Abu Hassan Muhammad Radzi, Hj Md Said Rosaida, Zainuddin Zalwani, Omar Haniza, Md Ali Siti Maisarah, Aris Siti Aishah, Chan Huan-Keat
Clinical Research Centre, Hospital Sultanah Bahiyah, Jalan Langgar, 05460, Alor Setar, Kedah, Malaysia.
Medical Department, Hospital Ampang, Jalan Mewah Utara, Taman Pandan Mewah, 68000, Ampang Jaya, Selangor, Malaysia.
Heliyon. 2023 May 30;9(6):e16652. doi: 10.1016/j.heliyon.2023.e16652. eCollection 2023 Jun.
and purpose: Non-alcoholic fatty liver disease (NAFLD) is a significant global health concern with limited pharmacotherapy options. This study aimed to evaluate the effectiveness of a standardized extract of in mild-to-moderate NAFLD.
This was a 12-month randomized controlled trial, in which adults with a controlled attenuation parameter (CAP) score >250 dB/m and a fibrosis score <10 kPa were randomly assigned to receive a standardized extract at a dose of 3,000 mg daily (n = 112) or a placebo (n = 114). The primary outcomes were changes in CAP score and liver enzyme levels, while the secondary outcomes were changes in other metabolic parameters. The analysis was performed on an intention-to-treat basis.
After 12 months, there was no significant difference in the change of CAP score between the intervention and control groups (-15.05 ± 36.76 dB/m vs. -14.74 ± 41.08 dB/m; p = 0.869). There was also no significant difference in the changes of liver enzyme levels between the two groups. However, the intervention group showed a significant reduction in fibrosis score, which was not observed in the control group (-0.64 ± 1.66 kPa versus 0.10 ± 1.61 kPa; p = 0.001). No major adverse events were reported in either group.
This study showed that did not significantly reduce CAP score and liver enzyme levels in patients with mild-to-moderate NAFLD. However, a significant improvement in fibrosis score was observed. Further research is needed to determine its clinical benefits at different dosages for NAFLD treatment.
非酒精性脂肪性肝病（NAFLD）是一个重大的全球健康问题，药物治疗选择有限。本研究旨在评估[提取物名称]标准化提取物对轻度至中度NAFLD的有效性。
这是一项为期12个月的随机对照试验，将受控衰减参数（CAP）评分>250 dB/m且纤维化评分<10 kPa的成年人随机分配，分别接受每日剂量为3000 mg的[提取物名称]标准化提取物（n = 112）或安慰剂（n = 114）。主要结局为CAP评分和肝酶水平的变化，次要结局为其他代谢参数的变化。分析基于意向性治疗原则进行。
12个月后，干预组和对照组的CAP评分变化无显著差异（-15.05±36.76 dB/m vs. -14.74±41.08 dB/m；p = 0.869）。两组肝酶水平的变化也无显著差异。然而，干预组的纤维化评分显著降低，而对照组未观察到这种情况（-0.64±1.66 kPa对0.10±1.61 kPa；p = 0.001）。两组均未报告重大不良事件。
本研究表明，[提取物名称]在轻度至中度NAFLD患者中未显著降低CAP评分和肝酶水平。然而，观察到纤维化评分有显著改善。需要进一步研究以确定其在不同剂量下治疗NAFLD的临床益处。
