Objectives Assessment of the efficacy, tolerability and aftereffect period on the single administration into Ist carpometacarpal and Ist metatarsophalangeal OA joints of 1.0ml (20mg) of hyaluronic acid (Durolane SJ) as compared with placebo.
Methods The study included 120 pts with OA of small hand joints or feet, pain intensity >40mm by VAS and consisted of two phases: “blind” phase up to 24 weeks, period of open assessment of long term efficacy results – 48 weeks. The efficacy was assessed by 40% pain subsiding, index AUSCAN (for the hand), daily dose of NSAID, total effect assessment by VAS.
Results Both groups were comparable by basic clinical criteria. 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 analyses of pain, stiffness and function by AUSCAN index revealed reliable differences between Durolane SJ and placebo. Adverse effects related to the therapy were not found. Effect, achieved to 24th week of observation included pain, stiffness, functional status, general assessment of condition by the therapist and patient, was preserved without changes to 48th week.
Conclusions High efficacy and 48 weeks considerable duration of aftereffect of single administration of Durolane SJ (small joints) as compared to placebo was demonstrated.
Disclosure of Interest None declared