title: A Comparative Randomized Controlled Clinical Trial on the Effectiveness, Safety, and Tolerability of a Homeopathic Medicinal Product in Children with Sleep Disorders and Restlessness.
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 (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.
authors.affiliation: Department Nutrition & Health, Louis Bolk Institute, 3972 Driebergen, Netherlands; Department of Health Sciences, Mid Sweden University, 85170 Sundsvall, Sweden; National Information and Knowledge Center on Integrative Medicine (NIKIM), Amsterdam, Netherlands.
authors.forename: Miek C
authors.initials: MC
authors.lastname: Jong
authors.affiliation: Russian State Medical University, Moscow 117997, Russia.
authors.forename: Lydia
authors.initials: L
authors.lastname: Ilyenko
authors.affiliation: Russian State Medical University, Moscow 117997, Russia.
authors.forename: Irina
authors.initials: I
authors.lastname: Kholodova
authors.affiliation: Department Nutrition & Health, Louis Bolk Institute, 3972 Driebergen, Netherlands.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Verwer
authors.affiliation: Deutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG, 76227 Karlsruhe, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Burkart
authors.affiliation: Acomed statistik, 04275 Leipzig, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Weber
authors.affiliation: Acomed statistik, 04275 Leipzig, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Keller
authors.affiliation: Deutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG, 76227 Karlsruhe, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Klement