1
PATTERN OF OTOMYCOSIS SEEN AMONG PATIENTS
IN THE OTORHINOLARYNGOLOGY CLINICS OF THE
UNIVERSITY OF NIGERIA TEACHING HOSPITAL
(UNTH),
ITUKU-OZALLA, ENUGU.
BY
DR. FRANCIS AMADI IBIAM
DEPARTMENT OF OTORHINOLARYNGOLOGY
UNIVERSITY OF NIGERIA TEACHING HOSPITAL
(UNTH), ITUKU-OZALLA, ENUGU STATE, NIGERIA
A DISSERTATION SUBMITTED TO
THE NATIONAL POSTGRADUATE MEDICAL COLLEGE
OF NIGERIA.
IN PARTIAL FULFILLMENT OF THE REQUIREMENTS
FOR THE AWARD OF THE FELLOWSHIP OF THE
MEDICAL COLLEGE IN OTORHINOLARYNGOLOGY
(F.M.C.O.R.L).
MAY, 2009.
2
ETHICAL CLEARANCE CERTIFICATION
3
DECLARATION
This is to certify that I, Dr. Francis Amadi Ibiam wrote this
dissertation and carried out the research work diligently under
appropriate supervision.
NAME: DR. FRANCIS AMADI IBIAM
SIGN:……………………………………………………….
DATE:………………………………………………………
4
ATTESTATION
THIS IS TO CERTIFY THAT I SUPERVISED THIS
DISSERTATION
TITLED:
PATTERN OF OTOMYCOSIS SEEN AMONG PATIENTS IN
THE OTORHINOLARYNGOLOGY CLINICS OF THE
UNIVERSITY OF NIGERIA TEACHING HOSPITAL (UNTH),
ITUKU-OZALLA, ENUGU.
BY
DR. FRANCIS AMADI IBIAM
DEPARTMENT OF OTORHINOLARYNGOLOGY,
UNIVERSITY OF NIGERIA TEACHING HOSPITAL (UNTH),
ITUKU-OZALLA, ENUGU.
IN PARTIAL FULFILLMENT OF THE REQUIREMENTS
FOR THE PART II FELLOWSHIP EXAMINATION
IN OTORHINOLARYNGOLOGY OF THE NATIONAL
POSTGRADUATE MEDICAL COLLEGE OF NIGERIA
PROF. B. C. EZEANOLUE (FMCORL, FWACS).
Professor of Otorhinolaryngology and Head,
Department of Otorhinolaryngology, University of Nigeria Teaching
Hospital, Ituku-Ozalla, Enugu.
ATTESTATION
5
THIS IS TO CERTIFY THAT I SUPERVISED THIS
DISSERTATION
TITLED:
PATTERN OF OTOMYCOSIS SEEN AMONG PATIENTS IN
THE OTORHINOLARYNGOLOGY CLINICS OF THE
UNIVERSITY OF NIGERIA TEACHING HOSPITAL (UNTH),
ITUKU-OZALLA, ENUGU.
BY
DR. FRANCIS AMADI IBIAM
DEPARTMENT OF OTORHINOLARYNGOLOGY,
UNIVERSITY OF NIGERIA TEACHING HOSPITAL (UNTH),
ITUKU-OZALLA, ENUGU.
IN PARTIAL FULFILLMENT OF THE REQUIREMENTS
FOR THE PART II FELLOWSHIP EXAMINATION
IN OTORHINOLARYNGOLOGY.OF THE NATIONAL
POSTGRADUATE MEDICAL COLLEGE OF NIGERIA.
DR. I.J OKORAFOR (FWACS).
Consultant Otorhinolaryngologist,
Department of Otorhinolaryngology, University of Nigeria Teaching
Hospital, Ituku-Ozalla, Enugu.
6
DEDICATION
This work is dedicated to my creator, the Almighty God who is the
author and finisher of my faith.
To my wife Christina whose unshakable love and understanding
kept the home front throughout my years of absence in chase of the
golden fleece.
To my daughters, Ebubechi and Ugochi whom God used in putting
smiles on my face as my Residency Training lasted.
To my parents, Omezue and Mrs Ibiam Iho for all their sacrifices
to give me education, and finally, to my siblings, sister, Vero,
Ogbonnaya and Mary who mean so much to me.
ACKNOWLEDGEMENT
It is with every humility and gratitude that I want to thank my
teacher and supervisor Prof. B. C. Ezeanolue for all his patience
and corrections on this work.
7
My gratitude also goes to Dr I. J. Okorafor my second supervisor,
and to Mr Aneke Francis the Microbiologist whom I worked with
in getting the culture results of my study.
I must also not forget to thank Prof C. O. O. Chukwu who has been
more than a brother, friend, teacher and above all inspired me in
my academic pursuits.
Lastly I want to thank Dr Cliford Okike my statistician, the
Residents of Otorhinolaryngology Department, UNTH, Enugu who
assisted me in my patient recruitment, not forgetting Miss Mary
Chukwu who did most of the typing job. I also thank every person
who in one way or the other contributed to the success of this
work.
TABLE OF CONTENTS
Title page i
Ethical clearance ii
Declaration iii
8
Attestation iv
Dedication vi
Acknowledgement vii
Table of contents viii
Summary x
CHAPTER ONE
Introduction 1
Justification for the study 3
Scope and limitations of the study 4
CHAPTER TWO
Aims and objectives of the study 6
CHAPTER THREE
Literature review 7
CHAPTER FOUR
Patients and Methods 17
CHAPTER FIVE
Results 25
CHAPTER SIX
Discussion 46
CHAPTER SEVEN
Conclusions/ Recommendations 52
References 54
Appendix I 61
9
Appendix II 65
SUMMARY
TITLE: PATTERN OF OTOMYCOSIS SEEN AMONG
PATIENTS IN THE OTORHINOLARYNGOLOGY CLINICS
OF UNIVERSITY OF NIGERIA TEACHING
HOSPITAL(UNTH) ITUKU-OZALLA, ENUGU.
BACK GROUND: Otomycosis is a common disease in the
tropics and sub tropics with paucity of knowledge and few
research work on the disease from Nigeria. Recently we have also
been seeing increasing number of cases of external ear infections
in our clinics as well as recurrent visits of such cases to our clinics.
10
AIMS AND OBJECTIVES: To determine the prevalence, age, and
sex distribution and the common organisms implicated in causing
otomycosis.
METHODOLOGY: This was a one-year hospital based
prospective study on consecutive patients attending the
Otorhinolaryngology clinics of the University of Nigeria Teaching
Hospital Enugu. Diagnosis of otitis externa were made from
symptoms and signs of patients. Informed consent was obtained
from those who met the inclusion criteria. Swabs of ear discharge
of patients were sent to the laboratories of the University of Nigeria
Teaching Hospital for bacterial and fungal culture studies. Patients
ears were manually cleaned by dry mopping and placed on
ototopical Locorten-Vioform® ear drops. This was done for three
consecutive weeks. Treatment outcome was assessed at the end of
three weeks.
RESULTS: A total of 3793 consecutive patients were assessed out
of which 153 were diagnosed with otitis externa. Out of these 153
patients, 127 patients met the inclusion criteria and were used for
the study. Prevalence of otomycosis was 0.74% and affected all
ages with equal male and female affectation. Aspergillus niger,
Apergillus fumigatus and Candida in decreasing frequency were
the commonest aetiologic fungal species isolated and most
responded to manual aural dry mopping and ototopical Locorten-
Vioform® at the end of three weeks of treatment.
11
CONCLUSION: Otomycosis is a common clinical disease in
Enugu and environs and responds to manual ear dry mopping and
ototopical medication with Locorten-Vioform® ear drops.
KEY WORDS: Otomycosis, fungus, otitis externa, bacteria.
CHAPTER ONE
INTRODUCTION
Acute otitis externa was defined as inflammation of the external ear
canal, which may also involve the pinna or tympanic membrane1. It
was also defined as redness or swelling of the external auditory
canal or debris within the canal accompanied by pain, itching,
otorrhea, hearing loss or a stuffy feeling for less than three weeks.2
The disease is also known as “Swimmer’s ear” and may be acute
or chronic.1
Studies done in South Eastern Nigeria by Okafor show that the
incidence of otitis externa, was quite high, with about 117 new
cases per year and ranking second to chronic suppurative otitis
media as the commonest otologic disease.3
In the Netherlands the incidence of acute otitis externa was about
12% to 14% of all otorhinolaryngology cases seen.4 The incidence
in humid tropical areas is higher than in temperate climates.5
Predisposing factors to developing otitis externa were: excessive
wetness of ear canal as in swimmers, being in warm and humid
places, harsh cleaning of the ear canal, trauma to the ear canal, dry
12
ear canal skin, foreign body in the ear canal, lack of cerumen (ear
wax), eczema and other forms of dermatitis.6
Otitis externa may be classified into two based on the causative
agents.
