Renukananda 2014.

Study characteristics
Methods	2‐arm, single‐blind, cross‐sectional study, with 2‐week duration of treatment and 8‐week duration of follow‐up
Participants	Location: India Setting of recruitment and treatment: ear, nose and throat outpatient department of tertiary hospital; October 2012 to September 2013 Sample size: Number randomised: 50 in intervention, 50 in comparison Number completed: 50 in intervention, 50 in comparison Participant (baseline) characteristics: Age: 20 to 69 years Gender (F/M): 40 (40%)/60 (60%) Main diagnosis: active ear discharge mucopurulent or purulent of more than 3 weeks with perforated tympanic membrane with microbial sensitivity to ciprofloxacin High‐risk population: Cleft palate (or other craniofacial malformation): not reported Down syndrome: not reported Indigenous groups (Australian Aboriginals/Greenland natives): not reported Immunocompromised: 0 (excluded from study) Diagnosis method: Confirmation of perforated tympanic membrane: yes, but method not stated Presence of mucopurulent discharge: yes Duration of symptoms (discharge): 3 weeks Other important effect modifiers: Alternative diagnosis of ear discharge: not reported Number who have previously had grommets inserted: none (excluded) Number who have had previous ear surgery: not reported, those with ear surgery within past year were excluded Number who had previous antibiotic treatment for CSOM: exclusion for within one month Inclusion criteria: Above 18 years Mucopurulent or purulent otorrhoea of more than 3 weeks duration with a tympanic membrane perforation Patients who have antibiogram revealing sensitivity to ciprofloxacin Exclusion criteria: Acute (< 21 days) perforation of tympanic membrane (acute otitis media) Underlying chronic diseases such as diabetes mellitus, tuberculosis Known case of immunodeficiency Atticoantral type of chronic suppurative otitis media Otomycosis Impending complications Large aural polyp in the middle ear Have used any antibiotic therapy in target ear in the past month Otological surgery within the past year Presence of tympanostomy tube Acute traumatic perforation Symptomatic conditions such as otitis externa, chronic sinusitis, chronic pharyngitis requiring systemic antibiotic therapy that could interfere with the evaluation of study drugs
Interventions	Intervention (n = 50): ciprofloxacin (500 mg) twice a day for 14 days Comparator group(n = 50): no intervention Concurrent treatment for both study arms: ciprofloxacin ear drops (concentration not specified), 3 drops 3 times per day for 14 days Patients were asked to prevent water entry into affected ear and to carry out dry mopping before instilling the ear drops. The right technique of instilling with intermittent tragal pressure was advised.
Outcomes	Outcomes of interest in the review: Primary outcomes: Resolution of ear discharge at 1 to 2 weeks Secondary outcomes: Not reported
Funding sources	No information provided
Declarations of interest	None declared
Notes	Unit of randomisation: person Methods for including patients bilateral disease: not specified; 33/100 patients had bilateral ear disease
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The patients were then allowed to their respective groups by random sampling method (picking one of the two coloured coins)." Comment: random sampling by picking coloured coins, but investigators involved in the recruitment were likely to be aware of the allocation.
Allocation concealment (selection bias)	Unclear risk	Quote: "The patients were then allowed to their respective groups by random sampling method (picking one of the two coloured coins)." Comment: there was no information that the investigators were unaware of the allocation (red = topical only, green = combination of topical and oral).
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: there was no description of use of placebo.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Defined as absence of otorrhoea or otoscopically inactive (no pooling of discharge, non‐inflamed middle ear mucosa)." Comment: no mention of blinding of outcome assessors. There was also no information on how outcomes in patients with bilateral ear disease were considered (133 ears assessed).
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Non‐compliant patients (moderate and poor) were substituted by new cases to meet the sample size." Comment: the number of patients who were excluded or did not complete the study was not reported. Only patients who had "good" compliance (forgot 0 to 3 times within 2 weeks) were included in the analysis. Unclear how many were excluded or whether balanced between groups.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol for the trial could be found on the clinicaltrials.gov website.