutraceutical products containing berberine.
“Prior reviews of berberine have several limitations as they included studies that did not make comparisons to placebo, compared berberine to diverse controls (e.g., statins, oral hypoglycemics, lifestyle modification), assessed extracts from the barberry plant or defined the intervention as combination nutraceutical products containing berberine such as Armolipid Plus®.(7-13)”
From Overall and sex-specific effect of berberine for dyslipidemia: systematic review and meta-analysis of placebo-controlled trials (2022) · cites this paper as [10]
Systematic reviews have previously reported the efficacy of berberine on the regulation of glycemic and lipid metabolisms.
“Systematic reviews have previously reported the efficacy of berberine on the regulation of glycemic and lipid metabolisms [16, 18].”
From The Effect of Berberine on Metabolic Profiles in Type 2 Diabetic Patients: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials (2021) · cites this paper as [18]
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“Consistent with previous systematic reviews, we did not identify any serious adverse events associated with berberine.(8, 10) Thus berberine appeared to be safe and well tolerated by trial participants when taken for up to 24 weeks.”
BackgroundMethodResultInfluential
- Authors
- Ju, J., Li, J., Lin, Q., & Xu, H.
- Affiliations
- Beijing University of Chinese Medicine (CN)
- China Academy of Chinese Medical Sciences (CN)
- Xiyuan Hospital (CN)
- Corresponding author
- Xu, Hao
- ORCID
- Venue
- Phytomedicine
- Publisher
- Elsevier BV
- Published
- 2018-11
- Volume
- 50
- Pages
- 25-34
- ISSN
- 0944-7113 (ISSN-L)
- OpenAlex
- W2893607518
- Cited by
- 124
- References
- 32
- Citations by year
- 2026: 17 · 2025: 15 · 2024: 9 · 2023: 20 · 2022: 21 · 2021: 19 · 2020: 14 · 2019: 7 · 2014: 1
- FWCI
- 1.17
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Phytomedicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Clinical Research Centre of Traditional Chinese Medicine (JDZX2015263)
- Capital's Funds for Health Improvement and Research (2018-1-4171)
- Topics
- Health Sciences › Medicine › Pharmacology › Berberine and alkaloids research
- Health Sciences › Medicine › Surgery › Natural Products and Biological Research
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Keywords
- berberine, dyslipidemia, lipid profile, total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol, adverse events, herbal medicine, lipid-lowering therapy, drug safety
- MeSH terms
- Berberine, Humans, Lipids, Cholesterol, HDL, Cholesterol, LDL, Triglycerides, Randomized Controlled Trials as Topic, Dyslipidemias
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