Key messages

• Decongestant or antihistamine medicines are sometimes given to children with acute middle ear infection (acute otitis media).

• It is unclear whether decongestants or antihistamines are effective treatments or have any unwanted side effects when used for treating acute otitis media.

• Because the existing evidence is very uncertain, further large studies may not be worthwhile.

What is acute otitis media?

Acute otitis media (AOM) is a bacterial infection of the middle ear. It is the most common bacterial infection in children and the most common reason for treating a child with antibiotics worldwide. The infection usually develops during or after a common cold. Symptoms include a sudden onset of ear pain, fever, irritation, and sometimes discharge from the ear canal. Fluid sometimes accumulates in the middle ear after the infection, which can impair hearing.

How is acute otitis media treated?

Traditionally, AOM is treated with antibiotics. However, the infection often clears up without treatment, and complications (such as the infection spreading to the skull or brain) are rare. Most treatment guidelines today recommend watchful waiting, which means not giving antibiotics straight away but waiting to see if the condition gets worse or doesn't get better in two or three days. Children with pain and fever are often given painkillers such as paracetamol or ibuprofen. Some researchers have suggested that other nonprescription medicines such as decongestants and antihistamines could help to treat AOM by reducing the middle ear inflammation caused by the infection. Decongestants are normally used to treat a blocked nose, and antihistamines are normally used to relieve allergy symptoms. They are available as tablets, syrups, and nasal sprays.

What did we want to find out?

We wanted to know if decongestants and antihistamines, alone or in combination, are effective as medicines for AOM in children to improve:

• recovery from AOM;

• ear pain;

• the number of complications of the infection; and

• the presence of middle ear fluid after the infection.

We also wanted to find out if decongestants or antihistamines were associated with any unwanted side effects.

What did we do?

We searched for studies comparing the treatment effect of decongestants and antihistamines in children with AOM. We compared and summarised their results, and we rated our confidence in the evidence based on factors such as study methods and sizes.

What did we find?

We included 15 studies with 3066 participants in our review. Across 12 studies, the children were aged three months to 15 years. One study also included a few adults, and one study may have included 18-year-olds. The studies were conducted between 1965 and 2003 and lasted between one year and five years. Some studies did not report study duration. They took place in the USA, Denmark, Canada, and the UK. Eight studies compared decongestants or antihistamines in the form of tablets or syrup with placebo (dummy) treatment or no treatment. We considered these the main comparisons of our review. No studies investigated nasal spray decongestants or antihistamines. In 12 studies, the children in both groups also received antibiotics.

It is unclear if decongestants are associated with more unwanted side effects or have an effect on ear pain or the presence of middle ear fluid after the infection. We found no studies to help us answer whether decongestants have an effect on recovery from AOM. Decongestants may have little to no effect on the risk of severe complications.

It is unclear if antihistamines improve recovery from AOM, are associated with unwanted side effects, or reduce ear pain. Antihistamines may have little to no effect on the risk of severe complications or the presence of middle ear fluid after the infection.

There are no ongoing studies investigating this question.

What are the limitations of the evidence?

We are not confident in the evidence on the benefits and harms of decongestants and antihistamines as additional treatment for AOM in children. The studies were generally too small and used methods that were likely to introduce errors in their results, such as children or assessors knowing which medicines the children received.

How up to date is this evidence?

The evidence is current to 19 February 2025.