| Study | Reason for exclusion |
|---|---|
| Abbott 2016 | POPULATION: not CSOM (acute otitis media without perforation) |
| Alper 2000 | POPULATION: animal study (monkeys) |
| Baba 1980 | INTERVENTION: comparison of antibiotics within same class and spectrum of activity (cefroxadine versus cephalexin); cefroxadine is a withdrawn drug DURATION: only 6 days of follow‐up |
| Baba 1982b | POPULATION: acute suppurative otitis media, including acute otitis media |
| Baba 1983 | POPULATION: acute suppurative otitis media |
| Baba 1983b | POPULATION: acute suppurative otitis media |
| Baba 1986 | STUDY DESIGN: not a RCT (all patients received same treatment, aztreonam) |
| Baba 1987 | POPULATION: acute suppurative otitis media |
| Baba 2008 | STUDY DESIGN: not a RCT (all patients received the same intervention) |
| Berman 1990 | POPULATION: middle ear effusion, not CSOM |
| Blekher 1967 | INTERVENTION: not interventions of interest |
| Block 2000 | POPULATION: not CSOM (acute otitis media without perforation of tympanic membrane) |
| Bluestone 2001 | STUDY DESIGN: not a RCT (systematic review) |
| Boesorire 2000 | COMPARISON: steroids added onto topical antibiotics (see CSOM‐4) |
| Brook 1979 | STUDY DESIGN: not a RCT ‐ (alternative treatment) aminoglycosides only added when Gram‐negative organisms present in large numbers |
| Brook 1980 | STUDY DESIGN: not a RCT (all patients received the same intervention, additional intervention only added based on bacteriological findings) |
| Bross Soriano 1996 | POPULATION: AOM; patients with CSOM were excluded |
| Browning 1983 | INTERVENTION: standard antibiotics were not given, the choice was dependent on cultures |
| Browning 1988 | COMPARISON: variety of topical antibiotics + steroids (see CSOM‐4) |
| Clayton 1990 | POPULATION: less than 20% had otorrhoea with "central perforation"; others were patients with otitis externa and mastoid cavity problems |
| Connolly 1997 | INTERVENTION: compared method of administration, i.e. delivery system (spray versus drops) of neomycin‐dexamethasone |
| Couzos 2003 | COMPARISON: steroids added onto topical antibiotics (see CSOM‐4) |
| Crowther 1991 | COMPARISON: topical antibiotic + variety of steroids (see CSOM‐4) |
| Deguchi 1985 | STUDY DESIGN: not a RCT |
| Deguchi 1986 | STUDY DESIGN: not a RCT |
| Deitmer 2002 | STUDY DESIGN: not a RCT |
| Dellamonica 1995 | INTERVENTION: within‐class comparison (cephalosporin) |
| Dohar 2002 | STUDY DESIGN: not a RCT (short review) |
| Eason 1986 | COMPARISON: systemic antibiotics versus none (see CSOM‐2), antiseptics versus none (see CSOM‐5), aural toilet versus none (see CSOM‐7) |
| Esposito 1992 | COMPARISON: topical versus systemic antibiotics (see CSOM‐3) |
| Esposito 2000 | STUDY DESIGN: not a RCT (all patients had the same intervention ‐ ceftazidime) |
| Fliss 1990 | COMPARISON: variety of systemic antibiotics (see CSOM‐2) |
| Fombeur 1994 | STUDY DESIGN: not a RCT (no mention of randomisation); INTERVENTION: high‐dose versus low‐dose ciprofloxacin |
| Fraysse 1988 | INTERVENTION: fenspiride (a bronchodilator/anti‐inflammatory agent) is not an intervention under investigation |
| Garcia‐Rodriguez 1993 | POPULATION: mixture of patients, less than half had CSOM. Patients were not stratified by diagnosis |
| Gehanno 1997 | STUDY DESIGN: not a RCT (all patients had the same intervention) |
| Gendeh 2001 | COMPARISON: steroids added onto topical antibiotics (see CSOM‐4) |
| Ghosh 2012 | COMPARISON: variety of systemic antibiotics (see CSOM‐2) |
| Granath 2007 | POPULATION: not CSOM (patients with recurrent AOM with discharge through tympanostomy tube) |
| Gupta 2015 | COMPARISON: antibiotic versus antiseptic (see CSOM‐6) |
