Table 2. Mean change from baseline to endpoint (repeated measures analysis): efficacy and health outcome measures.
| Combined duloxetine (n = 171) | 40 mg (n = 85) | 60 mg (n = 86) | Placebo (n = 167) | |||||
|---|---|---|---|---|---|---|---|---|
| Mean baseline (SD) | Mean change (SE) | Mean baseline (SD) | Mean change (SE) | Mean baseline (SD) | Mean change (SE) | Mean baseline (SD) | Mean change (SE) | |
| Weekly mean of | ||||||||
| 24‐h average pain score | 5.77 (1.20) | −2.47 (0.18)** | 5.79 (1.23) | −2.41 (0.21)† | 5.76 (1.17) | −2.53 (0.21)† | 5.78 (1.17) | −1.61 (0.18) |
| 24‐h worst pain score | 6.58 (1.33) | −2.51 (0.19)** | 6.54 (1.33) | −2.42 (0.22)† | 6.61 (1.33) | −2.59 (0.22)† | 6.66 (1.25) | −1.55 (0.19) |
| Night pain score | 5.62 (1.59) | −2.39 (0.19)** | 5.55 (1.64) | −2.33 (0.22)† | 5.69 (1.54) | −2.45 (0.23)† | 5.50 (1.49) | −1.56 (0.19) |
| BPI pain severity | ||||||||
| Worst pain | 6.6 (1.4) | −2.59 (0.21)** | 6.5 (1.4) | −2.51 (0.25)† | 6.6 (1.5) | −2.68 (0.25)† | 6.7 (1.4) | −1.62 (0.21) |
| Least pain | 4.1 (1.7) | −1.98 (0.21)** | 4.0 (1.8) | −1.92 (0.25)† | 4.2 (1.6) | −2.04 (0.25)† | 4.1 (1.8) | −1.13 (0.21) |
| Average pain | 5.7 (1.3) | −2.54 (0.20)** | 5.6 (1.3) | −2.53 (0.23)† | 5.7 (1.3) | −2.56 (0.23)† | 5.6 (1.3) | −1.54 (0.20) |
| Pain right now | 5.2 (1.7) | −2.59 (0.22)** | 5.2 (1.8) | −2.55 (0.25)† | 5.3 (1.4) | −2.62 (0.26)† | 5.1 (1.7) | −1.67 (0.22) |
| BPI interference | ||||||||
| General activity | 4.5 (2.5) | −2.29 (0.24) | 4.5 (2.7) | −2.48 (0.29)† | 4.5 (2.4) | −2.10 (0.29) | 4.4 (2.4) | −1.88 (0.24) |
| Mood | 4.1 (2.5) | −2.28 (0.24) | 3.9 (2.5) | −2.18 (0.29) | 4.2 (2.5) | −2.39 (0.29) | 4.2 (2.4) | −1.91 (0.24) |
| Walking ability | 4.4 (2.6) | −2.31 (0.23)* | 4.4 (2.8) | −2.32 (0.28) | 4.3 (2.5) | −2.31 (0.28) | 4.0 (2.6) | −1.82 (0.23) |
| Normal work | 4.1 (2.5) | −1.86 (0.23) | 3.9 (2.6) | −1.84 (0.28) | 4.3 (2.5) | −1.90 (0.28) | 3.7 (2.7) | −1.49 (0.23) |
| Relationship with other people | 2.8 (2.5) | −1.32 (0.23)* | 2.7 (2.7) | −1.16 (0.27) | 2.9 (2.4) | −1.49 (0.27)† | 2.6 (2.5) | −0.77 (0.23) |
| Sleep | 4.2 (2.8) | −2.15 (0.24)* | 4.0 (2.8) | −2.26 (0.29)† | 4.3 (2.7) | −2.05 (0.29) | 3.9 (2.7) | −1.69 (0.24) |
| Enjoyment of life | 3.9 (2.6) | −2.15 (0.23)* | 3.7 (2.7) | −1.96 (0.28) | 4.0 (2.5) | −2.35 (0.28)† | 3.5 (2.5) | −1.59 (0.23) |
| Average of 7 interference scores | 3.99 (2.18) | −2.04 (0.20)* | 3.88 (2.25) | −2.00 (0.24) | 4.09 (2.13) | −2.08 (0.24)† | 3.75 (2.15) | −1.56 (0.20) |
| PGI‐I | – | 2.53 (0.12)** | – | 2.53 (0.14)† | – | 2.52 (0.14)† | – | 3.18 (0.12) |
BPI, Brief Pain Inventory; PGI‐I, Patient’s Global Impression of Improvement.
*P < 0.05 vs placebo; **P < 0.0001 vs placebo; †95%CI of difference vs placebo does not include zero.