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Impacted Cerumen Composition, Production, Epidemiology
Impacted Cerumen Composition, Production, Epidemiology
doi:10.1093/qjmed/hch082
Review
Summary
In the UK, some 2.3 million people suffer cerumen double-blind studies comparing treatments, and
(‘ear wax’) problems serious enough to warrant accordingly, the evidence surrounding the manage-
management, with approximately 4 million ears ment of impacted cerumen is inconsistent, allow-
syringed annually. Impacted cerumen is a major ing few conclusions. The causes and management
cause of primary care consultation, and a common of impacted cerumen require further investigation.
comorbidity in ENT patients, the elderly, infirm Physicians are supposed to follow the edicts
and people with mental retardation. Despite this, the and principles of evidence-based medicine and
physiology, clinical significance and manage- clinical governance. Currently, in patients with
ment implications of excessive and impacted impacted cerumen, the lack of evidence makes
cerumen remain poorly characterized. There this impossible.
are no well-designed, large, placebo-controlled,
Introduction
Impacted cerumen (‘ear wax’) is common,1 often intention of facilitating removal dates to the 18th
causes unpleasant symptoms2 and is occasionally century.4 Since then, a large number of drugs
associated with serious sequelae, including hearing to loosen impacted cerumen have been routinely
loss, social withdrawal, poor work function and used in general practice and as over-the-counter
perforated eardrums.3 Impacted cerumen is also medications.
a common comorbidity in secondary care popula- To review the published literature, we con-
tions, including ENT patients, the elderly infirm30 ducted an electronic search of the Medline,
and people with mental retardation.27 Moreover, Embase, Health Star, Current Contents, NHSEED
management of impacted cerumen in, for exam- and Cochrane databases. The search terms for the
ple, diabetics and immunocompromised subjects, databases included ‘cerumen’, ‘ear wax’ and ‘hear-
can pose problems for secondary care physicians.36 ing loss’. The abstracts of the publications identified
Occasionally, surgery is an appropriate treatment. by this search strategy were assessed, and other
Clinicians have sought an effective means papers identified manually from the citations.
to remove impacted cerumen for centuries. For Despite excessive and impacted cerumen being
example, softening earwax with the specific common, the literature review presented in this
Address correspondence to Dr J.F. Guest, CATALYST Health Economics Consultants, 34b High Street,
Northwood, Middlesex HA6 1BN. e-mail: julian.guest@catalyst-health.co.uk
QJM vol. 97 no. 8 ! Association of Physicians 2004; all rights reserved.
478 M.J. Greener et al.
paper suggests that its physiology, clinical signifi- the prevalence of impacted cerumen or treatment
cance and management implications remain poorly outcome, is unknown.
characterized. There are no well-designed, large, As a result of the sebaceous glands’ secretions,
placebo-controlled, double-blind studies com- cerumen’s organic composition comprises satu-
paring treatments. The dearth of rigorous evidence rated and unsaturated long-chain fatty acids, alco-
negates any attempt at systematically assessing hols, squalene (which accounts for between 12%
optimal management strategies, our original inten- and 20% of the wax) and cholesterol (6–9%).
tion when planning this review. Indeed, the lack of Indeed, in about 15% of cases, an oily ring appears
rigorous evidence precluded a formal systematic when cerumen is placed on filter paper.8 However,
review in any of the areas covered. cerumen lipid and amino acid composition seems
Therefore, we outline the current state of knowl- to differ considerably from that expressed in the
edge concerning the composition, production and stratum corneum. For example, uncontaminated
genetics of cerumen. This paper also reviews the stratum corneum does not seem to express the
among Asians living in North America or Europe. empirical observation supports suggestions that
Rather, they seem to express the wet form. Further cerumen’s only role is to provide a mechanism for
studies in Asians living in North America or Europe excreting keratin.
