Student standardized patients versus occupational standardized patients for improving clinical competency among TCM medical students: a 3-year prospective randomized study.

BACKGROUND: Standardized patient (SP) simulations are well-recognized patterns for practicing clinical skills and interactions. Our previous study showed that a simulation program using occupational SP for Traditional Chinese Medicine (OSP-TCMs) was efficient, however, a high cost and time-intensive nature have limited its use. TCM postgraduates trained as student SPs (SSP-TCMs) present a potentially cost-effective alternative. The purpose of this study was to examine and determine whether SSP simulation offered more benefits over didactic training alone for improving clinical competency among TCM medical students, and conduct a multifaceted analysis comparing SSP-TCMs and OSP-TCMs. METHODS: This was a prospective, single-blinded, randomized controlled trial. Fourth-year TCM undergraduates were recruited as trainees from the Clinical Medical School, Chengdu University of TCM. Data were collected from September 2018 to December 2020. Trainees were randomly divided into the three following groups: traditional method training group, OSP-TCM training group, and SSP-TCM training group (1:1:1). At the end of a 10-week curriculum, trainees received a two-station examination comprising a systematic online knowledge test and an offline clinical performance examination. Post-training and post-exam questionnaires were administered to collect feedback from these trainees. RESULTS: Students assigned to the SSP-TCM training and OSP-TCM training groups received favorable marks for the "systematic knowledge test" and "TCM clinical skills" (2018, Pa=0.018, Pb=0.042; 2019, Pa=0.01, Pb=0.033; 2020, Pa=0.035, Pb=0.039) compared to the TM trainees. Additionally, trainees in the intervention groups demonstrated a positive post-training edge in scores of "medical records" (2018, Pa=0.042, Pb=0.034; 2019, Pa=0.032, Pb=0.042; 2020, Pa=0.026, Pb=0.03) and "TCM syndrome differentiation and therapeutic regimen" (2018, Pb=0.032; 2019, Pa=0.037, Pb=0.024; 2020, Pa=0.036, Pb=0.043). For the simulation encounter assessment given by SP-TCMs, OSP-TCM trainees and SSP-TCM trainees scored higher than TM trainees (2018, Pa=0.038, Pb=0.037; 2019, Pa=0.024, Pb=0.022; 2020, Pa=0.019, Pb=0.021). For the feedback questionnaires, the students in TM group provided less positive feedback for training efficacy and test performance compared to those in the SSP-TCM and OSP-TCM groups. The trainees responded that the training effect of clinical simulations was similar between the SSP-TCM and OSP-TCM groups. SSP-TCMs were more responsive to unexpected emergencies (Pa=0.022, Pb>0.05) and more likely to encourage questioning (Pa=0.029, Pb>0.05) but tended to provide implied hints (Pc=0.015) and utilize medical jargon (Pc=0.007) as compared to OSP-TCMs. CONCLUSION: Simulation training for SSP-TCMs and OSP-TCMs showed great benefits for enhancing clinical competency. SSP-TCM simulation was feasible, practical, and cost-effective, and may serve as an alternative method to OSP-TCM simulation.

Chinese herbal medicine combined with western medicine for the treatment of type 2 diabetes mellitus with hyperuricemia: A systematic review and meta-analysis.

Background: Chinese herbal medicine (CHM) has the advantage of being safe and effective and has been widely used in clinical practice for the treatment of type 2 diabetes mellitus (T2DM) with hyperuricemia (HUA), but its overall efficacy and safety remain unclear. This study aimed to evaluate the efficacy and safety of CHM for the treatment of T2DM with HUA based on randomized controlled trials (RCTs) to provide clinical evidence. Methods: The protocol evaluated in this study is registered with PROSPERO (CRD42022351519). As of November 2022, eight databases were searched, and RCTs of CHM for the treatment of T2DM with HUA were included. Outcome indicators observed included fasting blood glucose (FBG), 2-h postprandial glucose (2hPG), glycated hemoglobin (HbA1c), uric acid (UA), triglycerides (TG), total cholesterol (TC), overall effectiveness, and adverse events. Utilizing Review Manager 5.4, Stata V14.0, and GRADEpro, the included studies were evaluated, and the quality of the evidence was determined. Results: 18 RCTs covering 1,311 patients were included in this study. The results of the study demonstrated that the combination of CHM and western medicine (WM) was more effective in treating patients with T2DM with HUA than WM alone, with significant improvements in FBG (weighted mean differences (WMD) = -0.60.95% confidence interval (CI) [-0.81, -0.40], p < 0.00001), 2hPG (WMD = -1.12.95% CI [-1.64, -0.60], p < 0.0001), HbA1c (WMD = -0.80.95% CI [-1.04, -0.56], p < 0.00001), UA (WMD = -53.47.95% CI [-67.45, -39.48], p < 0.00001), TG (WMD = -0.56.95% CI [-0.74, -0.38], p < 0.00001), TC (WMD = -0.49.95% CI [-0.65, -0.33], p < 0.00001), and overall effective rate (risk ratio (RR) = 1.29.95%CI [1.13, 1.48], p = 0.0002). The quality of evidence for all outcomes was low. Conclusion: Compared with WM alone, the combination of CHM and WM was more effective in treating patients with T2DM with HUA, with significant improvements in glucose metabolism, uric acid, and lipids. However, further evaluation by high-quality RCT results is needed due to the low quality and high heterogeneity of the evidence. Systematic Review Registration: [https://systematicreview.gov/], identifier [CRD42022351519].

