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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
A randomized controlled trial to assess the safety and efficacy of silymarin on symptoms, signs and biomarkers of acute hepatitis
Phytomedicine, Volume 16, No. 5, Year 2009
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Description
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 >2.5 times the upper limit of normal were enrolled. 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). 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. © 2009 Elsevier GmbH. All rights reserved.
Authors & Co-Authors
El-Kamary, Samer S.
United States, Baltimore
University of Maryland School of Medicine
Shardell, Michelle D.
United States, Baltimore
University of Maryland School of Medicine
Abdel-Hamid, Mohamed A.
Egypt, Cairo
Faculty of Medicine
Egypt, Minya
Minia University
Ismail, Soheir
Egypt, Cairo
Faculty of Medicine
El-Ateek, Mohamed
Egypt, Tanta
Tanta Fever Hospital
Metwally, Mohamed Abd El Aziz
Egypt, Cairo
Faculty of Medicine
Egypt, Benha
Faculty of Medicine
NNH Mikhail, Nabiel N.H.
Egypt, Cairo
Faculty of Medicine
Egypt, Asyut
Assiut University
Hashem, Mohamed S.
United States, Baltimore
University of Maryland School of Medicine
Egypt, Cairo
Faculty of Medicine
Mousa, Amr
Egypt, Cairo
Faculty of Medicine
Aboul-Fotouh, Amr
Egypt, Cairo
Faculty of Medicine
El-Kassas, Mohamed
Egypt, Cairo
Faculty of Medicine
Esmat, Gamal
Egypt, Cairo
Faculty of Medicine
Strickland, George Thomas
United States, Baltimore
University of Maryland School of Medicine
Statistics
Citations: 104
Authors: 13
Affiliations: 6
Identifiers
Doi:
10.1016/j.phymed.2009.02.002
ISSN:
09447113
Research Areas
Infectious Diseases
Study Design
Randomised Control Trial
Cohort Study
Study Approach
Quantitative
Study Locations
Egypt