A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Effects of Kamishoyosan, a Traditional Japanese Medicine, on Menopausal Symptoms: The KOSMOS Study

Table 1

Baseline characteristics of the study participants.

	Placebo nonresponder (NR)			Placebo responder (R)			NR vs. R
	TJ-24 (n = 20)	Placebo (n = 20)	P value	TJ-24 (n = 7)	Placebo (n = 6)	value	value
Age (years)	51.5 ± 2.6	51.2 ± 3.4	0.798a	52.1 ± 2.5	50.7 ± 1.4	0.231a	0.881a
BMI (kg/m2)	21.0 ± 1.9	22.9 ± 4.2	0.072a	24.4 ± 2.6	22.6 ± 3.0	0.294a	0.126a
Time from LMP (days)	750.6 ± 889.7	708.0 ± 946.9	0.884a	498.3 ± 342.5	232.3 ± 136.6	0.103a	0.175a
Menopausal status
Premenopausal	11 (55.0%)	11 (55.0%)	1.000 b	2 (28.6%)	5 (83.3%)	0.103 b	1.000b
Postmenopausal	9 (45.0%)	9 (45.0%)		5 (71.4%)	1 (16.7%)
Disease duration (months)	26.3 ± 20.3	21.8 ± 19.7	0.500a	27.0 ± 18.3	11.8 ± 10.0	0.099a	0.521a
Excitability and irritability score	7.2 ± 1.3	6.9 ± 1.4	0.625c	3.7 ± 1.8	3.8 ± 1.9	1.000c	<0.001c
Hot flashes score	5.7 ± 2.2	6.0 ± 2.2	0.582c	5.7 ± 2.5	4.2 ± 2.1	0.184c	0.211c
Sweating score	6.3 ± 2.1	6.7 ± 2.2	0.534c	6.3 ± 0.8	4.2 ± 2.4	0.069c	0.048c
Difficulty in sleeping score	5.3 ± 2.6	5.4 ± 2.7	0.870c	4.1 ± 2.3	4.2 ± 2.9	0.885c	0.189c
Waking up at night score	4.6 ± 2.6	6.4 ± 2.2	0.024c	6.3 ± 1.9	3.8 ± 2.9	0.131c	0.723c

^aStudent’s t-test. ^bFisher’s exact test. ^cWilcoxon’s rank-sum test.