Chinese Herbal Medicine for Type 2 Diabetes Mellitus With Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis.

Objectives: To evaluate the efficacy and safety of Chinese herbal medicine (CHM) for type 2 diabetes mellitus (T2DM) with nonalcoholic fatty liver disease (NAFLD) with current evidence. Methods: This study was registered in PROSPERO as CRD42021271488. A literature search was conducted in eight electronic databases from inception to December 2021. The primary outcomes were lipid indices and liver functions, including triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), alanine transaminase (ALT), and aspartate transaminase (AST). Review Manager 5.2 and Stata v14.0 were applied for analysis. Results: The research enrolled 18 RCTs with 1,463 participants. Results showed CHM combined with western medicine (WM) was more effective than WM alone in TG (weighted mean differences (WMD) = -0.35.95% confidence interval (CI) [-0.51, -0.19], p < 0.0001), TC (WMD = -0.58.95%CI [-0.80, -0.36], p < 0.00001), LDL-C (WMD = -0.37, 95%CI [-0.47, -0.26], p < 0.00001), HDL-C (WMD = 0.20, 95%CI [0.10, 0.29], p < 0.0001), ALT (WMD = -4.99, 95%CI [-6.64, -3.33], p < 0.00001), AST (WMD = -4.76, 95%CI [-6.35, -3.16], p < 0.00001), homeostatic model assessment of insulin resistance (WMD = -1.01, 95%CI [-1.22, -0.79], p < 0.00001), fasting blood glucose (WMD = -0.87, 95%CI [-1.13, -0.61], p < 0.00001), 2-h postprandial glucose (WMD = -1.45.95%CI [-2.00, -0.91], p < 0.00001), body mass index (WMD = -0.73.95%CI [-1.35, -0.12], p = 0.02), and overall effective rate (risk ratio (RR) = 1.37.95%CI [1.29, 1.46], p < 0.00001). Conclusion: The CHM in combination with WM seems to be more beneficial in T2DM with NAFLD patients in improving lipid and glucose metabolism, liver function, and insulin resistance as well as improving overall efficiency and reducing body weight. Given the poor quality of reports from these studies and uncertain evidence, these findings should be interpreted cautiously. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021271488, identifier CRD42021271488.

Emodin Alleviates High-Glucose-Induced Pancreatic ß-Cell Pyroptosis by Inhibiting NLRP3/GSDMD Signaling.

Diabetes mellitus (DM) is a chronic noninfectious disease that is mainly featured by pancreatic ß-cell (ß-cell) dysfunction and impaired glucose homeostasis. Currently, the pathogenesis of dysfunction of the ß-cells in DM remains unclear, and therapeutic approaches to it are limited. Emodin (EMD), a natural anthraquinone derivative, has been preliminarily proven to show antidiabetic effects. However, the underlying mechanism of EMD on ß-cells still needs to be elucidated. In this study, we investigated the protective effects of EMD on the high glucose (50 mM)-induced INS-1 cell line and the underlying mechanism. INS-1 cells were treated with EMD (5, 10, and 20 µM) when exposed to high glucose. The effects of EMD were examined by using the inverted phase-contrast microscope, qRT-PCR, ELISA, and western blot. The results showed that EMD could alleviate cellular morphological changes, suppress IL-1ß and LDH release, and promote insulin secretion in high-glucose-induced INS-1 cells. Furthermore, EMD inhibits NOD-like receptor protein 3 (NLRP3) activation and gasdermin D (GSDMD) cleavage to alleviate pyroptosis induced by high glucose. Overexpression of NLRP3 reversed the above changes caused by EMD. Collectively, our findings suggest that EMD attenuates high-glucose-induced ß-cell pyroptosis by inhibiting NLRP3/GSDMD signaling.

