Efficacy and safety of intraarticular hylan or hyaluronic acids for osteoarthritis of the knee: a randomized controlled trial.
OBJECTIVE
To compare the efficacy and safety of intraarticular hylan and 2 hyaluronic acids (HAs) in osteoarthritis (OA) of the knee.


METHODS
This was a multicenter, patient-blind, randomized controlled trial in 660 patients with symptomatic knee OA. Patients were randomly assigned to receive 1 cycle of 3 intraarticular injections per knee of 1 of 3 preparations: a high molecular weight cross-linked hylan, a non-cross-linked medium molecular weight HA of avian origin, or a non-cross-linked low molecular weight HA of bacterial origin. The primary outcome measure was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 6 months. Secondary outcome measures included local adverse events (effusions or flares) in injected knees. During months 7-12, patients were offered a second cycle of viscosupplementation.


RESULTS
Pain relief was similar in all 3 groups. The difference in changes between baseline and 6 months between hylan and the combined HAs was 0.1 on the WOMAC pain score (95% confidence interval [95% CI] -0.2, 0.3). No relevant differences were observed in any of the secondary efficacy outcomes, and stratified analyses provided no evidence for differences in effects across different patient groups. There was a trend toward more local adverse events in the hylan group than in the HA groups during the first cycle (difference 2.2% [95% CI -2.4, 6.7]), and this trend became more pronounced during the second cycle (difference 6.4% [95% CI 0.6, 12.2]).


CONCLUSIONS
We found no evidence for a difference in efficacy between hylan and HAs. In view of its higher costs and potential for more local adverse events, we see no rationale for the continued use of hylan in patients with knee OA.
Jüni
Peter
P
University of Berne, Berne, Switzerland. juni@ispm.unibe.ch
Reichenbach
Stephan
S
Trelle
Sven
S
Tschannen
Beatrice
B
Wandel
Simon
S
Jordi
Beat
B
Züllig
Maya
M
Guetg
Reto
R
Häuselmann
Hans Jörg
HJ
Schwarz
Hans
H
Theiler
Robert
R
Ziswiler
Hans Rudolf
HR
Dieppe
Paul A
PA
Villiger
Peter M
PM
Egger
Matthias
M
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D001672:Biocompatible Materials / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy; D011788:Quality of Life; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D001672:Biocompatible Materials; C049816:hylan; D006820:Hyaluronic Acid