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Dr. Herrero-Beaumont has received speaking fees (less than $10,000) from Rottapharm.
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Research Article
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Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: A randomized, double-blind, placebo-controlled study using acetaminophen as a side comparator†
Article first published online: 30 JAN 2007
DOI: 10.1002/art.22371
Copyright © 2007 by the American College of Rheumatology
Additional Information
How to Cite
Herrero-Beaumont, G., Ivorra, J. A. R., del Carmen Trabado, M., Blanco, F. J., Benito, P., Martín-Mola, E., Paulino, J., Marenco, J. L., Porto, A., Laffon, A., Araújo, D., Figueroa, M. and Branco, J. (2007), Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: A randomized, double-blind, placebo-controlled study using acetaminophen as a side comparator. Arthritis & Rheumatism, 56: 555–567. doi: 10.1002/art.22371
- †
ClinicalTrials.gov identifier: NCT00110474.
Publication History
- Issue published online: 30 JAN 2007
- Article first published online: 30 JAN 2007
- Manuscript Accepted: 23 OCT 2006
- Manuscript Received: 16 MAY 2006
Funded by
- Rottapharm
- Abstract
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Abstract
Objective
To assess the effects of the prescription formulation of glucosamine sulfate (1,500 mg administered once daily) on the symptoms of knee osteoarthritis (OA) during a 6-month treatment course.
Methods
Three hundred eighteen patients were enrolled in this randomized, placebo-controlled, double-blind trial in which acetaminophen, the currently preferred medication for symptomatic treatment of OA, was used as a side comparator. Patients were randomly assigned to receive oral glucosamine sulfate 1,500 mg once daily (n = 106), acetaminophen 3 gm/day (n = 108), or placebo (n = 104). The primary efficacy outcome measure was the change in the Lequesne index after 6 months. Secondary parameters included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and response according to the Osteoarthritis Research Society International criteria. These outcome measures were assessed using an intent-to-treat analysis.
Results
At baseline, the study patients had moderately severe OA symptoms (mean Lequesne index ∼11 points). Glucosamine sulfate was more effective than placebo in improving the Lequesne score, with a final decrease of 3.1 points, versus 1.9 with placebo (difference between glucosamine sulfate and placebo −1.2 [95% confidence interval −2.3, −0.8]) (P = 0.032). The 2.7-point decrease with acetaminophen was not significantly different from that with placebo (difference −0.8 [95% confidence interval −1.9, 0.3]) (P = 0.18). Similar results were observed for the WOMAC. There were more responders to glucosamine sulfate (39.6%) and acetaminophen (33.3%) than to placebo (21.2%) (P = 0.004 and P = 0.047, respectively, versus placebo). Safety was good, and was comparable among groups.
Conclusion
The findings of this study indicate that glucosamine sulfate at the oral once-daily dosage of 1,500 mg is more effective than placebo in treating knee OA symptoms. Although acetaminophen also had a higher responder rate compared with placebo, it failed to show significant effects on the algofunctional indexes.