Randomized, double-blind, placebo-controlled study to evaluate the effect of treatment with an SPMs-enriched oil on chronic pain and inflammation, functionality, and quality of life in patients with symptomatic knee osteoarthritis: GAUDI study

Journal of Translational Medicine

Research

Jose A. Rodas¹  Francisco Angulo²  Jose María Villalón³  Gil Rodas⁴  Ingrid Möller⁵  Nina Martínez⁶  Josep Vergés⁶ 

[1] Asturias Football Federation, Avilés, Spain;Athletic FC, Bilbao, Spain;FC Atlético de Madrid, Madrid, Spain;FC Barcelona, Barcelona, Spain;Institut Poal de Reumatología, Barcelona, Spain;Osteoarthritis Foundation International (OAFI), Barcelona, Spain;

关键词: Specialized pro-resolving mediators;    SPMs;    Resolvins;    Supplementation;    Osteoarthritis;    Chronic pain;    Quality of life;    Placebo;   

DOI  :  10.1186/s12967-023-04283-4

 received in 2023-02-20, accepted in 2023-06-17,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundSpecialized pro-resolving mediators (SPMs), including 18-HEPE, 17-HDHA, and 14-HDHA are recognized as potentially therapeutic in inflammatory diseases because SPMs regulate the inflammation process, which leads to, for example; swelling and the sensation of pain. In osteoarthritis (OA), chronic pain is described as the symptom that reduces patients´ quality of life (QoL). The GAUDI study evaluated the efficacy of SPMs supplementation in reducing pain in the symptomatic knee of OA patients.MethodsThis randomized, multicenter, double-blind, and placebo-controlled parallel-group pilot study was performed in Spain and conducted on adults 18–68 years old diagnosed with symptomatic knee OA. Patients were enrolled in the study for up to 24 weeks, which included a 12-week intervention period and a follow-up visit on week 24. The primary endpoint was pain change measured through a Visual Analog Scale (VAS). Secondary endpoints included: Pain change evaluation, stiffness, and function according to the WOMAC index; assessment of constant, intermittent, and total pain according to the OMERACT-OARSI score; evaluation of changes in health-related QoL parameters; the use or not of concomitant, rescue, and anti-inflammatory medication; and safety and tolerability assessments.ResultsPatients were enrolled in the study from May 2018 to September 2021. VAS pain score was evaluated in the per protocol population (n = 51 patients), in which we observed a statistically significant reduction after 8 weeks (p = 0.039) and 12 weeks (p = 0.031) of treatment in patients consuming SPMs (n = 23 subjects) vs. placebo (n = 28 subjects). In line with the OMERACT-OARSI score, intermittent pain was reduced after 12 weeks with statistical significance (p = 0.019) in patients treated with SPMs (n = 23 subjects) vs. placebo (n = 28 subjects). Functional status as WOMAC score did not significantly change after SPMs or placebo consumption. Notably, patients consuming SPMs showed improvements in all five aspects of the EUROQoL-5, including a significant improvement in the usual-activities dimension. None of the patients required rescue medication, nor were any adverse events reported.ConclusionsThese findings suggest that sustained SPMs consumption reduces pain in OA patients while also improving their Quality of Life. These results also support the safety profile of SPMs supplementation.Trial registration NCT05633849. Registered 1 December 1 2022. Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT05633849

【 授权许可】

CC BY   
© The Author(s) 2023

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