In children with chronic suppurative otitis media, should one prescribe topical or systemic antibiotics?

Chronic suppurative otitis media (CSOM) is one of the most common chronic childhood infections worldwide. Considerable variation in prevalence is noted globally; the highest prevalence rates are reported in Aboriginal, and particularly, Inuit children populations, in which this disease is considered endemic. Literature on CSOM therapy primarily uses short-term clearance of ear drainage as the primary outcome. While the literature on CSOM has shortcomings in terms of length of follow-up, sample size, methodological quality and lack of paediatric studies, there is reasonable evidence for the efficacy of topical quinolones following aural toilet. The WHO defines CSOM as “otorrhea through a perforated tympanic membrane present for at least two weeks” (1). CSOM can occur when acute otitis media (AOM) causes acute perforation of the tympanic membrane or when AOM occurs in conjunction with chronic perforation or tympanostomy tubes (2). The most common sequela of CSOM is conductive or sensorineural hearing loss (3). The Cochrane Database of Systematic Reviews and Google Scholar were searched in January 2012, identifying three relevant articles: the 2004 WHO guidelines (4); a 2006 Cochrane review of topical versus systemic antibiotics (5); and a 2008 systematic review of topical versus systemic antibiotics for CSOM in children (6). The WHO guidelines, covering the relative effectiveness of topical and systemic antibiotics, drew on a 1998 Cochrane review of all interventions for CSOM, which was comprised of only adult trials (7). The evidence on topical versus systemic antibiotics was taken from six studies and favoured topical antibiotics (OR 0.46 [95% CI 0.30 to 0.68]) for resolving otorrhea and eradicating middle ear bacteria; the effect estimate was strengthened when heterogeneity was decreased by excluding the two lowest quality trials from the analysis (OR 0.19 [95% CI 0.1 to 0.32]). The Cochrane review concluded that of the topical antibiotics studied, topical quinolones were more effective than topical nonquinol-ones (OR 0.36 [95% CI 0.22 to 0.59]), and that there was no additive benefit from combining systemic and topical antibiotics (7). The guideline authors also note that “there is general agreement that aural toilet must be part of the standard medical treatment for CSOM” (3), because it reduces the quantity of infected material, thereby facilitating penetration of topical treatments. The 2006 Cochrane review on topical treatments (excluding steroids) versus systemic antibiotics included nine trials, all involving adults, although four also included children. No subgroup analysis according to age was performed. This review found that topical quinolone antibiotics alone were statistically significantly better than systemic antibiotics alone (pooled RR 3.21 [95% CI 1.88 to 5.49] for topical quinolones over systemic nonquinolones and RR 3.18 [95% CI 1.87 to 5.43] over systemic quinolones). However, the sole trial comparing systemic antibiotics with topical nonquinolones found an effect in favour of the systemic treatment, although the result crossed the line of no-effect (RR 0.74 [95% CI 0.46 to 1.19]). They also performed an analysis of systemic quinolone plus topical quinolone antibiotics versus systemic quinolone antibiotics alone, finding an effect in favour of the combination (RR 2.75 [95% CI 1.38 to 5.46]). The benefits of exclusively analyzing paediatric data motivated Woodfield and Dugdale (6) to rerun the searches from the Cochrane reviews, selecting only the trials involving children. None of these directly compared topical with systemic antibiotics. Nonetheless, they concluded that topical quinolones alone were the most effective short-term treatment for CSOM in children. There are some theoretical reasons for the superiority of topical over systemic administration of antibiotics for CSOM. Due to poor vascularization of the middle ear mucosa, systemically delivered antibiotics do not penetrate well. For example, oral amoxicillin at 90 mg/kg results in a middle ear concentration of only 6 μg/mL to 10 μg/mL compared with 3000 μg/mL of antibiotic following application of a 0.3% antibiotic solution of ciprofloxacin. Another advantage of topical administration is the decrease in side effects due to limited systemic absorption (8). The evidence presented here supports the use of topical quinolone antibiotics in conjunction with aural toilet for short-term resolution of otorrhea from uncomplicated CSOM, recognizing that there are no data on long-term hearing, which is the penultimate outcome. No studies that negated this conclusion were found. CSOM is one of the most common chronic childhood infections worldwide. The highest prevalence rates are reported in Aboriginal and, in particular, Inuit children (5), populations in which this disease is considered to be endemic. In some Aboriginal communities, up to 40% of children have been identified as having CSOM (9). The risk factors contributing to the high rates of CSOM in these populations are lack of breastfeeding, overcrowding, poor hygiene, poor nutrition, passive smoking, high rates of nasopharyngeal colonization with potentially pathogenic bacteria and inadequate/unavailable health care (10). Studies on racially associated craniofacial differences also suggest that Aboriginal populations have a eustachian tube dysfunction that increases their risk of otitis media (11). Literature on CSOM therapy primarily uses the short-term clearance of ear drainage as the primary outcome. The adult literature convincingly shows that topical antibiotics are superior to antiseptic drops, or no treatment, in shortening the duration of ear drainage (12). Rare and serious end points, such as mastoiditis, have not been quantified in the available studies, possibly because they are under-powered to do so. While the literature on CSOM has shortcomings with respect to the length of follow-up, sample size, methodological quality and the lack of paediatric studies, there is reasonable evidence for the efficacy of topical quinolones following aural toilet. Because the most common pathogen is Pseudomonas aeruginosa (13–15), followed by other aerobic bacteria, such as Staphylococcus aureus and Gram-negative organisms and, to a lesser degree, anaerobic pathogens, it makes sense that quinolones would work better than non-quinolones. Currently, ciprofloxacin is the only licensed quinolone available as an otic suspension in Canada (16). Are otic drops safe in children? Concern for ototoxicity with the use of aminoglycosides has prompted the American Academy of Otolaryngology–Head and Neck Surgery to recommend against aminoglycoside agents for topical middle ear use when other options with at least equivalent efficacy are available (17). Topical quinolones have a better safety profile than other agents (8,4). In a recent report from the American Academy of Pediatrics (18), although CSOM was not specifically addressed, quinolone-containing preparations were reported to represent a safer alternative for treating both otorrhea associated with tympanic membrane perforation and tympanostomy tube otorrhea than were aminoglycoside-containing otic preparations. However, there is a need for improved adverse event reporting. What is the impact of CSOM treatment on clinically important long-term outcomes? The most commonly reported and important long-term sequelae of CSOM are permanent tympanic membrane damage and hearing loss (3). These may affect a young child’s language development and school progress. Although decreasing the number of days of ear drainage will be appreciated by children and their parents, it is not clear whether this will have any effect on long-term hearing because no high-quality studies have long-term follow-up with regard to hearing. In studies of hearing involving populations with a high rate of CSOM, the average hearing loss appears to be more severe than that reported when AOM with effusion is present (10). Are there differences in treatment efficacy and long-term outcomes in particular populations? Although CSOM is particularly common in Aboriginal children worldwide, research specific to this population is sparse. What constitutes cost-effective and practical therapy? Topical quinolones are more expensive than other available options (6), and cost/benefit analysis may provide useful information in relatively economically disadvantaged populations and in developing countries where the disease is more prevalent and cost/benefit data are imperative for sustainable treatment. The effectiveness and practicality around aural toilet is also an important question not addressed in the present article but discussed in the WHO guidelines (4).

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