Otitis Media in Developing Countries

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REVIEW

ARTICLE

Otitis

Media

in

Developing

Countries

Stephen Berman, MD

ABSTRACT. Objective. This article reviews the

avail-able information concerning the disease burden,

epide-miology, and etiology of otitis media in developing

countries and the likelihood that case management with appropriate antibiotic therapy can reduce the burden of this disease.

Methodology. The available literature was reviewed to

determine the extent to which otitis media impacts

mortality and morbidity in developing countries.

Epidemiology. In community studies, perforation was

present in 0.4% to 33.3% of children and youth; otorrhea

occurred in 0.4% to 6.1%; and mastoiditis occurred in

0.19% to 0.74%. In school surveys, perforation was

iden-tified in 1.3% to 6.24% of students, and otorrhea was

found in 0.6% to 4.4% . Mastoiditis was diagnosed in 18%

of children and youth who presented to a hospital ear,

nose, and throat (ENT) clinic in Uganda. The proportion

of patients presenting to ENT clinics with mastoiditis

regardless of their initial symptoms varied from 1.7% to

5%. Patients presenting to these ENT clinics with

mastoiditis often experience severe complications,

in-cluding subperiosteal abscess, labyrinthitis, facial palsy,

meningitis, and brain abscess. Hearing impairment was a

major public health problem compromising the quality

of life in approximately one third of the population of

developing countries.

Etiology. The pathogens isolated from ear aspirates in

children with acute otitis media and chronic suppurative

otitis (CSOM) carried out in developing countries are

similar to those isolated in studies carried out in

developed countries.

Case Management. Historical data supports the

effec-tiveness of antibiotic therapy in reducing the frequencies

of mastoiditis and CSOM complicating acute otitis

me-dia. In addition, the introduction of primary care services

targeted at otitis media for high-risk populations living

in developed countries may have reduced the prevalence

of mastoiditis and CSOM. However, it is not clear

whether there is a causal relationship between these

pro-grams and the reduction because of the use of historical

controls.

Conclusions. International research organizations

should support controlled intervention studies to

docu-ment the impact of case management of otitis in

devel-oping countries. In addition, the efficacy of a conjugated

pneumococcal vaccine to prevent otitis and its

complica-lions should be evaluated in a developing country site.

Pending the results of studies, developing countries

should develop primary care case management programs

to diagnose and treat otitis and its associated

complica-From the Department of Pediatrics, University of Colorado School of

Medicine, Denver.

Received for publication Jul 25, 1994; accepted Oct 14, 1994. Reprints are not available.

Acad-emy of l’ediatrics.

tions. Pediatrics 1995;96:126-131; developing countries,

otitis media, hearing impairment, mastoiditis, chronic suppurative otitis.

ABBREVIATIONS. DALYs, disability-adjusted life years; CSOM, chronic suppurative otitis; AOM, acute otitis media.

Although otitis media is a common condition in

developing countries, the value of targeting limited

health care resources to the diagnosis and

manage-ment of otitis media is controversial. This article

reviews the available information concerning the

dis-ease burden, epidemiology, and etiology of otitis

media in developing countries and the likelihood

that case management with appropriate antibiotic

therapy can reduce the burden of this disease.

BURDEN OF OTITIS MEDIA

Death and Severe Disability

Although impaired hearing is the most frequent

effect of otitis media, death or severe disability often

complicates this disease in developing countries. In

the World Development Report 1993: Investing in Health

published by the World Bank and the World Health

Organization, otitis media is estimated to cause the

deaths of 51 000 children younger than 5 years of age each year in developing countries.’ This report also estimates the combined loss of life from premature death with the loss of healthy life from disability. The outcome measure used in this analysis is called dis-ability-adjusted life years (DALYs). In the develop-ing world, otitis media is estimated to result in 23.1

(xIOO 000) DALYs lost. Other conditions with a

sim-ilar impact on the quality of life in developing

coun-tries are meningitis (30.1 DALYs), syphilis (29.0

DALYs), trachoma (23.7 DALYs), and polio (19.9

DALYs).

