Background: Hepatitis is the most serious adverse effect of antitubercular therapy.^[1] Silymarin is used as a protective agent in acute and chronic liver disorders^[2]. We aimed to evaluate the hepatoprotective activity of silymarin in patients receiving antitubercular therapy.

Methods: After getting approval from the institutional human ethics committee and consent from the subjects, this randomized double-blinded placebo-controlled study was conducted. In this study, new cases of pulmonary tuberculosis were divided into two groups. Group 1 was assigned to receive silymarin and Group 2 received a placebo along with Category I antitubercular drugs. The outcome of interest were maximum liver enzymes at week 4 and 8 and the development of anti-TB DILI.

Results: A total of 83 out of 92 expected numbers of patients were enrolled. There were 13/42 (31%) and 30/41 (73.2%) patients who developed mild elevation of ALT as well as ALP in the silymarin and the placebo groups (p<0.001) respectively. The mean of ALT levels at week 8 in the silymarin and the placebo group was 29.83(12.7) IU/L and 49.21 (22.29) IU/L (p < 0.001). The mean of ALP levels at week 4 in the silymarin and the placebo group was 58.95(18.43) IU/L and 70.70 (30.40) IU/L (p = 0.03). The mean of AST levels at week 8 in the silymarin and the placebo group was 28.35(12.35) IU/L and 36.70 (14.41) IU/L (p = 0.007). 

Conclusion: Silymarin had an effect on reducing ALT, AST, and ALP levels (P<0.001), No serious adverse events were reported. Silymarin is a good choice for the improvement of the liver biochemical profile. Larger clinical trials are required to confirm the result of our study.

Keywords: Tuberculosis, Drug-induced liver injury, Alanine transaminase, Aspartate transaminase, Alkaline phosphatase.

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Senthilkumar.E

Post Graduate, Department of Pharmacology, Dhanalakshmi Srinivasan Medical College, Perambalur