Siddique 2016.

Methods	Two‐arm, unblinded, parallel‐group RCT, with unclear duration of treatment (probably 4 weeks) and 4‐week follow‐up
Participants	Location: Pakistan, 1 site Setting of recruitment and treatment: specialist/tertiary military hospital, Peshawar, January to December 2013 Sample size: 200 Number randomised: 200, but unclear how many to each group Number completed: 93 in intervention group, 93 in comparison group Participant (baseline) characteristics: Age: mean 38 years (range 12 to 70 years) Gender (F/M): 34 (18%)/152 (81.7%) Main diagnosis: tubotympanic type of CSOM (persistent or recurrent infections ascending via the Eustachian tube to the middle ear thereby causing infection and subsequent perforation in pars tensa) 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% Diagnosis method: Confirmation of perforated tympanic membrane: unclear Presence of mucopurulent discharge: unclear Baseline discharge Middle ear only: ciprofloxacin: 4%; neomycin: 5% Partially filling external auditory meatus: ciprofloxacin: 12%; neomycin: 24% Full external auditory meatus: ciprofloxacin: 84%; neomycin: 71% Duration of symptoms (discharge): unclear 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 above 12 years irrespective of gender, with a diagnosis of tubotympanic type of CSOM defined as: "persistent or recurrent infections ascending via the Eustachian tube to the middle ear thereby causing infection and subsequent perforation in pars tensa" Exclusion criteria: Immunocompromised patients Diabetic patients Patients having hypersensitivity to neomycin or quinolone Patients with any other ENT pathologies like tonsillitis, symptomatic DNS or sinusitis Pregnant females Patients with cholesteatoma or "Atticoantral or tympanomastoid type CSOM, involving predominantly the attic and antral region of the middle ear cleft"
Interventions	Intervention (n = 93): 'standard dosage' ciprofloxacin (Cipotec ear drops), 3 drops/12 hours. Unclear treatment duration (probably 4 weeks). Comparator group (n = 93): 'standard dosage' neomycin (Neosporin ear drops), 2 drops/12 hours. Unclear treatment duration (probably 4 weeks). Concurrent treatment: there is no information about the use of aural toileting or any additional treatments
Outcomes	Outcomes of interest in the review: Primary outcomes: Resolution of ear discharge ("dry ear"), measured at between 2 to 4 weeks. Unclear if otoscopically confirmed. Ear pain, discomfort, local irritation Secondary outcomes: Serious complications Suspected ototoxicity
Funding sources	"No funding was received from any agency or institution"
Declarations of interest	"Abstract and results of this study were accepted and presented in an oral presentation at the International conference on Medical Education, organised by Association for Excellence in Medical Education (AEME) and held on 07th‐09th March 2014 at University of Health Sciences (UHS) Lahore, Pakistan" No other conflicts were mentioned
Notes	Unit of randomisation: person Methods for including patients with bilateral disease: 15 patients (8%) had bilateral disease but how these cases were handled is not stated. The denominator in the trials is the person so it is assumed that no double counting occurred
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quotes: "Randomized clinical trial" and "patients… assigned to one or the other group based on consecutive non‐probability sampling." Comment: it is unclear what the actual process for the 'non‐probability' sampling was and how it ensured that the allocation was random
Allocation concealment (selection bias)	Unclear risk	Quote: "patients… assigned to one or the other group based on consecutive non‐probability sampling." Comment: it is not clear how much impact the investigators had in terms of allocating people to treatment groups
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: it does not appear that participants or personnel were blinded to treatment group. The treatment groups had different treatment regimens.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: it does not appear that the outcome assessors were blinded to treatment group although this would have been feasible
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Of the 200 patients included in the study 14 were lost to follow up." Comment: the rate of loss to follow‐up is low (7%) but there is no explanation of why patients were lost to follow‐up and to which groups they had been allocated. Due to the small numbers this is unlikely to have influenced the results.
Selective reporting (reporting bias)	High risk	Comment: no trial protocol was identified on clinicaltrials.gov or the WHO clinical trials registry site. Comment: whilst the methods state that the amount of ear discharge at both 2 weeks and 4 weeks was measured, only the amount of ear discharge at 4 weeks is reported.