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Table 2 Mixed-model results, including mean estimate under both treatments, the difference of treatments (melatonin minus placebo), effect size and significance level

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

  

Adjusted mean (95% CI)a

   
 

No. of participants

Melatonin treatment

Placebo treatment

Treatment effect estimate (95% CI)

Effect sizee (d)

p value

Primary outcomes

 PSQI, global score

33

7.68 (6.34 to 9.02)

9.47 (8.13 to 10.81)

-1.79 (-2.70 to -0.88)

0.46

<0.0001

 Sleep latency, minimumb

31

1.37 (1.26 to 1.48)

1.42 (1.31 to 1.53)

-0.05 (-0.14 to 0.03)

0.18

0.23

Secondary outcomes

 Sleep efficiencyc

31

-3.22 (-3.61 to -2.82)

-3.54 (-3.94 to -3.13)

0.32 (0.01 to 0.63)

0.28

0.04

 ESS, scored

33

2.36 (2.00 to 2.73)

2.53 (2.17 to 2.90)

-0.17 (-0.40 to 0.06)

0.17

0.15

 HADS anxiety, score

32

7.84 (6.23 to 9.45)

9.00 (7.39 to 10.61)

-1.15 (-1.97 to -0.34)

0.27

0.006

 HADS depression, score

32

8.53 (6.93 to 10.13)

8.34 (6.75 to 9.94)

0.18 (-0.70 to 1.07)

0.04

0.68

 FSS, scorec

33

-4.18 (-4.74 to -3.62)

-3.73 (-4.28 to -3.17)

-0.45 (-0.86 to -0.04)

0.29

0.03

SF-36 v1

 Physical functioning (PF), score

33

43.17 (39.15 to 47.20)

41.72 (37.69 to 45.75)

1.45 (-0.33 to 3.24)

0.13

0.11

vRole physical (RP), score

33

37.66 (33.61 to 41.70)

38.10 (34.06 to 42.15)

-0.44 (-3.38 to 2.49)

0.03

0.77

 Role-emotional (RE), score

33

37.58 (33.11 to 42.06)

36.85 (32.38 to 41.32)

0.73 (-3.38 to 4.84)

0.05

0.73

 Vitality (VT), score

33

42.43 (38.97 to 45.90)

38.76 (35.30 to 42.22)

3.67 (0.36 to 6.98)

0.35

0.03

 Mental health (MH), score

33

43.60 (40.00 to 47.24)

41.09 (37.45 to 44.73)

2.51 (0.58 to 4.42)

0.23

0.01

 Social functioning (SF), score

33

37.09 (33.05 to 41.13)

34.82 (30.78 to 38.86)

2.27 (-1.36 to 5.90)

0.19

0.22

 Bodily pain (BP), score

33

44.07 (39.85 to 48.30)

43.27 (39.05 to 47.50)

0.80 (-1.39 to 2.99)

0.06

0.48

 General health (GH), score

33

40.96 (36.95 to 44.97)

40.29 (36.28 to 44.30)

0.67 (-0.97 to 2.30)

0.06

0.42

  1. CI confidence interval, ESS Epworth Sleepiness Scale, FSS Fatigue severity scale, HADS Hospital Anxiety Depression Scale, PSQI Pittsburgh Sleep Quality Index
  2. aMeans adjusted for sequence and period
  3. bVariable was log transformed
  4. cVariable was reflected and square root transformed and then multiplied by -1 to restore directionality
  5. dSquare root transformation applied
  6. eCohens d effect size