Department of Epidemiology, School of Public Health, Sun Yat-Sen University, Guangzhou, China.
Department of Epidemiology, School of Public Health, Sun Yat-Sen University, Guangzhou, China; Sichuan Center for Disease Control and Prevention, Chengdu, China.
Clin Nutr ESPEN. 2024 Oct;63:2-12. doi: 10.1016/j.clnesp.2024.06.003. Epub 2024 Jun 10.
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.
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.
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).
SPS supplementation may have potential benefits in improving NAFLD, but further larger-scale trials are necessary to confirm these findings.
一些药用植物提取物已被证明具有保肝作用。然而，关于它们对非酒精性脂肪性肝病（NAFLD）的联合作用的数据仍然有限。本研究旨在探讨含有水飞蓟素、葛根素和丹参的片剂（SPS）对中国成年人 NAFLD 进展的影响。
这是一项随机、三盲、安慰剂对照的临床试验，共纳入 121 例经磁共振成像（MRI）诊断为 NAFLD 的患者（60 名女性和 61 名男性），年龄 18-65 岁。参与者被随机分配接受 SPS 片剂（n=60；每次剂量 3 片，每日 2 次）或安慰剂（n=61）治疗 24 周。每片 SPS 片剂含有约 23.0mg 的水飞蓟素、11.4mg 的葛根素和 10.9mg 的丹酚酸。由 BYHEALTH 有限公司（中国广州）生产的 SPS 片剂和安慰剂在外观、口感和气味上没有差异。主要终点是从基线到 24 周时肝脂肪含量（LFC）和脂肪变性程度的变化。次要结局包括肝纤维化和脂肪变性、氧化应激、炎症细胞因子、酒精代谢和葡萄糖代谢生物标志物/评分的变化。
共有 112 名参与者完成了研究。意向治疗结果显示，与安慰剂组相比，SPS 组 24 周后绝对 LFC（-0.52%）和 LFC 百分比（-4.57%）均有下降趋势，但这些变化没有达到统计学意义（p>0.05）。SPS 干预（与安慰剂相比）在 24 周时显著降低了超敏 C 反应蛋白水平（-6.76%），并增加了醛脱氢酶活性（+18.1%）（均 p<0.05）。方案分析进一步支持了这些效果。该试验在 ClinicalTrials.gov 注册（NCT05076058）。
SPS 补充剂可能对改善 NAFLD 具有潜在益处，但需要进一步的大规模试验来证实这些发现。
