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)
Participant (baseline) characteristics:
Inclusion criteria:
Exclusion criteria:
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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 |
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Outcomes |
Outcomes of interest in the review: Primary outcomes:
Secondary outcomes:
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Funding sources | No information provided | |
Declarations of interest | No information provided | |
Notes | Part of a 4‐arm trial with the following treatment groups:
Only the first 2 arms are presented in this review Unit of randomisation: person Methods for including patients with bilateral disease: unclear |
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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 |