Section Ⅱ Department of Endocrinology and Nephropathy, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.
J Tradit Chin Med. 2023 Aug;43(4):760-769. doi: 10.19852/j.cnki.jtcm.20230608.003.
To observe the efficacy of Shenlian formula (SL formula, ), which consist of Huanglian () and Renshen (), in the treatment of type 2 diabetes mellitus (T2DM) and explore the effects on gut microbiota and serum inflammatory cytokines.
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.
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)(?0.008 ± 1.404) mmol/L, 0.003], BMI [(?0.611 ± 0.524)(0.957 ± 2.212) kg/m, 0.01], FIL [(?1.627 ± 6.268)(3.976 ± 6.85) μIU/mL, 0.02], HOMA-IR [(?0.530 ± 1.461)(1.511 ± 2.288), 0.006], and C-reactive protein (CRP) [(?1.307 ± 0.684)(0.828 ± 0.557) mg/L, 0.04]. In terms of gut microbiota, compared with the placebo, the SL formula resulted in a significant decrease in species richness and evenness.
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.
观察黄连与人参组成的参连方（SL 方）治疗 2 型糖尿病（T2DM）的疗效，并探讨其对肠道菌群和血清炎症因子的影响。
采用双盲、随机、安慰剂对照的平行分组临床试验，将 31 例 T2DM 患者随机分为 SL 方组或安慰剂组，治疗 12 周。在基线和 12 周时评估体重指数（BMI）、血脂指标、血糖生物标志物包括糖化血红蛋白（HbA1C）、空腹血糖（FPG）、餐后血糖（PBG）、空腹胰岛素水平（FIL）、空腹 C 肽（C-P）、胰岛素抵抗的稳态模型评估（HOMA-IR）和炎症因子。通过 16S rRNA 基因 V3-V4 区的焦磷酸测序来测定肠道微生物群的含量。
16 例患者分配到治疗组，15 例患者分配到安慰剂组。与安慰剂相比，SL 方治疗后 PBG 显著降低[（-1.318±0.772）vs.（-0.008±1.404）mmol/L，P=0.003]，BMI 降低[（-0.611±0.524）vs.（0.957±2.212）kg/m，P=0.01]，FIL 降低[（-1.627±6.268）vs.（3.976±6.85）μIU/mL，P=0.02]，HOMA-IR 降低[（-0.530±1.461）vs.（1.511±2.288），P=0.006]，C 反应蛋白（CRP）降低[（-1.307±0.684）vs.（0.828±0.557）mg/L，P=0.04]。在肠道菌群方面，与安慰剂相比，SL 方治疗后物种丰富度和均匀度显著降低。
SL 方具有改善餐后血糖、胰岛素抵抗、BMI 和 CRP 水平的疗效。此外，它还可以减少总物种数、丰富度和均匀度，同时增加益生菌的丰度，从而调节 T2DM 患者的肠道菌群结构。然而，需要进一步的研究来探索中医对肠道菌群的更深层次机制。
