Peer Reviewed Continuing Medical Education

KP
4S

Cough and Cold Treatments for Children: Does

Anything Work?
Diane E Pappas, MD, JD; Gregory F Hayden, MD; J Owen Hendley, MD

Parents of young children know that colds

Parents often treat children with colds with over-the-counter cough
are extremely common, especially from and cold medicines. However, there is little evidence that these
fall until spring. Colds account for a large preparations have therapeutic benefit.
number of paediatric office visits and tel-
ephone calls—particularly during ‘cold
season’. Children with rhinorrhoea, cough
and fever may feel miserable. Their par-
ents often lose sleep and time from work
and want to do something to help their
children get better faster. Cough and cold
preparations are often seen as a likely so-
lution. Surveys have shown that over 50%
of preschoolers who had cough and cold
symptoms in the previous month had been
treated with one or more over-the-counter
(OTC) cough and cold medicines. 1
Unfortunately, there is little evi-
dence that these OTC preparations have
therapeutic benefit in children with colds.2
Because colds are self-limited and the
symptoms are largely subjective, any treat-
ment has the potential for a substantial
placebo effect. Just because a child recov-
ered from a previous cold after taking an
OTC preparation does not prove that the
drug was helpful. Many parents, neverthe-
less, remain convinced that these medica-
tions helped their child. These parents may
have felt surprised and saddened recently
when the Consumer Healthcare Products
Association—which represents the lead-
ing makers of OTC cough and cold medi-
cines—announced a voluntary withdrawal

JPOG Jan/Feb 2010 • 37

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 of such products for infants and toddlers
younger than 2 years. 3
This withdrawal was based on the
findings of a recent review by the US Food
and Drug Administration that identified
significant concerns about the safety of
cough/cold medications in young children.
OTC cough/cold medications and antihis-
tamines are in the ‘top 10’ for exposures
reported to US poison control centres in
children younger than 6 years. During
2004–2005, for example, an estimated
1,519 children younger than 2 years were
treated in US emergency departments for
adverse events, including overdoses, as-
sociated with these medications. Several 4
deaths have been attributed to toxicity of
cough and cold medications, especially in
children under 2 years. 5,6
Federal health officials have recom-
mended that the ‘consult your physician’
advice to parents on the labels of cold and
cough medicines intended for young chil-
dren be replaced by a warning not to use
the medications in children under 2 years
unless directed to do so by a healthcareOTC Cough/Cold
provider. The panel further recommended Preparations
that these medications not be used in
children younger than 6 years.7
On 17 January 2008, the FDA issued
its final recommendations in a public
health advisory, noting that because such
medications have not been shown to be
safe or effective, they should not be used
in children under 2 years of age. The FDA
8
is continuing to review the available data
for the use of cough and cold medications
in children aged 2 to 11 years. binations of these products, are marketed
The American Academy of Pediatrics
(AAP) has long held that OTC cough prepa-
JPOG Jan/Feb 2010 • 38
p37-44 JanFeb10_CME-ID-FA.indd 38
rations are not indicated for use in children
and supports changes in the FDA labelling
requirements for children’s cough and cold
preparations. Such support is based on
the fact that no discernible benefits can
be shown for children and that misdosing
of these preparations is frequent. The po-
tential for incorrect dosing is exacerbated
by the fact that there are many multi-in-
gredient products available that may lead
to confusion and unintended dosing errors
by parents. In addition, children under 2
years are apparently more sensitive to the
potentially fatal effects of some of these
ingredients.
Here we summarize the evidence
about the potential benefits (or lack
thereof) and possible adverse effects of
various cough/cold preparations (including
de-congestants, antihistamines, antitus-
sives, expectorants and zinc) and ancil-
lary therapies (eg, antipyretic/analgesics,
herbal preparations, ipratropium, bulb
suction, saline drops and antibiotics).
The discomfort produced by the symp-
toms of the common cold has led to
the development of over 800 OTC cough
and cold medications in the United States
designed to relieve a variety of symp-
toms—primarily nasal congestion, rhin-
orrhoea and cough. Antihistamines, de-
congestants, antitussives, expectorants,
herbal remedies and analgesics, or com-
in many forms. Unfortunately, little sci-
entific evidence supports the efficacy of
these products for treating cold symptoms
in children. This may be because there is
truly no benefit, or it may be because the
benefits to be measured are largely sub-
jective and cannot be accurately reported
by children, especially those younger than
6 years. Viral colds are self-limited and
the symptoms are so subjective that there
is the potential for a significant placebo
effect in treatment studies. Adequate
blinding of patient/parent and physician
is critical to eliminate the placebo effect
and effectively evaluate cold therapies for
children. No antiviral agents effective in
treating the common cold are presently
available.
Decongestants
Systemic sympathomimetic decongest-
ants, including pseudoephedrine, phenyl-
propanolamine and phenylephrine, are of-
ten used to treat nasal congestion. These
agents cause vasoconstriction that per-
sists for several hours. Pseudoephedrine
and phenylpropanolamine are well-
absorbed from the gastrointestinal (GI)
tract, but phenylephrine undergoes ex-
tensive biotransformation, which causes
variable bioavailability after oral admin-
istration. Adverse effects may include
tachycardia, irritability, sleeplessness, hy-
pertension, headaches, nausea, vomiting,
dysrhythmias, seizures and dystonic re-
actions. Hypertensive crises can result in
patients who receive monoamine oxidase
inhibitor therapy.
Phenylpropanolamine has been as-
sociated with intracranial haemorrhage
and stroke, leading the FDA to issue a
public health advisory removing phenyl-
22/01/2010 1:22 PM

