Adjuvant benefit of a peptide-rich marine biology formula (LD- 1227) in rheumatoid arthritis: a randomized, double-blind, controlled study
Bibliographic record
Abstract
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. Conclusion. One can conclude that LD-1227 may play a significant role on the management of RA and with a specrum and mechanisms of actions distinct from the canonical omega-3 while being devoid of any side effect or tolerability issues.Keywords: rheumatoid arthritis, cytokines, omega-3, marine peptides, inflammation, pain, gene expression
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".