Effectiveness and safety of Bifidobacterium and berberine in human hyperglycemia and their regulatory effect on the gut microbiota: a multi-center, double-blind, randomized, parallel-controlled study
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BACKGROUND: Berberine and Bifidobacterium have been reported to improve glucose tolerance in people with hyperglycemia or other metabolic disorders. This study aimed to assess the hypoglycemic effect and the regulation of the gut microbiota caused by berberine and Bifidobacterium and the possible additive benefits of their combination. METHODS: This was an 18-week, multi-center, randomized, double-blind, parallel-controlled study of patients newly diagnosed with hyperglycemia. After a 2-week run-in period, 300 participants were randomly assigned to the following four groups for 16 weeks of treatment: berberine (Be), Bifidobacterium (Bi), berberine and Bifidobacterium (BB), and placebo group. The primary efficacy endpoint was the absolute value of fasting plasma glucose (FPG) compared with baseline after 16 weeks of treatment. RESULTS: Between October 2015 and April 2018, a total of 297 participants were included in the primary analysis. Significant reductions of FPG were observed in the Be and BB groups compared with the placebo group, with a least square (LS) mean difference of - 0.50, 95% CI [- 0.85, - 0.15] mmol/L, and - 0.55, 95% CI [- 0.91, - 0.20] mmol/L, respectively. The Be and BB groups also showed significant reductions in 2-h postprandial plasma glucose. A pronounced decrease in HbA1c occurred in the BB group compared to the placebo group. Moreover, compared with the Bi and placebo groups, the Be and BB groups had more changes in the gut microbiota from the baseline. CONCLUSIONS: Berberine could regulate the structure and function of the human gut microbiota, and Bifidobacterium has the potential to enhance the hypoglycemic effect of berberine. These findings provide new insights into the hypoglycemic potential of berberine and Bifidobacterium. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03330184. Retrospectively registered on 18 October 2017.
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Berberine was associated with greater hypoglycemic events and fewer hyperglycemic events than placebo in 4 studies.
“Given its ability to reduce blood glucose, berberine was associated with greater hypoglycemic events and fewer hyperglycemic events than placebo in 4 studies.(24, 29, 37, 39)”
From Overall and sex-specific effect of berberine for dyslipidemia: systematic review and meta-analysis of placebo-controlled trials (2022) · cites this paper as [24]
The Discussion reports that berberine lowered blood glucose compared with placebo. In Results > Safety assessments (Table 3; page unavailable), a higher proportion of berberine participants had a hypoglycemia event (9/49 versus 14/99), but the number of events was lower (14 versus 19), and the table reports no significant difference. The paper does not report fewer hyperglycemic events; this source is one trial among the four cited, not evidence for the other three. (LLM, conf=0.86)
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- Authors
- Ming, J., Yu, X., Xu, X., Wang, L., Ding, C., Wang, Z., Xie, X., Li, S., Yang, W., Luo, S., He, Q., Du, Y., Tian, Z., Gao, X., Ma, K., Fang, Y., Li, C., Zhao, J., Wang, X., & Ji, Q.
- Affiliations
- Xijing Hospital (CN)
- Nanjing Drum Tower Hospital (CN)
- Second Affiliated Hospital of Xi'an Jiaotong University (CN)
- Yanan University Affiliated Hospital (CN)
- Xian Central Hospital (CN)
- Shangluo Central Hospital (CN)
- Air Force Medical University (CN)
- Shandong University (CN)
- Corresponding author
- Zhao, Jiajun
- Wang, Xiaokai
- Ji, Qiuhe
- ORCID
- Venue
- Genome Medicine
- Published
- 2021-08-09
- Volume
- 13
- Issue
- 1
- Pages
- 125-125
- ISSN
- 1756-994X (ISSN-L)
- PMC
- PMC8351344
- OpenAlex
- W3191335028
- Cited by
- 52
- References
- 54
- Citations by year
- 2026: 8 · 2025: 11 · 2024: 7 · 2023: 19 · 2022: 6 · 2021: 1
- FWCI
- 4.78
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Genome Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, cc-by)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Natural Science Foundation of Shaanxi Province, China (2013KTZB03-02-01)
- Key Research and Development Program of Shaanxi Province, China (2017ZDCXLSF0201)
- National Key R&D Program (2017YFC1309803)
- Topics
- Health Sciences › Medicine › Pharmacology › Berberine and alkaloids research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Natural Antidiabetic Agents Studies
- Keywords
- berberine, Bifidobacterium, hyperglycemia, gut microbiota, hypoglycemic effect, fasting blood glucose, postprandial blood glucose, HbA1c, glucose tolerance, combination therapy, prebiotics
- MeSH terms
- Gastrointestinal Microbiome, Aged, Berberine, Bifidobacterium, Blood Glucose, Combined Modality Therapy, Feces, Female, Humans, Hyperglycemia, Male, Middle Aged, Prognosis, Treatment Outcome, Disease Management, Probiotics
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