(a) Infective, which includes bacterial and fungal organisms.
(b) Non-infective causes: These are primarily dermatologic
disorders, which may be systemic e.g. atopic dermatitis,
psoriasis, seborrheic dermatitis, acne and lupus
erythematosus, or local dermatologic disorders e.g. contact
dermatitis, irritant or allergic.6
The most common cause of otitis externa is bacterial infection
though fungal overgrowth is a principal cause in 10% of
cases6. Fungal otitis externa is known as otomycosis.
OTOMYCOSIS
Otomycosis was defined as a superficial mycotic infection of the
outer ear canal, which may be either subacute or acute and is
characterized by inflammation, pruritus, scaling, and severe
discomfort7.
The mycosis results in inflammation, superficial epithelial
exfoliation, masses of debris containing hyphae, suppuration, and
pain.7
13
The disease is worldwide in distribution but was said to be
commonly found in hot and humid climate of tropical and
subtropical countries.8
Fungal organisms are found as saprophytes in the external auditory
meatus and may be superimposed on an underlying bacterial
infection, which appears to change the physico-chemical
environment of the meatus and facilitate fungal growth. The
prevalence of the disease is influenced by a number of predisposing
factors such as immuno-supression, pregnancy and use of steroids9.
Fungi and yeast are usually found in patients with chronic otitis
externa or those who are immuno-compromised.10, 11
There have also been reports of autoinoculation of the ear canal
that result in otomycosis by patients with untreated
dermatomycosis.12 The most common aetiological agents were
Aspergillus niger, Aspergillus fumigatus and Candida albicans.
Less frequently involved fungi are penicillium, scopulariopsis,
Mucor and other species of Aspergillus e.g Aspergillus flavus) and
Candida (e.g Candida tropicalis)8.
Although rarely life threatening, the disease presents a challenging
and frustrating entity for both patients and otologists, for it
frequently requires long term treatment and follow up, yet the
recurrent rate remains high12.
14
JUSTIFICATION FOR THE STUDY
Otomycosis is one of the common conditions encountered in a
general otolaryngology clinic. 8
There have also been increasing cases of external ear
infections as well
as recurrent visits to our clinics in Enugu by patients with
external ear
infections.
Though otomycosis is a recognized clinical entity in Africa and
presumably occurs frequently, reports on its incidence and
aetiology are rare from this continent 8.
There were previously published studies on otomycosis done in
this centre several years ago.3,8,9 These studies addressed different
aspects of otomycosis. This study evaluated the prevalence, age,
sex distribution, causative organisms and outcome of treating
otomycosis for three weeks with manual dry mopping of external
auditory canal and ototopical Locorten-Vioform® medication.
More over, there is an obvious time gap between the last studies
carried out on otomycosis in Enugu and now. In order to update
our knowledge on otomycosis in our environment, it has become
necessary to revisit otomycosis with a view to addressing the above
issues raised.
SCOPE AND LIMITATIONS OF THE STUDY
15
Only subjects who were 2 years of age and above that fulfilled the
inclusion criteria were recruited into the study. The study lasted
from, December 2007 to November 2008. (12 months). .
For this study, the topical anti-infective medication that was used
is Locorten- Vioform® ear drop – (which contains 0.02% w/v
flumetasone pivalate, 1% w/v clioquinol B. P. and polyethylene
glycol manufactured by Amdipharm Plc Basildon, Essex) for all
the patients.
The procedure to diagnose otitis externa has several limitations; it
is slow to culture organisms on growth media, fungal infections
may be missed and laboratory facilities and mycological expertise
are required.
Interpretations of fungal growths are subject to errors from the
human angle, therefore, identity of some species could be mistaken
for others.
Facility to carry out viral studies is lacking in our centres.
Therefore it is difficult to ascertain the exact cause of acute otitis
externa in cases that grew no isolates of organisms.
Micro-otoscopy has not become a routine in our clinics.
It is difficult to monitor drug compliance with a dosing frequency
of four times per day for three consecutive weeks.
It would have been desirable to do repeat cultures of ear swabs of
patients after a period of 4-6 months to determine complete cure,
16
but for time constraints. However it may still be difficult to
ascertain which growths are due to recurrence, new growths or re-
infection.
CHAPTER TWO
AIMS AND OBJECTIVES OF THE STUDY
General
To determine the prevalence of otomycosis in patients seen in the
Otorhinolaryngology Clinics of the University of Nigeria Teaching
Hospital Ituku-Ozalla, Enugu.
Specific
This study is done specifically to determine the;
(i) Proportion of clinical otitis externa in which fungal
organisms will be isolated in the laboratory from ear
swabs.
(ii) Causative fungal organisms in otomycosis; and
(iii) Age and sex distributions of patients seen in the
Otorhinolaryngology Clinics of the University of Nigeria
Teaching Hospital Ituku-Ozalla, Enugu, who had fungus
17
isolated in their ears that were symptomatic of otitis
externa.
18
CHAPTER THREE
LITERATURE REVIEW
3.1 PATHOPHYSIOLOGY OF OTITIS EXTERNA
The unique structure of the external auditory canal (EAC)
predisposes it to the development of otitis externa. It is the only
normal skin-lined cul-de-sac in the human body, and is about
2.5cm in length. The external auditory canal is warm, dark and
prone to becoming moist, making it an excellent environment for
bacterial and fungal growth6.
The skin in the EAC is very thin and the lateral one-third overlies
cartilage, while the medial two-thirds overlies bone. The canal is
easily traumatized. The exit of debris, secretions and foreign bodies
from the canal is impeded by a curve at the junction of the cartilage
and bone.6 The presence of hair, especially the thicker hair
common in older men, can be a further impediment to exit of
debris and secretions from the external auditory canal6.
Fortunately, the external auditory canal has some special defenses.
Cerumen creates acidic coat containing lysozymes and other
substances that probably inhibit bacterial and fungal growth.6 The
lipid-rich cerumen is also hydrophobic and prevents water from
penetrating to the skin and causing maceration.6 Too little cerumen
can predispose the ear canal to infection, but cerumen that is
excessive or too viscous can lead to obstruction, retention of water
19
and debris, and infection6. Additionally, the canal is defended by a
unique epithelial migration that occurs from the tympanic
membrane outward, carrying any debris with it, a process, which
slows with age6. When these defenses fail or when the epithelium
of the external auditory canal is damaged, the ear canal is easily
predisposed to infection.6 There are many precipitants of infection,
but the most common is excessive moisture that elevates the pH
and reduces the quantity and rate of production of cerumen.6 Once
the protective cerumen is removed, keratin debris absorbs water,
which creates a nourishing medium for bacterial and fungal
growth6.
3.2 PREDISPOSING FACTORS
Otomycosis is a recognized clinical entity worldwide; though
reports on its incidence and aetiology are rare from Africa8.
The world-wide distribution of otomycosis was also reported by
Ayse Demet et al in a study of the in-vitro susceptibilities of
Aspergillus species causing otomycosis to Amphotericin B,
Voriconazole and Itraconazole.13 Otomycosis is world-wide in
distribution, but commonly found in hot and humid climates of
tropical and sub-tropical countries13.
Prominent amongst the predisposing factors are immuno-
supression, pregnancy, humid climate and use of systemic
20
steroids9. Other predisposing factors reported by Tang et al were
humid climate, presence of cerumen, injury caused by
instrumentation of the ear, immuno-compromised host and
increased abuse of topical antibiotic preparations12. This discovery
that some antibiotic ear drops predisposes to otomycosis was
further buttressed by the findings of Jackman et al; that ear drops
containing ofloxacine remain an excellent choice for bacteria
otorrhea, but it appears to increase the incidence of otomycosis14.
