Review Article

Prophylactic Therapy of Silymarin (Milk Thistle) on Antituberculosis Drug-Induced Liver Injury: A Meta-Analysis of Randomized Controlled Trials

Table 1

Baseline characteristics of the trials included in the meta-analysis.

studyLuangchosiri et al. 2015 [19]Marjani et al. 2016 [20]Zhang et al. 2016 [21]Gu et al. 2015 [42]Heo et al. 2017 [43]

designRandomized
double-blind
controlled trial
randomized
double blind
randomized controlled
open labelled
open-label randomized multi-centerProspective
Randomized
double-blind placebo-controlled
patients randomized5872379568121
age56.0050.10< 41 years, 180
41 years, 190
37.42 ± 14.2857.73 ± 13.94
male22(40.00)37 (52.86)274(74.05)374(65.85)68(66.02)
diagosispulmonary TBdiagnosed of TBdiagnosed of TBdiagnosed of TB and having primary pulmonary TBdiagnosed of TB
anti-TB regimenstandard regimen consisting isoniazid (5 mg/kg), rifampin (10 mg/kg), pyrazinamide (25 mg/kg) and ethambutol (15 mg/kg)standard regimen consisting isoniazid (5 mg/kg), rifampin (10 mg/kg), pyrazinamide (20 mg/kg) and ethambutol (15 mg/kg)the standard anti-tuberculosis therapy including isoniazid (H), rifampicin (R), pyrazinamide (Z), and thambutol (E)the standard anti-TB treatment drugs including isoniazid (H), rifampicin (R), pyrazinamide (Z), and thambutol (E)the first line standard anti-TB treatment drugs including isoniazid, rifampicin, ethambutol and pyrazinamide
experimental groupsilymarin, 140 mg, tidsylibum marianum ( equivalent to 140 mg silymarin), tidsilybum marianum, 200 mg, bidsilibinin, 70 mg, tidsilymarin, 140 mg, bid
control groupplacebo, tidplacebo, tidvitamin C, bidnoneplacebo, bid
follow-upweek 2, 4week 2week 8Week2, 4, 8Week 2, 4, 8
CountryThailandIranChinaChinaKorea
Outcomes①②④①④①②③④①②③④①②③

Values are presented as number (%) or mean±SD.
①: the occurrence of anti-TB treatment related DILI; ②: liver function tests (ALT, AST, ALP, and TBIL); ③: the occurrence of interruption of anti-TB treatment or taking the second-line TB drugs; ④: adverse events.