Abstract

BackgroundMarine lipids contain omega-3 fatty acids that can be metabolized into anti-inflammatory and pro-resolving mediators—namely 17-HDHA and 18-HEPE—which can serve as modulators of the pain experience. The purpose of this study was to determine the impact of 4 weeks of oral supplementation with a fractionated marine lipid concentration, standardized to 17-HDHA and 18-HEPE, on health-related quality of life and inflammation in adults with chronic pain.MethodsThis study was a prospective, non-randomized, open-label clinical trial. Forty-four adults with ≥ moderate pain intensity for at least 3 months were recruited. The primary outcome was change in health-related quality of life (QOL) using the Patient Reported Outcomes Measurement Information System-43 Profile (PROMIS-43) and the American Chronic Pain Association (ACPA) QOL scale. Exploratory outcomes assessed safety and tolerability, changes in anxiety and depression, levels of pain intensity and interference, patient satisfaction, and impression of change. Changes in blood biomarkers of inflammation (hs-CRP and ESR) were also explored.ResultsOutcome measures were collected at Baseline, Week 2, and Week 4 (primary endpoint). At Week 4, PROMIS-43 QOL subdomains changed with significance from baseline (p < 0.05), with borderline changes in the ACPA Quality of Life scale (p < 0.052). Exploratory analyses revealed significant changes (p < 0.05) in all measures of pain intensity, pain interference, depression, and anxiety. There were no statistically significant changes in either hs-CRP or ESR, which stayed within normal limits.ConclusionWe conclude that oral supplementation with a fractionated marine lipid concentration standardized to 17-HDHA and 18-HEPE may improve quality of life, reduce pain intensity and interference, and improve mood within 4 weeks in adults with chronic pain. The consistency and magnitude of these results support the need for placebo-controlled clinical trials of marine lipid concentrations standardized to 17-HDHA and 18-HEPE.Trial registration ClinicalTrials.gov: Influence of an Omega-3 SPM Supplement on Quality of Life, NCT02683850. Registered 17 February 2016—retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02683850.

Highlights

  • Marine lipids contain omega-3 fatty acids that can be metabolized into anti-inflammatory and proresolving mediators—namely 17-HDHA and 18-HEPE—which can serve as modulators of the pain experience

  • The PROMIS-43 Profile provides a standardized, reliable, and valid measure of Pain Interference, Pain Intensity, Physical Function, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities

  • Primary outcome results The T-scores of all 4 quality of life PROMIS-43 subdomains can be found in Fig. 2, which shows summary results by dosing group at the Week 2 visit, i.e. those participants who increased versus those who decreased their dose at Week 2 based on their reported response

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Summary

Introduction

Marine lipids contain omega-3 fatty acids that can be metabolized into anti-inflammatory and proresolving mediators—namely 17-HDHA and 18-HEPE—which can serve as modulators of the pain experience. The purpose of this study was to determine the impact of 4 weeks of oral supplementation with a fractionated marine lipid concentration, standardized to 17-HDHA and 18-HEPE, on health-related quality of life and inflammation in adults with chronic pain. Once pain becomes chronic, research has shown NSAIDS are no longer effective, and many drugs show limited to no effectiveness [5, 6]. None of these prescriptions or over-the-counter medications are recommended for long-term use, nor do they resolve the chronic inflammation often associated with chronic pain

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