Topical antibiotics for chronic suppurative otitis media
- PMID: 31896168
- PMCID: PMC6956124
- DOI: 10.1002/14651858.CD013051.pub2
Topical antibiotics for chronic suppurative otitis media
Update in
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  Topical antibiotics for chronic suppurative otitis media.Cochrane Database Syst Rev. 2025 Jun 9;6(6):CD013051. doi: 10.1002/14651858.CD013051.pub3. Cochrane Database Syst Rev. 2025. PMID: 40484407
Abstract
Background: Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection (involving more than one micro-organism) 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. Topical antibiotics, the most common treatment for CSOM, 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, such as antiseptics or ear cleaning (aural toileting).
Objectives: To assess the effects of topical antibiotics (without steroids) 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Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials.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 1 April 2019.
Selection criteria: We included randomised controlled trials (RCTs) with at least a one-week follow-up involving participants (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks. The interventions were any single, or combination of, topical antibiotic agent(s) of any class, applied directly into the ear canal as ear drops, powders or irrigations, or as part of an aural toileting procedure. The two main comparisons were topical antibiotic compared to a) placebo or no intervention and b) another topical antibiotic (e.g. topical antibiotic A versus topical antibiotic B). Within each comparison we separated studies where both groups of participants had received topical antibiotic a) alone or with aural toileting 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; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.
Main results: We included 17 studies with a total of 2198 participants. Twelve studies reported the sample size in terms of participants (not ears); these had a total of 1797 participants. The remaining five studies reported both the number of participants and ears, representing 401 participants, or 510 ears. A: Topical antibiotics versus placebo or no treatment (with aural toilet in both arms and no other background treatment) One small study compared a topical antibiotic (ciprofloxacin) with placebo (saline). All participants received aural toilet. Although ciprofloxacin was better than saline in terms of resolution of discharge at one to two weeks: 84% versus 12% (risk ratio (RR) 6.74, 95% confidence interval (CI) 1.82 to 24.99; 35 participants, very low-certainty evidence), the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other. The study authors reported that "no medical side-effects and worsening of audiological measurements related to this topical medication were detected" (very low-certainty evidence). B: Topical antibiotics versus placebo or no treatment (with use of oral antibiotics in both arms) Four studies compared topical ciprofloxacin to no treatment (three studies; 190 participants) or topical ceftizoxime to no treatment (one study; 248 participants). In each study all participants received the same antibiotic systemically (oral ciprofloxacin, injected ceftizoxime). In at least one study all participants received aural toilet. Useable data were only available from the first three studies; ciprofloxacin was better than no treatment, resolution of discharge occurring in 88.2% versus 60% at one to two weeks (RR 1.47, 95% CI 1.20 to 1.80; 2 studies, 150 participants; low-certainty evidence). None of the studies reported ear pain or discomfort/local irritation. C: Comparisons of different topical antibiotics The certainty of evidence for all outcomes in these comparisons is very low. Quinolones versus aminoglycosides Seven studies compared an aminoglycoside (gentamicin, neomycin or tobramycin) with ciprofloxacin (734 participants) or ofloxacin (214 participants). Whilst resolution of discharge at one to two weeks was higher in the quinolones group the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other (RR 1.95, 95% CI 0.88 to 4.29; 6 studies, 694 participants). One study measured ear pain and reported no difference between the groups. Quinolones versus aminoglycosides/polymyxin B combination ±gramicidin We identified three studies but data on our primary outcome were only available in one study. Comparing ciprofloxacin to a neomycin/polymyxin B/gramicidin combination, for an unknown treatment duration (likely four weeks), ciprofloxacin was better (RR 1.12, 95% CI 1.03 to 1.22, 186 participants). A "few" patients experienced local irritation upon the first instillation of topical treatment (numbers/groups not stated). Others Other studies examined topical gentamicin versus a trimethoprim/sulphacetamide/polymixin B combination (91 participants) and rifampicin versus chloramphenicol (160 participants). Limited data were available and the findings were very uncertain.
Authors' conclusions: We are uncertain about the effectiveness of topical antibiotics in improving resolution of ear discharge in patients with CSOM because of the limited amount of low-quality evidence available. However, amongst this uncertainty there is some evidence to suggest that the use of topical antibiotics may be effective when compared to placebo, or when used in addition to a systemic antibiotic. There is also uncertainty about the relative effectiveness of different types of antibiotics; it is not possible to determine with any certainty whether or not quinolones are better or worse than aminoglycosides. These two groups of compounds have different adverse effect profiles, but there is insufficient evidence from the included studies to make any comment about these. In general, adverse effects were poorly reported.
Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
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.
Karen Head: none known.
Lee Yee Chong: 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.
Mahmood F Bhutta: Dr 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).
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                References
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References to studies excluded from this review
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Baba 1980 {published data only}
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Baba 1982b {published data only}
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Baba 1983b {published data only}
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Berman 1990 {published data only}
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Bluestone 2001 {published data only}
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Boesorire 2000 {published data only}
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Brook 1979 {published data only}
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Bross Soriano 1996 {published data only}
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Browning 1983 {published data only}
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Browning 1988 {published data only}
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Clayton 1990 {published data only}
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Connolly 1997 {published data only}
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Couzos 2003 {published data only}
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Deguchi 1985 {published data only}
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Deguchi 1986 {published data only}
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Deitmer 2002 {published data only}
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Dellamonica 1995 {published data only}
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Dohar 2002 {published data only}
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    - Dohar JE. Topical quinolones in the treatment of chronic suppurative otitis media and recurrent otorrhea. Ear, Nose, & Throat Journal 2002;81(8 Suppl 1):20. [CRS: 5716094] - PubMed
 
