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

Summary of findings 3. Topical quinolone compared to oral amoxicillin‐clavulanic acid combination for chronic suppurative otitis media.

Topical quinolone compared to oral amoxicillin‐clavulanic acid combination for chronic suppurative otitis media
Patient or population: adults with CSOM
Setting: otorhinolaryngology outpatient clinic of a university hospital, Hong Kong
Intervention: topical quinolone
Comparison: oral amoxicillin‐clavulanic acid combination
Outcomes Relative effect
(95% CI) Number of participants (studies) Anticipated absolute effects* (95% CI) Certainty of the evidence
(GRADE) What happens
Without topical quinolone (ear drops) With topical quinolone (ear drops) Difference
Resolution of ear discharge ‐ 1 to 2 weeks
Assessed with: unclear if otoscopically confirmed
Follow‐up: 1 to 2 weeks
RR 2.93
(1.50 to 5.72) 56
(1 RCT) Study population ⊕⊝⊝⊝
very low1,2 It is uncertain if there is a difference between topical quinolone (ear drops) and oral combination of amoxicillin‐clavulanic acid in resolution of ear discharge at 1 to 2 weeks.
25.9% 76.0%
(38.9 to 100) 50.0% more
(13 more to 122.4 more)
Resolution of ear discharge after 4 weeks The study did not report this outcome.
Health‐related quality of life The study did not report this outcome.
Ear pain (otalgia) or discomfort or local irritation
Assessed with: self‐reported
Follow‐up: 2 weeks
56
(1 RCT) The study reported that "no patient of the ofloxacin‐treated group complained of adverse side effects. There was no hypersensitivity reaction to the topical ofloxacin". It is not clear whether ear pain was specifically assessed. ⊕⊝⊝⊝
very low1,3 It is unclear if there is a difference between topical quinolone compared with oral amoxicillin‐clavulanic acid with regards to ear pain.
Hearing
Assessed with: bone conduction
Follow‐up: 2 weeks
56
(1 RCT) The study reported that "there were no significant differences between the pre‐treatment and post‐treatment audiograms of bone conduction thresholds at frequencies of 0.5, 1, 2 and 4KHz". ⊕⊝⊝⊝
very low1,3 It is unclear if there is a difference between topical quinolone compared with oral amoxicillin‐clavulanic acid with regards to hearing.
Serious complications The study did not report this outcome.
Suspected ototoxicity
Assessed with: bone conduction
Follow‐up: 2 weeks
56
(1 RCT) Bone conduction studies were completed and the study authors reported that "there were no significant differences between the pre‐treatment and post‐treatment pure‐tone audiograms of bone conduction thresholds at frequencies of 0.5, 1, 2, and 4kHz". No further details were provided for the results of patient diaries on dizziness or tinnitus. ⊕⊝⊝⊝
very low1,3 It is unclear if there is a difference between topical quinolone compared with oral amoxicillin‐clavulanic acid with regards to ototoxicity.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio
GRADE Working Group grades of evidenceHigh certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1Downgraded by one level for risk of bias (study limitations) as there was no blinding of participants (although outcome assessors were blinded).

2Downgraded by two levels for imprecision as there was only one study with a very small sample size (56 participants).

3Downgraded by two levels due to imprecision as this was a single study with only 56 participants and the data were only reported narratively.