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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.

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Page 1: DR. FRANCIS AMADI IBIAM - dissertation.npmcn.edu.ng

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.

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ETHICAL CLEARANCE CERTIFICATION

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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:………………………………………………………

Page 4: DR. FRANCIS AMADI IBIAM - dissertation.npmcn.edu.ng

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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

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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.

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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.

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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

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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

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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.

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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.

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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

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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

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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.

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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

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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,

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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

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isolated in their ears that were symptomatic of otitis

externa.

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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

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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

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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.

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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

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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

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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.

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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.

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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

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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

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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.

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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.

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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.

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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

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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

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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.

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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

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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

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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.

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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.

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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.

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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

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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

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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

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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.

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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

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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.

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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.

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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.

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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

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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

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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.

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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

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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)

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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

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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.

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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.

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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.

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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.

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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

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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

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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

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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.

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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.

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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

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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.

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.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.

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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.

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REFERENCES

1) Resenfeld R M, Lance B, Ron Connon C, Rowena J

D,Theodore G G, Maureen H, Phillip K, Michael M S, Peter

S R, Richard N S, Sandra S S, David L W. Clinical Practice

guideline: Acute otitis externa. Otolaryngology-head and

neck surgery 2006; 134: S4-S23.

2) Van Balen F A M, Smith M W, Zuithoff N P A, Verheij

Theo J M. Clinical efficacy of three common treatments in

acute otitis externa in primary care: randomized controlled

trial. BMJ 2003;327: 1201-1205.

3) Okafor B C. Pattern of Diseases of the Ear. Nigerian

Medical Journal, 1983; 13: 11-19.

4) Rowlands S, Devalia H, Smith C, Hubbard R, Dean A.

Otitis externa in UK general practice: a survey using the UK

General Practice Research Database. British J. Gen Pract

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5) Calderon R, Mood E W. An Epidemiological Assessment of

Water Quality and ‘Swimmer’s ear.’ Arch Environ Health

1982;37; 147 - 157

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6) Robert Sander. Otitis Externa: A practical guide to treatment

and prevention.Journal of American Academy of family

physician 2001; 63: 941-2.

7) Kaur R N, Kakkar M, Aggrawal A K, and Mathur M D.

Otomycosis. A Clinicomycologic study. Ear, Nose throat J

2000 79: 606-609.

8) Gugnani H, Okafor B C, Nzelibe F, and Njoku-obi A N U,

Etiological agents of otomycosis in Nigeria. Mycoses; 1998;

32 (5) 224-229.

9) Mgbor N, Gugnani C. Otomycosis in Nigeria: Treatment

with Mercurochrome. Mycoses. 2001; 44. 395-397.

10) Roland P S, Stroma D W. Microbiology of Acute Otitis

Externa. Laryngoscope 2002. 112;116 : 1166-77.

11) Dibb W L. Microbial Aetiology of Otitis Externa. J

Otolaryngol 1992; 13: 145 - 55.

12) Tang Ho, Jeffery T V, Donald Yoo and Newton J C,

Otomycosis Clinical features and treatment implications.

Otolaryngology Head and Neck Surgery 2006. 135: 787-791.

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13) Ayse D K, Nuri K. In vitro susceptibilities of Aspergillus

species causing otomycosis to Amphotericin B, voriconazole

and itraconazole. Mycoses 2007; 50 (6): 447-450.

14) Jackman A, Ward R, April N, Bent J. topical antibiotic

induced otomycosis. Arch otolaryngology Head and Neck

Surgery 2006; 132: 1294-8.

15) Martin T J, Kerschner J E, Flanay V A. Fungal causes of

otitis externa and tympanostomy tube otorrhea. Int J of

paediatric otorhnolaryngol 2005: 1503-1508.

16) Yavo W, Kassi R R, Kiki-Barro P C, Bamba A, Kple T,

Menan E L, Ehouo F, Kone M. Prevalence and risk factors

for otomycosis treated in the hospital setting in Abidjan

(Ivory Coast). Med Trop (Mars) 2004; 64 (1): 39-42.

17) Ozcan K M, Ozcan M, Karaarslan A, Karaarslan F.

Otomycosis in Turkey: Predisposing factors, aetiology and

therapy. J laryngol Otol. 2003; 117 (1): 39-42.

18) Rutka J Acute Otitis Externa: Treatment Perspectives.Ear

Nose Throat J 2004; 83: 20-22.