Eason 1986 {published data only}
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    - Eason RJ, Harding E, Nicholson R, Nicholson D, Pada J, Gathercole J. Chronic suppurative otitis media in the Solomon Islands: a prospective, microbiological, audiometric and therapeutic survey. New Zealand Medical Journal 1986;99:812‐5. [CENTRAL: CN‐00045614; CRS: 980668; PUBMED: 3466089] - PubMed
 
Esposito 1992 {published data only}
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    - Esposito S, Noviello S, D'Errico G, Montanaro C. Topical ciprofloxacin vs intramuscular gentamicin for chronic otitis media. Archives of Otolaryngology‐Head & Neck Surgery 1992;118(8):842‐4. [CENTRAL: CN‐00086057; CRS: 1020830; PUBMED: 1642836] - PubMed
 
Esposito 2000 {published data only}
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    - Esposito S, Noviello S, Ianniello F, D'Errico G. Ceftazidime for outpatient parenteral antibiotic therapy (OPAT) of chronic suppurative otitis media due to Pseudomonas aeruginosa. Journal of Chemotherapy (Florence, Italy) 2000;12(1):88‐93. [CRS: 7773949] - PubMed
 
Fliss 1990 {published data only}
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    - Fliss DM, Dagan R, Houri Z, Leiberman A. Medical management of chronic suppurative otitis media without cholesteatoma in children. Journal of Pediatrics 1990;116(6):991‐6. [CENTRAL: CN‐00067997; CRS: 1003023; PUBMED: 2189979] - PubMed
 
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Fombeur 1994 {published data only}
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    - Fombeur JP, Barrault S, Koubbi G, Laurier JN, Ebbo D, Lecomte F, et al. Study of the efficacy and safety of ciprofloxacin in the treatment of chronic otitis. Chemotherapy 1994;40 Suppl 1:29‐34. [CENTRAL: CN‐00108584; CRS: 1043206; PUBMED: 7805428] - PubMed
 
Fraysse 1988 {published data only}
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    - Fraysse B, Calvet H, Faure P, Schutz D. Value of fenspiride (Pneumorel (R) 80 mg) in the preoperative treatment of chronic open tympanum otitis. Double‐blind placebo‐controlled study. Rhinology 1988;26(Suppl 4):31‐41. [CENTRAL: CN‐00187914; CRS: 1114954; EMBASE: 1989095354] - PubMed
 
Garcia‐Rodriguez 1993 {published data only}
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    - Garcia Rodriguez JA, Garcia Sanchez JE, Garcia Garcia MI, Garcia Sanchez E, Munoz Bellido JL, Ramos Macias A. Efficacy of topical ciprofloxacin in the treatment of ear infections in adults. Journal of Antimicrobial Chemotherapy 1993;31(3):452‐3. [CENTRAL: CN‐00092937; CRS: 1027589; PUBMED: 8486586] - PubMed
 
