Table 3 Changes in outcomes from baseline by groups of sham-controlled study
Outcomes | Change from baseline | Between-group difference | P valuea | |
|---|---|---|---|---|
Active acupuncture (n = 69) | Sham acupuncture (n = 69) | Active acupuncture versus Sham acupuncture | ||
Primary outcome | ||||
ISI†| ||||
 Week-3 | − 4.4 (− 5.4 to − 3.5)# | − 3.6 (− 4.6 to − 2.6)# | − 0.8 (− 2.2 to 0.6) | 0.265 |
 Week-6 | − 5.9 (− 6.9 to − 4.9)# | − 5.5 (− 6.6 to − 4.5)# | − 0.4 (− 1.8 to 1.1) | 0.609 |
 Week-10 | − 6.5 (− 7.5 to − 5.5)# | − 6.6 (− 7.6 to − 5.5)# | 0.1 (− 1.4 to 1.6) | 0.894 |
 Week-14 | − 7.0 (− 7.9 to − 6.0)# | − 6.7 (− 7.8 to − 5.6)# | − 0.2 (− 1.7 to 1.2) | 0.736 |
 Week-18 | − 7.6 (− 8.6 to − 6.6)# | − 7.2 (− 8.2 to − 6.1)# | − 0.5 (− 1.9 to 1.0) | 0.541 |
 Week-30 | − 6.8 (− 7.8 to − 5.8)# | − 5.9 (− 7.0 to − 4.8)# | − 0.9 (− 2.3 to 0.6) | 0.249 |
 Week-42 | − 7.5 (− 8.5 to − 6.5)# | − 6.7 (− 7.7 to − 5.6)# | − 0.8 (− 2.3 to 0.6) | 0.265 |
Secondary outcomes | ||||
Actiwatch, week-6 | ||||
 SOL, min†| − 7.5 (− 9.8 to − 5.3)# | 1.5 (− 0.9 to 3.9) | − 9.0 (− 12.3 to − 5.7) | < .001 |
 WASO, min†| − 7.2 (− 12.1 to − 2.4)# | − 8.2 (− 13.5 to − 2.9)# | 1.0 (− 6.2 to 8.2) | 0.784 |
 TST, min‡ | 2.7 (− 4.2 to 9.6) | 2.3 (− 5.3 to 9.9) | 0.4 (− 9.8 to 10.6) | 0.943 |
 SE, % ‡ | 2.8 (1.8 to 3.8)# | 1.3 (0.3 to 2.4) | 1.5 (0.0 to 2.9) | 0.049 |
Sleep diary, week-6 | ||||
 SOL, min†| − 11.4 (− 18.9 to − 3.9)# | − 3.3 (− 11.1 to 4.6) | − 8.1 (− 16.1 to − 0.2) | 0.044 |
 WASO, min†| − 9.2 (− 16.2 to 2.2) | − 13.5 (− 21.2 to − 5.8)# | 4.3 (− 6.1 to 14.8) | 0.413 |
 TST, min‡ | 42.8 (32.2 to 53.3)# | 13.5 (1.9 to 25.1) | 29.2 (13.5 to 44.9) | < .001 |
 SE, % ‡ | 8.6 (6.5 to 10.6)# | 4.1 (1.8 to 6.4)# | 4.4 (1.3 to 7.5) | 0.005 |
PSQI†| ||||
 Week-3 | − 2.3 (− 3.0 to − 1.5)# | − 2.1 (− 2.9 to − 1.4)# | − 0.1 (− 1.2 to 0.9) | 0.808 |
 Week-6 | − 3.4 (− 4.2 to − 2.7)# | − 3.3 (− 4.2 to − 2.5)# | − 0.1 (− 1.2 to 1.0) | 0.894 |
 Week-10 | − 4.1 (− 4.8 to − 3.3)# | − 3.9 (− 4.7 to − 3.1)# | − 0.2 (− 1.3 to 0.9) | 0.742 |
 Week-14 | − 4.6 (− 5.3 to − 3.8)# | − 3.7 (− 4.5 to − 2.9)# | − 0.9 (− 2.0 to 0.2) | 0.123 |
