Abstract：
OBJECTIVE: 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).
CONCLUSIONS: SPS supplementation may have potential benefits in improving NAFLD, but further larger-scale trials are necessary to confirm these findings.
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).
CONCLUSIONS: SPS supplementation may have potential benefits in improving NAFLD, but further larger-scale trials are necessary to confirm these findings.
摘要：
目的：几种药用植物提取物已显示出保肝作用。然而,关于它们对非酒精性脂肪性肝病(NAFLD)的联合作用的数据很少.本研究旨在研究含水飞蓟片的效果，葛根,丹参（SPS）对中国成年人NAFLD进展的影响。
方法：在本随机分组中，三盲，安慰剂对照临床试验，121名NAFLD患者（60名女性和61名男性），通过磁共振成像（MRI）诊断，年龄在18-65岁之间，已注册。参与者被随机分配接受SPS片剂（n=60；每剂三片，每天两次）或安慰剂（n=61），持续24周。每片SPS含约23.0毫克水飞蓟宾，11.4毫克葛根素，和10.9毫克丹酚酸。外观上没有差异，BYHEALTHCo.制造的SPS片剂和安慰剂之间的味道和气味，有限公司（广州，中国）。主要终点是从基线到24周的肝脏脂肪含量（LFC）和脂肪变性等级的变化。次要结果包括肝纤维化和脂肪变性的生物标志物/评分的变化，氧化应激，炎性细胞因子，酒精代谢，和葡萄糖代谢。
结果：共有112名参与者完成了这项研究。意向治疗结果显示，与安慰剂组相比，24周后SPS组的绝对LFC（-0.52％）和LFC百分比（-4.57％）均有降低的趋势。但这些变化没有达到统计学意义(p>0.05)。SPS干预(vs.安慰剂）在干预后24周显着降低超敏C反应蛋白水平（-6.76％）和增加醛脱氢酶活性（18.1％）（所有p<0.05）。按方案分析进一步支持这些效果。该试验在ClinicalTrials.gov(NCT05076058)注册。
结论：补充SPS可能对改善NAFLD有潜在益处，但需要更大规模的试验来证实这些发现.
方法：在本随机分组中，三盲，安慰剂对照临床试验，121名NAFLD患者（60名女性和61名男性），通过磁共振成像（MRI）诊断，年龄在18-65岁之间，已注册。参与者被随机分配接受SPS片剂（n=60；每剂三片，每天两次）或安慰剂（n=61），持续24周。每片SPS含约23.0毫克水飞蓟宾，11.4毫克葛根素，和10.9毫克丹酚酸。外观上没有差异，BYHEALTHCo.制造的SPS片剂和安慰剂之间的味道和气味，有限公司（广州，中国）。主要终点是从基线到24周的肝脏脂肪含量（LFC）和脂肪变性等级的变化。次要结果包括肝纤维化和脂肪变性的生物标志物/评分的变化，氧化应激，炎性细胞因子，酒精代谢，和葡萄糖代谢。
结果：共有112名参与者完成了这项研究。意向治疗结果显示，与安慰剂组相比，24周后SPS组的绝对LFC（-0.52％）和LFC百分比（-4.57％）均有降低的趋势。但这些变化没有达到统计学意义(p>0.05)。SPS干预(vs.安慰剂）在干预后24周显着降低超敏C反应蛋白水平（-6.76％）和增加醛脱氢酶活性（18.1％）（所有p<0.05）。按方案分析进一步支持这些效果。该试验在ClinicalTrials.gov(NCT05076058)注册。
结论：补充SPS可能对改善NAFLD有潜在益处，但需要更大规模的试验来证实这些发现.
