scholarly journals Traditional Chinese medicine Lingguizhugan decoction treating non-alcoholic fatty liver disease with spleen-yang deficiency pattern: Study protocol for a multicenter randomized controlled trial

2019 ◽  
Author(s):  
Jing-juan Xu ◽  
Rui-rui Wang ◽  
Sheng-fu You ◽  
Lei Zhang ◽  
Pei-yong Zheng ◽  
...  

Abstract Background: Nonalcoholic fatty liver disease (NAFLD) is a metabolic stress liver injury induced by excessive fat accumulation in liver, which is closely related to insulin resistance (IR). Traditional Chinese medicine (TCM) has showed good curative effects and unique advantages in the prevention and treatment of NADLD, particularly in improving IR, liver function and clinical symptoms. This study will examine the efficacy and safety of Lingguizhugan decoction (LGZG) in the treatment of non-alcoholic fatty liver disease with spleen-yang deficiency pattern, and assess the optimal dosage. Methods/design: This study is a three-arm, dose-optimization, randomized, double-blinded, placebo-controlled clinical trial. A total of 243 NAFLD patients will be recruited and randomly assigned to standard dose Lingguizhugan decoction (SLGD) group, low dose Lingguizhugan decoction (LLGD) group, or the control group. The clinical indicator will be assessed during the 12-week intervention and follow-up 4 weeks. The primary outcome is the percentage of patients whose the decline of HOMA-IR reaches one standard unit. Secondary outcomes include body weight, body mass index, liver function, blood lipid metabolism, blood glucose metabolism, liver-kidney echo ratio, quantitative rating of clinical symptoms and signs, collecting sample(s) from participants, the medical outcomes study(MOS) item short from health survey(SF-36), Self-rating Depressive Scale(SAS), and Self-rating Anxiety Scale(SDS). Discussion: This study will provide initial evidence regarding the efficacy and safety of LGZG in the treatment of NAFLD with spleen-yang deficiency pattern, meanwhile establish the demonstration technique, and promote its application in community healthcare center. In addition, potential mechanism will be explored based on research of oral and gut microbiota. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1800014364. Registered on 01 January 2018. The final protocol version was V3.0. Keywords: Non-alcoholic fatty liver disease, Traditional Chinese medicine, Lingguizhugan decoction, Randomized, double-blind and controlled trial

2020 ◽  
Author(s):  
Jing-juan Xu ◽  
Rui-rui Wang ◽  
Sheng-fu You ◽  
Lei Zhang ◽  
Pei-yong Zheng ◽  
...  

Abstract Background Nonalcoholic fatty liver disease (NAFLD) is a metabolic stress liver injury induced by excessive fat accumulation in liver, which is closely related to insulin resistance (IR). Traditional Chinese medicine (TCM) has showed good curative effects and unique advantages in the prevention and treatment of NADLD, particularly in improving IR, liver function and clinical symptoms. This study will examine the efficacy and safety of Lingguizhugan decoction (LGZG) in the treatment of non-alcoholic fatty liver disease with spleen-yang deficiency pattern, and assess the optimal dosage. Methods/design This study is a three-arm, dose-optimization, randomized, double-blinded, placebo-controlled clinical trial. A total of 243 NAFLD patients will be recruited and randomly assigned to standard dose Lingguizhugan decoction (SLGD) group, low dose Lingguizhugan decoction (LLGD) group, or the control group. The clinical indicator will be assessed during the 12-week intervention and follow-up 4 weeks. The primary outcome is the percentage of patients whose the decline of HOMA-IR reaches one standard unit. Secondary outcomes include body weight, body mass index, liver function, blood lipid metabolism, blood glucose metabolism, liver-kidney echo ratio, quantitative rating of clinical symptoms and signs, collecting sample(s) from participants, the medical outcomes study(MOS) item short from health survey(SF-36), Self-rating Depressive Scale(SAS), and Self-rating Anxiety Scale(SDS). Discussion This study will provide initial evidence regarding the efficacy and safety of LGZG in the treatment of NAFLD with spleen-yang deficiency pattern, meanwhile establish the demonstration technique, and promote its application in community healthcare center. In addition, potential mechanism will be explored based on research of oral and gut microbiota.


2022 ◽  
Author(s):  
luyun xia ◽  
Zheng Luo ◽  
Haiyan Zhu ◽  
Yu-qin Tang ◽  
Lili Huang ◽  
...  

