2023 Dec 06

Amended

Plain language summary edited to remove one redundant sentence.

2015 Apr 26

New citation required but conclusions have not changed

The conclusions regarding the effectiveness and safety of antibiotics have essentially not changed, except for some new outcomes (e.g. long‐term effects on AOM recurrences) and minor changes to the risk of bias.

2015 Apr 26

New search has been performed

We updated the searches in April 2015.

In this updated review, we now provide outcome data on:

• pain at 24 hours, two to three days, four to seven days and 10 to 14 days (in earlier versions outcome data on pain were presented at 24 hours, two to three days and four to seven days);

• abnormal tympanometry findings at two to four weeks, six to eight weeks and three months (in earlier versions outcome data on abnormal tympanometry findings were presented at four to six weeks and three months);

• long‐term effects including number of parent‐reported AOM‐symptom episodes, antibiotic prescriptions, health care utilisation as assessed at least one year after randomisation (in earlier versions no data on long‐term effects were presented).

The outcome 'Adverse effects likely to be related to the use of antibiotics such as vomiting, diarrhoea or rash' has been added to primary outcomes (in earlier versions this outcome was listed as a secondary outcome) according to the recommendations described in Chapter 5.4.2 of the Cochrane Handbook for Systematic Reviews of Interventions ("the primary outcomes should include at least one desirable and at least one undesirable outcome") (Higgins 2011).

One new trial was identified for the review of antibiotics against placebo (Tapiainen 2014). This study included children aged between six months and 15 years and provided data on pain at days four to seven, adverse effects likely to be related to the use of antibiotics, abnormal tympanometry findings at two to four weeks and six to eight weeks, tympanic membrane perforation and serious complications.

New data were added to the review from previously included trials.

For the review of antibiotics against placebo:

• data on pain at 10 to 12 days (Hoberman 2011);

• data on abnormal tympanometry findings at two to four weeks (Kaleida 1991);

• data on long‐term effects (Burke 1991; Damoiseaux 2000).

For the review of immediate antibiotics against expectant observation:

• data on pain at 11 to 14 days (Spiro 2006);

• data on abnormal tympanometry findings at two to four weeks (McCormick 2005);

• data on long‐term effects (Little 2001).

We identified one ongoing trial (ACTRN12608000424303). The objective of this double‐blind, placebo‐controlled randomised clinical trial is to assess the effectiveness of azithromycin for seven days in aboriginal children with asymptomatic AOM, defined as a bulging tympanic membrane without associated symptoms at the time of diagnosis. The primary outcome is the proportion of children with a bulging tympanic membrane or ear discharge or withdrawn due to complications or side effects at 14 days.

Quality of evidence is now described based on the GRADE framework.

2012 Nov 08

New citation required but conclusions have not changed

The general conclusions and recommendations regarding the effectiveness of antibiotics on pain and adverse events remained unchanged. Antibiotic treatment lead to a statistically significant reduction of children with AOM experiencing pain at two to seven days compared with placebo, but since most children (82%) settle spontaneously, about 20 children must be treated to prevent one suffering from ear pain at two to three and four to seven days. (In the previous version the number needed to treat to benefit (NNTB) was 16). However, in this updated review antibiotic treatment appeared to have a statistically significant beneficial effect on the number of tympanic membrane perforations (risk ratio (RR) 0.37, 95% confidence interval (CI) 0.18 to 0.76; NNTB 33) and contralateral acute otitis media (AOM) episodes (RR 0.49, 95% CI 0.25 to 0.95, NNTB 11) as compared with placebo.

For every 14 children treated with antibiotics one child experienced an adverse event (such as vomiting, diarrhea or rash) that would not have been occurred if antibiotics were withheld. (In the previous version the number needed to treat to harm (NNTH) was 24).

Antibiotics are most useful in children under two years of age with bilateral AOM, or with both AOM and otorrhoea. For most other children with mild disease, an expectant observational approach seems justified. We have no data on populations with higher risks of complications.

2012 Nov 08

New search has been performed

A new review author joined the team to update this review. We updated the searches in November 2012. Two new trials were identified for the review of antibiotics against placebo (Hoberman 2011; Tähtinen 2011). These studies included children < 35 months of age and provided data on pain (Tähtinen 2011), contralateral otitis, late recurrences (Hoberman 2011), perforation and adverse events (Hoberman 2011, Tähtinen 2011).

The Laxdal 1970 trial has been removed from the review of antibiotics against placebo and added to the review of immediate antibiotics versus expectant observation.

No new trials were identified for the review of immediate antibiotics compared with expectant observation. Furthermore, we did not identify ongoing trials.

In this updated review, we now provide outcome data for pain at 24 hours, two to three days and four to seven days (in earlier versions outcome data for pain were presented at 24 hours and two to seven days).

2012 Jun 19

Feedback has been incorporated

Feedback added to review

2010 Aug 05

Amended

Contact details updated.

2009 Sep 02

Amended

95% confidence intervals for the outcome pain at 2‐7 days and adverse events stated in the abstract and body of the review corrected.

2008 Jul 02

New search has been performed

The search was updated in July 2008. Four new trials were identified and included in the review (Le Saux 2005, Spiro 2006, Neumark 2007 and McCormick 2005). One of these trials (Le Saux 2005) compared antibiotics with placebo. For the outcome pain at 24 hours and 2 to 7 days, inclusion of this trial did not alter the overall conclusions of the primary analysis. The three other new trials (Spiro 2006, Neumark 2007, McCormick 2005) compared immediate antibiotics with various observational approaches. One of the new trials compared immediate antibiotics with delayed prescribing (Spiro 2006). The other trials (McCormick 2005 and Neumark 2007) compared immediate antibiotics with 'watchful waiting', in which no prescription was supplied but advise on when to seek treatment was provided. Outcome data on pain at 3 to 7 days from these trials were analysed with data from another trial of immediate versus delayed prescription (Little 2001). In earlier versions of the review data from the Little (Little 2001) trial had been included in a sensitivity analysis. In this update, data from the four trials comparing immediate versus observational management strategies have been included in the main analysis. Information on subgroups of children who are most likely to benefit from treatment with antibiotics, obtained from a meta‐analysis of individual patient data has been included in this review (Rovers 2006). Methods of the IPD meta‐analysis, conducted by two authors on this review (and others) are also included. Survival curves from the IPD meta‐analysis showing the pattern of recovery from acute otitis media over time has been included as an extra figure. Two ongoing trials comparing antibiotics with placebo in children < 35 months have been identified.

2008 Jan 17

Amended

Converted to new review format.

2007 Sep 04

Feedback has been incorporated

Feedback added.

2005 Feb 18

Feedback has been incorporated

Feedback and reply added.

2017 May 10

Amended

Converted to new review format.