Allgemeine Homöopathische Zeitung 2017; 262(02): 2-76
DOI: 10.1055/s-0037-1601137
Vorträge
Georg Thieme Verlag KG Stuttgart · New York

Effectiveness of homeopathic complex medicinal remedies in children with sleep disorders – results of a randomized controlled trial

Wirksamkeit von homöopathischen Komplexmitteln bei Kindern mit Schlafstörungen – Ergebnisse einer randomisierten kontrollierten Studie

MC Jong
1   Loius Bolk Institute, Department Nutrition & Health, Driebergen, Netherlands
2   Mid Sweden University, Department of Health Sciences, Sundsvall, Sweden
3   National Information and Knowledge Center on Integrative Medicine (NIKIM), Amsterdam, Netherlands
,
L Ilyenko
4   Russian State Medical University, Moscow, Russian Federation
,
I Kholodova
4   Russian State Medical University, Moscow, Russian Federation
,
C Verwer
1   Loius Bolk Institute, Department Nutrition & Health, Driebergen, Netherlands
,
S Weber
5   ACOMED statistik, Leipzig, Germany
,
T Keller
5   ACOMED statistik, Leipzig, Germany
,
J Burkart
6   Deutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG, Medical Affairs & Clinical Research, Karlsruhe, Germany
,
P Klement
6   Deutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG, Medical Affairs & Clinical Research, Karlsruhe, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
21 March 2017 (online)

 

Aim:

Insufficient or poor sleep quality in children may have a major impact on the whole family. Homeopathy may offer a safe treatment option. In an open, multicenter, randomized, controlled trial the effectiveness of the homeopathic complex medication ZinCyp-3-02 (Dormikind®: cypripedium pubescens D4, magnesium carbonicum D10 and zincum valerianicum D12) was investigated in pediatric sleep disorders.

Methods:

Children (0 – 6 years) with sleep disorders for = 1 month received either ZinCyp-3-02 or Glycine tablets (control) for 28 days. Total score of five sleep related complaints + physical inactivity + restlessness (TSC, maximum 11 points), variances of the 7 individual complaints, satisfaction and incidence of adverse drug reactions (ADRs) were assessed by parents and/or investigators.

Results:

In the 179 children (ZinCyp-3-02: N = 89, control: N = 90) included and analyzed, TSC decreased from baseline to Termination Visit (ZinCyp-3-02: median 7.0 → 2.0; control: median 7.0 → 4.0) with significantly higher odds of showing lower TSC (Odds Ratio: 4.45 (95%-CI: 2.77 – 7.14), p < 0.0001; ITT) in the children with ZinCyp-3-02 treatment for 28 days. First clinical effects were seen already after 14 days, absence of individual complaints was demonstrated in significantly more ZinCyp-3-02 children (Chi2-test: all P values = 0.0475; ITT) at the study end. Significantly more very satisfied and satisfied ratings were obtained by the parents of the ZinCyp-3-02 group (N = 82 vs. N = 38; Chi2-test: p < 0.0001; ITT) and only few ADRs occurred (ZinCyp-3-02: N = 2 (nervousness, excitability); control: N = 1 (excitement)).

Conclusions:

ZinCyp-302 tablets in the test group showed to be superior compared to the control group, was safe in use and parents were satisfied with the treatment of their children.