Effect of Prophylactic Use of Silymarin on Anti-tuberculosis Drugs Induced Hepatotoxicity.
10.4046/trd.2017.80.3.265
- Author:
Eunyoung HEO
1
;
Deog Kyeom KIM
;
So Hee OH
;
Jung Kyu LEE
;
Ju Hee PARK
;
Hee Soon CHUNG
Author Information
1. Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea. heechung@snu.ac.kr
- Publication Type:Randomized Controlled Trial ; Original Article
- Keywords:
Tuberculosis;
Silymarin
- MeSH:
Bilirubin;
Humans;
Liver;
Models, Animal;
Prospective Studies;
Silymarin*;
Tuberculosis
- From:Tuberculosis and Respiratory Diseases
2017;80(3):265-269
- CountryRepublic of Korea
- Language:English
-
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.
