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

Ming, Jie; Yu, Xuefeng; Xu, Xiaoqiang; Wang, Li; Ding, Chao; Wang, Zhifeng; Xie, Xuan; Li, Sheli; Yang, Wenjuan; Luo, Shu; He, Qingzhen; Du, Yafang; Tian, Zhufang; Gao, Xiling; Ma, Kaiyan; Fang, Yujie; Li, Chen; Zhao, Jiajun; Wang, Xiaokai; Ji, Qiuhe

doi:10.1186/s13073-021-00942-7

Cited by 35 publications

(58 citation statements)

References 54 publications

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“…Bifidobacterium is a common gram-positive anaerobic beneficial bacterium, which the stability of relative abundance is crucial for maintaining normal intestinal function and body health. 69 , 70 Studies have shown that the number of Bifidobacterium decreased in UC, and increasing in intestinal tract could alleviate UC. 71–73 However, the present study suggests that the relative abundance of Bifidobacterium did not change over 14 days, but increased significantly by 21 days.…”

Section: Discussionmentioning

confidence: 99%

Dynamic Changes in Gut Microbiome of Ulcerative Colitis: Initial Study from Animal Model

Gu¹,

Zhang²,

Han³

et al. 2022

JIR

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Background An animal model of DSS-induced UC has been widely used in basic research, and the dysbiosis of gut microbiome is one of the important pathogenetic mechanisms of DSS-induced UC, but its dynamic changes and correlation with inflammatory factors are not clear yet. Methods Clinical signs and tissue damage degree of C57BL/6 ulcerative colitis mice model induced by different concentrations of DSS were compared with that of normal mice, and finally the optimal concentration of DSS was determined. Then we analyzed the sequencing results of gut microbiome and inflammatory factors to determine the dynamic patterns of gut microbiome and their correlation with the inflammatory factors. Results DSS at 2.5% and 3.0% concentration could cause intestinal injury and induce colitis. However, 3.0% DSS resulted in higher mortality. In addition, there were dynamic changes of gut microbiome in DSS-induced UC model: the relative abundance of intestinal flora increased first and then decreased in Bacteroides , Parabacteroides , Romboutsia , Clostridium_sensu_stricto_1, Lachnospiraceae_NK4A136_group, norank_f_norank_o_Clostridia_UCG-014, Parasutterella , and decreased first and then increased in Lactobacillus , Muribaculum , norank_f_Muribaculaceae, in addition, Bifidobacterium , Coriobacteriaceae_UCG-002 and Enterorhabdus did not change in the first 14 days but increased significantly on day 21. Moreover, inflammatory cytokines were closely associated with the imbalance of the intestinal microbiota in mice with UC: most pathogenic bacteria in the intestinal tract of the UC animal model were positively correlated with pro-inflammatory factors and negatively correlated with anti-inflammatory factors, while beneficial bacteria were the opposite. Conclusion Intestinal microecology plays an important role in DSS-induced UC model, and the relative abundance of gut microbiome changes dynamically in the occurrence and development of ulcerative colitis.

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Section: Discussionmentioning

confidence: 99%

Dynamic Changes in Gut Microbiome of Ulcerative Colitis: Initial Study from Animal Model

Gu¹,

Zhang²,

Han³

et al. 2022

JIR

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“…A total of 16 studies met the eligibility criteria with 1,529 participants (n= 761 berberine; 768 = placebo; Table 1; Supplementary file 3 p. 2 shows records for each study). (16-18, 23, 24, 29, 31-40) All studies were conducted in young or middle-aged adults and none of the studies enrolled participants with a history of coronary artery disease or stroke. Thirteen studies (81%) were conducted in mainland China and Hong Kong.…”

Section: Resultsmentioning

confidence: 99%

“…Trial duration ranged from 4 to 24 weeks. Patients enrolled in the studies most frequently had type 2 diabetes mellitus,(23, 24, 32, 35, 39, 40) PCOS,(17, 18, 33, 38) dyslipidemia,(16, 31, 34, 36) or schizophrenia. (29, 37) One study exclusively enrolled men,(16) four studies exclusively enrolled women with PCOS,(17, 18, 33, 38) and the remaining studies enrolled both men and women.…”

Section: Resultsmentioning

confidence: 99%

“…(23) Corr for apoB was assumed to be 0.5 For studies that provided detailed results, we extracted their mean difference and SD difference directly. (23, 24) For studies that reported medians and interquartile ranges (IQR), we estimated the mean and SD as described in Luo and Wan. (25, 26)…”

