| Study | Reason for exclusion |
|---|---|
| Abbott 2016 | POPULATION: not CSOM (acute otitis media without perforation) |
| Adler 2000 | POPULATION: acute otitis media with effusion for less than a week; patients with chronic or subchronic otitis media, acute exacerbation of otitis media were specifically excluded |
| Arguedas 1993 | STUDY DESIGN: not a RCT (all patients had the same intervention) |
| Baba 1980 | INTERVENTION: comparison of antibiotics within same class and spectrum of activity (cefraxadine versus cephalexin); cefraxadine a withdrawn drug DURATION: only 6 days of follow‐up |
| Baba 1982b | POPULATION: acute suppurative otitis media, including acute otitis media |
| Baba 1983a | POPULATION: acute suppurative otitis media |
| Baba 1983b | POPULATION: acute suppurative otitis media |
| Baba 1983c | INTERVENTION: comparing 2 different salts of medicamycin |
| 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) |
| Bakir 2013 | STUDY DESIGN: not a RCT (prospective case‐control study) |
| Berman 1990 | POPULATION: middle ear effusion, not CSOM |
| Block 2000 | POPULATION: not CSOM (acute otitis media without perforation of tympanic membrane) |
| Bogomil'skii 1999 | POPULATION: less than half were COM; not able to distinguish COM patients from other types of diagnosis ‐ data not reported separately |
| 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 1983b | INTERVENTION: culture sensitivity‐based prescribing versus empirical treatment with metronidazole |
| Browning 1984 | STUDY DESIGN: not a RCT |
| Chowdhury 2002 | STUDY DESIGN: not a RCT (compared 2 variants of CSOM) |
| CTRI/2019/09/021197 | INTERVENTION: ayurvedic preparation is not an intervention under investigation |
| Deitmer 2002 | STUDY DESIGN: not a RCT |
| Dellamonica 1995 | INTERVENTION: within‐class comparison (cephalosporin) |
| Esposito 1992 | COMPARISON: topical versus systemic antibiotics (see CSOM‐3) |
| Esposito 2000 | STUDY DESIGN: not a RCT (all patients had the same intervention ‐ ceftazidime) |
| 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 |
| Gehanno 1997 | STUDY DESIGN: not a RCT (all patients had the same intervention) |
| Granath 2007 | POPULATION: not CSOM (patients with recurrent acute otitis media 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 |
| Hemlin 1997 | POPULATION: unilateral or bilateral secretory otitis media (COME) INTERVENTION: systemic corticosteroids |
| Hwang 2015 | STUDY DESIGN: not a RCT (case‐control study) |
| IRCT20130427013136N6 | POPULATION: patients had otitis externa |
| IRCT2016082313136N4 | POPULATION: patients had otomycosis |
| 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) |
| 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 |
| Kantawala 1976 | STUDY DESIGN: not a RCT (cohort, no comparison group) INTERVENTION: mucolytic agent |
| 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 |
| 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 an RCT (compared compliance) |
| Lang 1992 | STUDY DESIGN: not a RCT (case series) |
| Lautala 1983 | STUDY DESIGN: not a RCT (case series) |
| Legent 1994 | STUDY DESIGN: microbiology was done on day 1, and patients who were found to have resistant strains were switched to the other group and considered as treatment failure in the group assigned. This was not a strictly empirical study. |
| Li 2004 | INTERVENTION: not an intervention of interest to the review (self‐prepared Chinese herbal medicine ear drops) |
| Lorentzen 1978 | POPULATION: AOM with intact or spontaneously erupted tympanic membrane INTERVENTION: surgery |
| 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 one case of chronic otitis media |
| Mira 1993 | COMPARISON: adding topical antibiotic to systemic antibiotic (see CSOM‐1) |
| 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 |
| 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 abscess) |
| Quick 1975 | POPULATION: not CSOM (only 6/145 patients had otitis media) |
| Roydhouse 1981 | INTERVENTION: bromhexine (mucolytic agent) |
| Saez‐Llorens 2005 | POPULATION: AOM |
| 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) |
| Stenstrom 1991 | POPULATION: acute otitis media, not CSOM |
| Sugiyama 1981 | STUDY DESIGN: not a RCT (no indication of randomisation) |
| 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 |
| Van de Heyning 1986 | STUDY DESIGN: not a RCT (cohort ‐ all patients received same treatment) |
| van Dongen 2014 | POPULATION: 1) inclusion of minimum 2 weeks (review defined exclusion of 6 weeks perioperatively), 2) maximum duration of otorrhoea was 1 week |
| van Hasselt 1998b | INTERVENTION: single dose of antibiotics, which was outside the inclusion criteria for the review (minimum 5 days) |
| Wintermeyer 1997 | STUDY DESIGN: not a RCT (cohort) |
| Yuen 1994 | COMPARISON: systemic versus topical antibiotics (see CSOM‐3) |
AOM: acute otitis media; CSOM: chronic suppurative otitis media; OME: otitis media with effusion; RCT: randomised controlled trial
For CSOM‐1 to ‐7 Cochrane Reviews see Table 5.