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. 2020 Jan 2;2020(1):CD013051. doi: 10.1002/14651858.CD013051.pub2

Kaygusuz 2002.

Methods Four‐arm, non‐blinded, single‐centre, parallel‐group RCT, with 3 weeks duration of treatment and follow‐up
Participants Location: Turkey, 1 site
Setting of recruitment and treatment: university ENT clinic; no dates (published in 2002)
Sample size: 80 patients (103 ears)
  • Number randomised: 20 in each intervention group

  • Number completed: 20 in each intervention group


Participant (baseline) characteristics:
  • Age: range: 18 to 60, mean 31 ± 11.5 years

  • Gender (F/M): 31 (39%)/49 (61%)

  • Main diagnosis: chronic suppurative otitis media (CSOM) with ear discharge without cholesteatoma. Perforation in ear membrane and ear discharge longer than 3 months.

  • 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 (otoscopic examination)

    • Presence of mucopurulent discharge: 100%

    • Duration of symptoms (discharge): longer than 3 months

  • 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: 0%

    • Number who had previous antibiotic treatment for CSOM: not reported


Inclusion criteria:
  • Patients diagnosed with CSOM with ear discharge without cholesteatoma

  • Perforation in ear membrane and ear discharge longer than 3 months


Exclusion criteria:
  • Patients < 18 years old

  • Previous ear surgery

  • Patients with cholesteatoma

  • General health problems

  • Allergy to aminoglycoside and fluoroquinolone antibiotics

Interventions Topical ciprofloxacin (n = 20): 0.3% ciprofloxacin hydrochloride eardrops, 2 drops, 3 times in a day, treatment duration = 21 days
Topical tobramycin (n = 20): 0.3% tobramycin eardrops, 2 drops, 3 times in a day, treatment duration = 21 days
Topical ciprofloxacin + dexamethasone (n = 20): 0.3% ciprofloxacin hydrochloride PLUS 0.1% dexamethasone combination eardrops, 2 drops, 3 times in a day, treatment duration = 21 days
Topical tobramycin + dexamethasone (n = 20): 0.3% tobramycin PLUS 0.1% dexamethasone combination ear drops, 2 drops, 3 times in a day, treatment duration = 21 days
Concurrent treatment: daily aspiration during exam for 3 weeks
Outcomes Outcomes of interest in the review:
Primary outcomes:
  • Resolution of ear discharge "dry ear", measured at between 2 to 4 weeks. Otoscopically confirmed.


Secondary outcomes:
  • Not reported

Funding sources No information provided
Declarations of interest No information provided
Notes Part of a 4‐arm trial with the following treatment groups:
  • Topical ciprofloxacin

  • Topical tobramycin

  • Topical ciprofloxacin + dexamethasone

  • Topical tobramycin + dexamethasone


Only the first 2 arms are presented in this review
Unit of randomisation: person
Methods for including patients with bilateral disease: unclear
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: no clear statement regarding "randomized". No description about randomisation method.
Allocation concealment (selection bias) Unclear risk Comment: there is no information about allocation concealment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: there is no clear statement regarding whether the study was blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: there is no clear statement regarding whether the study was blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no participants were lost to follow‐up
Selective reporting (reporting bias) Low risk Comment: there was no study protocol mentioned within the paper and no protocol was found on clinicaltrials.gov
All of the outcomes mentioned in the methods section are reported in the results