Early evidence of efficacy for orally administered SPM-enriched marine lipid fraction on quality of life and pain in a sample of adults with chronic pain

Nini Callan, Doug Hanes, Ryan Bradley, Nini Callan, Doug Hanes, Ryan Bradley

Abstract

Background: Marine 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.

Methods: This 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.

Results: Outcome 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.

Conclusion: We 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://ichgcp.net/clinical-trials-registry/NCT02683850 .

Keywords: Chronic pain; Fish oil; Mood; Pain; Quality of life; Resolvins; Specialized pro-resolving mediators; Spms.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT diagram of study enrollment and retention
Fig. 2
Fig. 2
Quality of Life: T-scores (with 95% CIs) for Quality of Life PROMIS-43 subdomains (Fatigue, Sleep, and Social Function); and ACPA Quality of Life scale, by dosing subgroups between Baseline, Week 2, and Week 4 measurements. Dose −: (N = 16) dose decreased at Week 2 study visit; Dose + : (N = 28) dose increased at Week 2 study visit
Fig. 3
Fig. 3
a Depression: T-score (with 95% CIs) for PROMIS-43 Depression subdomain, and PHQ-9—comparisons by dosing subgroups between Baseline, Week 2, and Week 4 measurements. Dose −: (N = 16) dose decreased at Week 2 study visit; Dose + : (N = 28) dose increased at Week 2 study visit. b Anxiety: T-score (with 95% CIs) for PROMIS-43 Anxiety subdomain, and GAD-7—comparisons by dosing subgroups between Baseline, Week 2, and Week 4 measurements. Dose −: (N = 16) dose decreased at Week 2 study visit; Dose + : (N = 28) dose increased at Week 2 study visit
Fig. 4
Fig. 4
a Pain Intensity: T-scores (with 95% CIs) for PROMIS-43 and BPI subdomains of pain intensity—comparison between Baseline, Week 2, and Week 4 measurements. Dose −: (N = 16) dose decreased at Week 2 study visit; Dose + : (N = 28) dose increased at Week 2 study visit. b Pain Interference: T-scores (with 95% CIs) for PROMIS-43 and BPI subdomains of pain interference (BPI multiplied by 10 for scaling)—comparison between Baseline, Week 2, and Week 4 measurements. Dose –: (N = 16) dose decreased at Week 2 study visit; Dose + : (N = 28) dose increased at Week 2 study visit
Fig. 5
Fig. 5
PGSS (Satisfaction) at Week 4
Fig. 6
Fig. 6
PGIC (Improvement) at Week 4

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