Table 2.
Outcomes of the per-protocol and modified intention-to-treat analyses.
| Characteristics | Effect estimate (95% CI) | P value | |
| Per-protocol (n=152) | |||
|
|
ACTa at 8 weeksb | 1.91 (0.31 to 3.51) | .02 |
|
|
Remission at 8 weeksc | 1.47 (0.75 to 2.90) | .26 |
|
|
ACT repeated measures (2, 4, 6, and 8 weeks)b | 1.34 (0.15 to 2.53) | .03 |
|
|
Remission repeated measures (2, 4, 6, and 8 weeks)c | 1.67 (0.62 to 4.52) | .31 |
|
|
SF-12d physical component score at 8 weeksb | 0.81 (–1.49 to 3.10) | .49 |
|
|
SF-12 mental component score at 8 weeksb | 0.84 (–1.97 to 3.65) | .56 |
|
|
SF-12 physical component score repeated measures (4 and 8 weeks)b | 0.611 (–1.32 to 2.54) | .53 |
|
|
SF-12 mental component score repeated measures (4 and 8 weeks)b | 0.91 (–1.21 to 3.03) | .40 |
|
|
MCIDe at 8 weeksc | 2.38 (1.20 to 4.70) | .01 |
|
|
Worse at 8 weeksc | 0.55 (0.23 to 1.32) | .18 |
| ITTf, multiple imputation for missing outcomes (n=262) | |||
|
|
ACT at 8 weeksb | 1.56 (0.32 to 2.79) | .01 |
|
|
Remission at 8 weeksc | 1.45 (0.80 to 2.63) | .22 |
|
|
ACT repeated measures (2, 4, 6, and 8 weeks)b | 1.23 (0.33 to 2.12) | .007 |
|
|
Remission repeated measures (2, 4, 6, and 8 weeks)c | 1.40 (0.85 to 2.32) | .19 |
|
|
SF-12 physical component score at 8 weeksb | 0.58 (–1.45 to 2.60) | .58 |
|
|
SF-12 mental component score at 8 weeksb | 0.73 (–1.75 to 3.22) | .56 |
|
|
SF-12 physical component score repeated measures (4 and 8 weeks)b | 0.75 (–1.15 to 2.64) | .44 |
|
|
SF-12 mental component score repeated measures (4 and 8 weeks)b | 0.23 (–1.93 to 2.40) | .83 |
|
|
MCID at 8 weeksc | 2.17 (1.25 to 3.78) | .006 |
|
|
Worse at 8 weeksc | 0.76 (0.39 to 1.56) | .45 |
| ITT, last observation carried forward for missing outcomes (N=262) | |||
|
|
ACT at 8 weeksb | 1.17 (0.02 to 2.31) | .046 |
|
|
Remission at 8 weeksc | 0.92 (0.53 to 1.57) | .75 |
|
|
ACT repeated measures (2, 4, 6, and 8 weeks)b | 1.03 (0.12 to 1.93) | .03 |
|
|
Remission repeated measures (2, 4, 6, and 8 weeks)c | 0.88 (0.41 to 1.93) | .76 |
|
|
SF-12 physical component score at 8 weeksb | 0.17 (–1.67 to 2.02) | .85 |
|
|
SF-12 mental component score at 8 weeksb | 0.61 (–1.63 to 2.85) | .59 |
|
|
SF-12 physical component score repeated measures (4 and 8 weeks)b | –0.13 (–2.21 to 1.95) | .90 |
|
|
SF-12 mental component score repeated measures (4 and 8 weeks)b | 0.76 (–1.69 to 3.21) | .54 |
|
|
MCID at 8 weeksc | 1.95 (1.17 to 3.24) | .01 |
|
|
Worse at 8 weeksc | 0.65 (0.35 to 1.21) | .17 |
aACT: Asthma Control Test.
b coefficient.
cOdds ratio.
dSF-12: 12-Item Short Form Health Survey.
eMCID: minimal clinically important difference.
fITT: intention-to-treat.