propanolamine from OTC medications
in 2000. Because pseudoephedrine can
be used illegally in the manufacture of
methamphetamine, the availability of
pseudoephedrine-containing products has
been severely limited by federal law
since 2005. Pseudoephedrine may be pur-
chased in limited quantities from behind
the counter only on presentation of a
photo identification, with a log kept of all
transactions.
Both pseudoephedrine and phenyl-
propanolamine have been shown to be
effective in adults in reducing symptoms
of the common cold—including nasal con-
gestion and sneezing—although many
patients experience side effects. No stud-
ies document similar benefits in children.
One study of a decongestant/antihista-
mine combination (phenylpropanolamine/
brompheniramine) in children found no
improvement in rhinorrhoea, nasal con-
gestion or cough for those treated when
compared with placebo. 9
Topical decongestants, such as
oxymetazoline, appear effective in reduc-
ing nasal congestion in adults, but their
use is limited by the development of signif-
icant rebound congestion when the medi-
cation is discontinued after several days’
use (‘rhinitis medicamentosa‘). Because
infants are preferential nose breathers,
this rebound may cause obstructive ap-
noea. The use of topical phenylephrine
during an upper respiratory tract infection
(URI) did not decrease nasal obstruction
and did not alter middle ear pressures
significantly in a study of children 6 to 18
months of age.10 Other topical decongest-
ants have not been studied in children.
p37-44 JanFeb10_CME-ID-FA.indd 39
Continuing Medical Education
Antihistamines
Antihistamines are commonly used to
treat symptoms of the common cold, al-
though research has clearly shown that
histamine levels do not increase during
the common cold and that histamine is
not the chemical mediator responsible
for cold symptoms. However, mean kinin
levels do increase as cold symptoms in-
crease in severity and are the mediators
responsible for these symptoms.
First-generation antihistamines—
including triprolidine, diphenhydramine,
hydroxyzine and chlorpheniramine—are
well known to affect the central nervous
system (CNS). Adverse effects may in-
clude sedation, paradoxical excitability,
dizziness, respiratory depression and hal-
lucination. Gastrointestinal and cardio-
vascular side effects, including tachycar-
dia, heart block and arrhythmias, may also
occur. First-generation antihistamines are
anticholinergic and may reduce secretions
Antihistamines are often used to treat symptoms of the common cold.
However, research demonstrates that histamine is not the chemical
mediator responsible for cold symptoms.
and cause dry mouth, blurred vision and
urinary retention. Overdose may cause
severe CNS effects, including coma,
seizures, dystonia or psychosis.
Second-generation antihistamines in-
clude terfenadine, astemizole, loratadine
and cetirizine. CNS side effects, especial-
ly sedation, are less common with these
medications than with the first-generation
antihistamines. Anticholinergic effects are
not seen, but serious CNS or cardiovascu-
lar impairment may result from overdose.
Studies in adults suggest that first-
generation antihistamines provide modest
symptomatic relief. One study of chlor-
pheniramine in adults showed a 35% to
40% reduction in symptoms, with signifi-
cantly less sneezing and higher mucocili-
ary clearance rates, but no improvement
in objective measures of nasal congestion
or eustachian tube dysfunction.11 Patients
treated with chlorpheniramine in another
study reported significantly fewer objec-
JPOG Jan/Feb 2010 • 39
22/01/2010 1:22 PM
 tive signs of a cold and significant im-
provement in symptoms compared with
those treated with placebo. 12
Similarly,
a multicentre placebo-controlled trial
showed that chlorpheniramine decreased
nasal discharge, sneezing, nose-blowing
and the duration of symptoms of the com-
mon cold in adults.13 It may be that the
anticholinergic effects of first-generation
antihistamines resulted in decreased na-
sal secretions and apparent benefit.
There are few well-designed studies
of antihistamine use in children. In chil-
