Randomized Observational Multicenter Study to Assess the Efficacy and Safety 0f the Association of Fortigel (10 Gr) and Fucoidan (100 Mg) in Patients with Gonarthrosis

Abstract

Purpose: In order to further elucidate the efficacy and safety of some nutritional supplements on gonarthrosis, we have conducted a preliminary randomized multicenter (n=9) observational study comparing the effects of an association of Fortigel®(10gr) and Fucoidan (100mg) (ACTEN®) versus another commonly therapeutically used formulation based on Glucosamine (500mg), Chondroitin Sulfate (400mg) hyaluronic Acid (50 mg) and Vitamin C (100 mg) (COMBIART). Patients and Methods: The protocol was administered over a 12-weeks period in a population (n=126) aged 40-65 years, with diagnosed mild-tomoderate Osteoarthritis (OA) of the knee (grade 2-3 of Kellgren Lawrence grading scale).Safety was measured by closely monitoring adverse events. Efficacy was measured by grading evaluations, at basal, 1 month and 3 months controls, of the Visual Analog Scale (VAS) and the Lequesnealgo functional index for severity of osteoarthritis (LAI) for particular functionality. Results: Both groups showed an important reduction (P<0.0001) in the mean visual analog scale values at T1 (28.5% ACTEN®, 21.3% COMBIART at1 month) and T3 (49.4% ACTEN®, 40.1% COMBIART at 3 months), as well as a marked reduction in the Lequesnealgo functional index means (P<0.0001) (ACTEN® 28.9% T1 44.9% T3, COMBIART T1 21.3% T3 37%). The effect seems to be time dependent, as the mean values decrease further for both parameters from T1 to T2 (P<0.0001, for VAS for both groups; P 0.0011 for ACTEN® group, P 0.0064 Control group for LAI). No statistically significant difference was found between the ACTEN® group and the COMBIART group at time T1 or T3. These interesting preliminary data will be further investigated on a larger scale. Conclusions: Fortigel®(10gr) and Fucoidan (100 mg) (ACTEN®) taken as oral nutritional supplements have a significant impact as therapeutic intervention for knee osteoarthritis as indicated by the marked decrease in VAS and LAI values over the course of the treatment. A similar effect, as expected, has been confirmed in the COMBIART group, and no statistically significant difference has been detected between the two groups.