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Meta-Analysis
. 2021 Feb 4;2(2):CD013052.
doi: 10.1002/14651858.CD013052.pub2.

Systemic antibiotics for chronic suppurative otitis media

Lee-Yee Chong  1 , Karen Head  2 , Katie E Webster  2 , Jessica Dew  3 , Peter Richmond  4 , Tom Snelling  5 , Mahmood F Bhutta  6 , Anne Gm Schilder  7   8 , Martin J Burton  9 , Christopher G Brennan-Jones  3
Affiliations
Meta-Analysis

Systemic antibiotics for chronic suppurative otitis media

Lee-Yee Chong et al. Cochrane Database Syst Rev. .

Update in

  • Systemic antibiotics for chronic suppurative otitis media.
    Chong LY, Head K, Webster KE, Daw J, Strobel NA, Richmond PC, Snelling T, Bhutta MF, Schilder AG, Brennan-Jones CG. Chong LY, et al. Cochrane Database Syst Rev. 2025 Jun 9;6(6):CD013052. doi: 10.1002/14651858.CD013052.pub3. Cochrane Database Syst Rev. 2025. PMID: 40484405

Abstract

Background: Chronic suppurative otitis media (CSOM) 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. Systemic antibiotics are a commonly used treatment option for CSOM, which act to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be used alone or in addition to other treatments for CSOM.

Objectives: To assess the effects of systemic antibiotics for people with CSOM.

Search methods: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL 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Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials.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 16 March 2020.

Selection criteria: We included randomised controlled trials comparing systemic antibiotics (oral, injection) against placebo/no treatment or other systemic antibiotics with at least a one-week follow-up period, involving patients with chronic (at least two weeks) ear discharge of unknown cause or due to CSOM. Other treatments were allowed if both treatment and control arms also received it.

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; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.

Main results: We included 18 studies (2135 participants) with unclear or high risk of bias. 1. Systemic antibiotics versus no treatment/placebo It is very uncertain if there is a difference between systemic (intravenous) antibiotics and placebo in the resolution of ear discharge at between one and two weeks (risk ratio (RR) 8.47, 95% confidence interval (CI) 1.88 to 38.21; 33 participants; 1 study; very low-certainty evidence). The study did not report results for resolution of ear discharge after two weeks. Health-related quality of life was not reported. The evidence is very uncertain for hearing and serious (intracranial) complications. Ear pain and suspected ototoxicity were not reported. 2. Systemic antibiotics versus no treatment/placebo (both study arms received topical antibiotics) Six studies were included of which five presented useable data. There may be little or no difference in the resolution of ear discharge at between one to two weeks for oral ciprofloxacin compared to placebo or no treatment when ciprofloxacin ear drops were used in both intervention arms (RR 1.02, 95% CI 0.93 to 1.12; 390 participants; low-certainty evidence). No results after two weeks were reported. Health-related quality of life was not reported. The evidence is very uncertain for ear pain, serious complications and suspected ototoxicity. 3. Systemic antibiotics versus no treatment/placebo (both study arms received other background treatments) Two studies used topical antibiotics plus steroids as background treatment in both arms. It is very uncertain if there is a difference in resolution of ear discharge between metronidazole and placebo at four weeks (RR 0.91, 95% CI 0.51 to 1.65; 40 participants; 1 study; very low-certainty evidence). This study did not report other outcomes. It is also very uncertain if resolution of ear discharge at six weeks was improved with co-trimoxazole compared to placebo (RR 1.54, 95% CI 1.09 to 2.16; 98 participants; 1 study; very low-certainty evidence). Resolution of ear discharge was not reported at other time points. From the narrative report there was no evidence of a difference between groups for health-related quality of life, hearing or serious complications (very low-certainty evidence). One study (136 participants) used topical antiseptics as background treatment in both arms and found similar resolution of ear discharge between the amoxicillin and no treatment groups at three to four months (RR 1.03, 95% CI 0.75 to 1.41; 136 participants; 1 study; very low-certainty evidence). The narrative report indicated no evidence of differences in hearing or suspected ototoxicity (both very low-certainty evidence). No other outcomes were reported. 4. Different types of systemic antibiotics This is a summary of four comparisons, where different antibiotics were compared to each other. Eight studies compared different types of systemic antibiotics against each other: quinolones against beta-lactams (four studies), lincosamides against nitroimidazoles (one study) and comparisons of different types of beta-lactams (three studies). It was not possible to conclude if there was one class or type of systemic antibiotic that was better in terms of resolution of ear discharge. The studies did not report adverse events well.

