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ARTICLE

Effect of Honey on Nocturnal Cough and Sleep Quality:


A Double-blind, Randomized, Placebo-Controlled Study
AUTHORS: Herman Avner Cohen, MD,a,b Josef Rozen, MD,b,c,† WHAT’S KNOWN ON THIS SUBJECT: Honey is recommended as
Haim Kristal, MD,b,d Yoseph Laks, MD,b,e Mati Berkovitch, a cough medication by the World Health Organization. To date, the
MD,b,f Yosef Uziel, MD,b,g Eran Kozer, MD,b,h Avishalom efficacy of this treatment has been shown in 2 studies: one tested
Pomeranz, MD,b,i and Haim Efratj only buckwheat honey and the other study was not blinded.
aPediatric Ambulatory Community Clinic, Petach Tikva, Israel;
bSackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; WHAT THIS STUDY ADDS: In a randomized controlled trial, we
cPediatric Ambulatory Community Clinic, Kefar Saba, Israel;
dPediatric Ambulatory Community Clinic, Kiryat Shmone, Israel;
compared 3 types of honey versus placebo as a treatment of
ePediatric Ambulatory Community Clinic, Ramat Aviv, Israel; upper respiratory tract infection–associated cough. These types
fClinical Pharmacology Unit, Assaf Harofeh Medical Center, of honey were superior to placebo in alleviating cough.
Zerifin, Israel; gDepartment of Pediatrics, Meir Medical Center,
Kfar Saba, Israel; hPediatric Emergency Unit, Assaf Harofeh
Medical Center, Zerifin, Israel; iDepartment of Pediatrics, Meir
Medical Center, Kfar Saba, Israel; and jZerifin Breeding Apiary,
Volcani Agricultural Research Center, Rechovot, Israel
KEY WORDS
abstract
cough, children, honey OBJECTIVES: To compare the effects of a single nocturnal dose of 3
ABBREVIATIONS honey products (eucalyptus honey, citrus honey, or labiatae honey) to
FDA—Food and Drug Administration
OTC—over-the-counter
placebo (silan date extract) on nocturnal cough and difficulty sleeping
URI—upper respiratory tract infection associated with childhood upper respiratory tract infections (URIs).
†Deceased.
METHODS: A survey was administered to parents on 2 consecutive
Dr Cohen was responsible for conception and design of study, days, first on the day of presentation, when no medication had been
data acquisition, analysis and interpretation of data, and he given the previous evening, and the following day, when the study prep-
drafted and revised the article and approved the final version;
Dr Rozen was responsible for data acquisition, data analysis and
aration was given before bedtime, based on a double-blind randomization
interpretation, and critical revision of the article; Drs Kristal, plan. Participants included 300 children aged 1 to 5 years with URIs,
Laks, Berkovitch, Uziel, Kozer, and Pomeranz were responsible nocturnal cough, and illness duration of #7 days from 6 general
for data acquisition, data analysis and interpretation, revising
pediatric community clinics. Eligible children received a single dose of
the article, and approving the final version; and Mr Haim was
responsible for preparing blinded specimens. 10 g of eucalyptus honey, citrus honey, labiatae honey, or placebo
This trial has been registered at www.clinicaltrials.gov administered 30 minutes before bedtime. Main outcome measures
(identifier NCT01575821). were cough frequency, cough severity, bothersome nature of cough,
www.pediatrics.org/cgi/doi/10.1542/peds.2011-3075 and child and parent sleep quality.
doi:10.1542/peds.2011-3075 RESULTS: In all 3 honey products and the placebo group, there was
Accepted for publication Apr 23, 2012 a significant improvement from the night before treatment to the night
Address correspondence to Herman Avner Cohen, MD, POB 187, of treatment. However, the improvement was greater in the honey
Yehud 56000 Israel. E-mail: hermanc@post.tau.ac.il groups for all the main outcome measures.
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). CONCLUSIONS: Parents rated the honey products higher than the silan
Copyright © 2012 by the American Academy of Pediatrics date extract for symptomatic relief of their children’s nocturnal cough
FINANCIAL DISCLOSURE: The authors have indicated they have and sleep difficulty due to URI. Honey may be a preferable treatment
no financial relationships relevant to this article to disclose.
for cough and sleep difficulty associated with childhood URI. Pediatrics
FUNDING: This study was supported in part by a research grant 2012;130:1–7
from the Israel Ambulatory Pediatric Association, Materna Infant
Nutrition Research Institute, and the Honey Board of Israel. The
funders had no role in the study design, data collection or
analysis, decision to publish, or preparation of the manuscript.

