Table 1.
Baseline demographic and clinical features for each arm of the study participants.
| Variables | Active (n = 29) |
Placebo (n = 22) |
p-Values |
|---|---|---|---|
| Age (years) | 52.90 ± 6.47 | 52.50 ± 7.48 | 0.90 |
| BMI (kg/m2) | 23.58 ± 3.15 | 22.95 ± 2.83 | 0.39 |
| Heart rate (bpm) | 75.27 ± 11.69 | 74.50 ± 7.71 | 1.00 |
| Concomitant drugs | |||
| Anticonvulsants | 9 | 6 | 0.98 |
| Antidepressants | 24 | 16 | 0.60 |
| Anxiolytics | 19 | 14 | 0.87 |
| Analgesics | 21 | 13 | 0.48 |
| NSAIDs | 6 | 5 | 0.86 |
Data are expressed as means ± standard deviation (SD) for continuous variables. In both cases, the non-parametric Mann–Whitney U test was used because the samples were not normally distributed. No significant differences were observed in either case, confirming that both samples were derived from the same population. The Chi-squared test of independence was performed with one degree of freedom, and no significant differences in the proportions were observed, so no variable was considered to exert a different influence depending on the group. Abbreviations: BMI, body mass index; NSAIDs, non-steroidal anti-inflammatory drugs.