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

OBJECTIVES: 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. 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)(?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. 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.

Comparative efficacy of 6 traditional Chinese patent medicines combined with lifestyle modification in patients with prediabetes: A network meta-analysis.

OBJECTIVE: To evaluate the efficacy of 6 Traditional Chinese patent medicines combined with lifestyle modification in the treatment of prediabetes with network meta-analysis. METHOD: The randomized controlled trials (RCTs) of Shen qi jiang tang capsule/granule (Shenqi), Tian mai xiao ke tablet (Tianmai), Tian qi capsule (Tianqi), Jin qi jiang tang tablet (Jinqi), Jin li da granule (Jinlida), Tang mai kang granule (Tangmaikang) in the treatment of prediabetes in PubMed, Web of Science, The Cochrane Library, EMbase, China Knowledge Network (CNKI), WanFang and Weipu databases were searched. Three reviewers independently conducted the screening, extracted the data and assessed methodological quality. Data analysis was performed using Rev Man 5.3 and STATA 15.0 software. RESULTS: A total of 50 RCTs, including 4594 patients, were included. The addition of Shenqi (OR 0.19 [95 %CI: 0.07, 0.52]) and Jinqi (OR 0.32 [95 %CI: 0.15, 0.71]) to existing lifestyle modification resulted in significant lower incidence rate of DM compared with none/placebo added to lifestyle modification. The addition of Jinlida (SMD -0.41% [95 %CI:-0.81, -0.01]) and Tangmaikang (SMD -0.83%[95 %CI: -1.46,-0.20]) resulted in significant additional HbA1c reductions compared with none/placebo added to lifestyle modification. The addition of all CTPMs except Tianqi resulted in significant additional FBG reductions and the addition of Shenqi (SMD -1.96[95 %CI: -3.64, -0.28]) resulted in significant additional PBG reductions. CONCLUSION: For patients with prediabetes, Shenqi + LM was among the most effective in reducing the incidence of diabetes for patients with prediabetes, while Jinlida + LM was among the least effective. Jinqi + LM and Tianqi + LM might be among the most effective, while western oral drugs + LM, Tianmai + LM, Tangmaikang + LM and Placebo + LM might be among the least effective. In addition, Tangmaikang + LM and Jinlida + LM might be among the most effective in reducing HbA1c, while Tianmai + LM, Tangmaikang + LM, Shenqi + LM, Jinlida + LM and Jinqi + LM might be among the most effective in reducing FPG for patients with prediabetes. Yet direct comparison and further investigation to explore mechanisms are warranted.