Antibiotics versus topical antiseptics for chronic suppurative otitis media
- PMID: 31902139
- PMCID: PMC6956626
- DOI: 10.1002/14651858.CD013056.pub2
Antibiotics versus topical antiseptics for chronic suppurative otitis media
Update in
-
Antibiotics versus topical antiseptics for chronic suppurative otitis media.Cochrane Database Syst Rev. 2025 Jun 9;6(6):CD013056. doi: 10.1002/14651858.CD013056.pub3. Cochrane Database Syst Rev. 2025. PMID: 40484400
Abstract
Background: Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Antibiotics and antiseptics kill or inhibit the micro-organisms that may be responsible for the infection. Antibiotics can be applied topically or administered systemically via the oral or injection route. Antiseptics are always directly applied to the ear (topically).
Objectives: To assess the effectiveness of antibiotics versus antiseptics for people with chronic suppurative otitis media (CSOM).
Search methods: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL; 2019, Issue 4, via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 April 2019.
Selection criteria: We included randomised controlled trials (RCTs) with at least a one-week follow-up involving patients (adults and children) who had chronic ear discharge of unknown cause or CSOM, where ear discharge had continued for more than two weeks. The intervention was any single, or combination of, antibiotic agent, whether applied topically (without steroids) or systemically. The comparison was any single, or combination of, topical antiseptic agent, applied as ear drops, powders or irrigations, or as part of an aural toileting procedure. Two comparisons were topical antiseptics compared to: a) topical antibiotics or b) systemic antibiotics. Within each comparison we separated where both groups of patients had received topical antibiotic a) alone or with aural toilet and b) on top of background treatment (such as systemic antibiotics).
Data collection and analysis: We used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks; health-related quality of life using a validated instrument; and ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.
Main results: We identified seven studies (935 participants) across four comparisons with antibiotics compared against acetic acid, aluminium acetate, boric acid and povidone-iodine. None of the included studies reported the outcomes of quality of life or serious complications. A. Topical antiseptic (acetic acid) versus topical antibiotics (quinolones or aminoglycosides) It is very uncertain if there is a difference in resolution of ear discharge with acetic acid compared with aminoglycosides at one to two weeks (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.72 to 1.08; 1 study; 100 participants; very low-certainty evidence). No study reported results for ear discharge after four weeks. It was very uncertain if there was more ear pain, discomfort or local irritation with acetic acid or topical antibiotics due to the low numbers of participants reporting events (RR 0.16, 95% CI 0.02 to 1.34; 2 RCTs; 189 participants; very low-certainty evidence). No differences between groups were reported narratively for hearing (quinolones) or suspected ototoxicity (aminoglycosides) (very low-certainty evidence). B. Topical antiseptic (aluminium acetate) versus topical antibiotics No results for the one study comparing topical antibiotics with aluminium acetate could be used in the review. C. Topical antiseptic (boric acid) versus topical antibiotics (quinolones) One study reported more participants with resolution of ear discharge when using topical antibiotics (quinolones) compared with boric acid ear drops at between one to two weeks (risk ratio (RR) 1.56, 95% confidence interval (CI) 1.27 to 1.92; 1 study; 409 participants; moderate-certainty evidence). This means that one additional person will have resolution of ear discharge for every five people receiving topical antibiotics (compared with boric acid) at two weeks. No study reported results for ear discharge after four weeks. There was a bigger improvement in hearing in the topical antibiotic group compared to the topical antiseptic group (mean difference (MD) 2.79 decibels (dB), 95% CI 0.48 to 5.10; 1 study; 390 participants; low-certainty evidence) but this difference may not be clinically significant. There may be more ear pain, discomfort or irritation with boric acid compared with quinolones (RR 0.56, 95% CI 0.32 to 0.98; 2 studies; 510 participants; low-certainty evidence). Suspected ototoxicity was not reported. D. Topical antiseptic (povidone-iodine) versus topical antibiotics (quinolones) It is uncertain if there is a difference between quinolones and povidone-iodine with respect to resolution of ear discharge at one to two weeks (RR 1.02, 95% CI 0.82 to 1.26; 1 RCT, 39 participants; very low-certainty evidence). The study reported qualitatively that there were no differences between the groups for hearing and no patients developed ototoxic effects (very low-certainty evidence). No results for resolution of ear discharge beyond four weeks, or ear pain, discomfort or irritation, were reported. E. Topical antiseptic (acetic acid) + aural toileting versus topical + systemic antibiotics (quinolones) One study reported that participants receiving topical and oral antibiotics had less resolution of ear discharge compared with acetic acid ear drops and aural toileting (suction clearance every two days) at one month (RR 0.69, 95% CI 0.53 to 0.90; 100 participants). The study did not report results for resolution of ear discharge at between one to two weeks, ear pain, discomfort or irritation, hearing or suspected ototoxicity.
