The Effect of Honey on Nocturnal Cough and Sleep Quality

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

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

Study Overview

• Status: Completed
• Conditions: Cough; Sleep
• Intervention / Treatment: Dietary supplement: Eucalyptus honey; Dietary supplement: Labiatae honey; Dietary supplement: Silan date extract; Dietary supplement: Citrus honey

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

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach-Tikva, Israel, 56000
    • 6 General Pediatric Community Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Collaborators: Ambulatory Pediatric Association
• Investigators: Principal Investigator: Cohen AV Herman, Israel Clalit Health Services

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: April 8, 2012
• First Submitted That Met QC Criteria: April 11, 2012
• First Posted (Estimate): April 12, 2012

Study Record Updates

• Last Update Posted (Estimate): April 12, 2012
• Last Update Submitted That Met QC Criteria: April 11, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: children, cough, honey
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: hermanhoney