The mortality and severe disabilities associated with otitis media are primarily related to the compli-cations of mastoiditis or chronic suppurative otitis

(CSOM), defined as otorrhea lasting 6 weeks or

longer. Complications that result in death include

sepsis (shock), meningitis, brain abscess, subdural

empyema, and lateral sinus vein thrombosis. These

complications also can cause disabilities of the cen-tral nervous system, including spasticity, paralysis, mental retardation, cortical blindness, and seizures.

Labyrinthitis and facial nerve paralysis are

addi-tional complications associated with acute otitis

me-dia (AOM) and CSOM that cause severe disability.

Children living in developing countries have a

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high risk of developing mastoiditis and/or CSOM

(Table 1) (A.W. Smith, personal communication,

1992).3-12 Possible reasons for this include: (1) a high

risk of having compromised nonimmune and

im-mune defenses because of malnutrition, deficiencies

of vitamin A or other trace minerals, and human

immunodeficiency virus or other chronic viral and

parasitic infections; (2) colonization with pathogenic organisms at an early age; (3) a large infecting

inoc-ulum size because of crowding, large family size,

and poor hygiene; and (4) lack of access to medical

services so that therapy may not be available, be

delayed, or be inadequate.

Hearing Impairment

Hearing impairment associated with otitis media

is common in many developing countries. In

Thai-land, a mild hearing impairment of 31 to 40 dB was

identified in 26.6% of the rural population (all ages)

surveyed.2 Another survey of all ages found a

mod-erate loss (41 to 55 db) in I I .4%, severe or profound loss (56 to 91 db) in 2.2%, and deafness (>91 db) in

0.5%.2 In a pediatric population less than 16 years of age, a moderate loss was identified in 4%, a severe or

profound loss in 0.5%, and deafness in 0.5%.2

Hear-ing impairment impacts the ability to work, to learn in school, or to develop basic language skills.

Long-term hearing loss related to CSOM persisting

throughout childhood and adolescence can be a

sig-nificant handicap. For example, in Bangkok,

Thai-land, low academic achievement levels among 6 year

olds were directly correlated with current hearing

loss.2 Wilson’3 also makes a strong case that hearing sufficient to comprehend normal speech is extremely important for illiterate individuals in developing

countries. Unfortunately, many individuals whose

hearing loss has progressed over time to the

moder-ate and severe range are further impaired by their

lack of access to amplification aids. Wilson’3 states

that case management and control of otitis media,

measles, mumps, meningitis, and rubella would

reduce by half the amount of avoidable hearing

impairment in developing countries.

Epidemiology

Published data from developing countries describ-ing the prevalence of perforation, otorrhea, and

mas-toiditis from community- and school-based studies

are reviewed in Table I (A.W. Smith, personal

communication, 1992).5-12 In community studies, per-foration was present in 0.4% to 33.3% of children and

youth; otorrhea occurred in 0.4% to 6.1 %; and

mastoiditis occurred in 0.19% to 0.74%. In school

surveys, perforation was identified in I .3% to 6.24% of students, and otorrhea was found in 0.6% to 4.4%. The best pediatric prevalence data on otitis media and mastoiditis in developing countries are available

from Thailand.2 A research team conducted monthly

visits from 1986 to 1991 and examined 1000 to 1500

subjects during a 3- to 5-day period. The encounter

included completion of a history form, otoscopic

ex-amination, tympanometry, and pure tone audiology

at 500, 1000, and 2000 Hz. In 2681 children younger

than 16 years of age, the prevalence of AOM was

0.8%; otitis media with effusion, 9.6%; otorrhea,

2.6%; perforation without otorrhea, I .9%; ossicular

damage, 0.056%; adhesive otitis media, 0.037%;

cho-lesteatoma, 0.03%; and postradical mastoidectomy, 0.013%.

Published incidence data on CSOM are difficult to

find. Simoes (personal communication, 1993) found

an incidence of otorrhea during the first 2 years of

life in Vellore, India, of 0.173 episodes per child year

with a cumulative prevalence of 23%.