| Gyde 1981 | POPULATION: less than 50% (27/68) had CSOM |
| Gyde 1982 | POPULATION: less than 50% had CSOM |
| Harris 2016 | STUDY DESIGN: not a RCT (systematic review) |
| Helmi 2000 | COMPARISON: steroids added onto topical antibiotics (see CSOM‐4) |
| Hemlin 1997 | POPULATION: unilateral or bilateral secretory otitis media (COME); INTERVENTION: systemic corticosteroids |
| Hwang 2015 | STUDY DESIGN: not a RCT (case control study) |
| I‐HEAR‐BETA | COMPARISON: systemic antibiotic versus none (see CSOM‐2), topical antiseptic versus none (see CSOM‐5), topical antiseptic versus topical antibiotic (see CSOM‐6) |
| Indudharan 2005 | COMPARISON: steroids added onto topical antibiotics (see CSOM‐4) |
| ISRCTN12149720 | INTERVENTION: antimicrobial peptide OP145 |
| ISRCTN84220089 | INTERVENTION: antimicrobial peptide OP145 |
| ISRCTN86106121 | INTERVENTION: not an intervention of interest to the review (oral zinc sulphate) |
| Jahn 1984 | STUDY DESIGN: not a RCT |
| Jang 2004 | STUDY DESIGN: not a RCT (mentioned use of a "control group", no mention of randomisation) |
| Jaya 2003 | COMPARISON: topical antibiotic versus topical antiseptic (see CSOM‐6) |
| Jiang 2016 | INTERVENTION: comparison of 2 agents of the same class of antibiotics (erythromycin versus azithromycin) used in addition to a traditional Chinese medicine product |
| Kadar 2003 | STUDY DESIGN: not a RCT |
| Kashiwamura 2004 | STUDY DESIGN: cohort (no comparison group); POPULATION: less than 50% with CSOM |
| Kenna 1986 | STUDY DESIGN: not a RCT ‐ cohort study (no comparison group) |
| Khanna 2000 | INTERVENTION: culture sensitivity‐based prescribing |
| Khon 2012 | POPULATION: not CSOM ‐ either diffuse otitis externa or acute otitis externa; STUDY DESIGN: no evidence of randomisation |
| Kiris 1998 | COMAPRISON: daily aural toilet versus singular aural toilet (see CSOM‐7) |
| Kothari 1969 | STUDY DESIGN: not a RCT (no comparison) |
| Kovacic 1999 | STUDY DESIGN: not a RCT (compared ofloxacin in patients who had previous ear surgery versus no previous ear surgery) |
| Kurilin 1976 | STUDY DESIGN: not a RCT (no mention of randomised controlled study design or control group included for comparison) |
| Lancaster 1999 | STUDY DESIGN: not a RCT (cross‐sectional survey) |
| Lancaster 2003 | STUDY DESIGN: not a RCT (compared compliance) |
| Lang 1992 | STUDY DESIGN: not a RCT (case series) |
| Lautala 1983 | STUDY DESIGN: not a RCT (case series) |
| Lazo Saenz 1999 | COMPARISON: steroids added onto topical antibiotics (see CSOM‐4) |
| Leach 2008 | COMPARISON: steroids added onto topical antibiotics (see CSOM‐4) |
| Legent 1994 | COMPARSION: variety of systemic antibiotics (see CSOM‐2) |
| Li 2004 | INTERVENTION: not an intervention of interest to the review (self‐prepared Chinese herbal medicine ear drops) |
| Loock 2012 | COMPARISON: variety of topical antiseptics (see CSOM‐5), topical antibiotic versus topical antiseptic (see CSOM‐6) |
| Lorentzen 1978 | POPULATION: AOM with intact or spontaneously erupted tympanic membrane; INTERVENTION: surgery |
| Macfadyen 2005 | COMPARISON: topical antibiotic versus topical antiseptic (see CSOM‐6) |
| Manolidis 2004 | STUDY DESIGN: not a RCT (review) |
| Mendelman 1992 | POPULATION: acute suppurative otitis media (symptoms of 7 days or less) |
| Merifield 1993 | STUDY DESIGN: not a RCT (case series) |
| Mesure 1973 | POPULATION: in clinical trial part of study (part 2) only 1 case of chronic otitis media |
| Minja 2006 | COMPARISON: systemic antibiotic versus none (see CSOM‐2) and topical antiseptic versus none (see CSOM‐5) |
| Miro 2000 | COMPARISON: steroids added onto topical antibiotics (see CSOM‐4) |
