Table 3.
Baseline characteristics [n, %, or mean (SD)]
| Study | A [14] | B [16] | C [15] | |||
|---|---|---|---|---|---|---|
| Treatment | Silexan | Placebo | Silexan | Placebo | Silexan | Placebo |
| Safety analysis set | 107 | 109 | 86 | 84 | 160 | 158 |
| Full analysis set | 104 | 108 | 86 | 84 | 159 | 156 |
| % Female | 73.1 | 76.9 | 72.1 | 71.4 | 66.0 | 72.4 |
| Age (years) | 45.6 (11.4) | 46.6 (11.3) | 48.0 (11.3) | 46.9 (12.7) | 47.7 (12.6) | 47.9 (12.6) |
| HAMA total score | 26.8 (5.4) | 27.1 (5.2) | 25.5 (6.0) | 26.5 (6.1) | 25.7 (5.6) | 25.7 (5.2) |
| Anxiety self-ratinga | 60.1 (9.9) | 61.1 (10.1) | 54.5 (12.3) | 55.9 (10.3) | 12.7 (3.6) | 12.4 (3.5) |
| CGI severity of illness | 4.6 (0.7) | 4.7 (0.6) | 4.4 (0.7) | 4.5 (0.7) | 4.4 (0.7) | 4.4 (0.7) |
| PSQI total score | 12.3 (2.9) | 12.5 (3.0) | 12.2 (205) | 12.7 (2.7) | NA | NA |
| SF-36 physical health | 51.7 (21.7) | 53.2 (22.1) | NA | NA | 48.2 (23.5) | 49.3 (22.7) |
| SF-36 mental health | 32.3 (17.4) | 32.6 (21.2) | NA | NA | 30.0 (19.5) | 33.4 (21.3) |
All results apply to the full analysis set. SF-36: higher values indicate less symptom severity; for all other scales, lower values indicate less symptom severity
NA not assessed, HAMA Hamilton Anxiety Rating Scale, CGI Clinical Global Impressions, PSQI Pittsburgh Sleep Quality Index, SF-36 SF-36 Health Survey Questionnaire
aTrials A, B: Zung Self-rating Anxiety Scale (SAS) total score; trial C: Hospital Anxiety and Depression Scale (HADS), anxiety subscale