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. 2020 Jan 2;2020(1):CD013051. doi: 10.1002/14651858.CD013051.pub2

Asmatullah 2014.

Methods Two‐arm, non‐blinded, parallel‐group RCT, with 10 days duration of treatment and 2‐week duration of follow‐up
Participants Location: Pakistan, 1 site
Setting of recruitment and treatment: ENT Department, Hayatabad Medical Complex, Peshawar, January to July 2012
Sample size: 134
  • Number randomised: 67 in gentamycin, 67 in ofloxacin

  • Number completed: 67 in gentamycin, 67 in ofloxacin


Participant (baseline) characteristics:
  • Age: gentamycin: 27.57 ± 9.16 years; ofloxacin: 27.76 ± 7.25 years

  • Gender (F/M): 54 (40.3%)/80 (59.7%)

  • Main diagnosis: active tubotympanic type of CSOM

  • 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: not reported

    • At baseline

      • 'Severe' otorrhoea: gentamycin: 62.7%, ofloxacin: 70.2%

      • 'Moderate' otorrhoea: gentamycin: 37.3%, ofloxacin: 29.8%

    • 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 (mastoid surgery was an exclusion criterion)

    • Number who had previous antibiotic treatment for CSOM: not reported (these were excluded if 2 weeks prior to trial)


Inclusion criteria:
  • Patients above 16 years of any gender having active tubotympanic type of chronic suppurative otitis media


Exclusion criteria:
  • Antibiotics in the last 2 weeks

  • Those with marginal perforation

  • Cholesteatoma

  • Aural polyps

  • History of mastoid surgery

Interventions Intervention (n = 67): gentamycin 0.3% ear drops, 4 drops 3 times daily, treatment continued for 10 days
Comparator group (n = 67): ofloxacin 0.3% ear drops, 4 drops 3 times daily, treatment continued for 10 days
Concurrent treatment: none listed. No aural toileting methods mentioned.
Outcomes Outcomes of interest in the review:
Primary outcomes:
  • Resolution of ear discharge, measured at between 1 week to 2 weeks. Otoscopically confirmed.


Secondary outcomes:
  • Not reported

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 Quote: "All patients were allocated into two groups by randomization done by lottery method."
Comment: not enough information to know whether this method was sufficient to generate a sufficiently randomised sequence
Allocation concealment (selection bias) Unclear risk Comment: no methods regarding allocation concealment were reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: there is no mention of blinding for any of the outcomes despite the ability to blind the trial (same treatment regimen)
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: there is no mention of blinding the treatment outcome. There may have been bias when judging the marginal cases such as the boundary between 'mild' and 'no' discharge.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: the description of patient allocation is not clear within the paper. Although the paper does not appear to have lost patients to follow‐up, there is no clear statement of this. It is unclear whether only patients included in the outcome were reported.
Selective reporting (reporting bias) High risk Comment: no trial protocol was mentioned in the paper or found on the clinicaltrials.gov website. The levels of discharge were not well defined in the methods section. In addition, there was no defined measuring or indeed mention of adverse events anywhere within the paper.