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. 2021 Feb 9;2021(2):CD013053. doi: 10.1002/14651858.CD013053.pub2

Mehboob 2019.

Methods 3‐arm, unclear blinding, single‐centre, parallel‐group, unclear if RCT, with unclear duration of treatment and unclear duration of follow‐up
Participants Location: Pakistan, 1 site
Setting of recruitment and treatment: ENT department of tertiary health care hospital in Karachi, May to September 2018
Sample size: 120 participants (120 ears)
  • Number randomised: 40 treated with ciprofloxacin, 40 treated with amoxicillin‐clavulanic acid, 40 untreated (control)

  • Number completed: not reported


Participant (baseline) characteristics:
  • Age: range 18 to 75 years (inclusion criteria)

  • Gender (F/M): 60 female (50%)/60 male (50%)

  • Main diagnosis: unilateral ear presentation of chronic suppurative otitis media

  • High‐risk population:

    • 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: not reported, otoscopically confirmed

    • Presence of mucopurulent discharge: without fluid discharge at time of pure‐tone audiometry

    • 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:
  • Patients aged between 18 to 75 years

  • Both the genders

  • Unilateral ear presentation of CSOM without fluid discharge at the time of pure‐tone audiometry


Exclusion criteria:
  • Paediatric population

  • Patients over 75 years

  • History of neurological disorder or profound psychological distress, cardiac arrest, family history of sensorineural hearing loss or using hearing aid

Interventions Intervention (n = 40 participants): ciprofloxacin, method of administration not reported, dosage not reported, duration of treatment not reported
Intervention (n = 40 participants): amoxicillin‐clavulanic acid, method of administration not reported, dosage not reported, duration of treatment not reported
Comparator group(n = 40 participants): untreated
Concurrent treatment: not reported
Outcomes Outcomes of interest in the review:
Primary outcomes:
  • Not reported


Secondary outcomes
  • Hearing: pure‐tone audiometry was examined at different frequencies using an audiometer with aural headphones to measure hearing thresholds

Notes Funding sources: "University Research funding committee of JSMU"
Unit of randomisation: person
Methods for reporting outcomes of patients with bilateral disease: not reported, only included unilateral presentation of CSOM
Hearing thresholds divided into 7 categories as normal (25 dB), mild (26 to 34 dB) hearing loss (HL), moderate (50 to 64 dB) HL, severe (65 to 79 dB) HL, profound (80 to 94 dB) HL and deaf
Objective: to study the correlation of hearing loss with depression, anxiety and stress in patients suffering from chronic suppurative otitis media in local population of Pakistan
Depression, anxiety and stress were scored taking depression, anxiety and stress scale (DASS) as tool and Likert scale was taken for scoring
Awaiting author reply regarding randomisation