They concluded by submitting that physicians need an elevated
suspicion of otomycosis as a cause of persistent otorrhea,
especially following treatment with topical antibiotic drops. Thus
its usage warrants careful post treatment follow-up.14
Earlier studies done by Martin et al on fungal causes of otitis
externa and tympanostomy tube otorrhea, pointed to the dangers of
abuse of ofloxacine containing ear drops for treatment of bacteria
otitis externa.15 They found out that otorrhea due to fungal
organisms occurs in a setting of refractory infection and is often
discovered after multiple aural and ototopical antibacterial
medications15. Due to the extended treatment period required to
clear fungal organisms, timely diagnosis with culture for bacteria
and fungus is required in patients with persistent otorrhea.15 An
increase in incidence of fungal infections of the ear was found in
the period after widespread use of ofloxacine began7.
21
A study done in Abidjan by Yavo et al implicated swimming in
natural or artificial pools, cleaning of the ear and excessive use of
ear drops as predisposing factors for otomycosis16. There have also
been reports of autoinoculation of the ear canal that results in
otomycosis by patients with untreated dermatomycosis12.
However, a study carried out in Turkey on the predisposing factors,
aetiology and therapy of otomycosis found wearing of head clothes
as the commonest predisposing factor to the development of
otomycosis17.
Studies by John Rutka in 2004 on acute otitis externa, treatment
perspectives; implicated prolonged exposure of EAC to water (e.g.
frequent swimming), certain dermatologic conditions (psoriasis and
eczema), trauma, anatomic abnormalities (e.g. exostoses and
narrow canals), some underlying conditions (e.g. diabetes) some
concomitant ear diseases (e.g. cholesteatoma), the use of hearing
assistive devices (e.g. hearing aids and ear plugs), and cancer
radiotherapy as predisposing factors to otomycosis.18
Prior otologic procedures also increase the risk of developing
otomycosis12.
In a study by Oliveri et al in Milan Italy on otomycosis, aetiology
and analyses of predisposing factors; working in gardens or using
mechanical removing devices were more frequent causes of
22
otomycosis than swimming, water irrigations or antibiotic
therapies.19
The presence of hair especially the thicker hair common in older
men can predispose to otomycosis6. Otomycosis is commoner in
females than males and Aspergillus niger is the major aetiologic
agent20.
However, in Ilorin Nigeria, Nwabuisi and Ologe reported that there
was no sex predilection in their study and equal males and females
were affected. Their patients fell in the age range of 21 years and
above.21 Adults also predominated in two separate studies in Enugu
by Gugnani et al and Mgbor et al8,9. Recent studies by Fasunla et al
in Ibadan, Nigeria on Otomycosis in Western Nigeria also showed
that females suffered more from otomycosis than males and
majority of the patients were adults.22
Of the predisposing factors for acute otitis externa, only swimming
has been shown to increase the risk .23,24,25
3.3 AETIOLOGICAL FUNGAL SPECIES IN OTOMYCOSIS
The growing significance of opportunistic fungi emphasized on
comprehensive studies to establish the aetiologic role in various
clinical disorders in human and animal medicine26. Most studies
agree on Aspergillus species as the commonest cause of
otomycosis. In a study on aetiological agents of otomycosis in
Enugu, Nigeria by Gugnani et al, the most common aetiology fungi
23
found were Aspergillus niger, Aspergillus fumigatus and Candida
albicans. Less frequently involved fungi included Penicillium,
Scopulariopsis, Mucor and other species of Aspergillus (e.g.
Aspergillus flavus) and Candidia (e.g. Candida tropicalis)8. A later
study carried out in the same center by Mgbor et al found similar
organisms as the commonest causes of otomycosis; species of
Aspergillus and Candida were the commonest aetiological fungi
found9.
The findings of Nwabuisi and Ologe in Ilorin did not differ
significantly from the earlier findings of Gugnani et al in Enugu.
This study in Ilorin found that Aspergillus, Candida and Mucor in
that order were the commonest organisms isolated in otomycosis21.
A study done in Abidjan in 2004 found similar aetiologic agents
for otomycosis; Aspergillus flavus, Candida albicans, Candida
parapsilosis and Aspergillus niger were the commonest agents
isolated16. Also Tang Ho et al working in Houston, Texas, USA in
2006 found Candida and Aspergillus as the most common fungal
species isolated in otomycosis.12
Studies carried out in Kathmandu, Napel showed that, the common
fungal pathogen found was Aspergillus, followed by Candida
albicans27. Aspergillus species and yeast mainly Candida also
came out as the commonest causes of otomycosis in a study on
fungal otitis externa of 83 patients in Libreville28.
24
3.4 ANTI-FUNGAL THERAPEUTIC AGENTS
The causative agents of otomycosis could be avoided or treated29.
Treatment with topical anti-fungal agents is not enough to ensure
complete cure. Furthermore, any treatment should aim to restore
the physiology of the external auditory canal29.
Multiple in vitro studies examined the efficacy of various
antifungal agents. There was no consensus on the most effective
agent. Various agents were used clinically with variable rates of
success12. Topical antifungal agents such as clotrimazole;
mycostatin, Locorten-Vioform®, gentian violet were used for
treatment of otomycosis. However, the outcome was very often
unsatisfactory9. A study by Kaur et al in 2000 on clinicomycologic
study showed nystatin, clotrimazole and econazole as antifungals
of proven efficacy7.
Stern et al in a different study on the in vitro effectiveness of 13
agents in otomycosis and review of literature also found nystatin,
clotrimazole and econazole as effective anti-fungal agents for the
treatment of otomycosis30.
Another study on aetiological significance of Candida albicans in
otitis externa confirmed the effectiveness of clotrimazole in the
treatment of otomycosis31. The topical application of one percent
(1%) clotrimazole lotion showed good response both clinically as
well as mycologically26.
25
Studies carried out in India on treatment of otomycosis by the use
of mercurochrome solution also showed that the patient responded
to topical 1% solution of Mercurochrome.32 The use of
mercurochrome in developing countries like India may be
recommended to treat fungal otitis externa in patients32. The above
study on the effectiveness of mercurochrome on otomycosis found
support in a later study in 2000 by Mgbor et al on treatment of
otomycosis in Nigeria with topical 1% solution of
mercurochrome9. They concluded that mercurochrome was
effective as reported in an earlier study in India and recommended
as a safe and economical drug for the topical treatment of
otomycosis in Nigeria.9
Most researchers generally agreed on mechanical cleaning of
external ear canal prior to application of various antifungal agents
to achieve good results. The therapeutic agents were always used in
conjunction with thorough mechanical debridement of visible
fungal elements in the external auditory canal12.
The EAC can also be cleaned by rinsing with sterile water or using
a suction device.33
Some clinicians may combine ototopical treatment with systemic
antifungal drugs. In a study on the general practice management of
otitis externa by Robertson et al, the results of questionnaires
survey showed that although all the respondents agreed that aural
26
toileting was important, only 50% felt confident in performing
aural toileting and packing.34 There also appeared to be much
greater scope for the use of astringents and effective preventive
measures in addition to aural toileting.34
Emgard et al in Sweden in 2005 observed that a 0.05% solution of
betametasone dipropionate (BD) was more effective in the
treatment of external otitis than ear drops containing antibiotics or
antifungals, whether the ear was infected or not35. They also
recorded no serious adverse effects and stated that lower cost
favoured a steroid solution without any antibiotic component. Their
conclusion was that a steroid solution should be the preferred
remedy for external otitis, whether infected or not.35
In yet another study by Emgard et al in 2005 on external otitis
caused by infection with Pseudomonas aeruginosa or Candida
albicans cured by use of a topical group III steroid, without any
antibiotics, it was found out that irrespective of the microbial
agents, a group III steroid solution cured external otitis efficiently
in a rat model.36 The conclusion was that the addition of antibiotic
components to steroid solution for the treatment of external otitis
was of questionable validity36.
The effectiveness of use of topical steroid was also evaluated by
Jacobsson et al in 1991 in Sweden by studying the clinical efficacy
of budesonide in the treatment of eczematous external otitis37. They
found out that budesonide treatment was associated with a
27
reduction in severity of all symptoms recorded and a marked
improvement in erythema, swelling and discharge37. They also
concluded that mechanical cleaning of the ear canal and placebo
was not a sufficient treatment for the group of patients used37.
