Esposito 1992.

Study characteristics
Methods	2‐arm, non‐blinded, parallel‐group RCT, with 5 to 10 days of treatment and follow‐up at 12 hours, 14 days and 21 days after interruption of treatment
Participants	Location: Naples, Italy, 1 site Setting of recruitment and treatment: Institutes of Infectious Diseases and Otolaryngology, University of Naples Sample size: Number randomised: 30 in intervention, 30 in comparison Number completed: 30 in intervention, 30 in comparison Participant (baseline) characteristics: Age: adults, mean 39 (range 18 to 65) Gender (F/M): 33 (55%)/27 (45%) Main diagnosis: mild to moderate chronic otitis media in acute stage with perforation of tympanic membrane High‐risk population: Cleft palate (or other craniofacial malformation): not reported Down syndrome: not reported Indigenous groups (Australian Aboriginals/Greenland natives): not reported Immunocompromised: not reported Diagnosis method: Confirmation of perforated tympanic membrane: otoscopy assessment before, during and after the therapy Presence of mucopurulent discharge: 60/60 (100%) Duration of symptoms (discharge): ≥ 15days Other important effect modifiers Alternative diagnosis of ear discharge: not reported Number who have previously had grommets inserted: not reported Number who have had previous ear surgery: not reported Number who had previous antibiotic treatment for CSOM: 40/60 (67%) Inclusion criteria: "The otitis media had lasted at least 3 years, purulent otorrhea had recurred at least once annually, and recurrent episodes of purulent otorrhea had been constant for at least 15 days" Exclusion criteria: Pregnant women Previous allergy to quinolone or aminoglycosides Younger than 18 years old Cholesteatoma or mastoiditis
Interventions	Intervention (n = 30): topical ciprofloxacin hydrochloride 250 mg/mL, 12‐hourly for 5 to 10 days Comparator group(n = 30): intramuscular gentamicin sulphate 80 mg 12‐hourly for 5 to 10 days Concurrent treatment: aural toileting not mentioned
Outcomes	Outcomes of interest in the review: Primary outcomes: Clinical and bacteriological resolution 12 hours, 14 days and 21 days after treatment Secondary outcomes: Ototoxicity
Funding sources	No information provided
Declarations of interest	Ciprofloxacin powder was provided by Bayer Italia Spa, Milan, Italy; gentamicin by Schering Plough, Milan
Notes	Unit of randomisation: not reported Methods for including patients with bilateral disease: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Ciprofloxacin was randomly given according to the following schedules" Comment: method of selection was not specific
Allocation concealment (selection bias)	Unclear risk	Comment: no specific information given
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: both treatments are by different routes of administration and given that no placebo was used, masking the intervention arms would not be achievable
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: no indication that outcomes assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: no dropouts reported
Selective reporting (reporting bias)	High risk	Quote: "the clinical and bacteriological evaluation was stated 12 hours and 14 and 21 days (follow‐up) after the interruption of treatment" Comment: study protocol not available for assessment. Although the methods section indicates that 3 time points were measured, only one time point (unclear which one) was reported. The other 2 time points were not reported.