Intra-articular injections of sodium hyaluronate (Hyalgan®) in osteoarthritis of the knee. a randomized, controlled, double-blind, multicenter trial in the asian population

Abstract

BackgroundThe efficacy and tolerability of 500-730 kDa sodium hyaluronate (Hyalgan®) for treatment of osteoarthritis (OA) pain has been established in clinical trials, but few data are available in the Asian population. We conducted a randomized, double-blind, multicenter, placebo-controlled study to evaluate the efficacy and tolerability of this preparation in a Taiwanese population.MethodsTwo hundred patients with mild to moderate OA of the knee were randomized to receive five weekly intra-articular injections of sodium hyaluronate or placebo. The primary efficacy outcome was the change from baseline to Week 25 in patients' evaluation of pain using a 100-mm visual analog scale (VAS) during the 50-foot walking test. Additional outcomes included Western Ontario and McMaster Universities (WOMAC) scores, time on the 50-foot walking test, patient's and investigator's subjective assessment of effectiveness, acetaminophen consumption, and the amounts of synovial fluid.ResultsThe Hyalgan® treatment group showed a significantly greater improvement from baseline to Week 25 in VAS pain on the 50-foot walking test than the placebo group (p = 0.0020). The Hyalgan® group revealed significant improvements from baseline to week 25 in WOMAC pain and function score than the placebo group (p = 0.005 and 0.0038, respectively) Other outcomes, such as time on the 50-foot walking test and subjective assessment of effectiveness, did not show any significant difference between groups. Both groups were safe and well tolerated.ConclusionsThe present study suggests that five weekly intra-articular injections of sodium hyaluronate are well tolerated, can provide sustained relief of pain, and can improve function in Asian patients with osteoarthritis of the knee.Level of EvidenceTherapeutic study, Level I-1a (randomized controlled trial with a significant difference).Trial registrationClinicalTrials.gov Identifier: NCT01319461

AMSSM scientific statement concerning viscosupplementation injections for knee osteoarthritis: importance for individual patient outcomes

“…Our results suggest that maximal benefit occurs at different times following injection with HA and IAS. These results are consistent with prior systematic reviews27 59 60 that found superiority of IAS injection over HA injection from 0 to 4 weeks after administration but that also found that HA injection was superior to IAS from 4 to 26 weeks. In this regard, each injectable medication may have a different role in treating those with knee OA.…”

The impact of ethnicity and cardiovascular risk on the pharmacologic management of osteoarthritis: a US perspective

“…Consequently, the 8% capsaicin patch is applied under medical supervision after a topical anesthetic has been applied [73]. Intra-articular injections of hyaluronan or corticosteroids have also demonstrated efficacy for treating OA without causing significant safety concerns [74,75]. Injections of DOI: 10.1080DOI: 10.…”

Intra-articular Injections for Management of Knee Osteoarthritis

“…Huang et al found 5 weekly doses of HA improved knee pain and functional status of the affected joint for up to 25 weeks after finishing the treatment course [24], while Foti et al added there are also significant improvements in range of motion and quality of life [25]. Bannuru et al investigated the time course of HA action and found it reached peak efficacy at 4 weeks post-injection and continued to confer benefit for up to 24 weeks duration [26].…”