While topical steroids had tremendous benefits in reducing
inflammation, they also had significant side effects. Most of these
side effects were seen with long-term usage, but some were noticed
within days of starting therapy. Such side effects to topical steroids
were, tachyphylaxis, steroid rosacea, skin atrophy, striae-stretch
marks, alteration of infection, topical allergy and glaucoma 38.
Nordang et al in 2003 in Sweden carried out a study on the
morphological changes in round window membrane after topical
hydrocortisone and dexametasone treatment in rats. They found
that although hydrocortisone has anti-inflammatory properties, it
seemed to provoke inflammatory reactions in the round window
membrane after topical instillation, but dexamethasone had no such
effects.38 This may or may not have the same effect in man.
Getu et al in 2005 found that after ototopical application of
0.6mg/ear of dexamethasone in dogs for 21 days, it was
sufficiently absorbed from the auditory canal to suppress the
hypothalamo-pituitory-adrenal function as well as alter metabolic
hemopoietic profiles.39 This may or may not produce the same
effect in man.
28
CHAPTER FOUR
PATIENTS AND METHODS
4.0 PATIENTS
Patients were recruited from those presenting for treatment at the
Otolaryngology clinics of the University of Nigeria Teaching
Hospital Ituku-Ozalla, Enugu.
4.1 DURATION/NATURE OF STUDY
This was a hospital based prospective study. Subjects with
provisional diagnosis of otitis externa based on clinical history and
findings on examination were recruited into the study. The study
lasted from December 2007 to November 2008, 12 months.
Clinical diagnosis of otitis externa were made based on presence of
one or more of three major symptoms of otalgia, itching and
fullness in the ear canal and one or more of minor complaints of
tinnitus, hearing impairment or ear discharge. Major otoscopic
findings such as tenderness on tragal palpation, accumulation of
debris in EAC, edema/narrowing/redness of external ear canal,
presence of mycelial growth, hyphae or spores in the EAC were
also used to diagnose otitis externa.
4.2 INCLUSION CRITERIA
Patients who met the following criteria were recruited into the
study.
29
a) Aged 2 years and above.
b) Had a clinical diagnosis of otitis externa as outlined above.
c) Did not use any topical ear drops or medications in the last
30 days.
d) Those with intact tympanic membrane and:
e) Gave informed consent to participate in the study.
4.3 EXCLUSION CRITERIA
a) Age below 2 years
b) Use of topical ear drops or medication within 30 days of
presentation.
c) Patients with tympanic membrane perforation.
d) Decline to give informed consent to participate in the study.
4.4 CONSENT AND ETHICAL CONSIDERATION
An informed consent was obtained from all patients and/or the
legal guardian of minors, who met the inclusion criteria outlined
above. The benefits of the study to the patient and the society were
explained to the patient. Any risks of participation in the study
were explained to the patient. The patient was at will to accept,
reject or withdraw from the study if he or she so desired at anytime
without loss of continued medical care. Ethical clearance was
sought and obtained from the UNTH Ethical Review Committee,
before commencing this study.
30
4.5 SAMPLE SIZE DETERMINATION.
The study sample size was calculated from Fisher’s formula40
N = Z2 Pq
d2
Appropriate, when studying proportions with population > 10,000.
Where N = The desired sample size (when
population is greater than 10,000).
Z = The standard normal deviation, usually set at
1.96, which corresponds to 95% confidence level.
P = The prevalence of the disease in the study
population. In this study, the prevalence rate was put at 6.8% as
reported by Okafor in his study on pattern of diseases of the Ear in
South Eastern Nigeria.3
q = I – P
d = Degree of accuracy desired; set at 0.05.
The sample size = N using the formula N = Z 2Pq
d2
N = (1.96)2 (0.068) (1-0.068)
(0.05)2
= (1.96)2 (0.068) (0.932)
(0.05)2
= 0.2434652
0.0025
= 97.38608
31
Allowing for attrition, the estimated minimum sample size was
approximated to 100.
N was therefore = 100.
4.6 METHODOLOGY
(a) Patient Recruitment.
Patients who had been tentatively diagnosed as suffering from
otitis externa from clinical history and physical examination in the
otorhinolaryngology clinics of the University of Nigeria Teaching
Hospital, Ituku-Ozalla, were informed by the investigator that they
were to be registered to participate in this study.
(b) Informed consent.
Details of the study were explained to them. They were informed
that they were at liberty to accept or decline participating in the
study, without risk of loss of continued treatment.
Consenting patients or legal guardian of minors, were asked to fill
a consent form indicating their willingness to participate in the
study. (Appendix 1)
(c) Data collection
A questionnaire was administered to each patient for data
collection (see Appendix II). The investigator assisted patients in
completing the questionnaire.
Two ear swabs or scrapings “A” and “B” were obtained aseptically
with gloved hands and sterile swab-sticks under direct vision (with
32
the patient in a sitting position) from the external auditory meatus
of the affected ear or ears. Each of these specimens were personally
taken by the investigator, to the mycology and bacteriology
laboratories respectively of the University of Nigeria Teaching
Hospital Ituku-Ozalla, Enugu within same hour of obtaining the
specimen.
(d) Laboratory procedure.
In the mycology laboratory a potassium hydroxide (KOH) mount
of the study specimen “A” was carried out for microscopy to
identify the spores and or hyphae of organisms where applicable.
Then two sub cultures of part of the specimen ‘A’ for fungal
studies were carried out as follows:
On Sabourauds Dextrose Agar (S) plus chloramphenicol (C). That
is S and C culture. Aim was to exclude bacteria e.g. Staph aureus,
Staph epidermidis etc.
On Sabourauds Dextrose Agar (S) plus chloramphenicol (C) plus
Actidione (A). That is S + C + A culture to exclude common
fungal organisms e.g. Aspergillus, Mucor, Candida and see if other
rare fungi e.g. Trychophyton and other Dermotophytes could grow.
The culture was incubated at room temperature for a minimum of
three weeks.
33
Any growth at the end of this period was mounted on lactophenol
cotton blue and read microscopically to identify the particular
fungal specie cultured.
In the bacteriology laboratory, the specimen ‘B’ was inoculated
into blood agar (BA) and incubated at 37 degrees centigrade for 24
hours. Macroscopy was carried out on any growth or colony and
was subjected to Gram stain to identify which was Gram +ve or
Gram –ve bacteria after microscopy.
(e) Patient treatment.
After the specimens for cultures were obtained, patient’s external
auditory canal was re-examined under vision by means of a head
mirror and otoscope. Cotton wool threaded on Jobson Horne’s
probe was used to manually clean the ear of fungal debris. The
patient was thereafter placed on ototopical Locorten-Vioform®
anti-infective ear drops (containing 0.02% w/v flumetasone
pivalate, 1% w/v clioquinol BP, polyethene glycol manufactured
by Amdipharm Plc Basildon Essex). Dosing frequency was four
times daily.
Locorten-Vioform® ear drop is a commonly used ototopical
medication in the treatment of otitis externa in the
otorhinolaryngology clinics of the University of Nigeria Teaching
Hospital, Ituku-Ozalla, Enugu. No severe adverse reaction to the
drug has been reported by patients using this drug for the treatment
34
of otitis externa. It is also available, affordable, easy to apply and
effective.
Patients were educated on how to apply the Locorten-Vioform®
solution thus: shake the solution first, then turn your head such that
the affected ear was uppermost and put two to three drops of the
Locorten-Vioform® solution into the ear canal. Apply gentle
pressure on the tragus and rock gently for the solution to adequately
enter the ear canal and stay in that position for 2-3 minutes. Repeat
same procedure for the other ear if bilateral. This was done 4
times/day for 3 consecutive weeks.
4.7 PATIENT FOLLOW UP AND TREATMENT END POINT.
Patients were reviewed weekly and the presence, absence or
severity of symptoms such as otalgia, itching, fullness in the ear,
discharge, hearing impairment were determined. Signs of EAC
redness, swelling, debris accumulation, narrowing and tragal
tenderness were also elicited and recorded.
For the purpose of this study, 3 weeks was the end point of
treatment of the patient’s otomycosis. Outcome were measured by
resolution of symptoms and signs.
4.8 EQUIPMENT AND ITEMS USED FOR THE STUDY.
These were:
Otoscope or Auroscope
Light source
Head-mirror
35
Sterile swab sticks
Locorten-Vioform® ear drop solution
Jobson Horne’s probe
Cotton wool
Surgical gloves
4.9 DATA ANALYSIS
The data collected from this study were collated and presented in
both tabular and graphical forms. Data were coded and analyzed
using Epi info version 3.2.1 and statistical package for the social
sciences (SPSS) version 12 statistical software. Relationships
between variables were assessed using chi-square and T-test. A P-
value equal to or less than 0.05 was considered statistically
significant.