Authors' conclusions: There was a limited amount of evidence available to examine whether systemic antibiotics are effective in achieving resolution of ear discharge for people with CSOM. When used alone (with or without aural toileting), we are very uncertain if systemic antibiotics are more effective than placebo or no treatment. When added to an effective intervention such as topical antibiotics, there seems to be little or no difference in resolution of ear discharge (low-certainty evidence). Data were only available for certain classes of antibiotics and it is very uncertain whether one class of systemic antibiotic may be more effective than another. Adverse effects of systemic antibiotics were poorly reported in the studies included. As we found very sparse evidence for their efficacy, the possibility of adverse events may detract from their use for CSOM.

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Conflict of interest statement

Lee Yee Chong: none known. Karen Head: none known. Katie Webster: none known. Jessica Daw: none known. Peter Richmond: none known. Tom Snelling: none known. Mahmood 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). Anne GM Schilder: Professor Anne Schilder was joint Co‐ordinating Editor of Cochrane ENT until April 2020, but had no role in the editorial process for this review. Her evidENT team at UCL is supported by the National Institute of Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre (BRC), with research being funded by the NIHR, Wellcome Trust and EU Horizon2020. She is the National Specialty Lead for the NIHR Clinical Research Network ENT and Surgical Specialty Lead for ENT for the Royal College of Surgeons of England's Clinical Research 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 in the hearing field. 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. Christopher G Brennan‐Jones: Dr Brennan‐Jones's research team is primarily funded by the Australian NHMRC and the WA Department of Health. He sits on the national Technical Advisory Group responsible for developing treatment guidelines for otitis media in Australia.

