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. 2017 Jul 24;10:1723–1731. doi: 10.2147/JPR.S138297

Table 1.

Demographic and clinical characteristics of patients with CLBP enrolled in 4 randomized, placebo-controlled trials of duloxetine treatment1417

Parameters Placebo (n = 653) Duloxetine 60 mg (n = 642) Total (N = 1,295)
Age, years
 Mean (SD) 54.7 (13.9) 56.0 (14.1) 55.3 (14.0)
 Median (min., max.) 55.5 (18.7, 90.9) 57.3 (19.4, 85.4) 56.6 (18.7, 90.9)
Sex, n (%)
 Male 271 (41.5) 280 (43.6) 551 (42.5)
 Female 382 (58.5) 362 (56.4) 744 (57.5)
Duration of CLBP, years
 Mean (SD) 9.6 (9.5) 9.4 (9.6) 9.5 (9.5)
 Median (min., max.) 6.9 (0.4, 64.2) 6.0 (0.5, 54.0) 6.2 (0.4, 64.2)
BPI average pain score
 Mean (SD) 5.6 (1.4) 5.6 (1.4) 5.6 (1.4)
 Median (min., max.) 5.0 (1.0, 10.0) 5.0 (2.0, 10.0) 5.0 (1.0, 10.0)
Patients with MBM data,a n 226 230 456
 Mean number of painful sites in past 3 months (SD) 3.3 (2.4) 3.6 (2.7) 3.5 (2.5)
 1 (isolated CLBP), n (%) 54 (23.9) 51 (22.2) 105 (23.0)
 ≥2, n (%) 172 (76.1) 179 (77.8) 351 (77.0)
Patients with BDI-II data,b n 454 447 901
 Mean total score (SD) 6.4 (6.9) 6.1 (6.7) 6.2 (6.8)
 Median total score (min., max.) 4.0 (0.0, 43.0) 4.0 (0.0, 37.0) 4.0 (0.0, 43.0)

Notes:

a

Data from Japanese Phase III trial.14

b

Data from Japanese Phase III and US trials.14,16

Abbreviations: BDI-II, Beck Depression Inventory-II; BPI, Brief Pain Inventory; CLBP, chronic low back pain; max., maximum; MBM, Michigan Body Map; min., minimum.