Table 1.
Baseline and Week 8 Scores for All Observer-Rated and Self-Rated Variablesa
| Duloxetine |
Placebo |
|||
| Variable | Baseline | Week 8 | Baseline | Week 8 |
| BPI-SF average pain, mean (SE) | 5.78 (0.13) | 3.43 (0.21) | 5.63 (0.12) | 4.09 (0.19) |
| BPI-SF interference, mean (SE) | 5.58 (0.15) | 2.72 (0.20) | 5.47 (0.14) | 3.79 (0.19) |
| General activity | 6.20 (0.17) | 3.28 (0.23) | 5.93 (0.15) | 4.32 (0.22) |
| Mood | 6.42 (0.17) | 3.00 (0.23) | 6.19 (0.16) | 4.17 (0.22) |
| Walking ability | 4.03 (0.23) | 2.09 (0.22) | 4.08 (0.22) | 2.99 (0.22) |
| Work | 5.69 (0.19) | 2.85 (0.22) | 5.53 (0.15) | 3.97 (0.21) |
| Relations with people | 4.88 (0.21) | 2.11 (0.21) | 4.78 (0.19) | 3.11 (0.21) |
| Sleep | 5.66 (2.20) | 2.91 (0.24) | 5.63 (0.19) | 3.91 (0.23) |
| Enjoyment of life | 6.18 (0.20) | 2.79 (0.23) | 6.14 (0.17) | 4.08 (0.23) |
| MADRS, mean (SE) | 29.91 (0.37) | 14.78 (0.85) | 29.30 (0.35) | 19.06 (0.74) |
| SCL-90-R, mean (SE) (GSI) | 1.46 (0.05) | 0.81 (0.06) | 1.51 (0.05) | 1.08 (0.06) |
| Somatization | 1.72 (0.76) | 0.99 (0.82) | 1.83 (0.70) | 1.31 (0.83) |
| Obsessive-compulsive symptoms | 1.80 (0.85) | 1.03 (0.91) | 1.83 (0.76) | 1.34 (0.90) |
| Interpersonal sensitivity | 1.35 (0.86) | 0.71 (0.81) | 1.41 (0.89) | 0.97 (0.89) |
| Depressive symptoms | 2.13 (0.76) | 1.14 (0.99) | 2.17 (0.72) | 1.51 (0.91) |
| Anxiety symptoms | 1.49 (0.85) | 0.81 (0.84) | 1.59 (0.78) | 1.10 (0.89) |
| Anger/hostility | 0.88 (0.82) | 0.47 (0.66) | 0.99 (0.93) | 0.71 (0.89) |
| Phobic anxiety | 0.83 (0.46) | 0.46 (0.72) | 0.82 (0.79) | 0.63 (0.79) |
| Paranoid ideation | 1.14 (0.96) | 0.64 (0.82) | 1.12 (0.90) | 0.80 (0.88) |
| Psychoticism | 0.84 (0.67) | 0.48 (0.64) | 0.87 (0.70) | 0.66 (0.75) |
| CGI-S, n (%)b | ||||
| Moderate | 130 (83.3) | 78 (50.0) | 134 (83.2) | 104 (65.4) |
| Severe | 26 (16.7) | 6 (3.9) | 27 (16.8) | 11 (6.9) |
a
Unadjusted means and standard errors (SE) of the mean at baseline and at visit 8 (using last-observation-carried-forward imputation method) are displayed in this table.
b
N = 156 duloxetine, N = 161 placebo (baseline); N = 156 duloxetine, N = 159 placebo (endpoint).
Abbreviations: BPI-SF = Brief Pain Inventory-Short Form, CGI-S = Clinical Global Impressions-Severity of Illness scale, GSI = general severity index, MADRS = Montgomery-Asberg Depression Rating Scale, SCL-90-R = Symptom Checklist-90-Revised.