Table 2 Patient characteristics.
Variable | ITT analysis | Per protocol analysis | ||||||
|---|---|---|---|---|---|---|---|---|
Verum (n = 259) | Sham (n = 279) | Total (N = 538) | P | Verum (n = 207) | Sham (n = 231) | Total (N = 438) | P | |
Age (yr) | 40.22 ± 11.62 | 42.0 ± 12.30 | 41.14 ± 12.00 | 0.087 | 40.64 ± 11.25 | 40.85 ± 11.84 | 40.75 ± 11.56 | 0.847 |
Gender | ||||||||
Female | 214 (82.6) | 229 (82.1) | 443 (82.3) | 0.868 | 173 (83.6) | 191 (82.7) | 364 (83.1) | 0.804 |
Male | 45 (17.4) | 50 (17.9) | 95 (17.7) | 34 (16.4) | 40 (17.3) | 74 (16.9) | ||
Headache pain at baseline | ||||||||
No pain | 1 (0.4) | 0 (0.0) | 1 (0.2) | 0.532 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.552 |
Mild | 1 (0.4) | 0 (0.0) | 1 (0.2) | 1 (0.5) | 0 (0.0) | 1 (0.2) | ||
Moderate | 155 (59.8) | 166 (59.5) | 321 (59.7) | 125 (60.4) | 143 (61.9) | 268 (61.2) | ||
Severe | 102 (39.4) | 113 (40.5) | 215 (40.0) | 81 (39.1) | 88 (38.1) | 169 (38.6) | ||
Symptoms at baseline | ||||||||
Photophobia | 247 (95.4) | 259 (92.8) | 506 (94.1) | 0.214 | 198 (95.7) | 214 (92.6) | 412 (94.1) | 0.183 |
Phonophobia | 207 (79.9) | 228 (81.7) | 435 (80.9) | 0.529 | 164 (79.2) | 189 (81.8) | 353 (80.6) | 0.482 |
Nausea | 169 (65.3) | 172 (61.6) | 341 (63.4) | 0.386 | 139 (67.1) | 144 (62.3) | 283 (64.6) | 0.293 |
Vomiting | 23 (8.9) | 24 (8.6) | 47 (8.7) | 0.909 | 18 (8.7) | 17 (7.4) | 35 (8.0) | 0.607 |
MBS at baseline | ||||||||
Photophobia | 162 (62.5) | 183 (65.6) | 345 (64.1) | 0.685 | 133 (64.3) | 149 (64.5) | 282 (64.4) | 0.469 |
Phonophobia | 38 (14.7) | 35 (12.5) | 73 (13.6) | 28 (13.5) | 32 (13.9) | 60 (13.7) | ||
Nausea | 55 (21.2) | 54 (19.4) | 109 (20.3) | 45 (21.7) | 45 (19.5) | 90 (20.5) | ||
Vomiting | 4 (1.5) | 7 (2.5) | 11 (2.0) | 1 (0.5) | 5 (2.2) | 6 (1.4) | ||
Migraine with aura | 113 (43.6) | 111 (39.8) | 224 (41.6) | 0.366 | 87 (42.0) | 88 (38.1) | 175 (40.0) | 0.401 |
Duration of treatment | 120.0, 30.0 | 120.0, 24.0 | 120.0, 25.0 | U = 35,011, 0.463 | 120.0, 0.0 | 120.0, 1.0 | 120.0, 0.0 | U = 21,014, 0.002 |
