Tuberc Respir Dis.  2017 Jul;80(3):265-269. 10.4046/trd.2017.80.3.265.

Effect of Prophylactic Use of Silymarin on Anti-tuberculosis Drugs Induced Hepatotoxicity

• Heo E
• Kim DK
• Oh SH
• Lee JK
• Park JH
• Chung HS

• KMID: 2385041
• DOI: http://doi.org/10.4046/trd.2017.80.3.265

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× 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× ULN 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.

Keyword

Tuberculosis; Silymarin

MeSH Terms

Bilirubin
Humans
Liver
Models, Animal
Prospective Studies
Silymarin*
Tuberculosis
Bilirubin
Silymarin

Figure

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  Figure 1 Flow chart. NTM: nontuberculous mycobacteria; TB: tuberculosis.

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  Figure 2 Number of patients with greater than 3× upper limit of normal (ULN) liver enzyme (A, B) and 2× ULN total bilirubin (C). *p=0.043.

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