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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