Cho Young Mi, Kwon Jeong Eun, Lee Minkyung, Lea Youngsung, Jeon Do-Yong, Kim Hyeong Jun, Kang Se Chan
1 Department of Oriental Medicine Biotechnology, College of Life Sciences, Kyung Hee University , Yongin, Korea.
2 BIOKOREA Co., Ltd. , Seoul, Korea.
J Med Food. 2018 Mar;21(3):282-288. doi: 10.1089/jmf.2017.4054. Epub 2018 Feb 27.
Agrimonia eupatoria L. has been shown to protect against liver injury due to its lipid lowering and antioxidant activities. The aim of this research was to evaluate the effect of A. eupatoria L. aqueous extract (AEE) on 80 subjects with elevated alanine transaminase (ALT) levels in a randomized, double-blind, placebo-controlled, 8-week study. This trial was conducted between January 2013 and July 2013 at the Oriental Medical Hospital (Jecheon) of Semyung University. The trial included subjects aged 20 years or older who were diagnosed with mildly to moderately elevated ALT levels (between 45 and 135 IU/L). Subjects received two capsules of placebo or AEE twice a day for 8 weeks. Adverse events were recorded. Eighty subjects were randomized to placebo or AEE groups who had similar baseline characteristics. During the 8 weeks of treatment, 11 subjects were excluded from the analysis for protocol violation or consent withdrawal; efficacy of treatment was, therefore, evaluated in 69 subjects (placebo = 35, AEE = 34). The AEE group showed a significant reduction in ALT and serum triglyceride (TG) at 8 weeks compared with the placebo group (ALT P = .044, TG P = .020). Significant group and time interactions were found in ALT (P = .038), aspartate aminotransferase (P = .040), and TG (P = .010). Alkaline phosphatase, total bilirubin, and gamma-glutamyl transferase levels were not different between the two groups. There were no reported severe adverse events during this study, and total protein, albumin, blood urea nitrogen, creatine, and total cholesterol levels were normal in both groups. AEE consumption was safe and generally well tolerated without severe adverse events.
由于其降脂和抗氧化活性,龙芽草已被证明可预防肝损伤。本研究的目的是在一项随机、双盲、安慰剂对照的8周研究中,评估龙芽草水提取物(AEE)对80名丙氨酸转氨酶(ALT)水平升高受试者的影响。该试验于2013年1月至2013年7月在青云大学东方医院(堤川)进行。试验纳入了年龄在20岁及以上、被诊断为ALT水平轻度至中度升高(45至135 IU/L之间)的受试者。受试者每天服用两次安慰剂或AEE胶囊,持续8周。记录不良事件。80名受试者被随机分为安慰剂组或AEE组,两组基线特征相似。在8周的治疗期间,11名受试者因违反方案或撤回同意而被排除在分析之外;因此,在69名受试者(安慰剂组 = 35名,AEE组 = 34名)中评估了治疗效果。与安慰剂组相比,AEE组在8周时ALT和血清甘油三酯(TG)显著降低(ALT P = 0.044,TG P = 0.020)。在ALT(P = 0.038)、天冬氨酸转氨酶(P = 0.040)和TG(P = 0.010)方面发现了显著的组间和时间交互作用。两组之间碱性磷酸酶、总胆红素和γ-谷氨酰转移酶水平无差异。本研究期间未报告严重不良事件,两组总蛋白、白蛋白、血尿素氮、肌酐和总胆固醇水平均正常。服用AEE是安全的,且一般耐受性良好,未出现严重不良事件。