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Table 1 Baseline characteristics across treatment sequence

From: Efficacy of melatonin for sleep disturbance following traumatic brain injury: a randomised controlled trial

  Treatment sequence  
TBI characteristics Melatonin then placebo (n = 18) Placebo then melatonin (n = 15) Overall (n = 33)
Age, mean (SD), years 35 (11) 38 (11) 37 (11)
Body mass index, mean (SD), kg/m2 25.5 (3.7) 26.1 (4.1) 25.7 (3.8)
Males, no. (%) 11 (61) 11 (73) 22 (67)
Paid employment, no. (%)a 4 (22) 3 (20) 7 (21)
Months post-injury, median (IQR Q1–Q3) 61 (28–115) 25 (10–72) 46 (13–102)
Lowest GCS, median (IQR Q1–Q3), raw value 5 (3–9) 8 (3–13) 6 (3–12)
PTA duration, median (IQR Q1–Q3), days 21 (12–45) 41 (27–60) 33 (13–47)
Mild TBI, no. (%), PTA 0 to ≤ 1 day 2 (13) 2 (6)
Moderate TBI, no. (%), PTA >1 to ≤ 7 days 2 (11) 1 (7) 3 (9)
Severe TBI, no. (%), PTA > 7 days 16 (89) 12 (80) 28 (85)
Patients prescribed medication, no. (%) 13 (72) 6 (40) 19 (58)
 Patients using analgesics, no. (%) 7 (38) 2 (13) 9 (27)
 Patients using antacids, no. (%) 1 (6) 1 (7) 2 (6)
 Patients using antidepressants, no. (%) 6 (33) 2 (13) 8 (24)
 Patients using antiepileptics, no. (%) 4 (22) 3 (20) 7 (21)
 Patients using multivitamins, no. (%) 1 (6) 1 (7) 2 (6)
 Patients using NSAIDs, no. 1 (6) 2 (13) 3 (9)
PSQI, global score 10 (3) 12 (4) 11 (3)
Sleep latency, minimum, median (IQR Q1–Q3) 25 (15–55) 23 (13–52) 24 (14–52)
Sleep efficiency, %, (IQR Q1–Q3) 76 (82–86) 81 (71–83) 81 (75–83)
ESS, score 7 (4) 9 (5) 8 (5)
HADS anxiety 8 (4) 8 (5) 8 (4)
HADS depression 11 (6) 8 (6) 10 (6)
FSS, score, median (IQR Q1–Q3) 48 (39–56) 49 (42–59) 49 (41–57)
SF-36 v1
 Physical functioning (PF), score 36 (16) 42 (13) 38 (15)
 Role physical (RP), score 39 (14) 38 (12) 38 (13)
 Role emotional (RE), score 38 (15) 41 (11) 39 (13)
 Vitality (VT), score 39 (9) 37 (10) 38 (9)
 Mental health (MH), score 40 (13) 40 (9) 40 (11)
 Social functioning (SF), score 38 (12) 35 (14) 37 (13)
 Bodily pain (BP), score 44 (14) 40 (12) 42 (13)
 General health (GH), score 42 (11) 39 (15) 40 (13)
  1. ESS Epworth Sleepiness Scale, FSS Fatigue severity scale, GCS Glasgow coma scale, HADS Hospital Anxiety Depression Scale, IQR inter-quartile range, PSQI Pittsburgh Sleep Quality Index, NSAID nonsteroidal anti-inflammatory drug, PTA Post-traumatic amnesia, SF-36 v1 Short-form health survey, TBI traumatic brain injury
  2. aPaid employment reflects part-time and full-time employment