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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. Introduction Osteoarthritis (OA) is a very common, slowly progressive joint condition that causes significant discomfort and disability in the adult population. The prevalence of the condition increases with age, with well-known risk factors such as genetics, obesity, local trauma, and occupation. Important radiographic changes of knee OA are found in 1% of adults of 25–35 years of age and increase almost to 50% in elders aged 75 years and older. OA of the hips and knees are the most common complaint in the adult population. Osteoarthritis has an inflammatory component, and a tissue breakdown component, which result in pain and stiffness [1] in these crucial weight-bearing joints. This often imposes an important disability, leading to an increased difficulty in undertaking normal activities of daily life, up to requiring joint replacement surgery in the most severe of cases. Acetaminophen and Non Steroidal Anti-Inflammatory Drugs (NSAIDs) are common treatments for patients with osteoarthritis to cope with pain and stiffness, in severe conditions on a daily basis. For this reason, in recent years many studies have focused on alternative molecules and nutritional supplements as therapeutic options to achieve cartilage tissue repair, while bypassing the negative effects of cyclooxygenase 2 (COX-2) inhibitors and other NSAIDs. Glucosamine has been extensively studied [2-18] showing positive results in the clinical management of pain and structural improvements [19]. Chondroitin sulfate coupled to Glucosamine, or by itself, has been the center of significant studies

clinical research and trials

Randomized observational multicenter study to assess the efficacy and safety of the association of Fortigel (10 Gr) and Fucoidan (100 Mg) in patients with Gonarthrosis