The Efficacy of Silymarin on the Prevention of Hepatotoxicity From Antituberculosis Drugs
The Efficacy of Silymarin on the Prevention of Hepatotoxicity From Antituberculosis Drugs
Hepatitis is one of the most common adverse effect from anti-tuberculosis. Silymarin showed
 its efficacy to decreased serum alanine transaminase enzyme in animal models from recent
 study. No confirmed this efficacy was performed in human.

 A prospective, double-blind, placebo-controlled trial was carried out according to Good
 Clinical Practice Guideline. This study is to define the efficacy of silymarin to prevent
 hepatotoxicity from anti-tuberculosis drugs. Informed consent is obtained prior to the study.
 New patients diagnosed with tuberculosis are enrolled. Patients with liver diseases, current
 alcohol drinking more than 20 g/day, regular use of herbal or other potential hepatotoxic
 drugs are excluded. Patients are treated with a standard regimen of four anti-tuberculosis
 therapy. They will randomize to receive either placebo or silymarin (140 mg) thrice daily.
 Liver function test (LFT) and clinical changes are assessed at 2- and 4-week after initiation
 of the treatment. DILI from anti-tuberculosis drugs ('atb-DILI') is defined as: i) a rise of
 alanine aminotransferase (ALT) to 2 times above normal upper limit, or ii) an elevation of
 total bilirubin more than 2 mg/dl with or without ALT elevation. The study endpoints are the
 level of ALT by week 4 and the number of patients who developed atb-DILI.

 Statistical analysis is used to compare the differences in ALT and number of atb-DILI
- Prevention of antituberculosis-related drug induced liver injury with silymarin is
 investigated.
Inclusion Criteria:

 -  tuberculosis cases

 -  treated with isoniazid, rifampicin, ethambutol and pyrazinamide

 Exclusion Criteria:

 -  no known liver disease (HBV, HCV), and HIV infection

 -  normal ALT level before enrollment

 -  refuse to participate