Abstract

Studies have suggested a lipid extract from hard-shelled mussel (Mytilus coruscus) (HMLE) possessed strong anti-inflammatory activity in arthritis model of rats. This study investigated whether HMLE could improve clinical conditions of rheumatoid arthritis patients. Fifty rheumatoid arthritis patients (28–75 years) were randomly assigned to receive HMLE capsules or receive placebo capsules for 6 months. Forty-two subjects and 50 subjects were included in per-protocol and intention-to-treat analysis, respectively. Significant differences in changes on disease activity score (DAS28) and clinical disease activity index (CDAI) after 6-month intervention (p < 0.01) were observed in both analyses with more evident efficacy shown in per-protocol population (∆DAS28 = 0.47; ∆CDAI = 4.17), which favored the benefits of the HMLE group. TNF-α (tumor necrosis factor α), interleukin (IL)-1β and PGE₂ (prostaglandin E2) but not IL-6, were significantly decreased in both groups, and the decrements were much larger in the HMLE group for TNF-α and PGE₂ after 6 months from baseline (p < 0.05). IL-10 was significantly increased in both groups and the change was much more evident in the HMLE group (p < 0.05). In conclusion, HMLE exhibited benefits for the clinical conditions of rheumatoid patients in relation to improvement in the balance between pro- and anti-inflammatory factors, which indicated its potential to serve as adjunctive treatment for rheumatoid arthritis. (ClinicalTrials.gov NCT02173587). View Full-Text