Pilot study of the efficacy and safety of lettuce seed oil in patients with sleep disorders

Figures & data

Table 1 Baseline characteristics of the study population

Characteristic	L. sativa (n = 25)	Placebo (n = 25)	P-value
Age, years (mean ± SD)	62.5 ± 8.5	63.6 ± 7.8	0.636
Gender (M/F)	18/7	17/8	0.5
Mean total STAI score	58 ± 8.6	57 ± 9.2	0.693
Mean total sleeping score	11.84 ± 6.2	12.08 ± 5.8	0.888

Abbreviations: M, male; F, female; STAI, State-Trait Anxiety Inventory; SD, standard deviation.

Table 2 Paired-samples descriptive statistics for STAI and sleep scores

Treatment group		Paired variables	Mean	n	SD
Experimental	Pair 1	Total STAI score after treatment	45.52	25	12.65
		Total STAI score before treatment	58.08	25	10.64
	Pair 2	Total sleep score after treatment	7.4	25	3.56
		Total sleep score before treatment	11.84	25	4.04
Placebo	Pair 1	Total STAI score after treatment	51.52	25	10.77
		Total STAI score before treatment	57	25	9.33
	Pair 2	Total sleep score after treatment	10.16	25	3.51
		Total sleep score before treatment	12.08	25	3.58

Abbreviations: STAI, State-Trait Anxiety Inventory; SD, standard deviation.

Table 3 Paired-samples t-test for STAI and sleep scores

Treatment group	Variable pairs	Paired differences		95% CI		t	df	P-value
		Mean	SD	Lower	Upper
Experimental	Pair 1	−12.56	12.23	−17.61	−7.51	−5.13	24	0.00
	Pair 2	−4.44	4.56	−6.32	−2.56	−4.87	24	0.00
Placebo	Pair 1	−5.48	10.31	−9.74	−1.22	−2.66	24	0.01
	Pair 2	−1.92	4.48	−3.77	−0.07	−2.14	24	0.04

Abbreviations: SD, standard deviation; CI, confidence interval; STAI, State-Trait Anxiety Inventory.

Table 4 Multivariate effects on outcome variables^a

Effect		Value	F^b	Significance	Partial eta squared
Baseline STAI score (covariate)	Pillai trace	0.138	3.435	0.041	0.138
	Hotelling trace	0.16	3.435	0.041	0.138
Baseline sleep score (covariate)	Pillai trace	0.425	15.903	0.000	0.425
	Hotelling trace	0.74	15.903	0.000	0.425
Treatment group (independent)	Pillai trace	0.163	4.199	0.022	0.163
	Hotelling trace	0.195	4.199	0.022	0.163
Study center	Pillai trace	0.013	0.292	0.748	0.013
	Hotelling trace	0.014	0.292	0.748	0.013
Group*center	Pillai trace	0.015	0.318	0.729	0.015
	Hotelling trace	0.015	0.318	0.729	0.015

Notes:

a Design baseline STAI + baseline sleep + treatment allocation + center + group*center;

b Exact statistic.

Abbreviation: STAI, State-Trait Anxiety Inventory.

Table 5 Univariate tests of between-subject effects

Source	Dependent variable	Type III sum of squares	df	Mean square	F	P-value	Partial eta squared
Model	Effect on STAI score after treatment	6053.78^a	6	1008.963	9.281	0.000	0.559
	Effect on sleep score after treatment	1012.105^b	6	168.684	13.424	0.000	0.647
Baseline STAI score (covariate)	Effect on STAI score	440.8265	1	440.827	4.055	0.050	0.084
Baseline sleep score (covariate)	Effect on sleep score	380.3215	1	380.321	30.266	0.000	0.408
Treatment group	Effect on STAI score	593.8728	1	593.873	5.463	0.024	0.110
	Effect on sleep score	94.32857	1	94.329	7.507	0.009	0.146
Study center	Effect on STAI score	60.64028	1	60.640	0.558	0.459	0.013
	Effect on sleep score	0.658766	1	0.659	0.052	0.820	0.001
Group*Center	Effect on STAI score	6.996249	1	6.996	0.064	0.801	0.001
	Effect on sleep score	3.32109	1	3.321	0.264	0.610	0.006
Error	Effect on STAI score	4783.22	44	108.710
	Effect on sleep score	552.8946	44	12.566
Total	Effect on STAI score	10837	50
	Effect on sleep score	1565	50

Notes:

a R² 0.559 (adjusted 0.498);

b R² 0.647 (adjusted 0.599).

Abbreviation: STAI, State-Trait Anxiety Inventory.