Why Antihistamines Are Not Recommended for Otitis Media with Effusion
Antihistamines should not be used to dry fluid behind the tympanic membrane because systematic reviews of randomized controlled trials demonstrate they are completely ineffective for treating otitis media with effusion (OME), while causing significant side effects—this is a strong recommendation against their use based on Grade A evidence. 1
The Evidence Against Antihistamines
The American Academy of Otolaryngology-Head and Neck Surgery provides an unequivocal strong recommendation against using antihistamines or decongestants for treating OME, based on high-quality systematic reviews of randomized controlled trials showing a preponderance of harm over benefit. 1
Why They Don't Work
Antihistamines fail to address the underlying pathophysiology of OME:
Middle ear effusion in OME is not primarily driven by histamine-mediated allergic inflammation—it results from Eustachian tube dysfunction and negative middle ear pressure following upper respiratory infections or acute otitis media. 1
The fluid accumulation is mechanical and inflammatory, not allergic in nature, making histamine blockade irrelevant to the disease process. 1
A comprehensive Cochrane systematic review of 15 trials involving 2,695 patients found no benefit for symptom resolution, early cure rates, prevention of surgery, or other complications when antihistamines were used for acute otitis media or OME. 2
The Harm They Cause
The risk-benefit ratio strongly favors avoiding these medications:
Children receiving antihistamines or decongestants experience a 5 to 8-fold increased risk of side effects, including excessive sedation, behavioral changes, and anticholinergic effects. 2
These side effects are particularly problematic in young children who already have hearing difficulties from the effusion—adding sedation and cognitive impairment compounds their communication challenges. 1
The medications provide no clinical benefit while exposing children to unnecessary adverse effects and costs. 1
What Actually Works
The evidence-based approach prioritizes natural resolution:
Approximately 75-90% of middle ear effusions resolve spontaneously within 3 months, making watchful waiting the preferred initial management strategy. 3, 4
Pneumatic otoscopy or tympanometry should be used to monitor the effusion at clinician discretion during the observation period. 3
If fluid persists beyond 3 months, obtain an age-appropriate hearing test rather than prescribing medications. 1, 3
Tympanostomy tubes should be considered only after documented hearing difficulties persist beyond 3 months of observation. 3, 4
Common Pitfalls to Avoid
Do not be misled by theoretical arguments or outdated practices:
Some clinicians have proposed that second-generation antihistamines might be more effective due to greater H1-receptor selectivity and lack of anticholinergic activity, but this remains unproven speculation without clinical trial evidence. 5
The single small study showing minimal benefit used combination decongestant-antihistamine therapy and demonstrated only a statistically significant but clinically meaningless reduction in persistent OME at 2 weeks (NNT = 10), with validity analyses revealing that only lower-quality studies found benefit. 2
Even if a child has concurrent allergic rhinitis, treating the allergy does not resolve the middle ear effusion—these are separate conditions requiring separate management. 1
Patient Education Points
Counsel families on the natural history and avoid medication pressure:
Educate parents that OME is an "occupational hazard of early childhood" with 90% of children experiencing at least one episode by age 2 years, and that the fluid cannot directly turn into an ear infection. 1
Explain that while hearing may be temporarily reduced, this typically resolves when the fluid clears spontaneously. 1
Optimize communication by having caregivers stand close, speak clearly, face the child, and use preferential seating rather than relying on ineffective medications. 3, 4
Recommend avoiding secondhand smoke exposure and discontinuing daytime pacifier use in children over 12 months, as these may help prevent recurrence. 4