To study clinical effectiveness, safety and duration of the effect of combined medication ARTRA (500 mg glucosamine hydrochloride+500 mg chondroitine sulphate) in osteoarthrosis.
Ninety women aged 40-75 suffering from knee OA and satisfying diagnostic criteria for OA of American Rheumatological Committee having x-ray II-III stages according to Kellgren-Lawrence; with distinct pain syndrome (pain intensity at walking 40 mm and more by the analogue visual scale); taking NSAIDS regularly during 30 days within 3 months before the study were enrolled in the study. The patients were randomly divided into 2 groups: 45 patients of the study group taking 1 tablet ARTRA 2 times a day within the first month, than 1 tablet a day within the following 5 months and diclofenac sodium 50 mg 2 times a day with gradual decrease of the dosage as the pain was decreasing; 45 patients of the control group taking only diclofenac sodium 50 mg twice a day during 6 months. Clinical examination of the patients was done before the treatment, 30, 120 and 180 days after the study. Long-term effects of ARTRA was evaluated 3 months after the study. The treatment efficacy was assessed by WOMAC index, daily need in NSAIDS intake, evaluation of the efficacy by the patient and the doctor.
The true WOMAC index decreased in 4 and 6 months of therapy in the study group (p < 0.03). 3 months after the treatment the study group patients experienced continuous reduction of the functional index and pain intensity unlike of the control patients experiencing a pain increase and worsening of joints functional ability. When analysing pain syndrome according to VAS, after 4 months of the treatment pain was relieved more in the study group (p = 0.008). The differences were stable for 6 months. On aftertreatment month 3 pain syndrome tended to attenuation in the study group but to intensification in the controls. While taking ARTRA, the patients decreased their need in NSAIDS intake (diclofenac). After 1 month of therapy 4.5% patients gave up taking diclofenac; after 4--20%, after 6--40%. Objective and subjective effects did not differ much (94 and 90%, respectively). ARTRA tolerability was very good. None of the patients of the study group discontinued therapy because of side effects, in the control group 14 patients gave up diclofenac because of the adverse effects.
Combined ARTRA medication decreases pain, improves joint function. Regular intake of ARTRA helps decrease NSAIDS dosage or discontinue intake in many cases. ARTRA is very well tolerated and is safe. ARTRA has an evident long lasting effect.