The Effects of Resistant Starch on Biomarkers of Inflammation and Oxidative Stress: A Systematic Review and Meta-Analysis.

The aim of this systematic review and meta-analysis was to investigate the effects of resistant starch (RS) on inflammation and oxidative stress related indicators. PubMed, Embase and The Cochrane library were systematically searched to find randomized controlled trials (RCTs) of RS intervention up to February 2020. We used from the effect size, as estimated by the standardized mean difference (SMD) with 95% confidence intervals (95%CI) to perform the random method meta-analysis, with P value ≦0.05 as statistically significant. The 16 included trials with 17 effect sizes included a total of 739 participants in this paper. The intervention duration was from 2 weeks to 3 months. The analysis indicated that RS decreases the levels of tumor necrosis factor-α (TNF-α) (SMD = -0.711; 95%CI: -1.227, -0.194; P = 0.007) and interleukin 6 (IL-6) (SMD = -0.609; 95%CI: -0.924, -0.294; P < 0.001), increases total antioxidant capacity (TAC) (SMD = 2.543, 95% CI: 0.069: 5.017, P = 0.044). No significant effects on C-reactive protein (CRP) (SMD = -0.583; 95%CI: -1.270, 0.104; P = 0.096), superoxide dismutase (SOD) (SMD = 0.091; 95%CI: -0.156, 0.338; P = 0.471), and malondialdehyde (MDA) (SMD = -0.320; 95%CI: -0.907, 0.266; P = 0.285). Subgroup analysis shown that CRP level significant reduced in subjects from the east (SMD = -1.501; 95%CI: -2.662, -0.340; P = 0.011) or suffering from diseases (SMD: -1.057; 95%CI: -1.999, -0.115; P = 0.028).Supplemental data for this article is available online at https://doi.org/10.1080/01635581.2021.2019284.

Shenqi compound ameliorates type-2 diabetes mellitus by modulating the gut microbiota and metabolites.

The gut microbiota (GM) and metabolites are important factors in mediating the development of type-2 diabetes mellitus (T2DM). An imbalance in the gut microbiota and metabolites can disrupt the function of the intestinal barrier, cause changes in the permeability of the intestinal mucosa and promote the immune inflammatory response, thereby aggravating the fluctuation of blood glucose level and promoting the occurrence and development of the chronic complications of DM. Manipulating the GM and metabolites is a promising therapeutic intervention and is being studied extensively. Shenqi compound (SQC) is a traditional Chinese medicine formulation, which has been widely used to improve T2DM. Studies have demonstrated that SQC can reduce glycemic variability, alleviate the inflammatory response, etc. However, its underlying mechanism remains unknown. Therefore, in this experiment, We administered SQC to Goto-Kakizaki (GK) rats and evaluated its effect on blood glucose homeostasis and the intestinal mucosal barrier. We identified the profiles of the GM and metabolites with the aid of 16S rDNA gene sequencing and non-target metabolomics analysis. It showed that SQC intervention could reduce glycemic variability, regulate serum levels of glucagon and insulin, and improve injury to the intestinal mucosal barrier of GK rats. In the gut, the ratio of bacteria of the phyla Bacteroidetes/Firmicutes could be improved after SQC intervention. SQC also regulated the relative abundance of Prevotellaceae, Butyricimonas, Bacteroides, Blautia, Roseburia, Lactobacillus, and Rothia. We found out that expression of 40 metabolites was significantly improved after SQC intervention. Further analyses of metabolic pathways indicated that the therapeutic effect of SQC might be related predominantly to its ability to improve gluconeogenesis/glycolysis, amino acid metabolism, lipid metabolism, citrate cycle, and butanoate metabolism. These results suggest that SQC may exert a beneficial role in T2DM by modulating the GM and metabolites in different pathways.

Efficacy and safety of traditional Chinese medicine external washing in the treatment of postoperative wound of diabetes complicated with anal fistula: Study protocol of a randomized, double-blind, placebo-controlled, multi-center clinical trial.

