背景:研究补充omega-3脂肪酸对心血管事件影响的随机临床试验(RCT)在很大程度上没有显示益处。然而,在这些试验中,有关于安慰剂的良性性质的争论。我们旨在对RCT进行网络荟萃分析,以比较补充omega-3脂肪酸与各种安慰剂油的结果。
方法:MEDLINE和EMBASE搜索了5月,2021年确定使用omega-3-脂肪酸制剂[二十碳五烯酸(EPA),癸酸(DHA),或组合]与安慰剂或标准护理对照。
结果:我们的分析包括17项随机对照试验,共纳入141,009名随机接受EPA治疗的患者(n=13,655),EPA+DHA(n=56,908),矿物油安慰剂(n=5,338),玉米油安慰剂(n=8,876),橄榄油安慰剂(n=41,009),和对照(无安慰剂油;n=15,223)。心血管死亡率[危险比(HR)(95%置信区间,CI)=0.80(0.65-0.98);p=0.033],心肌梗死[HR(95%CI)=0.73(0.55-0.97);p=0.029]和卒中[HR(95%CI)=0.74(0.58-0.94);p=0.014]在接受EPA的患者中明显低于接受矿物油的患者,但与接受其他油或对照的比率没有不同。接受EPA的患者的冠状动脉血运重建率显着低于接受EPA+DHA的患者,矿物油,玉米油,或橄榄油安慰剂,但不是控制。所有人群的全因死亡情况相似,但与对照组相比,EPA+DHA联合用药与心血管死亡风险降低相关[HR(95CI):0.83(0.71-0.98)].
结论:我们的分析表明,尽管补充EPA比其他油更能降低冠状动脉血运重建的风险,相对于护理标准可能没有好处。Further,EPA仅与矿物油相比可降低心血管事件的风险,而与其他安慰剂油或对照相比则没有。相比之下,与对照组相比,EPA+DHA联合用药与心血管死亡风险降低相关.
Randomized clinical trials (RCTs) investigating the impact of omega-3-fatty acid supplementation on cardiovascular events have largely shown no benefit. However, there is debate about the benign nature of the placebo in these trials. We aimed to conduct a network meta-analysis of RCTs to compare the outcomes of omega-3 fatty acid supplementation to various placebo oils.
MEDLINE and EMBASE were searched through May, 2021 to identify RCTs investigating cardiovascular outcomes with omega-3-fatty acid formulations [eicosapentaenoic acid (EPA), decosahexanoic acid (DHA), or the combination] versus placebo or standard of care controls.
Our analysis included 17 RCTs that enrolled a total of 141,009 patients randomized to EPA (n=13,655), EPA+DHA (n=56,908), mineral oil placebo (n=5,338), corn oil placebo (n =8,876), olive oil placebo (n=41,009), and controls (no placebo oil; n=15,223). Rates of cardiovascular death [hazard ratio (HR) (95% confidence interval, CI) =0.80 (0.65-0.98); p =0.033], myocardial infarction [HR (95% CI) =0.73 (0.55-0.97); p=0.029] and stroke [HR (95% CI) =0.74 (0.58-0.94); p=0.014] were significantly lower in those receiving EPA compared to those receiving mineral oil, but were not different from rates in those receiving other oils or controls. Rates of coronary revascularization were significantly lower in those receiving EPA than in those receiving either EPA+DHA, mineral oil, corn oil, or olive oil placebo, but not controls. All-cause death was similar among all groups, but combined EPA+DHA was associated with reduced risk of cardiovascular death compared to controls [HR (95%CI): 0.83 (0.71-0.98)].
Our analyses demonstrate that although EPA supplementation lowers risk of coronary revascularization more than other oils, there may not be a benefit relative to standard of care. Further, EPA reduces the risk of cardiovascular events only in comparison to mineral oil and not when compared with other placebo oils or controls. In contrast, combined EPA+DHA was associated with reduced risk of cardiovascular death compared to controls.