Mike: Hello, I'm Mike Clarke, podcast editor for the Cochrane Library. Over nearly 30 years, the Cochrane Acute Respiratory Infections Group has produced close to 200 reviews. One of their earliest, antibiotics for acute otitis media in children, was first published in 2000 and it was updated for the fourth time in November 2023. Here's two of the authors, Sharon Sanders and Paul Glasziou from the Institute for Evidence-Based Healthcare at Bond University in Australia to talk about the latest findings.

Sharon: Hello Paul.  Thanks very much for talking with me today. Shall we begin with a few words about acute otitis media, or AOM.  What is it?

Paul: Hello Sharon. It's good to be here. Acute otitis media is an infection of the middle ear, or the space just behind the ear drum.  It causes pain in the ear and can also cause some general symptoms of illness such as fever and irritability and problems with feeding and sleeping.  It's very common in children and most will have had at least one episode by the time they are 3 years of age.

Sharon: Thanks Paul. I know that antibiotics are one of the treatments that doctors might prescribe for children with acute otitis media, why is that and why is this review important?

Paul: It's generally believed that acute otitis media is caused by germs such as bacteria and or viruses moving from the throat up to the ear when a child has a cold.  As antibiotics are used to treat infections caused by bacteria, they are often given to children with acute otitis media to help them recover more quickly and to prevent complications. However, it's important to know how effective they actually are, and we did this review to find out whether antibiotics given to children with AOM reduce their pain. We also wanted to know if antibiotics reduce complications such as holes or tears in the eardrum, spread of the infection to other parts of the ear, or repeated infection or hearing problems in the weeks after infection.

Sharon: What evidence was out there, and what does it say about antibiotics as a treatment for acute otitis media in children?

Paul: We found 13 clinical trials that included just over 3400 children. These compared antibiotics with a placebo, which was a dummy medicine that looked like an antibiotic but did not contain any antibiotic ingredients. Based on the findings, antibiotics reduce the number of children who have pain in their ear, 2 to 3 days after they have seen the doctor, by a small amount compared to placebo.
In terms of complications, antibiotics reduced the number of children who had abnormal functioning of the middle ear by a small amount a couple of weeks after infection, but not any time beyond that. Antibiotics also slightly reduced the number of children with ruptured eardrums and infection in the other ear, but did not reduce the number of children who got AOM again. For the more serious complications, we're not sure whether antibiotics can reduce these, which include the spread of infection to other parts of the ear, because all the studies were done in high-income countries where these complications hardly ever occur.

Sharon: And what about safety?  Were there any unwanted effects from the antibiotics?

Paul: Yes, there were, in keeping with what we generally see with antibiotics. For example, the drugs often caused diarrhoea, vomiting and rashes in the children taking them.

Sharon: So, what do these findings mean, given the small beneficial effect of antibiotics on pain and some complications, and the unpleasant side effects?

Paul:  Well, the small benefits of antibiotics must be weighed against the possible harms.  One way to think about this is that about 20 children need to be treated with antibiotics for one fewer child to have pain 2-3 days after the infection starts. On the other hand, for every 14 children treated with antibiotics, one child will experience vomiting, diarrhoea or a rash.  However, these are averages, and some children are more at risk of poor outcomes from acute otitis media and hence more likely to benefit from treatment, for example very young children, or Aboriginal children.
Another important finding was that most of the children who did not receive antibiotics recovered on their own, without any ongoing problems, within a few days of getting their ear infection. Given this, we decided to look at whether it's possible to safely delay giving antibiotics to children with AOM. To do this, we looked at studies that compared treating children with antibiotics straight away or doing what we call 'watchful waiting', where children are just closely watched, or are given a prescription and instructions to take antibiotics only if they are not better after a few days.

Sharon: And what did you find?

Paul: Six trials had studied this. These showed that giving antibiotics straight away might reduce the number of children with pain a couple of days after the infection, but probably not reduce the number of children with pain after that. Again, unwanted side effects such as vomiting, diarrhoea and rash were common in the children who had antibiotics straight away.

Sharon: To sum up, what's your take-home message about antibiotics for treating acute otitis media in children?

Paul: Well, we know that in high-income countries such as Australia, the UK and Canada,  most children who have AOM will get better by themselves within a few days. We also know that antibiotics have only a slight effect on the ear pain in children with AOM and that one in every 14 children treated with antibiotics will experience an adverse event that would not have occurred if antibiotics were not given.  Therefore, for most children with AOM in high-income countries, watchful waiting - waiting a few days without antibiotics - is an appropriate and safe approach.

Sharon: Thanks Paul. If listeners would like to read the full review, how they can they get hold of it.

Paul: Thanks Sharon. The review's available online at Cochrane Library dot com. If people go to the website and search 'antibiotics for AOM', they'll see the link.