Effects of Aramchol in patients with nonalcoholic fatty liver disease (NAFLD). A systematic review and meta-analysis.

Introduction: Nonalcoholic fatty liver disease (NAFLD) comprises a wide range of related liver disorders affecting mainly people who drink no or very little alcohol. Aramchol is a new synthetic molecule that has been shown to reduce liver fat content. There is little evidence supporting its efficacy in humans. Aim: To evaluate the efficacy of Aramchol in patients with NAFLD according to different randomized clinical trials. Material and methods: We searched PubMed, SCOPUS, Web of Science, and Cochrane Library for relevant clinical trials assessing the use of Aramchol in patients with NAFLD. Risk of bias assessment was performed using Cochrane's risk of bias tool. We included the following outcomes: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP), glycated haemoglobin (HbA1c), total cholesterol (TC), triglyceride (TG), HOMA-IR, and insulin level. Results: We included 3 clinical trials. We found that the Aramchol group did not show any significant difference from the control group regarding ALT (MD = 3.92 (-21.20, 29.04), p = 0.76), AP (MD = -0.59 (-8.85, 7.67), p = 0.89), HbA1c (MD = -0.11 (-0.32, 0.10), p = 0.29), TC (MD = 14.25 (-626, 34.77), p = 0.17), TG (MD = 2.29 (-39.30, 43.87), p = 0.91), HOMA-IR (MD = -0.11 (-1.58, 1.37), p = 0.89), and insulin levels (MD = -0.88 (-5.82, 4.06), p = 0.73). AST levels were significantly higher in the Aramchol group (MD =11.04 (4.91, 17.16), p = 0.04). Conclusions: Aramchol was a safe and tolerable drug to be used in patients with NAFLD. However, it was not superior to placebo in reducing the biochemical liver markers.