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