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Efficacy and Safety of Berberine Alone for Several Metabolic Disorders: A Systematic Review and Meta-Analysis of Randomized Clinical Trials
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Background: Metabolic activity is the basic life activity of organisms and the fundamental for maintaining body functions. With the improvement of living standards, the incidence of metabolic disorder is also increasing. At present, most of the clinical treatment strategies and meta-analysis for metabolic disorder uncover that combined medicines with berberine ameliorate several metabolic disorders. However, evidence to disclose the therapeutic effect of berberine treatment alone and the possible factors affecting the efficacy is limited. Therefore, we have formulated strict inclusion criteria and selected more reliable data for meta-analysis through more refined screening strategies to provide evidence and guidance for clinical decision-making and understand the effect of berberine treatment alone and the factors affecting its efficacy. Methods and results: Using meta-analysis of “Cochrane Handbook for Systematic Reviews of Interventions” as guidelines, we searched PubMed, GeenMedical, Cochrane library, and china national knowledge infrastructure (CNKI) for trials reporting clinical treatment data of berberine. Another 417 trials were included through other sources to increase confidence in results. Among the 1,660 related documents retrieved from the four databases, 18 eligible documents were selected for analysis. Given the differences in trial design and measurement units, we used the standardized mean difference (SMD) method to eliminate the differences and then summarize the data for analysis. The main factors are triglyceride (TG), total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), homeostasis model assessment-insulin resistance (HOMA-IR), and fasting plasma glucose (FPG). Random-effect model analysis was performed: TG (SMD: 0.94; 95%CI: 0.49,1.38; p = 0.00), TC (SMD: 1.06; 95%CI: 0.64, 1.48; p = 0.00), LDL (SMD: 1.77; 95%CI: 1.11,2.44; p = 0.00), HDL (SMD: −1.59; 95%CI: −2.32, −0.85; p = 0.00), HOMA-IR (SMD: 1.25; 95%CI: 0.25,2.24; p = 0.01), and FPG (SMD: 0.65; 95%CI: 0.28,1.03; p = 0.00). This study aimed to conduct a systematic review and meta-analysis of the literature to evaluate the therapeutic effect of berberine singly on metabolic diseases. Conclusion: Berberine can improve obesity and hyperlipidemia by reducing TG, TC, and LDL and increasing HDL; reduce insulin resistance to improve type Ⅱ diabetes; and prevent diabetic encephalopathy.
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“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 [13]
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In the citing paper
“The anti-inflammatory effects of adiponectin in skeletal muscle are largely attributed to its ability to induce macrophage polarization toward an anti-inflammatory phenotype, characterized by the secretion of interleukin-10 (IL-10)”
From Exercise-Induced Muscle–Fat Crosstalk: Molecular Mediators and Their Pharmacological Modulation for the Maintenance of Metabolic Flexibility in Aging (2025) · cites this paper as [105]
Experimental — accuracy not yet measuredIn the citing paper
“Whether used alone or combined with other therapies, meta-analyses [16, 72] suggested that berberine improve obesity and hyperlipidemia by reducing TG, TC, and LDL and increasing HDL in the setting of several metabolic disorders along with improving glucose metabolism.”
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 [16]
In the citing paper
“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 [16]
In the citing paper
“Whether used alone or combined with other therapies, meta-analyses [16, 72] suggested that berberine improve obesity and hyperlipidemia by reducing TG, TC, and LDL and increasing HDL in the setting of several metabolic disorders along with improving glucose metabolism.”
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 [16]
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Metadata
- Authors
- Ye, Y., Liu, X., Wu, N., Han, Y., Wang, J., Yu, Y., & Chen, Q.
- Affiliations
- Hubei University of Science and Technology (CN)
- Hubei University of Medicine (CN)
- Corresponding author
- Yu, Yuandong
- Chen, Qingjie
- Venue
- Frontiers in Pharmacology
- Publisher
- Frontiers Media SA
- Published
- 2021-04-26
- Volume
- 12
- Pages
- 653887-653887
- ISSN
- 1663-9812 (ISSN-L)
- PMC
- PMC8107691
- OpenAlex
- W3160298538
- Cited by
- 109
- References
- 38
- Citations by year
- 2026: 18 · 2025: 28 · 2024: 18 · 2023: 24 · 2022: 15 · 2021: 6
- FWCI
- 1.99
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Frontiers in Pharmacology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Hubei Provincial Department of Education (BK202009, D20202803)
- Natural Science Foundation of Hubei Province (2020CFB851)
- Hubei University
- Hubei University of Science and Technology
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Berberine and alkaloids research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Natural Antidiabetic Agents Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Metabolism, Diabetes, and Cancer
- Keywords
- berberine, metabolic disorders, triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, insulin resistance, fasting blood glucose, serum lipids, treatment efficacy and safety
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