Summary of findings 2. Topical antibiotics on top of systemic antibiotics for chronic suppurative otitis media.
Topical antibiotics (ciprofloxacin) on top of systemic antibiotics (ciprofloxacin) for chronic suppurative otitis media | |||||||
Patient or population: CSOM, recurrence of CSOM or suppuration following mastoidectomy or tympanoplasty Settings: secondary care clinics in Spain and Italy Intervention: ciprofloxacin (topical) plus ciprofloxacin (systemic) Comparison: ciprofloxacin (systemic) | |||||||
Outcomes | Relative effect (95% CI) | Number of participants (studies) | Anticipated absolute effects* (95% CI) | Certainty of the evidence (GRADE) | Comments | ||
Without topical antibiotics | With topical antibiotics | Difference | |||||
Resolution of ear discharge‐ measured at 1 to 2 weeks Follow‐up: 7 to 10 days |
RR 1.47 (1.20 to 1.80) |
150 (2 RCTs) | Study population | ⊕⊕⊝⊝ low1 | Topical antibiotics in addition to systemic antibiotics may increase the number of patients with resolution of ear discharge at 7 to 10 days compared with systemic antibiotics alone. The NNTB is 4 (95% CI 3 to 9). | ||
60.0% | 88.2% (72.0 to 100) |
28.2% more (12 more to 48 more) |
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Resolution of ear discharge ‐ measured after 4 weeks | No studies reported this outcome. | ||||||
Health‐related quality of life | No studies reported this outcome. | ||||||
Ear pain (otalgia) or discomfort or local irritation | No studies reported this outcome. | ||||||
Hearing | No studies reported results for this outcome. | ||||||
Serious complications | No studies reported that any participant died or had any intracranial or extracranial complications. | ||||||
Suspected ototoxicity Follow‐up: 7 to 10 days | — | 190 (3 RCTs) | Three studies reported that they did not suspect ototoxicity in any participants, but it is unclear how this was measured (de Miguel 1999; Esposito 1990; Ramos 2003). | ⊕⊝⊝⊝ very low2 | — | ||
*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; NNTB: number needed to treat to benefit; RCT: randomised controlled trial; RR: risk ratio | |||||||
GRADE Working Group grades of evidence High 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 to low certainty: downgraded by one level due to study limitations (risk of bias) as both studies had unclear randomisation and allocation concealment and were unblinded. Downgraded by one level due to imprecision as there were only two small studies (150 participants) with the confidence interval crossing the line of minimally important benefit.
2Downgraded to very low certainty: downgraded by two levels due to study limitations (risk of bias) as all three studies had unclear randomisation, allocation concealment and were unblinded studies. It was also unclear how the outcome was reported. Downgraded by one level due to imprecision as numeric results were not reported and there were only three small studies (190 participants).