[Results of the multicenter clinical trial of structum preparation in Russia].

AIM:

To study clinical effectiveness and tolerance of structum in patients with osteoarthrosis (OA) of the knee joints (KJ) and hip joints (HJ) in a multicenter open randomised trial.

MATERIAL AND METHODS:

A 6-month trial of effectiveness and tolerance of structum has been performed in 9 medical centers and included outpatients (males and females) with KJ OA or HJ OA satisfying the OA diagnostic criteria of the American Rheumatology College, having x-ray stage I-III according to Kellgren-Lawrence with manifest pain, a total functional Leken index from 4 to 11, regular intake of non-steroid antiinflammatory drugs (NAID) for 30 days in the last 3 months. Consent was obtained from each patient. 192 patients received structum, 363 matched patients served control. Structum was given per os for 3 weeks in a dose of 1.5 g/day then in a dose 1.0 g/day up to 6 months. The patients continued on NAID. The patients' examination was performed in the beginning of the study, at its months 3 and 6.

RESULTS:

Leken index in HJ and KJ OA significantly fell after 3 months of structum treatment. Up to month 6 it fell still further (p < 0.05). After 6 months of treatment pain syndrome relieved both at rest and movement, pain at rest disappeared fully in 57% of NJ OA patients and 46% of HJ OA patients, for movement pain it was 17 and 13%, respectively. During the treatment NAID intake was less required in both groups (p < 0.05) while 55% of patients in both groups could discontinue NAID after 6 months of the treatment. Tolerance of the drug was rather good, side effects were mild.

CONCLUSION:

Structum (chondroitin sulphate) is an effective drug for treatment of KJ and HJ OA.: it relieves pain, preserves and improves articular function, allows to reduce or discontinue NAID, is well tolerated.