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.
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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双歧杆菌和小檗碱在人体高血糖中的有效性和安全性及其对肠道微生物群的调节作用：一项多中心、双盲、随机、平行对照研究
DOI：
10.1186/s13073-021-00942-7
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发表时间：
2021-08-09
期刊：
影响因子：
12.3
通讯作者：
Ji Q
中科院分区：
文献类型：
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作者：
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
据报道，黄连素和双歧杆菌可改善高血糖或其他代谢紊乱患者的糖耐量。本研究旨在评估黄连素和双歧杆菌的降糖作用以及对肠道微生物群的调节作用，以及二者联合使用可能带来的额外益处。
这是一项为期18周的多中心、随机、双盲、平行对照研究，对象是新诊断为高血糖的患者。经过2周的导入期后，300名参与者被随机分配到以下四组，接受16周的治疗：黄连素组（Be）、双歧杆菌组（Bi）、黄连素和双歧杆菌组（BB）以及安慰剂组。主要疗效终点是治疗16周后空腹血糖（FPG）与基线相比的绝对值。
在2015年10月至2018年4月期间，共有297名参与者被纳入主要分析。与安慰剂组相比，Be组和BB组的FPG显著降低，最小二乘（LS）均差分别为−0.50，95%置信区间[−0.85，−0.15]mmol/L和−0.55，95%置信区间[−0.91，−0.20]mmol/L。Be组和BB组的餐后2小时血糖也显著降低。与安慰剂组相比，BB组的糖化血红蛋白（HbA1c）显著降低。此外，与Bi组和安慰剂组相比，Be组和BB组的肠道微生物群从基线起有更多变化。
黄连素可调节人体肠道微生物群的结构和功能，双歧杆菌有可能增强黄连素的降糖作用。这些发现为黄连素和双歧杆菌的降糖潜力提供了新的见解。
ClinicalTrials.gov，NCT03330184。于2017年10月18日回顾性注册
网络版包含补充材料，可在10.1186/s13073 - 021 - 00942 - 7获取
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. 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. 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. 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. ClinicalTrials.gov, NCT03330184. Retrospectively registered on 18 October 2017 The online version contains supplementary material available at 10.1186/s13073-021-00942-7.
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影响因子：
6.3
作者：
Kouchaki, Ebrahim;Tamtaji, Omid Reza;Asemi, Zatollah
通讯作者：
Asemi, Zatollah
双歧杆菌和berberine在高血糖症患者中的有效性和安全性：随机对照试验的研究方案。
影响因子：
2.5
作者：
Ming J;Xu S;Liu C;Liu X;Jia A;Ji Q
通讯作者：
Ji Q
影响因子：
35.7
作者：
Chen, Ying-Xuan;Gao, Qin-Yan;Fang, Jing-Yuan
通讯作者：
Fang, Jing-Yuan
DOI：
10.1097/mpg.0000000000001422
发表时间：
2017-03-01
影响因子：
2.9
作者：
Famouri, Fatemeh;Shariat, Zainab;Kelishadi, Roya
通讯作者：
Kelishadi, Roya
影响因子：
16.2
作者：
通讯作者：
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