Gehanno 1997 {published data only}
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    - Gehanno P. Multicenter study of the efficacy and safety of oral ciprofloxacin in the treatment of chronic suppurative otitis media in adults. The French Study Group. Otolaryngology ‐ Head and Neck Surgery 1997;117(1):83‐90. [CENTRAL: CN‐00141764; CRS: 1076322; PUBMED: 9230329] - PubMed
 
Gendeh 2001 {published data only}
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    - Gendeh S. A comparative study of ofloxacin otic drops vs framycetin sulfate‐dexamethasone‐gramicidin otic drops in the medical treatment of otitis externa and chronic suppurative otitis media. 9th ASEAN ORL Head and Neck Congress, 31 March‐1 April, 2001. Singapore, 2001.
 
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    - Gendeh S. A comparative study of ofloxacin otic drops vs. framycetin sulfate‐dexamethasone‐gramicidin otic drops in the medical treatment of otitis externa and chronic suppurative otitis media. Department of ORL, Hospital University Kabangsaan Malaysia, Kuala Lumpur, Malaysia Unpublished, 2000.
 
Ghosh 2012 {published data only}
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    - CTRI/2011/10/002079. Comparison of effectiveness of ciprofloxacin and cefpodoxime in patients with acute attack of chronic middle ear infection [Comparison of efficacy and safety of ciprofloxacin and cefpodoxime in acute exacerbation of chronic suppurative otitis media: a randomized open labeled study]. Http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=3489 (first received 19 October 2011). [CENTRAL: CN‐01013255; CRS: 1743872]
 
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    - Ghosh A, Jana U, Khaowas A, Das S, Mandal A, Das N. Comparison of the effectiveness and safety of cefpodoxime and ciprofloxacin in acute exacerbation of chronic suppurative otitis media: a randomized, open‐labeled, phase IV clinical trial. Journal of Pharmacology & Pharmacotherapeutics 2012;3(4):320‐4. [CENTRAL: CN‐00905716; CRS: 1676041; EMBASE: 2013360430; PUBMED: 23326103] - PMC - PubMed
 
Granath 2007 {published data only}
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    - Granath A, Lindberg K, Rynnel‐Dagoo B. Tube associated otorrhea in children with recurrent otitis media: results of a prospective randomized treatment study. 9th International Symposium on Recent Advances in Otitis Media; 2007 Jun 3‐7; St. Pete Beach (FL). St. Pete Beach (FL), 2007. [CENTRAL: CN‐00614760; CRS: 1435660]
 
Gupta 2015 {published data only}
Gyde 1981 {published data only}
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    - Gyde MC. A double‐blind comparative study of trimethoprim‐polymyxin B versus trimethoprim‐sulfacetamide‐polymyxin B otic solutions in the treatment of otorrhea. Journal of Laryngology and Otology 1981;95(3):251‐9. [CENTRAL: CN‐00024381; CRS: 959452; PUBMED: 6257815] - PubMed
 
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Gyde 1982 {published data only}
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Harris 2016 {published data only}
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    - Harris AS, Elhassan HA, Flook EP. Why are ototopical aminoglycosides still first‐line therapy for chronic suppurative otitis media? A systematic review and discussion of aminoglycosides versus quinolones. Journal of Laryngology and Otology 2016;130(1):2‐7. [CRS: 8519203; PUBMED: 26584651] - PubMed
 
Helmi 2000 {published data only}
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    - Helmi A, Ratna D, Zainul A, Sosialisman E, Alfian FH, Bambang H. The efficacy and safety of ofloxacin otic solution for active suppurative otitis media. Faculty of Medicine, University of Indonesia, Jakarta, Indonesia Unpublished, 2000.
 
