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Table 3 Fibromyalgia Impact Questionnaire and SF-36 scores at baseline and final assessment

From: A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia

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

  1. 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.
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Arthritis Research & Therapy

ISSN: 1478-6362

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