Table 5.
Summary of Efficacy Results From 4 Studies of Duloxetine for the Treatment of Fibromyalgia
| Duloxetine |
Placebo |
|||||
| Measure | n | Least Squares Change, Mean (SE) | n | Least Squares Change, Mean (SE) | Between-Group Difference (95% CI at endpoint) | P Value |
| Brief Pain Inventory score | ||||||
| 24-h Average pain severity | 774 | −1.88 (0.09) | 526 | −1.12 (0.10) | 0.76 (0.50–1.02) | < .001 |
| Least pain severity | 774 | −1.99 (0.09) | 526 | −1.31 (0.11) | 0.68 (0.40–0.97) | < .001 |
| Worst pain severity | 775 | −1.36 (0.08) | 526 | −0.67 (0.10) | 0.69 (0.44–0.94) | < .001 |
| Pain right now | 775 | −1.90 (0.09) | 526 | −1.20 (0.11) | 0.69 (0.42–0.97) | < .001 |
| Pain interference | 775 | −2.01 (0.09) | 526 | −1.18 (0.10) | 0.83 (0.57–1.08) | < .001 |
| CGI-S score | 744 | −0.77 (0.04) | 506 | −0.44 (0.05) | 0.34 (0.21–0.46) | < .001 |
| FIQ total score | 756 | −12.62 (0.61) | 513 | −8.20 (0.69) | 4.43 (2.62–6.23) | < .001 |
| HDRS-17 total score | 620 | −3.04 (0.19) | 390 | −2.11 (0.24) | 0.93 (0.32–1.54) | < .01 |
| PGI-I score | 764 | 3.19 (0.06) | 516 | 3.60 (0.07) | 0.42 (0.24–0.59) | < .001 |
Abbreviations: CGI-S = Clinical Global Impressions-Severity of Illness scale, FIQ = Fibromyalgia Impact Questionnaire, HDRS-17 = 17-item Hamilton Depression Rating Scale, PGI-I = Patient Global Impressions-Improvement scale.