Segurança e eficácia da cartilagem de tubarão na osteoartrite de joelho: estudo fase II

Abstract

Osteoarthritis (OA) is the most common rheumatic disease. It is a joint disease characterized by degeneration of the articular cartilage, hypertrophy of the bone at the margins, and changes in the synovial membrane. Pain and stiffhess accompany it, particularly after prolonged activiiy. Non-steroidal anti- inflammatory drugs are used for the symptomatic treatment of osteoarthritis. Products as the shark cartilage (SC) are growing popular among patients with chronic and inflammatory disorders. The SC anti-angiogenic, anti-inflammatory and analgesic activities have been demonstrated in clinicai trials with a variety of results. The aim of this study was to evaluate the possible therapeutic potential, safety, tolerability (tolerance or toxicity) of 3g per day of SC in patients with knee OA for 16 weeks. 20 patients with ages between 40 and 80 years (media 57.7±7.79) and diagnosed with OA, as assessed by clinicai and laboratory test evaluations in accordance with the inclusion and exclusion criteria (pre- established), concluded the study. Clinicai and Laboratory test evaluations were accomplished before the beginning of the study, after 2, 4, 8 and 16 weeks of treatment and one week after the end of the study. The patients did not show significant changes in clinicai or laboratory test evaluations. In accordance with the radiological index ofDA, 4% of the patients were in levei I; 14% were in levei II; 68% were in levei III and 14% in levei IV. 75% of the sample presented 100% of adherence to the treatment. The VAS (Visual Analogic Scale) of pain and the Index of Lequesne showed significant changes from baseline (66.84±19.74; 14.18±0.73) in the 12th week (50.63* ± 24.07; 11.73* ± 1.10), 16th week (49.33* ± 25.77; 11.17* ± 1.31) and in the post study (54.21* ± 25.46; 12.18* ± 0.98) respectively. The HAQ (Health Assessment Questionnaire) presented reductien compared to the baseline (1.56 ± 0.07) in the 16th week (1.30* ± 0.15) and in the post study (1.35* ± 0.10). The SSS (Symptoms and Signs Scale) also showed reduction compared to the baseline of the 2nd week to the 16th week. The SC Selachii was well tolerated and safe, however it did not show efficacy in control of signs and symptoms of OA when administered in the dosage of 3g per day.