Efficacy and safety of acetyl-CoA carboxylase (ACC) inhibitors in the treatment of nonalcoholic steatohepatitis (NASH): A protocol for systematic review.

ABSTRACT

BACKGROUND: The pathological mechanism of nonalcoholic steatohepatitis (NASH) is closely related to abnormal lipid regulation in hepatocytes. Patients with NASH generally have a significant increase in de novo lipogenesis, which acetyl-CoA carboxylase (ACC) catalyzes the first committed step. However, the treatment with ACC inhibitors remains controversial. Thus, our study will systematically evaluate the efficacy and safety of ACC inhibitors for the treatment of NASH. METHODS: We plan to search PubMed, Cochrane Library, Web of Science, EMBASE, Google Scholar, ClinicalTrials.gov, China Science and Technology Journal Database, Chinese Biomedical Literature Database, Wan-fang Database and China National Knowledge Infrastructure to obtain literatures from January 2015 to January 2030 under the inclusion and exclusion criteria, and include randomized controlled trials containing intervention of ACC inhibitors for NASH. The proportion of patients with reduction in ballooning, inflammation and fibrosis will be accepted as the main outcome. RoB 2 will be used for the risk of bias, as well as Egger's test and funnel plot for reporting bias. We will adopt Review Manager 5.4.1 for data synthesis, subgroup analysis, meta-regression analysis and sensitivity analysis, and conduct trial sequential analysis and quality of evidence evaluation using trial sequential analysis 0.9.5.10 Beta software and GRADE Profiler 3.6.1 software respectively. RESULTS: This systematic review will assess the proportion of patients with reduction of ballooning, inflammation and fibrosis, changes in hepatic steatosis, levels of liver enzymes and liver injury markers, metabolic parameters, safety and tolerability to measure the clinical benefits of ACC inhibitors for NASH. CONCLUSION: The conclusion of this systematic review will achieve convincing evidence to evaluate the efficacy and safety of ACC inhibitors for NASH.