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ORIGINAL ARTICLE

Should we advise parents to administer over the counter


cough medicines for acute cough? Systematic review of
randomised controlled trials
K Schroeder, T Fahey
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arch Dis Child 2002;86:170175
Aims: To determine the effectiveness of over the counter (OTC) cough medicines for acute cough in
children.
Methods: Systematic review of randomised controlled trials (RCTs). An all language search of the
Cochrane Acute Respiratory Infections Group specialised register, Cochrane Controlled Trials Register,
Medline, Embase, and the UK Department of Health National Research Register was performed. RCTs
comparing oral OTC cough preparations with placebo in children suffering from acute cough as a
result of upper respiratory tract infection (URTI) in ambulatory settings, using cough symptoms as an
outcome, were included.
Results: Six trials involving 438 children met all inclusion criteria. Antitussives, antihistamine
decongestant combinations, other fixed drug combinations, and antihistamines were no more effective
than placebo in relieving symptoms of acute cough. Based on a single study, the mucolytic preparation
letosteine was superior to placebo, with differences in cough scores ranging from 0.1 to 0.3 points
from day 4 to day 10. Most drugs appeared to be well tolerated with a low incidence of mostly minor
adverse effects.
Conclusion: OTC cough medicines do not appear more effective than placebo in relieving symptoms
of acute cough. Even if statistically significant, effect sizes were small and of doubtful clinical relevance.
The number of trials in each category was small, and the results of this systematic review have to be
interpreted with caution. Based on the available evidence from a small number of studies, we cannot
recommend OTC cough medicines as a first line treatment for children with acute cough.
A
cute cough caused by upper respiratory tract infection
(URTI) can be a very troublesome symptom for
children, and parents often seek medical advice about
its treatment. Over the counter (OTC) cough medicines are
widely available and on sale to the public without prescription,
but paediatricians, general practitioners (GPs), and other
health professionals cannot be sure whether they should rec-
ommend these preparations to parents as a rst line treatment
for acute cough in their children. According to their perceived
mode of action, conventional OTC cough medicines can be
divided into different groups (table 1).
Total consultation rates in general practice for acute
respiratory infections in children under the age of 4 were over
13 000 per 10 000 patient years in 1991/92 in the UK,
1
and a
survey in the USA reported that almost 40% of preschool chil-
dren had been given one or more OTC cold medications during
the preceding month.
2
OTC cough medicines are widely self
prescribed, with retail sales having risen by 6.8% to 337.4
million between 1998 and 1999 in the UK.
3
The NHS direct
healthcare guide recommends simple cough medicines for dry
cough.
4
By 2002, all National Health Service (NHS) direct sites
nationally will be able to refer callers to their local pharmacy,
where appropriate, for advice on OTC medications.
5
There is little evidence for the effectiveness of OTC cough
medicines in children with acute URTI. We know of two previ-
ous reviews on this topic which did not show OTC products to
be better than placebo in relieving symptoms of acute cough in
children.
6 7
One of these reviews was limited to trials
published in English between 1966 and 1991 retrieved from
the Medline database,
7
and the other did not provide any
details about the process of searching for studies.
6
We
therefore carried out a systematic review to answer the ques-
tion whether conventional (non-homoeopathic) OTC cough
medicines for acute cough associated with URTI in children
are effective. This review is based on a Cochrane systematic
review of adults and children.
8
METHODS
Searching
We identied original randomised controlled trials (RCTs) by
searching the Cochrane Acute Respiratory Infections Group
specialised register, the Cochrane Controlled Trials Register
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Abbreviations: NHS, National Health Service; OTC, over the counter;
RCT, randomised controlled trial; URTI, upper respiratory tract infection