dren, a randomized, double-blind, placebo-
controlled trial of an antihistamine/de-
congestant combination (brompheniramine
and phenylpropanolamine) showed no
improvement in symptoms (cough, rhinor-
rhoea, nasal congestion) in the treated
group. However, half of the treated chil-
9
dren were asleep 2 hours after treatment,
and more than half of the children were
better 2 days later—regardless of treat-
ment group.9 In another study, the inci-
dence of acute otitis media in children
with URIs did not decrease with the use
of an antihistamine and decongestant
combination. 14
Antitussives
Although the cough reflex is beneficial
(clearing excessive secretions and main-
taining airway patency), cough is a major
concern of parents. A significant wors-
ening of the patient’s respiratory status
from inspissation of mucous plugs may
result from cough suppression and may
be particularly harmful in patients with
asthma, pertussis or cystic fibrosis.
Narcotic cough syrups containing
JPOG Jan/Feb 2010 • 40
p37-44 JanFeb10_CME-ID-FA.indd 40
codeine or hydrocodone are thought to
act centrally at the cough centre in the
brainstem. Even narcotic cough suppres-
sants cannot completely suppress cough
in adults. Common side effects include
nausea, vomiting, constipation, dizziness
and palpitations. Respiratory depression
may also occur and is directly related
to the dose administered; apnoea and
death may result. Infants are particularly
sensitive to these effects and may be at
greater risk for apnoea. This may result
from the fact that codeine is conjugated
in the liver, and these pathways may not
be fully developed in infants—espe-
cially in those younger than 6 months.
Nalaxone can be used to reverse respi-
ratory depression.
Dextromethorphan, a narcotic ana-
logue, has been shown to be as effec-
tive as codeine for cough suppression in
adults. When used in appropriate doses,
dextromethorphan has few CNS effects,
but overdose can cause respiratory de-
pression. One study reported no difference
among placebo, dextromethorphan and
codeine in children aged 18 months to 12
years with cough; also, cough improved
after 3 days in all children regardless of
treatment group.15 A recent study found
that when compared with placebo, neither
dextromethorphan nor diphenhydramine
had any significant effect on cough
frequency, sleep quality, cough sever-
ity or the bothersome nature of cough in
children with cold symptoms.16 Because
there are no well-controlled studies
documenting the efficacy of narcotics or
dextromethorphan to treat cough in chil-
dren and because serious adverse effects
may result, the AAP currently recommends
that paediatricians educate parents and
patients about the lack of proven efficacy
and the risk of adverse effects of these
products.17
A recent study examined the effect
on a single dose of honey given at bed-
time to children with cough and URIs.18
The effects of the honey were compared
with those of either honey-flavoured
dextromethorphan or with no treatment.
In pairwise statistical comparisons, the
honey was no better than the dextrometh-
orphan, and the dextromethorphan was no
better than no treatment, but the honey
was better than no treatment for reduc-
ing cough frequency and for decreasing a
combined symptom score. The sample size
was relatively small, however, and there
are concerns about inadequate blinding
and placebo effects.
Honey may represent an alternative
treatment for cough that is generally safe,
well tolerated and perhaps effective, but
more evidence of efficacy will be neces-
sary before its use can be recommended.
Honey is not recommended for use in chil-
dren younger than 12 months.
Expectorants
Agents such as guaifenesin are a common
ingredient in cough/cold preparations.
Guaifenesin is supposed to help thin se-
cretions, but a controlled study showed
no decrease in the volume or quality of
sputum.19 When used in young adults with
natural colds, patients did report a sub-
jective decrease in sputum quantity and
thickness; unfortunately, however, treat-
ment with guaifenesin did not change
22/01/2010 1:22 PM
 Continuing Medical Education

