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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.