Dose-Dependent Effects of the Cimicifuga racemosa Extract Ze 450 in the Treatment of Climacteric Complaints: A Randomized, Placebo-Controlled Study

Table 1

Demographic details: mean (SD), ITT population.

	n	Placebo	n	Low dose	n	High dose	P value^1
Age (years)	54	50.5 (7.0)	57	52.0 (6.3)	55	52.8 (6.0)	0.168
Weight (kg)	54	67.7 (11.6)	57	70.5 (13.0)	55	68.3 (12.2)	0.433
BMI (kg/m^2)	54	24.9 (4.3)	57	25.6 (5.1)	55	25.0 (3.9)	0.634
Height (cm)	54	164.9 (5.1)	57	166.3 (7.1)	55	165.2 (7.4)	0.537
KMI (points)	54	27.3 (6.5)	57	28.1 (6.9)	55	28.4 (8.0)	0.692
QoL (mm)	54	37.2 (15.6)	57	31.2 (15.9)	55	34.7 (17.6)	0.150
Premenopausal (n)	54	15	57	12	55	11	0.803^2
Early postmenopausal (n)	54	27	57	28	55	30
Late postmenopausal (n)	54	12	57	17	55	14
Baseline FSH ≤ 40 mIU/mL (n)	54	21	57	22	55	15	0.333^2
Baseline FSH > 40 mIU/mL (n)	54	22	57	26	55	33
Baseline FSH unknown	54	11	57	9	55	7
Baseline KMI ≤ 20	54	9	57	10	55	10	0.454^2
Baseline KMI 21–35	54	36	57	41	55	32
Baseline KMI > 35	54	9	57	6	55	13
Nonsmoker (n)	54	41	57	44	55	39	0.575^3
Occasional smoker (n)	54	3	57	0	55	4
Moderate smoker (n)	54	6	57	7	55	7
Heavy smoker (n)	54	4	57	6	55	5

¹Analysis of variance, ²Chi-square test, ³Fisher’s exact test.