Treatment options of traditional Chinese patent medicines for dyslipidemia in patients with prediabetes: A systematic review and network meta-analysis.

Objective: To compare the clinical efficacy and safety of SIX Traditional Chinese Patent Medicines (TCPM) recommended by guidelines in improving lipids for patients with prediabetes by network meta-analysis. Methods: Randomized controlled trials of 6 TCPM in the treatment of prediabetes were searched systematically in various databases. After extracting effective data, the risk of bias was assessed using Review Manager 5.3 and Cochrane Collaboration Systems Evaluator's Manual. Network meta-analysis was performed using STATA 15.0 based on the frequency statistical model. The effect size and credibility of the evidence for the intervention were summarized based on a minimal contextualized framework. Results: A total of 27 studies involving 2,227 patients were included. Compared with lifestyle modification (LM), Shenqi + LM [SMD -0.49 (95% CI: -0.85, -0.12)] and Jinqi + LM [SMD -0.44 (95% CI: -0.81, -0.06)] showed statistically significant effect in lowering TG, Shenqi + LM [SMD -0.51 (95%CI: -0.86, -0.17)] and Jinqi + LM [SMD -0.44 (95%CI: -0.80, -0.08)] in lowering TC, Jinlida + LM [SMD -0.31 (95%CI: -0.59, -0.04)] in lowering LDL-C, Shenqi + LM [SMD 0.29 (95%CI: 0.06, 0.51)] and Jinqi + LM [SMD 0.16 (95%CI: 0.01, 0.31)] in increasing HDL-C. Conclusion: For patients with prediabetes, Traditional Chinese patent medicine Jinqi and Shenqi combined with lifestyle modification were associated with a significant reduction in TG and TC, while Shenqi + LM was among the most effective. Jinlida + LM was among the least effective. Systematic Review Registration: https://clinicaltrials.gov/, identifier PROSPERO(CRD42021279332).

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.

Effect of RG (Coptis root and ginseng) formula in patients with type 2 diabetes mellitus: a study protocol for a randomized controlled and double-blinding trial.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a common metabolic disease with significant health, social, and economic consequences. Traditional Chinese medicine (TCM) could effectively regulate blood sugar and influence gut microbiota in T2DM patients. Preliminary studies showed that the Coptis root and ginseng (RG) formula could relieve insulin resistance and prevent the progression of diabetes in mice. OBJECTIVES: The purpose of this study is to explore the efficacy and safety of RG formula in the treatment of adult patients with T2DM, as well as observing its effects on gut microbiota. METHODS AND ANALYSIS: This trial is a randomized, double-blind, placebo-controlled study. A total of 60 participants will be randomized in a 1:1 ratio into an experiment group (RG formula) and a control group (placebo). Patients in both groups will be given diabetes education and basic blood glucose control. Glucose-lowering drugs with significant influence on gut microbiota will be avoided. This trial will last 25 weeks including 1-week run-in, 12-week intervention, and 12-week follow-up visit. The primary outcome is the change in the HbA1c. The secondary outcomes comprise the change in the fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FIL), fasting C-peptide(C-P), insulin resistance index (IRI), inflammatory factors, and species abundance of gut microbiota between the two groups. Safety of medication will also be evaluated. The correlation analysis will be explored between the glycemic indicators, inflammatory factors, and abundance of gut microbiota. DISCUSSION: This study will provide the clinical evidence for the efficacy of RG formula in regulating blood sugar and influencing gut microbiota, which will be beneficial to form the integrated therapeutic regimen in T2DM with TCM. TRIAL REGISTRATION: "Clinical Study on the Intervention of Coptis Root and Ginseng," Chinese Clinical Trials Registry ChiCTR 2100042126 . Registered on 14 January 2021.

Shenlian (SL) Decoction, a Traditional Chinese Medicine Compound, May Ameliorate Blood Glucose via Mediating the Gut Microbiota in db/db Mice.

Shenlian (SL) decoction is a herbal formula composed of Coptis and ginseng, of which berberine and ginsenoside are the main constituents. Even though SL decoction is widely used in treating diabetes in China, the mechanism of its antidiabetes function still needs further study. Gut microbiota disorder is one of the important factors that cause diabetes. To explore the effect of SL decoction on intestinal microbiota, gut microbiota of mice was analyzed by sequencing the gut bacterial 16S rRNA V3+V4 region and metagenomics. In this study, results demonstrated that SL decoction had a better hypoglycemic effect and ß cell protection effect than either ginseng or Coptis chinensis. Alpha diversity analysis showed that all interventions with ginseng, Coptis, and SL decoction could reverse the increased diversity and richness of gut microbiota in db/db mice. PCoA analysis showed oral SL decoction significantly alters gut microbiota composition in db/db mice. 395 OTUs showed significant differences after SL treatment, of which 37 OTUs enriched by SL decoction showed a significant negative correlation with FBG, and 204 OTUs decreased by SL decoction showed a significant positive correlation with FBG. Results of KEGG analysis and metagenomic sequencing showed that SL decoction could reduce the Prevotellaceae, Rikenellaceae, and Helicobacteraceae, which were related to lipopolysaccharide biosynthesis, riboflavin metabolism, and peroxisome, respectively. It could also upregulate the abundance of Bacteroidaceae, which contributed to the metabolism of starch and sucrose as well as pentose-glucuronate interconversions. In the species level, SL decoction significantly upregulates the relative abundance of Bacteroides_acidifaciens which showed a significant negative correlation with FBG and was reported to be a potential agent for modulating metabolic disorders such as diabetes and obesity. In conclusion, SL decoction was effective in hypoglycemia and its mechanism may be related to regulating gut microbiota via upregulating Bacteroides_acidifaciens.

