RESEARCH - Effect of chondroitin sulfate in symptomatic knee OA

January 6, 2007

Ann Rheum Dis. Published Online First: 4 January 2007

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Extended Report

Effect of chondroitin sulfate in symptomatic knee osteoarthritis: A

multicenter, randomized, double blind, placebo-controlled study

Abstract

Objectives: To evaluate the efficacy and tolerability of chondroitin sulfate

(CS) in knee osteoarthritis.

Patients and methods: A 24-week, randomized placebo controlled trial of CS

(1 g/day) was performed on patients with symptomatic knee osteoarthritis.

Pain on daily activities and Lequesne's index were the primary efficacy

criteria. Secondary outcomes include the rate of responders according to the

OMERACT-OARSI criteria, quality of life, patient's/physician's global

assessments and carry-over effect after treatment. Biochemical markers of

bone (CTX-I), cartilage (CTX-II) and synovium (hyaluronic acid) metabolism

were also measured. Safety was assessed by recording adverse events (AEs).

Statistical analysis was performed on the inter-group differences in the

intention-to-treat population.

Results: 307 patients were included. Twenty-eight (9%) discontinued the

study for lack of efficacy or AEs. At the end of treatment, decrease of pain

was -26.2±24.9 mm and -19.9±23.5 mm and improved function was -2.4±3.4

(-25%) and -1.7±3.3 (-17%) in the CS and placebo groups, respectively

(P=0.029 and 0.109). The OMERACT-OARSI responder rate was 68% in the CS and

56% in the placebo group (P=0.03). Investigator's assessments and SF-12

physical component reported improvement more frequently in the CS than in

the placebo group (P=0.044 and 0.021 respectively). No significant

difference was observed between treatment groups for changes in biomarkers

over 24 weeks. However, there was a significant difference between

non-responders and responders according to the OARSI criteria for 24 week

changes of CTX-I (P=0.018) and CTX-II (P=0.014). Tolerance was considered as

satisfactory.

Conclusion: This study failed to demonstrate an efficacy of CS on the two

primary criteria considered together, although CS was slightly more

effective than placebo on pain, OMERACT-OARSI response rate, investigator's

assessment and quality of life.

Not an MD

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