Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis: a multicentre, randomised, double blind, non inferiority trial versus celecoxib
Objectives To compare the efficacy and safety of chondroitin sulfate plus glucosamine hydrochloride (CS+GH) versus celecoxib in patients with knee osteoarthritis and severe pain. Methods Double blind Multicentre Osteoarthritis interVEntion trial with SYSADOA (MOVES) conducted in France, Germany, Poland and Spain evaluating treatment with CS+GH versus celecoxib in 606 patients with Kellgren and Lawrence grades 2 3 knee osteoarthritis and moderate to severe pain (Western Ontario and McMaster osteoarthritis index (WOMAC) score =301; 0 500 scale) Patients were randomised to receive 400 mg CS plus 500 mg GH three times a day or 200 mg celecoxib every day for 6 months. The primary outcome was the mean decrease in WOMAC pain from baseline to 6 months. Secondary outcomes included WOMAC function and stiffness, visual analogue scale for pain, presence of joint swelling/effusion, rescue medication consumption, Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT OARSI) criteria and EuroQoL 5D. Results The adjusted mean change (95% CI) in WOMAC pain was 185.7 200.3 to 171.1) (50.1% decrease) with CS+GH and 186.8 201.7 to 171.9) (50.2% decrease) with celecoxib, meeting the non inferiority margin of 40: 1.11 22.0 to 19.8; p=0.92) All sensitivity analyses were consistent with that result. At 6 months, 79.7% of patients in the combination group and 79.2% in the celecoxib group fulfilled OMERACT OARSI criteria. Both groups elicited a reduction >50% in the presence of joint swelling; a similar reduction was seen for effusion. No differences were observed for the other secondary outcomes. Adverse events were low and similarly distributed between groups. Conclusions CS+GH has comparable efficacy to celecoxib in reducing pain, stiffness, functional limitation and joint swelling/effusion after 6 months in patients with painful knee osteoarthritis, with a good safety profile. Trial registration number: NCT01425853.
Annals of the rheumatic diseases