Qingre Yiqi Method along with Oral Hypoglycemic Drugs in Treating Adults with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis.

OBJECTIVE: To evaluate the efficacy of the Qingre Yiqi method in the treatment of type 2 diabetes mellitus (T2DM) with meta-analysis. METHOD: The randomized controlled trials (RCTs) of the Qingre Yiqi method in the treatment of T2DM in the PubMed, Medline, EMBase, Cochrane Library, Web of Science, Weipu Journal, China Knowledge Network (CNKI), and Wanfang database were conducted. Three reviewers independently conducted the screening, extracted the data, and assessed methodological quality. Data analysis was performed using Rev Man 5.3 software for statistical analysis. RESULTS: A total of 15 RCTs, including 1440 patients, were included. The results showed that compared with oral hypoglycemic drugs alone, the add-on treatment of the Qingre Yiqi method could significantly improve Chinese medicine syndrome (OR (95%CI) = 3.66 [2.47,5.42], P < 0.00001) and lower the level of HbA1c (MD (95%CI) = -0.68 [0.91, -0.45], P < 0.00001), triglyceride (TG) (MD (95%CI) = -0.38 [-0.58,-0.17], P=0.0004), low-density lipoprotein cholesterol (LDL-C) (MD (95%CI) = -0.25 [-0.37, -0.13], P < 0.0001), and total cholesterol(TC) (MD(95%CI) = -0.40[-0.67, -0.13], P=0.003). In terms of fasting blood glucose (FBG) and postprandial blood sugar (PBG), subgroup analysis showed that the baseline of FBG and the number of combined oral hypoglycemic drugs of PBG were the major sources of heterogeneity. CONCLUSION: Compared with the standard treatment, the Qingre Yiqi method along with oral hypoglycemic drugs showed the more beneficial effects for T2DM on improving TCM syndromes and reducing the blood glucose and partial lipid parameter.

Tripterygium and its extracts for diabetic nephropathy: Efficacy and pharmacological mechanisms.

Diabetic nephropathy (DN) is a common but intractable diabetic microvascular complication. Tripterygium, a Chinses herb, has been proven to be effective for DN treatment. In this review, the efficacy and pharmacological mechanism of tripterygium and its extracts on DN is elucidated. Tripterygium and its extracts could effectively reduce urine protein and protect renal function. Its pharmacological mechanism involves anti-inflammation, anti-oxidation, anti-glomerulosclerosis and anti-fibrosis, which is achieved by balancing the Th1/Th2 cells, regulating macrophage infiltration, and regulating the following pathways: p38 MAPK, NF-κB, TGF-ß, Wnt/ß-catenin, Akt and Notch1. Although tripterygium and its extracts may result in some adverse effects, including liver-function damage, gastrointestinal reaction, menstrual disorders, and reproductive problems, they are considered good alternative medicines for DN if used with caution and in the proper manner.

[Expert consensus statement on treatment of type 2 diabetes with Xiaoke Pills in clinical practice].

Xiaoke Pills are Chinese and Western medicine compound preparations with effects of nourishing kidney and Yin,and supplementing Qi and promoting fluid. It is widely used in clinical treatment of type 2 diabetes( Qi and Yin deficiency syndrome),and continuously included in 2010,2013 and 2017 editions of Chinese prevention guide for type 2 diabetes. For the purpose of accurate positioning and rational use in clinic,it is necessary to further define the curative effect,indications,medication precautions and contraindications of Xiaoke Pills,in order to improve medication safety. This consensus was reached by reference of international clinical guidelines and expert consensus approach based on clinical evidence-based evidence,expert experience and standard specification. The evidence-based evaluation was oriented to clinical problems summarized by no less than 200 front-line clinical physicians in two rounds.GRADE system was adopted for quality classification and evaluation of the evidences,and then the nominal group method was used to form consensus recommendations or suggestions. This consensus defined the curative effect advantages,target users,dosage,administration method,contraindications and precautions of Xiaoke Pills,and provided valuable reference for the clinical use of the drug. Thisconsensus still needs to be updated and revised based on new clinical problems and evidence-based evidence in practical application in the future.

Effect of Qufengtongluo Decoction on PI3K/Akt Signaling Pathway in the Kidney of Type 2 Diabetes Mellitus Rat (GK Rat) with Diabetic Nephropathy.