Authors' conclusions: Treatment of CSOM with topical antibiotics (quinolones) probably results in an increase in resolution of ear discharge compared with boric acid at up to two weeks. There was limited evidence for the efficacy of other topical antibiotics or topical antiseptics and so we are unable to draw conclusions. Adverse events were not well reported.
Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
Karen Head: none known. Lee Yee Chong: none known. Mahmood F Bhutta: Mahmood Bhutta has received an honorarium from Novus Therapeutics for advice on an experimental treatment for otitis media (not related to any treatment in this review). Peter S Morris: Peter Morris has contributed to an Expert Advisory Group on chronic suppurative otitis media and conjugate pneumococcal vaccines in Australia for GlaxoSmithKline. He has also been a Chief Investigator on project grants from National Health and Medical Research Council of Australia addressing treatments for chronic suppurative otitis media. Shyan Vijayasekaran: none known. Martin J Burton: Professor Martin Burton is joint Co‐ordinating Editor of Cochrane ENT, but had no role in the editorial process for this review. Anne GM Schilder: Professor Anne Schilder is joint Co‐ordinating Editor of Cochrane ENT, but had no role in the editorial process for this review. Her evidENT team at UCL is supported in part by the National Institute of Health Research (NIHR) University College London Hospitals Biomedical Research Centre. The research is funded by the NIHR and EU Horizon2020. She is the national chair of the NIHR Clinical Research Network ENT Specialty. She is the Surgical Specialty Lead for ENT for the Royal College of Surgeons of England's Clinical Trials Initiative. In her role as director of the NIHR UCLH BRC Deafness and Hearing Problems Theme, she acts as an advisor on clinical trial design and delivery to a range of biotech companies, most currently Novus Therapeutics. Christopher G Brennan‐Jones: none known.
Figures
References
References to studies included in this review
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- Rotimi VO, Olabiyi DA, Banjo TO, Okeowo PA. Randomised comparative efficacy of clindamycin, metronidazole, and lincomycin, plus gentamicin in chronic suppurative otitis media. West African Journal of Medicine 1990;9(2):89-97. [CENTRAL: CN-00072366] [PMID: ] - PubMed
Roydhouse 1981 {published data only}
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Sanchez Gonzales 2001 {published data only}
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Siddique 2016 {published data only}
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Smith 1996 {published data only}
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Somekh 2000 {published data only}
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Subramaniam 2001 {published data only}
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- Subramaniam K, Jalaludin M, Krishnan G. Comparative study of ofloxacin otic drops versus neomycin-polymixin b-hydrocortisone in the medical management of chronic suppurative otitis media. Department of ORL, University Malaya Medical Center, Kuala Lumpur, Malaysia Unpublished, 2000.
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- Subramaniam K, Jaludin M, Krishnan G. Comparative study of ofloxacin otic drops versus neomycin-polymixin hydrocortisone in the medical management of chronic suppurative otitis media. In: 9th ASEAN ORL Head and Neck Congress, 31 March-1 April, 2001. Singapore, 2001.
