Tuberculosis and Respiratory Diseases

The Korean Academy of Tuberculosis and Respiratory Diseases (대한결핵및호흡기학회)
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Effect of Prophylactic Use of Silymarin on Anti-tuberculosis Drugs Induced Hepatotoxicity

  • Heo, Eunyoung (Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center) ;
  • Kim, Deog Kyeom (Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center) ;
  • Oh, So Hee (Department of Medical Statistics, Seoul Metropolitan Government-Seoul National University Boramae Medical Center) ;
  • Lee, Jung-Kyu (Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center) ;
  • Park, Ju-Hee (Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center) ;
  • Chung, Hee Soon (Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center)
  • Received : 2017.04.03
  • Accepted : 2017.04.05
  • Published : 2017.07.31
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Abstract

Background: The first line of anti-tuberculosis (TB) drugs are the most effective standard of drugs for TB. However, the use of these drugs is associated with hepatotoxicity. Silymarin has protective effects against hepatotoxicity of anti-TB drugs in animal models. This study aims to investigate the protective effect of silymarin on hepatotoxicity caused by anti-TB drugs. Methods: This is a prospective, randomized, double-blind and placebo-controlled study. Patients were eligible if they were 20 years of age or order and started the first-line anti-tuberculosis drugs. Eligible patients were randomized for receiving silymarin or a placebo for the first 4 weeks. The primary outcome was the proportion of patients who showed elevated serum liver enzymes more than 3 times the upper normal limit (UNL) or total bilirubin (TBil) > $2{\times}UNL$ within the first 8 weeks of anti-TB treatment. Results: We enrolled a total of 121 patients who silymarin or a placebo to start their anti-TB treatment, for the first 8 weeks. The proportions of elevated serum liver enzymes more than 3 times of UNL at week 2, week 4, and week 8 did not show any significant difference between the silymarin and placebo groups, at 0% versus 3.6% (p>0.999); 4.4% versus 3.6% (p>0.999); and 8.7% versus 10.8% (p=0.630), respectively. However, patients with TBil >$2{\times}UNL$ at week 8 were significantly low in the silymarin group (0% versus 8.7%, p=0.043). Conclusion: Our findings did not show silymarin had any significant preventive effect on the hepatotoxicity of anti-TB drugs.

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References

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