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Table 2 Efficacy and functional outcome measures

From: Effect of duloxetine in patients with fibromyalgia: tiredness subgroups

 

Mild subgroup

Moderate subgroup

Severe subgroup

 

Placebo

Duloxetine

Placebo

Duloxetine

Placebo

Duloxetine

 

BL

Mean (SD)

Change

Mean (SE)

BL

Mean (SD)

Change

Mean (SE)

BL

Mean (SD)

Change

Mean (SE)

BL

Mean (SD)

Change

Mean (SE)

BL

Mean (SD)

Change

Mean (SE)

BL

Mean (SD)

Change

Mean (SE)

BPI average Pain score

4.5 (1.3)

-1.8 (0.6)

5.6 (1.7)

-1.3 (0.5)

5.5 (1.3)

-1.1 (0.2)

5.5 (1.4)

-1.6 (0.2)

6.7 (1.5)

-1.1 (0.1)

6.6 (1.5)

-2.0 (0.1)***

FIQ

 

Total score

27.3 (11.4)

-1.0 (4.2)

26.4 (7.6)

1.0 (3.5)

40.1 (8.8)

-4.4 (1.7)

39.3 (9.6)

-7.7 (1.3)

54.9 (9.9)

-9.4 (0.8)

54.4 (10.8)

-14.4 (0.7)***

Physical Impairment score

1.8 (1.8)

-0.3 (0.6)

2.5 (1.9)

0.1 (0.5)

3.3 (2.0)

-0.2 (0.2)

3.2 (2.2)

-0.6 (0.2)

4.7 (2.1)

-0.4 (0.1)

4.8 (2.3)

-0.8 (0.1)*

Interference with work

3.0 (2.2)

-0.6 (0.7)

3.4 (2.2)

-0.0 (0.5)

5.0 (1.7)

-0.9 (0.3)

4.8 (2.3)

-1.3 (0.2)

6.9 (1.9)

-1.2 (0.1)

6.8 (2.2)

-2.0 (0.1)***

Pain

4.1 (2.4)

-0.7 (0.7)

5.2 (2.4)

-1.0 (0.6)

6.0 (1.6)

-0.9 (0.3)

6.2 (1.7)

-1.5 (0.2)

7.6 (1.7)

-1.4 (0.1)

7.5 (1.7)

-2.1 (0.1)***

Tiredness

2.7 (0.6)

1.6 (0.8)

2.5 (0.7)

2.4 (0.7)

5.3 (0.8)

0.1 (0.3)

5.3 (0.8)

-0.2 (0.2)

8.7 (1.1)

-1.6 (0.1)

8.6 (1.1)

-1.8 (0.1)

Rested

3.5 (2.0)

0.8 (0.7)

3.9 (1.7)

0.7 (0.6)

6.4 (1.9)

-0.9 (0.3)

6.3 (2.1)

-1.0 (0.3)

8.4 (1.6)

-1.5 (0.1)

8.4 (1.7)

-1.8 (0.1)

Stiffness

4.4 (2.4)

0.7 (0.7)

5.2 (2.6)

-1.5 (0.5)

6.5 (2.0)

-1.4 (0.3)

6.6 (2.0)

-1.8 (0.2)

8.1 (1.7)

-1.6 (0.1)

8.0 (1.7)

-2.5 (0.1)***

Anxiousa

2.7 (2.8)

-0.1 (0.6)

1.4 (1.9)

0.3 (0.5)

3.7 (2.3)

-0.6 (0.3)

3.1 (2.6)

-0.8 (0.2)

5.2 (3.0)

-0.8 (0.1)

5.0 (3.2)

-1.8 (0.1)***

Depression

1.2 (1.4)

0.2 (0.5)

1.3 (1.8)

0.2 (0.4)

2.5 (2.4)

-0.2 (0.2)

2.4 (2.5)

-0.8 (0.2)*

4.5 (3.0)

-0.5 (0.1)

4.4 (3.2)

-1.6 (0.1)***

SF-36

 

Mental component summary

55.2 (7.7)

-0.9 (2.4)

52.9 (8.0)

0.3 (2.0)

49.2 (10.3)

-0.1 (1.0)

51.1 (10.5)

1.6 (0.8)

42.7 (11.1)

2.0 (0.5)

42.8 (11.8)

5.4 (0.5)***

Physical component summary

33.8 (6.2)

3.8 (2.0)

33.9 (9.3)

2.8 (1.7)

31.6 (7.6)

2.5 (0.9)

31.2 (8.3)

4.2 (0.8)

27.6 (7.4)

3.1 (0.4)

27.8 (7.6)

4.1 (0.4)

Bodily pain

42.7 (8.4)

6.9 (4.8)

41.1 (17.8)

15.7 (3.9)

37.7 (13.2)

6.2 (2.1)

36.7 (12.2)

12.3 (1.7)*

27.8 (13.6)

8.6 (0.9)

28.4 (13.6)

14.2 (0.8)***

General health

60.1 (14.7)

3.5 (2.6)

58.9 (20.1)

6.9 (2.1)

53.3 (21.1)

0.7 (1.7)

53.9 (19.8)

4.1 (1.4)

41.8 (20.0)

5.1 (0.8)

44.0 (21.0)

7.7 (0.7)*

Mental health

75.3 (16.5)

1.3 (3.5)

77.2 (13.5)

3.5 (2.8)

69.5 (17.4)

1.8 (1.7)

72.6 (17.0)

4.6 (1.4)

60.9 (19.2)

3.3 (0.9)

61.2 (20.8)

9.9 (0.7)***

Physical functioning

53.1 (19.1)

9.4 (4.4)

57.2 (21.6)

8.0 (3.5)

51.3 (21.2)

6.9 (2.1)

48.9 (20.4)

8.0 (1.7)

40.2 (21.1)

5.7 (0.9)

39.4 (21.8)

9.5 (0.8)**

Role-emotional

88.9 (28.0)

-2.4 (8.4)

75.6 (37.2)

-1.5 (6.9)

69.3 (39.0)

1.1 (4.0)

71.8 (37.0)

4.7 (3.2)

50.0 (42.6)

5.5 (2.0)

48.4 (43.8)

16.1 (1.7)***

Role-physical

44.4 (34.9)

6.1 (8.8)

37.5 (41.4)

-6.8 (7.2)

25.0 (34.1)

5.7 (4.2)

30.6 (36.9)

12.7 (3.4)

13.0 (23.1)

8.7 (1.7)

12.5 (23.6)

13.6 (1.4)*

Social functioning

79.2 (23.1)

3.8 (4.7)

77.3 (19.6)

0.0 (3.8)

68.0 (22.5)

4.0 (2.2)

69.6 (25.0)

7.4 (1.7)

51.0 (23.3)

7.6 (1.1)

52.3 (24.8)

11.3 (1.0)*

Vitality

48.8 (16.8)

4.1 (5.2)

42.5 (20.0)

1.9 (4.2)

34.2 (17.0)

-0.3 (2.2)

38.5 (18.6)

5.6 (1.8)*

19.3 (15.7)

6.9 (1.1)

20.3 (17.3)

11.7 (0.9)***

  1. *P < 0.05 vs. placebo; **P < 0.01 vs. placebo; ***P < 0.001 vs. placebo; a P ≤ 0.1 therapy-by-fatigue subgroup interaction.
  2. BL, baseline; SD, standard deviation; SE, standard error; BPI, brief pain inventory; FIQ, fibromyalgia impact questionnaire; SF-36, Medical Outcomes Study Short Form-36.