摘要：Introduction.There is a growing interest on non-chemical therapies among patients suffering from rheumatoid arthritis (RA), although safety, efficacy and properly designed studies are often lacking.Objective.The aim of the present investigation was to explore the clinical effectiveness of a marine nutraceutical, LD-1227, endowed by fine molecular biology studies, in the management of RA.Methods.The study design was a 12-week, randomized, double-blind study involving forty patients with stable long-standing RA who were randomized to receive either LD-1227 (n = 20) or Omega-3 (n = 20) on top of their established maintenance therapy.Results.At study recruitment and after 12 weeks of treatment, their Health Assessment Questionnaire (HAQ), erythrocyte sedimentation rate (ESR), visual analogue scale (VAS), and Disease Activity Score (DAS) 28, anxiety and depression analysis, C-reactive protein (CRP) levels, CXCL1, several pro-inflammatory interleukins levels and related gene expression, were compared between the two groups.Primary end point was the proportion of patients with response at weeks 12 as from the 20 % to 50% improvement criteria of the American College of Rheumatology (ACR20).At 12 weeks, ACR20 beneficial response was 81.0 % in LD-1227 group and 44 % in omega-3 group, (p< 0.01).The superiority of LD-1227 appeared also when considering the ACR50 response at 12 weeks (62% in LD-1227 group as compared to 31 % in omega-3 group, p< 0.01).The LD-1227-treated group displayed a significant improvement of VAS scale, HAQ score, morning stiffness and tender points (p < 0.01 vs control and p < 0.05 vs omega-3, respectively).From the biochemical viewpoint, patients in the LD-1227 group showed a lower level of CRP, IL-6, TNF-α, IL-1β, CXCL1, IFNγ, IL-15 and IP-10 and significant downregulation of related gene expressions.Unlike what observed in LD-1227 group, in the omega-3 group, CRP and DAS28 did not reach statistical difference.A substantial reduction of extra pain killer use was noted under LD-1227 treatment.