PEDIATRICS Volume 130, Number 3, September 2012 1


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Cough is a common symptom in pedi- sore throat, myalgia, and headache. (family Labiatae), or citrus honey (family
atric practice. It can be particularly Patients were excluded if they had signs Rutaceae), or a placebo. Silan date ex-
troubling to children and their parents. or symptoms of asthma, pneumonia, tract was selected as the placebo be-
It often results in discomfort to the child laryngotracheobronchitis, sinusitis, and/ cause its structure, brown color, and
and loss of sleep for both the child and or allergic rhinitis. Patients were also taste are similar to that of honey.
parents. As a result, children miss day excluded if they had used any cough or
care or school and parents miss a day of cold medication or honey on the night Intervention
work. In an attempt to treat cough, before entering the study. Patients were The 3 honeys and the silan date extract
caregivers frequently administer over- not excluded when analgesic medica- were prepared by the staff of the Zerifin
the-counter (OTC) medications to their tions such as acetaminophen or ibupro- Breeding Apiary of the Volcani Agri-
children, with their attendant risks,1–7 fen were administered on either night of cultural Research Center in Rechovot,
lack of proven efficacy,8–11 and the dis- the study. Israel. All 3 types of honey and the silan
approval of professional organizations date extract were packed in small
such as the American Academy of Pe- Preintervention Study plastic containers of 10 g each and
diatrics,12 and the Food and Drug Ad- Questionnaire marked with the letters A, B, C, or D. The
ministration (FDA).13 After attaining informed consent, all study preparations were distributed to
A variety of home remedies and herbal participating parents were asked to the pediatric community clinics in
medications, such as licorice, cloves, complete a 5-item questionnaire re- blocks of 4. Parents were instructed to
lemon, and honey, are used by some garding their subjective assessments administer 10 g of their child’s treat-
caregivers to treat the symptoms as- of the child’s cough and sleep difficulty ment product within 30 minutes of the
sociated with upper respiratory tract on the previous night. The question- child going to sleep. The parents were
infections (URIs).14,15 The World Health naire used was a Hebrew version of a instructed that the preparation could
Organization has noted honey as a po- previously validated questionnaire22 be given undiluted or together with a
tential treatment of cough and cold (Fig 1). Survey responses were graded noncaffeinated beverage.
symptoms, and it is considered as a de- on a 7-point Likert scale. Minimum The parents, the physicians, and the
mulcent that is inexpensive, popular, and symptom severity score criteria were study coordinator did not know the
safe (outside of the infant population).14 established to determine which children content of the preparation that was
Honey has antioxidant properties and should enter the randomized trial. Only dispensed. The envelopes containing
increases cytokine release, which may children whose parents rated a severity the codes of the study preparations
explain its antimicrobial effects.16–21 of at least 3 for a minimum of 2 of the 3 were stored at the office of the Ministry
The objective of this trial was to com- questions related to nocturnal cough of Agriculture, Extension Service, Bee-
pare the effects on nocturnal cough and frequency, effect on the child’s sleep, and keeping Department, and were not
the sleep difficulty associated with URIs effect on parental sleep on the previous opened until after the statistical anal-
of a single nocturnal dose of 3 honey night were included. ysis was completed.
products compared with placebo.
Study Design Postintervention Study
METHODS A double-blind randomized design was Questionnaire
Patients used to conduct this study. Eligible The day after the treatment, the parent
Subjects were recruited from patients children were randomized to 4 treat- who completed the preintervention
who presented to 1 of 6 general pedi- ment groups: 3 groups were given 1 of 3 questionnaire was contacted by tele-
atric community clinics for an acute types of honey (eucalyptus honey phone. Trained research assistants who
care visit between January 2009 and (family Myrtaceae), labiatae honey were blinded to the treatment group
December 2009. Eligible patients were
those between the ages of 1 and 5 years
complaining of nocturnal cough that
was attributed to a URI. A URI was de-
fined by the presence of cough and
rhinorrhea of #7 days’ duration. Other
FIGURE 1
symptoms might have included but were Cough Severity Assessment Questionnaire. Scoring: 0 = not at all, 1 = not much, 2 = a little, 3 = somewhat, 4 =
not limited to nasal congestion, fever, a lot, 5 = very much, 6 = extremely.

