Publication: A double-blinded randomized controlled trial of silymarin for the prevention of antituberculosis drug-induced liver injury
Issued Date
2015
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eng
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Mahidol University
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BioMed Central
Bibliographic Citation
BMC Complementary and Alternative Medicine. Vol. 15, (2015), 334
Suggested Citation
Chote Luangchosiri, Ammarin Thakkinstian, Sermsiri Chitphuk, Wasana Stitchantrakul, Supanna Petraksa, Abhasnee Sobhonslidsuk A double-blinded randomized controlled trial of silymarin for the prevention of antituberculosis drug-induced liver injury. BMC Complementary and Alternative Medicine. Vol. 15, (2015), 334. doi:10.1186/s12906-015-0861-7 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/2715
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Title
A double-blinded randomized controlled trial of silymarin for the prevention of antituberculosis drug-induced liver injury
Abstract
Background: Hepatitis is a common adverse effect of antituberculosis drugs. Silymarin prevented drug-induced
hepatoxicity in animals with anti-oxidative mechanisms but its effect in human has been unknown. We aimed to
evaluate the efficacy of silymarin for preventing antituberculosis-drug induced liver injury (antiTB-DILI) in patients
with tuberculosis.
Methods: A double-blind randomized placebo-controlled trial was performed. Tuberculosis patients were randomly
allocated to receive placebo or silymarin. The outcomes of interests were antiTB-DILI and the maximum liver
enzymes at week 4. Antioxidative enzymes (i.e., superoxide dismutase (SOD), glutathione and malondialdehyde
assays) were assessed. The risks of antiTB-DILI between the two groups were compared. A number need to treat
was estimated.
Results: A total of 55 out of 70 expected numbers of patients were enrolled. There were 1/27 (3.7 %) and 9/28
(32.1 %) patients who developed antiTB-DILI in the silymarin and the placebo groups. Risk reduction was 0.28
(0.10, 0.47), i.e., receiving silymarin was 28 % at lower risk for antiTB-DILI than placebo. This led to prevention of
28 patients from being antiTB-DILI among 100 treated patients. Median (IQR) of ALT levels at week 4 in the placebo
and the silymarin group were 35.0 (15, 415) IU/L and 31.5 (20, 184) IU/L (p = 0.455). The decline of SOD level at week 4
in the silymarin group was less than the placebo group (p < 0.027).
Conclusions: Silymarin reduced the incidence of antiTB-DILI. The benefit of silymarin may be explained from
superoxide dismutase restoration. Larger clinical trials are required to confirm the result of our small study
[Clinicaltrials.Gov Identifier Nct01800487].