Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Clinical Trial Center, Ewha Womans University College of Medicine, Seoul, Korea.
Sci Rep. 2024 Nov 22;14(1):28951. doi: 10.1038/s41598-024-79428-6.
We explored the changes in metabolic dysfunction-associated steatotic liver disease (MASLD) severity over time by analyzing data from the placebo arms of randomized controlled trials (RCTs), focusing on the presence of diabetes.
RCTs on MASLD that included a placebo arm were identified using a systematic search of the literature. Primary outcomes were changes in hepatic steatosis and fibrosis.
The meta-analysis included 8 RCTs involving 386 patients without diabetes and 24 RCTs involving 637 patients with diabetes. The pooled estimate of mean change in steatosis grade was - 0.1 in patients without diabetes, and - 0.37 in patients with diabetes (P = 0.066). The mean change in fibrosis stage was 0.05 in patients without diabetes, and - 0.03 in patients with diabetes (P = 0.359). The mean change in nonalcoholic fatty liver disease activity score was - 0.55 in patients without diabetes, and - 1.50 in patients with diabetes (P = 0.100). The mean change in ALT and AST were significantly larger in patients without diabetes compared to those with diabetes (P < 0.05).
Placebo treatment had a greater effect in improving liver steatosis in patients with diabetes compared to those without. These findings highlight the importance of tailored treatment strategies in MASLD, particularly considering diabetes status.
我们通过分析随机对照试验（RCT）安慰剂组的数据，探讨了代谢功能障碍相关脂肪性肝病（MASLD）严重程度随时间的变化，重点关注糖尿病的存在。
通过系统文献检索，确定了包含 MASLD 安慰剂组的 RCT。主要结局是肝脂肪变性和纤维化的变化。
荟萃分析纳入了 8 项无糖尿病患者的 RCT（共 386 例患者）和 24 项有糖尿病患者的 RCT（共 637 例患者）。无糖尿病患者的肝脂肪变性分级平均变化估计值为 -0.1，糖尿病患者为 -0.37（P=0.066）。无糖尿病患者的纤维化分期平均变化为 0.05，糖尿病患者为 -0.03（P=0.359）。无糖尿病患者的非酒精性脂肪性肝病活动评分平均变化为 -0.55，糖尿病患者为 -1.50（P=0.100）。无糖尿病患者的 ALT 和 AST 平均变化明显大于糖尿病患者（P<0.05）。
与无糖尿病患者相比，糖尿病患者接受安慰剂治疗改善肝脂肪变性的效果更大。这些发现强调了 MASLD 个体化治疗策略的重要性，特别是考虑到糖尿病的状态。