 Week-18 | − 5.0 (− 5.7 to − 4.2)# | − 4.5 (− 5.3 to − 3.7)# | − 0.5 (− 1.6 to 0.7) | 0.408 |
 Week-30 | − 4.9 (− 5.6 to − 4.1)# | − 4.0 (− 4.9 to − 3.2)# | − 0.8 (− 2.0 to 0.3) | 0.148 |
 Week-42 | − 5.2 (− 6.0 to − 4.4)# | − 4.2 (− 5.0 to − 3.3)# | − 1.0 (− 2.1 to 0.1) | 0.084 |
HADS-Anxiety†| ||||
 Week-3 | − 1.0 (− 1.6 to − 0.4)# | − 0.5 (− 1.1 to 0.1) | − 0.5 (− 1.3 to 0.3) | 0.250 |
 Week-6 | − 2.0 (− 2.5 to − 1.4)# | − 1.2 (− 1.9 to − 0.6)# | − 0.7 (− 1.6 to 0.1) | 0.098 |
 Week-10 | − 2.1 (− 2.7 to − 1.5)# | − 1.0 (− 1.7 to − 0.4)# | − 1.1 (− 1.9 to − 0.2) | 0.016 |
 Week-14 | − 1.9 (− 2.5 to − 1.3)# | − 1.3 (− 2.0 to − 0.7)# | − 0.6 (− 1.4 to 0.3) | 0.213 |
 Week-18 | − 2.3 (− 2.9 to − 1.7)# | − 1.8 (− 2.4 to − 1.1)# | − 0.5 (− 1.4 to 0.4) | 0.256 |
 Week-30 | − 2.1 (− 2.7 to − 1.5)# | − 1.8 (− 2.5 to − 1.2)# | − 0.2 (− 1.1 to 0.6) | 0.593 |
 Week-42 | − 2.6 (− 3.2 to − 2.0)# | − 1.0 (− 1.7 to − 0.4)# | − 1.6 (− 2.4 to − 0.7) | 0.001 |
HADS-Depression†| ||||
 Week-3 | − 0.7 (− 1.4 to − 0.1)# | − 0.8 (− 1.5 to − 0.1)# | − 0.1 (− 0.9 to 1.0) | 0.889 |
 Week-6 | − 1.3 (− 1.9 to − 0.6)# | − 1.5 (− 2.2 to − 0.8)# | 0.2 (− 0.7 to 1.2) | 0.613 |
 Week-10 | − 2.0 (− 2.6 to − 1.3)# | − 1.5 (− 2.2 to − 0.8)# | − 0.5 (− 1.4 to 0.5) | 0.354 |
 Week-14 | − 2.1 (− 2.8 to − 1.5)# | − 1.7 (− 2.4 to − 1.0)# | − 0.4 (− 1.4 to 0.5) | 0.382 |
 Week-18 | − 2.2 (− 2.9 to − 1.6)# | − 2.2 (− 2.9 to − 1.5)# | − 0.0 (− 1.0 to 0.9) | 0.932 |
 Week-30 | − 2.1 (− 2.8 to − 1.5)# | − 1.5 (− 2.3 to − 0.8)# | − 0.6 (− 1.6 to 0.4) | 0.227 |
 Week-42 | − 3.2 (− 3.9 to − 2.5)# | − 1.3 (− 2.0 to − 0.6)# | − 1.9 (− 2.9 to − 0.9) | < .001 |
BFI†| ||||
 Week-3 | − 1.0 (− 1.5 to − 0.6)# | − 1.1 (− 1.5 to − 0.6)# | 0.0 (− 0.6 to 0.7) | 0.917 |
 Week-6 | − 1.7 (− 2.2 to − 1.3)# | − 1.7 (− 2.2 to − 1.2)# | − 0.0 (− 0.7 to 0.6) | 0.907 |
 Week-10 | − 2.1 (− 2.6 to − 1.7)# | − 1.6 (− 2.1 to − 1.1)# | − 0.5 (− 1.2 to 0.1) | 0.117 |
 Week-14 | − 2.5 (− 2.9 to − 2.0)# | − 2.1 (− 2.6 to − 1.6)# | − 0.4 (− 1.0 to 0.3) | 0.261 |
 Week-18 | − 2.6 (− 3.1 to − 2.2)# | − 2.2 (− 2.7 to − 1.7)# | − 0.4 (− 1.1 to 0.2) | 0.189 |