Table 1 Modes of action in groups of OTC cough
medicines
Antitussives Centrally acting opioid derivates
or peripherally acting agents
16
Mucolytics Aiming to decrease the viscosity
of bronchial secretions, making
them easier to clear through
coughing
17
Antihistaminedecongestant
combinations
Combine histamine H
1
receptor
antagonists and adrenoceptor
agonists which cause
vasoconstriction of mucosal blood
vessels
18
Other drug combinations Fixed drug combinations using
different ingredients
Antihistamines Histamine H
1
receptor antagonists
See end of article for
authors affiliations
. . . . . . . . . . . . . . . . . . . . . . .
Correspondence to:
Dr K Schroeder, Division of
Primary Health Care,
University of Bristol,
Cotham House, Cotham
Hill, Bristol BS6 6JL, UK;
k.schroeder@bristol.ac.uk
Accepted for publication
27 November 2001
. . . . . . . . . . . . . . . . . . . . . . .
170
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(The Cochrane Library issue 2, 2000), Medline (up to Decem-
ber 1999), Embase (up to December 1999), the UK Depart-
ment of Health National Research Register (December 2000),
our personal collections of references, and reference lists of all
retrieved articles (search strategy shown in box). We wrote to
authors of original studies, pharmaceutical companies, and
the Proprietory Association of Great Britain for information
on unpublished studies and made no constraints based on
language or publication status.
Study selection and validity assessment
We selected studies for review if: (1) the population of interest
was composed of children and adolescents (less than 16 years
of age) with acute cough (less than three weeks duration) as
a result of URTI in an ambulatory setting; (2) the interven-
tions were OTC cough preparations; (3) a reported outcome
was cough (for example, frequency, duration); and (4) studies
were RCTs with a contemporaneous control group receiving a
placebo.
We excluded studies if: (1) they tested OTC cough
medicines in chronic cough (more than three weeks duration
or caused by a chronic underlying disease such as asthma or
tuberculosis); (2) cough was induced articially in healthy
volunteers; (3) they used non-conventional (for example,
herbal or homoeopathic) or non-oral preparations.
We (KS and TF) screened potentially relevant citations
independently and applied the selection criteria using an
in/out/pending sheet in duplicate. We resolved any differences
at any stage of the review through discussion. To be included a
study had to meet all our inclusion criteria. We extracted data
and assessed the quality of studies independently. We
contacted investigators for additional information if necessary
and obtained translations of abstracts or papers written in
languages other than English or German. We were not masked
with regard to trial authors or journals and instead of apply-
ing a trial quality score, we listed data on potential sources of
bias such as randomisation, blinding, and follow up in a sepa-
rate table (table 2).
Search strategy*
cough
cough*:ME
(#1 or #2)
antitussive-agents*:ME
expectorants*:ME
cholinergic-antagonists*:ME
drug-combinations*:ME
prescriptions-non-drug*:ME
#4 or #5 or #6 or #7 or #8 or#9
#3 and #10
cough
(common next cold)
colds
#12 or #13 or #14
antitussiv*
expectorant*
antihistamin*
anticholinergic*
suppressant*
mucolytic*
(drug next combinations)
over-the-counter
non-prescription*
#16 or #17 or #18 or #19 or #20 or #21 or #22 or #23
#15 and #24
#11 or #25
*for searching the Cochrane Controlled Trials Register.
We used slightly amended versions for searching Medline
and Embase databases
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OTC medicines for acute cough 171
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RESULTS
Trial flow
We evaluated 328 citations and abstracts from all sources, of
which six trials involving 438 children met all our inclusion
criteria (g 1).
914
Study characteristics
Table 3 summarises the characteristics of included RCTs which
we grouped into ve drug classes (see table 1). The number of
trials in each group ranged from one to a maximum of two.
Cough outcomes included frequency and severity and were
reported by the parents using cough scores. Four studies
reported data on adverse effects.
The methodological quality of included studies was
generally low (table 2). None of the six RCT reports stated the
randomisation process. In four studies the outcome assessors
