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Updated: Apr 6, 2026
Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
Preventive use of a hepatoprotectant against anti-tuberculosis drug-induced liver injury: A randomized controlled
Simin Zhang1,2, Hongqiu Pan3, Xianzhen Peng1
1Department of Epidemiology, School of Public Health, Nanjing Medical University, Nanjing, China.
Background And Aim:
Hepatoprotectants are routinely prescribed in China to prevent anti-tuberculosis drug-induced liver injury (ATLI). However, their biological mechanisms have not yet been clearly demonstrated. This study aims to evaluate the preventive effects of Silybum marianum against drug-induced liver injury among tuberculosis patients and to provide clinical guidelines for tuberculosis management in China.
Methods:
A randomized controlled trial was performed in Jiangsu, China. Tuberculosis patients were randomly allocated to the experimental group (anti-tuberculosis therapy plus S. marianum capsule) or the control group (anti-tuberculosis therapy plus vitamin C tablet). The primary outcomes were the occurrence of probable and possible ATLI, the peak aspartate aminotransferase/alanine aminotransferase ratio and the maximum altered alkaline phosphatase or gamma-glutamyl transferase.
Results:
The final analysis comprised 183 cases in the experiment group and 187 cases in the control group. The risk of developing probable ATLI was not significantly different between the two groups. During the follow-up period, 43.72% of cases in the experiment group and 35.83% of cases in the control group were determined to have possible ATLI (relative risk = 1.23, 95% confidence interval: 0.94-1.54). When using a more strict definition of possible ATLI, the adjusted relative risk (95% confidence interval) was 1.76 (1.14-2.56). The risks of adverse drug reactions, prolonged treatment length, taking second-line tuberculosis drugs, and the clearance of tuberculosis bacteria were similar between the two groups.
Conclusions:
No significant preventive effect of silymarin was found for either lowering the risk of liver injury or boosting the positive outcomes. Worse, we even found a potential risk of liver damage caused by the hepatoprotectant.
Insights
Silymarin did not prevent liver injury in tuberculosis patients. This study found no significant benefit and a potential increased risk of liver damage from Silybum marianum in ATLI prevention.
Area of Science:
- Pharmacology
- Hepatology
- Infectious Diseases
Background:
- Hepatoprotectants are commonly used in China to prevent anti-tuberculosis drug-induced liver injury (ATLI).
- The biological mechanisms underlying the efficacy of these agents remain unclear.
- This study investigated the role of Silybum marianum as a preventive measure against ATLI.
Purpose of the Study:
- To evaluate the preventive effects of Silybum marianum on drug-induced liver injury in tuberculosis patients.
- To assess the impact of Silybum marianum on liver enzyme levels and ATLI occurrence.
- To inform clinical guidelines for tuberculosis management in China regarding hepatoprotectant use.
Main Methods:
- A randomized controlled trial was conducted in Jiangsu, China.
- Tuberculosis patients received either anti-tuberculosis therapy plus Silybum marianum or anti-tuberculosis therapy plus vitamin C.
- Primary outcomes included the incidence of probable and possible ATLI, and changes in liver enzymes (AST/ALT ratio, ALP/GGT).
Main Results:
- No significant difference in the risk of probable ATLI between the Silybum marianum and control groups.
- A higher incidence of possible ATLI was observed in the Silybum marianum group (43.72% vs. 35.83%), with an adjusted relative risk of 1.76 (1.14-2.56) under a stricter definition.
- Similar rates of adverse drug reactions, treatment length, and tuberculosis clearance were noted between groups.
Conclusions:
- Silybum marianum demonstrated no significant preventive effect against ATLI in tuberculosis patients.
- The study suggests a potential increased risk of liver damage associated with silymarin use.
- The findings question the routine use of Silybum marianum for ATLI prevention in this population.
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