ジヒドロミオセチンをベースとした食事性サプリメントのメタボリック機能障害関連脂肪肝疾患に対する効果：二重盲検、プラセボ対照、ランダム化臨床試験

Despite its increasing prevalence, effective treatment options for metabolic dysfunction-associated steatotic liver disease (MASLD) are limited. We assessed the efficacy of a dietary supplement containing dihydromyricetin (DHM) in MASLD.

Adult MASLD patients were randomized to receive a dietary supplement containing DHM (300 mg/day), vitamins C/E and choline (group A), or identical placebo (group B) for 12 months. Patients were assessed every ≤6 months for clinical and laboratory parameters and liver stiffness measurements (LSM).

Fifty-five patients were randomized to group A (n=28) or B (n=27), but 9 patients (group A/B=2/7) were withdrawn early for personal reasons. Median liver enzymes decreased at 6 or 12 months only in group A. Group A compared to B patients achieved higher 12-month rates of combined alanine aminotransferase (ALT)/γ-glutamyl transpeptidase (GGT) normalization (35% vs. 5%, P=0.028). Only in group A, glucose, glycated hemoglobin and total/low density lipoprotein mean levels had declined significantly at 6 and/or 12 months, whereas median liver stiffness measurements (LSM) were lower than baseline at both 6 and 12 months. In multivariate analysis, group A was the only factor associated with ALT/GGT normalization (P=0.038). Generalized estimating equation analysis revealed a significant treatment by time interaction for 12-month combined ALT/GGT normalization only in group A (P=0.021).

The 6/12-month use of DHM supplement seems to result in improvements in liver enzymes and LSM, as well as in diabetes and lipid parameters in MASLD patients. Therefore, the use of such a supplement in MASLD needs further evaluation.