Table 2.
Co-primary efficacy outcomes and secondary efficacy outcomes
| Group | p value | ||
|---|---|---|---|
| Laser acupuncture (n = 30) | Sham treatment (n = 30) | ||
| Co-primary efficacy outcomes | |||
| The change from baseline in MMD, mean ± SD, day | |||
| 4th week | -3.4 ± 4.3 | -1.5 ± 4.4 | 0.190a |
| 8th week | -5.2 ± 6.6 | -1.5 ± 3.8 | 0.015a* |
| 12th week | -7.3 ± 7.0 | -1.8 ± 3.5 | 0.001a* |
| The change from baseline in acute headache medications usage days per month, mean (SD), day | |||
| 4th week | -3.1 ± 3.9 | -0.4 ± 2.6 | 0.007a* |
| 8th week | -3.2 ± 4.3 | 0.0 ± 3.0 | 0.005a* |
| 12th week | -3.9 ± 3.8 | 0.0 ± 2.7 | < 0.001a* |
| Secondary efficacy outcomes | |||
| The change from baseline in headache lasting time, mean ± SD, hour | |||
| 4th week | -1.2 ± 4.2 | 0.0 ± 3.4 | 0.201a |
| 8th week | -2.2 ± 5.7 | -0.4 ± 2.9 | 0.130a |
| 12th week | -2.6 ± 5.3 | 0.0 ± 2.2 | 0.006a* |
| The change from baseline in headache severity, mean ± SD, NRS | |||
| 4th week | -1.1 ± 1.5 | -0.2 ± 1.5 | 0.011a* |
| 8th week | -1.2 ± 1.6 | -0.2 ± 1.5 | 0.006a* |
| 12th week | -1.3 ± 1.4 | 0.1 ± 1.5 | < 0.001a* |
| The change from baseline in MIDAS score, mean ± SD | |||
| 4th week | -15.7 ± 23.9 | -8.3 ± 24.6 | 0.193a |
| 8th week | -24.6 ± 33.1 | -5.9 ± 24.7 | 0.033a* |
| 12th week | -28.4 ± 33.5 | -5.5 ± 26.5 | 0.012a* |
| 30% reduction in migraine days, n (%) | |||
| 4th week | 8 (26.7%) | 4 (13.3%) | 0.197b |
| 8th week | 12 (40.0%) | 4 (13.3%) | 0.020b* |
| 12th week | 16 (53.3%) | 6 (20.0%) | 0.007b* |
MMD monthly migraine days, SD standard deviation, NRS Numeric Rating Scale, MIDAS Migraine Disability Assessment
ap values based on chi-squared test
bp values based on Fisher’s exact test
*p values less than 0.05