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ARTICLE

asked the parent the same 5 questions Research, Meir Medical Center, Kfar child’s cough: 1.78 points with eucalyptus
that had been answered in writing be- Saba, Israel. honey, 1.77 points with citrus honey, 1.94
fore the intervention, this time re- points with labiatae honey and 0.99
garding the previous evening when the RESULTS points with silan date extract (F = 5.78,
child had received the treatment. No P , .001). Parents felt the cough also
Three hundred children with URIs were
physician examination was performed was less bothersome on the second
enrolled and 270 (89.7%) completed the
on the second study day unless dictated night, with honey providing the greatest
single-night study (Fig 2). Sixty-four
by illness progression. relief with a 2.0-point change with euca-
children received eucalyptus honey,
lyptus honey, a 2.16-point change with
62 received citrus honey, 73 received
Outcome Measures citrus honey, and a 2.07-point change
labiatae honey, and 71 received pla-
The primary outcome was the cough with labiatae honey, compared with
cebo (silan date extract). The dropout
frequency. The primary outcome mea- a 1.25-point change with silan date
rate was higher in the citrus and eu-
sure was the change in the frequency of extract group (F = 4.63, P , .04). Parents
calyptus groups (P = .006).
cough between the 2 nights. Secondary rated their children’s sleep better after
The median age of the patients com- receiving honey, with improvement by
outcome measures of importance were
pleting the study was 29 months (range 2.13 points with eucalyptus honey, 1.98
changes in the cough severity, the both-
12–71 months), with no significant points improvement with citrus honey,
ersome nature of the cough, the effect of
difference in age among the treatment and 1.70 points with labiatae honey,
the cough on sleep for both the child and
groups (Table 1). One hundred forty-six compared with a 1.21-point change
the parent, and the combined score of
these five measures.
of the children (54%) were boys. The with silan date extract (F = 3.61, P ,
participants were ill a mean 6 SD of .014). As might be expected, parental
2.8 6 2.0 days before enrollment, with sleep improved in a fashion similar to
Sample Size Analysis
no significant differences among treat- that of their children, with the honey-
On the basis of previously published ment groups (P = .161). Almost half treatment arms improving the most,
data,8 we estimated that the sample (47%) of the children had .3 days of a mean of 2.16 points with eucalyptus
size necessary to detect a 0.75-point dif- coughing, with no difference among honey, 2.10 points with citrus honey,
ference between any 2 treatment groups groups (P = .9). In addition, there were no 1.90 points with labiatae honey, and
(using analysis of variance) with 90% significant differences between mea- 1.28 points with silan date extract (F =
power and an a of .05 was 60 subjects sures of symptom severity at baseline. 3.40, P , .018). When the results for
per treatment group.
When symptom scores were compared these outcomes were combined by add-
To compensatefor possibledropoutsand for each treatment group from the night ing the scores from the individual cate-
abnormal data distribution, we attemp- before treatment to the night of treat- gories, honey again proved to be the
ted to recruit 75 patients per group. ment, significant differences were de- most effective treatment. The children
tected in the amount of improvement improved by an average of 9.88 points
Statistical Analysis reported for all study outcome varia- with eucalyptus honey, 10.10 points with
Statistical comparisons of variables bles (Fig 3). No significant differences citrus honey, 9.51 points with labiatae
between treatment groups were per- were found among the different types honey, compared with 5.82 points for
formed by using the x 2 test for nominal of honey; however, each of the honey those treated with silan date extract (F =
variables and analysis of variance for groups had a better response com- 5.33, P , .001).
continuous variables. For comparisons pared with the silan date extract. For Stomachache, nausea, or vomiting were
of cough evaluation before and after cough frequency, those who received reported by the parents of 4 patients in
treatment, a paired Student t test was eucalyptus honey had a mean 1.77- thehoneytreatmentgroup(2inthecitrus,
used. A P value ,.05 was considered point improvement compared with a 1 in the eucalyptus, and 1 in the labiatae
statistically significant. All statistical 1.95-point change for those receiving honey group) and 1 in the placebo group.
analyses were done by using the SPSS citrus honey, 1.82 change for those The adverse events were not significantly
package for Windows (version 15.0.1, receiving labiatae honey, and a 1.00 different between the groups.
SPSS, Chicago, IL). point change for those who were treated
with silan date extract (placebo group)
Ethics on the second night (F = 5.708, P , DISCUSSION
The study was approved by the Com- .001). Parents also noted similar im- The results of this study (Fig 3) dem-
mittee for Ethics in Human Subjects provements in the severity of their onstrate that each of the 3 types of