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Hemlin 1997 {published data only}
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    - Hemlin C, Carenfelt C, Papatziamos G. Single dose of betamethasone in combined medical treatment of secretory otitis media. Annals of Otology, Rhinology, and Laryngology 1997;106(5):359‐63. [CENTRAL: CN‐00139646; CRS: 1074207; PUBMED: 9153098] - PubMed
 
Hwang 2015 {published data only}
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    - Hwang JH, Lee JH, Hwang JH, Chung KM, Lee EJ, Yoon YJ, et al. Comparison of arbekacin and vancomycin in treatment of chronic suppurative otitis media by methicillin resistant Staphylococcus aureus. Journal of Korean Medical Science 2015;30(6):688‐93. [CENTRAL: CN‐01257881; CRS: 4910884; PUBMED: 26028918] - PMC - PubMed
 
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I‐HEAR‐BETA {published data only}
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    - Morris P, Leach AJ. 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. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365450 (first received 5 March 2014). [ACTRN12614000234617]
 
Indudharan 2005 {published data only}
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    - Indudharan R, Ashraful Haq J, Mohamad H, Mohamad Z, Mohamad Z. Topical antibiotic versus antibiotic steroid combination in the management of chronic suppurative otitis media. XVI World Congress of Otorhinolaryngology Head and Neck Surgery; 1997 Mar 2‐7; Sydney. 1997:1153‐8. [CENTRAL: CN‐00549107; CRS: 1379203]
 
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    - Indudharan R, Valuyeetham KA, Raju SS. Role of glucocorticoids in ototopical antibiotic‐steroid preparations in the treatment of chronic suppurative otitis media. Archives of Medical Research 2005;36(2):154‐8. [CENTRAL: CN‐00512134; CRS: 1355519; EMBASE: 2005181801; PUBMED: 15847949] - PubMed
 
ISRCTN12149720 {published data only}
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    - ISRCTN12149720. Treatment of chronic suppurative otitis media with the antimicrobial peptide OP‐145 (AMP60.4Ac) in adults. Http://www.isrctn.com/isrctn12149720 (first received 13 October 2015). [CENTRAL: CN‐01601160; CRS: 8519222]
 
ISRCTN84220089 {published data only}
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    - ISRCTN84220089. An interventional, randomized, double‐blind, placebo‐controlled, parallel‐assignment, safety/efficacy study for treatment of chronic middle ear infection in adult patients with the antimicrobial peptide OP‐145. Http://isrctn.org/ISRCTN84220089 (first received 18 January 2008). [CENTRAL: CN‐01013171; CRS: 1743788]
 
ISRCTN86106121 {published data only}
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    - 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; CRS: 1564692]
 
Jahn 1984 {published data only}
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    - Jahn AF, Abramson M. Medical management of chronic otitis media. Otolaryngologic Clinics of North America 1984;17(4):673‐7. [CRS: 7774187] - PubMed
 
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    - Jang CH, Song CH, Wang PC, Wang PC. Topical vancomycin for chronic suppurative otitis media with methicillin‐resistant Staphylococcus aureus otorrhoea. Journal of Laryngology and Otology 2004;118(8):645‐7. [CENTRAL: CN‐00497367; CRS: 1342862] - PubMed
 
Jaya 2003 {published data only}
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    - Jaya C, Job A, Mathai E, Antonisamy B. Evaluation of topical povidone‐iodine in chronic suppurative otitis media. Archives of Otolaryngology‐Head & Neck Surgery 2003;129(10):1098‐100. [CENTRAL: CN‐00452670; CRS: 1305097; EMBASE: 37248310; PUBMED: 14568795] - PubMed
 
Jiang 2016 {published data only}
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    - Jiang S‐L, Li H‐Y, Gong Q‐H. Efficacy and safety compare of two antibiotics combined with Chinese patent medicine for chronic suppurative otitis media in children. International Journal of Clinical and Experimental Medicine 2016;9(2):4089‐94. [CENTRAL: CN‐01199922; CRS: 4437723; EMBASE: 20160256082]
 
Kadar 2003 {published data only}
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    - Kadar AA, Usman M, Tirmizi S. Topical quinolones versus topical aminoglycosides in the medical management of chronic suppurative otitis media: a comparative trial. Journal of Surgery Pakistan 2003;8(4):6‐9. [CENTRAL: CN‐00597098; CRS: 1421747]
 
Kashiwamura 2004 {published data only}
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    - Kashiwamura M, Chida E, Matsumura M, Nakamaru Y, Suda N, Terayama Y, et al. The efficacy of Burow's solution as an ear preparation for the treatment of chronic ear infections. Otology & Neurotology 2004;25(1):9‐13. [CRS: 1342915] - PubMed
 