Data have been published on the frequency of

CSOM

and mastoiditis among patients seen in

hos-pital otolaryngology clinics.’42’ These reports,

re-viewed in Table 2, suggest that mastoiditis and other

complications occur frequently in many areas of

de-veloping countries. In Uganda, 18% of patients with

chronically draining ears seen in the hospital clinic had mastoiditis.’4 In Tanzania, Nigeria, Angola, and

TABLE 1. Prevale nce of Pe rforation, Otorrhea, and Mastoi ditis in Com munity- and School-B ased Studies in D eveloping Countries*

Country Ref Date Setting Age (y) Perforation (%) Otorrhea (%) Mastoiditis (%)

S Africa 3 1985 R community 0-15 0.4 0.4 NA

S Africa 3 1985 R community >15 2.8 1.4 NA

Nigeria 4 1979 U school 3-11 NA 0.6 NA

Nigeria 4 1979 R school 3-11 NA 3.6 NA

Swaziland t 1987 U/R community 5-14 2.5 2.1 NA

Kenya 5 1992 U/R school 5-21 NA I .1 NA

Guam 6 1966 R school 5-18 2.2-8.3 NA NA

Solomon Islands 7 1984 R community 0- 5 NA 6.1 NA

Solomon Islands 7 1984 R community 0-15 NA 3.8 0.74

Micronesia 8 1985 R community 0-25 4 NA NA

Malaysia 9 1990 U/R school 7-12 NA 4.36 NA

Thailand 2 1986 U/R community 0-15 4.7 2.63 0.19

Thailand 2 1986 R school 6-12 1.23 0.88 0

Thailand 2 1986 U school 6-12 1.38 1 .20 0

S Korea 10 1981 U/R community 0-10 5.72 NA NA

S Korea 10 1981 U/R community All 3.3 NA NA

S Korea 10 1981 U school 6-12 1.69-6.24 NA NA

Israel 11 1984 U school 8-13 0.3 NA NA

Kuwait 12 1983 U/R school 7-10 1.6 NA NA

* U, urban; R, rural.

t A.W. Smith, personal communication, 1992.

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TABLE 2. Prevalence of Perforation, Otorrhea, and Mastoiditis in Hospital Clinic-Based Studies in Developing Countries

Country

Uganda

Ref

14

Date Clinic_Setting Age (yr) Perforation (%) Otorrhea (%) Mastoiditis (%)

1969 Urban 0-12 NA NA 18*

Gambia 15 1981 Rural 0-16 55 NA NA

Gambia 15 1981 Urban 0-16 48 NA NA

Zaire 16 1976 Urban All NA NA 3.2

Nigeria 17 1978 Urban All NA NA 1.8

Nigeria 18 1986 Urban 3-11 NA 7.2 NA

Tanzania 19 1978 Urban All NA 11.1 1.7

Angola 20 1981 Urban 0-15 NA NA 1.8

Sudan 21 1986 Urban All NA NA 5.0

* Mastoiditis in children presenting with otorrhea.

the Sudan, mastoiditis was associated with 1.7% to

5% of patients seen in hospital ear, nose, and throat clinics.

Patients who present to an ear, nose, and throat

clinic with CSOM often have severe complications.

In Nigeria, 10.9% of patients presenting with CSOM

had complications.’7 In a hospital-based clinic in the

Sudan, the frequency of complications among

pa-tients presenting with draining ears were: subperios-teal abscess, 5%; labyrinthitis, 2.5%; facial palsy,

1.7%;

meningitis, 1%; and brain abscess, 0.3%.22

When surgery is needed, a high proportion of

pa-tients will have complicated disease. In Bangkok,

Thailand, 815 patients operated on during a 5-year

period (1971 through 1975) for ear disease had the

following complications: postauricular abscess

(11%), postauricular fistula (7%), facial palsy (3%), meningitis (1 .5%), extradural abscess (0.9%),

labyrin-thitis (0.7%), brain abscess (0.5%), and Bezold’s

abscess (0.4%).2

Etiology

Etiologic pathogens isolated from ear aspirates in

children with AOM carried out in developing

coun-tries are similar to isolations obtained from children

living in developed countries. In Medellin,

Colom-bia, bacterial pathogens were isolated in 82 of III

children (74%)23 Haeinophilus influenzae (32

nontype-able strains and 8 type B strains) was isolated in 36% of the cases, and Streptococcus pneilmoniae was found

in 22%. Other isolations included Staphylococcus

au-reus (3%), enterobacter (1%), Moraxella catarrhalis (1%), 5 pyogeiies (1%), Gram-negative enterics (3%) and others (7%).

