Effectiveness, safety and tolerability of a complex homeopathic medicinal product in the prevention of recurrent acute upper respiratory tract infections in children: a multicenter, open, comparative, randomized, controlled clinical trial

Table 3 Complaints and symptoms severity total score

Outcome measure	Visit	Treatment group	Total score			Overall odds ratio (OR)
Outcome measure	Visit	Treatment group	Mean ± SD	Median (P25 %, P75 %)	Min-Max	Estimate (Lower - Upper 95 %-CI)	p
Complaints	Baseline (day 0)	CalSuli-4-02	3.3 ± 2.0	3.0 (2.0, 5.0)	0.0–8.0	1.99 (1.31–3.02)	0.0012
	Baseline (day 0)	Control	3.3 ± 2.0	3.0 (2.0, 4.0)	0.0–7.0
	2^nd FU (day 21)	CalSuli-4-02	1.1 ± 1.3	1.0 (0.0, 2.0)	0.0–6.0
	2^nd FU (day 21)	Control	1.6 ± 1.5	1.0 (0.0, 3.0)	0.0–6.0
	3^rd FU (3 months p-t)	CalSuli-4-02	0.9 ± 1.1	0.0 (0.0, 1.0)	0.0–5.0
	3^rd FU (3 months p-t)	Control	1.4 ± 1.5	1.0 (0.0, 3.0)	0.0–5.0
	Termination (6 months p-t)	CalSuli-4-02	0.6 ± 1.1	0.0 (0.0, 1.0)	0.0–6.0
	Termination (6 months p-t)	Control	0.9 ± 1.1	0.0 (0.0, 2.0)	0.0–4.0
Symptoms	Baseline (day 0)	CalSuli-4-02	2.6 ± 1.9	3.0 (1.0, 4.0)	0.0–9.0	1.93 (1.25–3.00)	0.0033
	Baseline (day 0)	Control	2.6 ± 2.0	3.0 (1.0, 4.0)	0.0–8.0
	2^nd FU (day 21)	CalSuli-4-02	1.0 ± 1.1	1.0 (0.0, 1.0)	0.0–5.0
	2^nd FU (day 21)	Control	1.3 ± 1.2	1.0 (0.0, 2.0)	0.0–6.0
	3^rd FU (3 months p-t)	CalSuli-4-02	0.6 ± 0.9	0.0 (0.0, 1.0)	0.0–4.0
	3^rd FU (3 months p-t)	Control	1.0 ± 1.2	1.0 (0.0, 2.0)	0.0–5.0
	Termination (6 months p-t)	CalSuli-4-02	0.4 ± 0.9	0.0 (0.0, 1.0)	0.0–5.0
	Termination (6 months p-t)	Control	0.8 ± 1.1	0.0 (0.0, 1.0)	0.0–5.0

CI confidence interval, FU follow-up, OR odds ratio (i.e. the estimated odds of getting a lower total score in children treated with CalSuli-4-02 divided by the estimated odds of getting a lower total score in children treated with the comparator homeopathic product as obtained from Proportional odds model), p-t post-treatment, SD standard deviation, ITT intention-to-treat analysis

ISSN: 2049-6958