Kenna 1986 {published data only}
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    - Kenna MA, Bluestone CD, Reilly JS, Lusk RP. Medical management of chronic suppurative otitis media without cholesteatoma in children. Laryngoscope 1986;96(2):146‐51. [CRS: 8519234; PUBMED: 3945144] - PubMed
 
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Khon 2012 {published data only}
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    - Khon EM, Dzhenzhera GE, Ovchinnikov AI. Local antibacterial therapy for the inflammatory diseases of the external and middle ear. Vestnik Otorinolaringologii 2012, (3):92‐4. [CENTRAL: CN‐00850158; CRS: 1626026; EMBASE: 365865807; PUBMED: 22951697] - PubMed
 
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    - Kiris M, Berktas M, Egeli E, Kutluhan A. The efficacy of topical ciprofloxacin in the treatment of chronic suppurative otitis media. Ear, Nose, & Throat Journal 1998;77(11):904‐5, 909. [CENTRAL: CN‐00306946; CRS: 1191282; PUBMED: 9846467] - PubMed
 
Kothari 1969 {published data only}
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    - Kurilin IA, Mokhort NA, Iurina RV, Garankina LA. Complex conservative method of treatment of chronic suppurative otitis media with the use of mefenamine sodium salt [Kompleksnyi konservativnyi metod lecheniia khronicheskikh gnoinykh srednykh otitov s primeneniem mefenamina natrievoi soli]. Zhurnal Ushnykh, Nosovykh I Gorlovykh Boleznei [Journal of Otology, Rhinology, and Laryngologie [sic]] 1976;2:64‐70. [CRS: 6614468; PUBMED: 1266398] - PubMed
 
Lancaster 1999 {published data only}
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    - Lancaster JL, Makura ZG, Porter G, McCormick M. Topical aminoglycosides in the management of active mucosal chronic suppurative otitis media. Journal of Laryngology and Otology 1999;113(1):10‐2. [CRS: 7774332] - PubMed
 
Lancaster 2003 {published data only}
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Lang 1992 {published data only}
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    - 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. [CRS: 5037742; PUBMED: 1454433] - PubMed
 
Lautala 1983 {published data only}
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Lazo Saenz 1999 {published data only}
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    - Lazo Saenz GJ, Alonzo Rojo SE, Perez Blanco A. Topical treatment in chronic otitis media [Tratamiento atopico en otitis media cronica]. Annales de Otorinolaringologia Mexicana 1999;45(1):17‐9. [CENTRAL: CN‐00477445; CRS: 1325497]
 
Leach 2008 {published data only}
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    - Leach A, Wood Y, Gadil E, Stubbs E, Morris P. Topical ciprofloxin versus topical framycetin‐gramicidin‐dexamethasone in Australian aboriginal children with recently treated chronic suppurative otitis media: a randomized controlled trial. Pediatric Infectious Disease Journal 2008;27(8):692‐8. [CENTRAL: CN‐00650088; CRS: 1463553; EMBASE: 2009258884; PUBMED: 18664984] - PubMed
 
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Legent 1994 {published data only}
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    - 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; CRS: 1043205; EMBASE: 1994301734; PUBMED: 7805426] - PubMed
 
Li 2004 {published data only}
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    - 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; CRS: 1349072; PUBMED: 15609596] - PubMed
 
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Macfadyen 2005 {published data only}
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Manolidis 2004 {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 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; CRS: 944928; PUBMED: 4697134] - PubMed
 
Minja 2006 {published data only}
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Miro 2000 {published data only}
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    - Miro N. Controlled multicenter study on chronic suppurative otitis media treated with topical applications of ciprofloxacin 0.2% solution in single‐dose containers or combination of polymyxin B, neomycin, and hydrocortisone suspension. Otolaryngology ‐ Head & Neck Surgery 2000;123(5):617‐23. [CENTRAL: CN‐00331261; CRS: 1206633; PUBMED: 11077352] - PubMed
 
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    - Mora R, Salzano FA, Mora E, Guastini L. Efficacy of a topical suspension of bacterial antigens for the management of chronic suppurative otitis media. European Archives of Oto‐rhino‐laryngology 2012;269(6):1593‐7. [CENTRAL: CN‐00849461; CRS: 1625459; PUBMED: 22037722] - PubMed
 
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    - 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. [CRS: 6791598; PUBMED: 135074] - PubMed
 