The etiology of CSOM is also similar in developing

and developed countries. Persistent otorrhea often

indicates a secondary infection with pseudomonas

and or other Gram-negative organisms. These

inva-sive organisms are difficult to eradicate with antibi-otics, are very destructive, and often lead to

compli-cations. In Costa Rica, organisms isolated from 40

patients with CSOM in 1991 and 1992 included

Pseudotnonas species (41 .9%), Gram-negative enterics

(29%), Staphylococcus (9.8%), and others (9.8%).#{176}

During 1985 and 1986, ear swab cultures obtained

from 58 children living in the Solomon Islands

yielded two or more pathogens in 67% of the

chil-dren. Proteus was identified in 41 %, Pseudoinotuas in

26%, Klebsiella in 16%, Escherichia coli in 9%, and S

aureus in 7%#{149}7Some developing countries report

tu-berculosis as a cause in a small proportion of

pa-tients. For example, I .2% of patients seen at a clinic in

Uganda and 0.38% in Tanzania had CSOM

associ-ated with tuberculosis.

Case Management With Antibiotic Therapy

Because data are not available for populations

living in developing countries, there is an urgent

need to conduct randomized clinical trials of

anti-biotic treatment of AOM in areas with high rates of

mastoiditis and CSOM. It is inappropriate to

gen-eralize the results of recent clinical trials of antibi-otic therapy in developed countries to developing

countries, because CSOM and mastoiditis are

rarely seen in developed countries regardless of

therapy. Because the etiology of otitis is similar in

developed and developing countries, the differing

rates of CSOM and mastoiditis most probably

re-flect differences in population characteristics and

environmental factors.

Therefore, an assessment of the value of case

man-agement of otitis media includes: (1) reviewing

antibiotic clinical trials for AOM carried out during

the 1940s and 1950s in Europe and the United States

when the prevalence of CSOM and mastoiditis was

similar to that currently observed in many develop-ing countries; and (2) reviewing the effectiveness of

providing enhanced primary care services to

under-served populations having a high prevalence of otitis

media such as Native American and Eskimo

populations.

The high rates of CSOM currently observed in

many areas of the developing world are comparable to the rates reported in the preantibiotic era, when

approximately 20% of untreated AOM cases

pro-gressed to CSOM and or clinical mastoiditis. The

complication rates for patients with CSOM described currently in many developing countries are also sim-ilar to those described in Europe in the preantibiotic

era. For example, complications occurred in 6.5% of

3225 patients with AOM and/or CSOM seen by

Kafka4’ in the preantibiotic era compared with the

10.9% complication rate reported in 1978 and 1980 by

Okafor in Nigeria.17 There is a precedent for using

this type of historical comparison. The World Health

Organization has used historical comparisons of

mortality rates from pneumonia and influenza to

assess the gap in health status between developed

and developing countries.42 For example, the 1987

infant mortality rates from pneumonia and influenza

for the countries of Central America (Guatemala,

Honduras, Nicaragua, and El Salvador) can be

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pared with the rates reported by Canada from 1930

to 1987. The 1987 mortality rate for Guatemala

cor-responds to the Canadian rate in 1937; the 1987 rate

for Honduras corresponds to the Canadian rate of

1945; and the 1987 rates for Nicaragua and El

Salva-dor correspond to the Canadian rate in 1949. The

observation that current infant mortality rates from

pneumonia and influenza among infants in

develop-ing countries are comparable with rates reported in

Canada in the preantibiotic era suggests that

popu-lation characteristics, living conditions, and primary medical care services also may be similar.

