Received: 18 May 2022

| Revised: 1 August 2022 | Accepted: 2 August 2022

DOI: 10.1111/apa.16509

ORIGINAL ARTICLE

Multicentre, randomised study found that honey had nopharmacological effect on nocturnal coughs and sleep quality
at 1–­5 years of age
Tatsuo Nishimura| Hiromi Muta | Taisuke Hosaka | Makoto Ueda | Kazue Kishida |on behalf of the Honey and Coughs Study Group of the Society of Ambulatory and General
Paediatrics of Japan
Nishimura Pediatric Clinic, Osaka, Japan
Correspondence
Tatsuo Nishimura, Nishimura Pediatric
Clinic, Osaka, Japan.
Email: tatsuo172460@gmail.com

Abstract
Aim: The World Health Organization has listed honey as a potential treatment forcoughs, but there is little evidence to support its use for coughs associated with upper
respiratory tract infections (URTIs). This study evaluated how effective honey was fortreating nocturnal coughs and sleep difficulties.
Methods: This multicentre, randomised, double-­blind, placebo-­controlled study focused on patients aged 1–­5 years with URTIs and coughs for up to 7 days. They wererecruited from 13 general paediatric community clinics in Japan. The participants
were given acacia honey or a honey-­flavoured syrup placebo in the hour before they
were put down to sleep on 2 consecutive nights. Their nocturnal cough and sleep difficulties were assessed on both nights using a 7-­point Likert scale.
Results: The data collection for 161 patients took place between 20 November 2021
and 28 February 2022, with 78 randomly allocated to the honey group and 83 to thesyrup placebo group. Both groups showed improvements on both the first and secondnights, with no significant differences between the two groups.
Conclusion: Both groups showed improvements in their nocturnal coughs and sleep
difficulties during the 2-­night study, but honey was no more effective than the syrup
placebo.
KEYWORDS

coughs, honey, placebo, randomised controlled trial, upper respiratory tract infection

1|

I NTRO D U C TI O Nestablished treatment for this condition.1,2 Coughs are most commonly associated with upper respiratory tract infections (URTIs) and

Coughs are a common symptom in paediatric practice, and they

many cultures use honey to treat URTI symptoms, including coughs.

can be particularly troubling for children and their parents at

In 2001, the World Health Organization (WHO) listed honey as anight, because they interfere with their sleep. However, there is nopotential treatment for cough and cold symptoms in its report on

Abbreviations: URTIs, upper respiratory tract infections; WHO, World Health Organization.

© 2022 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd
Acta Paediatrica. 2022;00:1–8.	﻿

wileyonlinelibrary.com/journal/apa

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NISHIMURA et al.

treating acute respiratory infections in young children.3 The reportsuggested that anti-­inflammatory agents could soothe the throat
and provide some relief from childhood coughs. However, there has
been little evidence published to support the use of honey for symptoms associated with URTIs.

4–­6

The aim of this study was to determine whether honey has antitussive effects. To do this, we compared the effects of a single night-­
time dose of honey or a honey-­flavoured syrup placebo on nocturnalcoughs and sleep difficulties for 2 consecutive nights.

Key Notes• The World Health Organization has listed honey as a potential treatment for coughs, but there is little evidence
to support its use for coughs associated with upper respiratory tract infections (URTIs).
• This multicentre, randomised study focused on patients
aged 1–­5 years with URTIs and coughs for up to 7 days.
• It found no significant differences in cough symptomscores when honey and a honey-­flavoured placebo were2|

M E TH O D S

used for 2 nights running.

2.1 | Study design and patients
Patients were recruited into this multicentre, double-­blind, randomised, placebo-­controlled study from 13 general paediatric community clinics in Japan. The children were eligible if they were aged
1–­5 years and they had URTIs, with an acute cough that had lasted
for up to 7 days. Patients were excluded if they had underlying
medical conditions, asthma, croup or any other obvious dyspnoea
or wheezing when they visited the clinics. They were also excluded
if they had taken other medication for their coughs before entering
the study, if a physician felt antimicrobials were necessary or if theirparents wanted to administer other cough suppressants. Patientswith suspected COVID-­19 were tested and those that were positive
for the virus that causes this were excluded from the study.
The children's parents provided written informed consent after
they were provided with full information about the objectives andF I G U R E 1 Honey and honey-­flavour syrup acacia honey on theright, honey-­flavour syrup as a placebo on the left

study protocol. The study protocol was reviewed, and approved,by the Ethics Committee of the Society of Ambulatory and Generaland half contained the placebo syrup. This number was chosen as it

Paediatrics of Japan (approval number 2021–­7). The trial was

ensured that all the facilities had more than enough supplies.

also registered with the University Hospital Medical Information
Network Clinical Trial Registry (UMIN000047374).