Section: Methodsmentioning

confidence: 99%

“…(4) Nutraceutical supplements of berberine, produced using chemical synthesis, are widely available in Europe, North America, and Asia through local and online retailers. Berberine has been recommended as a complement to statins by both the International Lipid Expert Panel and the 2019 European Atherosclerosis Society/European Society of Cardiology Guidelines for the treatment of dyslipidemia in statin-intolerant patients,(5 24, 6) yet, these guidelines have not provided explicit recommendations on the use of berberine because of the lack of high-quality evidence.…”

Section: Introductionmentioning

confidence: 99%

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Overall and sex-specific effect of berberine for dyslipidemia: systematic review and meta-analysis of placebo-controlled trials

Blais

Xin

Zhao

2022

Preprint

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Background: Berberine is a nutraceutical that may improve lipid profiles. Berberine may also affect sex hormones and exert sex-specific effects, which has been overlooked. Objectives: To comprehensively review the efficacy and safety of lipid-lowering effect of berberine with consideration of potential sex disparity. Methods: Eligible studies were randomized controlled trials in adults that compared berberine versus placebo and measured blood lipids or lipoproteins. Studies were identified from Medline, Embase, Wanfang, CNKI, two clinical trial registries and previous systematic reviews. Mean differences (MD) were estimated using inverse variance weighting with random effects models. Risk of bias was assessed using the Cochrane risk of bias tool for randomized trials. Results: 16 studies were included with treatment of 4 to 24 weeks. Berberine reduced low-density lipoprotein (LDL) cholesterol (-0.45 mmol/L, 95% CI -0.60 to -0.31, 12 studies, n=1,224), total cholesterol (-0.47 mmol/L, 95% CI -0.61 to -0.33, 15 studies, n=1,397), triglycerides (-0.32 mmol/L, 95% CI -0.44 to -0.19, 16 studies, n=1,421) and apolipoprotein B (-0.25 mg/dL, 95% CI -0.40 to -0.11, 2 studies, n=127). Berberine increased high-density lipoprotein (HDL) cholesterol by 0.06 mmol/L (95% CI 0.00 to 0.12, 13 studies, n=1,248). Notably, the effect on HDL cholesterol was different in women (0.11 mmol/L, 95% CI 0.09 to 0.13) from that in men (-0.07 mmol/L, 95% CI -0.16 to 0.02). Gastrointestinal adverse events were the most frequently reported adverse events. Conclusions: Berberine decreased LDL cholesterol, triglycerides, and apolipoprotein B, with a potential sex-specific effect on HDL cholesterol. Large-scale trials considering sex disparity are required.

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The triangular relationship between traditional Chinese medicines, intestinal flora, and colorectal cancer

Zou,

Wang,

Zhang

et al. 2023

Medicinal Research Reviews

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Over the past decade, colorectal cancer has reported a higher incidence in younger adults and a lower mortality rate. Recently, the influence of the intestinal flora in the initiation, progression, and treatment of colorectal cancer has been extensively studied, as well as their positive therapeutic impact on inflammation and the cancer microenvironment. Historically, traditional Chinese medicine (TCM) has been widely used in the treatment of colorectal cancer via promoted cancer cell apoptosis, inhibited cancer metastasis, and reduced drug resistance and side effects. The present research is more on the effect of either herbal medicine or intestinal flora on colorectal cancer. The interactions between TCM and intestinal flora are bidirectional and the combined impacts of TCM and gut microbiota in the treatment of colon cancer should not be neglected. Therefore, this review discusses the role of intestinal bacteria in the progression and treatment of colorectal cancer by inhibiting carcinogenesis, participating in therapy, and assisting in healing. Then the complex anticolon cancer effects of different kinds of TCM monomers, TCM drug pairs, and traditional Chinese prescriptions embodied in apoptosis, metastasis, immune suppression, and drug resistance are summarized separately. In addition, the interaction between TCM and intestinal flora and the combined effect on cancer treatment were analyzed. This review provides a mechanistic reference for the application of TCM and intestinal flora in the clinical treatment of colorectal cancer and paves the way for the combined development and application of microbiome and TCM.

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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

Cited by 35 publications

References 54 publications

Dynamic Changes in Gut Microbiome of Ulcerative Colitis: Initial Study from Animal Model

Dynamic Changes in Gut Microbiome of Ulcerative Colitis: Initial Study from Animal Model

Overall and sex-specific effect of berberine for dyslipidemia: systematic review and meta-analysis of placebo-controlled trials

The triangular relationship between traditional Chinese medicines, intestinal flora, and colorectal cancer

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