Effect of bicyclol on blood biomarkers of NAFLD: a systematic review and meta-analysis

OBJECTIVE: Non-alcoholic fatty liver disease (NAFLD) is a global epidemic without effective therapeutic agents in the clinic. This meta-analysis aimed to assess the efficacy of the marketed hepatoprotectant bicyclol at improving blood biomarkers in patients with NAFLD. DESIGN: Electronic databases were searched for randomised controlled trials (RCTs) published up to August 2020 using bicyclol to treat NAFLD. The risk of bias, quality of evidence and publication bias were evaluated. Blood biomarkers, including alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), triglyceride (TG) and total cholesterol (TC), were analysed using Review Manager V.5.3 software. Outcomes with significant heterogeneity (I(2) ≥75%) were divided into the bicyclol monotherapy subgroup and combination treatment subgroup. RESULTS: Twelve RCTs involving 1008 patients were finally included. No serious adverse events were reported in the bicyclol-treated groups. The total effective rate of bicyclol intervention for NAFLD was significantly higher than that of the control group. The decreases in the levels of AST (mean difference (MD) = −15.20; 95% CI −20.51 to −9.90; I(2)=74%), TBIL (MD = −1.72; 95% CI −2.72 to −0.72; I(2)=0%) and TC (MD = −0.52; 95% CI −0.70 to −0.34; I(2)=67%) treated by bicyclol were significantly higher than those in the control group. When a high heterogeneity existed (I(2) ≥75%), subgroup analyses were conducted and revealed significantly decreased ALT levels (MD = −34.07; 95% CI −36.70 to −31.43; I(2)=0%) merely in the bicyclol monotherapy subgroup, while TG level (MD = −0.39; 95% CI −0.45 to −0.33; I(2)=0%) was decreased in the bicyclol combination therapy subgroup. CONCLUSIONS: The study presents the evidence of bicyclol monotherapy and/or combination therapy for improving liver function and blood lipid biomarkers in patients with NAFLD. This preliminary study predicts that bicyclol might be an alternative drug for NAFLD therapy in the future.