Effects of Silybum marianum, Pueraria lobate, combined with Salvia miltiorrhiza tablets on non-alcoholic fatty liver disease in adults: A triple-blind, randomized, placebo-controlled clinical trial.

Autor: Li BY; Department of Epidemiology, School of Public Health, Sun Yat-Sen University, Guangzhou, China. Electronic address: liby35@mail2.sysu.edu.cn., Xi Y; Department of Epidemiology, School of Public Health, Sun Yat-Sen University, Guangzhou, China. Electronic address: xiyue5@mail2.sysu.edu.cn., Liu YP; Department of Epidemiology, School of Public Health, Sun Yat-Sen University, Guangzhou, China; Sichuan Center for Disease Control and Prevention, Chengdu, China. Electronic address: liuyuping9999@163.com., Wang D; BYHEALTH Institute of Nutrition & Health, Guangzhou 510663, China. Electronic address: wangd7@by-health.com., Wang C; Clinical Nutrition Department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University, China. Electronic address: wangcheng@mail.sysu.edu.cn., Chen CG; Clinical Nutrition Department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University, China. Electronic address: chenchg@mail.sysu.edu.cn., Fang XH; Guangzhou Universal Medical Imaging Diagnostic Center, Guangzhou 510080, China. Electronic address: 47947689@qq.com., Li ZX; BYHEALTH Institute of Nutrition & Health, Guangzhou 510663, China. Electronic address: lizx2@by-health.com., Chen YM; Department of Epidemiology, School of Public Health, Sun Yat-Sen University, Guangzhou, China. Electronic address: chenyum@mail.sysu.edu.cn.
Jazyk: angličtina
Zdroj: Clinical nutrition ESPEN [Clin Nutr ESPEN] 2024 Oct; Vol. 63, pp. 2-12. Date of Electronic Publication: 2024 Jun 10.
DOI: 10.1016/j.clnesp.2024.06.003
Abstrakt: Background & Aims: Several medicinal plant extracts have demonstrated hepatoprotective effects. However, data are scarce regarding their combined effects on non-alcoholic fatty liver disease (NAFLD). This study aimed to investigate the effects of tablets containing Silybum marianum, Pueraria lobata, and Salvia miltiorrhiza (SPS) on NAFLD progression in Chinese adults.
Methods: In this randomized, triple-blind, placebo-controlled clinical trial, 121 NAFLD patients (60 female and 61 male), diagnosed via magnetic resonance imaging (MRI) and aged 18-65 years, were enrolled. Participants were randomly allocated to receive SPS tablets (n = 60; three tablets per dose, twice daily) or placebo (n = 61) for 24 weeks. Each SPS tablet contained approximately 23.0 mg of silybin, 11.4 mg of puerarin, and 10.9 mg of salvianolic acid. There were no differences in appearance, taste and odour between the SPS tablets and placebo manufactured by BYHEALTH Co., LTD (Guangzhou, China). The primary endpoints were changes in the liver fat content (LFC) and steatosis grade from baseline to 24 weeks. Secondary outcomes included changes in biomarkers/scores of liver fibrosis and steatosis, oxidative stress, inflammatory cytokines, alcohol metabolism, and glucose metabolism.
Results: A total of 112 participants completed the research. The intention-to-treat results showed a trend toward reduction in both absolute LFC (-0.52%) and percentage of LFC (-4.57%) in the SPS group compared to the placebo group after 24 weeks, but these changes didn't reach statistical significance (p > 0.05). The SPS intervention (vs. placebo) significantly decreased hypersensitive C-reactive protein level (-6.76%) and increased aldehyde dehydrogenase activity (+18.1%) at 24 weeks post-intervention (all p < 0.05). Per-protocol analysis further supported these effects. This trial is registered at Clinical Trials.gov (NCT05076058).
Conclusion: SPS supplementation may have potential benefits in improving NAFLD, but further larger-scale trials are necessary to confirm these findings.
Competing Interests: Declaration of competing interest The tablets of S. marianum, P. lobata, and S. miltiorrhiza in the study was provided by BYHEALTH Co., LTD., China. Yu-ming Chen from Sun Yat-sen University received the grant supported by BYHEALTH Co., LTD., China, to complete this trial as the principal investigator. Zhong-xia Li and Di Wang are employees of BYHEALTH Co., LTD., China.
(Copyright © 2024 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: