Table 7.
Summary of Endpoint Changes for the SF-36 and Sheehan Disability Scale From 4 Studies of Duloxetine for the Treatment of Fibromyalgia
| Duloxetine |
Placebo |
Between-Group Difference (95% CI at endpoint) | ||||
| Measure | n | Least Squares Change, Mean (SE) | n | Least Squares Change, Mean (SE) | P Value | |
| SF-36 | ||||||
| Mental component summary | 717 | 4.60 (0.39) | 489 | 1.63 (0.45) | −2.97 (–4.14 to –1.81) | < .001 |
| Physical component summary | 717 | 4.09 (0.32) | 489 | 3.01 (0.37) | −1.08 (–2.03 to –0.12) | < .05 |
| Bodily pain | 723 | 14.1 (0.73) | 489 | 7.95 (0.84) | −6.19 (–8.39 to –4.00) | < .001 |
| General health | 720 | 7.02 (0.59) | 489 | 4.31 (0.69) | −2.71 (–4.47 to –0.95) | < .01 |
| Mental health | 723 | 8.85 (0.64) | 489 | 3.03 (0.75) | −5.82 (–7.73 to –3.91) | < .001 |
| Physical functioning | 723 | 9.28 (0.71) | 489 | 5.96 (0.83) | −3.32 (–5.45 to –1.20) | < .01 |
| Role limit, emotional | 720 | 13.0 (1.54) | 489 | 4.53 (1.76) | −8.43 (–13.0 to –3.85) | < .001 |
| Role limit, physical | 721 | 12.6 (1.34) | 489 | 7.74 (1.53) | −4.81 (–8.80 to –0.83) | < .05 |
| Social functioning | 722 | 10.4 (0.83) | 489 | 7.01 (0.97) | −3.43 (–5.93 to –0.93) | < .01 |
| Vitality | 723 | 10.5 (0.79) | 489 | 5.84 (0.93) | −4.66 (–7.03 to –2.28) | < .001 |
| Sheehan Disability Scale | ||||||
| Global impairment | 718 | −4.37 (0.27) | 487 | −2.88 (0.31) | 1.49 (0.69–2.29) | < .001 |
| Work/school | 628 | −1.46 (0.10) | 417 | −1.09 (0.12) | 0.37 (0.06–0.67) | < .05 |
| Family life | 725 | −1.40 (0.10) | 489 | −0.89 (0.11) | 0.51 (0.22–0.79) | < .001 |
| Social life | 724 | −1.53 (0.10) | 489 | −0.97 (0.11) | 0.56 (0.27–0.85) | < .001 |
Abbreviation: SF-36 = Medical Outcomes Study 36-Item Short-Form Health Survey.