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Background: Coronavirus disease 2019 (COVID-19) is a new global public health emergency. The therapeutic benefits of Cold‒Damp Plague Formula (CDPF) against COVID-19, which was used to treat "cold‒dampness stagnation in the lung" in Trial Versions 6 and 7 of the "Diagnosis and Treatment Protocol for COVID-19", have been demonstrated, but the effective components and their mechanism of action remain unclear. Methods: In this study, a network pharmacology approach was employed, including drug-likeness evaluation, oral bioavailability prediction, protein‒protein interaction (PPI) network construction and analysis, Gene Ontology (GO) terms, and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway annotation, and virtual docking, to predict the bioactive components, potential targets, and molecular mechanism of CDPF for COVID-19 treatment. Results: The active compound of herbs in CDPF and their candidate targets were obtained through database mining, and an herbs—ingredients—targets network was constructed. Subsequently, the candidate targets of the active compounds were compared to those relevant to COVID-19, to identify the potential targets of CDPF for COVID-19 treatment. Subsequently, the PPI network was constructed, which provided a basis for cluster analysis and hub gene screening. The seed targets in the most significant module were selected for further functional annotation. GO enrichment analysis identified four main areas: (1) cellular responses to external stimuli, (2) regulation of blood production and circulation, (3) free radical regulation, (4) immune regulation and anti-inflammatory effects. KEGG pathway analysis also revealed that CDPF could play pharmacological roles against COVID-19 through "multi components‒multi targets‒multi pathways" at the molecular level, mainly involving anti-viral, immune-regulatory, and anti-inflammatory pathways; consequently, a "CDPF—herbs—ingredients—targets—pathways—COVID-19" network was constructed. In hub target analysis, the top hub target IL6, and ACE2, the receptor via which SARS-CoV-2 typically enters host cells, were selected for molecular docking analyses, and revealed good binding activities. Conclusions: This study revealed the active ingredients and potential molecular mechanism by which CDPF treatment is effective against COVID-19, and provides a reference basis for the wider application and further mechanistic investigations of CDPF in the fight against COVID-19. [ABSTRACT FROM AUTHOR]

Introduction/Aim: To assess the effectiveness and safety of Traditional Chinese patent medicines (TCPMs) for managing impaired glucose tolerance (IGT). Methods: Seven databases were searched to identify eligible trials published from incepting to May 1, 2016. Randomized controlled trials (RCTs) involving TCPM for IGT with a minimum follow-up duration of 6 months were included for analysis. Data extraction and quality assessment were performed by two reviewers independently. Data synthesis was analyzed using Review Manager 5.3 software. Subgroup analysis was carried out to assess the robustness of results of meta-analysis. Results: Eighteen trials with a total of 3172 participants met the inclusion criteria. The methodological quality of the RCTs was variable. Comparing with receiving lifestyle modification (LM) alone, TCPM plus LM was significantly better at reducing the incidence of diabetes (risk ratio [RR] 0.45; 95% confidence interval [CI] 0.36–0.57, p  < 0.00001) and normalizing the blood glucose (RR 0.72; 95% CI 0.64–0.82, p  < 0.00001). TCPM plus LM was superior in decreasing the levels of 2hPG, body mass index (BMI), fasting insulin, and 2 h insulin compared with LM alone (2hPG: mean difference [MD] −1.13; 95% CI −1.68 to −0.58, p  < 0.0001; BMI: MD −0.42; 95% CI −0.71 to −0.14, p  = 0.004; fasting insulin: MD −2.44; 95% CI −3.79 to −1.09, p  = 0.0004; and 2 h insulin: MD −8.26; 95% CI −8.47 to −8.05, p  < 0.00001). Compared with placebo plus LM, TCPM plus LM was superior in reducing diabetes (RR 0.54; 95% CI 0.42–0.69, p  < 0.00001) and normalizing blood glucose (RR 0.55; 95% CI 0.41–0.73, p  < 0.00001; the interventions were also associated with a decline in the two-hour postprandial blood glucose (2hPG) levels (MD −1.45; 95% CI −2.11 to −0.79, p  < 0.0001) and BMI levels (MD −1.12; 95% CI −2.00 to −0.24, p  < 0.0001). There were no significant differences in adverse events between two groups. Subgroup analysis found no significant difference in overall effects among all study characteristics, indicating that the overall effects were stable. Conclusions: The study indicated that TCPM combined with moderate lifestyle modification had significant effect on IGT. Further studies are needed to provide more reliable evidence. The PROSPERO registration is No. CRD42016039312. [ABSTRACT FROM AUTHOR]