2.2 | Randomisation and masking

2.3 | Study medications and dosing regimen
After obtaining informed consent, the parents of all participants
were asked to complete a questionnaire. This included the children'sPatients were randomly assigned to receive either acacia honey orcharacteristics and 5 items concerning the frequency, severity, de-the honey-­flavoured syrup that was used as the placebo control. This

gree and effect of the cough on the child's sleep, and their parents'

was achieved with a 1:1 ratio, using a block randomisation scheme

sleep, the previous night (Figure 2). The survey responses were

implemented in Microsoft Excel 365 (Microsoft Inc, Washington,

graded on a 7-­point Likert scale. The parents were then given smallUSA). One member of the research team (KK) created a random

glass containers of the honey or placebo syrup, 2 plastic 3-­ml spoons

number table, which was kept hidden until the intervention had

and a cough evaluation questionnaire. The aim of the questionnaire

been completed. The patients, parents, treating physicians and staff

was to measure any changes in the same 5 items outlined above.

were all blinded to the group allocations. The honey group received

The parents were instructed to give the syrup to the children 1 houracacia honey, while the syrup group received a syrup that was cre-before bedtime on 2 consecutive nights. Staff from the participating

ated to mimic real honey and had the same colour, viscosity and fla-

facilities telephoned the parents the day after each administration tovour. This was made from a mixture of fructose, dextrose, sucrose,

ask whether the children were able to take what they had been given

maltose, honey flavouring and caramel (Table S1). Both the honeyand whether the questionnaire had been completed. During theand syrup were packed in 10-­g doses in small individual glass con-study period, the parents were instructed to refrain from giving thetainers that were labelled with numbers from 1 to 16 and sent to thechildren first-­generation antihistamines, cough suppressants or any

13 participating facilities (Figure 1). Half of these contained honeyother substances that had previously been provided and could affect

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NISHIMURA et al.

F I G U R E 2 Cough severity assessment
questionnaire. (A) Japanese questionnaire
used in this study (B) English version

(A)

(B)

their cough or sleep. However, expectorants, second-­generation an-variables. All statistical analyses were performed using StatFlex ver-tihistamines and leukotriene antagonists that did not affect sleep

sion 7 (Igakutoukeikenkyujyo, Yamaguchi, Japan).

were permitted.

2.4 | Outcome measures

3|

R E S U LT S

3.1 | Study population

The primary outcome measures were the differences between the
2 groups in the 5 items in the questionnaire on the first and second

The study population is outlined in a Consolidated Standards ofnights. The secondary outcome measures were changes in the com-

Reporting Trials diagram in Figure 3. The data collection was carried

bined scores.

out from 20 November 2021 to 28 February 2022. A total of 161 patients with URTIs received honey or syrup and were included in the

2.5 | Safety assessment

intention-­to-­treat analysis: 78 in the honey group and 83 in the syrupgroup. The number of patients enrolled varied from 1 to 16, depending on the facilities, but the study reached the target number. The

Safety evaluations were conducted on all patients enrolled in the

median age of the patients who completed the study was 2.7 years

study. The parents were asked if patients were able to take the(range 1.0–­5.9 years). The participants' baseline characteristics arehoney or placebo without problems. The patients were then care-summarised in Table 1. There were no significant differences in the

fully monitored for gastrointestinal symptoms, such as vomiting andbaseline clinical characteristics or cough assessments between thediarrhoea, until the end of the study.

2 groups. In the honey group, 60 patients received expectorants,
and 3 received herbal medicines. In the syrup group, 58 patients re-

2.6 | Statistical analysis

ceived expectorants, 1 patient received a leukotriene antagonist forsuspected allergic rhinitis, 2 patients received a second-­generation
antihistamine for eczema, and 3 patients received herbal medicines.

