Nawasreh 2001.

Methods	Two‐arm, non‐blinded, parallel‐group RCT, with 10‐day duration of treatment and follow‐up
Participants	Location: Jordan, 1 site Setting of recruitment and treatment: unclear setting, January to August 1999 Sample size: 88 at the end of the trial Number randomised: unclear Number completed: 48 in ciprofloxacin, 40 in gentamycin Participant (baseline) characteristics: Age: mean 30 years (range 9 to 62 years) Gender (F/M): 42 (48%)/46 (52%) Main diagnosis: chronic suppurative otitis media (persistent perforation of the tympanic membrane) and intermittent mucopurulent heavy discharge for more than 1 year 88% with "tubotympanic CSOM" and 12% with "atticoantral CSOM", i.e. at greater risk of cholesteatoma 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 Presence of mucopurulent discharge: unclear Duration of symptoms (discharge): 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: "All patients included in the study were examined carefully and diagnosed as having chronic suppurative otitis media before the start of treatment" Included patients stopped taking any medication at least 10 days prior to starting treatment Exclusion criteria: History of allergy to fluoroquinolone derivatives or aminoglycosides Under 9 years of age Past history of general health problems
Interventions	Intervention (n = 48): ciprofloxacin in distilled water (200 µg/mL), ear drops, 5 drops, 3 times per day. Treatment duration = 10 days Comparator group (n = 40): gentamicin sulphate (5 mg/mL) ear drops, 5 drops, 3 times per day. Treatment duration = 10 days Concurrent treatment: none listed. No mention of aural toileting.
Outcomes	Outcomes of interest in the review: Primary outcomes: Resolution of ear discharge ("dry ear"), measured at between 1 week to 2 weeks (10 days) Secondary outcomes: Hearing (measured as change in hearing threshold from baseline or at endpoint)
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)	High risk	Quote: "…[patients] were randomly placed…." Comment: the abstract mentions that randomisation occurred but there is no mention of randomisation or methods for randomisation in the full paper. The full paper describes the patients as "divided" between the 2 groups. It is unclear if the groups were evenly distributed as there were 40 in one group and 48 in the other but baseline characteristics between the groups were not provided.
Allocation concealment (selection bias)	Unclear risk	Comment: there is no information within the paper about allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: it does not appear that personnel or participants were blinded to treatment group, although both groups had the same treatment regimen so this would have been possible
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: it does not appear that any efforts were made to keep the outcome assessors blind to the treatment group
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Patients who failed to use the topical solution regularly or who took other medication during the study period were excluded." Comment: there is no information about how many people were in these categories or into which treatment group they had been allocated to show whether there was a difference between the groups that could have led to bias in the results. There is an imbalance in participants between the groups. There were nearly 20% fewer participants in the gentamicin group.
Selective reporting (reporting bias)	High risk	Comment: no trial protocol could be identified in clinicaltrials.gov. Some of the results that were identified in the methods section were not well presented in the paper (e.g. hearing, where there is only a statement that gives the basic significant difference between the start and end of treatment in each group, rather than a between treatment group comparison). Only 10‐day treatment results are presented, not 1‐, 5‐ and 7‐day treatment results.