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Table 3 Fibromyalgia Impact Questionnaire and SF-36 scores at baseline and final assessment

From: A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia

Assessment Baseline mean score ± SD Final assessment LS mean score ± SE Placebo-adjusted LS mean change from baseline with pregabalina
  Placebo Pregabalin Placebo Pregabalin Change 95% CI P-value
FIQ scoreb        
Morning tiredness 6.6 ± 2.1 6.8 ± 2.2 5.73 ± 0.15 5.13 ± 0.15 -0.59 -1.01, -0.18 0.0023*
Feeling good 6.7 ± 2.6 6.8 ± 2.6 5.94 ± 0.17 5.30 ± 0.17 -0.63 -1.12, -0.15 0.0052*
Fatigue 6.8 ± 1.9 7.0 ± 1.9 5.94 ± 0.14 5.45 ± 0.14 -0.49 -0.89, -0.10 0.0075*
Pain 6.4 ± 1.6 6.5 ± 1.6 5.36 ± 0.15 4.95 ± 0.15 -0.41 -0.81, 0.00 0.0238*
Physical functioning 3.2 ± 2.3 3.3 ± 2.4 3.03 ± 0.11 2.74 ± 0.11 -0.28 -0.59, 0.03 0.0376
Housework 5.5 ± 2.4 5.7 ± 2.5 4.61 ± 0.15 4.30 ± 0.15 -0.31 -0.74, 0.11 0.0729
Anxiety 4.5 ± 2.6 4.6 ± 2.6 3.92 ± 0.16 3.64 ± 0.16 -0.28 -0.72, 0.15 0.1011
Stiffness 5.9 ± 2.5 6.0 ± 2.5 5.05 ± 0.15 4.90 ± 0.15 -0.14 -0.57, 0.29 0.2568
Depression 3.9 ± 2.7 3.9 ± 2.6 3.38 ± 0.14 3.34 ± 0.14 -0.04 -0.44, 0.35 0.4165
Missing work 2.2 ± 3.0 2.2 ± 3.1 1.89 ± 0.15 1.87 ± 0.15 -0.01 -0.42, 0.40 0.4768
Total FIQ score 51.6 ± 15.0 52.7 ± 15.3 44.89 ± 1.08 41.56 ± 1.07 -3.33 -6.31, -0.35 0.0144*
SF-36 health surveyc        
Physical functioning 64.0 ± 20.9 63.4 ± 20.8 68.44 ± 0.93 72.73 ± 0.93 4.29 1.70, 6.88 0.0006*
Vitality 37.6 ± 19.4 36.2 ± 20.5 42.01 ± 1.22 46.43 ± 1.21 4.42 1.04, 7.80 0.0052*
Mental health 62.1 ± 18.0 60.1 ± 20.3 64.47 ± 0.98 67.11 ± 0.98 2.64 -0.08, 5.37 0.0287*
Bodily pain 34.6 ± 14.1 33.0 ± 14.0 43.27 ± 1.06 45.42 ± 1.06 2.15 -0.81, 5.10 0.0770
General health perception 42.6 ± 15.7 41.4 ± 16.0 44.82 ± 0.85 46.65 ± 0.85 1.83 -0.54, 4.19 0.0648
Physical role limitations 52.3 ± 26.1 52.7 ± 27.9 60.90 ± 1.30 62.58 ± 1.30 1.68 -1.93, 5.29 0.1805
Social functioning 61.4 ± 26.0 61.9 ± 28.2 68.51 ± 1.38 70.10 ± 1.37 1.59 -2.23, 5.41 0.2068
Emotional role limitations 71.7 ± 26.6 67.2 ± 27.2 72.99 ± 1.36 72.76 ± 1.35 -0.23 -4.00, 3.54 0.5480
  1. aDifference in mean change from baseline compared with placebo, using the baseline score as covariate. bFIQ scores for each assessment range from 0 to 10, with higher scores indicating greater impairment (total score range is from 0 to 100). cSF-36 health survey scores range from 0 to 100, with higher scores indicating better patient status. *Indicates statistical significance at the P <0.025 level. CI, confidence interval; FIQ, Fibromylagia Impact Questionnaire; LS, least squares; SD, standard deviation; SE, standard error.