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Effect of chondroitin sulphate in symptomatic knee osteoarthritis: a multicentre, randomised, double-blind, placebo-controlled study
  1. Bernard Mazières1,
  2. Michel Hucher2,
  3. Mohammed Zaïm2,
  4. Patrick Garnero3
  1. 1Paul Sabatier University, Toulouse-3 and Department of Rheumatology, Rangueil University Hospital, Toulouse, France
  2. 2Institut de Recherche Pierre Fabre; Ramonville Saint-Agne, France
  3. 3INSERM research Unit 664, Lyon, France
  1. Correspondence to:
    Professor B Mazières
    Department of Rheumatology, Rangueil University Hospital1, Avenue Jean-Poulhes, 31059 Toulouse Cedex 9, France; mazieres{at}cict.fr

Abstract

Objective: To evaluate the efficacy and tolerability of chondroitin sulphate (chondroitin sulphate) in knee osteoarthritis.

Patients and methods: A 24-week, randomised placebo-controlled trial of chondroitin sulphate (1 g/day) in patients with symptomatic knee osteoarthritis as measured on a visual analgue scale. Pain on daily activities and Lequesne’s Index were the primary efficacy criteria. Secondary outcomes included the rate of responders according to the outcome measures in rheumatoid arthritis clinical trials of the Osteoarthritis Research Society International (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 in the study. 28 (9%) patients discontinued the study because of lack of efficacy or AEs. At the end of treatment, the decrease in pain was −26.2 (24.9) and −19.9 (23.5) mm and improved function was −2.4 (3.4) (−25%) and −1.7 (3.3) (−17%) in the chondroitin sulphate and placebo groups, respectively (p = 0.029 and 0.109). The OMERACT-OARSI responder rate was 68% in the chondroitin sulphate and 56% in the placebo group (p = 0.03). The investigator’s assessments and short form 12 (SF-12) physical component reported improvement more frequently in the chondroitin sulphate 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 to be satisfactory.

Conclusion: This study failed to show an efficacy of chondroitin sulphate on the two primary criteria considered together, although chondroitin sulphate was slightly more effective than placebo on pain, OMERACT-OARSI response rate, investigator’s assessment and quality of life.

  • AE, adverse event
  • ATP, according to protocol
  • CTX-II, crosslinked C-telopeptide of type II collagen
  • CRP, case report form
  • CVs, coefficients of variation
  • ITT, intention to treat
  • JSN, joint space narrowing
  • LOCF, latest observation carried forward
  • NSAID, non-steroidal anti-inflammatory drug
  • OA, osteoarthritis
  • OARSI, Osteoarthritis Research Society International
  • OMERACT, outcome measures in rheumatoid arthritis clinical trials
  • S-CTX-I, serum crosslinked C-telopeptide of type I collagen
  • SF-12, short form 12
  • SYSADOA, symptomatic slow-acting drugs for treating osteoarthritis
  • U-CTX-I, urinary crosslinked C-telopeptide of type I collagen
  • VAS, visual analogue scale

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Footnotes

  • Published Online First 4 January 2007

  • Funding: This trial was funded by the Pierre Fabre Company. The sponsor and its employees, who are co-authors, played no role in the study design, or the analysis or interpretation of the data. MZ was in charge of data collection, and study centre monitoring was performed by a CRO under his supervision. MH, as a statistician, carried out the analyses especially those on the biomarkers under the supervision of PG. All the authors had full access to the database, and BM and PG had access to all the analyses they had requested. MZ and MH accept the submission of the paper for publication as it was written by BM and corrected by PG.

  • Competing interests: BM was reimbursed by the Pierre Fabre Company for attending the Boston OARSI meeting where the trial was first presented as a poster. MZ and MH are employees of Pierre Fabre. PG was funded to perform the biochemical analyses.

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