cough frequency.20 Many cough and cold There is limited randomized controlled-trial evidence to support the
use of herbal therapies for the relief of cold symptoms.
preparations contain both a cough sup-
pressant and an expectorant. If both per-
form as advertised, the patient may have
thinned secretions that he or she is un-
able to remove from the airway.

Zinc
In some studies with adults, treatment
with zinc gluconate significantly de-
creased the duration of cold symptoms.
The exact mechanism of action is unclear.
In vitro, zinc inhibits rhinovirus replication
and may combine with the rhinovirus to
coat proteins in such a way as to prevent
viral entry into the host cell.21 Treatment
seems most effective if begun within 24
hours of onset and requires dosing 5 or 6
times per day. Many patients find the zinc
lozenges difficult to tolerate. A similar
study in children 6 to 16 years old dem-
onstrated no benefit of zinc therapy and
frequent side effects, including bad taste,
nausea, irritation of the oropharynx and
diarrhoea. 22

Analgesics/Antipyretics
Aspirin and acetaminophen are commonly
used to treat the fever and discomforts
of the common cold. Unfortunately, stud-
ies in adults suggest that both aspirin
and acetaminophen are associated with
increased nasal symptoms and suppres-
sion of the host’s neutralizing antibody
response. Also, treatment with aspirin has
been associated with increased shedding
of rhinovirus.23,24
Herbal Therapies
Many herbal therapies, including echi-
nacea, are marketed for relief of cold
symptoms. A recent meta-analysis found
that echinacea treatment decreased
the likelihood of developing a cold and
also reduced the duration of a cold.25
Unfortunately, such a meta-analysis is
prone to publication bias because stud-
ies that found no benefit are much less
likely to be published and included in the
meta-analysis. A recent well-controlled
evaluation of echinacea in the prevention
and treatment of experimental rhinovirus
infections found no clinically significant
effects on the rate of infection or severity
of symptoms. 26 No known benefits of such
treatments have been demonstrated con-
clusively in randomized controlled trials.
Herbal therapies are not approved by
the FDA and do not undergo FDA review
before marketing. In addition, there are no
official standards of quality for purity of
the preparations, labelling, toxicity infor-

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p37-44 JanFeb10_CME-ID-FA.indd 41 22/01/2010 1:22 PM

