Tutkun 1995.

Methods	Two‐arm, non‐blinded, single‐centre, parallel‐group RCT, with 10 days duration of treatment and follow‐up
Participants	Location: Turkey, 1 site Setting of recruitment and treatment: tertiary medical centre, university hospital, Istanbul; November 1993 to June 1994 Sample size: 44 Number randomised: unclear Number completed: 24 in ciprofloxacin group, 20 in gentamicin group Participant (baseline) characteristics: Age: mean 28 years (range 9 to 65 years) Gender (F/M): 21 (48%)/23 (52%) Main diagnosis: chronic otitis media with purulent otorrhoea lasting for more than a year 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: yes (otoscope) Presence of mucopurulent discharge: yes, purulent discharge for more than 1 year Duration of symptoms (discharge): more than 1 year 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: not reported Inclusion criteria: History of purulent otorrhoea lasting more than 1 year Patients who were examined carefully and diagnosed with CSOM Exclusion criteria: History of allergy to fluoroquinolone derivatives or aminoglycosides Age < 9 years History of general health problems Did not use the topical solutions regularly Taken any other medication during the study period
Interventions	Intervention (n = 24): ciprofloxacin hydrochloride 200 µg/mL (0.02%), ear drop, 5 drops (equivalent volume unknown), 3 times daily, duration of 10 days (solution prepared by dissolving ciprofloxacin HCL in distilled water) Comparator group (n = 21): gentamicin sulfate 5 mg/mL, ear drops, 5 drops, 3 times daily, duration of 10 days Concurrent treatment: not reported All patients were free of any medications for at least 10 days before the treatment and were advised not to take any other medications during the course of the study
Outcomes	Outcomes of interest in the review: Primary outcomes: Resolution of ear discharge ("dry ear"), measured at 1 to 2 weeks. Otoscopically confirmed. Secondary outcomes: Hearing measured as the pure‐tone average of air conduction thresholds across 4 frequencies tested (500 Hz, 1000 Hz, 2000 Hz and 4000 Hz), of the affected ear Serious complications, including intracranial complications (such as otitic meningitis, lateral sinus thrombosis and cerebellar abscess) and extra cranial complications (such as mastoid abscess, postauricular fistula and facial palsy), and death
Funding sources	No information provided
Declarations of interest	No information provided
Notes	Unit of randomisation: person 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: "Patients were randomly divided into two groups." Comment: specific method not reported
Allocation concealment (selection bias)	Unclear risk	Comment: no method reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: no blinding or placebo mentioned. No other information on whether there was other concurrent treatment such as aural toileting, except that "taking any other medication… were excluded". The treatment regimens were the same for both groups.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: no blinding or placebo mentioned. The treatment regimens were the same for both groups.
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Patients who did not use the topical solutions regularly and those who had taken any other medication during the study period were also excluded…" Comment: it is unclear whether this statement referred to recruitment criteria or exclusion of patients after randomisation. There is no information regarding how many patients this related to, nor whether the patients who were excluded were different to those who completed. The study reported the results of 24 patients in the ciprofloxacin group and 20 patients in the gentamicin group It is unclear if there were dropouts from the intervention arm.
Selective reporting (reporting bias)	Unclear risk	Comment: no trial protocol was identified on clinicaltrials.gov or the European Clinical Trials registry. All of the outcomes listed in the methods section of the report are also presented in the results section. Standard deviations are not provided for continuous outcomes. Insufficient information to judge.