title: Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis: a multicentre, randomised, double-blind, non-inferiority trial versus celecoxib.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  NCT01425853.
authors.affiliation: University of Maryland School of Medicine, Baltimore, Maryland, USA.
authors.forename: Marc C
authors.initials: MC
authors.lastname: Hochberg
authors.affiliation: Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Montreal, Quebec, Canada.
authors.forename: Johanne
authors.initials: J
authors.lastname: Martel-Pelletier
authors.affiliation: Servei de Reumatologia, Hospital del Mar, Barcelona, Spain IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Monfort
authors.affiliation: Instituto Poal de Reumatología, Barcelona, Spain.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Möller
authors.affiliation: Clinical Pharmacology Unit, Virgen del Rocío University Hospital, Seville, Spain.
authors.forename: Juan Ramón
authors.initials: JR
authors.lastname: Castillo
authors.affiliation: Oxford NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, UK MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK Arthritis Research UK, Centre for Sports, Exercise and Osteoarthritis, University of Oxford, Nuffield Orthopaedic Centre, Oxford, UK.
authors.forename: Nigel
authors.initials: N
authors.lastname: Arden
authors.affiliation: Department of Rheumatology, Sorbonne University, INSERM UMR S938, UPMC, University of Paris 06, DHU i2B, Assistance Publique-Hôpitaux de Paris, Saint-Antoine Hospital, Paris, France.
authors.forename: Francis
authors.initials: F
authors.lastname: Berenbaum
authors.affiliation: INIBIC-Complejo Hospitalario Universitario A Coruña, A Coruña, Spain.
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Blanco
authors.affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & National Institute for Health Research Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK.
authors.forename: Philip G
authors.initials: PG
authors.lastname: Conaghan
authors.affiliation: Asociación Hipótesis Alternativa (H1), Biostatistics Unit, Faculty of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Gema
authors.initials: G
authors.lastname: Doménech
authors.affiliation: Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, Institute of Pathology, CHU Sart-Tilman, Liège, Belgium Physical Therapy and Rehabilitation Department, Princess Paola Hospital, Marche-en-Famenne, Belgium.
authors.forename: Yves
authors.initials: Y
authors.lastname: Henrotin
authors.affiliation: Institute of Experimental Musculoskeletal Medicine, University Hospital Münster, Münster, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pap
authors.affiliation: Université Paris Diderot, UFR Médicale; Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Fédération de Rhumatologie, Paris, France INSERM 1132, Université Paris-Diderot, Hôpital Lariboisière, Paris, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Richette
authors.affiliation: University of Utah School of Medicine, Salt Lake City, Utah, USA.
authors.forename: Allen
authors.initials: A
authors.lastname: Sawitzke
authors.affiliation: Department of Pharmacology, Faculty of Medicine, University of Montreal, Montreal, Quebec, Canada.
authors.forename: Patrick
authors.initials: P
authors.lastname: du Souich
authors.affiliation: Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Montreal, Quebec, Canada.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Pelletier
mesh_terms: D000368:Aged; D000068579:Celecoxib / Q000627:therapeutic use*; D002809:Chondroitin Sulfates / Q000009:adverse effects / Q000627:therapeutic use*; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004487:Edema / Q000209:etiology*; D005260:Female; D005944:Glucosamine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D059352:Musculoskeletal Pain / Q000188:drug therapy / Q000209:etiology; D020370:Osteoarthritis, Knee / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D004338:Drug Combinations; D002809:Chondroitin Sulfates; D000068579:Celecoxib; D005944:Glucosamine
keywords: Analgesics; NSAIDs; Osteoarthritis