Antibiotic therapy reduced the frequency of

mas-toiditis and CSOM in Europe and North America

during an era when living conditions and mortality

rates were similar to current conditions in many

developing countries. Numerous studies from

Eu-rope and North America reviewed in Tables 3 and 4

documented the efficacy of antibiotic treatment.22’2439

Twelve studies carried out from 1939 to 1947

corn-pared patients who received sulfonamide therapy

with untreated control patients (Table 3). The

fre-quency of mastoiditis and/or CSOM in 3431

un-treated patients was 32% (frequency range, 9% to

70%).22.24 The frequency of clinical mastoiditis

and/or CSOM in 3131 patients treated with

sulfon-amides was 6% (range, I .5% to 28%). The difference

between untreated patients and those treated with

sulfonamide was statistically significant in 1 1 of the 12 studies. From 1949 to 1953, six studies assessed the effectiveness of penicillin treatment to prevent

clinical mastoiditis and CSOM.39 The frequency of

mastoiditis among 1247 untreated patients was 8%

(range, 0% to 30%) compared with I % in 1561

pa-tients treated with penicillin (range, 0% to 3.5%)

(Table 4). In all six of the studies, the differences

between treated and untreated patients were

signif-icant. Although most of the studies presented in the

tables were not randomized, blinded, placebo-con-trolled trials, Rudberg- published an extensive

ran-domized controlled trial in 1951 documenting the

efficacy of antibiotic treatment in reducing mastoid-itis in 1365 patients with acute uncomplicated otitis

media seen in Gothenburg, Sweden (Tables 3 and 4).

The incidence of clinical mastoiditis and CSOM was

higher for children younger than 3 years of age than for older patients, and clinical mastoiditis was found

to be more common when organisms were identified

that were resistant to the antibiotics used. An

addi-tional finding of this study was that untreated

pa-tients had ear discharges of longer durations than

treated patients.

The medical effectiveness of antibiotic therapy is

supported by additional reports from this era that

document a large decline in surgery for mastoiditis and CSOM as well as mortality related to intracranial

complications after the introduction of antibiotic

treatment for AOM. Sorensen43 reported a decrease

in the proportion of patients with otitis media and

mastoiditis requiring mastoidectomy from 20% in

1938 to 2.5% in 1948. Lund44 reported a decrease in

the mortality rate from intracranial complications of

otitis media from 36% in 1939 to 0% in 1971.

There are no published controlled community

in-tervention trials of the effectiveness of primary care

case management of otitis media in developing

coun-tries. However, there are prevalence surveys before

and after the introduction of primary care services

for otitis media in Native American and Eskimo

populations. Unfortunately, it is not possible to

es-tablish a causal relationship when a study design

uses historical controls. Todd and Bowman45 studied

the impact of improved primary care services on

perforations and CSOM in the Apache Native

Amer-ican population. Although the prevalence of

epi-sodes of otitis media did not decline, there were

reductions in chronic perforations and CSOM. In

New Zealand, the prevalence of CSOM among Maori

children was reduced from 10% to 3% in 4 years with

the implementation of a treatment program for otitis media.44 However, investigators could not document

any benefit of a special treatment program for

Ab-original children with otitis in Western Australia.47

CONCLUSIONS

A review of the available literature supports the

belief that otitis media is responsible for a significant burden of disease in developing countries. Otitis me-dia has a direct impact on mortality and severe mor-bidity because of high rates of mastoiditis and CSOM

and because it is the major contributor to hearing

impairment. Hearing impairment is a major public

health problem compromising the quality of life in

approximately one third of the population of

devel-TABLE 3. Results of Clinical Trials

Antibiotic Therapy

Comp aring Outcomes of Mastoiditis or CSOM with S ulfonamide Therapy Compared With No

Trial Ref Date No Antibiotic Therapy Sulfonamide Therapy

No. Cases No. (%) Mastoiditis/CSOM No. Cases No. (%) Mastoiditis/CSOM

Fisher 24 1939 95 66 (69.5) 88 7 (7.9)

Hansen 22 1940 130 22(17.0) 127 16 (12.6)

Horan and French 25 1938 607 137 (22.7) 155 7 (4.5)

Horan and French 26 1940 621 21 (3.4)

Key-Aberg 27 1940 201 42 (21.0) 213 8 (3.7)

Duggan 28 1941 108 43 (39.8) 96 11 (11.5)

Hamberger 29 1942 203 43 (21.1) 202 18 (8.9)

Falbe-Hansen and Becker-Christensen 30 1944 323 30 (9.3) 335 5 (1.5)

Hansen 31 1945 468 73(15.5) 500 23 (4.5)

