3. Summary of study characteristics.
Ref ID (no. participants) |
Setting | Population | Intervention 1 | Intervention 2 | Treatment duration | Follow‐up | Background Treatment | Notes |
Topical antibiotics versus placebo/no treatment (no background or aural toileting) | ||||||||
Kasemsuwan 1997 (n = 50) |
Specialist hospital, Thailand | Mucopurulent otorrhoea with perforated tympanic membrane (CSOM) | Ciprofloxacin 250 mg/mL, 5 drops per 8 hours | Saline, 5 drops per 8 hours | 1 week | 1 week | Aural toilet on day 1, 4 and 7 | Randomised by person |
Topical antibiotic versus placebo/no treatment (systemic antibiotic as background treatment) | ||||||||
de Miguel 1999 (n = 50) |
General hospital, Spain | Simple chronic otitis media (36%), osteitic chronic otitis media (25.6%), cholesteatomas chronic otitis media (13.6%), post surgery cases (24.8%) | Topical ciprofloxacin 0.2%, 3 drops per 8 hours and oral ciprofloxacin, 500 mg per 12 hours | No treatment | 7 days | 15 days | Aural toileting before beginning treatment, analgesics and antipyretics. Oral ciprofloxacin, 500 mg per 12 hours | Part of 5‐arm trial Randomised by person |
Esposito 1990 (n = 40) |
University clinic, Italy | Mild or moderate CSOM in acute stage | Ciprofloxacin 250 µg/mL, 3 drops per 12 hours | No treatment | 5 to 10 days | 2 weeks | Oral ciprofloxacin, 250mg per 12 hours | Part of 3‐arm trial Randomised by person |
Mira 1993 (n = 50) |
University clinic, Italy | Recurrence of CSOM or suppuration following mastoidectomy or tympanoplasty | Ceftizoxime 500 µg/mL, 2 x 2 mL washes per 12 hours | Saline, 2 x 2 mL washes per 12 hours | 1 week | 3 weeks | Systemic ceftizoxime by intramuscular route every 12 hours Aural toilet at first visit |
Randomised by person |
Ramos 2003 (n = 100) |
ENT departments, Spain | Simple chronic otitis media (42.7%), chronic otitis media with osteolysis (19%), chronic cholesteatoma (14%), chronic otorrhoea in operated ears 24.3%) | Ciprofloxacin 0.2%, 0.5 mL per 8 hours | No treatment | 1 week | 10 days | Oral ciprofloxacin, 500 mg per 12 hours | Part of a 6‐arm trial Randomised by person |
Quinolones versus aminoglycosides | ||||||||
Asmatullah 2014 (n = 134) |
ENT department, Pakistan | Active tubotympanic type CSOM | Ofloxacin 0.3%, 12 drops per day | Gentamycin 0.3%, 12 drops per day | 10 days | 2 weeks | None mentioned | Randomised by person |
Fradis 1997 (n = 40) |
Outpatient clinic, Israel | Chronic otitis media | Ciprofloxacin (no conc), 15 drops per day | Tobramycin (no conc), 15 drops per day | 3 weeks | 3 weeks | None mentioned | Part of 3‐arm trial Randomised by ear |
Kaygusuz 2002 (n = 40) |
University ENT clinic, Turkey | CSOM | Ciprofloxacin 0.3%, 6 drops per day | Tobramycin 0.3%, 6 drops per day | 3 weeks | 3 weeks | Daily aspiration | Translated from Turkish Part of 4‐arm trial Randomised by person. |
Nawasreh 2001 (n = 88) |
Unclear setting, Jordan | CSOM and intermittent mucopurulent heavy discharge for more than 1 year | Ciprofloxacin 200 µg/mL (0.02%), 15 drops per day | Gentamicin 5 mg/mL, 15 drops per day | 10 days | 2 weeks | None mentioned | Randomised by person |
Lorente 1995 (n = 308) |
Hospital ENT clinics, Spain | CSOM (purulent discharge > 3 months and perforated membrane) | Ciprofloxacin 0.3%, 15 drops per day | Gentamycin 0.3%, 15 drops per day | 8 days | 30 days | Unclear | Translated from Spanish Assume this is same as Sabater paper Randomised by person |
Tutkun 1995 (n = 44) |
University hospital, Turkey | CSOM and purulent discharge for more than 1 year | Ciprofloxacin 200 µg/mL (0.02%), 15 drops per day | Gentamicin 5 mg/mL, 15 drops per day | 10 days | 10 days | None mentioned | Randomised by person |
Jamalullah 2016 (n = 80) |
Otolaryngology department, Pakistan | CSOM (tubotympanic type) | Ofloxacin 0.6%, 12 drops per day | Gentamycin 0.3%, 12 drops per day | 2 weeks | 2 weeks | One aural toilet at start | Randomised by person |
Quinolones versus others | ||||||||
Siddique 2016 (n = 200) |
Specialist hospital, Pakistan | Tubotympanic type of CSOM | Ciprofloxacin (no conc), 3 drops per 12 hours | Neomycin/polymixin/gramicidin‐D (no conc), 2 drops per 12 hours | Unclear (probably 4 weeks) | 4 weeks | No information | Randomised by person |
van Hasselt 1997 (n = 50) |
Rural setting, Malawi | Children with CSOM | Ofloxacin 0.3%, 3 drops per 8 hours | Neomycin 0.5%/polymixin B 0.1%, 3 drops per 8 hours | 2 weeks | 2 weeks | Aural toilet at start and weekly | Part of a 3‐arm trial Only presented as an internal report Unclear unit of randomisation, results reported by ear |
van Hasselt 1998a (n = unclear) |
Rural setting, Malawi | "Mainly children" with CSOM | Ofloxacin 0.3%, 6 drops per 12 hours | Neomycin/polymixin B (no conc), 6 drops per 12 hours | 2 weeks | 8 weeks | Aural toilet at start and weekly | Only a presentation given at a conference available Unclear unit of randomisation, results presented by ear Part of 4‐arm trial ‐ once weekly arms have not been included. |
Aminoglycosides versus trimethoprim, sulphacetamide and polymixin B (TSP) | ||||||||
Gyde 1978 (n = 91) |
Outpatient clinic, Canada | Otitis externa (21%), CSOM (51%), subacute otitis (16%), postoperative infection (21%) | Trimethoprim, sulphacetamide and polymyxin B, 16 drops per day | Gentamicin 0.3%, 16 drops per day | Mean: 16 days | 12 months | Not reported | Translated from French Randomised by person but reported by ear Semi cross‐over trial |
Rifampicin versus chloramphenicol | ||||||||
Liu 2003 (n = 160) |
Outpatient department, China | CSOM | Rifampicin 0.1%, 9 drops per day | Chloramphenicol 0.25%, 9 drops per day | 2 weeks | 2 weeks | 3% hydrogen peroxide ear wash daily | Translated from Chinese Randomised by person |
CSOM: chronic suppurative otitis media