Table 4.

Mean change from baseline: additional secondary efficacy assessments at 15 and 27 sssweeks (LOCF).

VariablePlacebo, n = 22315 Weeks Milnacipran 100 mg/day, n = 224Milnacipran 200 mg/day, n = 441Placebo, n = 22327 Weeks Milnacipran 100 mg/day, n = 224Milnacipran 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 score0.10–1.60–2.28b0.16–1.56–2.68b
MOS-Sleep Problems Index Ic–1.57–1.68–0.99–0.060.12–1.65
MOS-Sleep Problems Index IIc–2.09–2.17–1.43–0.96–0.43–2.11
  Physical functioning2.243.273.55b2.432.993.34
  Role limit-physical5.255.405.484.915.075.21
  Bodily pain4.075.486.05a3.785.22b5.86a
  General health perception1.902.272.251.672.231.97
  Social functioning3.925.255.133.745.004.99
  Role limit-emotional1.903.903.601.413.092.92
  Mental health1.502.683.70a0.973.00a3.07b
  • 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.