 Week-30 | − 2.4 (− 2.9 to − 2.0)# | − 1.9 (− 2.4 to − 1.4)# | − 0.5 (− 1.2 to 0.1) | 0.110 |
 Week-42 | − 2.7 (− 3.2 to − 2.2)# | − 2.1 (− 2.6 to − 1.6)# | − 0.5 (− 1.2 to 0.2) | 0.134 |
BPI-SF pain severity†| ||||
 Week-3 | − 0.7 (− 1.2 to − 0.2)# | − 0.5 (− 1.0 to 0.0)# | 0.2 (− 0.9 to 0.5) | 0.578 |
 Week-6 | − 0.6 (− 1.1 to − 0.1) | − 0.6 (− 1.2 to − 0.1)# | 0.0 (− 0.7 to 0.8) | 0.914 |
 Week-10 | − 1.0 (− 1.5 to − 0.5)# | − 1.2 (− 1.7 to − 0.6)# | 0.2 (− 0.6 to 0.9) | 0.642 |
 Week-14 | − 1.0 (− 1.4 to − 0.5)# | − 1.0 (− 1.5 to − 0.5)# | 0.0 (− 0.7 to 0.8) | 0.917 |
 Week-18 | − 0.7 (− 1.2 to − 0.2) | − 1.2 (− 1.7 to − 0.6)# | 0.4 (− 0.3 to 1.2) | 0.232 |
 Week-30 | − 1.0 (− 1.5 to − 0.5)# | − 1.2 (− 1.8 to − 0.7)# | 0.3 (− 0.5 to 1.0) | 0.470 |
 Week-42 | − 1.1 (− 1.6 to − 0.6)# | − 0.7 (− 1.2 to − 0.2)# | 0.4 (− 1.1 to 0.4) | 0.285 |
BPI-SF pain interference†| ||||
 Week-3 | − 0.8 (− 1.3 to − 0.3)# | − 0.5 (− 1.0 to 0.0)# | − 0.3 (− 1.0 to 0.4) | 0.375 |
 Week-6 | − 0.9 (− 1.4 to − 0.4) | − 0.8 (− 1.3 to − 0.3)# | − 0.1 (− 0.8 to 0.6) | 0.817 |
 Week-10 | − 1.2 (− 1.7 to − 0.7)# | − 1.0 (− 1.5 to − 0.5)# | − 0.2 (− 0.9 to 0.5) | 0.528 |
 Week-14 | − 1.5 (− 2.0 to − 1.0)# | − 1.3 (− 1.8 to − 0.8)# | − 0.2 (− 0.9 to 0.5) | 0.530 |
 Week-18 | − 1.2 (− 1.7 to − 0.7)# | − 1.5 (− 2.1 to − 1.0)# | 0.4 (− 0.4 to 1.1) | 0.331 |
 Week-30 | − 1.2 (− 1.7 to − 0.7)# | − 1.6 (− 2.1 to − 1.1)# | 0.4 (− 0.3 to 1.1) | 0.300 |
 Week-42 | − 1.6 (− 2.1 to − 1.1)# | − 1.2 (− 1.7 to − 0.6)# | − 0.5 (− 1.2 to 0.3) | 0.210 |
FACT-B‡ | ||||
 Week-3 | 6.3 (3.3 to 9.4)# | 6.8 (3.6 to 10.0)# | − 0.4 (− 4.9 to 4.0) | 0.842 |
 Week-6 | 10.6 (7.5 to 13.7)# | 9.8 (6.5 to 13.1)# | 0.8 (− 3.8 to 5.3) | 0.742 |
 Week-10 | 14.2 (11.1 to 17.3)# | 10.5 (7.1 to 13.9)# | 3.7 (− 0.9 to 8.3) | 0.118 |
 Week-14 | 14.7 (11.6 to 17.9)# | 9.4 (6.0 to 12.8)# | 5.3 (0.7 to 9.9) | 0.024 |
 Week-18 | 15.8 (12.6 to 18.9)# | 12.3 (8.9 to 15.7)# | 3.5 (− 1.2 to 8.1) | 0.141 |
 Week-30 | 14.4 (11.3 to 17.6)# | 12.6 (9.2 to 16.0)# | 1.8 (− 2.8 to 6.5) | 0.441 |
 Week-42 | 19.1 (15.9 to 22.3)# | 10.1 (6.6 to 13.5)# | 9.0 (4.3 to 13.7) | < .001 |