Table of Contents Author Guidelines Submit a Manuscript
Evidence-Based Complementary and Alternative Medicine
Volume 2016, Article ID 9539030, 11 pages
http://dx.doi.org/10.1155/2016/9539030
Research Article

A Comparative Randomized Controlled Clinical Trial on the Effectiveness, Safety, and Tolerability of a Homeopathic Medicinal Product in Children with Sleep Disorders and Restlessness

1Department Nutrition & Health, Louis Bolk Institute, 3972 Driebergen, Netherlands
2Department of Health Sciences, Mid Sweden University, 85170 Sundsvall, Sweden
3National Information and Knowledge Center on Integrative Medicine (NIKIM), Amsterdam, Netherlands
4Russian State Medical University, Moscow 117997, Russia
5Deutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG, 76227 Karlsruhe, Germany
6Acomed statistik, 04275 Leipzig, Germany

Received 22 December 2015; Accepted 5 April 2016

Academic Editor: Jenny M. Wilkinson

Copyright © 2016 Miek C. Jong et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A prospective, multicenter, randomized, open-label, controlled clinical trial was performed to evaluate the effectiveness and safety of the homeopathic product ZinCyp-3-02 in children with sleep disorders for ≥ one month compared to glycine. Children ≤ six years old received either ZinCyp-3-02 () or comparator glycine (). After treatment for 28 days, total sleep-disorder-associated complaints severity scores decreased in both groups from median 7.0 (out of maximum 11.0) points to 2.0 (ZinCyp-3-02) and 4.0 (glycine) points, respectively, with overall higher odds of showing improvement for ZinCyp-3-02 (odds ratio: 4.45 (95% CI: 2.77–7.14), , POM overall treatment related effect). Absence of individual complaints (time to sleep onset, difficulties maintaining sleep, sleep duration, troubled sleep (somniloquism), physical inactivity after awakening, restlessness for unknown reason, and sleep disorders frequency) at study end were significantly higher with ZinCyp-3-02 (all values < 0.05). More children with ZinCyp-3-02 were totally free of complaints (). Treatment effectiveness () and satisfaction assessments () were more favorable for ZinCyp-3-02. Few nonserious adverse drug reactions were reported (ZinCyp-3-02: , glycine: ) and both treatments were well tolerated. Treatment with the homeopathic product ZinCyp-3-02 was found to be safe and superior to the comparator glycine in the treatment of sleep disorders in children.