NCT02592096 {published data only}
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NCT02817347 {published data only}
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    - 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 solution in patients with otitis media and otorrhea]. Https://clinicaltrials.gov/show/nct02817347 (first received 29 June 2016). [CENTRAL: CN‐01383192; CRS: 6333841]
 
Nwokoye 2015 {published data only}
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Onali 2018 {published data only}
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    - Onali MA, Bareeqa SB, Zia S, Ahmed SI, Owais A, Ahmad AN. Efficacy of empirical therapy with combined ciprofloxacin versus topical drops alone in patients with tubotympanic chronic suppurative otitis media: a randomized double‐blind controlled trial. Clinical Medicine Insights. Ear Nose & Throat 2018;11:1179550617751907. [CENTRAL: CN‐01445979; CRS: 7538061; PUBMED: 29348711] - PMC - PubMed
 
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Panchasara 2015 {published data only}
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    - CTRI/2012/07/002784. Efficacy and safety of ofloxacin and its combination with dexamethasone in chronic suppurative otitis media ‐ a randomized, double blind, parallel group, comparative study. http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4129 (first received 11 July 2012). [CENTRAL: CN‐00867279; CRS: 1641742] - PMC - PubMed
 
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Papastavros 1989 {published data only}
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Poliakova 1991 {published data only}
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Povedano 1995 {published data only}
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Principi 1995 {published data only}
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Quick 1973 {published data only}
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Quick 1975 {published data only}
Renukananda 2014 {published data only}
Rotimi 1990 {published data only}
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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; CRS: 1007294; PUBMED: 2268574] - PubMed
 
Saez‐Llorens 2005 {published data only}
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Sanchez Gonzales 2001 {published data only}
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Shkil' 1964 {published data only}
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    - 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. [CRS: 6614470; PUBMED: 5876597] - PubMed
 
Singhal 1992 {published data only}
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    - Singhal S, Sharma SC, Singhal KC. Adverse reactions to gentamycin in patients with ear, nose or throat infections. Indian Journal of Physiology and Pharmacology 1992;36(3):189‐98. [CRS: 8527046] - PubMed
 
Smith 1996 {published data only}
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    - Mackenzie IJ, Smith AW, Hatcher J, Machria I. Randomized controlled trial of treatment of chronic suppurative otitis media in Kenyan school children [abstract]. Clinical Otolaryngology 1997;22:81. [CENTRAL: CN‐00262473; CRS: 1161574]
 
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    - Smith AW, Hatcher J, Mackenzie IJ, Thompson S, Bal I, Macharia I, et al. Randomised controlled trial of treatment of chronic suppurative otitis media in Kenyan school children. Lancet 1996;348(9035):1128‐33. [CENTRAL: CN‐00132594; CRS: 1067178; EMBASE: 1996327505; PUBMED: 8888166] - PubMed
 
Somekh 2000 {published data only}
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Stenstrom 1991 {published data only}
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    - 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; CRS: 1009472; EMBASE: 1991091483; PUBMED: 1901686] - PubMed
 
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. 9th ASEAN ORL Head and Neck Congress, 31 March‐1 April, 2001. Singapore, 2001.
 
Sultan 2017 {published data only}
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Sumitsawan 1995 {published data only}
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    - 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. [CRS: 6796558; PUBMED: 7561571] - PubMed
 
Supiyaphun 1995 {published data only}
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Tachibana 1986 {published data only}
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    - 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. [CRS: 7774884]
 
Thomsen 1976 {published data only}
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Tong 1996 {published data only}
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van der Veen 2007 {published data only}
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van Dongen 2014 {published data only}
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    - 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; CRS: 1705907]
 
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Vishwakarma 2015 {published data only}
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Wilde 1995 {published data only}
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Wintermeyer 1997 {published data only}
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Wright 2009 {published data only}
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Xu 1999 {published data only}
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Yuen 1994 {published data only}
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    - Yuen PW, Lau SK, Chau PY, Hui Y, Wong SF, Wong S, et al. Ofloxacin eardrop treatment for active chronic suppurative otitis media: prospective randomized study. American Journal of Otology 1994;15(5):670‐3. [CENTRAL: CN‐00122894; CRS: 1057491; EMBASE: 1994288260; PUBMED: 8572070] - PubMed
 
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.
 
Abes 1998 {published data only}
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Yorgancılar 2013
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