Double-blind randomized placebo-controlled clinical trial of omega 3 fatty acids for the treatment of diabetic patients with nonalcoholic steatohepatitis.
Double-blind randomized placebo-controlled clinical trial of omega 3 fatty acids for the treatment of diabetic patients with nonalcoholic steatohepatitis.
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DOI：
10.1097/mcg.0000000000000099
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发表时间：
2015-02
影响因子：
2.9
通讯作者：
McCullough AJ
中科院分区：
文献类型：
--
作者：
Dasarathy S;Dasarathy J;Khiyami A;Yerian L;Hawkins C;Sargent R;McCullough AJ
非酒精性脂肪性肝炎（NASH）在糖尿病患者中常见且严重。虽然目前还没有针对糖尿病患者NASH的有效治疗方法，但初步报告表明，多不饱和脂肪酸（PUFA）可能对这些患者有益。在患有糖尿病的NASH患者中进行了一项前瞻性、随机、双盲安慰剂对照研究（NCT 00323414）。根据CONSORT指南，37例（50.6 ± 9.8岁）糖尿病控制良好（HbA1C <8.5%）的患者随机接受含二十碳五烯酸2160 mg和二十二碳六烯酸1440 mg的PUFA或含玉米油的等热量相同安慰剂治疗48周。在随机化和治疗结束时进行临床、人口统计学、生化实验室检查、使用DEXA®的身体组成和肝活检。根据NASH CRN标准对肝活检进行评分。进行意向治疗分析。入选时，两个治疗组的性别、年龄、体重、生化检查、血糖控制和肝脏组织学相似。研究期间，两组的肝酶、体重或身体组成均无变化。在治疗结束时，安慰剂组肝脏脂肪变性和活动评分改善（p <0.05），小叶炎症恶化（p <0.001），但PUFA组无变化。在治疗结束时，胰岛素抵抗（血清葡萄糖和HOMA）恶化与PUFA，但不是安慰剂。PUFA在NASH糖尿病患者中没有提供优于安慰剂的益处。PUFA对组织学和胰岛素抵抗的影响劣于安慰剂。这些数据不支持PUFA补充剂治疗NASH。
Nonalcoholic steatohepatitis (NASH) is common and severe in patients with diabetes mellitus. Although, there are no effective treatments for NASH in diabetic patients, preliminary reports suggest that polyunsaturated fatty acids (PUFA) may be beneficial in these patients. A prospective, randomized, double blind placebo controlled study (NCT 00323414) was performed in NASH patients with diabetes. 37 patients (50.6±9.8y) with well controlled diabetes (HbA1C<8.5%) were randomized to receive either PUFA containing eicosapentaenoic acid 2160 mg and docosahexaenoic acid 1440 mg daily or an isocaloric, identical placebo containing corn oil for 48 weeks under CONSORT guidelines. Clinical, demographics, biochemical laboratory tests, body composition using DEXA® and liver biopsy were done at randomization and at the end of treatment. Liver biopsy was scored by the NASH CRN criteria. An intention to treat analysis was performed. At inclusion, gender, age, body weight, biochemical tests, glucose control and liver histology were similar in the 2 treatment groups. There was no change in liver enzymes, body weight or body composition during the study in either group. At the end of treatment, hepatic steatosis and the activity score improved (p<0.05) and lobular inflammation worsened (p<0.001) with placebo but was unchanged with PUFA. At the end of treatment, insulin resistance (serum glucose and HOMA) worsened with PUFA but not placebo. PUFA provided no benefit over placebo in NASH patients with diabetes. The effects of PUFA on histology and insulin resistance were inferior to placebo. These data provide no support for PUFA supplements in NASH.