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Table 2 Changes in efficacy measures from baseline to endpoint or at endpoint

From: A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients

Variable Placebo (n = 195) Duloxetine (n = 191) Difference (95 % CI) p Value
Baseline Change Baseline Change
BPI average pain score       
 MMRM 6.13 ± 1.35 −1.58 ± 0.23 6.05 ± 1.29 −1.90 ± 0.23 −0.32 (−0.70, 0.06) 0.0988
 LOCF 6.13 ± 1.35 −1.22 ± 0.26 6.05 ± 1.29 −1.60 ± 0.26 −0.38 (−0.74, −0.02) 0.0408a
 BOCF 6.13 ± 1.35 −0.92 ± 0.25 6.05 ± 1.29 −1.38 ± 0.25 −0.45 (−0.81, −0.10) 0.0132a
 WOCF 6.13 ± 1.35 −0.88 ± 0.26 6.05 ± 1.29 −1.35 ± 0.26 −0.47 (−0.84, −0.10) 0.0132a
BPI other pain       
 Worst 7.44 ± 1.40 −1.35 ± 0.26 7.36 ± 1.28 −1.91 ± 0.26 −0.56 (−0.99, −0.12) 0.0126a
 Least 4.46 ± 1.81 −1.23 ± 0.22 4.68 ± 1.70 −1.72 ± 0.22 −0.49 (−0.87, −0.12) 0.0092a
 Right now 5.90 ± 1.69 −1.20 ± 0.26 5.99 ± 1.52 −1.77 ± 0.26 −0.57 (−1.00, −0.15) 0.0083a
Patient diary       
 Average pain 5.98 ± 1.39 −1.48 ± 0.18 5.79 ± 1.35 −1.82 ± 0.18 −0.33 (−0.70, 0.03) 0.0755
 Worst pain 7.23 ± 1.28 −1.34 ± 0.19 7.05 ± 1.24 −1.81 ± 0.19 −0.47 (−0.88, −0.06) 0.0232a
BPI interference scores       
 General activities 5.82 ± 2.31 −1.76 ± 0.32 5.82 ± 2.14 −2.22 ± 0.31 −0.46 (−0.98, 0.06) 0.0807
 Mood 5.33 ± 2.53 −1.42 ± 0.33 5.65 ± 2.40 −2.17 ± 0.32 −0.75 (−1.29, −0.22) 0.0057a
 Walking ability 4.08 ± 2.85 −1.29 ± 0.30 4.29 ± 2.73 −1.67 ± 0.29 −0.38 (−0.84, 0.09) 0.1114
 Normal work 5.50 ± 2.46 −1.76 ± 0.32 5.61 ± 2.42 −2.18 ± 0.31 −0.42 (−0.94, 0.09) 0.1081
 Relationships with people 3.54 ± 2.97 −0.53 ± 0.30 3.90 ± 2.89 −1.09 ± 0.30 −0.55 (−1.04, −0.07) 0.0264a
 Sleep 5.22 ± 2.91 −1.57 ± 0.36 5.30 ± 2.81 −1.82 ± 0.35 −0.24 (−0.81, 0.32) 0.3959
 Enjoyment of life 5.13 ± 2.75 −1.24 ± 0.32 5.12 ± 2.65 −1.90 ± 0.31 −0.66 (−1.18, −0.15) 0.0119a
 Average of all 7 items 4.95 ± 2.09 −1.44 ± 0.27 5.10 ± 2.07 −1.95 ± 0.27 −0.52 (−0.96, −0.07) 0.0222a
FIQ       
 Physical functioning 3.85 ± 2.32 −0.37 ± 0.26 3.36 ± 2.35 −0.84 ± 0.25 −0.47 (−0.86, −0.09) 0.0160a
 Feeling good 7.11 ± 2.73 −0.79 ± 0.41 7.17 ± 2.72 −1.59 ± 0.40 −0.80 (−1.39, −0.21) 0.0082a
 Missing work 2.44 ± 2.79 −0.48 ± 0.28 2.33 ± 3.09 −0.97 ± 0.27 −0.49 (−0.93, −0.06) 0.0270a
 Housework 5.86 ± 2.39 −1.69 ± 0.36 5.86 ± 2.45 −2.14 ± 0.35 −0.45 (−0.97, 0.08) 0.0932
 Pain 7.01 ± 1.67 −1.76 ± 0.35 6.83 ± 1.52 −2.37 ± 0.34 −0.62 (−1.11, −0.12) 0.0148a
 Fatigue 7.27 ± 2.08 −1.45 ± 0.35 7.08 ± 1.97 −1.96 ± 0.34 −0.52 (−1.03, 0.00) 0.0479a
