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

Journal: Journal of translational medicine 2021;18(1):401

PMID: 33087142

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Plain Language Summary

Alternatives for the management of chronic pain are needed due to the high side effect profiles, high incidence of developing tolerance, and high potential for addiction in the most common treatments which are currently used. Marine lipids (i.e. fish oil) are a well-known source of the long chain omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). EPA and DHA can be metabolised in the body into potent anti-inflammatory and pro-resolving mediators, which are integral parts of a fatty acid metabolite class known as specialized pro-resolving mediators (SPMs). The aim of this study was to collect preliminary data on the effects of SPM-enriched marine lipid supplementation on quality of life, pain, mood, and inflammation in adults with a history of chronic pain. This study is a single-arm, open-label clinical trial. Forty-four adults with moderate pain intensity for at least 3 months were recruited. Results show improved quality of life in an adult population with chronic pain after supplementation. Furthermore, there were also reductions in measures of pain intensity, pain interference, depression, and anxiety, as well as an increase in physical function. Authors conclude that orally administered supplements containing resolving precursors may improve the quality of life, reduce pain intensity and interference, and improve mood within 4 weeks of supplementation.

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://clinicaltrials.gov/ct2/show/NCT02683850 .

Address: National University of Natural Medicine, Helfgott Research Institute, 2220 SW 1st Ave, Portland, OR, 97201, USA.; National University of Natural Medicine, Helfgott Research Institute, 2220 SW 1st Ave, Portland, OR, 97201, USA. [email protected].; Herbert Wertheim School of Public Health, University of California, San Diego, La Jolla, CA, USA. [email protected].

DOI: 10.1186/s12967-020-02569-5