(as well as other populations) are needed to con- Furthermore, if cerumen was important in host
firm or deny this clinical impression. defence, production might change in response to
Furthermore, no firm data correlate phenotype, infection risk. However, as mentioned above,
the risk of developing impacted cerumen and clini- cerumen production does not vary markedly over
cal outcomes with, for example, different agents. the year,10 despite seasonal differences in the risk
The differences in the biochemical composition of of infections.
wet and dry cerumen might suggest that different Several other strands of evidence also fail to sup-
drugs could be effective in different patient groups. port suggestions that cerumen is associated with
However, there is no evidence to support this. significant effects on host defence. For example,
On the other hand, there is now a growing, impacted cerumen exposed to water, possibly from
Eekhof et al.28 Randomized Patients with cerumen Water drops at body Mean number of syringing The use of water as a dispersant for
controlled study impaction attending temperature for 15 min attempts was 3.0 per patient impacted cerumen is quick and
a general practice (n ¼ 22 patients) more convenient for the patient.
Oil for three nights Mean number of syringing
before sleeping attempts was 2.4 per patient
(n ¼ 20 patients)
Lyndon et al.4 Open randomized Adult patients (n ¼ 36) Audax ear drops for 39% of patients did not require A non-significant trend was observed
study with cerumen 4 days syringing, 58% experienced easy showing less impaction post-
impaction attending syringing and 3% difficult syringing treatment with Audax than with
a general practice Earex ear drops for 21% of patients did not require Earex. However, a significant
4 days syringing, 35% experienced difference was seen in favour of
easy syringing and 32% Audax for the frequency and ease
difficult syringing of syringing (p < 0.005).
Chaput De Double-blind Out-patients who had Triethanolamine 20 had complete wax removal and Triethanolamine polypeptide
Saintonge & comparison impacted wax and polypeptide oleate- 12 had partial wax removal preparation needed a significantly
Johnstone47 were considered condsate ear drops smaller volume of water and
suitable for syringing (n ¼ 32 ears) resulted in less patient discomfort.
Olive oil (n ¼ 35 ears) 21 had complete wax removal,
10 had partial wax removal and
4 had negligible wax removal
Fahmy & Controlled trial Patients with cerumen 5% urea hydrogen 15% of ears treated with Exterol did Exterol was significantly superior to
Whitefield48 impaction attending peroxide in glycerol not require syringing, whereas with both glycerol and Cerumol at
M.J. Greener et al.
a hospital ENT (Exterol) glycerol, syringing was always dispersing wax completely and
department or necessary. facilitating syringing (p < 0.001).
general practice Glycerol control 40% of ears treated with
Cerumol Exterol did not require syringing,
compared to only 15% with
Cerumol.
Carr & Smith15 Randomized Adults (n ¼ 33) and children 10% aqueous sodium There was a 66% improvement. There was no difference between
controlled trial (n ¼ 36) presenting to a bicarbonate the efficacy of the two treatments
community family 2.5% aqueous There was a 78% improvement. in reducing the amount of wax but
practice clinic who had acetic acid both were more efficacious in
cerumen occluding children (96% improvement) than
at least one external in adults (45% improvement)
auditory canal
Jaffe & Grimshaw49 Randomized, Patients (n ¼ 106) with Otocerol drops for 74% of patients required syringing Otocerol was marginally better than
double-blind cerumen impaction 3 days (n ¼ 53) and syringing was easy in 57% Cerumol in all parameters
controlled trial attending a general of the group evaluated.
practice Cerumol drops for 89% of patients required syringing
3 days (n ¼ 53) and syringing was easy in 64%
of the group
Impacted cerumen can cause a variety of impacted cerumen. For example, using cotton buds
symptoms2 including itching, pain, hearing loss, to clean the canal can lead to impacted cerumen.
tinnitus, dizziness and increased infection risk. In one study, cotton-tipped swabs were associated
Furthermore, untreated impacted wax can lead with 75% of cerumen occlusion on the left side,
to ‘hearing loss, social withdrawal, poor work func- but not on the right side in paediatric patients.
