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Randomized observational study to assess the efficacy and safety of the association of fortigel (10 g) and fucoidan (100 mg) in patients with gonarthrosis
Martin-Martin LS, Pierluigi B, La Medica C, Melis G, Nuvoli G, Piccinni V, Pietrapertosa M, Vincenti B & Vinicola V9Purpose: 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® (10 g) and Fucoidan (100 mg) (ACTEN®) versus another commonly therapeutically used formulation based on Glucosamine (500 mg), Chondroitin Sulfate (400 mg) 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-to-moderate 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 Lequesne algofunctional index for severity of osteoarthritis (LAI) for articular 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 at 1 month) and T3 (49.4% ACTEN®, 40.1% COMBIART™ at 3 months), as well as a marked reduction in the Lequesne algofunctional 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® (10 g) 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.