Dose-Dependent Effects of the Cimicifuga racemosa Extract Ze 450 in the Treatment of Climacteric Complaints: A Randomized, Placebo-Controlled Study
Table 3
Change in symptom severity of KMI sub-items after treatment during 12 weeks (ITT population).
Subitem
Treatment group
Baseline
Final examination (12 weeks)
Absolute differences
Hierarchial test
Valid n
Mean (SD)
95% CI
Valid N
Mean (SD)
95% CI
Valid N
Mean (SD)
95% CI
Step 1
Step 2
Step 3
Placebo
54
8.37 (3.83)
7.33–9.42
54
9.93 (3.27)
9.03–10.82
54
1.56 (3.60)
0.57–2.54
Ref.
Ref.
Hot flushes
Low dose
57
8.56 (3.25)
7.70–9.42
57
6.32 (4.34)
5.16–7.47
57
−2.25 (4.47)
−3.43 to −1.06
Ref.
High dose
55
8.65 (3.83)
7.62–9.69
55
3.20 (3.48)
2.26–4.14
55
−5.45 (4.17)
−6.58 to −4.33
Placebo
54
3.85 (2.05)
3.29–4.41
54
4.70 (1.61)
4.26–5.14
54
0.85 (2.08)
0.28–1.42
Ref.
Ref.
Sweating
Low dose
57
4.14 (1.77)
3.67–4.61
57
2.74 (2.26)
2.14–3.34
57
−1.40 (2.20)
−1.99 to −0.82
Ref.
High dose
55
4.18 (1.82)
3.69–4.67
55
1.60 (1.70)
1.14–2.06
55
−2.58 (2.02)
−3.13 to −2.03
Placebo
54
4.00 (1.90)
3.48–4.52
54
4.19 (1.87)
3.67–4.70
54
0.19 (2.31)
−0.44–0.81
Ref.
Ref.
Insomnia
Low dose
57
4.04 (1.98)
3.51–4.56
57
2.91 (2.27)
2.31–3.51
57
−1.12 (2.11)
−1.68 to −0.56
Ref.
High dose
55
3.93 (2.07)
3.37–4.49
55
1.75 (1.81)
1.26–2.23
55
−2.18 (2.32)
−2.81 to −1.56
Placebo
54
4.11 (1.71)
3.64–4.58
54
4.00 (2.02)
3.45–4.55
54
−0.11 (2.11)
−0.69–0.46
Ref.
Ref.
Nervousness, irritability
Low dose
57
4.14 (1.64)
3.70–4.58
57
2.70 (2.12)
2.14–3.26
57
−1.44 (1.96)
−1.96 to −0.92
Ref.
High dose
55
3.67 (2.03)
3.12–4.22
55
1.64 (1.54)
1.22–2.05
55
−2.04 (2.13)
−2.61 to −1.46
Depressive events, melancholy
Placebo
54
1.59 (1.11)
1.29–1.89
54
1.54 (0.97)
1.27–1.80
54
−0.06 (1.11)
−0.36–0.25
Ref.
Ref.
Low dose
57
1.77 (1.09)
1.48–2.06
57
1.26 (1.09)
0.97–1.55
57
−0.51 (0.98)
−0.77 to −0.25
Ref.
High dose
55
1.80 (1.06)
1.51–2.09
55
0.71 (0.76)
0.50–0.92
55
−1.09 (1.02)
−1.37 to −0.81
Placebo
54
0.67 (0.89)
0.42–0.91
54
0.74 (0.87)
0.50–0.98
54
0.07 (1.01)
−0.20–0.35
Ref.
Ref.
Vertigo
Low dose
57
0.65 (0.86)
0.42–0.88
57
0.49 (0.83)
0.27–0.71
57
−0.16 (0.56)
−0.31 to −0.01
Ref.
High dose
55
0.84 (0.94)
0.58–1.09
55
0.42 (0.63)
0.25–0.59
55
−0.42 (0.81)
−0.64 to −0.20
NS
Placebo
54
1.31 (0.97)
1.05–1.58
54
1.02 (1.00)
0.75–1.29
54
−0.30 (1.02)
−0.58 to −0.02
Ref.
Ref.
Concentration weakness
Low dose
57
1.42 (1.03)
1.15–1.70
57
1.02 (1.09)
0.73–1.31
57
−0.40 (0.90)
−0.64 to −0.16
NS
Ref.
High dose
55
1.56 (0.94)
1.31–1.82
55
0.76 (0.86)
0.53–1.00
55
−0.80 (0.91)
−1.05 to −0.55
NS**
Placebo
54
1.26 (1.17)
0.94 (1.58)
54
1.06 (1.14)
0.74–1.37
54
−0.20 (0.94)
−0.46–0.05
Ref.
Ref.
Joint pain
Low dose
57
1.49 (1.20)
1.17–1.81
57
1.04 (1.20)
0.72–1.35
57
−0.46 (0.95)
−0.71 to −0.21
NS
Ref.
High dose
55
1.53 (1.18)
1.21–1.85
55
0.58 (0.81)
0.36–0.80
55
−0.95 (0.95)
−1.20 to −0.69
Placebo
54
0.89 (0.92)
0.64–1.14
54
0.93 (0.80)
0.71–1.14
54
0.04 (1.05)
−0.25–0.32
Ref.
Ref.
Headache
Low dose
57
0.81 (0.91)
0.56–1.05
57
0.54 (0.85)
0.32–0.77
57
−0.26 (0.61)
−0.43 to −0.10
Ref.
High dose
55
0.96 (0.96)
0.70–1.22
55
0.38 (0.56)
0.23–0.53
55
−0.58 (0.85)
−0.81 to −0.35
NS
Placebo
54
1.24 (0.80)
1.02–1.46
54
0.85 (0.90)
0.61–1.10
54
−0.39 (0.83)
−0.62 to −0.16
Ref.
Ref.
Palpitations
Low dose
57
1.11 (0.90)
0.87–1.34
57
0.63 (0.88)
0.40–0.86
57
−0.47 (0.93)
−0.72 to −0.23
NS
Ref.
High dose
55
1.31 (1.10)
1.01–1.61
55
0.40 (0.68)
0.22–0.58
55
−0.91 (0.99)
−1.18 to −0.64
NS**
*Two-sided Mann-Whitney test stratified to baseline values; Ref.: reference.
**Not applicable due to hierarchical design; NS: not significant; 95% CI: 95% confidence interval; n: number of patients.