Qufengtongluo (QFTL) decoction is an effective treatment for diabetic nephropathy (DN). However, the underlying molecular mechanism is still unclear. In this study, we try to investigate whether QFTL decoction acts via inhibiting PI3K/Akt signaling pathway. Twenty-four GK rats were randomly divided into 3 groups: blank group, sham-operated group, and QFTL group. After model establishment, rats in QFTL group were given QFTL decoction by gavage, while the rest were given pure water. During the 8-week intervention, 24 hr urinal protein was measured every 2-3 weeks. After intervention, kidneys were removed for pathological smear, quantitative real-time PCR, and western blotting to detect expression levels of p-PI3K, p-Akt, PTEN, TGF-ß, PI3K mRNA, Akt mRNA, PTEN mRNA, and TGF-ß mRNA. QFTL group showed a slighter degree of renal fibrosis in Masson and PASM staining and a greater reduction of 24 hr urinal protein than blank group. Compared to blank group, expression levels of p-PI3K, p-Akt, PI3K mRNA, and Akt mRNA were lower in QFTL group, while expression levels of PTEN and PTEN mRNA were higher. Besides, TGF-ß was downregulated by QFTL decoction. In conclusion, this study suggests that QFTL decoction might inhibit PI3K/Akt signaling pathway via activating PTEN and inhibiting TGF-ß.

Study on the relationship between Chinese medicine constitutive susceptibility and diversity of syndrome in diabetic nephropathy.

OBJECTIVE: To explore the relationship between Chinese medicine (CM) constitutive susceptibility and syndrome diversity in diabetic nephropathy (DN). METHODS: Epidemiologic investigation on constitution adopting the "Constitution in Chinese Medicine Questionnaire" (CCMQ), and survey on syndrome type by CM syndrome scale (preliminary) were carried out in 180 DN patients. Cluster analysis on symptom items was used to determine the syndrome type, and canonical correlation analysis was used to analyze the relationship between patients' constitution and syndrome. RESULTS: Baseline levels in all enrolled patients were not different statistically. Cluster analysis showed 8 syndromes existed in DN patients, namely: I, qi-yin deficiency with qi-stagnancy type; II, yin-yang deficiency with heat-water-blood stasis type; III, qi-yin deficiency with dampness-heat type; IV, yin-yang deficiency with blood-stasis and heat type; V, qi-yin deficiency with stagnant heat type; VI, yin-yang deficiency with inner dampness-heat stagnancy type; VII, yin deficiency with heat stagnancy type; and VIII, Kidney (Shen)-Spleen (Pi) deficiency with stagnant heat type. Correlation analysis on the 8 syndromes and the 9 constitutions showed statistical significant correlations between syndrome III and dampness-heat constitution (P=0.0001); syndrome IV and blood-stasis constitution (P=0.0001); and syndrome VII and yin-deficiency constitution (P=0.0180). CONCLUSION: Certain relationship revealed between CM constitutions and syndrome types; constitution decides the disease genesis, its syndrome type and prognosis, as well as the change of syndromes.

Association of Chinese medicine constitution susceptibility to diabetic nephropathy and transforming growth factor-ß1 (T869C) gene polymorphism.

OBJECTIVE: To explore the association of Chinese medicine constitution susceptibility to diabetic nephropathy (DN) and transforming growth factor (TGF)-ß1 (T869C) gene polymorphism. METHODS: TGF-ß1 gene polymorphism detected with polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) was screened for 180 DN cases and 180 type 2 diabetic mellitus (T2DM) cases without combined DN. Patients with DN were surveyed epidemiologically with constitution in the Chinese medicine questionnaire (CCMQ). Binary logistic regression analysis was utilized to study the correlation between nine types of Chinese medicine constitution and TGF-ß1 (T869C) gene polymorphisms. RESULTS: The DN group has a higher frequency of TGF-ß1 (T869C) gene polymorphism than the T2DM group, and CC/CT genotypes than the T2DM group [CC, CT, TT (DN group): 88, 87, 5 (cases) versus (T2DM group) 71, 73, 36 (cases), P<0.05]. The phlegm-dampness constitution, damp-heat constitution, and blood stasis constitution have correlations with TGF-ß1 (T869C) gene polymorphism. CONCLUSION: Chinese medicine constitutions were associated with TGF-ß1 (T869C) gene polymorphism, a potential predictor of susceptibility to DN in T2DM patients.

[The recent research situation of Euonymus alatus].

The functions of Euonymus alatus in herbal canon, are removing blood stasis, restoring menstrual flow and killing worms, especially for gynecological diseases. The recently researches show E. alatus can depress blood sugar and blood lipid, resist hypersusceptibility, regulate immunity, and calcium abundant. It is effective for diabetes, hyperglycemia, chronic nephropathy, rheumatoid arthritis, urinary tract infection and prostate diseases, etc internal diseases, no matter singleness or together with other herbs.