| ORIGINAL ARTICLE |
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| Year : 2023 | Volume
: 14
| Issue : 1 | Page : 48 |
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The effectiveness of silymarin in the prevention of anti-tuberculosis drug-induced hepatotoxicity: A randomized controlled clinical trial
Ali Talebi1, Rasool Soltani2, Farzin Khorvash3, Soroush Mohammadi Jouabadi4
1 Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Isfahan, Iran
2 Department of Clinical Pharmacy and Pharmacy Practice, School of Pharmacy, Isfahan University of Medical Sciences; Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
3 Department of Infectious Diseases, School of Medicine, Isfahan University of Medical Sciences; Nosocomial Infections Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
4 Department of Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands
Correspondence Address:
Rasool Soltani
Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Hezar-Jerib Ave., Isfahan
Iran
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/ijpvm.ijpvm_81_22
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Background: Several animal studies have shown the protective effect of silymarin (the extract of Silybum marianum seeds) against anti-tuberculosis drug-induced hepatotoxicity (ATDH). However, the knowledge of ATDH of silymarin in humans is scarce. In this study, we aimed to clinically evaluate it. Methods: During this randomized controlled clinical trial, 36 new cases of tuberculosis (TB) were enrolled to receive either silymarin 150 mg twice daily for two weeks along with a standard anti-TB therapeutic regimen (experimental group; n = 16) or standard anti-TB therapeutic regimen alone (control group; n = 21). Liver function tests (serum AST, ALT, ALP, and total bilirubin) at the end of weeks 1 and 2 as well as the rate of ATDH during the study were determined and compared between the groups. Results: No significant differences between the experimental and control groups were observed at the end of the first week regarding liver function tests; However, at the end of the second week, the mean serum levels of AST (P = 0.03) and ALP (P = 0.04) were significantly lower in the experimental group. ALT (P = 0.016) and ALP (P = 0.027) levels in the experimental group significantly decreased during the study, while the changes in the control group were not significant. Two patients in the control group (9.5%) developed ATDH, while no one in the experimental group manifested this adverse effect. Conclusions: Our study suggests that silymarin use has the potential for the reduction of anti-TB drug-induced hepatotoxicity.
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