|
Assessment
|
Baseline mean score ± SD
|
Final assessment LS mean score ± SE
|
Placebo-adjusted LS mean change from baseline with pregabalina
|
|---|
| |
Placebo
|
Pregabalin
|
Placebo
|
Pregabalin
|
Change
|
95% CI
|
P-value
|
|---|
|
FIQ scoreb
| | | | | | | |
|
Morning tiredness
|
6.6 ± 2.1
|
6.8 ± 2.2
|
5.73 ± 0.15
|
5.13 ± 0.15
|
-0.59
|
-1.01, -0.18
|
0.0023*
|
|
Feeling good
|
6.7 ± 2.6
|
6.8 ± 2.6
|
5.94 ± 0.17
|
5.30 ± 0.17
|
-0.63
|
-1.12, -0.15
|
0.0052*
|
|
Fatigue
|
6.8 ± 1.9
|
7.0 ± 1.9
|
5.94 ± 0.14
|
5.45 ± 0.14
|
-0.49
|
-0.89, -0.10
|
0.0075*
|
|
Pain
|
6.4 ± 1.6
|
6.5 ± 1.6
|
5.36 ± 0.15
|
4.95 ± 0.15
|
-0.41
|
-0.81, 0.00
|
0.0238*
|
|
Physical functioning
|
3.2 ± 2.3
|
3.3 ± 2.4
|
3.03 ± 0.11
|
2.74 ± 0.11
|
-0.28
|
-0.59, 0.03
|
0.0376
|
|
Housework
|
5.5 ± 2.4
|
5.7 ± 2.5
|
4.61 ± 0.15
|
4.30 ± 0.15
|
-0.31
|
-0.74, 0.11
|
0.0729
|
|
Anxiety
|
4.5 ± 2.6
|
4.6 ± 2.6
|
3.92 ± 0.16
|
3.64 ± 0.16
|
-0.28
|
-0.72, 0.15
|
0.1011
|
|
Stiffness
|
5.9 ± 2.5
|
6.0 ± 2.5
|
5.05 ± 0.15
|
4.90 ± 0.15
|
-0.14
|
-0.57, 0.29
|
0.2568
|
|
Depression
|
3.9 ± 2.7
|
3.9 ± 2.6
|
3.38 ± 0.14
|
3.34 ± 0.14
|
-0.04
|
-0.44, 0.35
|
0.4165
|
|
Missing work
|
2.2 ± 3.0
|
2.2 ± 3.1
|
1.89 ± 0.15
|
1.87 ± 0.15
|
-0.01
|
-0.42, 0.40
|
0.4768
|
|
Total FIQ score
|
51.6 ± 15.0
|
52.7 ± 15.3
|
44.89 ± 1.08
|
41.56 ± 1.07
|
-3.33
|
-6.31, -0.35
|
0.0144*
|
|
SF-36 health surveyc
| | | | | | | |
|
Physical functioning
|
64.0 ± 20.9
|
63.4 ± 20.8
|
68.44 ± 0.93
|
72.73 ± 0.93
|
4.29
|
1.70, 6.88
|
0.0006*
|
|
Vitality
|
37.6 ± 19.4
|
36.2 ± 20.5
|
42.01 ± 1.22
|
46.43 ± 1.21
|
4.42
|
1.04, 7.80
|
0.0052*
|
|
Mental health
|
62.1 ± 18.0
|
60.1 ± 20.3
|
64.47 ± 0.98
|
67.11 ± 0.98
|
2.64
|
-0.08, 5.37
|
0.0287*
|
|
Bodily pain
|
34.6 ± 14.1
|
33.0 ± 14.0
|
43.27 ± 1.06
|
45.42 ± 1.06
|
2.15
|
-0.81, 5.10
|
0.0770
|
|
General health perception
|
42.6 ± 15.7
|
41.4 ± 16.0
|
44.82 ± 0.85
|
46.65 ± 0.85
|
1.83
|
-0.54, 4.19
|
0.0648
|
|
Physical role limitations
|
52.3 ± 26.1
|
52.7 ± 27.9
|
60.90 ± 1.30
|
62.58 ± 1.30
|
1.68
|
-1.93, 5.29
|
0.1805
|
|
Social functioning
|
61.4 ± 26.0
|
61.9 ± 28.2
|
68.51 ± 1.38
|
70.10 ± 1.37
|
1.59
|
-2.23, 5.41
|
0.2068
|
|
Emotional role limitations
|
71.7 ± 26.6
|
67.2 ± 27.2
|
72.99 ± 1.36
|
72.76 ± 1.35
|
-0.23
|
-4.00, 3.54
|
0.5480
|
- aDifference in mean change from baseline compared with placebo, using the baseline score as covariate. bFIQ scores for each assessment range from 0 to 10, with higher scores indicating greater impairment (total score range is from 0 to 100). cSF-36 health survey scores range from 0 to 100, with higher scores indicating better patient status. *Indicates statistical significance at the P <0.025 level. CI, confidence interval; FIQ, Fibromylagia Impact Questionnaire; LS, least squares; SD, standard deviation; SE, standard error.
