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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