Table 1. Baseline demographic and clinical characteristics of the study patients .
| Characteristic |
Melatonin
(n=30) # |
Placebo
(n=30) # |
P value * |
| Age (years)a | 46.10±23.92 (18-97) | 49.27±19.96 (18-93) | 0.580 |
| Male/femaleb | 24/6 | 24/6 | 1.000 |
| Admission's wardc | |||
| ICU | 29 (96.67) | 26 (86.67) | 0.353 |
| Neurology | 1 (3.33) | 4 (13.33) | |
| Diagnosis categoryc | |||
| Ischemic stroke | 3 (10.00) | 6 (20.00) | 0.081d |
| Hemorrhagic stroke | 5 (16.66) | 11 (36.67) | |
| Brain tumor | 2 (6.67) | 0 (0) | |
| Traumatic brain injury | 20 (66.67) | 13 (43.33) | |
| Non-traumatic/traumaticb | 10/20 | 17/13 | 0.119 |
| Multiple traumac | 11 (36.67) | 12 (40.00) | 0.791 |
| Laboratory datae | |||
| Serum creatinine (mg/dL) | 1.04±0.32 | 1.02±0.22 | 0.889 |
| BUN (mg/dL) | 15.13±9.21 | 14.77±6.33 | 0.858 |
| WBC (103/mm3) | 9.94±2.86 | 9.76 ±3.86 | 0.844 |
| Hb (g/dL) | 10.84±2.15 | 10.95±2.19 | 0.849 |
| Platelet (103/mm3) | 119.23±43.46 | 126.79±43.45 | 0.507 |
| AST (U/L) | 47.25±43.07 | 32.00±14.59 | 0.252 |
| ALT (U/L) | 28.94±18.99 | 24.45±11.31 | 0.488 |
| Albumin (g/dL) | 3.29±0.49 | 3.35±0.58 | 0.690 |
| CRP (mg/L) | 80.28±20.74 | 76.28±33.68 | 0.882 |
| GCSf | 7 (5.75-10.5) | 7.5 (6-15) | 0.249 |
| GCS ≤8c | 21 (70.00) | 17 (56.67) | 0.422 |
| GCS >8c | 9 (30.00) | 13 (43.33) | |
| APACHE II scoree | 14.96±5.43 | 12.46±6.17 | 0.116 |
| SOFAf | 6 (4-7) | 5.5 (1.75-8) | 0.419 |
| RLAS-Rf | 3 (3-5) | 4.5 (3-6) | 0.073 |
| mRSf | 5 (5-5) | 5 (5-5) | 0.960 |
| MDA (µmol/L)f | 14.85 (10.82-24.82) | 11.35 (9.35-17.84) | 0.174 |
| S100B (pg/mL)f | 232.10 (74.18-458.54) | 392.87 (123.35-481.68) | 0.620 |
ICU: intensive care unit; BUN: blood urea nitrogen; WBC: white blood cell; Hb: hemoglobin; AST: aspartate aminotransferase; ALT: alanine aminotransferase; CRP: C-reactive protein; GCS: Glasgow coma scale; APACHE: acute physiology and chronic health evaluation; SOFA: sequential organ failure assessment; RLAS-R: Rancho Los Amigos revised scale; mRS: modified Rankin scale; MDA: malondialdehyde.
#The values of CRP, MDA, and S100B are referred to 20 patients in each group. APACHE II and SOFA scores were measured only in ICU-admitted patients; *Independent-samples t-test and Mann-Whitney U test were used to compare parametric and nonparametric values, respectively. Chi-square test was performed to compare nominal values; aMean ± standard deviation (range); bNumber; cNumber (%); dThere were no significant differences regarding tumor types and their numbers between the two groups; eMean ± standard deviation; fMedian (first and third quartiles).