Abstract
Background: Nonalcoholic fatty liver disease (NAFLD) has no approved pharmacological therapy at present. Pioglitazone is a potential therapeutic option for NAFLD. We performed a systematic review and meta-analysis of randomized, placebo-controlled trials to compare the response to pioglitazone in patients with NAFLD with or without type 2 diabetes. Methods: We searched the databases for the randomized controlled trials (RCTs) of pioglitazone vs placebo involving patients with NAFLD with or without type 2 diabetes/prediabetes, which were included in the analysis. Methodological quality was evaluated in domains recommended by the Cochrane Collaboration. The changes in alanine transaminase, blood lipids, fasting blood glucose (FBS), weight, body mass index (BMI), histology (fibrosis, hepatocellular ballooning, inflammation, steatosis), and adverse events before and after treatment were analyzed. Results: This review included seven randomized trials (561 patients in total), three of which were nondiabetic RCTs. Treated participants with type 2 diabetes or prediabetes, compared with placebo, showed improvements in aspartate transaminase (AST), alanine aminotransferase (ALT), high-density lipoprotein (HDL), triglycerides, FBS, fibrosis, hepatocellular ballooning, lobular inflammation and steatosis. However, compared with placebo, only ALT, lobular inflammation and steatosis were improved in nondiabetic patients. There was no difference in adverse effects between the two treatment groups compared with placebo. Conclusions: Pioglitazone can improve liver function, blood lipids, and histology, including fibrosis, steatosis, inflammation, and hepatocellular ballooning in NAFLD patients with type 2 diabetes. However, pioglitazone has limited efficacy in NAFLD patients without type 2 diabetes. Large sample sizes of RCT studies are needed to further confirm these conclusions. Funding Statement: None. Declaration of Interests: All authors declare no conflicts of interest.
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