Safety and efficacy of US-approved viscosupplements for XXXX : a systematic review and meta-analysis of randomized, saline-controlled trials.

@entity1 @entity626 @entity571 @entity158
BACKGROUND: Intra-articular injection of hyaluronic acid is a common, yet controversial, therapeutic option for @entity1 with @entity626 ( @entity571 ). The purpose of this research was to determine the safety and efficacy of US-approved viscosupplements for symptomatic knee @entity571 . METHODS: We searched MedLine and EMBase for randomized, sham-controlled trials evaluating safety and/or clinical efficacy of US-approved viscosupplements in @entity1 with symptomatic knee @entity571 . Knee @entity158 severity and knee joint function were assessed at 4 to 13 weeks and 14 to 26 weeks. Safety outcomes included serious adverse events, treatment-related serious adverse events, @entity1 withdrawal, and adverse event-related @entity1 withdrawal occurring at any time during follow-up. RESULTS: A total of 29 studies representing 4,866 unique @entity1 (active: 2,673, control: 2,193) were included. All sham-controlled trials used saline injections as a control. Viscosupplementation resulted in very large treatment effects between 4 and 26 weeks for knee @entity158 and function compared to preinjection values, with standardized mean difference values ranging from 1.07 to 1.37 (all P<0.001). Compared to controls, standardized mean difference with viscosupplementation ranged from 0.38 to 0.43 for knee @entity158 and 0.32 to 0.34 for knee function (all P<0.001). There were no statistically significant differences between viscosupplementation and controls for any safety outcome, with absolute risk differences of 0.7% (95% confidence interval [CI]: -0.2 to 1.5%) for serious adverse events, 0% (95% CI: -0.4 to 0.4%) for treatment-related serious adverse events, 0% (95% CI: -1.6 to 1.6%) for @entity1 withdrawal, and 0.2% (95% CI: -0.4 to 0.8%) for adverse event-related @entity1 withdrawal. CONCLUSION: Intra-articular injection of US-approved viscosupplements is safe and efficacious through 26 weeks in @entity1 with symptomatic knee @entity571 .
