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

Table 2 Sleep Diary and Daytime Function Measures by Treatment Group

	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 Quality^c	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 Score^d	13.9 ± 3.6	11.6 ± 4.5	15.1 ± 3.7	11.9 ± 4.7	0.28	0.60
PSQI Total Score^d	9.5 ± 2.1	7.1 ± 2.7	10.1 ± 2.5	7.5 ± 3.3	0.10	0.88
Daytime Functioning Measures
FSS^d	30.9 ± 9.1	32.3 ± 10.0	32.1 ± 10.6	27.9 ± 9.3	0.55	0.11
BDI^d	6.0 ± 6.0	4.8 ± 5.0	3.2 ± 1.6	2.4 ± 2.4	0.31	0.60
STAI
Trait Subscale^d	37.5 ± 11.3	40.8 ± 15.5	36.3 ± 10.1	35.5 ± 11.0	0.57	0.45

^aEffect size is calculated using Cohen's d
^bP-value is derived from a general linear model adjusted for group assignment and baseline value of measure
^cSleep quality rated from 1 (very poor) to 5 (very good)
^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.

ISSN: 2662-7671