Division of Gastroenterology and Hepatology, 1st Department of Internal Medicine, AHEPA University Hospital, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Laboratory of Hygiene, Social & Preventive Medicine and Medical Statistics, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece; Third Department of Internal Medicine, G. H. "Papageorgiou", School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Nutrition. 2021 Mar;83:111092. doi: 10.1016/j.nut.2020.111092. Epub 2020 Nov 25.
Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease affecting a significant proportion of the general population. Recently, randomized clinical trials have been conducted examining the efficacy of silymarin in individuals with NAFLD, with conflicting results. The aim of this meta-analysis was to evaluate the efficacy of silymarin in the treatment of NAFLD by examining changes in liver biochemistry, body mass index, and liver histology.
We searched major electronic databases PubMed/MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials, as well as gray-literature sources, up to June 2020 for randomized clinical trials examining the efficacy of treatment with silymarin in individuals with NAFLD compared to placebo. The primary outcomes were changes in the mean values of transaminases (alanine aminotransferase and aspartate aminotransferase). Secondary outcomes included changes in body mass index and liver histology. Quality analysis was performed with the risk-of-bias tool 2.0. We synthesized results using weighted mean differences for continuous outcomes, along with 95% confidence intervals.
In the meta-analysis, eight randomized clinical trials were included. A cutoff level of 0.05 was considered to provide statistically significant results. Silymarin treatment led to a statistically significant greater reduction in the levels of transaminases compared to placebo, irrespective of weight loss.
Silymarin seems to be effective in reducing transaminase levels in individuals with NAFLD. Despite the statistical benefits, we call attention to potential flaws related to the quality of the included studies. Further well-designed studies should be carried out to examine whether this reduction in transaminase levels corresponds to histologic improvement.
非酒精性脂肪性肝病（NAFLD）是一种影响相当一部分普通人群的慢性肝脏疾病。最近，已经进行了随机临床试验来研究水飞蓟素在 NAFLD 患者中的疗效，结果存在争议。本荟萃分析的目的是通过检查肝生化、体重指数和肝组织学的变化来评估水飞蓟素治疗 NAFLD 的疗效。
我们检索了主要的电子数据库 PubMed/MEDLINE、Embase 和 Cochrane 对照试验中心注册库，以及灰色文献来源，截至 2020 年 6 月，以评估与安慰剂相比水飞蓟素治疗 NAFLD 患者的疗效的随机临床试验。主要结局是转氨（丙氨酸氨基转移酶和天冬氨酸氨基转移酶）的平均值变化。次要结局包括体重指数和肝组织学的变化。使用风险偏倚工具 2.0 进行质量分析。我们使用加权均数差值来综合连续结局的结果，并提供 95%置信区间。
荟萃分析纳入了八项随机临床试验。0.05 的截值被认为提供了统计学上显著的结果。无论是否有体重减轻，水飞蓟素治疗与安慰剂相比，导致转氨水平的统计学显著降低。
水飞蓟素似乎能有效降低 NAFLD 患者的转氨水平。尽管具有统计学意义，但我们注意到与纳入研究质量相关的潜在缺陷。应该进行更多设计良好的研究，以检查这种转氨水平的降低是否对应于组织学改善。
