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PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. PEDIATRICS is owned, published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, 60007. Copyright 1995 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
REVIEW
ARTICLE
Otitis
Media
in Developing
Countries
Stephen
Berman,
MD
Objective.
This
article
disease media
concerning etiology of
the otitis
developing mastoiditis,
countries, chronic
The available literature was reviewed to 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 identified 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
Although otitis media is a common condition in developing countries, the value of targeting limited health care resources to the diagnosis and management of otitis media is controversial. This article reviews the available information concerning the disease 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 Death and Severe OF OTITIS MEDIA
symptoms to these
varied ENT
experience abscess,
Disability
meningitis,
and
brain
abscess.
Hearing
impairment
was
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 media. 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
controls.
and
the
reduction
because
of the
use
of historical
Conclusions.
should ment support the impact
International research organizations controlled intervention studies to docuof case management of otitis in devel-
oping
countries.
In addition,
the efficacy
of a conjugated
its complicacountry site. countries programs complica-
pneumococcal vaccine to prevent otitis and lions should be evaluated in a developing Pending the results of studies, developing should develop primary care case management to diagnose and treat otitis and its associated
From
Medicine,
the
Department
Denver.
of
Pediatrics,
School
of
Received Reprints
PEDIATRICS
Copyright
1995
Acad-
emy
of lediatrics.
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 disability-adjusted life years (DALYs). In the developing world, otitis media is estimated to result in 23.1 (xIOO 000) DALYs lost. Other conditions with a similar impact on the quality of life in developing countries 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 complications 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 central nervous system, including spasticity, paralysis, mental retardation, cortical blindness, and seizures. Labyrinthitis and facial nerve paralysis are additional complications associated with acute otitis media (AOM) and CSOM that cause severe disability. Children living in developing countries have a
126
PEDIATRICS Vol. from 96 No. I July 1995 Downloaded pediatrics.aappublications.org at Indonesia:AAP Sponsored on April 4, 2013
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 immune 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 inoculum 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
reduce by impairment
Epidemiology
hearing
Hearing impairment associated with otitis media is common in many developing countries. In Thailand, 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 moderate 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 Hearing impairment impacts the ability to work, to learn in school, or to develop basic language skills. Longterm hearing loss related to CSOM persisting throughout childhood and adolescence can be a significant handicap. For example, in Bangkok, Thailand, low academic achievement levels among 6 year olds were directly correlated with current hearing loss.2 Wilson3 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 moderate and severe range are further impaired by their lack of access to amplification aids. Wilson3 states that case management and control of otitis media, measles, mumps, meningitis, and rubella would
Published data from developing countries describing the prevalence of perforation, otorrhea, and mastoiditis from communityand school-based studies are reviewed in Table I (A.W. Smith, personal communication, 1992).5-12 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 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 examination, 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%; cholesteatoma, 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 hospital otolaryngology clinics.42 These reports, reviewed in Table 2, suggest that mastoiditis and other complications occur frequently in many areas of developing 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. Country
Prevale
nce
of Pe rforation, Ref 3 3 4 4 t 5 6 7 7 8 9 2 2 2 10 10 10 11 12 Date 1985 1985 1979 1979 1987 1992 1966 1984 1984 1985 1990 1986 1986 1986 1981 1981 1981 1984 1983
Otorrhea,
and Setting
Mastoi
ditis
munity-
and
School-B (%)
ased
Studies
Countries* (%)
Perforation 0.4 2.8 NA NA 2.5 NA 2.2-8.3 NA NA 4 NA 4.7 1.23 1.38 5.72 3.3 1.69-6.24 0.3 1.6
Otorrhea 0.4 1.4 0.6 3.6 2.1 I .1 NA 6.1 3.8 NA 4.36 2.63 0.88 1 .20 NA NA NA NA NA
S Africa S Africa Nigeria Nigeria Swaziland Kenya Guam Solomon Solomon Micronesia Malaysia Thailand Thailand Thailand S Korea S Korea S Korea Israel
Kuwait
*
Islands Islands
R community R community U school R school U/R community U/R school R school R community R community R community U/R school U/R community R school U school U/R community U/R community U school U school U/R school
0-15 >15 3-11 3-11 5-14 5-21 5-18 0- 5 0-15 0-25 7-12 0-15 6-12 6-12 0-10 All 6-12 8-13 7-10
0.74 NA NA 0.19 0 0 NA NA NA NA NA
U, urban; Smith,
t A.W.
