Plain language summary
Metabolic-associated fatty liver disease (MAFLD) is characterised by excessive lipid accumulation in hepatocytes. Weight management by the treatment to target strategy through lifestyle intervention remains the primary approach for MAFLD treatment. The aim of this study was to compare the efficacy of a conventional energy-restricted diet (the control group), orlistat, and an experimental diet in the Asian population with obesity and MAFLD. This study was a prospective, open-label, monocentric randomised controlled study. Participants (n = 118) were randomly assigned to the control (n = 39), orlistat (n = 40), or experimental diet (n = 39) groups at a 1:1:1 allocation. Results showed that: - orlistat and the experimental diet were superior to lifestyle intervention in ameliorating liver steatosis [fatty liver]. - the experimental diet had an advantage over lifestyle intervention when patients adhered to the diet. - orlistat was superior to the experimental diet and lifestyle modifications in decreasing liver fat content. Authors conclude that more multicentre, large-scale, prospective studies are needed to verify the long-term efficacy and safety of the experimental diet and orlistat treatment in subjects with MAFLD.
Abstract
BACKGROUND Losing weight by lifestyle interventions is the first-line treatment for metabolic-associated fatty liver disease (MAFLD) but is limited by low compliance. OBJECTIVES This study aimed to compare the effects of orlistat or an experimental high-protein/lower-carbohydrate diet with a control diet in Asian patients with obesity and MAFLD. METHODS A total of 118 Asian patients with obesity and MAFLD confirmed with MRI-based proton density fat fraction with Dixon sequence were enrolled and allocated to the control group, the orlistat group, or the experimental diet group for 24 wk. The primary endpoint was the relative change in liver fat content (LFC) assessed by MRI-based proton density fat fraction. RESULTS A total of 118 subjects with obesity and MAFLD were randomly assigned to the control group (n = 39), the orlistat group (n = 40), or the experimental diet group (n = 39). All 3 groups demonstrated improvement in liver steatosis at wk 24. The absolute decrease in LFC in the orlistat group was 9.1% and 5.4% in the experimental diet group, both significantly higher than that in the control group (P < 0.05). The relative reduction in LFC was 30.2% in the experimental diet group, which was significantly higher than the 12.2% observed in the control group (P = 0.01). CONCLUSIONS Orlistat and the experimental diet group reduced liver steatosis compared to the control group. This trial was registered at Chinese Clinical Trial Registry (ChiCTR-1900027172). http://www.chictr.org.cn.
Methodological quality
Jadad score
:
3
Allocation concealment
:
Yes