were blind to treatment allocation, and three studies did not
report whether participants and/or treatment providers were
blinded. Loss to follow up was documented in three studies,
with differential loss to follow up in the treatment arms
reported in only one study. None of the studies fullled all the
quality criteria. Three trials reported a power calculation.
Quantitative data synthesis
We felt that pooling of the results was inappropriate because
of the small numbers of trials in each category, the limited
quantitative data available, and the notable differences
between trials in terms of participants, interventions, and
outcome measurements.
Effects on cough
Table 3 summarises the impact of OTC cough preparations on
cough outcome.
Antitussives
One study involving 57 children with night cough compared a
single dose for three nights of dextromethorphan and codeine
with placebo.
9
Mean cough and composite scores decreased in
each of the three treatment groups on each day of the study.
Neither dextromethorphan (cough score reduction of 2.1,
p = 0.41) nor codeine (cough score reduction of 2.2, p = 0.70)
was more effective than placebo (cough score reduction of 2.2)
on day 3. Adverse effects included drowsiness, diarrhoea, and
hyperactivity with no statistically signicant differences
between the three groups.
Mucolytics
One study involving 40 children compared the mucolytic leto-
steine with placebo.
10
The symptom score on a four point scale
favoured active treatment from day 4 until day 10, with an
average difference of about 0.2 points (p < 0.01). No adverse
effects were reported in both groups.
Antihistaminedecongestant combinations
Two studies involving 155 children compared antihistamine
decongestant combinations with placebo.
11 12
Brompheniramine/phenylpropanolamine was no more effec-
tive than placebo in reducing the number of children coughing
two hours after each dose (49.0% v 43.1%, p = 0.66). A higher
proportion of children were reported asleep in the active
treatment group (46.6%) than in the placebo group (26.5%,
p = 0.53), and no other adverse effects were reported.
11
In the second study (n = 96), brompheniramine/
phenylephrine/phenylpropanolamine was no more effective
than placebo or no treatment in improving cough symptoms
(67% v 58% and 70%, p = 0.5 and p = 0.8 respectively).
12
Other drug combinations
One trial involving 43 children tested two paediatric cough
syrups (Triaminicol syrup and Dorcol pediatric cough
syrup).
13
Compared to placebo, 69% of children in both active
treatment groups showed a satisfactory response reported by
their parents compared to 57% of children in the placebo
group (p = 0.5). Adverse effects were not reported.
Antihistamines
One trial involving 143 children compared the antihistamines
clemastine and chlorpheniramine with placebo.
14
There was
spontaneous improvement in all groups. In both active
treatment groups, cough scores observed by physicians and
participants improved in 39.6% of individuals compared with
27.6% in the placebo group (p = 0.2). Drowsiness and sleepi-
ness were reported in 20% of children, with no statistically
signicant difference between the groups.
DISCUSSION
Summary of key findings
In this systematic review we found that there is no good evi-
dence for or against the effectiveness of OTC cough medicines
in acute cough. This concurs with the ndings of previous
reviews.
6 7
In the only study showing a statistically signicant
result, the effect size was small and of doubtful clinical
relevance. OTC cough preparations were generally well
tolerated and did not lead to major adverse effects. Many of
the reported adverse effects could in fact have been a result of
the underlying URTI.
Study limitations and potential sources of bias
The results of this systematic review have to be interpreted
with caution, as the number of trials in each category was
small. Studies were very different with regard to settings,
populations, interventions (drugs, doses, and frequency) and
outcome measures, making them difcult to compare.
Individual RCTs were of variable methodological quality with
respect to randomisation, blinding of outcome assessment,
and losses to follow up. Many studies described differences in
cough scores between the treatment groups, which are
difcult to interpret for the purpose of making informed
treatment decisions.
Figure 1 Progress through the stages of the systematic review.
Potentially relevant RCTs identified and screened for
