The aim of this study was to investigate the combined effect of n-3 fatty acids (EPA and DHA, at an EPA:DHA ratio of 150:500) and phytosterol esters (PS) on non-alcoholic fatty liver disease (NAFLD) patients. We conducted a randomised, double-blind, placebo-controlled trial. Ninety-six NAFLD subjects were randomly assigned to the following groups: the PS group (receiving 3·3 g/d PS); the FO group (receiving 450 mg EPA + 1500 mg DHA/d); the PS + FO combination group (receiving 3·3 g/d PS and 450 mg EPA + 1500 mg DHA/d) and the PO group (a placebo group). The baseline clinical characteristics of the four groups were similar. The primary outcome was liver:spleen attenuation ratio (L:S ratio). The percentage increase in liver–spleen attenuation (≤1) in the PS + FO group was 36 % (P = 0·083), higher than those in the other three groups (PS group, 11 %, P = 0·519; FO group, 18 %, P = 0·071; PO group, 15 %, P = 0·436). Compared with baseline, transforming growth factor-β (TGF-β) was significantly decreased in the three study groups at the end of the trial (PS, P = 0·000; FO, P = 0·002; PS + FO, P = 0·001) and TNF-α was significantly decreased in the FO group (P = 0·036), PS + FO group (P = 0·005) and PO group (P = 0·032) at the end of the intervention. Notably, TGF-β was reduced significantly more in the PS + FO group than in the PO group (P = 0·032). The TAG and total cholesterol levels of the PS + FO group were reduced by 11·57 and 9·55 %, respectively. In conclusion, co-supplementation of PS and EPA + DHA could increase the effectiveness of treatment for hepatic steatosis.

中文翻译：

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n-3 脂肪酸和植物甾醇酯对减轻非酒精性脂肪肝患者肝脏脂肪变性的联合作用：一项双盲安慰剂对照临床试验

本研究的目的是研究n-3 脂肪酸（EPA 和 DHA，EPA:DHA 比例为 150:500）和植物甾醇酯 (PS) 对非酒精性脂肪肝病 (NAFLD) 患者有效。我们进行了一项随机、双盲、安慰剂对照试验。96 名 NAFLD 受试者被随机分配到以下组：PS 组（接受 3·3 g/d PS）；FO 组（接受 450 mg EPA + 1500 mg DHA/d）；PS + FO 联合组（接受 3·3 g/d PS 和 450 mg EPA + 1500 mg DHA/d）和 PO 组（安慰剂组）。四组的基线临床特征相似。主要结果是肝：脾衰减比（L：S比）。PS + FO 组肝脾衰减 (≤1) 增加的百分比为 36 % (磷= 0·083), 高于其他三组 (PS 组, 11 %,磷= 0·519; FO 组, 18 %,磷= 0·071; PO 组, 15 %,磷= 0·436)。与基线相比，转化生长因子-β（TGF-β) 在试验结束时三个研究组显着下降 (PS,磷= 0·000；佛，磷= 0·002; PS + FO，磷= 0·001) 和 TNF-αFO组显着降低（磷= 0·036), PS + FO 组 (磷= 0·005) 和采购订单组 (磷= 0·032) 在干预结束时。值得注意的是，TGF-βPS + FO 组比 PO 组显着减少（磷= 0·032)。PS + FO 组的 TAG 和总胆固醇水平分别降低了 11·57 和 9·55 %。总之，PS 和 EPA + DHA 的共同补充可以提高肝脂肪变性的治疗效果。