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Clinical efficacy and safety of glucosamine, chondroitin sulphate, their combination, celecoxib or placebo taken to treat osteoarthritis of the knee: 2-year results from GAIT
  1. Allen D Sawitzke1,
  2. Helen Shi2,
  3. Martha F Finco1,
  4. Dorothy D Dunlop3,
  5. Crystal L Harris4,
  6. Nora G Singer5,
  7. John D Bradley6,
  8. David Silver7,
  9. Christopher G Jackson1,
  10. Nancy E Lane8,
  11. Chester V Oddis9,
  12. Fred Wolfe10,
  13. Jeffrey Lisse11,
  14. Daniel E Furst12,
  15. Clifton O Bingham13,
  16. Domenic J Reda2,
  17. Roland W Moskowitz5,
  18. H James Williams1,
  19. Daniel O Clegg1
  1. 1University of Utah School of Medicine, Salt Lake City, Utah, USA
  2. 2Hines VA Cooperative Studies Program Coordinating Center, Hines, Illinois, USA
  3. 3Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA
  4. 4Albuquerque VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico, USA
  5. 5Case Western Reserve University, Cleveland, Ohio, USA
  6. 6Indiana University, Indianapolis, Indiana, USA
  7. 7Cedars Sinai Medical Center, Los Angeles, California, USA
  8. 8University of California at Davis, Sacramento, California, USA
  9. 9University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  10. 10Arthritis Research Center, Wichita, Kansas, USA
  11. 11Univerity of Arizona, Tucson, Arizona, USA
  12. 12University of California at Los Angeles, Los Angeles, California, USA
  13. 13Johns Hopkins University, Baltimore, Maryland, USA
  1. Correspondence to Dr Allen D Sawitzke, University of Utah School of Medicine, 30E 1900 S SOM 4B200, Salt Lake City UT 84132, USA; allen.sawitzke{at}


Background Knee osteoarthritis (OA) is a major cause of pain and functional limitation in older adults, yet longer-term studies of medical treatment of OA are limited.

Objective To evaluate the efficacy and safety of glucosamine and chondroitin sulphate (CS), alone or in combination, as well as celecoxib and placebo on painful knee OA over 2 years.

Methods A 24-month, double-blind, placebo-controlled study, conducted at nine sites in the US ancillary to the Glucosamine/chondroitin Arthritis Intervention Trial, enrolled 662 patients with knee OA who satisfied radiographic criteria (Kellgren/Lawrence grade 2 or 3 changes and baseline joint space width of at least 2 mm). This subset continued to receive their randomised treatment: glucosamine 500 mg three times daily, CS 400 mg three times daily, the combination of glucosamine and CS, celecoxib 200 mg daily, or placebo over 24 months. The primary outcome was a 20% reduction in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain over 24 months. Secondary outcomes included an Outcome Measures in Rheumatology/Osteoarthritis Research Society International response and change from baseline in WOMAC pain and function.

Results Compared with placebo, the odds of achieving a 20% reduction in WOMAC pain were celecoxib: 1.21, glucosamine: 1.16, combination glucosamine/CS: 0.83 and CS alone: 0.69, and were not statistically significant.

Conclusions Over 2 years, no treatment achieved a clinically important difference in WOMAC pain or function as compared with placebo. However, glucosamine and celecoxib showed beneficial but not significant trends. Adverse reactions were similar among treatment groups and serious adverse events were rare for all treatments.

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  • Funding Supported by NIH (National Institute of Arthritis and Musculoskeletal and Skin Diseases and National Center for Complementary and Alternative Medicine, contract N01-AR-2236.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the University of Utah and each participating centre.

  • Provenance and peer review Not commissioned; externally peer reviewed.