PMID- 17204566
OWN - NLM
STAT- MEDLINE
DCOM- 20070523
LR  - 20181113
IS  - 0003-4967 (Print)
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Linking)
VI  - 66
IP  - 5
DP  - 2007 May
TI  - Effect of chondroitin sulphate in symptomatic knee osteoarthritis: a multicentre, 
      randomised, double-blind, placebo-controlled study.
PG  - 639-45
AB  - 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 analogue 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.
FAU - Mazieres, Bernard
AU  - Mazieres B
AD  - Department of Rheumatology, Rangueil University Hospital1, Avenue Jean-Poulhes, 
      31059 Toulouse Cedex 9, France. mazieres@cict.fr
FAU - Hucher, Michel
AU  - Hucher M
FAU - Zaim, Mohammed
AU  - Zaim M
FAU - Garnero, Patrick
AU  - Garnero P
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20070104
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Biomarkers)
RN  - 0 (Collagen Type I)
RN  - 0 (Collagen Type II)
RN  - 0 (Peptide Fragments)
RN  - 9007-28-7 (Chondroitin Sulfates)
SB  - IM
MH  - Administration, Oral
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Inflammatory Agents/*administration & dosage
MH  - Biomarkers/analysis
MH  - Chondroitin Sulfates/*administration & dosage/adverse effects
MH  - Collagen Type I/blood
MH  - Collagen Type II/urine
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis, Knee/*drug therapy/metabolism
MH  - Pain Measurement/methods
MH  - Peptide Fragments/analysis
MH  - Prospective Studies
MH  - Treatment Outcome
PMC - PMC1954603
COIS- 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.
EDAT- 2007/01/06 09:00
MHDA- 2007/05/24 09:00
PMCR- 2010/05/01
CRDT- 2007/01/06 09:00
PHST- 2007/01/06 09:00 [pubmed]
PHST- 2007/05/24 09:00 [medline]
PHST- 2007/01/06 09:00 [entrez]
PHST- 2010/05/01 00:00 [pmc-release]
AID - ard.2006.059899 [pii]
AID - ar59899 [pii]
AID - 10.1136/ard.2006.059899 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2007 May;66(5):639-45. doi: 10.1136/ard.2006.059899. Epub 2007 Jan 
      4.