 Morning tiredness 6.81 ± 2.41 −1.68 ± 0.39 6.86 ± 2.40 −1.80 ± 0.37 −0.13 (−0.69, 0.44) 0.6618
 Stiffness 6.26 ± 2.56 −1.59 ± 0.35 6.20 ± 2.57 −2.10 ± 0.34 −0.51 (−1.03, 0.02) 0.0577
 Anxiety 5.43 ± 2.67 −1.18 ± 0.36 5.33 ± 2.59 −1.86 ± 0.35 −0.68 (−1.20, −0.15) 0.0114a
 Depression 4.79 ± 2.71 −0.96 ± 0.35 4.91 ± 2.76 −1.62 ± 0.34 −0.66 (−1.18, −0.14) 0.0129a
 Total score 56.82 ± 16.14 −13.05 ± 2.65 55.95 ± 16.25 −18.41 ± 2.57 −5.35 (−9.26, −1.45) 0.0073a
SF-36       
 Physical functioning 62.51 ± 19.82 3.04 ± 2.15 63.72 ± 18.75 7.40 ± 2.13 4.36 (1.35, 7.37) 0.0046a
 Physical role limitations 49.13 ± 25.60 0.44 ± 2.98 49.25 ± 25.57 8.20 ± 2.96 7.76 (3.57, 11.94) 0.0003a
 Bodily pain 36.60 ± 11.71 5.28 ± 2.08 36.53 ± 12.40 10.95 ± 2.07 5.67 (2.76, 8.59) 0.0002a
 General health perceptions 38.76 ± 14.77 3.31 ± 1.94 39.37 ± 17.67 6.55 ± 1.92 3.25 (0.53, 5.96) 0.0192a
 Vitality 31.96 ± 18.80 3.35 ± 2.53 32.43 ± 21.03 10.05 ± 2.51 6.70 (3.15, 10.25) 0.0002a
 Social functioning 55.71 ± 26.54 3.28 ± 3.06 55.76 ± 27.53 10.32 ± 3.04 7.04 (2.74, 11.34) 0.0014a
 Emotional role limitations 61.24 ± 26.80 −3.63 ± 3.36 60.34 ± 29.16 5.50 ± 3.35 9.12 (4.41, 13.83) 0.0002a
 Mental health 56.10 ± 19.84 −2.00 ± 2.52 55.50 ± 18.85 5.91 ± 2.51 7.91 (4.39, 11.43) <0.0001a
CGI-Ib 3.27 ± 0.16 2.83 ± 0.15 −0.44 (−0.71, −0.18) 0.0012a
PGI-Ib 3.32 ± 0.16 2.83 ± 0.16 −0.49 (−0.76, −0.22) 0.0003a
BDI-II score (0–63) 14.89 ± 9.62 −1.19 ± 0.85 15.34 ± 9.73 −4.09 ± 0.84 −2.90 (−4.37, −1.44) 0.0001a
ACR 2010       
 WPI (0–19) 12.08 ± 3.57 −1.06 ± 0.60 12.14 ± 3.58 −2.34 ± 0.58 −1.28 (−2.12, −0.44) 0.0029a
 SS (0–12) 6.59 ± 1.88 −1.00 ± 0.28 6.60 ± 1.82 −1.37 ± 0.27 −0.36 (−0.79, 0.06) 0.0906
 Total (0–31) 18.67 ± 4.53 −2.24 ± 0.77 18.74 ± 4.36 −3.88 ± 0.74 −1.64 (−2.74, −0.54) 0.0037a
  1. ACR American College of Rheumatology, BDI-II Beck Depression Inventory II, BOCF baseline observation carried forward, BPI Brief Pain Inventory, CGI-I Clinical Global Impressions–Global Improvement, CI confidence interval, FIQ Fibromyalgia Impact Questionnaire, LOCF last observation carried forward; MMRM mixed-effects model repeated measures, PGI-I Patient Global Impression of Improvement, SF-36 36-Item Short Form Survey; SS symptom severity; WOCF worst observation carried forward, WPI widespread pain index
  2. Values are means ± SD (baseline) or least-squares means ± SE (change)
  3. aStatistically significant at a two-sided level of 0.05
  4. bMean scores at the end of treatment based on a 7-point scale