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 Medicines 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 39200 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 ORL2 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 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9

Medically unresponsive chronic suppurative otitis media Disease in the only or better hearing ear where surgery is contemplated presence of cholesteatoma uncooperative patients where an adequate otoscopic examination may be compromised patients with an atypical course high risk patients patients in whom the tympanic membrane cannot be adequately visualized patients who have had previous mastoid surgery 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 13 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 nonquinolone 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 costeffective (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, coamoxiclav, 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 510 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 gentamicinhydrocortisone (for 4 weeks) with and without oral metronidazole given for 2 weeks (6/14 [43%] with topical gentamicinhydrocortisone 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.

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4. Surgery must be performed on all cases of CSOM with suppurative complications. Grade C Recommendation 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.
1

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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.

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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; MarApr 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 / Recurrent EAR DISCHARGE > 3 mos in an adult

OTOSCOPY and other relevant ORL exams Aural Toilet TM Perforation?

Appropriate Management

Y
DIAGNOSIS OF CHRONIC SUPPURATIVE OTITIS MEDIA PTA-ST

With Cholesteatoma and/or Complications?

Appropriate Management

N
Consider common pathogens e.g. Pseudomonas, Staph. aureus, Proteus mirabilis TOPICAL QUINOLONES x 10-14 days

Resolution of Discharge?

Y N

OBSERVE

Continue TOPICAL QUINOLONES x 2 wks

Resolution of Discharge?

OBSERVE

N
Consider other microbial pathogens GS/CS, AFB, Fungal Studies

APPROPRIATE MANAGEMENT

N
Resolution of Discharge?

OBSERVE

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