Introduction: Anal fistula is one of the commonest ailments seen by anorectal surgeons as surgery is currently the preferred treatment for it. Diabetes mellitus is a risk factor that can lead to slow wound healing after anal fistula surgery. Because of the large postoperative wound surface of anal fistula, patients with diabetes can have an increased probability of wound infection, which makes it hard to heal. There is an extensive clinical experience for wound healing in traditional Chinese medicine (TCM). The Jiedu Shengji decoction (JSD) is a widely used external washing decoction in clinical practice. However, the current evidence on it is still insufficient. Therefore, we report this carefully designed clinical trial to assess the efficacy and safety of JSD in the treatment of postoperative wounds in diabetic patients with anal fistula. Methods and analysis: This study was designed to be a randomized, double-blind, placebo-controlled, multi-center clinical trial. There were 60 eligible participants who were randomized at a 1:1 ratio to the intervention and placebo groups. Both groups received the same standard treatment. The intervention group was given external washing decoction of TCM (JSD), while the placebo group was given the placebo made of excipients and flavoring agents. The main outcome measures include wound healing, distribution of wound pathogens, levels of inflammatory mediators, and blood glucose. The secondary outcome measures included lipids, the quality of the life evaluation scale (Short-Form Health Survey 36). Assessments were performed before the start of the study, at 1st, 2nd, 3rd, and 4th weeks after the intervention, and at 8th, 12th, and 16th follow-up weeks. Discussion: The clinical study we proposed will be the first randomized, double-blind, placebo-controlled, multi-center clinical trial study to assess the efficacy and safety of TCM external washing (JSD) in the treatment of postoperative wounds in diabetic patients with anal fistula. Ethics and dissemination: The Medical Ethics Committee of Hospital of Chengdu University of Traditional Chinese Medicine has reviewed this study protocol and gave its approval and consent on 17 March, 2022 (Ethical Review Number: 2022KL-018).

Efficacy and Safety of the Chinese Patent Medicine Yuquan Pill on Type 2 Diabetes Mellitus Patients: A Systematic Review and Meta-Analysis.

BACKGROUND: Yuquan Pill (YQP), a Chinese patent medicine for the treatment of diabetes, is widely used in the treatment of diabetes and its complications in China. However, the efficacy of YQP on type 2 diabetes mellitus (T2DM) has not been completely assessed. The aim of this study is to evaluate the efficacy and safety of YQP in the treatment of T2DM. MATERIALS AND METHODS: We systematically searched 9 databases for specific keywords from inception to Oct 2021. We included randomized controlled trials (RCTs) involving YQP in the treatment of T2DM without language limitation. The study conformed to the Cochrane Handbook and Review Manager software was used for data analysis. The weighted mean differences (WMDs) and 95% confidence intervals (CIs) were used to measure treatment effects. RESULTS: The final analysis included 10 publications. Analysis showed that the combination of YQP and conventional treatment was more effective than conventional treatment alone with regard to the levels of fasting blood glucose (WMD = -0.83; 95% CI [-1.01,-0.66]; p < 0.00001), two-hour postprandial glucose (WMD = -1.40; 95% CI [-1.49,-1.31]; p < 0.00001), glycosylated hemoglobin (WMD = -0.87; 95% CI [-1.26, -0.49]; p < 0.00001), total cholesterol (WMD = -0.50; 95% CI [-0.61, -0.39]; p < 0.00001), c-reactive protein (WMD = -0.58; 95%CI [-0.88, -0.28]; p=0.0002), and overall effective rate (RR = 1.21; 95% CI [1.12, 1.31]; p < 0.00001). CONCLUSION: Evidence suggested that YQP might improve glucose and lipid metabolism and inflammation in patients with T2DM. Serious adverse events were not reported. The quality of the evidence analyzed was low and therefore our results should be interpreted with caution. More high-quality RCTs are now needed to verify these findings.

Tuina for diabetes with obesity: Protocol for a systematic review and meta-analysis.

BACKGROUND: Obesity is an independent risk factor for the occurrence and development of diabetes. Patients with diabetes combined with obesity will face serious burdens such as increase in insulin resistance and difficulty in blood glucose control. As a safe, effective, economical, and simple intervention, Tuina is more acceptable to the public than drugs. The objective of this systematic evaluation and meta-analysis is to evaluate the efficacy and safety of Tuina for diabetes with obesity. METHODS: We will search the following electronic databases: PubMed, Embase, Cochrane Library, Web of science, Chinese National Knowledge Infrastructure (CNKI), Sino Med, Wanfang, Chinese Clinical Trial Registry System, China Biomedical Literature Database (CBM). The time limit for retrieving studies is from establishment to November 2020 for each database. Randomized controlled clinical trials related to Tuina intervention on diabetes with obesity will be included. Data synthesis, sensitivity analysis, subgroup analysis as well as the assessment of bias risk will be conducted by using Stata V.13.0 and Review manager 5.3 software. RESULTS: This study will provide a quantitative and standardized evaluation for the efficacy of Tuina therapy on diabetes with obesity. CONCLUSION: This systematic review and meta-analysis will provide the high-quality evidence of whether Tuina is an effective intervention for diabetes with obesity. REGISTRATION NUMBER: INPLASY2020110106.