The required sample size was 73 subjects in each group, with a total

A total of 141 patients completed the study and were included in theof 146 subjects. This was calculated using G*Power software, ver-per-­protocol analysis: 68/78 (87.1%) in the honey group and 73/83

sion 3.1.9.2 (Kiel University, Kiel, Germany), with a two-­t ailed test,(87.0%) in the syrup group.

effect size of 0.5, alpha error of 0.05 and power of 0.85. We planned
to recruit 160 subjects, allowing for a rate of loss to follow-­up of
about 10%. The primary outcome was analysed on the basis of

3.2 | Outcome measuresintention-­to-­treat and per-­protocol analyses. Between-­group comparisons were performed using the chi-­square test for categorical

Both groups showed improvements in all of the 5 questionnairevariables and the Mann–­Whitney U test or t-­test for continuous

items and in the combined symptom score on the first and second

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NISHIMURA et al.

F I G U R E 3 Study enrolment, screening
and participant inclusion flow chart

TA B L E 1 Baseline characteristics

Characteristic
Age, median ± interquartile range, yPatients receiving honeyPatients receiving honey-­flavour syrup(n = 78)(n = 83)p-­value

2.8 ± 1.7

2.7 ± 2.3

0.24

41 (52.6)

32 (38.6)

0.074

Sex, no. (%)
FemaleMaleDay-­c are attendance

37 (47.4)

51 (61.4)

58 (74.4)

62 (74.7)

0.96

Highest body temperature, mean ± SD, °C

37.0 ± 0.65

37.1 ± 0.84

0.39

Duration of illness, mean ± SD, days

2.3 ± 1.5

2.6 ± 1.6

0.29

Cough frequency score, mean ± SD

2.9 ± 1.1

2.7 ± 1.1

0.28

Cough severity score, mean ± SD

2.5 ± 1.0

2.3 ± 1.0

0.28

Bothersome cough score, mean ± SD

2.7 ± 1.1

2.5 ± 1.1

0.27

Effect of cough on child's sleep score, mean ± SD

2.5 ± 1.4

2.2 ± 1.4

0.24

Effect of cough on parent's sleep score, mean ± SD

2.3 ± 1.4

2.0 ± 1.3

0.28

Combined symptom score, mean ± SD

12.7 ± 5.2

11.7 ± 5.1

0.20

Failed to take medication for 1 or 2 days, no. (%)

10 (12.8)

10 (12.0)

0.99

nights in the intention-­to-­treat analysis. However, there were no sig-

compared the scores for the first and second nights to the baseline

nificant differences between the honey and syrup groups in either

data. The scores for the first night in the honey and syrup groups

the intention-­to-­treat analysis (Figure 4) or the per-­protocol analysis

decreased by 5.4 ± 6.2 points and 5.0 ± 5.5 points, respectively, from

(Figure 5).

baseline (p = 0.40). On the second night, the scores decreased by

In the intention-­to-­treat analysis, the combined score of the

7.4 ± 6.1 and 6.8 ± 5.3 points, respectively (p = 0.54). There were nohoney group at baseline was 12.7 ± 5.2 points, which decreased todifferences between the 2 groups, even when testing was limited to

7.5 ± 5.0 points for the first night (p < 0.001), then decreased fur-severe cases, with a baseline score of 10 or higher. These comprised

ther to 5.5 ± 5.2 points for the second night (p = 0.017). The syrup

59 in the honey group and 53 in the syrup group.

group had a baseline score of 11.7 ± 5.1 points, which decreased

The per-­protocol analysis showed that the scores in the honeyto 6.8 ± 5.0 points for the first night (p < 0.001) and decreased fur-group and the syrup group decreased by 5.3 ± 6.4 points and by

ther to 5.0 ± 4.6 points (p = 0.018) for the second night. We also

5.2 ± 5.5 points on the first night, respectively, (p = 0.52) and by

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NISHIMURA et al.

Frequency

(A)

2
1

5
4

p=086

p=0.39

3
2
1
0

(C)

5

p=0.72p=0.592
1
Baseline First night Second
night
honey

7.5 ± 6.1 points and 6.8 ± 5.4 points (p = 0.53) on the second night.

