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

Allen D. Sawitzke, Helen Shi, Martha F. Finco, Dorothy D. Dunlop, Crystal L. Harris, Nora G. Singer, John D. Bradley, David Silver, Christopher G. Jackson, Nancy E. Lane, Chester V. Oddis, Fred Wolfe, Jeffrey R Lisse, Daniel E. Furst, Clifton O. Bingham, Domenic J. Reda, Roland W. Moskowitz, H. James Williams, Daniel O. Clegg

Research output: Contribution to journalArticle

154 Citations (Scopus)

Abstract

Background: Knee osteoarthritis (OA) is a major cause of pain and functional limitation in older adults, yet longerterm 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.

Original languageEnglish (US)
Pages (from-to)1459-1464
Number of pages6
JournalAnnals of the Rheumatic Diseases
Volume69
Issue number8
DOIs
StatePublished - Aug 2010

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Celecoxib
Chondroitin Sulfates
Knee Osteoarthritis
Glucosamine
Placebos
Safety
Pain
Osteoarthritis
Chondroitin
Therapeutics
Rheumatology
Ontario
Arthritis

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Allergy

Cite this

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. / Sawitzke, Allen D.; Shi, Helen; Finco, Martha F.; Dunlop, Dorothy D.; Harris, Crystal L.; Singer, Nora G.; Bradley, John D.; Silver, David; Jackson, Christopher G.; Lane, Nancy E.; Oddis, Chester V.; Wolfe, Fred; Lisse, Jeffrey R; Furst, Daniel E.; Bingham, Clifton O.; Reda, Domenic J.; Moskowitz, Roland W.; Williams, H. James; Clegg, Daniel O.

In: Annals of the Rheumatic Diseases, Vol. 69, No. 8, 08.2010, p. 1459-1464.

Research output: Contribution to journalArticle

Sawitzke, AD, Shi, H, Finco, MF, Dunlop, DD, Harris, CL, Singer, NG, Bradley, JD, Silver, D, Jackson, CG, Lane, NE, Oddis, CV, Wolfe, F, Lisse, JR, Furst, DE, Bingham, CO, Reda, DJ, Moskowitz, RW, Williams, HJ & Clegg, DO 2010, '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', Annals of the Rheumatic Diseases, vol. 69, no. 8, pp. 1459-1464. https://doi.org/10.1136/ard.2009.120469
Sawitzke, Allen D. ; Shi, Helen ; Finco, Martha F. ; Dunlop, Dorothy D. ; Harris, Crystal L. ; Singer, Nora G. ; Bradley, John D. ; Silver, David ; Jackson, Christopher G. ; Lane, Nancy E. ; Oddis, Chester V. ; Wolfe, Fred ; Lisse, Jeffrey R ; Furst, Daniel E. ; Bingham, Clifton O. ; Reda, Domenic J. ; Moskowitz, Roland W. ; Williams, H. James ; Clegg, Daniel O. / 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. In: Annals of the Rheumatic Diseases. 2010 ; Vol. 69, No. 8. pp. 1459-1464.
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abstract = "Background: Knee osteoarthritis (OA) is a major cause of pain and functional limitation in older adults, yet longerterm 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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T2 - 2-Year results from GAIT

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AU - Shi, Helen

AU - Finco, Martha F.

AU - Dunlop, Dorothy D.

AU - Harris, Crystal L.

AU - Singer, Nora G.

AU - Bradley, John D.

AU - Silver, David

AU - Jackson, Christopher G.

AU - Lane, Nancy E.

AU - Oddis, Chester V.

AU - Wolfe, Fred

AU - Lisse, Jeffrey R

AU - Furst, Daniel E.

AU - Bingham, Clifton O.

AU - Reda, Domenic J.

AU - Moskowitz, Roland W.

AU - Williams, H. James

AU - Clegg, Daniel O.

PY - 2010/8

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N2 - Background: Knee osteoarthritis (OA) is a major cause of pain and functional limitation in older adults, yet longerterm 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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