The efficacy of 5-element therapy for senile diabetes with depression: A protocol for a systematic review and meta-analysis.

BACKGROUND: Senile diabetes with depression is a common and frequently-occurring disease, and it is also a difficult and hot point in domestic and international research. However, the efficiency of combination hypoglycemic agents and antidepressants in the treatment of senile diabetes with depression is poor, and new intervention methods are urgently needed. Research shows the 5-element therapy, as a Chinese traditional non-drug intervention, has definite curative effect on the prevention and treatment of various physical and mental diseases. The purpose of this systematic review and meta-analysis is to evaluate the efficacy of 5-element therapy on senile diabetes with depression. METHODS: The electronic databases including Pubmed, Embase, Cochrane Library, Web of science, Chinese National Knowledge Infrastructure, Wanfang Database, Sino Med,China Biomedical Literature Database will be searched. The time limit for retrieving studies is from establishment to October 2020 for each database. Randomized controlled clinical trials related to 5-element therapy intervention on senile diabetes with depression will be included. Stata V.13.0 and Review manager 5.3 software will be implemented for data synthesis, sensitivity analysis, subgroup analysis, and the assessment of bias risk. We will use the grading of recommendations assessment, development, and evaluation system to assess the quality of evidence. RESULTS: This study will provide a quantitative and standardized evaluation for the efficacy of 5-element therapy on senile diabetes with depression. CONCLUSION: This systematic review and meta-analysis will provide the high-quality evidence to assess whether the 5-element therapy has a positive treatment effect for senile diabetes with depression. REGISTRATION NUMBER: INPLASY2020100081.

Chinese herbal medicine si-miao-san decoction for acute gouty arthritis: A protocol for systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The prevalence of gout is increasing worldwide, and the symptoms of acute arthritis appearing in gout patients seriously affect the quality of life. The pain and functional limitation caused by acute gouty arthritis (AGA) bring great pain to patients. At present, mainstream drugs have problems such as poor efficacy and side effects. Traditional Chinese medicine has extensive clinical experience in the prevention and treatment of gout, and it also shows clear advantages in the treatment of AGA. Clinical studies have confirmed that si-miao-san decoction (SMSD), a traditional Chinese medicine decoction, can improve the clinical symptoms and signs of AGA patients. Therefore, we will conduct a systematic review to clarify the effectiveness and safety of SMSD for AGA. METHODS: We will search different database from the built-in to October 2020. The electronic database includes PubMed, Embase, Cochrane Library, Web of Science, CNKI, WanFang, VIP, and CBM. At the same time, we will also search for clinical registration tests and gray literatures. This study only screened clinical randomized controlled trials (RCT) for SMSD for AGA. The 2 researchers independently conducted literature selection, data extraction, and quality assessment. Dichotomous data are represented by relative risk (RR), continuous data are represented by mean difference (MD) or standard mean deviation (SMD), and the final data are fixed effect model (FEM) or random effect model (REM), depending on whether it exists heterogeneity. The main outcomes are clinical efficacy, including pain score, joint function, and degree of swelling. The secondary outcomes include: blood uric acid (BUA), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). Finally, a meta-analysis was conducted through Review Manager software version 5.3. RESULTS: This study will conduct a comprehensive analysis based on the currently released Si-Miao-San data for the treatment of AGA and provide high-quality evidence of clinical efficacy and safety. CONCLUSION: This systematic review aims to provide new options for SMSD treatment of AGA in terms of its efficacy and safety. ETHICS AND DISSEMINATION: The review is based solely on a secondary study of published literatures and does not require ethics committee approval. Its conclusion will be disseminated in conference papers, magazines, or peer-reviewed journals. INPLASY REGISTRATION NUMBER: INPLASY202040163.