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FIGURE 2
Patient flow diagram.

TABLE 1 Baseline Patient Characteristics by Group


Characteristic A (n = 64) B (n = 62) C (n = 73) D (n = 71) P Value
group, whereas our study compared
the effectiveness of 3 types honey to
Age in months (mean 6 SD) 27.5 6 13.9 29 6 13.5 30 6 16.6 29 6 14.9 .235
Male gender placebo.
Number (%) 36 (56) 26 (36) 39 (53) 23 (32) .018 In contrast with Paul et al, we did not
Days of illness (mean 6 SD) 2.4 6 1.4 3.5 6 3.1 2.7 6 1.6 2.7 6 1.8 .16
Cough frequency score 3.72 6 1.02 3.76 6 1.14 3.68 6 0.9 3.58 6 0.82 .73
document symptoms of hyperactivity,
(mean 6 SD) nervousness, and insomnia in the honey
Cough severity score (mean 6 SD) 3.66 6 0.96 3.71 6 1.08 3.75 6 0.91 3.55 6 0.77 .59 treatment groups versus the placebo
Cough bother score (mean 6 SD) 3.78 6 1.15 3.85 6 1.13 3.85 6 1.05 3.70 6 1.07 .84
group. Shadkam et al23 also reported
Child sleep score (mean 6 SD) 3.72 6 1.40 3.61 6 1.31 3.49 6 1.32 3.69 6 1.19 .74
Parental sleep score (mean 6 SD) 3.75 6 1.60 3.66 6 1.38 3.75 6 1.26 3.70 6 1.35 .98 that honey had a more alleviating effect
Combined symptom score 18.63 6 5.62 18.60 6 5.00 18.48 6 4.59 18.23 6 4.55 .96 on URI-induced cough compared with
(mean 6 SD) dextromethorphan and diphenhydramine.
A, eucalyptus honey; B, citrus honey; C, labiatae honey; D, silan date extract.
That study was not blinded, however.
Thus, our study further supports the
honey (eucalyptus, citrus, and labiatae) honey products may have a beneficial recommendations of the World Health
was more effective than the placebo for effect for symptomatic relief of noc- Organization to use honey as a poten-
the treatment of all of the outcomes turnal cough associated with URIs. Our tial treatment of cough.14
related to nocturnal cough, child sleep, study differs, however, from the study of Honey is a remarkably complex natural
and parental sleep. Paul et al because they compared the liquid that is reported to contain at least
The results of our study strengthen the effect of 1 type of honey (buckwheat) to 181 substances.24 It has well-established
observation made by Paul et al8 that dextromethorphan and a no-treatment antioxidant and antimicrobial effects

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ARTICLE

FIGURE 3
The effect of different types of honey and silan date extract on cough frequency (I), cough severity (II), cough bothersome to child (III), the child’s sleep (IV),
parent’s sleep (V), and combined symptoms score (VI). P , .05 for the comparisons between group D and the other groups. A, eucalyptus honey; B, citrus
honey; C, labiatae honey; D, silan date extract.

that have been suggested as the mech- that the darker a honey’s color, the the observed effect in patients treated
anism for honey’s efficacy in wound higher its antioxidant capacity. The with silan date extract because this
healing and may help to explain its su- levels of certain antioxidant compo- is also a sweet substance. However,
perior results in this study.16–21 nents decrease with processing and the significant difference between the
The antioxidants present in honey come storage of honey.21 However, available honey products and the silan date ex-
from a variety of sources, such as vi- data show that phenolic antioxidants tract suggests that other factors in
tamin C, monophenolics, flavonoids, from processed honey are bioavailable addition to the sweet taste of honey
and polyphenolics. Although there is a and increase the antioxidant activity of contribute to its beneficial effect on
wide spectrum of antioxidant types, plasma.19 children with cough.
monophenolicssuchas 4-hydroxybenzoic Eccles26 provided another possible ex- Silan was used as placebo in this study.
and 4-hydroxycinnamic acids predom- planation for some of the beneficial An alternative hypothesis is that silan
inate in many honeys.21,25 Most of the effects of honey. Because of the close date extract could worsen cough and
antioxidant components in processed anatomic relationship between the cold symptoms. However, our data
honey are water, not lipid, soluble.21 sensory nerve fibers that initiate cough clearly show that patients treated with
Different types of honey vary widely in and the gustatory nerve fibers that silan date extract actually improved.
the quantity of water-soluble antioxi- taste sweetness, an interaction be- There is also no reason to believe silan
dants they contain.26,27 This variability tween these fibers may produce an caused allergic symptoms or bron-
is dependent on the honey’s floral source, antitussive effect of sweet substances chospasm because dates are not a
as well as seasonal, environmental, and via a central nervous system mecha- common food allergen in the Israeli
other external factors. It was observed nism. This theory may explain some of population.27

