title: Intra-articular injections of sodium hyaluronate (Hyalgan®) in osteoarthritis of the knee. a randomized, controlled, double-blind, multicenter trial in the Asian population.
abstract: BACKGROUND
  The 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.
  
  
  METHODS
  Two 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  Therapeutic study, Level I-1a (randomized controlled trial with a significant difference).
authors: Department of Orthopaedic, National Taiwan University and University Hospital, 7 Chung Shan South Road, Taipei, Taiwan. d95548008@ntu.edu.tw
authors: Teng-Le
authors: TL
authors: Huang
authors: Chi-Ching
authors: CC
authors: Chang
authors: Chian-Her
authors: CH
authors: Lee
authors: Shih-Ching
authors: SC
authors: Chen
authors: Chien-Hung
authors: CH
authors: Lai
authors: Ching-Lin
authors: CL
authors: Tsai
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000627:therapeutic use*; D000368:Aged; D044466:Asian People; D004311:Double-Blind Method; D005080:Exercise Test; D005260:Female; D006304:Health Status; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D010147:Pain Measurement; D020127:Recovery of Function; D013624:Taiwan / Q000453:epidemiology; D016896:Treatment Outcome; D016138:Walking
chemical_list: D000276:Adjuvants, Immunologic; D006820:Hyaluronic Acid