A Comparative Randomized Controlled Clinical Trial on the Effectiveness, Safety, and Tolerability of a Homeopathic Medicinal Product in Children with Sleep Disorders and Restlessness
Table 3
Treatment related difference of absence vs. presence evaluation of individual complaints.
Individual complaints
Visit
Absence of complaints
-test
Estimated difference in proportion of absence ()
ZinCyp-3-02
Control
Estimate (%)
Lower CL
Upper CL
%
%
Time to sleep onset
V1 (day 0)
13
14.6
16
17.8
—
—
—
—
V2 (days 3–5)
19
21.4
25
27.8
6.14
V3 (day 14)
58
65.2
36
40.0
25.17
11.01
39.33
V4 (day 28)
74
84.1
46
52.3
31.82
18.88
44.75
Difficulties maintaining sleep
V1 (day 0)
11
12.4
8
8.9
—
—
—
—
V2 (days 3–5)
19
21.4
11
12.2
9.13
20.00
V3 (day 14)
36
40.5
24
26.7
13.78
0.09
27.47
V4 (day 28)
58
65.9
37
42.1
23.86
9.56
38.16
Sleep duration (per day)
V1 (day 0)
34
38.2
43
47.8
—
—
—
—
V2 (days 3–5)
46
51.7
50
55.6
10.73
V3 (day 14)
63
70.8
56
62.2
8.56
22.33
V4 (day 28)
75
85.2
56
63.6
21.59
9.10
34.08
Troubled sleep (somniloquism)
V1 (day 0)
12
13.5
9
10.0
—
—
—
—
V2 (days 3–5)
20
22.5
14
15.6
6.92
18.37
V3 (day 14)
33
37.1
21
23.3
13.75
0.44
27.05
V4 (day 28)
46
52.3
30
34.1
18.18
3.79
32.57
Physical inactivity and slowness of movements after awakenings
V1 (day 0)
60
67.4
61
67.8
—
—
—
—
V2 (days 3–5)
62
69.7
60
66.7
3.00
16.64
V3 (day 14)
71
79.8
63
70.0
9.78
22.40
V4 (day 28)
77
87.5
66
75.0
12.50
1.12
23.88
Restlessness for unknown reason
V1 (day 0)
23
25.8
30
33.3
—
—
—
—
V2 (days 3–5)
33
37.1
31
34.4
2.63
16.67
V3 (day 14)
44
49.4
41
45.6
3.88
18.50
V4 (day 28)
57
64.8
44
50.0
14.77
0.32
29.22
Sleep disorders frequency
V1 (day 0)
0
0.0
0
0.0
—
—
—
—
V2 (days 3–5)
2
2.3
1
1.1
1.14
4.90
V3 (day 14)
8
9.0
1
1.1
7.88
1.55
14.20
V4 (day 28)
22
25.0
6
6.8
18.18
7.71
28.65
A: data for the one withdrawn child was not replaced for V4 (day 28), B: data for the two withdrawn children were not replaced for V4 (day 28), CL: confidence limit, and : Chi-square. Intention-to-treat analysis.