Thorpe 2000 {published data only}
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- Thorp MA, Gardiner IB, Prescott CA. Burow's solution in the treatment of active mucosal chronic suppurative otitis media: determining an effective dilution. Journal of Laryngology and Otology 2000;114(6):432-6. [CENTRAL: CN-00299231] [PMID: ] - PubMed
Tong 1996 {published data only}
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- Tong MC, Woo JK, Hasselt CA. A double-blind comparative study of ofloxacin otic drops versus neomycin-polymyxin B-hydrocortisone otic drops in the medical treatment of chronic suppurative otitis media. Journal of Laryngology & Otology 1996;1104:309-14. - PubMed
Tutkun 1995 {published data only}
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- Ozagar A, Koc A, Ciprut A, Tutkun A, Akdas F, Sehitoglu MA. Effects of topical otic preparations on hearing in chronic otitis media. Otolaryngology - Head and Neck Surgery 1997;117(4):405-8. [CENTRAL: CN-00144419] [PMID: ] - PubMed
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van der Veen 2007 {published data only}
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- Boonacker CW, Veen EL, Wilt GJ, Schilder AG, Rovers MM. Trimethoprim-sulfamethoxazole in children with chronic otitis media: a randomized comparison of costs and effects. Otology & Neurotology 2008;29(7):961-4. [CENTRAL: CN-00666283] [PMID: ] - PubMed
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- Verhoeff M, Rovers MM, Sanders EAM, Schilder AGM. The COCO-study: a randomized clinical trial of the efficacy of trimethoprim-sulfamethoxazole (co-trimoxazole) in children with chronic suppurative otitis media. Clinical Otolaryngology and Allied Sciences 2004;29(4):460. [CENTRAL: CN-00874123]
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- Veen EL, Rovers MM, Albers FW, Sanders EA, Schilder AG. Effectiveness of trimethoprim/sulfamethoxazole for children with chronic active otitis media: a randomized, placebo-controlled trial. Pediatrics 2007;119(5):897-904. [CENTRAL: CN-00588516] [PMID: ] - PubMed
van Hasselt 1998a {published data only}
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- Hasselt P, Kregten E. Treatment of chronic suppurative otitis media with ofloxacin in hydroxypropyl methylcellulose ear drops: a clinical/bacteriological study in a rural area of Malawi. International Journal of Pediatric Otorhinolaryngology 2002;63(1):49-56. [CENTRAL: CN-00519676] - PubMed
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- Hasselt P. A controlled trial of the treatment of CSOM in rural Malawi. In: Conference of the Pan-African Federation of Otorhinolaryngological Societies (PAFOS); 1998; Nairobi. Nairobi, 1998. [CENTRAL: CN-00519673]
van Hasselt 1998b {published data only}
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- Hasselt P, Kregten E. Treatment of chronic suppurative otitis media with ofloxacin in hydroxypropyl methylcellulose ear drops: a clinical/bacteriological study in a rural area of Malawi. International Journal of Pediatric Otorhinolaryngology 2002;63(1):49-56. [CENTRAL: CN-00519676] - PubMed
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Yuen 1994 {published data only}
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References to studies awaiting assessment
Abdul 2005 {published data only}
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- Abdul ME, Shabana Y, Ghonim M. Comparative study of the efficacy of local ciprofloxacin versus aluminum acetate 3.5% in the management of active chronic suppurative otitis media [CSOM]. New Egyptian Journal of Medicine 2005;32:190-3.
References to ongoing studies
I‐HEAR‐BETA {published data only}
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- ACTRN12614000234617. Comparing cotrimoxazole and/or povidone-iodine ear wash with standard dry mopping and ciprofloxacin ear drops in Indigenous children with chronic suppurative otitis media (CSOM) [Among Aboriginal children (2 months of age and up to 17 years of age) with chronic suppurative otitis media, is 4 months of povidone-iodine ear wash and/or oral cotrimoxazole in addition to standard treatment (cleaning and dry mopping with tissue spears plus topical ciprofloxacin) superior to standard treatment alone for resolving ear discharge? A 2x2 factorial randomised controlled trial]. Http://www.anzctr.org.au/ACTRN12614000234617.aspx (first received 5 March 2014). [CENTRAL: CN-01013236]
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References to other published versions of this review
Head 2018b
Macfadyen 2005a
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