Clinical effect of Silybum marianum preparation in the prophylactic treatment of antitubercular agent-induced liver injury: A Meta-analysis of randomized controlled trials / 临床肝胆病杂志

ABSTRACT

ObjectiveTo evaluate the clinical effect of Silybum marianum preparation in the prophylactic treatment of antitubercular agent-induced liver injury (ATB-DILI), since there have always been controversies over the development of Silybum marianum preparation for the prophylactic treatment of ATB-DILI. MethodsMEDLINE, PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched for randomized controlled trials (RCTs) on Silybum marianum preparation versus placebo in preventing ATB-DILI published up to November 30, 2018. STATA 12.0 software was used for statistical analyses. Standardized mean difference (SMD) and risk ratio (RR) with 95% confidence intervals (CI) were used to evaluate the effect of Silybum marianum preparation. The Cochrane handbook was used to assess the quality of RCTs, and funnel plots and Egger’s tests were used to evaluate publication bias. A sensitivity analysis was conducted to assess the influence of each RCT on overall effect. ResultsA total of five RCTs with 1198 patients were included, and among these patients, 585 received Silybum marianum preparation and 613 received placebo. Silybum marianum preparation significantly reduced the risk of the onset of ATB-DILI at week 4 (RR=0.33, 95%CI 0.15-0.75, P=0.008). In addition, Silybum marianum preparation had a protective effect on liver function in patients receiving antitubercular agents (alanine aminotransferase SMD=-0.15, 95%CI -0.24 to -0.07, P＜0.001; aspartate aminotransferase SMD=-0.14, 95%CI -0.23 to -0.06, P=0.001; alkaline phosphatase SMD=-0.12, 95%CI -0.20 to-0.03, P=0.008). Silybum marianum preparation had a similar risk of adverse events as placebo (RR=1.09, 95%CI 0.86-1.39, P=0.47). ConclusionIn patients with tuberculosis, prophylactic treatment with Silybum marianum preparation can significantly reduce the risk of the onset of ATB-DILI after 4 weeks of treatment. In addition, Silybum marianum preparation can also improve the liver function of patients treated with antitubercular agents.