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. 2020 Jan 5;2020(1):CD013056. doi: 10.1002/14651858.CD013056.pub2

Vishwakarma 2015.

Study characteristics
Methods Two‐arm, non‐blinded, parallel‐group RCT, with 2 weeks duration of treatment and follow‐up
Participants Location: India, Moradabad
Setting of recruitment and treatment: Teethanker Mahaveer Medical College and Research Centre, TMU Moradabad, March 2014 to December 2014
Sample size:

  • Number randomised: 50 in gentamicin, 50 in acetic acid

  • Number completed: 50 in gentamicin, 50 in acetic acid


Participant (baseline) characteristics:

  • Age, mean ± SD: gentamicin 27.08 ± 10.86; acetic acid 30.42 ± 13.49 (range 10 to 60)

  • Gender (F/M): 39 (39%)/61 (61%)

  • Main diagnosis: tubotympanic (safe) type of CSOM

  • High‐risk population: no

    • Cleft palate (or other craniofacial malformation): not reported

    • Down syndrome: not reported

    • Indigenous groups (Australian Aboriginals/Greenland natives): not reported

    • Immunocompromised: 0% (exclusion criteria)

  • Diagnosis method:

    • Confirmation of perforated tympanic membrane: yes (otoscopic examination)

    • Presence of mucopurulent discharge: not reported

    • Duration of symptoms (discharge): not reported

  • 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:

  • Age 10 years and above, diagnosed with tubotympanic (safe) type of CSOM based upon detailed history and otoscopic examination


Exclusion criteria:

  • Patient with atticoantral types of CSOM

  • Cholesteatoma

  • Known case of hypersensitivity to acetic acid and aminoglycosides

  • Cases in which culture and sensitivity showed resistance of bacteria to either gentamicin or acetic acid or both

  • Immunocompromised patients

  • Pregnant females and lactating mothers
Interventions Intervention (n = 50): gentamicin (0.3%), ear drops, 3 drop every 8 hours. Duration of treatment = 2 weeks.
Comparator group(n = 50): acetic acid (1.5%), ear drops, 3 drops every 8 hours. Duration of treatment = 2 weeks.
Concurrent treatment: no aural toileting or additional interventions listed
Outcomes Outcomes of interest in the review:
Primary outcomes:

  • Resolution of ear discharge or "dry ear" (whether otoscopically confirmed or not) measured at between 1 week to 2 weeks. Unclear if otoscopically confirmed.

  • Ear pain (otalgia) or discomfort or local irritation


Secondary outcomes:

  • Not reported
Funding sources "No funding source"
Declarations of interest "None declared"
Notes Unit of randomisation: person
Methods for including patients with bilateral disease: not reported
The authors also completed a cost analysis for the trial
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "A randomised, open label study was carried out in the department of …"
Comment: the method of randomisation was not explained
Allocation concealment (selection bias) Unclear risk Comment: no information provided
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "A randomised, open label study was carried out in the department of …"
Comment: there is no blinding in this study
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "A randomised, open label study was carried out in the department of …"
Comment: there is no blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: no participants were reported as lost to follow‐up and all participants were included in the results
Selective reporting (reporting bias) Unclear risk Comment: no protocol was identified on the WHO clinical trials registry.
The primary outcome of the study was measured in two ways: an otological symptom score for which no reference to validation was made, and "treatment success" for which the definition was "clinical success" or "clinical improvement", neither of which was defined within the paper.

COM: chronic otitis media; CSOM: chronic suppurative otitis media; F: female; IQR: interquartile range; M: male; RCT: randomised controlled trial; SD: standard deviation; WHO: World Health Organization; WHO ICTRP: World Health Organization International Clinical Trials Registry Platform