A randomized controlled trial to assess the safety and efficacy of silymarin [milk thistle extract] on symptoms, signs and biomarkers of acute hepatitis – Source: Phytomedicine, May 2009

[Note: liver inflammation, called hepatitis, can be caused by toxins, viral infections, or autoimmune process, and may improve or progress. Hepatitis is termed “acute” if it has been present less than six months; "chronic" if it persists and leads to scarring.]

Purpose: Milk thistle or its purified extract, silymarin (Silybum marianum), is widely used in treating acute or chronic hepatitis. Although silymarin is hepatoprotective in animal experiments and some human hepatotoxic exposures, its efficacy in ameliorating the symptoms of acute clinical hepatitis remains inconclusive. In this study, our purpose was to determine whether silymarin improves symptoms, signs and laboratory test results in patients with acute clinical hepatitis, regardless of etiology.

Methods: This is a randomized, placebo-controlled trial in which participants, treating physicians and data management staff were blinded to treatment group. The study was conducted at two fever hospitals in Tanta and Banha, Egypt where patients with symptoms compatible with acute clinical hepatitis and serum alanine aminotransferase (ALT) levels more than 2.5 times the upper limit of normal were enrolled. [ALT is the variable most commonly measured to assess liver disease.]

The intervention consisted of three times daily ingestion of either a standard recommended dose of 140 mg of silymarin (Legalon, MADAUS GmbH, Cologne, Germany), or a vitamin placebo for four weeks with an additional four-week follow-up. The primary outcomes were symptoms and signs of acute hepatitis and results of liver function tests on days 2, 4 and 7 and weeks 2, 4, and 8. Side-effects and adverse events were ascertained by self-report.

Results: From July 2003 through October 2005, 105 eligible patients were enrolled after providing informed consent.

• No adverse events were noted and both silymarin and placebo were well tolerated.

• Patients randomized to the silymarin group had quicker resolution of symptoms related to biliary retention: dark urine (p=0.013), jaundice (p=0.02) and scleral icterus (p=0.043). [Bile is a fluid produced in the liver to aid fat digestion and disposal of waste and toxins. Biliary retention is a buildup of harmful substances that can damage liver tissue (cirrhosis).]

• There was a reduction in indirect bilirubin among those assigned to silymarin (p=0.012), but other variables including direct bilirubin, ALT and aspartate aminotransferase (AST) were not significantly reduced.

Conclusions: Patients receiving silymarin had earlier improvement in subjective and clinical markers of biliary excretion. Despite a modest sample size and multiple etiologies for acute clinical hepatitis, our results suggest that:

• Standard recommended doses of silymarin are safe and may be potentially effective in improving symptoms of acute clinical hepatitis

• Despite lack of a detectable effect on biomarkers of the underlying hepatocellular inflammatory process.
Source: Phytomedicine, May 2009;16(5):391-400. PMID: 19303273, by El-Kamary SS, Shardell MD, Abdel-Hamid M, Ismail S, El-Ateek M, Metwally M, Mikhail N, Hashem M, Mousa A, Aboul-Fotouh A, El-Kassas M, Esmat G, Strickland GT. Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA. [E-mail: selkamar@epi.umaryland.edu]

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