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Cough due to a viral URI is generally self- cough and cold medications in infants The study is limited by the subjective
limited. However, parents often wish need to be increased.29 nature of the survey used. However,
some active intervention. This tends to Lokker et al reported that unintentional clinicians and parents often make de-
lead to the use of OTC cough medi- misuse of OTC cold products is common cisions based on subjective assess-
cations. However, these medications and could result in harm if medications ments of symptom severity. It should
are potentially dangerous. Many of the are given inappropriately. Label lan- also be noted that it is possible that
adverse events reported were caused guage and graphics seem to influence some of the improvement measured
by inadvertent overdoses when parents inappropriate interpretation of OTC could also be attributed to the nat-
gave the drug to a child too often or at product age indications.30 As a result of ural history of URIs, which generally
a higher than recommended dose. these studies, an FDA advisory com- improve with time and supportive
Some overdoses were caused when the mittee recommended against the use care. Furthermore, compliance with
parents gave a child a combination of OTC cough and cold medications in honey and placebo administration
of cold and cough medicines, not re- children aged ,6 years, and a sub- could not be guaranteed. However,
alizing the product containing the same sequent FDA public health advisory was every parent reported that their child
ingredient. issued recommending against the use took the treatment as recommended.
Dart et al28 reported 118 cases of fatal- of these medications in children ,2 Another limitation is the fact that the
ities in children younger than 12 years years of age.13 effect of only a single dose was
of age that were judged as possibly, evaluated. If the intervention period
Honey is an alternative that is generally
likely, or definitely related to a cough would have been longer and more
regarded as safe for children older
and cold ingredient. Of these 118 cases, than 1 dose given, the results would
than 1 year. Allan et al31 stated that
103 involved a nonprescription medica- have been more reliable and more
evidence for honey in acute pediatric
tion, and the ingredients most often valuable.
cough supports a small effect, but
mentioned were pseudoephedrine (n = clinical significance is uncertain. Our The dropout rate was higher for chil-
45), diphenhydramine (n = 38), and randomized, placebo-controlled study dren receiving citrus and eucalyptus
dextromethorphan (n = 36). Of these seems to indicate that treatment with honey. The exact reason for the higher
cases, the evidence indicated that 88 honey can be clinically effective. dropout rate in these groups is not
involved an overdose. Several contrib- known. Because these types of honey
We suggest, in concordance with the
uting factors were identified, age ,2 FDA13 and the Israeli Ministry of Health
are more aromatic, it is possible that
years, use of medication for sedation, some children disliked the honey
Pharmaceutical Administration, that
use in day-care settings, use of 2 taste.
caregivers and clinicians should be
medicines with the same ingredient, aware of the risk of serious adverse
failure to use a measuring device, events from administering cough and CONCLUSIONS
product misidentification, and use of cold medications to children ,2 years Parents rated each of the honey prod-
a nonprescription product intended of age and use several precautions ucts more favorably than the silan
for adult use. when using them in older children (2– date extract for symptomatic relief of
Rimsza et al reported 10 unexpected 11 years). We believe that educational their children’s nocturnal cough and
deaths that were associated with the campaigns to decrease the use of OTC sleep difficulty due to URI. Honey may
use of OTC cough and cold medications cough and cold medications in children be a preferable treatment of cough
in a 1-year period.29 The authors rec- need to be increased. On the basis of and sleep difficulties associated with
ommended that such medications our findings, honey can be offered as childhood URI. In light of this study,
should not be given to infants because an alternate treatment to children .1 honey can be considered an effective
they may present a serious health year of age. Honey should not be given and safe treatment of children .1 year
hazard, and there is no evidence to to children ,1 year of age because of of age.
support the efficacy and safe dosage of the risk of infantile botulism.32 Because
these medications in infants. Rimsza frequent use of honey can cause dental ACKNOWLEDGMENT
et al also suggest that educational caries, the recommendation should be We thank Dorit Krash of Clalit Health
campaigns to decrease the use of OTC for a short course of honey. Services for statistical analysis.

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PEDIATRICS Volume 130, Number 3, September 2012 7


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Effect of Honey on Nocturnal Cough and Sleep Quality: A Double-blind,
Randomized, Placebo-Controlled Study
Herman Avner Cohen, Josef Rozen, Haim Kristal, Yoseph Laks, Mati Berkovitch,
Yosef Uziel, Eran Kozer, Avishalom Pomeranz and Haim Efrat
Pediatrics; originally published online August 6, 2012;
DOI: 10.1542/peds.2011-3075
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Services http://pediatrics.aappublications.org/content/early/2012/08/01
/peds.2011-3075
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PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly


publication, it has been published continuously since 1948. PEDIATRICS is owned, published,
and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk
Grove Village, Illinois, 60007. Copyright © 2012 by the American Academy of Pediatrics. All
rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.

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Effect of Honey on Nocturnal Cough and Sleep Quality: A Double-blind,
Randomized, Placebo-Controlled Study
Herman Avner Cohen, Josef Rozen, Haim Kristal, Yoseph Laks, Mati Berkovitch,
Yosef Uziel, Eran Kozer, Avishalom Pomeranz and Haim Efrat
Pediatrics; originally published online August 6, 2012;
DOI: 10.1542/peds.2011-3075

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/early/2012/08/01/peds.2011-3075

PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly


publication, it has been published continuously since 1948. PEDIATRICS is owned,
published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point
Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2012 by the American Academy
of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.

Downloaded from pediatrics.aappublications.org by guest on October 12, 2015