Efficacy and safety of a single intra-articular injection of 6 ml Hylan G-F 20 compared with placebo in Chinese patients with symptomatic knee osteoarthritis
BMC Musculoskeletal Disorders May 13, 2021
Ke Y, Jiang W, Xu Y, et al. - In this randomized clinical trial among Chinese patients with knee osteoarthritis (OA) , researchers compared intra-articular (IA) administration of single 6 ml Hylan G-F 20 injection vs placebo, to ultimately assess clinical efficacy and safety of single 6 ml Hylan G-F 20 injection. A total of 440 adults with knee OA were administered a single 6 ml Hylan G-F 20 or placebo injection. In both treatment groups, WOMAC (Western Ontario and McMaster Universities) A1 score reduced significantly at 26 weeks post-injection vs baseline. At 26 weeks, there were clinically important decreases in pain in 67.0 and 68.2% in single 6 ml Hylan G-F 20 injection and placebo groups. In terms of safety, both groups had similar treatment-emergent adverse events. Findings showed that in terms of efficacy and safety of the drug, the observed magnitude of the impact of a single 6 ml Hylan G-F 20 injection herein was consistent with previously published literature, however, a strong IA placebo effect was evident in this study and single 6 ml Hylan G-F 20 injection was not established as a superior choice than IA placebo in Chinese knee OA patients.
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