Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery
Table 3
Quality of life and treatment satisfaction scores.
Full analysis set
Buprenorphine transdermal system ()
Oral tramadol/acetaminophen ()
value (-test)
EQ-5D index, mean ± SD
Baseline (week 0)
0.57 ± 0.13
0.46 ± 0.27
—
Week 6 (LOCF)
0.68 ± 0.18
0.65 ± 0.14
—
Improvement (week 0 to week 6)
0.10 ± 0.19
0.19 ± 0.21
0.0258
value (paired test)
0.0004
<0.0001
—
EQ-5D-3L dimension scores
(1) Mobility
Baseline (week 0)
0.86 ± 0.08
0.85 ± 0.11
0.7111
Week 6 (LOCF)
0.89 ± 0.03
0.88 ± 0.03
0.6256
Improvement (week 0 to week 6)
0.03 ± 0.08
0.03 ± 0.11
0.8326
value (paired test)
0.0080
0.0281
(2) Self-care
Baseline (Week 0)
0.83 ± 0.07
0.78 ± 0.14
0.0161
Week 6 (LOCF)
0.87 ± 0.05
0.84 ± 0.07
0.0108
Improvement (week 0 to week 6)
0.04 ± 0.08
0.06 ± 0.13
0.3247
value (paired test)
0.0008
0.0021
(3) Usual activities
Baseline (week 0)
0.88 ± 0.01
0.82 ± 0.14
0.0007
Week 6
0.89 ± 0.02
0.89 ± 0.05
0.6431
Improvement (Week 0 to Week 6)
0.01 ± 0.01
0.07 ± 0.13
0.0006
value (paired test)
0.0019
0.0002
(4) Pain/discomfort
Baseline (week 0)
0.80 ± 0.02
0.78 ± 0.10
0.1245
Week 6 (LOCF)
0.81 ± 0.09
0.82 ± 0.05
0.6831
Improvement (week 0 to week 6)
0.01 ± 0.09
0.04 ± 0.12
0.1731
value (paired test)
0.2940
0.0158
(5) Anxiety/depression
Baseline (Week 0)
0.88 ± 0.04
0.88 ± 0.08
0.8932
Week 6 (LOCF)
0.89 ± 0.07
0.90 ± 0.03
0.5537
Improvement (week 0 to week 6)
0.01 ± 0.08
0.02 ± 0.07
0.6613
value (paired test)
0.1865
0.0479
Treatment satisfaction scores at week 6, mean ± SD
CGIC
2.46 ± 1.28
2.37 ± 0.98
0.7067
PGIC
2.53 ± 1.28
2.39 ± 0.92
0.5304
of life (EQ-5D-3L, Korean version): consists of 5 items, that is, mobility, self-care, normal activities, pain/discomfort, and anxiety/depression. EQ-5D-3L scores were computed according to Table 1; , PGIC: Clinical Global Impression of Change, Patient Global Impression of Change. 1 = very much improved since the initiation of treatment; 2 = much improved; 3 = minimally improved; 4 = no change from baseline (the initiation of treatment); 5 = minimally worse; 6 = much worse; 7 = very much worse since the initiation of treatment. values < 0.05 are marked in bold text.