Abstract
BackgroundAcute otitis media (AOM) is associated with high antibiotic prescribing rates. Antibiotics are somewhat effective in improving pain and middle ear effusion (MEE); however, they have unfavourable effects. Alternative treatments, such as corticosteroids as anti-inflammatory agents, are needed. Evidence for the efficacy of these remains inconclusive. We conducted a pilot study to test feasibility of a proposed large-scale randomised controlled trial (RCT) to assess the efficacy of corticosteroids for AOM.MethodsWe conducted a pilot, pragmatic, parallel, open-label RCT of oral corticosteroids for paediatric AOM in primary and secondary/tertiary care centres in Indonesia. Children aged 6 months–12 years with AOM were randomised to either prednisolone or control (1:1). Physicians were blinded to allocation. Our objectives were to test the feasibility of our full RCT procedures and design, and assess the mechanistic effect of corticosteroids, using tympanometry, in suppressing middle ear inflammation by reducing MEE.ResultsWe screened 512 children; 62 (38%) of 161 eligible children were randomised and 60 were analysed for the primary clinical outcome. All study procedures were completed successfully by healthcare personnel and parents/caregivers, despite time constraints and high workload. All eligible, consenting children were appropriately randomised. One child did not take the medication and four received additional oral corticosteroids. Our revised sample size calculation verified 444 children are needed for the full RCT. Oral corticosteroids did not have any discernible effects on MEE resolution and duration. There was no correlation between pain or other symptoms and MEE change. However, prednisolone may reduce pain intensity at day 3 (Visual Analogue Scale mean difference − 7.4 mm, 95% confidence interval (CI) − 13.4 to − 1.3, p = 0.018), but cause drowsiness (relative risk (RR) 1.8, 95% CI 1.1 to 2.8, p = 0.016). Tympanometry curves at day 7 may be improved (RR 1.8, 95% CI 1.0 to 2.9). We cannot yet confirm these as effects of corticosteroids due to insufficient sample size in this pilot study.ConclusionsIt is feasible to conduct a large, pragmatic RCT of corticosteroids for paediatric AOM in Indonesia. Although oral corticosteroids may reduce pain and improve tympanometry curves, it requires an adequately powered clinical trial to confirm this.Trial registrationStudy registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018.
Highlights
Acute otitis media (AOM) is associated with high antibiotic prescribing rates
Change of middle ear effusion We found no difference in middle ear effusion (MEE) change represented by static acoustic admittance (SAA) between the prednisolone and control groups at day 3 (MD 0.04 mmho, 95% − 0.07 to 0.16), day 7 (MD 0.07 mmho, 95% − 0.06 to 0.19), day 30 (MD − 0.05 mmho, 95% − 0.19 to 0.09) and day 90 (MD 0 mmho, 95% − 0.14 to 0.14)
For clinical outcomes of this pilot study, we found that prednisolone reduced pain severity at day 3 by 7 mm (MD − 7.37, 95% confidence interval (CI) − 13.36 to − 1.39, p = 0.018)
Summary
Acute otitis media (AOM) is associated with high antibiotic prescribing rates. Antibiotics are somewhat effective in improving pain and middle ear effusion (MEE); they have unfavourable effects. Alternative treatments, such as corticosteroids as anti-inflammatory agents, are needed. A Cochrane review showed that antibiotics are effective in improving acute pain and tympanometry results, as well as other clinical outcomes (e.g. tympanic membrane perforation, contralateral AOM). Due to their modest benefits along with significant potential for unfavourable effects, antibiotics are not mandatory treatment for AOM, for mild AOM.
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