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Table 2 Results in outcome variables at entry and at 12 and 24 weeks

From: A multicenter, double-blind, randomized, controlled phase III clinical trial of chicken type II collagen in rheumatoid arthritis

Outcome variables CCII Pvaluea MTX Pvaluea Pvalueb
Pain (VAS)      
   Entry 6.02 ± 1.43   5.91 ± 1.76   >0.05
   12 weeks 4.59 ± 2.22 <0.01 4.09 ± 1.99 <0.01 >0.05
   24 weeks 3.58 ± 2.55 <0.01 3.38 ± 2.35 <0.01 <0.05
Morning stiffness, minutes      
   Entry 99.26 ± 25.14   104.89 ± 26.42   >0.05
   12 weeks 62.66 ± 25.06 <0.01 45.83 ± 21.28 <0.01 <0.01
   24 weeks 36.12 ± 17.21 <0.01 33.98 ± 12.59 <0.01 >0.05
Tender joint count      
   Entry 13.34 ± 6.43   14.09 ± 6.82   >0.05
   12 weeks 9.14 ± 6.67 <0.01 8.78 ± 6.01 <0.01 >0.05
   24 weeks 6.34 ± 4.81 <0.01 7.22 ± 6.91 <0.01 >0.05
Swollen joint count      
   Entry 10.38 ± 6.63   10.57 ± 7.25   >0.05
   12 weeks 6.89 ± 5.46 <0.01 5.63 ± 4.97 <0.01 <0.01
   24 weeks 4.26 ± 2.03 <0.01 4.38 ± 2.94 <0.01 >0.05
HAQ      
   Entry 0.82 ± 0.56   0.86 ± 0.55   >0.05
   12 weeks 0.65 ± 0.41 <0.01 0.51 ± 0.42 <0.01 <0.01
   24 weeks 0.43 ± 0.27 <0.01 0.44 ± 0.21 <0.01 <0.05
Physician's assessment (VAS)      
   Entry 5.83 ± 1.54   5.78 ± 1.26   >0.05
   12 weeks 4.68 ± 2.09 <0.01 4.03 ± 2.06 <0.01 <0.01
   24 weeks 3.81 ± 1.52 <0.01 3.53 ± 1.64 <0.01 >0.05
Patient's assessment (VAS)      
   Entry 6.01 ± 1.51   6.06 ± 1.71   >0.05
   12 weeks 4.86 ± 2.01 <0.01 4.31 ± 2.06 <0.01 <0.01
   24 weeks 3.92 ± 2.45 <0.01 3.71 ± 2.04 <0.01 <0.05
ESRc, mm/hour      
   Entry 38.18 ± 17.58   42.51 ± 19.37   >0.05
   12 weeks 38.03 ± 14.17 >0.05 35.84 ± 13.24 <0.01 <0.01
   24 weeks 37.53 ± 10.22 >0.05 34.21 ± 15.25 <0.01 <0.01
C-reactive protein, mg/L      
   Entry 17.52 ± 8.27   23.24 ± 9.81   >0.05
   12 weeks 17.27 ± 15.14 >0.05 16.01 ± 13.41 <0.01 <0.05
   24 weeks 15.56 ± 12.38 >0.05 15.08 ± 12.25 <0.01 <0.05
Rheumatoid factor, U/mL      
   Entry 203.65 ± 61.95   198.99 ± 21.31   >0.05
   24 weeks 150.21 ± 16.18 >0.05 123.35 ± 11.32 >0.05 >0.05
  1. In both groups, there were decreases in pain, morning stiffness, tender joint count, swollen joint count, health assessment questionnaire (HAQ), and global assessment of efficacy by investigator and patient. Within-group differences (study entry versus 12 and 24 weeks) were statistically significant. In the methotrexate (MTX) group, erythrocyte sedimentation rate (ESR) and C-reactive protein decreased, but changes in the two variables in the chicken type II collagen (CCII) group were not significant. Rheumatoid factor was not significantly affected by either drug therapy. VAS, visual analogue scale. P valuea, entry versus 12 or 24 weeks in CCII group or MTX group; P valueb, CCII group versus MTX group;cESR, erythrocyte sedimentation rate.