| Mora 2012 | INTERVENTION: polyvalent bacterial lysate (antigens) |
| Morgon 1976 | STUDY DESIGN: single‐arm study |
| NCT02592096 | INTERVENTION: phase I dose finding trial ‐ compared different concentrations of pazufloxacin |
| NCT02817347 | INTERVENTION: phase II trial ‐ compared different concentrations of piperacillin against tazobactam plus dexamethasone |
| Nwokoye 2015 | COMPARISON: variety of systemic antibiotics (see CSOM‐2) |
| Onali 2018 | COMPARISON: systemic antibiotic versus none (see CSOM‐2) |
| Otwombe 2003 | STUDY DESIGN: systematic review, not a RCT |
| Panchasara 2015 | COMPARISON: steroids added onto topical antibiotics (see CSOM‐4) |
| Papastavros 1989 | COMPARISON: topical antiseptic versus none (see CSOM‐5) |
| Picozzi 1983 | COMPARISON: topical antibiotic + steroid versus none (see CSOM‐4) |
| Picozzi 1984 | COMPARISON: systemic metronidazole versus placebo in people who already had gentamicin plus hydrocortisone ear drops (see CSOM‐2) |
| Poliakova 1991 | STUDY DESIGN: not a RCT |
| Povedano 1995 | COMPARISON: systemic versus topical antibiotics (see CSOM‐3) |
| Principi 1995 | POPULATION: acute and recurrent otitis media |
| Quick 1973 | POPULATION: not CSOM (included acute tonsillitis, acute pharyngitis, acute sinusitis, acute otitis media, chronic sinusitis and peritonsillar) |
| Quick 1975 | POPULATION: not CSOM (only 6/145 patients had otitis media) |
| Renukananda 2014 | COMPARISON: systemic antibiotics added onto topical antibiotics (see CSOM‐2) |
| Rotimi 1990 | COMPARISON: variety of systemic antibiotics (see CSOM‐2) |
| Saez‐Llorens 2005 | POPULATION: AOM |
| Sanchez Gonzales 2001 | COMPARISON: variety of systemic antibiotics (see CSOM‐2) |
| Shkil' 1964 | INTERVENTION: no comparison of interest (antiseptic arms used a number of different agents ‐ unclear which) |
| Singhal 1992 | STUDY DESIGN: not a RCT (no comparison group) |
| Smith 1996 | COMPARISON: aural toilet versus no treatment (see CSOM‐7) |
| Somekh 2000 | COMPARISON: variety of systemic antibiotics (see CSOM‐2) |
| Stenstrom 1991 | POPULATION: acute otitis media, not CSOM |
| Subramaniam 2001 | COMPARISON: steroids added onto topical antibiotics (see CSOM‐4) |
| Sultan 2017 | STUDY DESIGN: not a RCT ‐ single intervention (oral levofloxacin) studied |
| Sumitsawan 1995 | STUDY DESIGN: not a RCT ‐ single intervention (ofloxacin drops) studied |
| Supiyaphun 1995 | STUDY DESIGN: not a RCT (cohort ‐ all patients received same treatment) |
| Tachibana 1986 | STUDY DESIGN: not a RCT (all patients received same treatment) |
| Thomsen 1976 | STUDY DESIGN: not a RCT; POPULATION: acute suppurative otitis media |
| Tong 1996 | COMPARISON: steroids added onto topical antibiotics (see CSOM‐4) |
| van der Veen 2007 | COMPARISON: systemic antibiotics versus none (see CSOM‐2) |
| van Dongen 2014 | POPULATION: 1) inclusion of minimum 2 weeks (review defined exclusion of 6 weeks perioperatively); 2) max duration of otorrhoea was 1 week |
| van Hasselt 1998b | COMPARISON: povidone iodine added in hydroxypropyl methylcellulose ear drops (see CSOM‐5) |
| Vishwakarma 2015 | COMPARISON: topical antiseptic versus topical antibiotic (see CSOM‐6) |
| Wilde 1995 | INTERVENTION: different ways of administering the same ear drops (ribbon gauze versus drops) |
| Wintermeyer 1997 | STUDY DESIGN: not a RCT (cohort) |
| Wright 2009 | STUDY DESIGN: not a RCT (review) |
| Xu 1999 | INTERVENTION: not a comparison of interest ‐ antibiotics versus Chinese medicine |
| Yuen 1994 | COMPARISON: systemic versus topical antibiotics (see CSOM‐3) |
AOM: acute otitis media; CSOM: chronic suppurative otitis media; RCT: randomised controlled trial