Abstract Background Non-alcoholic fatty liver disease (NAFLD), the most prevalent chronic liver disease in the world, has yet to identify a particular medicine for treatment. Danggui Shaoyao San (DSS), a traditional Chinese medicine formula, has steadily been employed to treat NAFLD in recent years. Methods The active ingredients of the DSS were screened from the Traditional Chinese Medicine Systems Pharmacology (TCMSP), and the candidate targets of the ingredients were collected through the PharmMapper platform. NAFLD-related targets were acquired from NCBI, DisGeNet, Genecards databases. Venn diagram was used to identify possible DSS drug strategies in the treatment of NAFLD. Active ingredients - potential therapeutic targets network constructed in Cytoscape. The STRING database provides PPI networks. Metascape was used to evaluate targets using Gene Ontology (GO) and the Kyoto Encyclopedia of Genes and Genomes (KEGG). Finally, molecular docking simulations were performed using Pymol 2.4.0, AutoDuck Tools 1.5.6 and LigPlot 2.2.4 software to assess the affinity of key ingredients and targets. Results 51 compounds were screened in the DSS, including paeoniflorin, poric acid A and poric acid B. There are a total of 38 cross-targets between herbs and NAFLD. PPI network analysis identified AKT1, ALB, PPARG, and CASP3 as priority targets. GO analysis focused on vesicle lumen, nutrition levels, and nitrous-oxide synthase regulator activity. DSS may have therapeutic benefits via the pathways in cancer,foxo signaling pathway,IL-17 signaling pathway, Th17 cell differentiation, PI3K-Akt signaling pathway according to KEGG analysis. Sitosterol and β- sitosterol were proven to be true promising compounds with excellent affinity in the final molecular docking. Conclusions DSS entails a number of components, targets, and routes, and it provides novel therapy and preventative alternatives for NAFLD.


Drug Research ◽  
2017 ◽  
Vol 67 (04) ◽  
pp. 244-251 ◽  
Author(s):  
Yunes Panahi ◽  
Parisa Kianpour ◽  
Reza Mohtashami ◽  
Ramezan Jafari ◽  
Luis Simental-Mendía ◽  
...  

2017 ◽  
Vol 26 (1) ◽  
pp. 59-67 ◽  
Author(s):  
Ahmed Elgebaly ◽  
Ibrahim A. I. Radwan ◽  
Mohamed M. AboElnas ◽  
Hamza H. Ibrahim ◽  
Moutaz F. M. Eltoomy ◽  
...  

Background: Resveratrol is a potential treatment option for management of non-alcoholic fatty liver disease (NAFLD) due to its anti-inflammatory, antioxidant properties, and calorie restriction-like effects. We aimed to synthesise evidence from published randomized clinical trials (RCTs) about the efficacy of resveratrol in the management of NAFLD.Methods: A computer literature search of PubMed, Scopus, Web of Science, and Cochrane Central was conducted using relevant keywords. Records were screened for eligible studies and data were extracted and synthesized using Review Manager Version 5.3 for windows. Subgroup analysis and sensitivity analysis were conducted.Results: Four RCTs (n=158 patients) were included in the final analysis. The overall effect estimates did not favor resveratrol group in terms of: serum ALT (MD -2.89, 95%CI [-15.66, 9.88], p=0.66), serum AST (MD -3.59, 95%CI [-13.82, 6.63], p=0.49), weight (MD -0.18, 95%CI [-0.92, 0.55], p=0.63), BMI (MD -0.10, 95 %CI [-0.43, 0.24], p=0.57), blood glucose level (MD -0.27, 95%CI [-0.55, 0.01], p=0.05), insulin level (MD -0.12, 95%CI [-0.69, 0.46], p=0.69), triglyceride level (MD 0.04, 95%CI [-0.45, 0.53], p=0.87), and LDL level (MD 0.21, 95%CI [-0.41, 0.83], p=0.51). Pooled studies were heterogeneous.Conclusion: Current evidence is insufficient to support the efficacy of resveratrol in the management of NAFLD. Resveratrol does not attenuate the degree of liver fibrosis or show a significant decrease in any of its parameters.Abbreviations: ALT: Alanine aminotransferase; AMPK: AMP-activated protein kinase; AST: Aspartate aminotransferase; BMI: Body mass index; CK-18: Cytokeratin-18; CRP: C-reactive protein; HC: Head circumference; HDL: High density lipoprotein; IL-6: Interleukin-6; LDL: Low density lipoprotein; MD: Mean difference; NAFLD: Non-alcoholic fatty liver disease; NASH: Non-alcoholic steatohepatitis; RCT: Randomized Controlled Trial; RR: Relative risk; SIRT1: Silent information regulation 2 homologue 1; TNF-α: Tumor necrosis factor α; WC: Waist circumference; WHR: Waist hip ratio.


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