School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia.
Nutr J. 2013 Dec 27;12(1):166. doi: 10.1186/1475-2891-12-166.
Nonalcoholic fatty liver disease (NAFLD) is one of the commonest liver disorders. Obesity, insulin resistance, lipid peroxidation and oxidative stress have been identified amongst the possible hits leading to the onset and progression of this disease. Nutritional evaluation of NAFLD patients showed a lower-than-recommended intake of vitamin E. Vitamin E is a family of 8 isoforms, 4 tocopherols and 4 tocotrienols. Alpha-tocopherol has been widely investigated in liver diseases, whereas no previous clinical trial has investigated tocotrienols for NAFLD. Aim of the study was to determine the effects of mixed tocotrienols, in normalising the hepatic echogenic response in hypercholesterolaemic patients with ultrasound-proven NAFLD.
Eighty-seven untreated hypercholesterolaemic adults with ultrasound-proven NAFLD were enrolled and randomised into control group (n = 44) and tocotrienols group (n = 43). The treatment, either mixed tocotrienols 200 mg twice daily or placebo, had a 1-year duration.Normalisation of hepatic echogenic response, being the trial primary aim, was used in sample size calculations. The data were assessed according to intention to treat principle as primary outcome. Per protocol analysis was also carried out as secondary outcome measurement.
Thirty and 34 participants concluded the study in the tocotrienols and placebo group respectively. Alpha-tocopherol levels were within the normal range for all subjects. As primary outcome, the normalisation of hepatic echogenic response was significantly higher for the tocotrienols treated group compared to the placebo group in the intention to treat analysis (P = 0.039; 95% CI = 0.896-6.488). As secondary objective, the per protocol assessment also showed significant rate of remission (P = 0.014; 95% CI = 1.117-9.456). Worsening of NAFLD grade was recorded in two patients in the placebo group, but none in the group treated with tocotrienols. No adverse events were reported for both groups.
This is the first clinical trial that showed the hepatoprotective effects of mixed palm tocotrienols in hypercholesterolemic adults with NAFLD.
非酒精性脂肪性肝病（NAFLD）是最常见的肝脏疾病之一。肥胖、胰岛素抵抗、脂质过氧化和氧化应激已被确定为导致这种疾病发生和发展的可能因素。对 NAFLD 患者的营养评估显示，其维生素 E 的摄入量低于推荐量。维生素 E 是一族 8 种异构体，包括 4 种生育酚和 4 种生育三烯酚。α-生育酚已广泛应用于肝脏疾病的研究，而以前的临床试验尚未研究过生育三烯酚对 NAFLD 的作用。本研究的目的是确定混合生育三烯酚在正常化高胆固醇血症伴超声证实的 NAFLD 患者肝脏回声反应中的作用。
共纳入 87 例未经治疗的高胆固醇血症成年患者，经超声证实患有 NAFLD，并随机分为对照组（n=44）和生育三烯酚组（n=43）。治疗组给予混合生育三烯酚 200mg，每日 2 次，或安慰剂，疗程为 1 年。正常化肝脏回声反应是本研究的主要目标，用于计算样本量。根据意向治疗原则评估数据作为主要结果。还进行了方案分析作为次要结果测量。
30 名和 34 名参与者分别完成了生育三烯酚组和安慰剂组的研究。所有受试者的α-生育酚水平均在正常范围内。作为主要结果，意向治疗分析显示，生育三烯酚治疗组肝脏回声反应正常化率明显高于安慰剂组（P=0.039；95%CI=0.896-6.488）。作为次要目标，方案评估也显示缓解率显著（P=0.014；95%CI=1.117-9.456）。安慰剂组有 2 例患者的 NAFLD 严重程度恶化，但生育三烯酚组无 1 例。两组均未报告不良反应。
这是首个临床研究，显示了混合棕榈生育三烯酚对高胆固醇血症伴 NAFLD 的成年患者的肝脏保护作用。