retrieval: n = 328
RCTs excluded: n = 235
Single main reasons:
RCTs retrieved for more detailed evaluation: n = 93
Study not a randomised controlled trial: n = 19
Study not placebo controlled: n = 39
Study not testing over-the-counter cough medicine: n = 86
Cough artificially induced: n = 26
Chronic cough lasting more than three weeks: n = 65
RCTs excluded: n = 87
Reasons:
Study not a randomised controlled trial: n = 4
Study not placebo controlled: n = 2
Study not testing over-the-counter cough medicine: n = 23
Cough artificially induced: n = 3
Chronic cough lasting more than three weeks: n = 25
No cough outcome: n = 15
Participants adults only: n = 15
RCTs included in the review: n = 6
172 Schroeder, Fahey
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Table 3 Characteristics of RCTs of OTC cough preparations versus placebo for the treatment of acute cough
Participants Intervention Outcome Results
Study
Participant characteristics
(no., age, sex, smoking
status), setting, country
Definition of
illness Drug Dosage Frequency
Treatment
duration
Method of
measuring
main cough
outcome Efficacy Adverse effects
Antitussives
Taylor et al
9
57 children, mean age 4.7
years (range 18 months to
12 years), 53% boys, 82%
white, private paediatric
practices, USA
Night cough due
to URTI
1. Dextromethorphan/
guaiphenesin
2. Codeine/
guaiphenesin
15mg/5ml
(dextromethorphan),
100mg/5ml (guaiphenesin)
10mg/5ml (codeine)
100mg/5ml (age 18 months
to 5 years: 2.5ml; 6 to 11
years: 5ml)
Single dose at
bedtime
3 nights Parent
questionnaire,
cough score
from 0 to 4
Mean reductions in
cough scores 2.2
(codeine) and 2.1
(dextromethorphan)
versus 2.2 in the
placebo group,
p=0.52 and 0.97
respectively
Mainly drowsiness,
diarrhoea and
hyperactivity: placebo:
7/13 (54%),
dextromethorphan:
6/19 (32%), p=0.2,
codeine: 5/17 (29%),
p=0.8
Mucolytics
Nespoli et al
10
40 children, age range 2
to 12 years (median 7.5
years), paediatric clinic,
Italy
Acute febrile
bronchitis
Letosteine 25mg Three times daily 10 days Cough score
from 0 to 3,
unclear how
measured
Lower cough scores
in the active
treatment group
compared to
placebo (difference
between groups
ranging from 0.1 to
0.3 points from day
four to 10, p<0.01)
No side effects in both
groups reported
Antihistaminedecongestant combinations
Clemens et al
11
59 preschool children (6
months to 5 years, mean
age 2 years), 4 paediatric
offices, USA
URTI of less than
7 days duration
Brompheniramine
Phenylpropanolamine
2mg/5ml
12.5mg/5ml
(6 mths to 1 year:
1
2
teaspoon, 2 to 5 years: 1
teaspoon)
4-hourly as
needed
48 hours Parent
questionnaire,
7-point Likert
scale, also
counted
responses after
each dose
Mean cough scores
4.67 (active
treatment) and 4.57
(placebo), p=0.53.
Not reported. Higher
proportion asleep in the
active treatment group
(41/88 responses =
47%) compared to
placebo (28/65
responses = 26.5%)
Hutton et al
12
96 inner-city black
children, 6 months to 5
years, mean age about 2
years, primary care clinic,
USA
Symptoms of
URTI
Brompheniramine
Phenylephrine
Propanolamine
4mg/5ml
5mg/5ml
5mg/5ml
(doses calculated to achieve
brompheniramine dosage of
0.5 to 0.75 mg/kg/day)
Three times daily 2 days 9-point symptom
score by parents
or physician,
follow-up
telephone
interviews
Improvement
reported in 20/30
(67%) in the active
treatment group
compared to 14/24
(58%) in the
placebo group and
21/30 (70%) in the
group receiving
treatment (p=0.5
and 0.8
respectively)
Loose stools (n=1) in the
placebo group and
hyperactivity in the
active treatment group
(n=1)
Other combinations
Reece et al
13
43 children, mean age 3.6
years (range 2 months to
12 years), 58% boys,
ambulatory private
practice, USA
Cough due to
URTI
1. Triaminicol syrup:
Phenylpropanolamine
Pheniramine, Pyrilamine
Dextromethorphan
Ammonium chloride
2. Dorcol paediatric
cough syrup:
Dextromethorphan
Phenylpropanolamine
Glyceryl guaiacolate
Alcohol
12.5mg, 6.25mg, 6.25mg,
15mg, 90mg
7.5mg
8.75mg
37.5mg
5%
Unclear Unclear Parent
assessment
Satisfactory
response in 11/16
(69%) and 9/13
(69%) in the
intervention groups
compared to 8/14
(57%) in the
placebo group,
p=0.5 for both
comparisons*
Not reported
O
T
C
m
e
d
i
c
i
n
e
s
f
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w
w
w
.
a
r
c
h
d
i
s
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h
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l
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.
c
o
m

