The Effect of Honey on Nocturnal Cough and Sleep Quality

Study Overview
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Brief Summary
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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
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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

Official Title
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The Effect of Honey on Nocturnal Cough and Sleep Quality: a Double-blind, Randomized,Placebo-controlled Study

Conditions
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Cough, Sleep

Intervention / Treatment
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* Dietary Supplement: Eucalyptus honey
* Dietary Supplement: Labiatae honey
* Dietary Supplement: Citrus honey
* Dietary Supplement: Silan date extract


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eucalyptus honey ,<br>75 children | Dietary Supplement: Eucalyptus honey<br>* Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.<br>|
| Experimental: Labiatae honey<br>75 children allocated | Dietary Supplement: Labiatae honey<br>* Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.<br>|
| Experimental: Silan date extract (placebo)<br>75 children allocated | Dietary Supplement: Silan date extract<br>* Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.<br>|
| Experimental: Citrus honey<br>75 children allocated | Dietary Supplement: Citrus honey<br>* Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Pre intervention study questionnaire: The parents were asked to complete a five item questionnaire regarding parental subjective assessments of the child's cough and sleep difficulty on the previous night.Survey responses were graded on a seven point scale ranging from extremely (6 points) to not at all (0 points). On the day following the treatment,the parent completed the same questionnaire that had been answered before the intervention, this time regarding the previous evening when the child had received the treatment. | changes between two nights ( the night before treatment and the night with treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Assessment was been done by completing the pre and post intervention questionnaire as was described in the  primary outcome measurment. | changes between two nights ( the night before treatment and the night with treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, cough, honey