Trial reportGenome medicine2021
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.
Trial report in Genome medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03330184 (Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level), which is not on this map. Cited by 32 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level: an Multicenter, Randomized, Double-blinded, Placebo-controlled Study.
Who cites it
32 citing papers in PubMed, 8 syntheses or guidelines pooled it, 49 citations in OpenAlex.
- The Integrative Role of Berberine in Gut Microbiota Modulation and Cardiometabolic Outcomes: A Systematic Review of Randomised Clinical Trials.Nutrients · 2026Pooled it
- The relationship between intestinal flora and androgen level, glucose and lipid metabolism, inflammatory response and reproductive hormones: a systematic review and meta-analysis.BMC endocrine disorders · 2026Pooled it
- Pooled it
- The effect of berberine on obesity indices: a systematic review and meta-analysis.International journal of obesity (2005) · 2026Pooled it
- Efficacy and safety of berberine on the components of metabolic syndrome: a systematic review and meta-analysis of randomized placebo-controlled trials.Frontiers in pharmacology · 2025Pooled it
- The Effects of Bifidobacterium Probiotic Supplementation on Blood Glucose: A Systematic Review and Meta-Analysis of Animal Models and Clinical Evidence.Advances in nutrition (Bethesda, Md.) · 2024Pooled it
- The Effect of Probiotic Supplementation on Glucolipid Metabolism in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis.Nutrients · 2023Pooled it
- Pooled it
- Trial
- Intervening at the microbial crossroads: targeting inflammation across the oral-gut-reproductive microbiome crosstalk in atherosclerosis.Antonie van Leeuwenhoek · 2026Review
- Epitranscriptomics, immunometabolism, and NETosis: unlocking novel mechanisms of traditional Chinese medicine in COPD.Frontiers in immunology · 2026Review
- The Beneficial Effects of Berberine on Brain Functions in Age-Related Neurological Disorders: From Molecular Signaling to Treatment.Food science & nutrition · 2025Review
- Can Nature Overcome Invasive Gastrointestinal Infections?International journal of molecular sciences · 2025Review
- Diet-Microbiota-Host Interactions in Regulation of Cardiometabolic Homeostasis: Emerging Mechanisms and Therapeutic Potential.Microbiota and host · 2025Article
- Perspectives on Berberine and the Regulation of Gut Microbiota: As an Anti-Inflammatory Agent.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Multi-omics analysis identifiesFrontiers in microbiology · 2025Article
- Repurposed Drugs and Plant-Derived Natural Products as Potential Host-Directed Therapeutic Candidates for Tuberculosis.Biomolecules · 2024Review
- Efficacy and Molecular Mechanism of Quercetin on Constipation Induced by Berberine via Regulating Gut Microbiota.International journal of molecular sciences · 2024Article
- The Impact of ProbioticLife (Basel, Switzerland) · 2024Review
- Environmental Cadmium Exposure Perturbs Gut Microbial Dysbiosis in Ducks.Veterinary sciences · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 11 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBerberine 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.
methodsThis 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.
resultsBetween 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.
conclusionsBerberine 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 registrationClinicalTrials.gov , NCT03330184. Retrospectively registered on 18 October 2017.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.