CHRONIC SUPPURATIVE OTITIS MEDIA IN ADULTS

SCOPE OF THE PRACTICE GUIDELINE

This clinical practice guideline is for use by the Philippine Society of Otolaryngologists. It covers
the diagnosis and management of chronic suppurative otitis media in adults (19 years old and
above).

OBJECTIVES
The objectives of the guideline are (1) to emphasize the requisites of diagnosis of chronic
suppurative otitis media in adults; (2) to evaluate current diagnostic techniques; and (3) to
describe treatment options.1

LITERATURE SEARCH
This guideline is based on the 1997 Clinical Practice Guidelines of the Philippine Society of
Otorhinolaryngology– Head and Neck Surgery and the 2002 Clinical Practice Guidelines of the
Philippine General Hospital Department of Otorhinolaryngology and revised according to new
evidence. The National Library of Medicine’s PubMed database and Cochrane Reviews including
the whole web were searched for literature using the keyword otitis media, suppurative. The
search was limited to articles involving humans and those published in English in the last fifteen
years, WHO reports, and the PGH Annual Report. The search yielded 549 articles. Thirty-eight
(38) abstracts were chosen and results were further assessed for relevance. Full text articles
were obtained when possible. The chosen articles were divided as follows:
Meta-analysis 2
Randomized controlled trial 2
Non-randomized controlled study 3
Descriptive study 1
Committee report 1

DEFINITION
Chronic suppurative otitis media (CSOM) is a persistent inflammation of the middle ear or
mastoid cavity which presents with persistent or recurrent ear discharge (otorrhea) over 3 months
through a perforation of the tympanic membrane. Synonyms include “chronic otitis media
(without effusion)”, “chronic mastoiditis” and “chronic tympanomastoiditis”. Chronic suppurative
otitis media does not include chronic perforations of the eardrum that are dry, or discharge only
occasionally, and have no signs of active infection. 1

PREVALENCE
Worldwide prevalence of chronic suppurative otitis media is 65-330 million people. Between 39-
200 million (60%) suffer from significant hearing impairment. Otitis media has been estimated to
cost 28,000 deaths and loss of over 2 million Disability Adjusted Life Years in 2000, 94% of which
are in developing countries. Most of these deaths are presumably due to chronic suppurative
otitis media because acute otitis media is a self-limiting infection. 1

In the Philippines, the prevalence of CSOM is estimated at 2.5-29.5% based on several surveys
among children in Metro Manila and Mindanao. It has been reported that CSOM patients
constitute 14% of outpatient consults in the Santo Tomas University Hospital, 30% of emergency
cases and 60% of operated ears in the PGH .1

The number of consults (pediatric and adult patients) with diagnosis of CSOM in the ORL-
Outpatient Department of the Philippine General Hospital is 325 (5.6%) in 2002. 2

RISK FACTORS
Inadequate antibiotic treatment, frequent upper respiratory tract infections, nasal disease, and
poor living conditions with poor access to medical careare related to the development of CSOM.
Poor housing, hygiene and nutrition are associated with higher prevalence rates, and

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improvementin these aspects was found to halve the prevalence of CSOM in Maori children
between 1978 and 1987. Proximity to a health care facility significantly reduced the otitis media
attack rate among Arizona Indian children living in reservations. Bottle-feeding, passive exposure
to smoking, attendance in congested centres such as day-care facilities, and a family history of
otitis media are some of the risk factors for otitis media. The predisposition of certain races, such
as the South-western American Indians, Australian Aborigines, Greenlanders, and Alaskan
Eskimos, to CSOM is also well documented. These risk factors probably favour the development
of CSOM by weakening the immunological defences, increasing the inoculum, and encouraging
early infection.3