36
CHAPTER 5
RESULTS
5.1 A total of 3,793 consecutive patients that attended the
otorhinolaryngology clinics of the University of Nigeria Teaching
Hospital during the period under study were assessed for clinical
diagnosis of otitis externa. Out of these, 153 patients were
diagnosed as having otitis externa, and 127 of these 153 patients
met the inclusion criteria and hence used for the study. Based on
the exclusion criteria for this study, 26 patients were excluded from
the study. Out of the 127 patients that met the inclusion criteria, 99
had unilateral ear disease and 28 had bilateral ear disease. These
gave a total of 155 ears from which samples were collected and
sent to the laboratories. Out of the 127 patients with 155 ears, 28
ears had pure fungus isolated from the culture of ear swabs, 32 ears
had mixed fungal and bacterial growths and 71 ears had pure
bacteria isolated from them and 24 ears had no organisms isolated
from their ear cultures. Based on the 3793 patients assessed, the 28
ears that had pure fungus isolated from their swabs represented
0.74% of all patients assessed, 71 ears with bacterial isolates
represented 1.87% , 32 ears with mixed bacterial+fungal isolates
represented 0.84% and 24 ears with no isolates of organisms
represented 0.63% of the 3793 patients assessed.
37
5.2 Age distribution of the study population
The age ranges of patients were from 2 years to 88 years with a
mean of 37 years. Patients within the age range of 23-32 years
were most commonly affected by otitis externa comprizing 30
patients (23%) of the study population while patients within the
age range of 53-62 years were the least affected 7(5.5%) of the
study population. See Table I below.
38
Table I: Age group distribution of the study population.
Age group in years Frequency Percentage
2-12 22 17.3
13-22 22 17.13
23-32 30 23.6
33-42 18 I4.2
43-52 17 13.4
53-62 7 5.5
63 and above 11 8.7
Total 127 100
Mean = 37± 1.81years
Fig 1: Age group distribution of the study population.
2 - 12 13 - 22
Age of patient
0
5
10
15
20
25
30
Mean = 3.4016 Std. Dev. = 1.81379 n = 127
23 -32 33-42
42
43-52
52
63 & above 53-62
62
Frequency
39
5.3 Sex of subjects
There were 66(52%) males and 61(48%) females. See Table II
below.
Table II: Sex distribution of the study population.
n = 127
P- value = 0.735 not statistically significant.
As many males as females suffered from otitis externa.
Gender Frequency Percentage
Male 66 52
Female 61 48
Total 127 100
40
5.4 Ear affectation
A total of 155 ears were studied from 127 patients of which 99
patients had unilateral ear disease and 28 had bilateral ear disease.
See Table III below.
Table III: Distribution of ears according to unilateral or
bilateral
affectation.
n =155
Ear affectation
Number of
patients
affected
Number of
ears affected
Unilateral 99 99
Bilateral 28 56
Total 127 155
41
bacteria only fungi only mixed bacteria and fungi growth
no growth
Type of organism isolated
0
20
40
60
80
5.5 Type of organisms isolated and ear affectation.
See Table IV below.
Table IV: Type of organisms isolated and ear affectation
n = 155
Type of organism isolated
Number of ear affected
Total
Percentage
Unilateral Bilateral
Bacteria only 40 31 71 45.8
Fungi only 19 9 28 18.1
Mixed bacteria and fungi
Growth 24 8 32 20.6
No growth 16 8 24 15.5
Total 99 56 155 100
P-value = 0.291
Frequency
Fig. 2 Type of organisms isolated.
42
5.6 Age group of patients versus ear affectation
All age groups were affected by otitis externa, and all age groups
had both unilateral and bilateral ear affectation. Patients in the 53-
62 years age group, had more bilateral ear affectation than
unilateral ear affectation when compared with the other groups. Ear
affectation did not depend on age group of patients. See Table V
below.
Table V: Age group of patients versus ear affectation.
n = 155
P-value = 0.390, not statistically significant.
Age group of
patients. (years)
Number of ear affected
Total
Unilatera
l Bilateral
2-12 17 9 26
13-22 15 7 22
23-32 21 19 40
33-42 15 6 21
43-52 15 7 22
53-62 4 5 9
63 and above 12 3 15
Total 99 56 155
43
5.7 Sex of patients versus ear affectation
Table VI below shows that males had 80 ears as against females
that had 75 ear with otitis externa. Ear affectation did not depend
on sex of patient.
Table VI: Sex of patient versus ear affectation.
n = 155
Sex of patients
Number of ear affected
Total
Unilatera
l Bilateral
Male 50 30 80
Female 49 26 75
Total 99 56 155
P-value = 0.714, not statistically significant.
44
5.8 Profile of patients according to age, and type of organisms
isolated
Patients in the age range of 23-32 years suffered most from
otomycosis and were most commonly affected by all types of
isolates of organisms. Isolates did not depend on the age of
patients. See Table VII below.
Table VII: Profile of patients according to age, and type of
organisms
isolated.
n = 155
Age group of
patients (years)
Type of organism cultured
Total
Bacteria
only
Fungi
only
Mixed
bacteria
and fungi
growth
No
growth
2-12 13 0 8 5 26
13-22 10 7 2 3 22
23-32 19 6 7 8 40
33-42 11 3 3 4 21
43-52 9 6 5 2 22
53-62 4 3 2 0 9
63 and above 5 3 5 2 15
Total 71 28 32 24 155
P-value = 0.449, not statistically significant.
45
5.9 Profile of patients according to sex and type of organism
isolated.
Both males and females suffered from all isolates of organisms.
Organisms isolated did not depend on sex of patient. See Table
VIII below.
Table VIII: Profile of patients according to sex and type of
organism isolated.
n = 155
Sex of
patients
Type of organism cultured
Total
Bacteria
only
Fungi
only
Mixed
bacteria
and fungi
growth
No
growth
Male 37 17 18 8 80
Female 34 11 14 16 75
Total 71 28 32 24 155
P-value = 0.219, not statistically significant.
46
5.10 Profile of all species of organisms isolated from ears of
subjects
Staphylococcus, Pseudomonas and Proteus species in that order
were the commonest bacteria isolated. Aspergillus niger,
Aspergillus fumigatus, Candida albicans and Aspergillus flavus in
descending order were the commonest fungal species isolated.
Mixed bacteria and mixed bacterial and fungal isolates also
occurred. See Table IX below.
Table IX: Type of organisms and the frequency distribution of
ears from which they were isolated.
n = 155
Species of organisms isolated
Frequency
of Ears Percentage
Bacteria
Pseudomonas 18 11.6
Staphylococcus 22 14.2
Proteus 12 7.7
Streptococcus 6 3.9
Fungi
Aspergillus niger 14 9.0
Aspergillus fumigatus 12 7.7
Aspergillus flavus 5 3.2
Candida albicans 7 4.5
Penicillium 1 .6
Dematioceous fungi 1 .6
Mixed
Bacteria
Pseudomonas+Staphylococcus 3 1.9
Proteus+Staphylococcus 11 7.1
Mixed fungi Aspergillus niger+Candida 4 2.6
Mixed
Bacteria and
Fungi
Pseudomonas+Aspergillus 3 1.9
Staphylococcus+Aspergillus 5 3.2
Staphylococcus+Candida 7 4.5
No Growth no growth 24 15.5
Total Total 155 100.0
47
Fig 3 Frequency of species isolated.
Frequency
pseudomonas
staphylococcus
proteus
streptococcus
aspergillus niger
aspergillus fumigatus
aspergillus flavus
candida albicans
penicillium
Dem
atioceous fungi
pseudomonas+staphylococcus
proteus+staphylococcus
aspergillus niger+candida
pseudomonas+aspergillus
staphylococcus+aspergillus
staphylococcus+candida
no growth
species of all organisms isolated
0
5
10
15
20
25
Fre
qu
en
cy
species of all organisms isolated
Species of all organisms isolated
Frequency
1
5.11 Age group of patients versus specie of organisms isolated.
Specie of organism did not depend on age of patient. P-value = 0.833
See Table X below.
