Open, Observational, Single-Arm, Multicenter Study Assessing the Effectiveness of a Dietary Supplement Containing Hydrolyzed Collagen, Chondroitin Sulfate, and Glucosamine for Osteoarthritis Pain Reduction.

Osteoarthritis (OA) is an age-related degenerative joint disease with a great impact on patients' well-being and quality of life. This is an observational, open, single-arm multicenter study aimed to evaluate the effectiveness of a nutritional supplement in patients with knee and/or hip OA. A total of 186 patients were recruited from Spanish centers and received a supplement containing hydrolyzed collagen (3000 mg), chondroitin sulfate (800 mg), glucosamine sulfate (700 mg), turmeric extract (250 mg) and devil's claw (150 mg), once daily during 6 months. The primary outcome was the patients' self-perceived pain in the affected joints measured with a visual analogue scale (VAS). Secondary outcome was the patient's functioning, measured with the Lequesne Functional Index and the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Participants showed a significant reduction in self-perceived pain after 3 (mean reduction ± standard deviation, 1.99 ± 1.05) and 6 months (3.57 ± 1.39) of treatment (p < 0.0001 in both comparisons). Lequesne Functional Index score was significantly reduced at 3 months (3.86 ± 2.94) and at 6 months (6.73 ± 4.30) of treatment (p < 0.0001 in both comparisons). The WOMAC index was also significantly reduced after 3 (14.24 ± 10.04) and 6 months (26.43 ± 17.35) of treatment (p < 0.0001 in both comparisons). Significant reductions in WOMAC subdomains (p < 0.0001 in all comparisons) were observed. No severe adverse events were reported during the study. The main results arising from this study show that this nutritional supplementation can improve OA-related symptoms and physical function with a good safety profile in patients with hip and/or knee OA.

Eficacia y seguridad de un tratamiento oral a base de mucopolisacáridos, colágeno tipo i y vitamina C en pacientes con tendinopatías / Efficacy and safety of an oral treatment based on mucopolysaccharides, collagen type i and vitamin C in patients with tendinopathies

Introducción y objetivos: La tendinopatía es una lesión frecuente durante la práctica deportiva que cursa con una alteración estructural del tendón. El objetivo de este estudio fue evaluar la eficacia y la seguridad de un complemento alimentario a base de mucopolisacáridos, colágeno tipo i y vitamina C (Tendoactive(R)) sobre la evolución clínica y estructural de las tendinopatías del tendón de Aquiles, rotuliano y del epicóndilo lateral del codo. Material y métodos: Se realizó un estudio multicéntrico prospectivo, de tipo exploratorio en fase IV, abierto y no comparativo. Se incluyeron un total de 98 pacientes con tendinopatías (32 de Aquiles, 32 de rotuliano y 34 del epicóndilo lateral) que recibieron una dosis diaria de 435 mg de mucopolisacáridos, 75 mg de colágeno tipo I y 60 mg de vitamina C (equivalente a 3 cápsulas al día de Tendoactive(R)) durante 90 días consecutivos. Mensualmente se evaluó el dolor en reposo y en actividad mediante una escala visual analógica (EVA), la función articular mediante los cuestionarios VISA-A, VISA-P y PRTEE, y se caracterizó ecográficamente el tendón afectado. Resultados: En los 3 tipos de tendinopatía se registró una reducción significativa del dolor tanto en reposo como en actividad desde la primera visita de control (día 30) hasta el final del estudio (día 90). Asimismo el día 90 se detectó una mejora del 38% en VISA-A, del 46% en VISA-P y del 77% en PRTEE (p < 0,001). Simultáneamente se registró una reducción del 12% en el grosor del tendón de Aquiles, del 10% en el rotuliano y del 20% en el tendón del epicóndilo lateral (p < 0,05). Conclusiones: Los resultados del estudio indican que la administración de Tendoactive(R) es segura y eficaz para mejorar los síntomas clínicos y la evolución estructural de las tendinopatías del tendón de Aquiles, tendón rotuliano y tendón del epicóndilo lateral

Introduction and objectives: The aim of this study was to evaluate the efficacy and safety of a diet supplement containing mucopolysaccharides, collagen type I and vitamin C (Tendoactive(R)) on the clinical symptoms and tendon structure of patients with Achilles, patellar, or lateral epicondyle tendinopathy. Material and methods: Between September 2012 and February 2013, a total of 98 patients with tendinopathy were included in the study (32 of Achilles tendon, 32 of patellar tendon, and 34 of lateral epicondyle tendon). The patients received a daily dose of Tendoactive(R) containing 435 mg of mucopolysaccharides, 75 mg of collagen type I and 60 mg of vitamin C (equivalent to 2 capsules per day) for 90 consecutive days, and were followed up monthly during the study period. Clinical assessments included pain intensity, which was assessed at rest and during activity using a visual analog scale (VAS), and also a specific functional scale (VISA-A questionnaire for Achilles, VISA-P for patella, and PRTEE for the elbow). Tendon structure was analyzed using ultrasound, including measurements of cross-sectional thickness of the tendon, paratenon blurring, heteroechogenicity and hypoechogenicity levels, and neovascularization. Results: There was a significant reduction in pain at rest and during activity from the first follow-up visit (day 30) until the end of the study (day 90) for the three types of tendinopathy. The same pattern of response was observed with the functional scales. On day 90 the improvement from baseline was 38% for VISA-A, 46% for VISA-P, and 77% for PRTEE (P <0.001). Simultaneous to the clinical improvement, there was a reduction of the tendon thickness (12% in Achilles, 10% in patellar tendon and 20% in lateral epicondyle tendon; P < 0.05). Conclusions: The overall results show that Tendoactive(R) is a safe and effective treatment for improving the clinical symptoms, as well as structural evolution of injured tendons, as demonstrated in Achilles, patellar and lateral elbow epicondyle tendinopathy