Lorente 1995.

Methods	Two‐arm, double‐blinded, multicentre, parallel‐group RCT, with 8 days duration of treatment and 30 days duration of follow‐up
Participants	Location: Spain, 4 centres Setting of recruitment and treatment: hospital ENT clinics, Barcelona, no dates (published in 1995) Sample size: 308 Number randomised: unclear Number completed: 159 in ciprofloxacin, 149 in gentamicin Participant (baseline) characteristics: Age: 42.23 ± 13.92 years Gender (F/M): 140 (45.5%)/168 (54.5%) Main diagnosis: CSOM (purulent discharge for more than 3 months and perforated tympanic membrane) 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: yes (no method is given) Presence of mucopurulent discharge: yes (no method is given). Mild discharge: 22%; moderate discharge: 56%; severe discharge: 21% Duration of symptoms (discharge): 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: not reported Number who had previous antibiotic treatment for CSOM: not reported Inclusion criteria: Patients age 18 to 65 years Chronic otitis media in suppurative phase with purulent discharge for more than 3 months with a perforated ear drum Exclusion criteria: Cholesteatoma Pregnant/breastfeeding Severe renal or hepatic insufficiency Antibiotic treatment in previous 48 hours Bilateral hearing loss > 60 dB Otomycosis
Interventions	Intervention (n = 159): ciprofloxacin 0.3% (3 mg/mL), ear drops, 5 drops, 3 times a day, duration of treatment = 8 days Comparator group (n = 149): gentamicin 0.3% (3 mg/mL), ear drops, 5 drops, 3 times a day, duration of treatment = 8 days Concurrent treatment: not reported
Outcomes	Outcomes of interest in the review: Primary outcomes: Complete resolution of ear discharge, measured at between 1 week to 2 weeks (8 days) and after 4 weeks (30 days). Otoscopically confirmed. Adverse effects: ear pain, itching, stinging (measured on a 4‐point scale: 0 = none to 3 = severe) Secondary outcomes: Hearing Suspected ototoxicity
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	Comment: the study indicates that it was "randomised" but does not provide any further details
Allocation concealment (selection bias)	Unclear risk	Comment: the study does not provide any details about allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: the study indicates that it is "double‐blind" but does not provide any details on how blinding of participants and healthcare professionals was ensured
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: the study indicates that it is "double‐blind" but does not indicate if this includes those people who assessed the outcomes
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: the paper does not mention that any participants were lost to follow‐up. The paper presents the number of people available for analysis at the end of the trial but does not specifically state how many were randomised to treatment. In a trial of 300 participants for 30 days it would be unusual to have no participants withdrawing from treatment.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol could be identified on clinicaltrials.gov or in the European clinical trials registry. Although the outcomes as presented in the methods section are presented in the results section, the level of reporting is not always clear. The hearing results just show that there was no significant difference between the groups.