Decongestants and antihistamines for acute otitis media in children

RATIONALE: Acute otitis media (AOM) is one of the most common bacterial infections in children worldwide, and the most common reason for prescribing antibiotics. Although serious complications (e.g. mastoiditis or meningitis) are rare, the infection causes acute pain and can lead to hearing impairment. Since AOM often resolves spontaneously, current treatment guidelines recommend an approach of watchful waiting (no initial antibiotics). However, decongestants and antihistamines, administered orally or nasally, might reduce inflammation and mucosal oedema in the middle ear and help resolve AOM in children. OBJECTIVES: To assess the benefits and harms of decongestants and antihistamines in treating acute otitis media in children. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, the World Health Organization (WHO) trials portal, and ClinicalTrials.gov in February 2025. We checked reference lists of relevant articles for additional studies. ELIGIBILITY CRITERIA: We included randomised controlled trials (RCTs) with children (from any setting) with AOM. Eligible comparisons were decongestants versus no intervention or placebo, antihistamines versus no intervention or placebo, decongestants plus antihistamines versus no intervention or placebo, decongestants versus antihistamines, one decongestant versus another, and one antihistamine versus another. The route of administration could be oral or nasal. OUTCOMES: Our critical outcomes were presence of AOM within seven days from starting treatment, severe complications (e.g. mastoiditis, meningitis, sinus thrombosis, facial paralysis, labyrinthitis), any adverse events (e.g. drowsiness), otalgia (yes/no) within seven days from starting treatment, and otalgia (score) within seven days from starting treatment. Our important outcomes included the presence of otitis media with effusion (OME) within 10 to 14 days from starting treatment. RISK OF BIAS: Two review authors used the Cochrane risk of bias tool (RoB 2) to independently assess risk of bias. SYNTHESIS METHODS: We used standard Cochrane methods. We evaluated the benefits and harms using a random-effects model, calculating risk ratios (RRs) and risk differences (RDs) with 95% confidence intervals (CIs) for dichotomous outcomes, and mean differences (MDs) or standardised mean differences (SMDs) for continuous outcomes. Where the results could not be pooled due to the nature of the data, we described them narratively. We assessed the certainty of evidence using the GRADE approach. INCLUDED STUDIES: We identified 15 studies (3066 participants) conducted in the USA (11 studies), Denmark (2 studies), Canada (1 study), and the UK (1 study), and published between 1965 and 2003. In 12 studies, the children's ages ranged from three months to 15 years. One study also included a few adults aged up to 40 years, and one study may have also included adults aged 18 years. Participants received concomitant antibiotics in 12 studies. Four studies evaluated decongestants versus placebo or no intervention. Four studies evaluated antihistamines versus placebo or no intervention. Two studies contained three parallel treatment arms (decongestants versus antihistamines versus placebo). Three studies compared combinations of decongestants and antihistamines to placebo or no intervention. Two studies contained four parallel treatment arms (combinations of decongestants and antihistamines versus decongestants versus antihistamines versus placebo). SYNTHESIS OF RESULTS: Decongestants versus placebo or no intervention 1. No studies reported the presence of AOM within seven days. 2. Evidence from one study suggests that decongestants may result in little to no difference in severe complications compared to no intervention (no events; low-certainty evidence). 3. The evidence is very uncertain about the effect of decongestants on any adverse events compared to placebo (RR 3.60, 95% CI 0.16 to 83.28; I² = 71%; 3 studies, 296 participants; very low-certainty evidence). 4. The evidence is very uncertain about the effect of decongestants on otalgia within seven days compared to placebo (RR 3.24, 95% CI 0.14 to 75.91; 1 study, 50 participants; very low-certainty evidence). 5. No studies reported an otalgia score within seven days. 6. The evidence is very uncertain about the effect of decongestants on the presence of OME within 10 to 14 days compared to placebo (RR 0.83, 95% CI 0.53 to 1.29; I² = 0%; 2 studies, 239 participants; very low-certainty evidence). Another study, excluded from the meta-analysis, reported OME at 14 days after starting treatment, with 46/101 events in the decongestant group and 34/94 events in the placebo group. The certainty of evidence was low to very low mainly due to study limitations (risk of bias), inconsistency, and imprecision. Antihistamines versus placebo or no intervention 1. The evidence is very uncertain about the effect of antihistamines on the presence of AOM within seven days compared to placebo (RR 1.05, 95% CI 0.32 to 3.36; 1 study, 90 participants; very low-certainty evidence). 2. Evidence from one study suggests that antihistamines may result in little to no difference in severe complications compared to no intervention (no events; low-certainty evidence). 3. The evidence is very uncertain about the effect of antihistamines on any adverse events compared to placebo (RR 7.00, 95% CI 0.37 to 133.12; I² = not applicable; 2 studies, 192 participants; very low-certainty evidence). 4. The evidence is very uncertain about the effect of antihistamines on otalgia within seven days compared to placebo (RR 3.52, 95% CI 0.15 to 82.34; 1 study, 48 participants; very low-certainty evidence). 5. No studies reported an otalgia score within seven days. 6. Antihistamines may result in little to no difference in the presence of OME within 10 to 14 days compared to placebo (RR 1.13, 95% CI 0.89 to 1.45, I² = 0%; 3 studies, 439 participants; low-certainty evidence). The certainty of evidence was low to very low, mainly due to study limitations (risk of bias) and imprecision. AUTHORS' CONCLUSIONS: The evidence is very uncertain about the benefits and harms of oral or nasal decongestants or antihistamines for children with AOM. No relevant trials have been published since 2003. No studies are ongoing. FUNDING: This Cochrane review received no dedicated funding. REGISTRATION: Protocol (2023): doi.org/10.1002/14651858.CD015839.

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