Clinical Question

What is the best treatment for otitis media with tympanic membrane perforation?

Evidence-Based Answer

Acute otitis media with tympanic membrane perforation in children should be treated with an oral antibiotic. (Strength of Recommendation [SOR]: A, based on meta-analysis of randomized controlled trials [RCTs]). Topical ciprofloxacin/dexamethasone (Ciprodex) is better than oral amoxicillin/clavulanic acid (Augmentin) for treating acute otitis media in children with tympanostomy tubes. (SOR: B, based on a small RCT). Topical quinolone antibiotics, with or without topical corticosteroids, are the best treatment for chronic suppurative otitis media. (SOR: A, based on systematic reviews of RCTs).

Evidence Summary

There are three different types of otitis media associated with a perforation of the tympanic membrane: (1) acute otitis media complicated by perforation of the tympanic membrane, presenting as otorrhea; (2) acute otitis media in a patient with tympanostomy tubes; and (3) chronic suppurative otitis media, defined as tympanic membrane perforation with chronic inflammation of the middle ear and persistent otorrhea for two weeks to three months.¹

ACUTE OTITIS MEDIA WITH PERFORATION

A meta-analysis of six RCTs of children six months to 12 years of age with acute otitis media examined the effectiveness of amoxicillin or amoxicillin/clavulanic acid versus placebo or delayed treatment in reducing pain, fever, or both at three to seven days. The authors concluded that antibiotics were more effective than placebo or delayed treatment in children with acute otitis media and otorrhea (relative risk [RR] = 0.52; 95% confidence interval [CI], 0.37 to 0.73; number needed to treat [NNT] = 3) versus children with acute otitis media without otorrhea (RR = 0.80; 95% CI, 0.70 to 0.92; NNT = 8).²

ACUTE OTITIS MEDIA WITH TYMPANOSTOMY TUBES

An industry-sponsored, single-blind RCT of 80 children six months to 12 years of age with tympanostomy tubes and acute otitis media compared ciprofloxacin/dexamethasone otic suspension with amoxicillin/clavulanic acid oral suspension. The children treated with ciprofloxacin/dexamethasone had a median time to cessation of otorrhea of four days compared with seven days for those treated with amoxicillin/clavulanic acid. Clinical cure, defined as cessation of otorrhea at 18 days, was 84.6 percent in the ciprofloxacin/dexamethasone group versus 58.5 percent in the amoxicillin/clavulanic acid group (RR = 0.69; 95% CI, 0.52 to 0.92; NNT = 4).³

CHRONIC SUPPURATIVE OTITIS MEDIA

A 2007 clinical evidence review of adults with chronic suppurative otitis media concluded that topical antibiotics, with or without topical corticosteroids, are likely to reduce persistent otorrhea.⁴ A 2005 Cochrane review included two short studies of variable quality (n = 197) that showed that topical quinolone antibiotics clear aural discharge better than no drug treatment (RR = 0.45; 95% CI, 0.34 to 0.59). The Cochrane review also included three studies (n = 263) that showed that topical quinolones were better than topical antiseptics, such as Burow's solution, povidone-iodine (Betadine), and boric acid, at clearing aural discharge (RR = 0.52; 95% CI, 0.41 to 0.67).⁵ Topical therapy with non-quinolone antibiotics appeared to work about as well, but the data were not as consistent. A 2006 Cochrane review of five generally short studies (n = 291) of variable quality found that topical quinolone antibiotics can clear aural discharge better at one to two weeks than systemic quinolone (RR = 3.18; 95% CI, 1.87 to 5.43) or nonquinolone antibiotics (RR = 3.21; 95% CI, 1.88 to 5.47).⁶

Recommendations from Others

A 2004 joint practice guideline from the American Academy of Pediatrics and the American Academy of Family Physicians includes otorrhea as a verification of middle ear effusion in its diagnostic criteria for acute otitis media. The recommendation to treat most children who require antibiotics with amoxicillin (80 to 90 mg per kg per day) does not differentiate between patients with and those without tympanic membrane perforation.⁷ An expert consensus panel convened by the American Academy of Otolaryngology—Head and Neck Surgery recommends topical quinolone antibiotics for treatment of chronic suppurative otitis media and tympanostomy tube otorrhea in the absence of systemic infection or serious underlying disease.⁸ In 2004, the World Health Organization recommended topical quinolone antibiotics without additional oral antibiotics for treating chronic suppurative otitis media.¹