A randomized controlled trial found that treatment with LD-1227 had a clinically meaningful effect on the fibromyalgia diagnostic metrics of widespread pain index (WPI), total tender points (TTP), and symptom severity score [SSS], as well as inflammatory markers and parasympathetic balance.

Reza Rastmanesh et al. wanted to see how a new proprietary marine lipo-peptide formula compared to omega-3 affected cytokine profiles, anxiety, and pain symptoms in fibromyalgia patients. Group A volunteers (n=21) were supplemented with LD-1227, 1c twice a day while Group B volunteers (n=20) were given Omega-3, 900 mg 1c twice a day.

Clinical evaluation-based or questionnaire-based parameters such as weekly pain intensity ratings, SSS, cognitive symptom severity, fatigue severity ratings, Beck depression inventory, fibromyalgia impact questionnaire, TTP, and WPI patient global impression of change were assessed. Additional cytokine biochemistry and gene expression analyses (Interleukin [IL]-6, Tumor necrosis factor [TNF]-α, IL-1β, Macrophage Chemoattractant Protein [MCP]-1, IL-8, IL-13, IL-1, and granulocyte-macrophage colony-stimulating factor [GM-CSF]) was also done.

Depending on whether the distribution was non-parametric or parametric, the assessment of data was done utilizing paired t-test or Wilcoxon signed rank test. When the data from before and after therapy for Group B were compared, there was a clinically meaningful decrease in TTP, WPI score, and SSS score. These findings demonstrated that a 3-month therapy with LD-1227, but not omega-3 treatment, illustrated a favorable effect on fibromyalgia pain and accompanying anxiety/depressive symptoms. Heart rate variation and cytokines revealed a clinically meaningful improvement following LD1227 therapy.

Unlike the omega-3 supplemented group, the majority of subjects experienced a reduction in WPI and weekly pain intensity symptoms after therapy with LD-1227. TPC, WPI, and SSS scores decreased substantially in Group B before and after therapy. No adverse effects were noted. Hence, the novel lipo-peptide marine compound appears to be effective for the management of fibromyalgia pain and accompanying symptoms of depression and anxiety.