Evidence map›Paper›PMID 27242915›Full record

ArticleEvidence-based complementary and alternative medicine : eCAM2016

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

Miek C Jong, Lydia Ilyenko, Irina Kholodova, Cynthia Verwer, Julia Burkart, Stephan Weber, Thomas Keller, Petra Klement

Open access · hybridAbstract read
In one paragraph

Article in Evidence-based complementary and alternative medicine : eCAM, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 4 countries.

Miek C JongDepartment 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.
Lydia IlyenkoRussian State Medical University, Moscow 117997, Russia.
Irina KholodovaRussian State Medical University, Moscow 117997, Russia.
Cynthia VerwerDepartment Nutrition & Health, Louis Bolk Institute, 3972 Driebergen, Netherlands.
Julia BurkartDeutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG, 76227 Karlsruhe, Germany.
Stephan WeberAcomed statistik, 04275 Leipzig, Germany.
Thomas KellerAcomed statistik, 04275 Leipzig, Germany.
Petra KlementDeutsche Homöopathie-Union, DHU-Arzneimittel GmbH & Co. KG, 76227 Karlsruhe, Germany.
Deutsche Homöopathie-Union · DEInstitut für Angewandte Statistik · DELouis Bolk Instituut · NLMid Sweden University · SEPirogov Russian National Research Medical University · RURussian State Social University · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Identifiers

PMID27242915
PMCPMC4875989
OpenAlexW2346419458

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.