Samarei 2014.

Methods	2‐arm, non‐blinded, single‐centre, parallel‐group "RCT", with 10 to 17 days duration of treatment and 30 days duration of follow‐up
Participants	Location: Iran, 1 site Setting of recruitment and treatment: not reported Sample size: Number randomised: unclear – it appears some patients may have been excluded from the study Number completed: 40 in topical ciprofloxacin, 32 in systemic ciprofloxacin Participant (baseline) characteristics: Age: not reported Gender (F/M): not reported Main diagnosis: purulent active otorrhoea and perforated tympanic membrane for more than 3 months High‐risk population: unclear 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: unclear (no method described but inclusion criteria implies all patients had perforated membrane) Presence of mucopurulent discharge: unclear (no method described but inclusion criteria implies all patients had purulent discharge) Duration of symptoms (discharge): 3 months (inclusion criteria) Other important effect modifiers: Alternative diagnosis of ear discharge: 0% 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: Purulent active otorrhoea and perforated tympanic membrane for more than 3 months Exclusion criteria: Age less than 18 years Pregnancy Breastfeeding Recent local drug "Proposals for viral infections" Sensitivity to the fluoroquinolone drug group Use of systemic medications that are ototoxic Concurrent infection of the middle and external fungal
Interventions	Intervention (n = 40): ciprofloxacin ear drops, unclear concentration, 2 drops twice daily, 10 days treatment and additional 7 days if ear not dry at 10 days Comparator group(n = 32): ciprofloxacin orally 500 mg, 1 tablet twice daily, 10 days treatment and additional 7 days if ear not dry at 10 days Concurrent treatment: "regular suction for outer middle ear washings." No other concurrent treatment mentioned.
Outcomes	Outcomes of interest in the review: Primary outcomes: Adverse effects (reported as measured in the methods but no results given) Secondary outcomes: Hearing loss (measured as change in hearing threshold from baseline or at endpoint) Adverse effects from treatment (reported as measured in the methods but no results given)
Notes	Unit of randomisation: person Methods for including patients with bilateral disease: not reported Awaiting author reply regarding randomisation

CSOM: chronic suppurative otitis media; F: female; M: male; RCT: randomised controlled trial