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19) Oliveri S, Capello G, Napolitano M G, Triolo C, Grillo C.

Otomycosis: aetiology and analyses of predisposing factors,

Bol 1st Sieroter Milan 1984; 63 (6): 537-42.

20) Ali Z M, Mycological studies in 15 cases of otomycosis. Pak

J Med Sci 2006: 22 (4): 486-488.

21) Nwabuisi C, Ologe F E. The fungal profile of otomycosis

patients in Ilorin Nigeria. Niger J Med 2001; 10(3): 124-6.

22) Fusunla J, Ibekwe T, Onakoya P. Otomycosis in Western

Nigeria Mycoses 2008; 51: 67-70.

23) Springer G L,Shapiro E D. Fresh water swimming as a risk

factor for otitis externa: a case controlled study. Arch

environ health 1985; 40: 202-6.

24) Van Asperen I A,De Rover C M, Schijven J F, Detomo S B,

Schellekens J F, Van Leeuwen N J, et al. Risk of otitis

externa after swimming in recreational fresh water lakes

containing pseudomonas aeruginosa. BMJ 1995;311:1407-

10.

25) Agius A M, Pickles J M, Burch K L. A prospective study of

otitis externa . Laryngoscope 2002; 112: 1166-77.

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26) Jadhar V J, Pal M, Mishra G A. Etiological significance

Candida albicans in otitis externa. Mycopathologic. 2003;

156 (4): 313-5.

27) Pradliam B, Tuladhar N R, Amatya R M. Prevalence of

Otomycosis in outpatient department of Otolaryngology in

Tribhuvan University Teaching Hospital, Kathmandu Napel.

Ann Rhinol Laryngol 2003; 112 (4): 384-7.

28) Kombila M, Gomez de Diaz M, de Bievre C, Crepet G,

Debris J C, Belembaogo E, Richard – Lenoble D. Fungal

Otitis in Libreville. A study of 83 cases. Bull Soc Pathol

Exot Filiales 1983; 82 (2): 201-7.

29) Marchal F. Otomycosis A 451 patients study. Acta

otorhinolaryngology Esp. 2005; 56 (5): 181-6.

30) Stern J C, Shah M K and Lucante F E. In vitro effectiveness

of 13 agents in otomycosis and review of the literature

Laryngoscope. 1988: 1173-7.

31) Jadhav V J, Pal M, Mishra G S. Etiological significance of

Candida albicans in otitis externa. Mycopathologia 2003;

156 (4): 313-5.

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32) Mishra G S. Mehta N, Pal M. Treatment of otomycosis by

the use of Mercurochrome solution. Mycoses 2004; 47:

82-4.

33) Rooijackers-Lemmens E, Van WijngaardenJ J, Opstelton W,

Broen A, Romeijnders A C M. NHG-Standard otitis externa.

Huisarts Wet 1995; 28(6) :265-71.

34) Robertson D G, Benett J D. The general practice

management of otitis externa. J R Army Med. Corps. 1992;

138 (1): 27-32.

35) Emgard P, Hellstrom S. A group III steroid solution without

antibiotic components. An effective cure for external otitis.

J. Laryngol Otol. 2005: 119(5): 342-7.

36) Emgard P, Hellstrom S, Holm S, External otitis caused by

infection with pseudomonas or Candida albican cured by use

of ototopical group III steroid, without any antibiotic. Acta

otolaryngol, 2005. 125 (4): 346-52.

37) Jocobsson S, Karlsson G, Ringer P, Scanner E, Schrewelius

C. Clinical efficacy of budesonide in the treatment of

eczematous external otitis. Eur Arch otorhinolaryngol, 1991;

248 (4): 246-9.

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38) Nordang L, Linder B, Anniko M. Morphologic changes in

round window membrane after topical hydrocortisone and

dexamethasone treatment. Otol Neurotol. 2003; 24 (2): 339-

43.

39) Abraham G, Gottshchalk J, Ungemach F R, Evidence for

ototopical glucocorticoid – induced decreased in

hypothalamic – pituitary – Aderenal axis response and liver

function. Endocrinology 2005; 146 (7): 33163-3171.

40) Aroye M O, Research Methodology with statistic for health

and social sciences. Nathadex, Ilorin Nigeria, 2004: 115-124.

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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,

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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

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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

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…………………………………… …………………………..

Investigator’s signature/date Witness sign/date

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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

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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

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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

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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

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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

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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

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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.