4

Baseline First night Second
night

|

p=0.284
p=0.563

p=0.812
10Baseline First night Second
night
HFS

Combined symptom
score

(F)

20

HFS

HFS

Parent’s sleep

honey

p=0.27

3

0

5

HFS

Bothersome

4

1

(E)

Baseline First night Second
night
honey

p=0.802

honey

Cough severity

p=0.28p=0.23

3

HFS

Likert Scale Score(B)

p=0.2440

Baseline First night Second
night
honey

Likert Scale Score

p=0.41

Likert Scale Score

p=0.4730

Likert Scale Score5

p=0.284Child’s sleep(D)

Combined Likert Scale Score

5
Likert Scale Score

F I G U R E 4 Comparison of the effects
of honey and honey-­flavour syrup on
cough frequency in intention-­to-­treat
analysis. (A) Cough frequency. (B) Coughseverity. (C) Cough bothersome to thechild. (D) Child's sleep. (E) Parent's sleep.
(F) Combined symptom score

p=0.20p=0.4415

p=0.5710
50Baseline

First
night

honey

Secondnight

HFS

DISCUSSION

None of these differences were statistically significant.
Honey has been shown to have well-­established antioxidant and an-

3.3 | Safety outcomestimicrobial effects.7–­9 The WHO has suggested that its topical demulcent effect may contribute to a beneficial effect on coughs.3 In
addition, a Cochrane Report stated that honey may be more effec-

Two patients had problems taking the honey and one had a problem

tive in alleviating coughs and reducing their impact on a child's sleep

taking the syrup. Post-­dose vomiting occurred in 4 patients in theat night than no treatment.4 Moreover, several randomised stud-honey group and in 1 patient in the syrup group. There was no differ-

ies have shown that honey significantly reduced cough symptoms,

ence in the rate of adverse events between the 2 groups.

compared with existing cough suppressants and expectorants.5,6,10

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NISHIMURA et al.

(A)5

p=0.483
2
1

Likert Scale Score

p=0.713

p=0.49

2
1

(E)

5
4

p=0.583

p=0.882
1
Baseline First night Second
night
honey

HFS

HFS

Parent’s sleep
p=0.27p=0.263

p=0.83

2
1

Baseline First night Second
night
honey

p=0.304

Baseline First night Second
night

HFS

Bothersome

5

F I G U R E 5 Comparison of the effect ofhoney and honey-­flavour syrup on coughfrequency in per-­protocol analysis. (A)Cough frequency. (B) Cough severity. (C)Cough bothersome to the child. (D) Child's
sleep. (E) Parent's sleep. (F) Combined
symptom score

1

Baseline First night Second
night

(C)

0

2

0

honey

p=0.98honey

p=0.294

p=0.12

HFS

Cough severity5

p=0.32

3

Baseline First night Second
night

(B)

Child's sleep

4

0

honey

0

Likert Scale Score

p=0.35

Likert Scale Score

Likert Scale Score5

p=0.44

40

Likert Scale Score(D)

Frequency

HFS

Combined symptom
score

(F)

20
Combined Likert Scale Score6

p=0.25p=0.3015

p=0.6910
50Baseline First night Second
night
honey

HFS

However, there is still a lack of strong evidence for using honey forfrom English may have affected the results. Second, the subjects

treating coughs.

were children who visited primary care paediatricians in Japan. Japan

The present study was a multicentre, double-­blind, randomised,

has a universal health insurance system and children have good ac-placebo-­controlled trial to determine whether honey had an antitus-

cess to medical facilities, so their parents may seek medical care forsive effect.

their child at an early stage, even for minor symptoms. Third, URTIs

In contrast to previous studies, it found that honey was not sig-

may have changed since other studies were conducted. Some honeynificantly more effective than the syrup that we used as a placebo

studies5,6 were conducted during the transition from the 7-­valent

control. Several factors may be responsible for the differences be-

to 13-­valent pneumococcal conjugate vaccine. The latter now forms

tween our study and previous reports. First, the Likert scale waspart of Japan's routine vaccination programme and the vaccinationtranslated into Japanese, and differences in the wording of the scalerate is extremely high. Advances in vaccines and high vaccination

| 7

NISHIMURA et al.

rates may have resulted in changes in the nasopharyngeal flora in

6|

CO N C LU S I O N

11Japanese children.

