Background Osteoarthritis (OA) is the most prevalent chronic articular disease, aggravating with age. OA is combined with such condition as IHD, arterial hypertension, diabetes mellitus, insult, osteoporosis and malignant neoplasm, which leads to difficulties in choosing adequate symptomatic therapy.
Objectives Assessment of the efficacy, tolerability and period of aftereffect of the single administration into Ist carpometacarpal and Ist metatarsophalangeal joints of 1.0 ml (20mg) of hyaluronic acid, produced by NASHA technology (Durolane®) as compared with placebo.
Methods The study included 120 pts (60 pts in experimental and control groups) of both sex older than 40 with OA of small hand joints or feet, pain intensity ?40 mm by VAS. The study consisted of two phases: “blind” phase up to 24 weeks, period of assessment of long term efficacy results – 48 weeks. The efficacy was assessed by 40% pain subsiding in analyzed joint, index dynamics AUSCAN (for the hand) daily dose of NSAID, total assessment of the effect separately by patient and therapist by VAS (mm).
Results Both groups were comparable by basic clinical criteria. Average age of pts was 64.3 yrs (42-82), duration of OA of small joints – 5.0 yrs (3.0-10.0) and term of aggravation – 7.4 weeks. Experimental and control groups demonstrated prevailing of AH (61.7% and 58.3%), chronic gastritis (20% and 17%), diabetes mellitus (7% and 12%). 40% pain subsiding by VAS (mm) was noted in experimental group to 24th week in 79.7%, in the placebo group – 30% (chi-square: p<10-5), relation of chances (OR) equal to 9.1 (3.9-21.1). Dispersion analysis (ANOVA for repeated measures) of pain, stiffness and function of AUSCAN index revealed reliable differences between Durolane and placebo, Reliable differences (p<0.0001) according to assessment of general condition by the therapist and patient were found out in experimental group from the 4th week and were stable till 24th week. Adverse effects related to the therapy were not found. NSAID dose was decreased in 45.7% in experimental group and in 30% in placebo group.
Conclusions High efficacy and considerable duration of aftereffect after single administration of Durolane SJ (small joints) as compared with placebo was demonstrated. After follow-up phase (48 weeks) additional data on long term effects will be reported.
Disclosure of Interest None declared