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Table 2 Sleep Diary and Daytime Function Measures by Treatment Group

From: Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: A randomized placebo-controlled pilot study

  Placebo N = 17 Mean ± SD Chamomile N = 17 Mean ± SD   
Measure Baseline Week 4 Baseline Week 4 Effect Size a P-value b
Subjective Sleep Measures
Sleep Latency (min) 33.9 ± 32.2 32.9 ± 4.3 50.3 ± 53.0 34.2 ± 6.6 0.47 0.41
Wake After Sleep Onset (min) 44.6 ± 46.3 25.9 ± 24.4 49.0 ± 36.6 32.0 ± 27.3 0.06 0.51
Awakenings (#) 1.6 ± 1.1 1.3 ± 0.7 2.2 ± 1.3 1.4 ± 0.6 0.61 0.46
Total Sleep Time (hrs) 5.8 ± 1.0 6.5 ± 1.0 5.9 ± 1.7 6.1 ± 1.2 0.59 0.07
Sleep Qualityc 3.0 ± 0.7 3.3 ± 0.5 2.7 ± 0.7 3.1 ± 0.5 0.23 0.86
Sleep Efficiency (%) 76.7 ± 12.0 83.3 ± 7.7 71.9 ± 16.7 77.5 ± 12.9 0.09 0.21
ISI Scored 13.9 ± 3.6 11.6 ± 4.5 15.1 ± 3.7 11.9 ± 4.7 0.28 0.60
PSQI Total Scored 9.5 ± 2.1 7.1 ± 2.7 10.1 ± 2.5 7.5 ± 3.3 0.10 0.88
Daytime Functioning Measures
FSSd 30.9 ± 9.1 32.3 ± 10.0 32.1 ± 10.6 27.9 ± 9.3 0.55 0.11
BDId 6.0 ± 6.0 4.8 ± 5.0 3.2 ± 1.6 2.4 ± 2.4 0.31 0.60
STAI       
Trait Subscaled 37.5 ± 11.3 40.8 ± 15.5 36.3 ± 10.1 35.5 ± 11.0 0.57 0.45
  1. aEffect size is calculated using Cohen's d
  2. bP-value is derived from a general linear model adjusted for group assignment and baseline value of measure
  3. cSleep quality rated from 1 (very poor) to 5 (very good)
  4. d BDI = Beck Depression Inventory, a score of ≥ 14 is consistent with mild depression, a score of ≥ 20 is consistent with moderate depression and a score ≥ 29 indicates severe depression; ISS = Insomnia Severity Index, 0-7 no clinically significant insomnia, 8-14 is subthreshold insomnia, 15-21 moderate clinical insomnia and ≥ 22 severe clinical insomnia; PSQI = Pittsburgh Sleep Quality Index, scores range from 0-21 with ≥ 6 suggests poor sleep quality; STAI = State Trait Anxiety Inventory, scores range from 20 (no to mild anxiety) to 80 (severe anxiety); FSS = Fatigue Severity Scale, scores range from 9-59 with a score of ≥ 36 indicating significant fatigue and impairment in daytime functioning.