| |
Change from baseline
|
Repeated measures two-way ANOVA
|
|---|
|
Week 4
|
Week 8
|
Week 12
|
Group
|
Time
|
Interaction
|
|---|
|
Mean
|
SD
|
Mean
|
SD
|
Mean
|
SD
|
|---|
|
Physical functioning (PF)
|
|
Placebo
|
1.00
|
7.18
|
0.38
|
7.20
|
0.25
|
6.20
|
0.768
|
0.081
|
0.343
|
|
CLE
|
0.77
|
5.91
|
1.71
|
5.61
|
0.64
|
7.18
|
|
Role physical (RP)
|
|
Placebo
|
1.25
|
10.60
|
0.78
|
12.10
|
1.87
|
8.27
|
0.719
|
0.158
|
0.538
|
|
CLE
|
−0.65
|
12.40
|
0.16
|
9.36
|
2.24
|
10.08
|
|
Bodily pain (BP)
|
|
Placebo
|
−0.8
|
14.0
|
−2.0
|
14.3
|
−2.1
|
11.4
|
0.544
|
0.612
|
0.999
|
|
CLE
|
−2.4
|
14.9
|
−3.1
|
13.9
|
−3.7
|
15.6
|
|
General health (GH)
|
|
Placebo
|
−0.30
|
10.99
|
0.18
|
13.35
|
0.63
|
11.71
|
0.121
|
0.881
|
0.884
|
|
CLE
|
−3.08
|
9.73
|
−3.58
|
10.91
|
−3.05
|
12.80
|
|
Vitality (VT)
|
|
Placebo
|
−2.51
|
14.36
|
−0.94
|
11.88
|
1.71
|
10.49
|
0.692
|
0.040
|
0.734
|
|
CLE
|
−2.56
|
13.28
|
−1.32
|
11.99
|
−0.32
|
11.99
|
|
Social functioning (SF)
|
|
Placebo
|
−0.94
|
13.69
|
0.31
|
14.57
|
−0.63
|
13.56
|
0.438
|
0.221
|
0.749
|
|
CLE
|
0.32
|
18.02
|
3.95
|
14.85
|
1.92
|
12.35
|
|
Role emotional (RE)
|
|
Placebo
|
0.63
|
11.99
|
0.84
|
12.20
|
1.04
|
12.27
|
0.924
|
0.648
|
0.850
|
|
CLE
|
−0.21
|
13.04
|
0.88
|
11.76
|
1.49
|
11.78
|
|
Mental health (MH)
|
|
Placebo
|
−3.63
|
10.50
|
−3.38
|
11.29
|
−1.75
|
9.37
|
0.032
|
0.127
|
0.416
|
|
CLE
|
−0.90
|
9.86
|
2.89*
|
10.24
|
1.92
|
10.68
|
|
Physical component summary (PCS)
|
|
Placebo
|
1.22
|
4.85
|
0.77
|
4.66
|
0.54
|
3.67
|
0.574
|
0.836
|
0.491
|
|
CLE
|
0.23
|
4.97
|
0.28
|
4.02
|
0.52
|
4.63
|
|
Mental component summary (MCS)
|
|
Placebo
|
−1.76
|
5.10
|
−1.18
|
5.33
|
−0.38
|
4.39
|
0.618
|
0.144
|
0.766
|
|
CLE
|
−1.21
|
5.72
|
−0.10
|
4.55
|
−0.37
|
5.24
|
- aValues represent the means and standard deviations for n = 40 (placebo group) or n = 39 (CLE group). *p < 0.05: Significant difference from the placebo group by repeated measures two-way ANOVA, followed by the two-tailed unpaired Student’s t test when variance was homogeneous or the Aspin-Welch t test when variance was heterogeneous
