Table 3.
Complete list of adverse events (AEs) and their severity levels in the AEs Groups and in the 3 treatment subgroups
| AEs group | HF | LF | SHAM | p value | |
|---|---|---|---|---|---|
| Total AEs | 52 | 30 (57.7%) | 13 (25.0%) | 9 (17.3%) | 0.0008** |
| Mild | 21 (40.4%) | 11 (36.7%) | 5 (38.5%) | 5 (55.6%) | 0.1801 |
| Moderate | 27 (51.9 %) | 16 (53.3%) | 7 (53.8%) | 4 (44.4%) | 0.0060** |
| Severe | 4 (7.7%) | 3 (10.0%) | 1 (7.7%) | 0 (0.0%) | – |
| Headache | 21 (40.4%) | 14 (66.7%) | 5 (23.8%) | 2 (9.5%) | 0.0038** |
| Mild | 6 (24.6 %) | 2 (14.3%) | 2 (40.0%) | 2 (100%) | – |
| Moderate | 13 (61.9%) | 10 (71.4%) | 3 (60.0%) | 0 (0.0%) | – |
| Severe | 2 (9.5%) | 2 (14.3%) | 0 (0.0%) | 0 (0.0%) | – |
| Local pain/discomfort | 10 (19.2%) | 7 (70.0%) | 1 (10.0%) | 2 (20.0%) | 0.0450* |
| Mild | 4 (40.0%) | 3 (42.8%) | 0 (0.0%) | 1 (50.0%) | – |
| Moderate | 6 (60.0%) | 4 (57.1%) | 1 (100.0%) | 1 (50.0%) | – |
| Severe | 0 (0.0%) | 0 (0.0%) | 0 (0.0) | 0 (0.0%) | – |
| Drowsiness | 8 (15.4%) | 3 (37.5%) | 2 (25.0%) | 3 (37.5%) | 0.08825 |
| Mild | 6 (75.0%) | 2 (66.6%) | 2 (100.0%) | 2 (66.6%) | – |
| Moderate | 2 (25.0%) | 1 (33.3%) | 0 (0.0%) | 1 (33.3%) | – |
| Severe | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | – |
| Insomnia | 4 (7.7%) | 2 (50.0%) | 2 (50.0%) | 0 (0.0%) | – |
| Mild | 2 (50.0%) | 2 (100%) | 0 (0.0%) | 0 (0.0%) | – |
| Moderate | 2 (50.0%) | 0 (0.0%) | 2 (100%) | 0 (0.0%) | – |
| Severe | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | – |
| Paresthesia | 4 (7.7%) | 2 (50.0%) | 1 (25.0%) | 1 (25.0%) | – |
| Mild | 2 (50.0%) | 1 (50.0%) | 1 (100.0%) | 0 (0.0%) | – |
| Moderate | 2 (50.0%) | 1 (50.0%) | 0 (0.0%) | 1 (100.0%) | – |
| Severe | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | – |
| Vasovagal reactions | 3 (5.7%) | 2 (66.7%) | 1 (33.3%) | 0 (0.0%) | – |
| Mild | 1 (33.3%) | 1 (50.0%) | 0 (0.0%) | 0 (0.0%) | – |
| Moderate | 1 (33.3%) | 0 (50.0%) | 1 (100.0%) | 0 (0.0%) | – |
| Severe | 1 (33.3%) | 1 (50.0%) | 0 (0.0%) | 0 (0.0%) | – |
| Hypertensive crisis | 2 (3.8%) | 0 (0.0%) | 1 (50.0%) | 1 (50.0%) | – |
| Mild | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | – |
| Moderate | 1 (50.0%) | 0 (0.0%) | 0 (0.0%) | 1 (100%) | – |
| Severe | 1 (50.0%) | 0 (0.0%) | 1 (100%) | 0 (0.0%) | – |
Data are expressed as percentage (%) of the total number of AEs (N.52) both in AEs group and in the subgroups (HF, LF, and Sham). The percentages of a single AE refer to the total AEs of each subgroup (HF, LF, and Sham). The percentages relative to the severity levels of AEs refer to the number of each single AE. Comparisons between the three subgroups of the treatment (HF, LF, and Sham) have been performed by Chi-square test for each analyzed variable. The Chi-square test has been applied only to those comparisons where the number of groups allowed it
AE adverse events, HF high frequency, LF low frequency
*p < 0.05; **p < 0.001