Clinical trial NCT01575821: The Effect of Honey on Nocturnal Cough and Sleep Quality
Official title: The Effect of Honey on Nocturnal Cough and Sleep Quality: a Double-blind, Randomized,Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cough
Sleep
Keywords: children, cough, honey
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Ambulatory Pediatric Association
First posted: 2012-04-12
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cough is a common symptom in pediatric practice. It can be particularly troubling to children and their parents.It often results in discomfort to the child and loss of sleep to both the child and the parent. The objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with URIs of a single nocturnal dose of three different honey products compared to placebo

Detailed description: Cough is a common symptom in pediatric practice.As a result, children miss daycare or school and parents miss a day of work. In an attempt to threat cough, caregivers frequently administer OTC medication to their children,with their attendant risks, kack of proven efficacy and the disapproval of professional organizations such as the AAP and the FDA. The WHO has noted honey as a potential treatment for cough and cold symptoms. Honey has antioxidant properties and increases cytokine release. The objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with URIs of a single nocturnal dose of three different honey products compared to placebo

Eligibility criteria: Inclusion Criteria:

* 1-5 years of age complying of nocturnal cough that was attributed to a URI.

Exclusion Criteria:

* asthma,
* pneumonia,
* laryngotracheobronchitis,
* sinusitis,
* allergic rhinitis,
* use of cough or cold medication on the night before entering the study.

Primary outcomes:
measure: The principal outcome measure of interest was the change in the frequency of cough between the 2 nights (before treatment and tthe night with treatment).
timeFrame: changes between two nights ( the night before treatment and the night with treatment)
Secondary outcomes:
measure: changes in the cough severity, the bothersome nature of the cough, the effect of the cough on sleep for both the child and parents between the two nights
timeFrame: changes between two nights ( the night before treatment and the night with treatment)
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: 6 General Pediatric Community Clinics
Study officials:
affiliation: Israel Clalit Health Services
name: Cohen AV Herman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin CM Jr. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc Med. 2007 Dec;161(12):1140-6. doi: 10.1001/archpedi.161.12.1140.
citation: Cohen HA, Rozen J, Kristal H, Laks Y, Berkovitch M, Uziel Y, Kozer E, Pomeranz A, Efrat H. Effect of honey on nocturnal cough and sleep quality: a double-blind, randomized, placebo-controlled study. Pediatrics. 2012 Sep;130(3):465-71. doi: 10.1542/peds.2011-3075. Epub 2012 Aug 6.