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A Comparative Randomized Controlled Clinical Trial on the Effectiveness, Safety, and Tolerability of a Homeopathic Medicinal Product in Children with Sleep Disorders and Restlessness
Mid Sweden University, Faculty of Human Sciences, Department of Nursing Sciences. Louis Bolk Inst, Dept Nutr & Hlth, NL-3972 Driebergen, Netherlands.;Mid Sweden Univ, Dept Hlth Sci, S-85170 Sundsvall, Sweden.;Natl Informat & Knowledge Ctr Integrat Med NIKIM, Amsterdam, Netherlands..
Russian State Med Univ, Moscow 117997, Russia.
Russian State Med Univ, Moscow 117997, Russia.
Louis Bolk Inst, Dept Nutr & Hlth, NL-3972 Driebergen, Netherlands.
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2016 (English)In: Evidence-based Complementary and Alternative Medicine, ISSN 1741-427X, E-ISSN 1741-4288, 9539030Article in journal (Refereed) Published
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Abstract [en]

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 (N = 89) or comparator glycine (N = 90). 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), p < 0.0001, 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 p values < 0.05). More children with ZinCyp-3-02 were totally free of complaints (p = 0.0258). Treatment effectiveness (p < 0.0001) and satisfaction assessments (p < 0.0001) were more favorable for ZinCyp-3-02. Few nonserious adverse drug reactions were reported (ZinCyp-3-02: N = 2, glycine: N = 1) 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.

Place, publisher, year, edition, pages
2016. 9539030
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Nursing Pediatrics
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URN: urn:nbn:se:miun:diva-28482DOI: 10.1155/2016/9539030ISI: 000376338500001Scopus ID: 2-s2.0-84973320546OAI: oai:DiVA.org:miun-28482DiVA: diva2:949592
Available from: 2016-07-21 Created: 2016-07-21 Last updated: 2017-01-10Bibliographically approved

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