House 32 1946 1241 570 (45.9) 193 34 (17.6)

Bateman 33 1947 372 35 (9.5) 334 50 (15.0)

Rudberg 34 1954 254 44 (17.3) 267 4 (1.5)

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TABLE 4. Results of C Antibiotic Therapy

linical Tn als Compar ing Outcomes of Mastoiditis or CSOM With Penicillin Therapy Compared With No

Trial

Gulsvik Riskaer

Jersild and Kiorboe Rudberg

Lahikainen Rudberg

Ref Date No Antibiotic Therapy Penicillin Therapy*

No. Cases No. (%)

Mastoiditis/CSOM

No. Cases No. (%)

Mastoiditis/CSOM 35 36 37 38 39 34 1949 1949 1950 1950 1953 1954

57 17 (29.8)

177 19(11.0)

66 20 (30.3)

240 33(13.7)

453 9 (2.0)

254 44 (17.3)

186 4 (2.2)

175 0

144 5 (3.5)

272 4(1.5)

176 0

608 0

* Total of 267 cases treated with penicillin tablets and 275 cases treated with injectable penicillin.

oping countries. In addition, the hospital-based

resources spent treating complications of CSOM and

mastoiditis could be saved if primary care

manage-ment can prevent the progression of AOM. Historical data support the effectiveness of antibiotic therapy in

reducing the frequencies of mastoiditis and CSOM

complicating AOM. In selected high-risk populations

living in developed countries, the introduction of

primary care and case management programs for

otitis have been associated with a reduction in the

frequency of CSOM and mastoiditis. International

research organizations should support controlled

in-tervention studies to document the impact of case

management of AOM in developing countries. In

addition, the efficacy of a conjugated pneumococcal

vaccine to prevent AOM and its complications

should be evaluated in a developing country site.

Pending the results of studies, developing

coun-tries should develop primary care case

manage-ment programs to diagnose and treat AOM and its

associated complications.

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COMPARISON OF INTRAMUSCULAR AND INTRAVENOUS QUININE

FOR THE TREATMENT OF SEVERE AND COMPLICATED MALARIA IN

CHILDREN

Schapira

A, Solomon T, Julien M, et al

Abstract. Intravenous (IV) quinine is the standard treatment for severe malaria

where chloroquine resistant Plasmodiurn falCiparuni is found. Because of the

advan-tages of intramuscular (IM) administration, a study was performed to compare

these methods of administration in children with severe and complicated malaria.

The study population was children from 6 months to 7 years of age, all of whom

had asexual Plasmodium falCiparum in the blood smear and at least one of the

following: rigorously defined cerebral malaria; probable cerebral malaria;

hyper-parasitemia; or severe malaria. Exclusions included those who had: received

qui-nine within a week; received an excessive dose of chloroquine within 48 hours;

a history of quinine intolerance; or signs of circulatory shock or hemorrhagic

diathesis.

Patients were randomly allocated to one of two treatment groups: 1) quinine

dihydrochloride administered intravenously with an initial loading dose of 20

mg/kg in 5% glucose, 20 mL/kg over 4 hours, followed by 10 mg/kg in 5%

glucose, 10 mL/kg intravenously over 2 hours every 8 hours; 2) quinine

dihydro-chloride 10 mg/kg by deep IM injection at alternating sites every 8 hours. A

loading dose was applied by repetition of the initial dose after 2 hours. Treatment

was changed to oral medication 10 mg/kg every 8 hours when they were well

enough to do so.

There were 47 patients in the IV group and 57 in the IM group. The two groups

were comparable in all aspects including malnutrition, anemia, and splenomegaly.

Seventeen percent (17%) of the IV group died and 7% of the IM group died. The

mean parasite clearance, fever clearance, and coma clearance times were similar in

both groups. There were two sterile abscesses in the IM group.

The authors conclude that IM quinine is as effective as IV in children with severe and complicated malaria.

Commentary: One possible weakness in the study is that laboratory personnel

were blinded but clinical personnel were not. It appears from this study that IM

does the trick and therefore should be used. J Trop Med Hyg. 1993;87:299-302.

Submitted by the Committee on International Child Health

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1995;96;126

Pediatrics

Stephen Berman