Table 2.
Primary outcome measurements of full analysis set population. Values are mean (SD) unless stated otherwise
| Time point | Manual acupuncture (n=58) | Sham acupuncture (n=60) | Usual care (n=29) | P value* | Pairwise comparisons—mean (95% CI) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Manual v sham | P value* | Manual v usual care | P value* | Sham v usual care | P value* | |||||
| Change from baseline in mean number of days with migraine | ||||||||||
| Weeks 1-4 | −2.2 (2.0) | −1.6 (3.0) | −0.7 (2.9) | 0.003 | −0.9 (−1.8 to 0.0) | 0.052 | −1.5 (−2.5 to −0.4) | 0.004 | −0.6 (−1.7 to 0.5) | 0.589 |
| Weeks 5-8 | −3.1 (2.6) | −2.7 (3.6) | −1.3 (2.5) | 0.002 | −0.7 (−1.6 to 0.2) | 0.198 | −1.7 (−2.8 to −0.5) | 0.001 | −1.0 (−2.1 to 0.2) | 0.119 |
| Weeks 9-12 | −3.5 (2.6) | −2.9 (3.8) | −1.3 (2.7) | <0.001 | −1.0 (−2.0 to 0.1) | 0.077 | −2.1 (−3.4 to −0.8) | <0.001 | −1.1 (−2.4 to 0.1) | 0.100 |
| Weeks 13-16 | −3.5 (2.5) | −2.4 (3.4) | −1.0 (2.4) | <0.001 | −1.4 (−2.4 to −0.3) | 0.005 | −2.4 (−3.7 to −1.2) | <0.001 | −1.1 (−2.3 to 0.2) | 0.136 |
| Weeks 17-20 | −3.9 (3.0) | −2.2 (3.2) | −1.4 (2.7) | <0.001 | −2.1 (−2.9 to −1.2) | <0.001 | −2.4 (−3.5 to −1.4) | <0.001 | −0.4 (−1.4 to 0.7) | 0.495 |
| Change from baseline in mean number of migraine attacks | ||||||||||
| Weeks 1-4 | −1.1 (1.3) | −1.0 (2.5) | −0.2 (1.5) | 0.032 | −0.3 (−0.9 to 0.3) | 0.643 | −0.8 (−1.6 to −0.1) | 0.026 | −0.5 (−1.3 to 0.2) | 0.305 |
| Weeks 5-8 | −1.8 (1.4) | −1.7 (2.5) | −0.7 (1.3) | 0.002 | −0.3 (−0.9 to 0.2) | 0.526 | −1.0 (−1.7 to −0.4) | <0.001 | −0.7 (−1.4 to 0.0) | 0.032 |
| Weeks 9-12 | −1.9 (1.3) | −1.8 (2.7) | −0.4 (1.3) | <0.001 | −0.4 (−1.0 to 0.2) | 0.410 | −1.5 (−2.3 to −0.8) | <0.001 | −1.1 (−1.9 to −0.4) | 0.001 |
| Weeks 13-16 | −2.1 (1.5) | −1.8 (2.7) | −0.7 (1.3) | <0.001 | −0.6 (−1.2 to 0.1) | 0.092 | −1.3 (−2.1 to −0.6) | <0.001 | −0.8 (−1.5 to 0.0) | 0.043 |
| Weeks 17-20 | −2.3 (1.7) | −1.6 (2.5) | −0.4 (1.3) | <0.001 | −1.0 (−1.5 to −0.5) | <0.001 | −1.8 (−2.4 to −1.2) | <0.001 | −0.8 (−1.4 to −0.2) | 0.008 |
*
P values, differences, and confidence intervals were based on analysis of covariance adjusted for days with migraine (or number of migraine attacks) at baseline. According to fixed sequence procedure planned for primary analyses, pairwise comparisons at weeks 17-20 were made at nominal α level without further adjustment. For visits other than weeks 17-20, multiple pairwise comparisons were adjusted by Bonferroni approach.