RESUMEN

BACKGROUND: Prediabetes strongly increases the risk of type 2 diabetes and cardiovascular events. However, lifestyle intervention, the first-line treatment for prediabetes currently, was inconsistently beneficial for glucose metabolism, and the conventional medicines, such as metformin, is controversial for prediabetes due to the possible side effects. PURPOSE: This study was designed to evaluate the effects of Zhenyuan Capsule, a Chinese patented medicine consisting of ginseng berry saponins extracted from the mature berry of Panax Ginseng, on the glucose metabolism of prediabetic patients as a complementary therapy. STUDY DESIGN AND METHODS: In this randomized, double-Blinded, placebo-controlled, crossover trial, 195 participants with prediabetes were randomized 1:1 to receive either placebo followed by Zhenyuan Capsule, or vice versa, alongside lifestyle interventions. Each treatment period lasted 4 weeks with a 4-week washout period in between. The primary outcomes were the changes in fasting plasma glucose (FPG) and 2-h postprandial plasma glucose (2-h PG) from baseline. Secondary outcomes includes the changes in fasting and 2-h postprandial insulin and C-peptide, the homeostatic model assessment-insulin resistance (HOMA-IR) index and quantitative insulin sensitivity check index (QUICKI) from baseline. Blood lipids and adverse events were also assessed. RESULTS: Compared with placebo, Zhenyuan Capsule caused remarkable reduction in 2-h PG (-0.98 mmol/l) after adjusting treatment order. Zhenyuan Capsule also reduced the fasting and 2-h postprandial levels of insulin and C-peptide, lowered HOMA-IR index (-1.26), and raised QUICKI index (+0.012) when compared to placebo. Additionally, a significant increase in high density lipoprotein cholesterol (HDL-C; +0.25 mmol/l) was found in patients with Zhenyuan Capsule. No serious adverse event occurred during the study. CONCLUSIONS: Among prediabetic patients, Zhenyuan Capsule further reduced 2-h PG level, alleviated insulin resistance and raised HDL-C level on the background of lifestyle interventions. The study protocol is registered with the Chinese Clinical Trial Registry (ChiCTR2000034000).

Asunto(s)

Glucemia , Estudios Cruzados , Frutas , Resistencia a la Insulina , Panax , Estado Prediabético , Saponinas , Humanos , Panax/química , Estado Prediabético/tratamiento farmacológico , Masculino , Femenino , Método Doble Ciego , Persona de Mediana Edad , Glucemia/efectos de los fármacos , Saponinas/farmacología , Frutas/química , Insulina/sangre , Insulina/metabolismo , Adulto , Péptido C/sangre , Medicamentos Herbarios Chinos/farmacología , Anciano , Periodo Posprandial , Hipoglucemiantes/farmacología

RESUMEN

Quality markers (Q-markers) are of great significance for quality evaluation of herbal medicines. Zhenyuan Capsule (ZYC) is a kind of Chinese patent medicine used to treat cardiovascular diseases. However, reliable and effective Q-markers for ZYC are still lacking. Herein, a UHPLC-Q/Orbitrap-MS/MS was performed to characterise the preliminary chemical profile of ZYC. A total of 86 components were characterised among which 20 constituents were unambiguously identified by reference compounds. Based on network pharmacology, seven major ginsenosides with great importance in the network were identified as Q-markers among which ginsenoside Re with the highest betweenness was screened to inhibit the development of coronary heart disease (CHD) by binding with vascular endothelial growth factor A (VEGFA). Docking and molecular dynamics simulation studies suggested that ginsenoside Re stably bound to VEGFA. Quantitative determination and chemical fingerprinting analysis were performed using HPLC-DAD. The results showed that ginsenosides screened might function as potential Q-markers for ZYC.

RESUMEN

To systematically review the adjuvant effects of Zhenyuan capsule on improving the cardiac function of patients with chronic heart failure. Databases including PubMed, EMbase, the Cochrane Library, CBM, CNKI, VIP and Wanfang Data were searched electronically from inception to October 2016 to collect randomized controlled trials (RCTs) about Zhenyuan capsule for adjuvant treatment of chronic heart failure. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, Meta-analysis was performed by using RevMan 5.3 software. A total of 14 RCTs involving 1 204 patients were included. The results of Meta-analysis showed that the Zhenyuan capsule group had significantly better effectiveness in cardiac function (RR=1.27, 95%CI 1.20 to 1.35, P < 0.000 01), stroke volume (WMD=7.62, 95%CI 6.39 to 8.84,P < 0.000 01), scores of HAMA (WMD=-4.16, 95%CI -5.59 to -2.72, P < 0.000 01), psychological effect of HAMA (RR=1.47, 95%CI 1.15 to 1.89, P=0.002), and traditional Chinese medical syndrome (RR=1.46, 95%CI 1.25 to 1.72, P < 0.000 01) than those of the control group, with statistically significant differences. Current evidence showed that Zhenyuan capsule combined with routine treatment could improve the cardiac function and quality of life of patients with chronic heart failure, and with high safety. Due to the limited quantity and quality of the included studies, the above conclusion still needs to be verified by carrying out more high-quality RCTs.

Asunto(s)

Medicamentos Herbarios Chinos/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Adyuvantes Farmacéuticos/farmacología , Cápsulas , Humanos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto

RESUMEN

To systematically review the adjuvant effects of Zhenyuan capsule on improving the cardiac function of patients with chronic heart failure. Databases including PubMed, EMbase, the Cochrane Library, CBM, CNKI, VIP and Wanfang Data were searched electronically from inception to October 2016 to collect randomized controlled trials (RCTs) about Zhenyuan capsule for adjuvant treatment of chronic heart failure. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, Meta-analysis was performed by using RevMan 5.3 software. A total of 14 RCTs involving 1 204 patients were included. The results of Meta-analysis showed that the Zhenyuan capsule group had significantly better effectiveness in cardiac function (RR=1.27, 95%CI 1.20 to 1.35, P < 0.000 01), stroke volume (WMD=7.62, 95%CI 6.39 to 8.84,P < 0.000 01), scores of HAMA (WMD=-4.16, 95%CI -5.59 to -2.72, P < 0.000 01), psychological effect of HAMA (RR=1.47, 95%CI 1.15 to 1.89, P=0.002), and traditional Chinese medical syndrome (RR=1.46, 95%CI 1.25 to 1.72, P < 0.000 01) than those of the control group, with statistically significant differences. Current evidence showed that Zhenyuan capsule combined with routine treatment could improve the cardiac function and quality of life of patients with chronic heart failure, and with high safety. Due to the limited quantity and quality of the included studies, the above conclusion still needs to be verified by carrying out more high-quality RCTs.

RESUMEN

AIM:To observe the clinical effect of Zhenyuan Capsule on patients with chronic heart failure. METHODS: 78 patients with chronic heart failure were randomly divided into two groups.The therapeutic group (n=39) was treated with routine western medicine and Zhenyuan Capsule and the control group (n=39) was treated with routine western medicine.The heart function grading,traditional Chinese medicine symdromes and left ventricle ejection fraction (LVEF) were observed after one course of treatment (28 d). RESULTS: The effective rates for the heart function grading, traditional Chinese medicine symdroms and LVEF in test group were better than those in the control group. There was a statistical significant difference between the two groups (P