Background: Diabetic distal symmetric polyneuropathy (DSPN) is one of the most common microvascular complications of diabetes mellitus, and it has become a major public health problem worldwide because of its high and increasing prevalence, morbidity, and disability rate. The current medications for DSPN are not entirely satisfactory. Preliminary studies indicated that the Chinese herbal TangBi Formula may alleviate signs and symptoms and improve the velocity of nerve conduction in patients with DSPN. This study was designed to determine if Chinese herbal medicine used in combination with conventional treatment is more effective than conventional treatment alone.Methods/design: We are conducting a multicenter, placebo-controlled, double-blind, randomized, controlled clinical trial as a means of assessing the therapeutic effects of traditional Chinese medicine (TCM) treatment. A total of 188 patients will be randomized in a 1:1 ratio to a treatment group (TangBi Formula plus mecobalamin) and a control group (placebo plus mecobalamin). The test period lasts 6 months, during which all of the patients will be given standard medical care as recommended by established guidelines. The primary outcome will be development of differences in changes in clinical symptoms and signs in patients and changes in Michigan Diabetic Neuropathy Score (MDNS) between the two groups before and after treatment. The secondary outcome will be changes in nerve conduction velocity and in single clinical signs and symptoms. Safety assessments and adverse events will also be evaluated.Discussion: We postulate that patients with DSPN will benefit from therapy that includes TCM. If successful, this work will provide an evidence-based complementary therapeutic approach for treatment of DSPN.Trial Registration: ClinicalTrials.gov, NCT03010241 . Registered on 2 January 2017. [ABSTRACT FROM AUTHOR]

Introduction: Prevention of the rapid growth in incidence of type 2 diabetes (T2DM) is a big challenge for clinicians. In China, many trials have indicated that Tianqi capsule, which contains several Chinese herbal medicines as part of a large healing system called traditional Chinese medicine, could decrease the incidence of T2DM. The review assessed the effectiveness of Tianqi capsule in prevention of T2DM. Methods: Seven electronic databases were searched to identify eligible trials published from the inception of the databases up until May 1, 2017. Randomized controlled trials (RCTs) of Tianqi capsule for impaired glucose tolerance (IGT) were included. Data extraction and quality assessment were performed according to the Cochrane review standards. A random or a fixed effect model was used to analyze outcomes which were expressed as risk ratios (RRs) or mean differences (MD), and I statistics were used to assess heterogeneity. Results: Six trials were identified that included 1027 subjects. Meta-analysis showed that subjects who received Tianqi capsule plus lifestyle modification (LM) were less likely to progress to T2DM compared to controls (RR 0.55, 95% CI 0.44-0.68). Subjects who received Tianqi capsule plus LM were more likely to have glucose return to normal compared to controls (RR 0.69; 95% CI 0.62-0.78); and they had reduced fasting plasma glucose (FBG) (MD − 0.35; 95% CI − 0.55 to − 0.16) and 2-h plasma glucose (2 h PG) (MD − 1.04; 95% CI − 1.75 to − 0.32). There was no statistical difference between the two groups for IGT stabilized incidence (RR 0.89; 95% CI 0.71-1.12). No obvious adverse events occurred. Conclusion: In patients with IGT, Tianqi capsule reduced the risk of progression to T2DM and increased the possibility of regression toward normoglycemia. As a result of the limited number of RCTs and the methodological drawbacks of the included studies, the results should be interpreted with caution. [ABSTRACT FROM AUTHOR]

Aim: Early interventions in prediabetes can prevent or delay the incidence of type 2 diabetes mellitus (T2DM). The aim of this review was to assess the efficacy and safety of traditional Chinese patent medicine (TCPM) on the prevention of T2DM.Methods: Seven electronic databases were searched to identify eligible trials published until June 1, 2016. Randomized controlled trials (RCTs) that compared TCPM plus lifestyle modification (LM) versus LM alone were included for in the. RCTs that used TCPM plus LM compared with placebo plus LM were also included. Methodological quality was assessed using the Cochrane Collaboration Risk of Bias tool. A random- or fixed-effect model was used to analyze outcomes that were expressed as risk ratios (RRs) or mean differences (MD), and the I2 statistic was used to assess heterogeneity.Results: Twenty-six trials with a total of 4169 participants met the inclusion criteria. Subgroup analysis confirmed that, compared with LM alone, TCPM and LM together were significantly better at reducing diabetes (RR, 0.47; 95% CI, 0.38-0.59) and normalizing blood glucose (RR, 0.76; 95% CI, 0.69-0.85). They also caused a greater reduction in fasting plasma glucose (FBG) (MD, -0.37; 95% CI, -0.62 to -0.13), 2-h plasma glucose (2h PG) (MD, -0.91; 95% CI, -1.35 to -0.47) and body mass index (BMI) (MD, -0.45; 95% CI, -0.76 to -0.14). Compared with placebo plus LM, TCPM plus LM was superior at reducing diabetes (RR, 0.55; 95% CI, 0.45-0.68) and normalizing blood glucose (RR, 0.62; 95% CI, 0.50-0.76). The interventions were also associated with a decline in FBG levels (MD, -0.68; 95% CI, -1.25 to -0.11) and 2h PG levels (MD, -1.07; 95% CI, -1.85 to -0.29). There were no significant differences in adverse events in either group. Subgroup and sensitivity analyses found no significant difference in overall effects among all study characteristics, indicating that the overall effects were stable. Generally, the quality of evidence was low for the effect of TCPM on the incidence of diabetes and normalization of blood glucose, and was very low for the effects of TCPM on FBG, 2h PG, and BMI.Conclusions: Based on this systematic review, TCPM may reduce the risk of progression to T2DM and increase the possibility of regression toward normoglycemia. As a result of the methodological drawbacks of the included studies, more rigorously designed RCTs are required to more reliably assess the efficacy of TCPM and long-term follow-up is needed before TCPM can be recommended for prediabetic patients. [ABSTRACT FROM AUTHOR]