tion and even mild paranoia’. Some patients with However, the study did not show a causal relation-
impacted wax present with perforated eardrums.3 ship between the use of cotton-tipped swabs and
In most cases, the latter is self-induced—cerumen impacted cerumen. Clearly, however, such swabs
by itself cannot cause perforation. Nevertheless, do not necessarily clear cerumen from the external
perforation can in turn, lead to perilymph fistula: canal.26 Any future prospective studies of cerumen
a tear or opening in the round or oval cochlear removal strategies need to take account of such
windows, which can cause nystagmus, neurosen- behavioural factors.
sory hearing loss and tinnitus. Moreover, tinnitus
of those that replied saw at least 21 patients a needed impacted cerumen removed ‘often every
month. About half (50.7%) saw 10 or fewer patients year‘.31
for cerumen removal a month. The reasons for the increased prevalence of
Such surveys are prone to recollection bias. impacted cerumen among people with mental retar-
Nevertheless, the survey provides an ‘order of dation are not clear. However, anatomical differ-
magnitude’ estimate of the health care burden ences in the structure of the canal (for example,
associated with impacted cerumen in Scotland. The associated with trisomy 21) or excessive cerumen
GPs managed a population of around 650 000 production may play, at least, contributory roles.27
people, and the researchers estimated that some Again, the association between mental retardation
44 000 ears are syringed each year in this popula- and excessive cerumen production requires fur-
tion. Assuming the same proportion applies to the ther analysis, not least because very few people
whole UK population of around 59 million, approxi- with mental retardation visit a clinician because
mately 4 million ears are syringed annually. This of cerumen impaction.
a perforated eardrum, water and infections can enter Finally, a case history37 supports the anecdotal
the middle ear. Residual water can also promote evidence that severe audiovestibular loss can follow
infection.30 Indeed, ear syringing can be associated ear syringing to remove cerumen.
with several potentially serious complications.24
In the aforementioned GP survey, 38% of those
that responded reported experiencing a total of 127 Agents to loosen impacted cerumen
complications associated with cerumen removal.
Against this background, agents that loosen ceru-
Failure of cerumen removal accounted for 29%
men seem to offer the only effective, relatively
of complications. Otitis externa (17%), eardrum
well-tolerated management alternative to physical
perforation (15%) and damage to the external
removal. Indeed, softeners are often sufficient to
canal (12%), emerged as the next most common
treat mild cases of impacted cerumen, as well as
adverse events. Pain, vertigo, otitis media and
reducing the need for surgical removal in more
discovered perforation each accounted for fewer
the assessment was qualitative and the samples some patients might not apply the drops for long
were pooled. However, it suggests that Waxsol enough before syringing. Moreover, patients may
may be more effective. not allow them to soak into the external meatus for
long enough before standing up.14
Despite these limitations, a number of papers
Clinical studies
purport to advocate other agents as effective treat-
A number of clinical studies assess the efficacy ments for cerumen removal. However, the evi-
and safety of cerumen softeners. However, there is dence is often mixed and inconsistent. To take one
a need for further well designed, large, placebo- example, docusate sodium (dioctyl sodium sulpho-
controlled, double-blind studies. succinate), widely used as a stool softener, offers
An analysis of docusate sodium enrolled a ‘highly effective’ means of removing cerumen. No
302 patients in whom cerumen either partially or side-effects emerged over five years’ clinical experi-
completely blocked the tympanic membrane. One ence.43 However, in another study44 docusate
for their invaluable insight and contributions to this 20. Campos A, Betancor L, Arias A, et al. Influence of human
wet cerumen on the growth of common and pathogenic
review. We would also like to thank the anonymous
bacteria of the ear. J Laryngol Otol 2000; 114:925–9.
reviewers for their comments.
21. Stroman DW, Roland PS, Dohar J, et al. Microbiology
of normal external auditory canal. Laryngoscope 2001;
111:2054–9.
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