Table 3 Number of dropouts and days with headache and migraine per 4 weeks related to treatment sequence and use of placebo in baseline period (N = 264)
Placebo given in baseline period | Placebo not given in baseline period | All | ||||
|---|---|---|---|---|---|---|
Treatment sequence | Placebo in first period | Active treatment in first period | Placebo in first period | Active treatment in first period | Placebo in first period | Active treatment in first period |
Number included | 60 | 60 | 60 | 84 | 120 | 144 |
Dropouts during first period | 2 | 5 | 1 | 11 | 3 | 16 |
Migraine days/month, mean (SD) | ||||||
Baseline period | 6.0 (2.9) | 6.2 (3.4) | 5.5 (2.4) | 5.2 (2.9) | 5.8 (2.7) | 5.6 (3.1) |
Placebo treatment period | 5.0 (3.0) | 5.5 (3.2) | 3.9 (2.2) | 3.9 (2.7) | 4.4 (2.6) | 4.6 (3.0) |
Washout period | 4.6 (3.9)1 | 5.9 (4.3)1 | 3.8 (3.1)2 | 4.0 (2.7)2 | 4.2 (3.5)2 | 4.8 (3.6)2 |
Number of responders (% of eligible)4 | 16 (27.6)5 | 15 (27.3)5 | 16 (27.1)5 | 24 (32.9)5 | 32 (27.4)5 | 39 (30.5)5 |
Headache days/month, mean (SD) | ||||||
Baseline period | 8.4 (3.7) | 9.8 (5.3) | 6.8 (3.0) | 7.7 (4.1) | 7.6 (3.5) | 8.5 (4.8) |
Placebo treatment period | 7.0 (4.1) | 7.4 (4.1) | 4.9 (2.8) | 5.7 (3.9) | 5.9 (3.6) | 6.4 (4.1) |
Washout period | 6.1 (4.3)3 | 9.1 (6.5)3 | 4.5 (3.5)1 | 5.6 (4.2)1 | 5.3 (4.0)3 | 7.1 (5.6)3 |
Number of responders (% of eligible)4 | 13 (22.4)5 | 13 (23.6)5 | 16 (27.1)5 | 19 (26.0)5 | 29 (24.8)5 | 32 (25.0)5 |