However, our results do not rule out honey as an alternative ther-

This multicentre, double-­
blind, randomised, placebo-­
controlled

apy for coughs. The children in both the honey and placebo syrup

study demonstrated that honey was no more effective againstgroups showed rapid improvements in their cough symptoms within

nocturnal coughs and sleep difficulties in children than a honey-­

2 days of visiting the study clinics. Eccles noted that the efficacy offlavoured syrup placebo.

any cough medicine depended on the strong placebo effect of thetreatment.12 Placebo effects can be divided into the perceived pla-

AC K N OW L E D G E M E N T S

cebo effects and the true placebo effects. Perceived placebo effects

We are grateful to the families that took part in the trial, the staff athave been attributed to the taste, viscosity and the colour of thethe participating facilities and the other members of the Honey anddrugs. As the honey-­flavour syrup that was used as a placebo control

Coughs Study Group: Teruo Okasora, Yasuyuki Nomura, Hirokazu

in this study had similar characteristics to honey, it is possible that

Hidaka, Akira Inoue, Katsura Sugihara, Hiromi Hashimoto, Takashi

both the honey and the syrup had equivalent perceived placebo ef-

Ozaki, Kosaburo Shichijo, Naoki Niitsu, Yukio Noguchi and Atsushi

fects. These perceived placebo effects may have been so large that

Yamamoto.

they masked the pharmacological effect of the honey in this study.
Paul et al. reported that honey and dextromethorphan weremore effective than no treatment.5 However, as the children's noc-F U N D I N G I N FO R M AT I O N
None.

turnal coughs were evaluated by the parents, the major difference
between no treatment and honey was that the parents' action of

C O N FL I C T O F I N T E R E S T

giving their children honey may have created a placebo effect. In ad-

The authors have no conflicts of interest to declare.

dition, the Centers for Disease Control and Prevention recommends
honey for sore throats, as it may temporarily moisten the throat and

ORCID

relieve pain.13 When a child receives temporary relief of their coughTatsuo Nishimura

https://orcid.org/0000-0002-8423-8037

symptoms, because their parent has given them honey, it may increase the trust between the child and parent.
Honey is inexpensive, readily available and is often found inhouseholds. In contrast, giving children codeine is unsafe14 anddextromethorphan and diphenhydramine are not recommended
child cough suppressants, due to a lack of evidence of efficacy.15–­19
Tipepidine hibenzate, which is often used in Japan, is thought to beineffective. 20 Honey is relatively safe, as long as it is not given tochildren under 1 year of age. 21 It is necessary to continue to explore
ways in which honey can be used to treat URTI symptoms in children.

5|

LI M ITATI O N SThis study had several limitations. First, we did not compare the effects of honey to no treatment. Therefore, the observed reduction
in cough symptoms in both groups may have been due to the natural
course of the disease. Second, quantitatively assessing cough symptoms in children is difficult. This study was limited by the subjective nature of the questionnaire used, as in previous studies. Third,
3 patients in the placebo group received a leukotriene antagonist
and a second-­generation antihistamine, which are known to reduceallergic reactions and may have had some effect on acute coughs
caused by URTIs. Fourth, the dose of honey that was used in thisstudy was less than in previous studies22 and may not have been
sufficient to produce pharmacological effects. In addition, the study
was conducted over a 2-­day period, but we only evaluated the effects during the night. The parents' evaluation of how much theirchild was coughing may have varied greatly, depending on whether
or not they were asleep themselves.

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S U P P O R T I N G I N FO R M AT I O N
Additional supporting information can be found online in the
Supporting Information section at the end of this article.

How to cite this article: Nishimura T, Muta H, Hosaka T,
Ueda M, Kishida K & the Honey and Coughs Study Groupof the Society of Ambulatory and General Paediatrics ofJapanMulticentre, randomised study found that honey had
no pharmacological effect on nocturnal coughs and sleep
quality at 1–­5 years of age. Acta Paediatr. 2022;00:1–8.
https://doi.org/10.1111/apa.16509