Figures

1
1
Study flow diagram
2
2
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Systemic antibiotics versus no treatment/placebo, Outcome 1: Resolution of ear discharge at 1 to 2 weeks
2.1
2.1. Analysis
Comparison 2: Systemic antibiotics versus no treatment/placebo (both study arms had topical antibiotics), Outcome 1: Resolution of ear discharge (1 to 2 weeks)
2.2
2.2. Analysis
Comparison 2: Systemic antibiotics versus no treatment/placebo (both study arms had topical antibiotics), Outcome 2: Ear pain
2.3
2.3. Analysis
Comparison 2: Systemic antibiotics versus no treatment/placebo (both study arms had topical antibiotics), Outcome 3: Serious complications
2.4
2.4. Analysis
Comparison 2: Systemic antibiotics versus no treatment/placebo (both study arms had topical antibiotics), Outcome 4: Ototoxicity
3.1
3.1. Analysis
Comparison 3: Systemic antibiotics versus no treatment/placebo (both study arms had topical antibiotics plus steroids), Outcome 1: Resolution of ear discharge (after 4 weeks)
3.2
3.2. Analysis
Comparison 3: Systemic antibiotics versus no treatment/placebo (both study arms had topical antibiotics plus steroids), Outcome 2: Serious complications
4.1
4.1. Analysis
Comparison 4: Systemic antibiotics versus no treatment/placebo (both study arms had topical antiseptic plus dry mopping), Outcome 1: Resolution of ear discharge at 2 to 4 weeks
4.2
4.2. Analysis
Comparison 4: Systemic antibiotics versus no treatment/placebo (both study arms had topical antiseptic plus dry mopping), Outcome 2: Resolution of ear discharge after 4 weeks
4.3
4.3. Analysis
Comparison 4: Systemic antibiotics versus no treatment/placebo (both study arms had topical antiseptic plus dry mopping), Outcome 3: Sensitivity analysis: Resolution of ear discharge at 2 to 4 weeks
4.4
4.4. Analysis
Comparison 4: Systemic antibiotics versus no treatment/placebo (both study arms had topical antiseptic plus dry mopping), Outcome 4: Sensitivity analysis: Resolution of ear discharge after 4 weeks
5.1
5.1. Analysis
Comparison 5: Quinolones versus beta‐lactams, Outcome 1: Resolution of ear discharge (1 to 2 weeks)
5.2
5.2. Analysis
Comparison 5: Quinolones versus beta‐lactams, Outcome 2: Suspected ototoxicity
6.1
6.1. Analysis
Comparison 6: Different beta‐lactams, Outcome 1: Resolution of ear discharge (1 to 2 weeks)
6.2
6.2. Analysis
Comparison 6: Different beta‐lactams, Outcome 2: Resolution of ear discharge (2 to 4 weeks)
7.1
7.1. Analysis
Comparison 7: Lincosamides versus nitroimidazoles (both study arms also received gentamicin), Outcome 1: Resolution of ear discharge (1 to 2 weeks)
7.2
7.2. Analysis
Comparison 7: Lincosamides versus nitroimidazoles (both study arms also received gentamicin), Outcome 2: Resolution of ear discharge (2 to 4 weeks)
7.3
7.3. Analysis
Comparison 7: Lincosamides versus nitroimidazoles (both study arms also received gentamicin), Outcome 3: Resolution of ear discharge (after 4 weeks)
See this image and copyright information in PMC

