Mean change from baseline: additional secondary efficacy assessments at 15 and 27 sssweeks (LOCF).
| Variable | Placebo, n = 223 | 15 Weeks Milnacipran 100 mg/day, n = 224 | Milnacipran 200 mg/day, n = 441 | Placebo, n = 223 | 27 Weeks Milnacipran 100 mg/day, n = 224 | Milnacipran 200 mg/day, n = 441 |
|---|---|---|---|---|---|---|
| FIQ total score | –15.91 | –17.68 | –17.27 | –14.98 | –17.73 | –16.69 |
| MDHAQ Disability subscale score | –2.44 | –2.91 | –3.11 | –2.46 | –2.63 | –3.12 |
| ASEX total score | –0.14 | –0.74 | –0.41 | –0.36 | –0.71 | –0.46 |
| PGDS total score | –17.78 | –17.04 | –19.20 | –16.48 | –16.13 | –18.48 |
| MFI total score | –3.04 | –5.15b | –5.62b | –3.35 | –5.00 | –5.80b |
| MASQ total score | 0.10 | –1.60 | –2.28b | 0.16 | –1.56 | –2.68b |
| MOS-Sleep Problems Index Ic | –1.57 | –1.68 | –0.99 | –0.06 | 0.12 | –1.65 |
| MOS-Sleep Problems Index IIc | –2.09 | –2.17 | –1.43 | –0.96 | –0.43 | –2.11 |
| SF-36 | ||||||
| Physical functioning | 2.24 | 3.27 | 3.55b | 2.43 | 2.99 | 3.34 |
| Role limit-physical | 5.25 | 5.40 | 5.48 | 4.91 | 5.07 | 5.21 |
| Bodily pain | 4.07 | 5.48 | 6.05a | 3.78 | 5.22b | 5.86a |
| General health perception | 1.90 | 2.27 | 2.25 | 1.67 | 2.23 | 1.97 |
| Energy/vitality | 4.43 | 5.39 | 5.71 | 3.59 | 4.84 | 5.23 |
| Social functioning | 3.92 | 5.25 | 5.13 | 3.74 | 5.00 | 4.99 |
| Role limit-emotional | 1.90 | 3.90 | 3.60 | 1.41 | 3.09 | 2.92 |
| Mental health | 1.50 | 2.68 | 3.70a | 0.97 | 3.00a | 3.07b |
↵a p < 0.01 vs placebo;
↵b p < 0.05 vs placebo; comparisons to placebo are based on least squares mean changes from baseline (ANCOVA), with treatment group and study center as factors and baseline value as covariate.
↵c MOS-Sleep Problems Index scores are adjusted for sleep medication use. ASEX: Arizona Sexual Experiences Scale; FIQ: Fibromyalgia Impact Questionnaire; LOCF: last observation carried forward; MASQ: Multiple Ability Self-report Questionnaire; MDHAQ: Multidimensional Health Assessment Questionnaire; MFI: Multidimensional Fatigue Index; MOS: Medical Outcomes Study; PGDS: Patient Global Disease Status.