ARTICLE
127
TABLE
Country Uganda Gambia Gambia Zaire
Nigeria
2.
Prevalence Ref 14 15 15 16
17
and
in Hospital (yr)
Clinic-Based Perforation NA 55 48 NA
NA
Studies
in Developing Otorrhea NA NA NA NA
NA
(%)
(%)
(%)
Nigeria
Tanzania
18
19
1986
1978
Urban
Urban
3-11
All
NA
NA
7.2
11.1
NA
1.7
Angola
Sudan
*
20
21
1981
1986
Urban
Urban
0-15
All
NA
NA
NA
NA
1.8
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 patients presenting with draining ears were: subperiosteal 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 patients 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%), labyrinthitis (0.7%), brain abscess (0.5%), and Bezolds abscess (0.4%).2
Etiology
With
Antibiotic
Therapy
Etiologic pathogens isolated from ear aspirates in children with AOM carried out in developing countries are similar to isolations obtained from children living in developed countries. In Medellin, Colombia, bacterial pathogens were isolated in 82 of III children (74%)23 Haeinophilus influenzae (32 nontypeable strains and 8 type B strains) was isolated in 36% of the cases, and Streptococcus pneilmoniae was found in 22%. Other isolations included Staphylococcus aureus (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 invasive organisms are difficult to eradicate with antibiotics, are very destructive, and often lead to complications. 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 children. Proteus was identified in 41 Pseudoinotuas in 26%, Klebsiella in 16%, Escherichia coli in 9%, and S aureus in 7%#{149}7 Some developing countries report tuberculosis as a cause in a small proportion of pa%), %,
Because data are not available for populations living in developing countries, there is an urgent need to conduct randomized clinical trials of antibiotic treatment of AOM in areas with high rates of mastoiditis and CSOM. It is inappropriate to generalize the results of recent clinical trials of antibiotic 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 reflect differences in population characteristics and environmental factors. Therefore, an assessment of the value of case management 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 developing countries; and (2) reviewing the effectiveness of providing enhanced primary care services to underserved 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 progressed to CSOM and or clinical mastoiditis. The complication rates for patients with CSOM described currently in many developing countries are also similar 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 corn-
128
OTITIS
Downloaded from pediatrics.aappublications.org at Indonesia:AAP Sponsored on April 4, 2013 MEDIA IN DEVELOPING COUNTRIES
pared with the rates reported by Canada from 1930 to 1987. The 1987 mortality rate for Guatemala corresponds 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 Salvador correspond to the Canadian rate in 1949. The observation that current infant mortality rates from pneumonia and influenza among infants in developing countries are comparable with rates reported in Canada in the preantibiotic era suggests that population characteristics, living conditions, and primary medical care services also may be similar. Antibiotic therapy reduced the frequency of mastoiditis 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 Europe and North America reviewed in Tables 3 and 4 documented the efficacy of antibiotic treatment.222439 Twelve studies carried out from 1939 to 1947 cornpared patients who received sulfonamide therapy with untreated control patients (Table 3). The frequency of mastoiditis and/or CSOM in 3431 untreated patients was 32% (frequency range, 9% to 70%).22.24 The frequency of clinical mastoiditis and/or CSOM in 3131 patients treated with sulfonamides 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 patients treated with penicillin (range, 0% to 3.5%) (Table 4). In all six of the studies, the differences between treated and untreated patients were significant. Although most of the studies presented in the tables were not randomized, blinded, placebo-controlled trials, Rudbergpublished an extensive randomized controlled trial in 1951 documenting the efficacy of antibiotic treatment in reducing mastoiditis 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 additional finding of this study was that untreated patients 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 intervention trials of the effectiveness of primary care case management of otitis media in developing countries. 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 establish 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 American population. Although the prevalence of episodes 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 Aboriginal 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 media has a direct impact on mortality and severe morbidity 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
Antibiotic
3.
of Clinical
Trials
Comp
aring
Outcomes
of Mastoiditis
or
CSOM
with
S ulfonamide
Therapy
Compared
With
No
Ref
Date No. Cases 95 130 607 201 108 203 323 468 1241 372
254
No
Antibiotic No.
