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. 2017 Aug 4;13:2115–2124. doi: 10.2147/NDT.S136448

Table 3.

Subgroup analysis of baseline BPI-SF average pain score (≤6 vs >6) effect on all scales

Patient characteristic Week Duloxetinea
SSRIsa
Treatment difference
(95% CI)b
P-value
n LS mean change
(95% CI)
n LS mean change
(95% CI)
Baseline BPI-SF average pain score ≤6
 BPI-SF average pain score24 2 137 −1.6 (−1.9, −1.3) 141 −1.6 (−1.9, −1.4) −0.1 (−0.5, 0.3) 0.734
4 158 −2.3 (−2.6, −2.0) 171 −2.2 (−2.4, −1.9) 0.2 (−0.3, 0.6) 0.420
8 121 −3.0 (−3.3, −2.6) 129 −2.7 (−3.0, −2.3) 0.3 (−0.2, 0.8) 0.213
12 117 −3.3 (−3.6, −2.9) 122 −3.1 (−3.4, −2.7) 0.2 (−0.3, 0.7) 0.369
 HAM-D17 total score27 2 110 −5.2 (−6.1, −4.3) 134 −6.1 (−6.9, −5.3) −0.9 (−2.2, 0.3) 0.125
4 139 −9.7 (−10.8, −8.7) 162 −10.8 (−11.7, −9.9) −1.1 (−2.5, 0.4) 0.143
8 98 −13.9 (−15.1, −12.8) 124 −14.1 (−15.1, −13.0) −0.1 (−1.7, 1.4) 0.884
12 93 −16.4 (−17.5, −15.2) 112 −16.3 (−17.3, −15.2) 0.1 (−1.5, 1.7) 0.879
 GAF26 12 110 20.6 (18.5, 22.7) 121 18.8 (16.8, 20.8) 1.8 (−1.2, 4.8) 0.249
 SASS28 12 97 8.9 (7.5, 10.2) 114 8.8 (7.6, 10.0) 0.1 (−1.8, 1.9) 0.937
 EQ-5D25 12 104 0.2926 (0.2617, 0.3235) 119 0.2816 (0.2529, 0.3104) 0.0109 (−0.0327, 0.0546) 0.622
 Ability to work 0 177 48.6% 185 40.5% 0.139
12 126 85.8% (77.3%, 91.5%) 123 81.5% (72.3%, 88.1%) 1.374 (0.689, 2.740) 0.367
Baseline BPI-SF average pain score >6
 BPI-SF average pain score24 2 72 −2.4 (−2.9, −1.9) 43 −2.7 (−3.4, −2.1) −0.3 (−1.1, 0.5) 0.485
4 78 −4.0 (−4.5, −3.5) 48 −3.5 (−4.1, −2.8) 0.5 (−0.3, 1.3) 0.219
8 61 −5.0 (−5.6, −4.5) 35 −4.1 (−4.8, −3.4) 0.9 (0.0, 1.9) 0.051
12 62 −5.2 (−5.8, −4.6) 43 −4.4 (−5.1, −3.6) 0.8 (−0.2, 1.8) 0.109
 HAM-D17 total score27 2 60 −5.3 (−6.7, −3.9) 39 −5.8 (−7.5, −4.1) −0.5 (−2.7, 1.7) 0.673
4 67 −10.7 (−12.3, −9.1) 47 −9.7 (−11.7, −7.8) 1.0 (−1.6, 3.5) 0.461
8 50 −14.8 (−16.6, −12.9) 30 −12.5 (−14.8, −10.2) 2.2 (−0.8, 5.2) 0.140
12 50 −17.0 (−19.0, −15.0) 36 −14.5 (−16.9, −12.1) 2.5 (−0.7, 5.7) 0.125
 GAF26 12 55 19.5 (16.4, 22.6) 40 16.5 (12.8, 20.3) 3.0 (−2.0, 8.0) 0.238
 SASS28 12 56 9.7 (7.5, 11.9) 40 8.8 (6.1, 11.4) 0.9 (−2.6, 4.5) 0.604
 EQ-5D25 12 58 0.3316 (0.2873, 0.3758) 39 0.2960 (0.2410, 0.3510) 0.0355 (−0.0365, 0.1075) 0.330
 Ability to work 0 96 41.7% 65 32.3% 0.250
12 65 84.6% (73.8%, 91.5%) 44 67.8% (47.0%, 83.3%) 2.614 (1.065, 6.416) 0.036c

Notes:

a

For change from baseline, all values are presented as scores, except for ability to work, which is presented as a percentage.

b

For treatment difference, ability to work is presented as an odds ratio (values >1 favor duloxetine). All other treatment differences presented are the least squares mean change difference between treatment groups (positive values indicate favorable outcome with duloxetine; negative values indicate favorable outcome with SSRIs).

c

Statistically significant difference favoring duloxetine, P<0.05. BPI-SF, higher score indicates more pain; EQ-5D, lower score indicates less healthy; GAF, lower score indicates greater severity of illness; HAM-D17, higher score indicates more depression; SASS, higher score indicates greater social adjustment.

Abbreviations: BPI-SF, Brief Pain Inventory-Short Form; CI, confidence interval; EQ-5D, EuroQol 5-dimension questionnaire for quality of life; GAF, Global Assessment of Functioning Scale; HAM-D17, 17-item Hamilton Rating Scale for Depression; LS, least squares; n, number of affected patients; SASS, Social Adaptation Self-Evaluation Scale; SSRIs, selective serotonin reuptake inhibitors.