To treat or not to treat?

The decision to treat with oral antibiotics or use a watchful waiting approach has caused much controversy in recent years.

Otitis media is one of the more common conditions receiving antibiotic treatment in young children. 

The decision to treat with oral antibiotics or use a watchful waiting approach has caused much controversy in recent years.

A number of prominent committees and colleges from Europe, the US and Australasia have come out in favour of the watchful waiting policy advocated by the Europeans in the past 15–20 years because of the prevalence of viral upper respiratory tract infections causing fever and malaise in this age group. 

In the presence of viral upper respiratory tract infections, it may be very difficult to distinguish between an early acute bacterial otitis media from the typical preceding viral infection. 

This is particularly the case with professionals less practised in examination of the ear canal (otoscopy) and those who see fewer children in their practice.

Added to the complexity is the push for fewer rather than greater prescriptions of antibiotics due to concerns about evolving bacterial resistance, the risk of unnecessary side effects for the child from antibiotics that may not be needed and the cost to the health budget of potentially unhelpful treatments for a viral infection. 

So what has changed? A couple of well designed studies, one from Finland 1 and the other from the US, 2 were published back to back in the New England Journal of Medicine in 2011 with an editorial that favours the use of oral antibiotics in the case of a “certain” diagnosis of acute otitis media in young children.

Each study had approximately 150 children in each treatment arm. The crux of the studies centres upon the efforts taken to ensure the diagnosis of acute otitis media in children; aged 6–23 months in the US study by Hoberman and colleagues and 6–35 months in the study by Tahtinen and colleagues from Finland. 

The Finnish study showed that the use of amoxycillin-clavulanate [40mg/kg/day of amoxycillin in two divided doses] for seven days reduced the treatment failure rate from approximately 45% in the placebo group to 19% in the antibiotic group.

The treatment failures were mostly apparent by day three of treatment, which suggests that the more conservative option is valid, so long as children with ongoing symptoms return for review after 48 hours of observation. Moreover, only half of the patients in the placebo group were ‘treatment failures’, suggesting that not every child with acute otitis media needs antibiotics. 

Overall, the study suggested that the number needed to treat for one child to benefit from antimicrobial therapy was 3.8, lower than the previously calculated range of 7–17 from previous studies, which had significant limitations. 

The American study  showed a more modest benefit of amoxycillin-clavulanate at a similar dose for those less than two years in terms of resolution of symptoms and overall symptom burden.In the study the children who recovered faster also returned to daycare faster and their parents had less time off work. 

The main side-effects were diarrhoea and nappy rash, which in the vast majority of cases did not limit tolerance of therapy. 

There were no cases of mastoiditis in patients in the Finnish study and one case in a child in the placebo arm of the American study. 

In an era of pneumococcal vaccination, the use of amoxycillin-clavulanate was favoured over amoxycillin alone because of its ability to treat non-typeable Haemophilus influenzae and Moraxella catarrhalis.

The impression gained from these studies is that for a confident diagnosis of acute otitis media in a young child, there may be some advantages in using antimicrobials immediately.

Clinical Professor Dominic Fitzgerald

MBBS, PhD, FRACP

Paediatric respiratory and sleep physician at The Children’s Hospital at Westmead, NSW.

References

1. Tahtinen P. et al N Engl J Med 2011;364:116-26.
2. Hoberman A. et al N Engl J Med 2011;364:105-15