Question

• For children with acute otitis media, how much better is a ten day course of Augmentin, compared with a 5 day course?

Clinical Bottom Lines

1. A ten day course of Augmentin will result in a few more kids being improved at the end of the 10 days, when compared with a group that received only 5 days.  After another 3 to 5 weeks, however, the difference will be minimal.
2. Parents may benefit from knowing what to expect in terms of outcome of short term vs. standard, 10 day therapy.

Summary of Key Evidence

1. A ten day course of Augmentin, is a little bit better than 5 days, when improvement or cure is compared at 12 to 14 days after starting (86.5% vs. 71.1% ), NNT =  6.¹
2. In this same study, outcome measurements at 5 weeks after starting were much less striking.  10 day group ‘improved or cured’  = 63.1% vs. 5 day group rate of 57.8%   The number of children needed to be treated to prevent one ‘failure’ at 5 weeks, is 19. 
3. This study was originally done to compare diarrhea side effects of the then new BID formulation of Augmentin (45mg/kg/day Amox; 6.4 mg/kg/day Clavulanate) with the previous TID version.  Diarrhea was much less with the BID version, whether used for 5 or 10 days (TID x 10 days 26.7%,  BID x 10 days, 9.6%,  BID x 5 days 8.7%).
4. A similar study,² done in France with higher doses (80/kg of Amox, 10/kg of Clavulanate divided BID), found a slightly better rate of early ‘success’ :  88.1% after 10 days, and 76.7 after 5 days (NNT = 9); ‘Success’ at 4 to 6 weeks was again, much less impressive, 46% vs. 40.4%. (NNT = 20)

Additional Comments

• Both of these large studies could be faulted for a large number of patients who were originally randomized but who failed to be followed and accounted for. (40% in study 1; 27% in study 2)
• Both studies pooled data from multiple practices and practitioners. Both had good design with regard to blinding.
• A formulation of Augmentin, closer to the amounts used in study 2 is about to be marketed. It may have some benefit in increasing early successes.

Citation

1. Hoberman A, Paradise JL, Burch DJ, Equivalent efficacy and reduced occurrence of diarrhea from a new formulation of Augmentin for treatment of acute otitis media in children.  Pediatric Infect Dis J  1997; 16:463-70
2. Cohen R, Levy C, Boucherat M, Langue J, LaRoocque F, A multicenter, randomized, double blind trial of 5 vs 10 days of antibiotic therapy for acute otitis media in young children.  J Peds 1998;  133: 635-639
3. See critically appraised topic by Dr. Matthew Hebdon, for yet more insightful commentary.

CAT Author: Ken Pituch, MD

CAT Appraisers:

Date appraised: March 20, 1999