Summary of findings for the main comparison. Topical antibiotics versus placebo/no treatment for chronic suppurative otitis media.
Topical antibiotics (ciprofloxacin) versus placebo/no treatment for chronic suppurative otitis media | |||||||
Patient or population: patients with mucopurulent otorrhoea Settings: specialist hospital in Thailand Intervention: ciprofloxacin ear drops Comparison: saline | |||||||
Outcomes | Relative effect (95% CI) | Number of participants (studies) | Anticipated absolute effects* (95% CI) | Certainty of the evidence (GRADE) | Comments | ||
Without topical antibiotic | With topical antibiotic | Difference | |||||
Resolution of ear discharge ‐ measured at 1 to 2 weeks Follow‐up: 7 days |
RR 6.74 (1.82 to 24.99) | 35 (1 RCT) | Study population | ⊕⊝⊝⊝ very low1 | Topical antibiotics may increase the number of patients with resolution of ear discharge at 7 days compared with placebo, but we are very uncertain about the results. | ||
12.5% | 84.2% (22.8 to 100.0) |
71.8% more (10.3 to 299.9) |
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Resolution of ear discharge ‐ measured after 4 weeks | No study measured this outcome. | ||||||
Health‐related quality of life | No study measured this outcome. | ||||||
Ear pain (otalgia) or discomfort or local irritation Follow‐up: 7 days |
— | 35 (1 RCT) | Authors reported "no medical side‐effects and worsening of audiological measurements related to this topical medication were detected". | ⊕⊝⊝⊝ very low2 | — | ||
Hearing Follow‐up: 7 days |
— | 35 (1 RCT) | Authors reported "no ... worsening of audiological measurements related to this topical medication were detected." | ⊕⊝⊝⊝ very low3 | — | ||
Serious complications | No studies reported that any participant died or had any intracranial or extracranial complications. | ||||||
Suspected ototoxicity Follow‐up: 7 days |
— | 35 (1 RCT) | Authors report "no suspected ototoxicity" but it is unclear how this was measured. | ⊕⊝⊝⊝ 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; 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 very low certainty: downgraded by one level due to study limitations (risk of bias) because there were concerns about incomplete data (50 people entered the study but results are only reported for 35). Downgraded by two levels due to imprecision as there was one very small study (35 participants) with wide confidence intervals.
2Downgraded to very low certainty: downgraded by two levels due to study limitations (risk of bias) because there were concerns about incomplete data (50 people entered the study but results are only reported for 35) and it is unclear how this outcome was measured as the paper just reports "no medical side effects". Downgraded by one level due to imprecision as numeric results were not provided and it was only one very small study (35 participants).
3Downgraded to very low certainty: downgraded by two levels due to study limitations (risk of bias) because of concerns about incomplete data (50 people entered the study but results are only reported for 35) and the methods used for measuring hearing were not provided in the paper. Downgraded by one level due to imprecision as numeric results were not reported and it was only one very small study (35 participants).