Background/Purpose:  The inflammatory response has an initiation phase and a resolution phase. Ideally, inflammation leads to complete resolution that enables tissue healing and a return to previous healthy condition. However, if it is left unresolved, the surrounding tissues can be damaged over time. Chronic unresolved inflammation has been linked to many chronic diseases, and clinically often manifests as pain in joint-related conditions. During the resolution phase, specialized pro-resolving mediators (SPMs) are produced from polyunsaturated fatty acids at the affected tissue site, orchestrating the resolution activities and expediting the return to homeostasis. Some individuals may not produce desirable levels of SPMs—due to lifestyle behaviors, dietary choices, age, or health status—and the inflammatory response is left unresolved. The objective of this study was to observe the effect of a natural product (LM-O3) containing standardized SPMs on select inflammatory biomarkers and on overall well-being assessed by multiple questionnaires in subjects with OA, RA, or other chronic inflammatory conditions.

Methods:  The 8-week, IRB-approved, open-label case series was conducted at 6 clinical sites from where participants were recruited. Main inclusion criteria included individuals with (1) chronic pain lasting ≥ 3 months, (2) OA, RA or other joint-related conditions, or (3) fibromyalgia. LM-O3 contained fractionated lipid concentrate from natural sources standardized to 2 SPMs (18-hydroxyeicosapentaenoic acid and 17-hydroxydocosahexaenoic acid). After baseline assessment, all participants consumed 750 mg of LM-O3 as 6 softgels once daily taken with a lipid-containing meal. After Week 4, the dose of LM-O3 was titrated up to 1000 mg as 8 softgels once daily. Participants returned to the clinic at Weeks 4 and 8 for clinical evaluation (biochemical measurements, clinical symptomology and quality of life assessments relevant to clinical condition, compliance, and adverse events). Changes from baseline to Week 4 and Week 8 were analyzed separately using two-sided paired t-test.

Results:  Thirty-four participants completed the study. Levels of hs-CRP were significantly reduced from 9.2±15.8 mg/L (mean±SD) at baseline to 5.2±9.5 mg/L at Week 4 (p=0.031) and to 6.3±10.6 mg/L at Week 8 (p=0.007). PGE₂levels were also significantly reduced from 590.6±802.0 pg/mL at baseline to 350.6±334.3 pg/mL at Week 8 (p=0.039). Total scores on the Brief Pain Inventory, the American Chronic Pain Association Quality of Life Scale, and other subject-reported scales reflective of clinical diagnoses were significantly reduced at Week 4 and 8 compared with baseline. Results at the Week 4 and 8 assessments were comparable. No serious adverse events were reported. A subgroup analysis of 14 subjects diagnosed with OA or RA showed comparable results, including reduced pain and improved activities of daily living.

Conclusion:  A SPM-containing natural product exerted beneficial effects on inflammatory biomarkers and reduced the severity of pain as well as the impact of pain on activities of daily function in subjects with health conditions associated with chronic unresolved inflammation.

« Back to 2016 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/effects-of-a-natural-product-containing-specialized-pro-resolving-mediators-in-subjects-with-oa-ra-or-other-chronic-inflammatory-conditions-in-a-multi-clinic-case-series/