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MINERVA ORTOPEDICA E TRAUMATOLOGICA
A Journal on Orthopedics and Traumatology
Minerva Ortopedica e Traumatologica 2012 February;63(1):9-17
The clinical effectiveness of glucosamine sulfate, chondroitin sulfate, hydrolyzed collagen type II, hydrolized hyaluronic acid and L carnitine supplement in patients with osteoarthritis of the knee: a multicenter randomized double blind controlled clinical trial
Geraci A. 1, Zatta D. 1, Strazzabosco C. 1, Tomasello G. 2, Alongi G. 3, Genovese M. 4, Sanfilippo A. 5, D’Arienzo M. 5
1 Orthopedic and Traumatology Department, Santa Maria del Prato Hospital, Feltre, Belluno, Italy;
2 Department of General and Emergency Surgery and Organ Transplantation, University of Palermo, Palermo, Italy;
3 Orthopedic and Traumatology Department, Sant’Antonio Abate Hospital, Trapani, Italy;
4 Free Pratictioner, Povegliano, Treviso, Italy;
5 Orthopedic and Traumatology Department, University of Palermo, Palermo, Italy
Aim. Osteoarthritis (OA) is a degeneration of articular cartilage. Four components of the cartilage structure, glucosamine, chondroitin collagen type II and hyaluronic acid are available in a food supplement. It has been claimed that they reduce the pain of OA and help rebuild cartilage in patients with early OA.
Methods. A multicentre, randomized, double-blind ascorbic acid controlled study was carried out in patients with osteoarthritis of the knee. The purpose of the study was to evaluate the effectiveness of a food supplement sachet containing glucosamine sulfate (500 mg), chondrotin sulfate (400 mg), hydrolyzed collagen type II and hyaluronic acid mixture (300 mg), L-carnitine fumarate (345 mg). One hundred twenty patients suffering from osteoarthritis of the knee were randomized into 2 groups. Sixty randomized patients in group A received a single sachet daily for 60 days. Sixty randomized patients in group B received a placebo sachet daily containing 1 gram of ascorbic acid. Clinical follow-up was performed at 2, 4, 8, and 12 weeks. The degree of knee pain was assessed using a VAS score. WOMAC score, KOOS scale and Lequesne index were used to assess the knee injury and OA outcome score.
Results. The reduction of VAS score from baseline through week 12 was statistically significant only in group A (P<0.05). WOMAC and KOOS scales showed improvement only in Group A for pain at week 4, for stiffness and difficulty in carrying out normal physical activities at week 8. Also the Lequesne index showed an improvement exclusively in group A, after week 4.
Conclusion. The results show that the combination of substances contained in the food supplement studied can be considered as a response to pain symptoms in patients with mild to moderate osteoarthritis.