The efficacy and safety of sodium hyaluronate injection (Adant®) in treating degenerative osteoarthritis: a multi-center, randomized, double-blind, positive-drug parallel-controlled and non-inferiority clinical study

Abstract

Objective: To compare the efficacy and safety of two different sodium hyaluronate drugs in treating degenerative osteoarthritis (OA) of the knee.

Method: This randomized, multi-center, double-blind, positive-drug, parallel-controlled study included 229 patients aged ≥ 45 years who were clinically diagnosed with degenerative OA of the knee. The patients were randomly assigned to receive for 5 consecutive weeks a once-weekly intra-articular injection of the investigational drug Adant®, which is manufactured by fermentation, or the control drug Artz®, which is manufactured by extraction of cockscomb. The follow-up examinations were conducted 1, 2, 3, 4 and 6 weeks after the first injection. The primary efficacy parameter was the decrease in the visual analog scale (VAS) scores of pain on movement caused by load-bearing, and the secondary efficacy parameter was the decrease in the Lequesne index.

Results: The intra-articular injections of Adant® and Artz® produced a significant reduction in the VAS scores for pain on movement (50.4 and 50.3 mm, respectively) and in the Lequesne index. There were no significant differences in efficacy and safety between the two drugs and non-inferiority in VAS score decreases was confirmed.

Conclusion: The results of this study show that both Adant® and Artz® are effective for the treatment of OA and that there were no statistical differences between them in the VAS scores of pain on movement, Lequesne index or safety during the observation period with short-time follow up.

Keywords: multi-center randomized controlled clinical study; osteoarthritis; sodium hyaluronate.