TABLE 2.
Primary and secondary outcomes (intention-to-treat population)a.
| Outcome | Acupuncture group (n = 86) | Medication group (n = 84) | Between-group difference |
|
| Value (95% CI) | P-valueb | |||
| Primary outcome | ||||
| Average number of migraine days per perimenstrual periodc, cycles 1−3, mean (95% CI) | ||||
| 0.89 (0.74 to 1.05) | 1.06 (0.95 to 1.17) | 0.17 (−0.24 to 0.36) | 0.0862 | |
| Change from the baseline average number of migraine days per perimenstrual periodd, cycles 1−3, mean (95% CI)e | ||||
| 0.94 (0.82 to 1.07) | 0.61 (0.50 to 0.71) | 0.33 (0.17 to 0.50) | 0.0001 | |
| Secondary outcomes | ||||
| Change from the baseline average number of migraine days per perimenstrual period, cycles 4−6, mean (95% CI)e | ||||
| 0.84 (0.72 to 0.97) | 0.44 (0.32 to 0.56) | 0.41(0.24 to 0.58) | <0.0001 | |
| Change from the baseline average number of migraine days outside the perimenstrual period, mean (95% CI)e | ||||
| Cycles 1−3 | 1.08 (0.89 to 1.27) | 0.49 (0.39 to 0.60) | 0.59 (0.37 to 0.80) | <0.0001 |
| Cycles 4−6 | 0.95 (0.75 to 1.16) | 0.31 (0.21 to 0.41) | 0.64 (0.41 to 0.87) | <0.0001 |
| Change from the baseline mean number of migraine hours during the perimenstrual periodf, mean (95% CI)e | ||||
| Cycles 1−3 | 7.61 (6.22 to 9.02) | 5.01 (3.83 to 6.20) | 2.60 (0.79 to 4.41) | 0.0055 |
| Cycles 4−6 | 5.65 (4.36 to 6.93) | 3.09 (2.14 to 4.05) | 2.55 (0.97 to 4.13) | 0.0019 |
| Change from the baseline mean number of migraine hours outside the perimenstrual periodf, mean (95% CI)e | ||||
| Cycles 1−3 | 4.56 (3.56 to 5.66) | 2.59 (1.99 to 3.19) | 1.97 (0.82 to 3.12) | 0.0010 |
| Cycles 4−6 | 3.52 (2.66 to 4.37) | 1.51 (0.86 to 2.15) | 2.01 (0.95 to 3.07) | 0.0003 |
| Change from the baseline mean VAS score during the perimenstrual period, mean (95% CI)e | ||||
| Cycles 1−3 | 2.52 (2.15 to 2.90) | 2.14 (1.84 to 2.44) | 0.38 (−0.10 to 0.85) | 0.1221 |
| Cycles 4−6 | 2.39 (2.05 to 2.73) | 1.30 (1.09 to 1.52) | 1.08 (0.69 to 1.48) | <0.0001 |
| Change from the baseline mean VAS score outside the perimenstrual period, mean (95% CI)e | ||||
| Cycles 1−3 | 2.17 (1.76 to 2.57) | 1.81 (1.53 to 2.09) | 0.36 (−0.12 to 0.85) | 0.1462 |
| Cycles 4−6 | 1.45 (1.20 to 1.69) | 0.95 (0.71 to 1.18) | 0.50 (0.17 to 0.83) | 0.0039 |
| 50% migraine responder rate, participants, n (%)g | ||||
| Cycles 1−3 | 54 (62.8%) | 36 (42.9%) | 19.9 (5.22 to 34.64) | 0.0092 |
| Cycles 4−6 | 50 (58.1%) | 32 (38.1%) | 20.0 (5.33 to 34.76) | 0.0089 |
| Use of acute pain medication, participants, n (%)g | ||||
| Cycles 1−3 | 24 (27.9%) | 35 (41.7%) | 13.8 (−27.94 to 0.42) | 0.0595 |
| Cycles 4−6 | 40 (46.5%) | 46 (54.8%) | 8.3 (−23.23 to 6.73) | 0.2821 |
aSix participants in the acupuncture group and seven in the medication group were missing information on the average number of migraine days during/outside the perimenstrual period, mean number of migraine hours during/outside the perimenstrual period, and mean VAS score during/outside the perimenstrual period over cycles 1−3. Six participants in the acupuncture group and seven in the medication group were missing these details in cycles 4−6. The missing data of participants who dropped out were replaced using the last observation carried forward method. The number of participants with imputed data: 6 (7.0%) in the acupuncture group and 7 (8.3%) in the medication group.
bAll tests were two-sided. P-value < 0.05 was considered significant.
cThe perimenstrual period is starts from the two days before the onset of menstruation to first three days of menstruation.
dBaseline was calculated as the cycle average of the three-cycle screening phase prior to the start of treatment.
eAnalyzed by fitting a mixed-effect model using the baseline value as a covariate, treatment as a fixed effect, and center as a random effect.
fBaseline was calculated the daily average of the three-cycle screening phase prior to the start of treatment.
gAnalyzed using the chi-square test.
CI, confidence interval; VAS, visual analog scale.