Table X: Age group versus species of organisms isolated.
n = 155
Species of all organisms isolated.
Age groups of patients (Years)
Total
2-12
13-
22
23-
32
33-
42
43-
52
53-
62
63 and
above
Bacteria
Pseudomonas 4 3 6 2 2 1 0 18
Staphylococcus 4 2 6 2 3 2 3 22
Proteus 2 2 3 2 2 0 1 12
Streptococcus 0 2 2 1 0 0 1 6
Fungi
Aspergillus niger 1 4 2 1 4 1 1 14
Aspergillus fumigatus 3 1 3 1 2 1 1 12
Aspergillus flavus 1 2 2 0 0 0 0 5
Candida albicans 0 2 0 1 1 1 2 7
Penicillium 0 0 0 1 0 0 0 1
Dematioceous fungi 1 0 0 0 0 0 0 1
Mixed
Bacteria
Pseudomonas+Staphylococ
cus 0 0 3 0 0 0 0 3
Proteus+Staphylococcus 2 0 1 2 3 0 3 11
Mixed Fungi Aspergillus niger+Candida 2 0 1 1 0 0 0 4
Mixed
Bacteria and
Fungi
Pseudomonas+Aspergillus 0 0 1 1 1 0 0 3
Staphylococcus+Aspergillu
s 1 0 1 0 0 2 1 5
Staphylococcus+Candida 0 1 2 2 1 0 1 7
No Growth No growth 5 3 7 4 3 1 1 24
Total Total 26 22 40 21 22 9 15 155
P-value = 0.833, not statistically significant.Specie of organism
isolated did not relate with age group of patient.
2
5.12 Sex of patients versus specie of organism isolated
There was no difference between male and female patients and the
specie of organism isolated from each of them. See table XI below.
Table XI: Shows sex of patients and species of organisms isolated.
n = 155
P-value = 0.424, not statistically significant.
Species of all organisms isolated Sex of patients Total
Bacteria
Male Female
Pseudomonas 8 10 18
Staphylococcus 14 8 22
Proteus 10 2 12
Streptococcus 3 3 6
Fungi
Aspergillus niger 9 5 14
Aspergillus fumigatus 5 7 12
Aspergillus flavus 4 1 5
Candida albicans 3 4 7
Penicillium 0 1 1
Dematioceous fungi 0 1 1
Mixed
Bacteria
Pseudomonas+Staphylococcu
s 2 1 3
Proteus+Staphylococcus 3 8 11
Mixed
Fungi
Aspergillus niger+Candida 2 2 4
Mixed
Bacteria
and Fungi
Pseudomonas+Aspergillus 1 2 3
Staphylococcus+Aspergillus 2 3 5
Staphylococcus+Candida 4 3 7
No growth no growth 10 14 24
Total Total 80 75 155
3
5.13 Outcome of treatment by manual aural dry mopping and
ototopical locorten-vioform® medication at weekly intervals
after three weeks of treatment.
125 patients (80.6%) were cured of their ear disease after three
weeks of treatment. No patient got worse after three weeks of
treatment. See Table XII below.
Table XII: Patients outcome after three weeks of treatment by
manual
aural dry mopping and ototopical Locorten-Vioform® medication. n = 155
Outcome
Visit 1 Visit 2
Visit 3
Frequency
(% age)
Frequency
(% age)
Frequency
(% age)
Cured 70
(45.16%)
110
(70.97%)
125
(80.6%)
Responding but with
residual symptoms
60
(38.71%) 36 (23.23%) 25 (16.1%)
No change 25
(16.13%) 9 (5.81%) 5 (3.2%)
Worsened 0 0 0
Total 155.0
(100) 155.0 (100) 155.0(100)
4
Cured Not completely improved No change
Outcome of treatment at visit 3.
0
25
50
75
100
125
Fig. 4 Bar Chart of treatment outcome at visit 3
Worsened
Frequency
5
5.14 Outcome of treatment versus age group of patients.
The outcomes at the end of three weeks of treatment by age groups
of patients were shown in table XIII. There were no associations
between outcome and age groups of patients. See Table XIII
below.
Table XIII: Association between outcome and age group of
patients.
n = 155
Age group
of patients
(Years)
Outcome after 3 wks of treatment. Tota
l
Cured
Improved but
with residual
symptoms
No improvement
after 3 weeks of
treatment
2-12 21 3 2 26
13-22 19 3 0 22
23-32 32 7 1 40
33-42 18 3 0 21
43-52 17 5 0 22
53-62 6 2 1 9
63 and above 12 2 1 15
Total 125 25 5 155
P-value = 0.797, not statistically significant.
There were no associations between outcome and age group
of patients.
1
5.15 Outcome of treatment versus sex of patients.
Both male and female patients responded equally to treatment of
otomycosis at the end of three weeks. Four females as against one
male did not respond to treatment. Response to treatment did not
depend on sex of patient.
Table XIV: Outcome of treatment versus sex of patients.
n = 155
Sex of
patients
Outcome after three weeks of treatment. Tota
l
Cured
Improved but
with residual
symptoms
No improvement
after 3 weeks of
treatment
Male 66 13 1 80
Female 59 12 4 75
Total 125 25 5 155
P-value = 0.355, not statistically significant.
Outcome did not depend on sex of patient.
2
5.16 Outcome of treatment versus ear affectation.
Both unilateral and bilateral ear diseases showed good response to
treatment at the end of three weeks. Only two cases of unilateral
and 3 cases of bilateral otomycosis did not respond to treatment.
No patient got worse at the end of three weeks of treatment. There
was no association between outcome of treatment and ear
affectation. See Table XV below.
Table XV: Outcome of treatment versus ear affectation.
n = 155
Number of
ears affected
Outcome after 3 weeks of treatment. Tota
l
Cured
Improved but with
residual symptoms
No improvement
after 3 weeks of
treatment
Unilateral 82 15 2 99
Bilateral 43 10 3 56
Total 125 25 5 155
P-value = 0.459, not statistically significant.
Outcome did not depend on ear affectation.
3
5.17 Outcome of treatment versus Type of organisms isolated.
The outcome at the end of three weeks of treatment by types of
organisms isolated were shown in Table XVI below. There were no
associations between outcomes and types of organisms isolated.
Table XVI: Association between outcome of treatment and type of
organisms isolated.
n = 155
Outcome after three
weeks of treatment
Type of organism cultured
Tota
l
Bacteria
only
Fungi
only
Mixed
bacteria
and fungi
growth
No
growth
Cured 61 21 25 18 125
Improved but with
residual symptoms
8 7 6 4 25
No improvement after
3 weeks of treatment
2 0 1 2 5
Total 71 28 32 24 155
P-value = 0.434, not statistically significant.
1
5.18 Outcome of treatment versus specie of organism isolated.
The outcome at the end of three weeks of treatment by species of organisms
isolated were shown in Table XVII below. There were no statistically
significant associations between outcomes and species of organisms isolated.
Table XVII: Association between outcome of treatment and species of
organisms isolated.
n = 155
Species of all organisms isolated
Outcome after 3 weeks of treatment.
Total
Cure
d
Improved
but with
residual
symptoms
No
improvement
after 3 weeks
of treatment
Bacteria
Pseudomonas 16 1 1 18
Staphylococcus 17 4 1 22
Proteus 11 1 0 12
Streptococcus 4 1 1 6
Fungi
Aspergillus niger 10 4 0 14
Aspergillus fumigatus 9 3 0 12
Aspergillus flavus 3 2 0 5
Candida albicans 5 2 0 7
Penicillium 1 0 0 1
Dematioceous fungi 1 0 0 1
Mixed
Bacteria
Pseudomonas+Staphyloc
occus 3 0 0 3
Proteus+Staphylococcus 9 2 0 11
Mixed Fungi Aspergillus
niger+Candida 3 0 1 4
Mixed
Bacteria and
Fungi
Pseudomonas+Aspergillu
s 3 0 0 3
Staphylococcus+Aspergil
lus 5 0 0 5
Staphylococcus+Candida 5 2 0 7
No Growth no growth 20 3 1 24
Total Total 125 25 5 155
P-value = 0.849, not statistically significant
CHAPTER SIX
DISCUSSION
6.1 Prevalence of Otomycosis
Fungal otitis externa is world wide in distribution and was
commonly found in hot and humid climates of tropical and sub
tropical countries.8 Out of 3793 consecutive patients, that attended
the Otolaryngology clinics of University of Nigeria Teaching
Hospital Enugu, assessed, 153 patients were diagnosed with otitis
externa, using clinical diagnostic criteria. Of these 153 patients,
127 met the inclusion criteria. Out of the 127 patients that met the
inclusion criteria, 28 ears had pure otomycosis. Based on the 3793
patients assessed this gave a prevalence rate of 0.74% for
otomycosis.
