Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences, Poznan, Poland.
Doctoral School, Poznan University od Medical Sciences, Poznan, Poland.
J Physiol Pharmacol. 2024 Jun;75(3). doi: 10.26402/jpp.2024.3.06. Epub 2024 Jul 18.
Globally, the metabolic dysfunction-associated fatty liver disease (MAFLD) holds the position as the most widespread chronic liver condition. Berberine (BBR) shows promise as a natural compound for managing obesity, hepatic steatosis, and metabolic disorders. The study aimed to investigate the effectiveness of BBR in addressing factors linked to MAFLD. This is a randomized, double-blind, and placebo-controlled clinical trial. Seventy individuals with MAFLD were enrolled in this study and randomly assigned in a 1:1 ratio to two groups. BBR (1500 mg/day) or placebo was administrated orally for 12 weeks. Selected anthropometric, hepatic, and metabolic parameters were assessed. After a 12-week intervention, the BBR group demonstrated a statistically significant decrease in alanine transaminase (ALT) p=0.0105, and de Ritis ratio p=0.0011 compared to the control group. In both groups we observed a decrease in trunk fat (kg) - BBR group p=0.0185, and placebo group p=0.0323. After three months, a significant divergence between the BBR and placebo groups was evident in the alteration of Δ total cholesterol (TC) p=0.0009, favoring the BBR group. Nevertheless, there were no significant differences detected in other lipid and glucose parameters. In the BBR group, we found significant correlations between changes and amelioration of certain variables: Δ body mass index (BMI) correlated with ΔALT (r=0.47; p=0.0089) and D aspartate aminotransferase (AST) (r=0.47; p=0.0081) levels; Δ trunk fat with Δ fatty liver index (FLI) (r=0.55; p=0.0337), Δ homeostasis model assessment for insulin resistant index (HOMA-IR) (r=0.37; p=0.0020), and AST (r=0.42; p=0.0202); D the de Ritis ratio correlated with Δ fibrosis-4 index (FIB-4) levels (r=0.59; p=0.0011); and ΔFLI correlated with ΔHOMA-IR (r=0.37; p=0.0409) and Δ visceral adiposity index (VAI) (r=0.54; p=0.0019), while no significant differences were observed in the Placebo group. The results show that BBR appears to be a bioactive compound that positively impacts MAFLD, however, additional research with extended intervention durations is required to fully assess its efficacy and potential clinical use.
全球范围内，代谢相关性脂肪性肝病（MAFLD）是最普遍的慢性肝脏疾病。小檗碱（BBR）作为一种天然化合物，在治疗肥胖症、肝脂肪变性和代谢紊乱方面显示出良好的效果。本研究旨在探讨 BBR 对 MAFLD 相关因素的影响。这是一项随机、双盲、安慰剂对照的临床试验。共纳入 70 例 MAFLD 患者，按 1:1 比例随机分为两组，分别给予 BBR（1500mg/d）或安慰剂口服 12 周。评估两组患者的各项人体测量学、肝脏和代谢参数。经过 12 周的干预，BBR 组丙氨酸转氨酶（ALT）p=0.0105 和 de Ritis 比值 p=0.0011 显著低于对照组。两组患者的躯干脂肪（kg）均有所下降，BBR 组 p=0.0185，安慰剂组 p=0.0323。治疗 3 个月后，BBR 组的总胆固醇（TC）变化（ΔTC）与安慰剂组有显著差异（p=0.0009），有利于 BBR 组。然而，其他血脂和血糖参数没有明显差异。在 BBR 组，我们发现某些变量的变化与改善之间存在显著相关性：Δ体重指数（BMI）与 ΔALT（r=0.47;p=0.0089）和 D 天冬氨酸转氨酶（AST）（r=0.47;p=0.0081）水平相关；Δ躯干脂肪与 Δ脂肪肝指数（FLI）（r=0.55;p=0.0337）、Δ稳态模型评估胰岛素抵抗指数（HOMA-IR）（r=0.37;p=0.0020）和 AST（r=0.42;p=0.0202）相关；D de Ritis 比值与 Δ纤维化-4 指数（FIB-4）水平相关（r=0.59;p=0.0011）；ΔFLI 与 ΔHOMA-IR（r=0.37;p=0.0409）和 Δ内脏脂肪指数（VAI）（r=0.54;p=0.0019）相关，而安慰剂组无明显差异。结果表明，BBR 似乎是一种具有生物活性的化合物，对 MAFLD 有积极影响，但需要更长时间的干预来全面评估其疗效和潜在的临床应用。
