Alcohol and hepatotoxic viruses cause the majority of liver diseases. Randomised clinical trials have assessed whether extracts of milk thistle, Silybum marianum (L) Gaertneri, have any effect in patients with alcoholic and/or hepatitis B or C virus liver diseases.
To assess the beneficial and harmful effects of milk thistle or milk thistle constituents versus placebo or no intervention in patients with alcoholic liver disease and/or viral liver diseases (hepatitis B and hepatitis C).
TheCochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and full text searches were combined (December 2003). Manufacturers and researchers in the field were contacted.
Only randomised clinical trials in patients with alcoholic and/or hepatitis B or C virus liver diseases (acute and chronic) were included. Interventions encompassed milk thistle at any dose or duration versus placebo or no intervention. The trials could be double blind, single blind, or unblinded. The trials could be unpublished or published and no language limitations were applied.
Data collection and analysis
The primary outcome measure was mortality. Binary outcomes are reported as relative risks (RR) with 95% confidence interval (CI). Subgroup analyses were performed with regard to methodological quality.
Thirteen randomised clinical trials assessed milk thistle in 915 patients with alcoholic and/or hepatitis B or C virus liver diseases. The methodological quality was low: only 23% of the trials reported adequate allocation concealment and only 46% were considered adequately double-blinded. Milk thistle versus placebo or no intervention had no significant effect on mortality (RR 0.78, 95% CI 0.53 to 1.15), complications of liver disease (RR 0.95, 95% CI 0.83 to 1.09), or liver histology. Liver-related mortality was significantly reduced by milk thistle in all trials (RR 0.50, 95% CI 0.29 to 0.88), but not in high-quality trials (RR 0.57, 95% CI 0.28 to 1.19). Milk thistle was not associated with a significantly increased risk of adverse events (RR 0.83, 95% CI 0.46 to 1.50).
Our results question the beneficial effects of milk thistle for patients with alcoholic and/or hepatitis B or C virus liver diseases and highlight the lack of high-quality evidence to support this intervention. Adequately conducted and reported randomised clinical trials on milk thistle versus placebo are needed.
酒精和肝炎病毒是引起大多數肝病的主要原因。隨機臨床試驗評估是否奶薊提取物, Silybum marianum (L) Gaertneri對於酒精性肝病、B肝或C肝病毒肝病的病人有效。
結合The Cochrane HepatoBiliary Group Controlled Trials Register 、The Cochrane Central Register of Controlled Trials、 MEDLINE、EMBASE和全文搜索(2003年12月)。同時聯繫該領域的廠商和研究人員。
主要結果的測量值是死亡率。二分法結果記錄以相對風險(relative risks ，RR) 及其95% 信賴區間 (CI)。實施亞組分析來評估研究方法學品質。
共有13個針對奶薊治療酒精性肝病和B肝或C肝病毒性肝病的隨機臨床試驗，評估915位病人。研究方法品質較差: 只有23% 的試驗記錄有充足的分配方案隱匿，46% 的試驗認為具有合宜雙盲法。 比較安慰劑或無干預法， 在死亡率(RR 0.78, 95% CI 0.53 – 1.15), 肝病併發症(RR 0.95, 95% CI 0.83 – 1.09),肝臟病理學等方面，奶薊沒有顯著作用。在所有試驗，奶薊明顯降低和肝臟有關的死亡率(RR 0.50, 95% CI 0.29 – 0.88)，但是在高品質試驗 (RR 0.57, 95% CI 0.28 – 1.19)中效果不彰。奶薊和不良事件的顯著增加沒有關聯性 (RR 0.83, 95% CI 0.46 1.50)。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。
沒有證據支持或反對酒精性肝病、B肝或C肝病毒性肝病的病人使用奶薊。從古希臘時代開始，奶薊(Silybum marianum (L) Gaertneri)提取物一直被人們當做是一種藥物治療的方法。酒精性肝病和肝毒性病毒是引起大多數肝病的主要原因。幾次試驗研究奶薊治療肝病病人的效果。本次系統性文獻回顧無法呈現奶薊在死亡率，肝病併發症等方面，對酒精性肝病和B肝或C肝肝病的病人有明顯療效。結合所有試驗或高品質試驗之後，低品質試驗指出奶薊具有有利療效。需要實施奶薊對照安慰劑的高品質的隨機臨床試驗。