RECOMMENDATIONS ON THE DIAGNOSIS OF CHRONIC SUPPURATIVE OTITIS MEDIA

1. The diagnosis of CSOM is made by thorough history and otoscopic examination.

Grade A Recommendation

The assessment begins with a thorough history of the frequency, duration, and
characteristics of the discharge. Physical examination of the affected ear requires cleansing
of the external auditory canal before the tympanic membrane can be accurately assessed.
The eardrum must be adequately visualized for accurate diagnosis. 1,4
The presence of tympanic membrane perforation and persistent/ recurrent otorrhea > 3
month is still considered by the panel to be diagnostic of CSOM. Typical findings may include
thickened granular middle ear mucosa, mucosal polyps and cholesteatoma within the middle
ear., 5, 6

2. Pure tone audiometry and speech testing may be performed as part of the evaluation.

Grade C Recommendation

The panel recognized the value of the PTA-ST in the initial evaluation of patients with
CSOM because it provides information on the etiology of hearing loss (conductive, mixed and
sensorineural) in the ipsilateral and contralateral ear. Moreover, it gives baseline data
regarding the pre-operative hearing status that is important for surgical planning and for
evaluating the effectivity of tympanoplasty and ossiculoplasty. 1 It must be emphasized that
PTA and ST must be done ONLY AFTER thoroughly cleaning the ear and in the absence of
acute suppurative symptoms.

3. Radiographic imaging in the form of computerized tomographic imaging or plain

mastoid radiography are considered ancillary diagnostic tools.

Grade C Recommendation

Current international literature indicates that computerized tomographic imaging is the

diagnostic radiologic imaging study of choice in the assessment of chronic suppurative otitis
media. 7,8

At present, there are no internationally accepted guidelines with regards to the indications
for imaging studies in chronic suppurative otitis media. Most otologists would agree that
imaging studies are not routinely necessary. Radiographic imaging in the form of high-
resolution computerized tomography may have value in the following situations:
3.1 medically unresponsive chronic suppurative otitis media
3.2 disease in the only or better hearing ear where surgery is contemplated
3.3 presence of cholesteatoma
3.4 uncooperative patients where an adequate otoscopic examination may be
compromised
3.5 patients with an atypical course

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 3.6 high risk patients
3.7 patients in whom the tympanic membrane cannot be adequately visualized
3.8 patients who have had previous mastoid surgery
3.9 patients with intratemporal or intracranial complications

However, the panel feels that in the local setting, plain mastoid radiography still has a role
in the assessment of CSOM, especially where access to CT scan technology is limited.
CSOM is a disease of the poor and the high cost of CT scans makes it unaffordable to most
patients. Although plain mastoid X-rays are inferior to CT scan in terms of clarity and
precision of diagnostic imaging of the middle ear and mastoid pathology, they can be used to
assess the status of mastoid aeration, especially in situations where this finding is expected
to be altered by the disease process.

4. Culture and sensitivity of ear discharge is not part of the routine initial diagnostic
assessment.

Grade A Recommendation

Both local and international studies have shown that the bacteria most commonly seen in
CSOM may be aerobic (e.g. Pseudomonas aeruginosa, E. Coli, S. aurues, Streptococcus
pyogenes, Proteus mirabilis, Klebsiella species) or anaerobic (e.g. Bacteroides,
Peptostreptococcus, Proprionibacterium) However, In the prospective study of Khanna et.
al., they found that there is no definite role of culture and sensitivity in the initial management
of all cases of CSOM. This is further supported by the local studies that show no significant
change in the pathogenic organisms in patients with CSOM within the last twenty (20) years.
In addition, reliable and sensitive culture facilities are often not available particularly in rural
and far-flung areas. Poor patients may find the added expense of the test prohibitive. 9,10,11,12

In patients who does not respond or has persistent infection despite maximal medical
therapy, and does not develop any complications of chronic suppurative otitis media, further
investigations must be done. Laboratory work-ups such as culture sensitivity must be done
for other microbes other than the common pathogens.

RECOMMENDATIONS ON THE TREATMENT OF CHRONIC SUPPURATIVE OTITIS MEDIA

1. Aural toilet is an essential part of the treatment of CSOM in all patients.

Grade A Recommendation

Ear cleansing, also known as aural toilet, consists of mechanical removal of ear
discharge and other debris from the ear canal and middle ear by mopping with cotton
swab/buds, wicking with gauze, flushing with sterile solution, or suctioning. This can be done
with an otomicroscope, or under direct vision with adequate illumination of the middle ear. In
health care settings wherein these resources are not available, health workers can still wick
or flush the ear canal as long as it can be clearly visualized. Patients and their caregivers
must be instructed on proper and regular self-cleansing of their ears. 1

Two RCTs in children have been reported (Acuin, 2005) to find no evidence of benefit
with ear cleansing alone compared with no treatment (persisting otorrhoea: 125/170 [74%]
with ear cleansing v 91/114 [80%] with no ear cleansing; OR 0.63, 95% CI 0.36 to 1.12;
persisting tympanic perforations: 1 RCT; 125/144 [87%] v 63/73 [87%]; OR 1.04, 95% CI 0.46
to 2.38). However, aural toilet, when combined with antibiotic treatment, is more effective in
drying up otorrhea and eradicating middle ear bacteria than no treatment. Treatment with
antibiotics or antiseptics accompanied by aural toilet was more effective in resolving otorrhea
than no treatment (two trials, odds ratio 0.37, 95% confidence interval 0.24 to 0. 57) or aural
toilet alone (six trials, odds ratio 0.31, 95% confidence interval 0.23 to 0.43). Thus, the panel

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 agreed that aural toilet should be part of the medical management of CSOM in order (1) to
clean the ear canal and middle ear cavity; (2) adequately visualize and assess the middle
ear; (3) to allow the topical antibiotic to reach the middle ear cavity; and (4) to provide
symptomatic relief for the patient.13,14,15

2. Topical antibiotics are recommended for the initial management of CSOM for a period
of 10-14 days. Topical quinolones or non-quinolones may be used. No particular
quinolone or non-quinolone is recommended. Topical combinations of antibiotics and
steroids are not recommended over topical antibiotics alone.

Grade A Recommendation

Two methodologically weak RCTs have been reported (Acuin, 2005) to provide
limited evidence that topical quinolone antibiotics improved otorrhoea and middle ear
inflammation at 1–3 weeks compared with placebo in adults with chronic suppurative otitis
media. However, in a separate review by MacFadyen and Acuin (2005), no difference was
found between quinolones and non quinolones at weeks 1 or 3: RR (95% CI) were, 0.89
(0.59 to 1.32) at week 1 and 0.97 (0.54 to 1.72) at week 3. A difference in favour of
quinolones was seen at week 2, pooled RR (95% CI) 0.65 (0.46 to 0.92), although when one
trial was removed to reduce heterogeneity, pooled estimates showed no difference between
quinolone and non-quinolone antibiotics, with fixed RR (95% CI) 0.84 (0.57 to 1.23) (I2=0%,
chi2 p=0.53).

In contrast, Abes et al, concluded in their meta-analysis that 0.3% ofloxacin otic solution
is better than other antibiotic otic drops and oral antibiotics in terms of overall cure rate and
resolution of secondary outcome parameters. Thus, the topical ofloxacin given for 10-14 days
is highly recommended. 5,15
.
Two RCTs that compared different topical non-quinolone antibiotics have been reported
(Acuin, 2005) to find no significant difference in the proportion of people who still had a wet
ear on otoscopy at the end of treatment. The same report found three RCTs that compared
topical antibiotics plus topical steroids versus topical antibiotics alone. The RCTs found no
clear evidence of a difference between treatments in clinical response.
2.1. For persistent otorrhea, the patient must be re-evaluated. Continuing medical
therapy for an additional two weeks may be considered.

Grade C Recommendation

Compliance by the patient or caregiver with the daily regimen of ear cleansing
and topical antibiotic instillation must be verified and reinforced. Other risk factors
should be sought and addressed. Culture and sensitivity studies of the ear discharge
may be done to search for other microbes.
None of the RCTs on topical antibiotics were performed on treatment failures or
observed patients long enough to determine the effects of topical treatments on long
terms outcomes such as healing of perforation and hearing improvement. Thus there
is very little evidence to guide clinicians in this situation. However, difficulties in
complying with the daily regimen of meticulous ear cleansing followed by proper
topical antibiotic instillation are commonly observed among patients and their
caregivers. No RCTs have shown that removal of risk factors is effective in resolving
CSOM, although there is ample evidence that these risk factors by themselves have
adverse health effects. Owing to the decreased vascularity, fibrosis and deep-seated
nature of the infection, CSOM may not necessarily respond with two weeks therapy.
The panel therefore saw it prudent to recommend continuing treatment unless
complications are detected. This must be balanced however with the potential
ototoxic effects of some topical antibiotics, except quinolones.

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 .
In patients who do not respond or has persistent infection despite maximal
medical therapy, and do not develop any complications of chronic suppurative otitis
media, further investigations must be done. Laboratory work-ups such as culture
sensiltivity must be done for other microbes other than the common pathogens.

Duration and time frame of medical treatment for patients who remain
asymptomatic still remain unclear. Due to lack of studies, we believe this is an area of
future research.
2.2. Topical antiseptics may be used if topical antibiotics are not immediately
available.

Grade C recommendation

A systematic review reported one RCT in 51 adults) that compared three

treatments: topical antiseptics (boric acid and iodine powder plus ear cleansing under
microscopic vision), topical antibiotics (gentamicin or chloramphenicol), and oral
antibiotics (cefalexin, flucloxacillin, cloxacillin, or amoxicillin, according to bacterial
sensitivity). It found no significant difference between topical antiseptics and topical
antibiotics in persistent activity on otoscopy (13/20 [65%] with topical antiseptics v
15/18 [83%] with topical antibiotics; OR 0.40, 95% CI 0.10 to 1.66). No significant
difference was also found between oral antibiotics and topical antiseptics in the rate
of persistent activity on otoscopy (8/13 [62%] with oral antibiotics v 13/20 [65%] with
topical antiseptics v 15/18 [83%] with topical antibiotics; OR 0.87, 95% CI 0.21 to
3.61). These results do not suggest equivalence between antiseptics and antibiotics
because these RCTs may have been underpowered by their small sample sizes to
detect differences. However, these RCTs do suggest that antiseptics are
pharmacologically active agents and can exert some beneficial effects on weeping
ears. In addition, they may be potentially cost-effective (see table below). Thus
among patients who can not yet afford topical antibiotics, topical antiseptics may offer
some benefit. These antiseptics include boric acid, zinc peroxide powder, iodine
powder, Dilute acetic acid drops, alum acetate, and others. 13

3. Systemic antibiotics should not be routinely given to patients with CSOM either alone
or in combination with topical antimicrobials.

Grade A recommendation

One systematic review reported 5 RCTs, 291 adults, which found a better resolution of
otorrhea with topical antibiotics than with systemic antibiotics (34/153 [22%] with topical
antibiotics v 77/138 [56%] with systemic antibiotics; OR 0.23, 95% CI 0.14 to 0.37).. The
topical antibiotics used were ofloxacin, ciprofloxacin, gentamicin, and chloramphenicol. The
systemic antibiotics were oral cefalexin, cloxacillin, amoxicillin, ofloxacin, ciprofloxacin, co-
amoxiclav, and intramuscular gentamicin.
There is no clear benefit with adding a systemic to a topical antibiotic. The same
systematic review mentioned above reported 2 RCTs ( 90 adults) that found no significant
difference between systemic-topical combinations and topicals alone. The first RCT (60
adults) identified by the review compared three treatments: oral ciprofloxacin, topical
ciprofloxacin, and oral plus topical ciprofloxacin. It found no significant difference in otorrhoea
at 2 weeks with topical ciprofloxacin with or without oral ciprofloxacin given for 5–10 days
(5/20 [25%] with oral plus topical ciprofloxacin v 3/20 [15%] with topical ciprofloxacin alone;
OR 1.84, 95% CI 0.40 to 8.49).41 The second RCT(30 adults) identified by the review found
no significant difference in otorrhoea at the end of treatment with topical gentamicin–
hydrocortisone (for 4 weeks) with and without oral metronidazole given for 2 weeks (6/14
[43%] with topical gentamicin–hydrocortisone plus oral metronidazole v 6/16 [38%] with

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 topical gentamicin–hydrocortisone alone: OR 1.24, 95% CI 0.29 to 5.23). A third RCT (80
adults, 89 ears), compared topical plus oral non-quinolone antibiotics versus topical
quinolone antibiotics alone. It found that topical ofloxacin (0.3%) reduced the proportion of
ears exhibiting persistent signs (ear pain, discharge, or inflammation on otoscopic
examination) after 2 weeks compared with oral amoxicillin (amoxycillin) plus topical
chloramphenicol (33% of ears with topical ofloxacin v 63% of ears with oral amoxicillin plus
topical chloramphenicol; P < 0.001).
This recommendation has an economic implication because poor patients should not be
burdened with systemic antibiotics given alone or with topical antibiotics. Systemic antibiotics
are not only more costly but less effective than topical antibiotics (see cost-effectiveness
analysis below). 3,17
3.1 The use of systemic antibiotics may be considered in the presence of
bacterial upper respiratory infections and/or complications.

Grade C Recommendation

There are no systematic reviews or RCTs that compared the benefits of

systemic antibiotics versus no treatment among CSOM patients with associated
bacterial infections. Systematic reviews of the effectiveness of antibiotics for sore
throat and for otitis media report modest benefits as well as significantly higher
adverse effects and costs. Therefore, giving systemic antibiotics to CSOM
patients with presumptive bacterial infections is an option that clinicians may take
after considering patients’ preferences as well as the presence of other risk
factors for CSOM. 18,19

4. Surgery must be performed on all cases of CSOM with suppurative complications.

Grade A Recommendation

The goal of surgery is the eradication of infection and permanent resolution of otorrhea. 1
Panel members agreed that the presence of intracranial and extracranial complications in
patients with CSOM is an absolute indication for mastoidectomy based on pathophysiologic
understanding of the disease and numerous case series. These complications include:
1. brain abscess 5. facial nerve paralysis
2. meningitis 6. labyrinthitis
3. otitic hydrocephalus 7. subperiosteal abscesses
4. lateral sinus thrombophlebitis

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5. Surgery may be performed in most cases of CSOM with cholesteatoma.

Grade C Recommendation

Selected cases of cholesteatoma may not be treated surgically, such as in an elderly

patient with a poor general medical condition. Depending on the extent of disease, it may be
possible to manage the cholesteatoma in the office with otomicroscopy and aggressive aural
toilet. Thorough cleaning at routine intervals with removal of all accessible squamous debris
may be adequate to prevent extension of the disease process and development of infection
and other complications. This regimen is particularly useful in those patients in whom disease
is limited to an attic or posterosuperior retraction pocket that allows adequate visualization
and access. A reliable and cooperative patient is essential.

6. Surgery may be performed for those who fail to respond to adequate medical
treatment based on Recommendations 1 and 2.

Grade C Recommendation

There are no randomized clinical trials to date comparing medical treatment and
mastoidectomy in those patients in whom either procedure is a valid alternative. However,
case series describing the intraoperative findings of medically intractable cases have been
published. The indications for abandoning medical therapy are currently unclear; thus, the
panel saw no justification in making definite recommendations for the performance of either
procedure.1,13
Duration and time frame of medical treatment for patients who remain asymptomatic still
remain unclear. Due to lack of studies, we believe this is an area of future research.

References
1. Philippine Society of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines 1997.
2. 2002 Annual Report, Out-patient Department, Philippine General Hospital.
3. Chronic suppurative otitis media. Burden of illness and management options. WHO, 2004.
4. Acuin, J. Chronic Suppurative Otitis Media. Clinical Evidence. 2004.
5. Abes G, Espallardo N, Tong M, Subramaniam KN, Hermani B, Lasiminigrum L, Anggraeni R. “A Systematic
Review Of The Effectiveness of Ofloxacin Otic Solution For The Treatment Of Suppurative Otitis Media.”
J ORL & Health Specialties; Mar-Apr 2003.
6. Ramsey AM. “Diagnosis and Treatment of the Child with a Draining Ear” J. Pediatr. Health Care. 2002 Jul-
Aug; 16(4) :161-9.
7. Leighton SE, Robson AK, Anslov P., Melford CA, “The Role of CT Imaging in the Management of CSOM.
Clin. Otolaryngol. 1993 Feb; 18(1):23-9.
8. O ‘Reilly BJ, et al. “The Value of CT Scanning in Chronic Suppurative Otitis Media.” J. Laryngol. Otol.
1991 Dec; 105(12):990-4.
9. Khanna, V., Chander J. Nagarkar NM, Dass A. “ Clinicomicrobiologic evaluation of active tubotympanic
type of chronic suppurative otitis media.” J. Otolaryngol. 2000 June; 29(3):148-53.
10. Abes G.T, and Jamir. Bacteriology of CSOM. PJO-HNS Acta Otol. 1983
11. Del Rosario et al . Bacteriology of CSOM 1993.
12. Brook I, Frazier E. Microbial Dynamics of persistent purulent otitis media in Children. J Pediatrics 1996.
13. Acuin J, Smith A, Mackenzie I. “Interventions For Chronic Suppurative Otitis Media.” Cochrane Database
Syst Rev. 2000; (2): CD000473.
14. Acuin, J. Chronic suppurative Otitis Media: burden of illness and management options. Child and
Adolescent Health and Development Prevention of Blindness and Deafness. World Health Organization
Geneva, Switzerland, 2004.
15. Chronic suppurative Otitis Media. In Clinical Evidence. December 2005.
16. Suzuki K, Nishimura T, Baba S, Yanagita N, Ishigami H. “Topical Ofloxacin For Chronic Suppurative Otitis
Media And Acute Exacerbation Of Chronic Otitis Media: Optimum Duration Of Treatment.” Otol Neurotol.
2003 May; 24(3): 447-52.
17. Acuin, et al . The Cochrane Library, 1997.
18. Acute Otitis Media. In Clinical Evidence 2004.
19. Sore Throat. In Clinical Evidence. December 2004.

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 ALGORITHM FOR THE DIAGNOSIS AND TREATMENT OF CHRONIC SUPPURATIVE
OTITIS MEDIA IN ADULTS

Persistent / Recurrent OTOSCOPY

EAR DISCHARGE and other relevant ORL exams
> 3 mos in an adult
Aural Toilet

Y
Appropriate
Persistent / Recurrent OTOSCOPY TM Perforation? Management
EAR DISCHARGE and other relevant ORL exams
> 3 mos in an adult N
Aural Toilet
DIAGNOSIS OF CHRONIC
SUPPURATIVE OTITIS MEDIA
N
TM Perforation? Appropriate
PTA-STManagement

Y
With Cholesteatoma Y Appropriate
DIAGNOSIS OF CHRONIC
and/or Management
SUPPURATIVE OTITISComplications
MEDIA ?
N
PTA-ST
Consider common pathogens e.g.
Pseudomonas, Staph. aureus, Proteus mirabilis
Y Appropriate
With Cholesteatoma
TOPICAL OFLOXACIN x 10-14 days Management
and/or Complications?

N
Resolution of Discharge? Y
OBSERVE
Consider common pathogens e.g.
Pseudomonas, Staph. aureus, Proteus mirabilis
N

TOPICAL QUINOLONES x 10-14 days

Continue TOPICAL OFLOXACIN x 2 wks

N
Resolution of Discharge? Y
Resolution Y OBSERVE
of OBSERVE
Discharge?
N
N
Consider
Continue TOPICAL other microbial
QUINOLONES pathogens
x 2 wks

GS/CS, AFB, Fungal Studies

Y
Resolution of OBSERVE
APPROPRIATE
Discharge? MANAGEMENT
N Y
N
Resolution OBSERVE
of
Consider other microbial pathogens
Discharge?
GS/CS, AFB, Fungal Studies

APPROPRIATE MANAGEMENT

N
8
TOPICAL ANTIBIOTICS x
Resolution of
Discharge?
10-14 days Y OBSERVE