Table 4 Adverse events.
Adverse event, # (%) | Verum (n = 259) | Sham (n = 279) | Total (N = 538) | P | Verum (n = 207) | Sham (n = 231) | Total (N = 438) | P |
|---|---|---|---|---|---|---|---|---|
Forehead paresthesias, discomfort or burning | 9 (3.5) | 1 (0.4) | 10 (1.9) | 0.009 | 4 (1.9) | 1 (0.4) | 5 (1.1) | 0.194 |
Nausea/vomiting | 4 (1.5) | 0 (0.0) | 4 (0.7) | 0.053 | 3 (1.4) | 0 (0.0) | 3 (0.7) | 0.105 |
Dizziness | 1 (0.4) | 2 (0.7) | 3 (0.6) | 1.000 | 1 (0.5) | 1 (0.4) | 2 (0.5) | 1.000 |
Neck stiffness/muscle tension | 1 (0.4) | 2 (0.7) | 3 (0.6) | 1.000 | 1 (0.5) | 2 (0.9) | 3 (0.7) | 1.000 |
Worsened headache | 2 (0.8) | 0 (0.0) | 2 (0.4) | 0.231 | 0 (0.0) | 0 (0.0) | 0 (0.0) | – |
Orodynia—tooth or jaw pain | 1 (0.4) | 1 (0.4) | 2 (0.4) | 1.000 | 0 (0.0) | 1 (0.4) | 1 (0.2) | 1.000 |
Restlessness | 1 (0.4) | 1 (0.4) | 2 (0.4) | 1.000 | 1 (0.5) | 1 (0.4) | 2 (0.5) | 1.000 |
Abdominal discomfort or cramping | 0 (0.0) | 2 (0.7) | 2 (0.4) | 0.500 | 0 (0.0) | 0 (0.0) | 0 (0.0) | – |
Dry mouth | 1 (0.4) | 0 (0.0) | 1 (0.2) | 0.481 | 1 (0.5) | 0 (0.0) | 1 (0.2) | 0.473 |
Excessive sweating | 2 (0.8) | 0 (0.0) | 2 (0.4) | 0.231 | 2 (1.0) | 0 (0.0) | 2 (0.5) | 0.223 |
Sedation/sleepiness | 1 (0.4) | 0 (0.0) | 1 (0.2) | 0.481 | 1 (0.5) | 0 (0.0) | 1 (0.2) | 0.473 |
Total patients with an adverse effect | 22 (8.5) | 8 (2.9) | 30 (5.6) | 0.004 | 14 (6.8) | 5 (2.2) | 19 (4.3) | 0.018 |
