Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis: a multicentre, randomised, double-blind, non-inferiority trial versus celecoxib

被引:244
作者
Hochberg, Marc C. [1 ]
Martel-Pelletier, Johanne [2 ]
Monfort, Jordi [3 ,4 ]
Moeller, Ingrid [5 ]
Ramon Castillo, Juan [6 ]
Arden, Nigel [7 ,8 ,9 ]
Berenbaum, Francis [10 ]
Blanco, Francisco J. [11 ]
Conaghan, Philip G. [12 ,13 ]
Domenech, Gema [14 ]
Henrotin, Yves [15 ,16 ]
Pap, Thomas [17 ]
Richette, Pascal [18 ,19 ,20 ]
Sawitzke, Allen [21 ]
du Souich, Patrick [22 ]
Pelletier, Jean-Pierre [2 ]
机构
[1] Univ Maryland, Sch Med, 10 S Pine St,MSTF 8-34, Baltimore, MD 21201 USA
[2] Univ Montreal, Hosp Res Ctr CRCHUM, Osteoarthrit Res Unit, Montreal, PQ, Canada
[3] Hosp del Mar, Serv Reumatol, Barcelona, Spain
[4] IMIM Hosp del Mar Med Res Inst, Barcelona, Spain
[5] Inst Poal Reumatol, Barcelona, Spain
[6] Virgen Rocio Univ Hosp, Clin Pharmacol Unit, Seville, Spain
[7] Univ Oxford, Oxford NIHR Musculoskeletal Biomed Res Unit, Oxford, England
[8] Univ Southampton, MRC Lifecourse Epidemiol Unit, Southampton, Hants, England
[9] Univ Oxford, Ctr Sports Exercise & Osteoarthrit, Nuffield Orthopaed Ctr, Arthrit Res UK, Oxford, England
[10] Univ Paris 06, Dept Rheumatol, Sorbonne Univ, INSERM UMR S938,DHU i2B,AP HP,St Antoine Hosp, Paris, France
[11] INIBIC Complejo Hosp Univ A Coruna, La Coruna, Spain
[12] Univ Leeds, Leeds Inst Rheumat & Musculoskeletal Med, Leeds, W Yorkshire, England
[13] Natl Inst Hlth Res Leeds Musculoskeletal Biomed R, Leeds, W Yorkshire, England
[14] Univ Autonoma Barcelona, Fac Med, Biostat Unit, Asociac Hipotesis Alternat H1, E-08193 Barcelona, Spain
[15] Univ Liege, Bone & Cartilage Res Unit, Arthropole Liege, Inst Pathol,CHU Sart Tilman, Liege, Belgium
[16] Princess Paola Hosp, Phys Therapy & Rehabil Dept, Marche En Famenne, Belgium
[17] Univ Hosp Munster, Inst Expt Musculoskeletal Med, Munster, Germany
[18] Univ Paris Diderot, UFR Med, Paris, France
[19] Federat Rhumatol, AP HP, Hop Lariboisiere, Paris, France
[20] Univ Paris Diderot, INSERM 1132, Hop Lariboisiere, Paris, France
[21] Univ Utah, Sch Med, Salt Lake City, UT USA
[22] Univ Montreal, Fac Med, Dept Pharmacol, Montreal, PQ H3C 3J7, Canada
关键词
NONSTEROIDAL ANTIINFLAMMATORY DRUGS; COMPARING ETORICOXIB; 200; MG; PLACEBO; EFFICACY; MANAGEMENT; METAANALYSIS; SAFETY; COMBINATION; DICLOFENAC;
D O I
10.1136/annrheumdis-2014-206792
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
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.
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页码:37 / 44
页数:8
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