Therapy
Mastoiditis/CSOM No. Cases
Sulfonamide
No.
Therapy
(%)
(%)
Mastoiditis/CSOM
Fisher Hansen Horan and Horan and Key-Aberg Duggan Hamberger Falbe-Hansen Hansen House Bateman
Rudberg
French French
and
Becker-Christensen
24 22 25 26 27 28 29 30 31 32 33
34
1939 1940 1938 1940 1940 1941 1942 1944 1945 1946 1947
1954
66 (69.5) 22(17.0) 137 (22.7) 42 (21.0) 43 (39.8) 43 (21.1) 30 (9.3) 73(15.5) 570 (45.9) 35 (9.5)
44 (17.3)
7 16 7 21 8 11 18 5 23 34 50
4
ARTICLE
129
TABLE
Antibiotic
4.
Trial
Results Therapy
of C linical
Tn als
Compar
ing
Outcomes
of
Mastoiditis
or
CSOM
With
Penicillin
Therapy
Compared
With
No
Ref
Date
No.
No
Cases
Antibiotic
Therapy
No. Mastoiditis/CSOM
Penicillin
Therapy*
No. Mastoiditis/CSOM
(%)
No.
Cases
(%)
Kiorboe
57
177
Total
of 267
cases
oping countries. In addition, the hospital-based resources spent treating complications of CSOM and mastoiditis could be saved if primary care management 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 intervention 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 countries should develop primary care case management programs to diagnose and treat AOM and its associated complications.
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Health Organization. World Dezelopinent Report 1 993: Investing in Health. Oxford: Oxford University Press; 1993:215-222 2. Presansuk 5, Siriyananda C, Na-Nakorn A. Report on f/ic Prevalence of Hearing Disability and Ear Diseases in Thailand. Bangkok: The World Health Organization, International Federation of Oto-Rhino-Laryngological Societies, International Society of Audiology, and of otitis Faculty media of in lot I . World
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countries:
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107):1-87 I, et suppurative al. Ceftazidime otitis media for without with 45. 46. the 44.
Nort/i
Lund otogenic 495-501 complications Todd
Am. WS.
1977;10:45-50
A review of between CA. Otitis 50 cases 1961 of and media intracranial 1977. C/in complications Otolariiiigol. Day, Ariz: from 1978;3: a 16-year infection
J.
1993;12:246-247 and with cerebral complications. Respiratory in otitis Control. media. Larilngoscope. Infections Pan in American Cliii t/ie 47.
NW,
Bowman
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review of 3225 1935;45:790-822 42. Arias Americas: Health 43. Sorenson SJ, Benguigui
Acute Advances
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Watson in the Healt/i.
school
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preschool
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health region of
I.
1980;91
Trends, 1992:40. in
primary Australia.
Public
OF TREATMENT
AND
INTRAVENOUS
QUININE MALARIA IN
COMPLICATED
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
cerebral malaria; probable cerebral malaria; hyperExclusions included those who had: received quian excessive dose of chloroquine within 48 hours; or signs to one of circulatory treatment shock or groups: hemorrhagic 1) quinine
were
randomly
allocated
of two
dihydrochloride administered intravenously with an initial mg/kg in 5% glucose, 20 mL/kg over 4 hours, followed glucose, 10 mL/kg intravenously over 2 hours every 8 hours;
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 There to do so. were 47 patients in the IV group and 57 in the IM group. The two groups The in
were comparable Seventeen percent mean parasite both groups. The authors complicated Commentary: were blinded does the trick and
clearance,
There were two sterile abscesses in the conclude that IM quinine is as effective
IM group. as IV in children
severe
malaria. One possible weakness in the study is that laboratory personnel but clinical personnel were not. It appears from this study that IM and therefore Submitted should by be used. the
J Trop Med
on
Hyg.
Committee
International
ARTICLE
131
Reprints
PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. PEDIATRICS is owned, published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, 60007. Copyright 1995 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.