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
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 supplemen...
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Format: | Article |
Language: | English |
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BMC
2020-10-01
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Series: | Journal of Translational Medicine |
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Online Access: | http://link.springer.com/article/10.1186/s12967-020-02569-5 |
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author | Nini Callan Doug Hanes Ryan Bradley |
author_facet | Nini Callan Doug Hanes Ryan Bradley |
author_sort | Nini Callan |
collection | DOAJ |
description | 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 . |
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format | Article |
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institution | Directory Open Access Journal |
issn | 1479-5876 |
language | English |
last_indexed | 2024-12-13T17:51:30Z |
publishDate | 2020-10-01 |
publisher | BMC |
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series | Journal of Translational Medicine |
spelling | doaj.art-a43bd0e20f0b48b395cf588b8856accd2022-12-21T23:36:30ZengBMCJournal of Translational Medicine1479-58762020-10-0118111310.1186/s12967-020-02569-5Early evidence of efficacy for orally administered SPM-enriched marine lipid fraction on quality of life and pain in a sample of adults with chronic painNini Callan0Doug Hanes1Ryan Bradley2National University of Natural Medicine, Helfgott Research InstituteNational University of Natural Medicine, Helfgott Research InstituteNational University of Natural Medicine, Helfgott Research InstituteAbstract 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 .http://link.springer.com/article/10.1186/s12967-020-02569-5Chronic painPainSpmsResolvinsSpecialized pro-resolving mediatorsFish oil |
spellingShingle | Nini Callan Doug Hanes Ryan Bradley 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 Journal of Translational Medicine Chronic pain Pain Spms Resolvins Specialized pro-resolving mediators Fish oil |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Chronic pain Pain Spms Resolvins Specialized pro-resolving mediators Fish oil |
url | http://link.springer.com/article/10.1186/s12967-020-02569-5 |
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