Placebo-controlled randomized clinical trial of fish oil's impact on fatigue, quality of life, and disease activity in Systemic Lupus Erythematosus.
BACKGROUND
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov Identifier: NCT02021513 (registered 13 December 2013).
Division of Rheumatic Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA. cristina-arriens@omrf.org.
Cristina
C
Arriens
Departments of Clinical Sciences (Biostatistics) and Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA. linda.hynan@utsouthwestern.edu.
Linda S
LS
Hynan
Functional Medicine Research Center, Metagenics, Inc, Gig Harbor, WA, USA. rhlerman@gmail.com.
Robert H
RH
Lerman
Division of Rheumatic Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA. david.karp@utsouthwestern.edu.
David R
DR
Karp
Department of Biomedical Engineering, University of Houston, Houston, TX, USA. texascmohan@gmail.com.
Chandra
C
Mohan
D000328:Adult; D015415:Biomarkers / Q000097:blood; D015992:Body Mass Index; D019587:Dietary Supplements; D005221:Fatigue; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage; D005260:Female; D005395:Fish Oils / Q000008:administration & dosage*; D006801:Humans; D007249:Inflammation / Q000188:drug therapy; D018664:Interleukin-12 / Q000097:blood; D018793:Interleukin-13 / Q000097:blood; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D018384:Oxidative Stress / Q000187:drug effects; D010865:Pilot Projects; D011788:Quality of Life; D016037:Single-Blind Method; D055815:Young Adult
D015415:Biomarkers; D015525:Fatty Acids, Omega-3; D005395:Fish Oils; D018793:Interleukin-13; D018664:Interleukin-12