• Users Online: 223
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Ahead of print Browse Articles Search Archives Submit article Instructions Subscribe Contacts Login 
Year : 2023  |  Volume : 14  |  Issue : 1  |  Page : 48

The effectiveness of silymarin in the prevention of anti-tuberculosis drug-induced hepatotoxicity: A randomized controlled clinical trial

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
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijpvm.ijpvm_81_22

Rights and Permissions

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.

Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)

 Article Access Statistics
    PDF Downloaded16    
    Comments [Add]    

Recommend this journal