References

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Browning 1984 {published data only}
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Chowdhury 2002 {published data only}
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Deitmer 2002 {published data only}
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Esposito 1992 {published data only}
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Esposito 2000 {published data only}
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Gupta 2015 {published data only}
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IRCT20130427013136N6 {published data only}
    1. IRCT20130427013136N6. The efficacy of ceftazidime on bacterial otitis. http://en.irct.ir/trial/45218 (first received 13 February 2020).
IRCT2016082313136N4 {published data only}
    1. IRCT2016082313136N4. The effect clotrimazole ointment comparison to ceftizoxime powder and clotrimazole ointment in the treatment of patients with fungal otitis media. http://www.who.int/trialsearch/Trial2.aspx?TrialID=IRCT2016082313136N4 (first received 13 October 2016).
ISRCTN86106121 {published data only}
    1. ISRCTN86106121. Treatment of chronic suppurative otitis media (CSOM) in Kenyan children: a double blind, two-group comparative randomised placebo controlled trial [Randomised trial of treatment of chronic suppurative otitis media (CSOM) in Kenyan children]. http://isrctn.org/ISRCTN86106121 (first received 17 December 2008). [CENTRAL: CN-00766897]
Jahn 1984 {published data only}
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Kantawala 1976 {published data only}
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Kovacic 1999 {published data only}
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Kurilin 1976 {published data only}
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Lancaster 1999 {published data only}
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Lancaster 2003 {published data only}
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Lang 1992 {published data only}
    1. Lang R, Goshen S, Raas-Rothschild A, Raz A, Ophir D, Wolach B, et al. Oral ciprofloxacin in the management of chronic suppurative otitis media without cholesteatoma in children: preliminary experience in 21 children. Pediatric Infectious Disease Journal 1992;11(11):925-9. [PMID: ] - PubMed
Lautala 1983 {published data only}
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Legent 1994 {published data only}
    1. Legent F, Bordure P, Beauvillain C, Berche P, Bordure PH. Controlled prospective study of oral ciprofloxacin versus amoxycillin/clavulanic acid in chronic suppurative otitis media in adults. Chemotherapy 1994;40(Suppl 1):16-23. [CENTRAL: CN-00108583] [EMBASE: 1994301734] [PMID: ] - PubMed
Li 2004 {published data only}
    1. Li KY, Zhao NJ, Zhu JC. Clinical observation on treatment of chronic suppurative otitis media caused large tympanic membranes perforation by ear-dropping with combined Chinese and Western drugs. Zhongguo Zhong Xi Yi Jie He Za Zhi [Chinese Journal of Integrated Traditional and Western Medicine] 2004;24(11):989-91. [CENTRAL: CN-00504865] [PMID: ] - PubMed
Lorentzen 1978 {published data only}
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Mendelman 1992 {published data only}
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Merifield 1993 {published data only}
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Mesure 1973 {published data only}
    1. Mesure R. Double-blind study of the association of sulfamethoxazole and trimethoprim in otorhinolaryngological infections [Essai en double aveugle de l'association de sulfamethoxazole et de trimethoprime dans les infections oto-rhino-laryngologiques]. Acta Oto-rhino-laryngologica Belgica 1973;27(1):27-33. [CENTRAL: CN-00008422] [PMID: ] - PubMed
Mira 1993 {published data only}
    1. Mira E, Benazzo M, Mira E, Benazzo M. Ceftizoxime as local therapy in the treatment of recurrences of chronic suppurative otitis media. Journal of Drug Development Supplement 1993;6(Suppl 2):39-44. [CENTRAL: CN-00362597]
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Morgon 1976 {published data only}
    1. Morgon A. Role of antibiotic therapy with clindamycin in the treatment of chronic suppurative otitis media [Place de l'antibiotherapie par la clindamycine dans le traitement des otites moyennes suppurees chroniques]. JFORL. Journal Francais d'Oto-rhino-laryngologie; Audiophonologie et Chirurgie Maxillo-faciale 1976;25(4):353-4. [PMID: ] - PubMed
NCT02592096 {published data only}
    1. NCT02592096. Pazufloxacin mesilate ear drops clinical trial protocol [A single dose phase I clinical study of pazufloxacin mesilate ear drops for the patients with otitis media]. https://clinicaltrials.gov/show/nct02592096 (first received 30 October 2015). [CENTRAL: CN-01104441]
NCT02817347 {published data only}
    1. NCT02817347. A clinical trial of YH1177 in patients with otitis media and otorrhea [A randomized, double-blind, multicenter, phase2 trial to evaluate the safety and efficacy of YH1177 or YH1177-D otic soultion [sic] in patients with otitis media and otorrhea]. https://clinicaltrials.gov/show/nct02817347 (first received 29 June 2016). [CENTRAL: CN-01383192]
