| 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 |