Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases

  • Review
  • Intervention

Authors

  • Andrea Rambaldi,

    Corresponding author
    1. Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Cochrane Hepato-Biliary Group, Copenhagen, Denmark
    • Andrea Rambaldi, Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, DK-2100, Denmark. arambaldi@hotmail.com. rambaldi.andrea@libero.it.

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  • Bradly P Jacobs,

    1. University of California San Francisco, Osher Center for Integrative Medicine, San Francisco California, California, USA
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  • Christian Gluud

    1. Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Cochrane Hepato-Biliary Group, Copenhagen, Denmark
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Abstract

Background

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.

Objectives

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).

Search methods

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.

Selection criteria

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 The trials could be unpublished or published and no language limitations were applied.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.

Main results

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).

Authors' conclusions

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.

摘要

背景

使用奶薊治療酒精性肝病和B肝或C肝病毒性肝病

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。

目標

評估奶薊或奶薊成分,對照安慰劑、無干預法,治療酒精性肝病和病毒性肝病病人的利弊(B肝和C肝)。

搜尋策略

結合The Cochrane HepatoBiliary 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。

選擇標準

只納入有關酒精性和B肝或C肝病毒肝病的病人(急性和慢性)的隨機臨床試驗。包含任意劑量、任意治療期的奶薊治療,對照安慰劑或無干預法的試驗。

資料收集與分析

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。

主要結論

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)。

作者結論

我們的結果對奶薊對酒精性肝病、B肝或C肝病毒性肝病的益處提出質疑,並突顯出缺少高品質的證據來支持此類療法。未來需要適當設計、記錄詳實的奶薊對照安慰劑的隨機臨床試驗。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

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。

Plain language summary

No evidence supporting or refuting milk thistle for alcoholic and/or hepatitis B or C virus liver diseases

Milk thistle (Silybum marianum (L) Gaertneri) extracts have been used as medical remedies since the time of ancient Greece. Alcohol and hepatotoxic viruses are the major causes of liver diseases. Several trials have studied the effects of milk thistle for patients with liver diseases. This systematic review could not demonstrate significant effects of milk thistle on mortality or complications of liver diseases in patients with alcoholic and/or hepatitis B or C liver diseases combining all trials or high-quality trials. Low-quality trials suggested beneficial effects. High-quality randomised clinical trials on milk thistle versus placebo are needed.

Laički sažetak

Nema dokaza da je biljka sikavica (lat. Silybum marinum, engl. milk thistle) djelotvorna za bolest jetre uzrokovanu alkoholom ili hepatitisom B ili C

Ekstrakti biljke sikavice (Silybum marianum (L) Gaertneri) koristili su se kao tradicionalni lijek od vremena starih Grka. Alkohol i virusi koji oštećuju jetru (hepatotoksični virusi) glavni su uzročnici bolesti jetre. Više studija (13 studija s 915 ispitanika) istražilo je učinke biljke sikavice na pacijente s bolestima jetre. Kad su analizirani kvalitetni pokusi, ovaj Cochrane sustavni pregled nije utvrdio značajne učinke biljke sikavice na smrtnost ili komplikacije jetrenih bolesti u pacijenata s bolesti jetre uzrokovanom alkoholom ili hepatitisom B ili C. Studije loše kvalitete ukazuju na mogući blagotvoran učinak. Stoga su potrebne dodatne studije visoke kvalitete, koje će nasumično razvrstati ispitanike u skupine, da bi se propisno istražila moguća djelotvornost i sigurnost sikavice za te jetrene bolesti.

Bilješke prijevoda

Cochrane Hrvatska
Prevela: Livia Puljak
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr