CHRONIC SUPPURATIVE OTITIS MEDIA IN ADULTS

SCOPE OF THE PRACTICE GUIDELINE

This clinical practice guideline is for use by the Philippine Society of Otolaryngology-Head and
Neck Surgery. 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
1
describe treatment options.

LITERATURE SEARCH
This guideline is based on the 1997 Clinical Practice Guidelines of the Philippine Society of
Otolaryngology– 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
1
occasionally, and have no signs of active infection.

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
1
otitis media because acute otitis media is a self-limiting infection.

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
1
cases and 60% of operated ears in the PGH .

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

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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
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
3
early infection.

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.
1,4
The eardrum must be adequately visualized for accurate diagnosis.

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
, 5, 6
middle ear.

2. Pure tone audiometry and speech testing must 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
1
evaluating the effectivity of tympanoplasty and ossiculoplasty. 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 B Recommendation

Current international literature indicates that computerized tomographic imaging is the

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

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:

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 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
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
9,10,11,12
and far-flung areas. Poor patients may find the added expense of the test prohibitive.

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 pledgets, 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
1
instructed on proper and regular self-cleansing of their ears.

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 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
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
13,14,15
symptomatic relief for the patient.

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
5,15
is highly recommended. .

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, 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.
Continuing the same topical antibiotic therapy for an additional two weeks may be
considered.

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 Grade C Recommendation

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.

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 sensitivity 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.

These antiseptics include boric acid, zinc peroxide powder, iodine powder, Dilute acetic
acid drops, alum acetate, and others.

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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 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
3,17
analysis below).

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
18,19
well as the presence of other risk factors for CSOM.

18
4. Surgery must be performed on all cases of CSOM with suppurative complications.

Grade C Recommendation
1
The goal of surgery is the eradication of infection and permanent resolution of otorrhea ,
and to achieve an ear that is easy to care and free of recurrent or residual infection with
20
hearing improvement as the secondary aim .

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
2. meningitis
3. otitic hydrocephalus
4. lateral sinus thrombophlebitis
5. facial nerve paralysis
6. labyrinthitis
7. subperiosteal abscesses

Surgery is also recommended for patients who, from the time of examination, evident clinical
cholesteatoma is seen by the clinician.

While eradication of infection and consequent permanent resolution of otorrhea is considered

the primary aim, there is also the secondary aim of hearing preservation or improvement
which must be stated as well considering the state of modern middle ear surgery for chronic
otitis media. This may be applied individually depending on the expertise of the surgeon and
the pathology involved among other factors.Local and foreign studies have shown that with or
without cholesteatoma, disease eradication and hearing improvement is possible in about
50% of cases. On the other hand, it was shown by Garap et al that even canal
mastoidectomy without tympanoplasty resulted in draining ears in significant proportion with
21
disappointing hearing results.

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5. 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
1,13
procedure.

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.

20
 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.
20. Hildman H, Sudhoff H, Jahnke K. Principles of individualized approach to
cholesteatoma surgery. In Jahnke K, Middle Ear Surgery: Recent Advances and
Future Directions. Thieme Publishers New York, 2004:81.
21. Garap et al. Canal down Mastoidectomy-experience in 81 cases. Otol Neurotol
2001:451-456.

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

Persistent / OTOSCOPY
Recurrent and other relevant ORL
EAR DISCHARGE exams
> 3 mos in an adult Aural Toilet

TM Perforation? N Appropriate
Management
Y

DIAGNOSIS OF CHRONIC
SUPPURATIVE OTITIS MEDIA

PTA-ST

Y
With Cholesteatoma and/or Appropriate
Complications? Management

Consider common pathogens e.g.

Pseudomonas, Staph. aureus, Proteus mirabilis

TOPICAL QUINOLONES x 10-14 days

Resolution of Y
Discharge? OBSERVE

N
Continue TOPICAL QUINOLONES x 2 wks

Y
Resolution of OBSERVE
Discharge?

N
Consider other microbial pathogens

GS/CS, AFB, Fungal Studies

APPROPRIATE MANAGEMENT

Resolution of Y OBSERVE
Discharge?

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