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

The efficacy and safety of sodium hyaluronate injection (Adant^®) in treating degenerative osteoarthritis

Article specifications

This clinical trial was published in 2016 in International Journal of Rheumatic Diseases (IF2016: 2.62) by Chinese orthopedics.  The aim of this study is to compare the efficacy and safety of two different sodium hyaluronate drugs in treating degenerative osteoarthritis (OA) of the knee. This randomized, multi-center, double-blind, positive-drug, parallel-controlled study included 229 patients over 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 Adant^® a 2.5 mL sodium hyaluronate injection containing 25 mg of sodium hyaluronate which is manufactured by fermentation, or the control drug Artz^® a 2.5 mL sodium hyaluronate injection containing 25 mg of sodium hyaluronate 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 results of this study showed 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.