 Frequent hand washing can reduce the
transmission of colds.
mation and drug interaction information.
There is only limited post-marketing sur-
veillance for adverse reactions.
Humidified air
Adult studies abroad suggested that inha-
lation of steam improved nasal obstruction
for up to a week following treatment and
postulated that the heated humidified air
inhibited rhinovirus replication, leading to
symptomatic improvement. Unfortunately,
studies in the United States failed to show
any benefit from inhaled steam; instead,
the result was an increased duration of
symptoms and increased nasal resist-
ance in patients treated with steam in-
halation.27 Furthermore, viral shedding of
experimental rhinovirus infection is not
affected by steam inhalation treatments. 28
Vapour burns are a potential adverse ef-
fect of such treatment.
Menthol vapour is often added to
inhalation treatments to relieve nasal
congestion. Objective evaluation of na-
sal resistance using rhinometry before
and after menthol inhalation shows no
consistent effect on nasal resistance,
JPOG Jan/Feb 2010 • 42
p37-44 JanFeb10_CME-ID-FA.indd 42
but many patients report
subjective improvement
in nasal airflow. The use
of menthol topically may
cause chemical irritation
or burns, and if ingested
in excess, menthol may
cause nausea, vomiting,
ataxia and coma.
Ipratropium
This anticholinergic nasal
spray effectively decreases
the nasal discharge and sneezing of the
common cold. It is licensed for use in chil-
dren 5 years and older, but its usefulness is
limited by bothersome side effects, includ-
ing excessive dryness of the nose and throat,
nosebleeds and headache.
Bulb Suction/Saline Drops
Bulb suction remains a mainstay of thera-
py for infants with cold symptoms. Saline
nose drops used to humidify and loosen
nasal mucus may improve the effective-
ness of suctioning as a kind of reverse
nose blowing. OTC saline drops are avail-
able, but parents can make their own sup-
ply at home less expensively by mixing ¼
tsp of salt in 1 cup of water.
Antibiotics
Because of the viral aetiology of the com-
mon cold, antibiotics have no beneficial
effect on the clinical course. Antibiotics
may be useful for the treatment of second-
ary infections, such as acute otitis media
and sinusitis, that may sometimes accom-
pany or follow a cold. Furthermore, anti-
biotics have limited effectiveness in pre-
venting acute otitis media among children
who are otitis-prone and who are treated
at the onset of new cold symptoms.
Antibiotics are not effective for children
with uncomplicated colds. Also, indiscrimi-
nate use of antibiotics can promote the de-
velopment of antibiotic-resistant bacteria.
Preventive Measures
Because therapeutic measures have such
limited effectiveness, are there any preven-
tive measures that can be recommended?
Breastfeeding
Breastfed children tend to have fewer
colds than children who are bottle-fed.
This constitutes yet another reason to rec-
ommend breastfeeding to all mothers.
Hand Washing
Theoretically, frequent hand washing can
reduce the transmission of colds. Even
physicians are often poor hand washers,
so the practical value of suggesting fre-
quent hand washing for young children is
extremely limited.
Virucidal Nasal Tissues and Hand
Lotions
Virucidal nasal tissues are effective in
the laboratory in blocking the passage
of rhinovirus from one side to the other.
In controlled studies among adults with
rhinovirus colds, they prevent viral hand
contamination during nose-blowing and
subsequent spread to others via hand
contamination. Unfortunately, virucidal
tissues have not been shown effective in
preventing transmission of colds in the
22/01/2010 1:22 PM
 Continuing Medical Education

real-world family setting. The usefulness
of virucidal hand lotions in preventing the
hand transmission of colds remains under
investigation.
Influenza Vaccinations
Immunization is moderately effective in
preventing influenza, and vaccines against
respiratory syncytial virus (RSV) are in de-
velopment. But with more than 100 sero-
types of rhinoviruses, vaccines will not
soon be available to protect against this
most frequent causative agent. A human-
ized monoclonal antibody against RSV has
limited efficacy in preventing RSV infec-
tions among extremely high-risk infants
(ie, extremely premature infants with bron-
chopulmonary dysplasia), but the high cost
makes this approach totally impractical for
more general use.
© 2008 CMP Healthcare Media LLC. Initially published in
Consultant 2008;48:233–238. Reprinted with permission.
About the Authors
Dr Pappas is Associate Professor of Pediatrics, and Dr
Hayden and Dr Hendley are Professors of Pediatrics. All
are affiliated with the University of Virginia School of
Medicine in Charlottesville, Virginia, US.

Recommendations

Despite the desires of patients, parents and physicians, there is currently no effective pharmacological treatment of the common cold
in children. Nothing—decongestants, antihistamines, cough suppressants, expectorants, zinc or herbal remedies—has been shown to
have any beneficial effect in children and many may carry a substantial risk of side effects. Even routine symptomatic therapies such as
antipyretics and humidified air may be counterproductive.
The best medicine is education. Parents need to understand the duration and expected symptoms of the common cold, and to
know what specific changes in symptoms (eg, rapid or laboured breathing) or duration (eg, a cold lasting 10 days or more without
improvement) would warrant a re-evaluation by their child’s physician. Parents also need to be educated about the lack of proven efficacy
and the potential side effects of available cold remedies. Saline nose drops, adequate fluids and use of antipyretics for bothersome fever
may provide limited symptomatic relief—but time is still the only known cure.

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