Danggui Sini decoction for treating diabetic peripheral neuropathy: A protocol of systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Diabetic peripheral neuropathy (DPN) is one of the most common chronic complications of diabetic patients, which seriously affects the quality of life of patients. At present, mainstream drugs have problems such as poor efficacy and side effects. Traditional Chinese medicine (TCM) has extensive clinical experience in the prevention and treatment of diabetes and chronic complications, and it also shows clear advantages in the treatment of DPN. Clinical studies have confirmed that Danggui Sini decoction (DSD), a TCM decoction, can improve the clinical symptoms and signs of DPN patients. Therefore, we will conduct a systematic review to clarify the effectiveness and safety of DSD for DPN. METHODS: We will search every database from the built-in to October 2020. Chinese literature comes from CNKI, Wanfang, VIP, and CBM databases. English literature mainly searches Cochrane Library, PubMed, Web of Science, and EMBASE. At the same time, we will also search for clinical registration tests and gray literatures. This study only screened clinical randomized controlled trials (RCT) for DSD for DPN. The two researchers independently conducted literature selection, data extraction and quality assessment. Dichotomous data is represented by relative risk (RR), continuous data is represented by mean difference (MD) or standard mean deviation (SMD), and the final data is fixed effect model (FEM) or random effect model (REM), depending on whether it exists Heterogeneity. The main result is clinical efficacy and nerve conduction velocity. Fasting blood glucose, 2 hours postprandial blood glucose, blood lipid, hemorheology, and adverse events are secondary results. Finally, a meta-analysis was conducted through Review Manager software version 5.3. RESULTS: This study will conduct a comprehensive analysis based on the currently released DSD data for the treatment of DPN and provide high-quality evidence of clinical efficacy and safety. CONCLUSION: This systematic review aims to provide new options for DSD treatment of DPN in terms of its efficacy and safety. ETHICS AND DISSEMINATION: The review is based solely on a secondary study of published literatures and does not require ethics committee approval. Its conclusion will be disseminated in conference papers, magazines, or peer-reviewed journals. INPLASY REGISTRATION NUMBER: INPLASY202040157.

Huangqi Guizhi Wuwu decoction for diabetic peripheral neuropathy: Protocol for a systematic review.

BACKGROUND: Diabetic peripheral neuropathy (DPN) is one of the most common causes of disability in diabetic population, and its pathogenesis is related to a variety of factors. There is currently no effective treatment for such chronic disease. Traditional Chinese medicine has a long clinical history for the prevention and treatment of diabetes and chronic complications, and it also shows certain advantages in the treatment of DPN. Many clinical studies have confirmed that Chinese medicine Huangqi Guizhi Wuwu decoction (HGWD) can reduce the clinical symptoms and improve neuronal function of patients with DPN. So we intend to conduct a systematic review further clarified the effectiveness and safety of HGWD for DPN. METHODS: We will search each database from the built-in until June 2019. The English literature mainly searches Cochrane Library, PubMed, EMBASE, and Web of Science, while the Chinese literature comes from CNKI, CBM, VIP, and Wangfang database. Simultaneously we will retrieval clinical registration tests and grey literatures. This study only screen the clinical randomized controlled trials (RCTs) about HGWD for DPN to assess its efficacy and safety. The 2 researchers worked independently on literature selection, data extraction, and quality assessment. The dichotomous data is represented by relative risk (RR), and the continuous is expressed by mean difference (MD) or standard mean difference (SMD), eventually the data is synthesized using a fixed effect model (FEM) or a random effect model (REM) depending on whether or not heterogeneity exists. The clinical efficacy, median sensory nerve conduction velocity, median motor nerve conduction velocity, peroneal sensory nerve conduction velocity, and peroneal motor nerve conduction velocity were evaluated as the main outcomes. Fasting blood glucose, 2 hours postprandial blood glucose, hemorheology, and adverse reactions were secondary outcomes. Finally, meta-analysis was conducted by RevMan software version 5.3. RESULTS: This study will synthesize and provide high-quality evidence based on the data of the currently published HGWD for the treatment of DPN, especially in terms of clinical efficacy, neurological function, blood glucose, hemorheology, and safety. CONCLUSION: This systematic review aims to provide new options for HGWD treatment of DPN in terms of its efficacy and safety. PROSPERO REGISTRATION NUMBER: PROSPERO 2019 CRD42019132031.

The effect of zinc supplementation in pre-diabetes: A protocol for systematic review and meta-analysis.

