Placebo-controlled randomized clinical trial of fish oil's impact on fatigue, quality of life, and disease activity in Systemic Lupus Erythematosus.
Placebo-controlled randomized clinical trial of fish oil's impact on fatigue, quality of life, and disease activity in Systemic Lupus Erythematosus.
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DOI：
10.1186/s12937-015-0068-2
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发表时间：
2015-08-18
影响因子：
5.4
通讯作者：
Mohan C
中科院分区：
文献类型：
--
作者：
Arriens C;Hynan LS;Lerman RH;Karp DR;Mohan C
最近对系统性红斑狼疮（SLE）患者血清的代谢组学筛查发现抗氧化剂和能量生成底物减少。这些代谢改变可能是SLE最常见的特征之一——疲劳的基础。代谢组学研究也注意到omega-3脂肪酸的减少，这是一种强大的抗氧化剂。这种缺乏可能与SLE的氧化应激、炎症、疾病活动性和疲劳有因果关系。在其他研究中，SLE患者使用鱼油补充omega-3脂肪酸已被证明可以减少氧化应激。作为一项随机临床试验的一部分，本研究的目的是评估鱼油补充剂对疲劳、生活质量和疾病活动的临床指标的影响。在门诊招募的50例SLE患者按1:1的比例随机分为鱼油补充剂组和橄榄油安慰剂组，并对治疗组进行盲法观察。在基线和治疗6个月后，完成RAND Short Form-36 （RAND SF-36）、疲劳严重程度量表（FSS）、SLE疾病活动指数（SLEDAI）和医师总体评估（PGA）；同时采集血清进行可溶性介质分析。32名患者完成了这项研究。与安慰剂组相比，鱼油组PGA显著改善（p = 0.015）。RAND SF-36能量/疲劳和情绪幸福感得分有改善趋势（p = 0.092和0.070）。FSS和SLEDAI无明显差异（p = 0.350和p = 0.417）。红细胞沉降率和血清IL-12降低（p = 0.008和p = 0.058）；鱼油组血清IL-13升高（p = 0.033）。在这项为期6个月的随机安慰剂对照试验中，随机服用鱼油补充剂的SLE患者的PGA、RAND SF-36和一些循环炎症标志物均有改善。ClinicalTrials.gov标识符：NCT02021513（2013年12月13日注册）。
A recent metabolomic screen of sera from patients with Systemic Lupus Erythematosus (SLE) found reduction of antioxidants and substrates for energy generation. These metabolic alterations may underlie one of the most common features of SLE - fatigue. The metabolomic studies also noted reduced omega-3 fatty acids, which are powerful anti- oxidants. This deficiency may be causally related to oxidative stress, inflammation, disease activity, and fatigue in SLE. Supplementation of omega-3 fatty acids using fish oil in SLE has been shown to reduce oxidative stress in other studies. The objective of this study is to evaluate the effect of fish oil supplementation on clinical measures of fatigue, quality of life, and disease activity as part of a randomized clinical trial. Fifty SLE patients recruited in outpatient clinics were randomized 1:1 to fish oil supplementation or olive oil placebo, and blinded to their treatment group. At baseline and after 6 months of treatment, RAND Short Form-36 (RAND SF-36), Fatigue Severity Scale (FSS), SLE Disease Activity Index (SLEDAI), and Physician Global Assessment (PGA) were completed; serum was also collected for soluble mediator analysis. Thirty-two patients completed the study. PGA improved significantly in the fish oil group compared with the placebo group (p = 0.015). The RAND SF-36 Energy/fatigue and Emotional well-being scores demonstrated improvement trends (p = 0.092 and 0.070). No clear difference was seen in FSS and SLEDAI (p = 0.350 and p = 0.417). Erythrocyte sedimentation rate and serum IL-12 were reduced (p = 0.008 and p = 0.058); while serum IL-13 was increased by fish oil supplementation (p = 0.033). In this randomized, placebo-controlled 6-month trial, SLE patients randomized to fish oil supplementation demonstrated improvement in their PGA, RAND SF-36, and some circulating inflammatory markers. ClinicalTrials.gov Identifier: NCT02021513 (registered 13 December 2013).