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m
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.
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o
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o
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A
p
r
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l

3
,

2
0
1
4

-

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u
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l
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e
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b
y

a
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.
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m
j
.
c
o
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D
o
w
n
l
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a
d
e
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f
r
o
m

Although we attempted to obtain information on unpub-
lished studies, we received little response from pharmaceuti-
cal companies and study authors. If studies with negative
results were less likely to be submitted for publication, this
could have led to publication bias.
Implications
Cough caused by URTI can be a very troublesome symptom for
a child, and for a health professional, not to offer any
treatment may seem unacceptable to many parents and lay
people. However, as this systematic review shows, there is very
little evidence to suggest that OTC cough medicines are effec-
tive. For this reason, we cannot recommend these as rst line
treatment for acute cough. It is, however, vital that paediatri-
cians, GPs, and other health care workers take the symptoms
of acute cough seriously, taking a careful history and perform-
ing a thorough physical examination to search for possible
underlying diagnoses. If a viral URTI seems the most likely
diagnosis, the treatment options and the lack of evidence for
the effectiveness of OTC cough medicines should be discussed
carefully with parents. Whether a child is being treated or not,
parents should always be offered a further appointment in
case the cough persists, which may suggest the possibility of
another underlying condition.
At present, the NHS encourages self medication for acute
self limiting illnesses and the use of cough preparations as a
home remedy.
4
Though OTC cough preparations appear to be
relatively free from adverse effects, their safety in children has
been questioned.
15
In addition, purchase of OTC cough medi-
cines may lead to an unnecessary nancial burden for health
care consumers.
If health professionals want to recommend OTC cough
medicines to parents of children who suffer from cough
caused by acute URTI, advice should be restricted to less
expensive preparations until more evidence about their effec-
tiveness becomes available.
Suggestions for future research
Health professionals need more evidence from carefully
designed RCTs before recommending OTC cough medicines to
their patients. Identication of effective self care treatments
may help reduce suffering in children with cough as well as
the number of consultations in primary care. Future studies
should therefore use outcome measures that can be easily
used in a primary care setting and that produce clinically
meaningful results.
Conclusions
We conclude from the limited evidence available that OTC
cough medicines do not appear to be more effective than pla-
cebo in acute cough caused by URTI and should not be recom-
mended as a rst line treatment for the resolution of acute
cough. Although these medicines are generally well tolerated,
their use may lead to unnecessary expenses for health care
consumers.
ACKNOWLEDGEMENTS
We thank Steve McDonald and Ron DSouza for their support in
designing the search strategy and performing additional searches.
Many thanks also to Debbie Sharp and Massimo Pignatelli for their
help with the French and Italian translations. Both authors were
involved in all stages of the review. This review is registered for inclu-
sion in the Cochrane database of systematic reviews. The Division of
Primary Health Care, University of Bristol and the South & West
Research and Development Directorate funded this study. KS is
funded through an MRC Training Fellowship in Health Services
Research. TF is funded through the NHS R&D National Primary Care
Career Scheme.
. . . . . . . . . . . . . . . . . . . . .
Authors affiliations
K Schroeder, T Fahey, Division of Primary Health Care, University of
Bristol, Bristol BS6 6JL, UK
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174 Schroeder, Fahey
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ARCHIVIST ........................................................................................................
Schoolchildren born of heroin dependent mothers
A
report from Jerusalem (Asher Ornoy and colleagues. Developmental Medicine and Child Neurology
2001;43:66875) has shown the effects of maternal heroin dependency on school age children. The
study included 65 children born to heroin dependent mothers, 34 of whom had been adopted. They
were compared with 33 children of heroin dependent fathers, 32 children with environmental depriva-
tion but no parental addiction, and 30 control children. All children in the study were aged 512 years and
attending mainstream schools. The children of heroin dependent mothers raised at home were of low
gestational age (mean 35 weeks) and birthweight (mean 2410 g). On tests of verbal and performance
skills, reading, and arithmetic the environmentally deprived, drug dependent father, and home-raised
drug dependent mother groups all did signicantly worse than the control group. The adopted children
born of drug dependent mothers, however, performed normally apart from poor performance skills.
Attention decit hyperactivity disorder (ADHD) was common among all children of heroin dependent
parents and among environmentally deprived children, but commonest among home raised children of
heroin dependent mothers. These mothers also had a high rate of childhood ADHD.
The children of drug dependent parents performed poorly at school when raised at home. Those
adopted at an early age performed almost normally. ADHD was common in the children and their
mothers.
OTC medicines for acute cough 175
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doi: 10.1136/adc.86.3.170
2002 86: 170-175 Arch Dis Child

K Schroeder and T Fahey

trials
Systematic review of randomised controlled
cough? the counter cough medicines for acute
Should we advise parents to administer over
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