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Journal of Traditional Chinese Medicine >

2023 , Vol. 43 >Issue 4: 760 - 769

DOI: https://doi.org/10.19852/j.cnki.jtcm.20230608.003

Effects of Shenlian formula (参连方) on microbiota and inflammatory cytokines in adults with type 2 diabetes: a double-blind randomized clinical trial

  • Li JIANG ,
  • Qiang FU ,
  • Shidong WANG ,
  • Jinxi ZHAO ,
  • Yu CHEN ,
  • Jiayue LI ,
  • Yonghua XIAO ,
  • Weijun HUANG ,
  • Ruixi SUN ,
  • Yao XIAO ,
  • Aijia SHEN ,
  • Junheng WANG ,
  • Jiangteng LIU ,
  • Xiaozhe FU ,
  • Yuanyuan LI ,
  • Yu ZHAO ,
  • Taiqi XUE
Expand
  • Section Ⅱ Department of Endocrinology and Nephropathy, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China

Received date: 2021-11-22

  Accepted date: 2022-05-23

  Online published: 2023-06-08

Supported by

National Key R&D Program of China: the Study on Syndrome Differentiation Standard of Yin Deficiency Syndrome in Type 2 Diabetes Mellitus(2018YFC1704402);Project for Young Teachers of Beijing University of Chinese Medicine: Clinical Study on Intervention of Shenlian Formula based on Microbiota in Type 2 Diabetes Mellitus(2018-JYBZZ-JS062)

Fold

Abstract

OBJECTIVES: To observe the efficacy of Shenlian formula (SL formula, 参连方), which consist of Huanglian (Rhizoma Coptidis) and Renshen (Radix Ginseng), in the treatment of type 2 diabetes mellitus (T2DM) and explore the effects on gut microbiota and serum inflammatory cytokines.

METHODS: In a double-blind, randomized, placebo-controlled parallel-group clinical trial, 31 adults with T2DM were randomly allocated to receive the SL formula or placebo for 12 weeks. Body mass index (BMI), blood lipid indices, glycemic biomarkers including glycated hemoglobin (HbA1C), fasting plasma glucose (FPG), postprandial blood glucose (PBG), fasting insulin levels (FIL), fasting C-peptide (C-P), homoeostasis model assessment for insulin resistance (HOMA-IR) and inflammatory cytokines were assessed at baseline and 12 weeks. The contents of gut microbiota were determined by pyrosequencing of the V3-V4 regions of 16S rRNA genes.

RESULTS: Sixteen cases were allocated in the treatment group and 15 in the placebo group. Compared with the placebo, SL formula resulted in a higher significant reduction in PBG [(?1.318 ± 0.772) vs (?0.008 ± 1.404) mmol/L, P = 0.003], BMI [(?0.611 ± 0.524) vs (0.957 ± 2.212) kg/m2, P = 0.01], FIL [(?1.627 ± 6.268) vs (3.976 ± 6.85) μIU/mL, P = 0.02], HOMA-IR [(?0.530 ± 1.461) vs (1.511 ± 2.288), P = 0.006], and C-reactive protein (CRP) [(?1.307 ± 0.684) vs (0.828 ± 0.557) mg/L, P = 0.04]. In terms of gut microbiota, compared with the placebo, the SL formula resulted in a significant decrease in species richness and evenness.

CONCLUSIONS: The SL formula showed the efficacy to improve postprandial blood glucose, insulin resistance, BMI and CRP levels. In addition, it could reduce the total number, richness and evenness of species, meanwhile increase the abundance of probiotics to modulate the structure of gut microbiota in patients with T2DM. However, further studies are required for exploring the deeper mechanism of TCM on gut microbiota.

Key words： Huanglian (Rhizoma Coptidis); Renshen (Radix Ginseng); diabetes mellitus, type 2; gut microbiota; cytokines; clinical trial

Cite this article

Li JIANG , Qiang FU , Shidong WANG , Jinxi ZHAO , Yu CHEN , Jiayue LI , Yonghua XIAO , Weijun HUANG , Ruixi SUN , Yao XIAO , Aijia SHEN , Junheng WANG , Jiangteng LIU , Xiaozhe FU , Yuanyuan LI , Yu ZHAO , Taiqi XUE . Effects of Shenlian formula (参连方) on microbiota and inflammatory cytokines in adults with type 2 diabetes: a double-blind randomized clinical trial[J]. Journal of Traditional Chinese Medicine, 2023 , 43(4) : 760 -769 . DOI: 10.19852/j.cnki.jtcm.20230608.003

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