Okafor in a study from this centre, carried out over a 5 year period,
July 1973-June 1978 on pattern of otologic diseases in South
Eastern Nigeria, reported a figure of 35 patients(6.8%) for
otomycosis.3 In Okafor’s study, not all cases of otomycosis were
confirmed by laboratory studies. In addition, the period when
Okafor did his study was about thirty years ago when ear infections
were probably more common than now that we have improved
health services, nutrition and hygiene.
Prevalence figures quoted elsewhere were 12%-14% in the
Netherlands and 10% in Houston, Texas.4,6 These figures however
2
will depend on the population of study, inclusion and exclusion
criteria, duration and the location where study was undertaken.
6.2 Age distribution of subjects.
Adults predominated in the number of patients suffering from
otitis externa as well as in those diagnosed as suffering from
otomycosis.( Table 1, V, V11 ). This finding was in agreement
with the report of Nwabuisi and Ologe in Ilorin Nigeria.21 Two
separate studies carried out in Enugu by Gugnani et al and Mgbor
et al also found adults to predominate in their respective studies.8,9
Patients in the age range of 23-32 years suffered most from
otomycosis 23.6% and closely followed by patients in the age
range of 2-12, and 13-22 years 17.3% respectively. Adults within
the age range of 53-62 years of age (5.5%) suffered least from
otomycosis. One did not expect any difference in the distribution of
otomycosis between adults and children because pathology of
otomycosis was not influenced by hormones,
6.3 Sex distribution of subjects.
Males and females were equally affected by otomycosis from the
results of this study. This was in agreement with studies in Ilorin
by Nwabisi and Ologe in the past that equal number of males and
females suffered from otomycosis.21 However reports of studies
carried out in Turkey by Ali Z M et al and in Ibadan by Fasunla et
al. were that of female preponderance over males in cases of
3
otomycosis.20,22 One did not expect any differences in the
distribution of otomycosis between males and females because
pathology of otomycosis was not influenced by hormones.
6.4 Ear affectation, age and sex distribution.
More cases of unilateral otomycosis than bilateral otomycosis
occurred in this study. The predisposing factors to otomycosis like
trauma, instrumentation of the ear, suppurative ear infection are
likely to affect or begin with one ear, hence we had more cases of
unilateral otomycosis. This is not to exclude swimming as a
predisposing factor which could cause bilateral otomycosis; but
even then, might start as unilateral otomycosis. The ear affected did
not depend on age and sex .This was expected as hormones do not
influence the ear affected
6.5 Fungal and bacterial isolates.
Organisms isolated in this study in descending order of frequency
included: bacteria 45.8%, mixture of fungi and bacteria 20.6% and
fungi only 18.1%.
From this result, we saw that bacterial causes of otitis externa out
numbered pure fungal cause of otitis externa and mixed
fungal+bacterial causes put together. This is in agreement with the
findings of Robert Sander that the most common cause of otitis
externa is bacterial infection6.
4
The commonest fungi isolated from this study was Aspergillus
niger 9.0% followed by Aspergillus fumigatus 7.7, Candida
albicans (4.5%) These were similar to the reports of Gugnani et al
and Mgbor et al in Enugu.8,9 Only one case each of Penicillium and
Dematioceous fungi occurred representing 0.60% of all species
respectively.
Amongst the bacterial species isolated, Staphylococcus aereus
14.2%, Pseudomonas aeruginosa 11.6%, and Proteus 7.7% were
seen. See Table IX.
About 15.5% of the ears (24 ears) had no organisms isolated from
the culture of their aural specimens. Reasons may be due to use of
ototopical medication beyond one month before presentation or
lack of obtaining a critical quantity of specimen to grow any
significant organisms, or could be due to a viral cause.
6.6 Age, sex, type and specie of organisms.
Tables X, XI respectively show the relationships between age
group and specie of organisms, and sex versus specie of organisms.
Age and sex had no influence on the type and specie of organism
isolated from this study. This is not surprising because hormones
like explained before have no influence on the pathology of
otomycosis.
6.7 Outcome, age, sex, ear affectation, type of organism, species
of organisms.
5
Tables XII-XVII illustrated the relationships between, outcome,
age, sex, ear affectation, type of organism and species of organisms
isolated. By the end of first week of treatment with Locorten-
Vioform® ear drops and manual aural dry mopping, 45.16% of
patients had been cured of their otomycosis and about 38.71% were
responding to treatment with residual symptoms, and 16.13% had
no response to treatment yet.
By the end of three weeks of treatment of the ear with manual aural
dry mopping and Locorten-Vioform® ear drops, 80.6% of patients
had been cured of their otomycosis and 16.10% were responding
with residual symptoms, while the number of patients with no
change in their symptoms had fallen to only 3.2%. This showed
that Locorten-Vioform® ear drop with manual aural dry mopping
was an efficacious mode of treatment for otomycosis. All age
groups and sexes responded to manual aural dry mopping with
Locorten-Viofom® ear drops. This was an expected outcome
because the therapeutic effect of Locorten-Vioform® ear drops and
manual aural dry mopping were not hormone dependent.
Patients with bacterial, fungal, mixed bacterial, mixed fungal
isolates, mixed bacterial+fungal isolates as well as those in whom
no isolates of organisms were isolated responded to medication at
the end of three weeks. This was expected because Locorten-
Vioform® ear drop is a broad spectrum anti-infective ototopical
6
medication containing (1% w/v Clioquinol BP, 0.02% w/v
flumetasone pivalate, and polyethene glycol).
Some of the patients that had no organisms isolated from their ear
cultures were also cured by ototopical Locorten-Vioform® ear
drops and manual aural dry mopping at the end of three weeks. (
See Tables XVI, XVII.) This raises the question of whether there
could be a third possible cause of otomycosis, may be a viral
cause? This opens up a possible area for research. Inability to grow
viruses is one of the limitations of this study. Another area of
interest is the question of whether manual ear dry mopping alone
could have been responsible for the cure of those patients that had
no organisms isolated from their ear cultures? This yet is another
possible area of research interest.
7
.CHAPTER SEVEN
CONCLUSIONS AND RECOMMENDATIONS
7.1 CONCLUSIONS.
Otomycosis was a common clinical disease encountered in the
Otolaryngology clinics of University of Nigeria Teaching Hospital
Enugu.
1 The prevalence of otomycosis in the population studied
was 0.74%.
2 The proportion of clinical otitis externa in which fungal
organisms were isolated in the laboratory from ear swabs
was 60 out of 155 ears, that is approximately one case of
otomycosis out of every three cases of otitis externa.
3 The causative organisms in otomycosis were: Aspergillus
niger, Aspergillus fumigatus, Candida albicans,
Aspergillus flavus, Penicillium, and Dematioceous fungi in
decreasing frequency.
4 Otomycosis affected all age groups, and equal males and
females suffered from otomycosis.
8
7.2 RECOMMENDATIONS
The following recommendations are suggested:
1. There should be a high index of suspicion for
otomycosis when evaluating patients with external ear
disease in the tropics, because otomycosis is a commonly
encountered ear disease in this region.
2. Otitis externa is caused by both bacterial and fungal
organisms. Laboratory diagnosis is essential to identify the
type and specie of organisms involved and hence the proper
ototopical medication to apply into the affected ears.
3. Effective manual ear dry mopping and ototopical medication
for at least three weeks is necessary to achieve disease
control in otomycosis.
4. Manual ear dry mopping and the application of ototopical
Locorten-Vioform ® ear drops for three weeks cured over
80% of the patients and so is an effective treatment modality
for otomycosis.
9
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induced otomycosis. Arch otolaryngology Head and Neck
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(Ivory Coast). Med Trop (Mars) 2004; 64 (1): 39-42.
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Otomycosis in Turkey: Predisposing factors, aetiology and
therapy. J laryngol Otol. 2003; 117 (1): 39-42.
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Nose Throat J 2004; 83: 20-22.
