Effectiveness and safety of bifidobacteria and berberine in people with hyperglycemia: study protocol for a randomized controlled trial.
Effectiveness and safety of bifidobacteria and berberine in people with hyperglycemia: study protocol for a randomized controlled trial.
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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。
DOI：
10.1186/s13063-018-2438-5
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发表时间：
2018-01-26
期刊：
影响因子：
2.5
通讯作者：
Ji Q
中科院分区：
文献类型：
--
作者：
Ming J;Xu S;Liu C;Liu X;Jia A;Ji Q
小檗碱是具有降糖作用的中药中最重要的例子之一，但还没有在更大的样本中进行随机对照试验。此外，使用益生菌生物疗法来维持适当的肠道菌群可能是对高血糖的有效早期干预。不幸的是，在人口层面上对这种可能性的相关研究一直很缺乏。本研究旨在确定双歧杆菌和小檗碱对新诊断的糖尿病前期或糖尿病患者的降糖效果和安全性。这是一项多中心、双盲、随机、平行对照的研究，包括2周的磨合期和16周的治疗期，将于2015年6月至2018年10月进行。300名随机患者将被分配到以下四组进行16周的治疗：双歧杆菌组、小檗碱组、双歧杆菌联合小檗碱组和安慰剂对照组。主要终点是治疗16周后空腹血糖与基线比较的绝对值。这是第一个随机对照试验，旨在确定双歧杆菌和小檗碱对新诊断的糖尿病前期或糖尿病患者的降糖效果和安全性。这可能为使用小檗碱和双歧杆菌治疗糖尿病提供支持。ClinicalTrials.gov, ID: NCT03330184。追溯注册于2017年10月18日。本文的在线版本（doi:10.1186/s13063-018-2438-5）包含补充材料，仅供授权用户使用。
Berberine is one of the most important examples of a Chinese traditional medicine that has hypoglycemic effects but there have been no randomized controlled trials of the drug in a larger sample. In addition, the use of probiotic biotherapy to maintain an appropriate intestinal flora may represent an effective early intervention for hyperglycemia. Unfortunately, there has been a shortage of relevant research on this possibility at the population level. This study was designed to determine the hypoglycemic effect and safety of both bifidobacteria and berberine administration to newly diagnosed patients with pre-diabetes or diabetes mellitus. This is a multicenter, double-blind, randomized, and parallel-controlled study that includes a run-in period of 2 weeks and a treatment period of 16 weeks, which will be conducted between June 2015 and October 2018. The 300 randomized patients will be assigned to the following four groups for 16 weeks’ treatment: Bifidobacterium, berberine, Bifidobacterium combined berberine, and placebo control groups. The primary outcome is the absolute value of fasting plasma glucose compared with baseline after 16 weeks of treatment. This is the first randomized controlled trial to determine the hypoglycemic effect and safety of both bifidobacteria and berberine administration to newly diagnosed patients with pre-diabetes or diabetes mellitus. It may provide support for the use of berberine and bifidobacteria in the treatment of diabetes. ClinicalTrials.gov, ID: NCT03330184. Retrospectively registered on 18 October 2017. The online version of this article (doi:10.1186/s13063-018-2438-5) contains supplementary material, which is available to authorized users.
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影响因子：
9.8
作者：
Yin, J;Hu, RM;Chen, JL
通讯作者：
Chen, JL
影响因子：
158.5
作者：
Yang, Wenying;Lu, Juming;He, Jiang
通讯作者：
He, Jiang
DOI：
10.1155/2012/591654
发表时间：
2012
期刊：
Evidence-based complementary and alternative medicine : eCAM
影响因子：
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作者：
Dong H;Wang N;Zhao L;Lu F
通讯作者：
Lu F
影响因子：
16.2
作者：
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通讯作者：
Diabetes Prevention Program Research Group
影响因子：
9.8
作者：
Kong, Wei-Jia;Zhang, Hao;Jiang, Jian-Dong
通讯作者：
Jiang, Jian-Dong