Poliakova 1991 {published data only}
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Povedano 1995 {published data only}
    1. Povedano Rodriguez V, Seco Pinero MJ, Jurado Ramos A, Lopez Villarejo P. Efficacy of topical ciprofloxacin in the treatment of chronic otorrhea [Eficacia del ciprofloxacino topico en el tratamiento de la otorrea cronica]. Acta Otorrinolaringologica Espanola 1995;46(1):15-8. [CENTRAL: CN-00113534] [PMID: ] - PubMed
Principi 1995 {published data only}
    1. Principi N. Multicentre comparative study of the efficacy and safety of azithromycin compared with amoxicillin/clavulanic acid in the treatment of paediatric patients with otitis media. European Journal of Clinical Microbiology & Infectious Diseases 1995;14(8):669-76. [CENTRAL: CN-00120943] [EMBASE: 1995280756] [PMID: ] - PubMed
Quick 1973 {published data only}
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Quick 1975 {published data only}
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Roydhouse 1981 {published data only}
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Saez‐Llorens 2005 {published data only}
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Shkil' 1964 {published data only}
    1. Shkil' AM. On the complex treatment of chronic suppurative otitis media [O kompleksnom lechenii khronicheskikh gnoinykh srednikh otitov]. Zhurnal Ushnykh, Nosovykh I Gorlovykh Boleznei [Journal of Otology, Rhinology, and Laryngologie [sic]] 1964;24(6):17-22. [PMID: ] - PubMed
Singhal 1992 {published data only}
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Stenstrom 1991 {published data only}
    1. Stenstrom C, Lundgren K, Ingvarsson L, Bertilson SO. Amoxycillin/clavulanate versus amoxycillin in recurrent otitis media and therapeutic failure in children. Acta Oto-Laryngologica 1991;111(1):120-9. [CENTRAL: CN-00074552] [EMBASE: 1991091483] [PMID: ] - PubMed
Sugiyama 1981 {published data only}
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Sumitsawan 1995 {published data only}
    1. Sumitsawan Y, Tharavichitkul P, Prawatmuang W, Ingsuwan B, Sriburi P. Ofloxacin otic solution as treatment of chronic suppurative otitis media and diffuse bacterial otitis externa. Chotmaihet Thangphaet [Journal of the Medical Association of Thailand] 1995;78(9):455-9. [PMID: ] - PubMed
Supiyaphun 1995 {published data only}
    1. Supiyaphun P, Chochaipanichnon L, Tonsakulrungruang K, Chongtateong A, Samart Y. The treatment of chronic suppurative otitis media and otitis externa with 0.3 per cent ofloxacin otic solution: a clinico-microbiological study. Chotmaihet Thangphaet [Journal of the Medical Association of Thailand] 1995;78(1):18-21. - PubMed
Tachibana 1986 {published data only}
    1. Tachibana M, Ohshima W, Mizukoshi O, Yanohara K, Nishimura T. Clinical trial of BRL 28500 (clavulanic acid-ticarcillin) in the treatment of chronic suppurative otitis media. Chemotherapy 1986;34(Suppl 4):1120-4.
Thomsen 1976 {published data only}
    1. Thomsen VF, Olsen JS, Sorensen H, Thomsen J. Bacteriology and antibiotics in acute suppurative otitis media. Journal of Otolaryngology 1976;5(4):289-97. - PubMed
Van de Heyning 1986 {published data only}
    1. Van de Heyning PH, Pattyn SR, Valcke HD. Ciprofloxacin in oral treatment of ear infections. Pharmaceutisch Weekblad. Scientific Edition 1986;8(1):63-6. [PMID: ] - PubMed
van Dongen 2014 {published data only}
    1. NTR1481. Comparison of ototopical antibiotic-steroid drops or oral antibiotics versus watchful waiting in children with acute tympanostomy tube otorrhea [Comparison of Bacicoline-B eardrops or oral Augmentin versus watchful waiting in children with acute tympanostomy tube otorrhea]. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1481 (first received 6 October 2008). [CENTRAL: CN-00974948]
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van Hasselt 1998b {published data only}
    1. 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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Wintermeyer 1997 {published data only}
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References to studies awaiting assessment

Mehboob 2019 {published data only}
    1. Mehboob S, Rafi ST, Ahmed N, Mehjabeen. Association of hearing loss with depression, anxiety and stress in patients suffering from Chronic Suppurative Otitis Media. Pakistan Journal of Medical Sciences 2019;35(2):510-4. [PMID: ] - PMC - PubMed

References to ongoing studies

I‐HEAR‐BETA {published data only}
    1. 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]
    1. Wigger C, Leach AJ, Beissbarth J, Oguoma V, Lennox R, Nelson S, et al. Povidone-iodine ear wash and oral cotrimoxazole for chronic suppurative otitis media in Australian aboriginal children: study protocol for factorial design randomised controlled trial. BMC Pharmacology & Toxicology 2019;20(1):46. [CENTRAL: CN-01954293] [PMID: ] - PMC - PubMed

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