Dose-Dependent Effects of the Cimicifuga racemosa Extract Ze 450 in the Treatment of Climacteric Complaints: A Randomized, Placebo-Controlled Study
Table 4
Change in symptom severity as assessed by total KMI in patient subgroups.
Treatment
n
Baseline
End of study
Absolute differences
Hierarchical test procedure*
Mean (SD)
Mean
Mean (SD)
95% CI
Step 1
Step 2
Step 3
Baseline KMI ≤ 20
Placebo
9
17.7 (2.2)
29.9 (4.3)
12.2 (4.7)
8.58–15.86
Ref.
Ref.
Low dose
10
18.4 (2.7)
13.0 (8.5)
−5.4 (8.3)
−11.35 to −0.55
Ref.
High dose
10
17.3 (3.0)
6.8 (5.0)
−10.5 (4.4)
−13.65 to −7.35
NS
21 ≤ baseline KMI ≤ 35
Placebo
36
27.2 (3.6)
27.8 (8.1)
0.6 (7.8)
−2.01–3.23
Ref.
Ref.
Low dose
41
28.7 (4.1)
19.1 (12.6)
−9.6 (11.5)
−13.23 to −5.99
Ref.
High dose
32
27.5 (4.0)
9.7 (7.6)
−17.8 (8.6)
−20.87 to −14.70
Baseline KMI > 35
Placebo
9
37.2 (1.1)
32.4 (7.7)
−4.8 (8.5)
−11.27–1.72
Ref.
Ref.
Low dose
6
40.5 (3.5)
34.7 (13.0)
−5.8 (12.0)
−18.38–6.71
NS
Ref.
High dose
13
39.3 (2.4)
19.2 (10.7)
−20.1 (9.5)
−25.83 to −14.33
Premenopausal
Placebo
15
29.5 (6.4)
28.4 (8.9)
−1.1 (7.8)
−5.43–3.16
Ref.
Ref.
Low dose
12
25.5 (8.6)
25.3 (12.3)
−0.2 (5.4)
−3.62–3.29
NS
Ref.
High dose
11
27.6 (9.5)
6.7 (6.3)
−20.9 (7.6)
−26.00 to −15.82
Early postmenopausal
Placebo
27
26.4 (6.8)
29.6 (6.7)
3.3 (7.9)
0.13–6.39
Ref.
Ref.
Low dose
28
27.5 (6.0)
16.6 (12.7)
−11.0 (11.2)
−15.31 to −6.62
Ref.
High dose
30
28.4 (7.2)
11.2 (9.0)
−17.2 (9.7)
−20.81 to −13.53
Late postmenopausal
Placebo
12
26.6 (5.6)
28.1 (8.3)
1.5 (12.1)
−6.21–9.21
Ref.
Ref.
Low dose
17
30.9 (6.5)
20.7 (13.6)
−10.2 (11.2)
−15.99 to −4.48
Ref.
High dose
14
29.2 (8.9)
15.6 (9.8)
−13.6 (5.8)
−16.91 to −10.24
NS
*Two-sided Mann-Whitney test stratified to baseline values; Ref.: reference; descriptive P values.
**Not applicable due to hierarchical design; NS: not significant; SD: standard deviation; 95% CI: 95% confidence interval; n: number of patients.