BACKGROUND: The number of people with diabetes and pre-diabetes is growing exponentially. Human studies have shown that zinc supplementation is beneficial for pre-diabetes. However, owing to the low quality, small sample size, and methodological heterogeneity of these studies, this conclusion is not convincing. Consequently, in order to determine whether zinc supplementation is effective and safe in pre-diabetic patients, it is necessary to conduct a meta-analysis of high-quality clinical trials. METHODS: We will retrieve MEDLINE (PubMed), EMBASE, the Web of Science, Cochrane Library, and the ClinicalTrials.gov website without restriction on language. Randomized controlled trials (RCTs) of Zinc supplementation for adult patients with pre-diabetes will be searched in multiple databases from inception to October 2020. The primary outcome of the meta-analysis is the HbA1c. The secondary outcomes include the fasting blood glucose (FBG), fasting insulin (FINS), homeostasis model assessment of insulin resistance (HOMA-IR), and quantitative insulin sensitivity check index (QUICKI). Two assessors will utilize the Cochrane Collaboration's risk of bias tool to evaluate the RCTs and all statistical data will be analyzed by using the Review Manage software V5.3.0. RESULTS: This study will provide high-quality synthesis of effectiveness and safety of zinc supplementation for pre-diabetes. CONCLUSION: This systematic review and meta-analysis will provide the available evidence to assess whether the zinc supplementation is beneficial to glucose control and insulin resistance in patients with pre-diabetes. PROSPERO REGISTRATION NUMBER: CRD 42018095724.

Exploration of the Effect and Mechanism of ShenQi Compound in a Spontaneous Diabetic Rat Model.

BACKGROUND: Type 2 Diabetes Mellitus (T2DM) is a world-wide metabolic disease with no cure from drugs and treatment. In China, The Traditional Chinese Medicine (TCM) herbal formulations have been used to treat T2DM for centuries. METHODS: In this study, we proposed a formula called ShenQi Compound (SQC), which has been used in clinical therapeutics in China for several years. We evaluated the effect of SQC in a spontaneous diabetic rat model (GK rats) by detecting a series of blood indicators and performing histological observations. Meanwhile, the gene microarray and RT-qPCR experiments were used to explore the molecular mechanism of SQC treatment. In addition, western medicine, sitagliptin was employed as a comparison. RESULTS: The results indicated that SQC and sitagliptin could effectively improve the serum lipid (blood Total Cholesterol (TC) and blood Triglycerides (TG)), hormone levels (serum insulin (INS), Glucagon (GC) and Glucagon-Like Peptide-1 (GLP-1)), alleviated the inflammatory response (hypersensitive C-Reactive Protein (hsCRP)), blood glucose fluctuation (Mean Blood Glucose (MBG), standard deviation of blood glucose (SDBG) and Largest Amplitude of plasma Glucose Excursions (LAGE)), pancreatic tissue damage and vascular injury for T2DM. Compared with sitagliptin, SQC achieved a better effect on blood glucose fluctuation (p<0.01). Meanwhile, the gene microarray and RT-qPCR experiments indicated that SQC and sitagliptin may improve the T2DM through affecting the biological functions related to apoptosis and circadian rhythm. Moreover, SQC might be able to influence the mTOR signaling pathway by regulating Pik3r1, Ddit4 expression. CONCLUSION: All these results indicate that SQC is an effective therapeutic drug on T2DM. Notably, SQC presents an obvious blood glucose fluctuation-preventing ability, which might be derived from the regulation of the mTOR signaling pathway.

Platelet lysate supports the in vitro expansion of human periodontal ligament stem cells for cytotherapeutic use.

Human platelet lysate (PL) produced under optimal conditions of standardization and safety has been increasingly suggested as the future 'gold standard' supplement to replace fetal bovine serum (FBS) for the ex vivo propagation of mesenchymal stem cells for translational medicine and cell therapy applications. However, the multifaceted effects of PL on tissue-specific stem cells remain largely unexplored. In the present study, we investigated the stem cell behaviours of human periodontal ligament stem cells (PDLSCs) in media with or without PL. Our data indicate that human PL, either as an adjuvant for culture media or as a substitute for FBS, supports the proliferation and expansion of human PDLSCs derived from either 'young' or 'old' donors to the same extent as FBS, without interfering with their immunomodulatory capacities. Although PL appears to inhibit the in vitro differentiation of 'young' or 'old' PDLSCs, their decreased osteogenic potential may be restored to similar or higher levels compared with FBS-expanded cells. PL- and FBS-expanded PDLSCs exhibited a similar potential to form mineralized nodules and expressed similar levels of osteogenic genes. Our data indicate that large clinically relevant quantities of PDLSCs may be yielded by the use of human PL; however, further analysis of its precise composition and function will pave the way for determining optimized, defined culture conditions. In addition to the potential increase in patient safety, our findings highlight the need for further research to develop the potential of PL-expanded PDLSCs for clinical use. Copyright © 2016 John Wiley & Sons, Ltd.

Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial.

BACKGROUND: Periodontitis, which progressively destroys tooth-supporting structures, is one of the most widespread infectious diseases and the leading cause of tooth loss in adults. Evidence from preclinical trials and small-scale pilot clinical studies indicates that stem cells derived from periodontal ligament tissues are a promising therapy for the regeneration of lost/damaged periodontal tissue. This study assessed the safety and feasibility of using autologous periodontal ligament stem cells (PDLSCs) as an adjuvant to grafting materials in guided tissue regeneration (GTR) to treat periodontal intrabony defects. Our data provide primary clinical evidence for the efficacy of cell transplantation in regenerative dentistry. METHODS: We conducted a single-center, randomized trial that used autologous PDLSCs in combination with bovine-derived bone mineral materials to treat periodontal intrabony defects. Enrolled patients were randomly assigned to either the Cell group (treatment with GTR and PDLSC sheets in combination with Bio-oss(®)) or the Control group (treatment with GTR and Bio-oss(®) without stem cells). During a 12-month follow-up study, we evaluated the frequency and extent of adverse events. For the assessment of treatment efficacy, the primary outcome was based on the magnitude of alveolar bone regeneration following the surgical procedure. RESULTS: A total of 30 periodontitis patients aged 18 to 65 years (48 testing teeth with periodontal intrabony defects) who satisfied our inclusion and exclusion criteria were enrolled in the study and randomly assigned to the Cell group or the Control group. A total of 21 teeth were treated in the Control group and 20 teeth were treated in the Cell group. All patients received surgery and a clinical evaluation. No clinical safety problems that could be attributed to the investigational PDLSCs were identified. Each group showed a significant increase in the alveolar bone height (decrease in the bone-defect depth) over time (p < 0.001). However, no statistically significant differences were detected between the Cell group and the Control group (p > 0.05). CONCLUSIONS: This study demonstrates that using autologous PDLSCs to treat periodontal intrabony defects is safe and does not produce significant adverse effects. The efficacy of cell-based periodontal therapy requires further validation by multicenter, randomized controlled studies with an increased sample size. TRIAL REGISTRATION: NCT01357785 Date registered: 18 May 2011.

Neferine induces autophagy of human ovarian cancer cells via p38 MAPK/ JNK activation.

Ovarian cancer is the most lethal gynecological malignancy. Patients usually have poor prognosis because of late diagnosis, relapse, and chemoresistance. It is pressing to seek novel agent for the treatment of ovarian cancer. Neferine is a bisbenzylisoquinoline alkaloid isolated from the embryos of lotus (Nelumbo nucifera). In this study, we investigated the antitumor effect of neferine on ovarian cancer cells. We found that neferine exhibited growth-inhibitory effect on human ovarian cancer cells, whereas showing less cytotoxic to non-malignant fallopian tube epithelial cells. Furthermore, we demonstrated that neferine induced autophagy and inactivated the mTOR pathway. Finally, we found that both p38 MAPK and JNK signaling pathways were activated by neferine treatment and contributed to the induction of autophagy in ovarian cancer cells. In conclusion, our findings showed that neferine induced autophagy of human ovarian cancer cells via p38 MAPK/JNK activation. Neferine may be explored as a promising antitumoral agent in ovarian cancer.

[FlU Zhonghua's clinical experience of Fu's subcutaneous needling for cervical spondylosis].

Professor FU Zhonghua's unique clinical experience of Fu's subcutaneous needling (FSN) for cervical spondylosis (CS) is discussed in this paper, which is analyzed from the aspects of recognition of CS pathogenesis, treatment mechanism of FSN, advantage indications of FSN for CS and examples of medical cases. Professor FU introduced the theory of myofascial trigger points (MTrP) into the field of the management of CS. The site of neck MTrP should be carefully examined, and FSN needles for single use are used to sweep the affected area or subcutaneous layer of adjacent upper limb. This method can rapidly improve ischemia and hypoxia state of the relevant muscles and prompt the self-recovery of neck muscles. During FSN treatment, reperfusion approach is recommended to adopt to improve the qi and blood circulation and recovery of neck function.