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Candida albicans in otitis externa. Mycopathologia 2003;
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the use of Mercurochrome solution. Mycoses 2004; 47:
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Broen A, Romeijnders A C M. NHG-Standard otitis externa.
Huisarts Wet 1995; 28(6) :265-71.
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management of otitis externa. J R Army Med. Corps. 1992;
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J. Laryngol Otol. 2005: 119(5): 342-7.
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C. Clinical efficacy of budesonide in the treatment of
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16
APPENDIX I
CONSENT
Consent given by subjects to participate in the study titled:
PATTERN OF OTOMYCOSIS SEEN AMONG PATIENTS IN
THE OTORHINOLARYNGOLOGY CLINICS OF THE
UNIVERSITY OF NIGERIA TEACHING HOSPITAL (UNTH),
ITUKU-OZALLA, ENUGU.
Being carried out by;
Dr. F. A IBIAM of the Department of Otorhinolaryngology,
University of Nigeria Teaching Hospital
Ituku-Ozalla, Enugu.
This study aims to determine:
Prevalence of otomycosis
The percentage of otitis externa accounted for by otomycosis
Fungal organisms implicated in otomycosis.
Age/sex distribution of patients suffering from otomycosis.
The subjects will comprise patients presenting to the
Otorhinolaryngology Clinics of the University of Nigeria Teaching
Hospital Ituku-Ozalla, Enugu.
Questionnaires will be administered seeking complaints by patients
such as tinnitus, ear itching, ear fullness, pain, hearing impairment,
17
ear discharge. Specimen for cultures will be obtained and manual
aural dry mopping done, with subsequent application of ear drops.
RISK AND DISCOMFORT
The patient will be exposed to the discomfort of taking ear swab.
There is no foreseeable risk to the patient.
STATEMENT OF CONFIDENTIALITY
I hereby undertake in writing the subject’s confidentiality through
out the course of this study and after.
…………………………………………………………
DR. F. A IBIAM
BENEFIT TO SUBJECTS
The subjects who participate in this study will derive the following
benefits:
Will benefit from ear examination.
Will benefit from manual dry mopping of their ears.
Will benefit from fungal studies and knowing, which particular
fungus or fungi is/are responsible for his or her ear infection.
Will benefit from adequate treatment of their disease in line with
mycology report.
The investigator will bear the full cost of the laboratory tests
involved in this study.
OWNERSHIP AND DISSEMINATION OF RESULT
18
The result is for use in partial fulfillment of the National
Postgraduate Medical College of Nigeria in part II dissertation and
is owned by the College.
I, ………………………………………..of………………………
………………………………………………………………………
…………………………….. hereby consent to participate in the
study titled:
Pattern of Otomycosis seen among patients in the
Otorhinolaryngology Clinics of the University of Nigeria Teaching
Hospital, Ituku-Ozalla, Enugu.
I acknowledge that I have been fully informed about the scope of
the study, which will entail history taking, laboratory and clinical
investigations. I agree that any abnormal findings detected will be
discussed and explained to me and made available to my physician
before any further specialist care is entertained.
The benefit of the study has been explained to me.
I am aware that I can choose to participate or withdraw from this
study at any time without prejudice.
I am also at liberty to question and seek clarification on any part of
the study from the Ethical committee.
……………………………… …………………………..
Patient’s or guardian signature/date Witness sign/date
19
…………………………………… …………………………..
Investigator’s signature/date Witness sign/date
20
APPENDIX II
QUESTIONNAIRE ON PATTERN OF OTOMYCOSIS SEEN
AMONG PATIENTS IN THE OTORHINOLARYNGOLOGY
CLINICS OF THE UNIVERSITY OF NIGERIA TEACHING
HOSPITAL (UNTH), ITUKU-OZALLA, ENUGU.
BIODATA
Hospital Number………………………………………………..
Name:………………………………………………………………
Address:……………………………………………………………
Age (yrs): 2-12, 13-22, 23-32, 33-42, 43-52, 53-
62,
63 and above .
Sex: Male Female
Occupation:…………………………………………………………
Hobbies: a. Swimming b. Diver c. Music presenter
d. Fishing e. Any
other…………………………………………
PMHx: a. I have had ear problems in the past
I have never had ear problems in the past
I have another underlying disease
Diabetes Mellitus
21
Acquired immuno deficiency syndrome (AIDS)/HIV
Liver disease iv) Any other……………………
SECTION ONE: First Visit
Please tick whichever option that applies to you.
(1) What symptom(s) brought you to hospital?
Symptom Severity Duration
a. Itching: Right ear
Left ear
Mild
Moderate
Severe
Unbearable
< 3weeks
3wks – 1 month
1month – 3 months
4 – 6 months
> 6 months
Symptom Severity Duration
b. Pain: Right ear
Left ear
Mild
Moderate
Severe
Unbearable
< 3weeks
3wks – 1 month
1month – 3 months
4 – 6 months
> 6 months
Symptom Severity Duration
c. Fullness in the ear
Right ear
Left ear
Mild
Moderate
Severe
Unbearable
< 3weeks
3wks – 1 month
1month – 3 months
4 – 6 months
> 6 months
Symptom Severity Duration
d. Noise in the ear
Right ear
Left ear
Mild
Moderate
< 3weeks
3wks – 1 month
22
Severe
Unbearable
1month – 3 months
4 – 6 months
> 6 months
Symptom Severity Duration
e. Discharge:
Right ear
Left ear
Mild
Moderate
Severe
Unbearable
< 3weeks
3wks – 1 month
1month – 3 months
4 – 6 months
> 6 months
Symptom Severity Duration
f. Hearing Loss:
Right ear
Left ear
Mild
Moderate
Severe
Unbearable
< 3weeks
3wks – 1 month
1month – 3 months
4 – 6 months
> 6 months
Have you used any medication(s) before coming to the hospital?
Specify which.
Topical antibiotic ear drop
Topical anti-fungal ear drop
23
Systemic antibiotic drugs
Systemic anti-fungal drugs
Antibiotic + anti-fungal ear drop
How long have you used the medication(s) specified above?
Less than one week
One week to two weeks
Two weeks to three weeks
Three weeks to one month
Above one month
Findings on initial visit to the clinic (investigator only)?
Canal redness b. Debris in external auditory canal
c. Narrowed and swollen external auditory canal
d. Tenderness on tragal traction
e. No obvious abnormal findings
24
SECTION TWO: Follow-up visit(s):
(5) State the severity of symptom(s) after commencement of
treatment?
Symptom Severity Time it took symptom
to disappear
a. Itching:
Right ear
Left ear
Still very severe
Not as severe as before
Mild
Completely gone
< 1 week
1wk – 2wks
2wks – 3wks
No response at all after 3wks of
treatment
Symptom Severity Time it took symptom
to disappear
b. Pain: Right ear
Left ear
Still very severe
Not as severe as before
Mild
Completely gone
< 1 week
1wk – 2wks
2wks – 3wks
No response at all after 3wks of
treatment
Symptom Severity Time it took symptom
to disappear
c. Fullness in the ear:
Right ear
Left ear
Still very severe
Not as severe as before
Mild
Completely gone
< 1 week
1wk – 2wks
2wks – 3wks
No response at all after 3wks of
treatment
Symptom Severity Time it took symptom
To disappear
25
d. Discharge:
Right ear
Left ear
Still very severe
Not as severe as before
Mild
Completely gone
< 1 week
1wk – 2wks
2wks – 3wks
No response at all after 3wks of treatment
Symptom Severity Time it took symptom
to disappear
e. Noise in the ear:
Right ear
Left ear
Still very severe
Not as severe as before
Mild
Completely gone
< 1 week
1wk – 2wks
2wks – 3wks
No response at all after 3wks of treatment
Symptom Severity Time it took symptom
to disappear
f. Hearing Loss:
Right ear
Left ear
Still very severe
Not as severe as before
Mild
Completely gone
< 1 week
1wk – 2wks
2wks – 3wks
No response at all after 3wks of treatment
(6) Weekly findings on ear examination (investigator only)
Wk I Growth has
completely disappeared
Growth has not
completely disappeared
No changes
noted
Any other
changes noted
26
Wk II Growth has
completely disappeared
Growth has not
completely disappeared
No changes
noted
Any other
changes noted
Wk III Growth has
completely disappeared
Growth has not
completely disappeared
No changes
noted
Any other
changes noted
Thank you.