What is the best treatment for acute otitis media?

From the Guidelines

The best treatment for acute otitis media is amoxicillin as first-line therapy, typically prescribed at a dose of 80-90 mg/kg/day divided twice daily for 5-10 days. This recommendation is based on the most recent and highest quality study available, which emphasizes the importance of accurate diagnosis and optimal management of ear pain 1. The study suggests that amoxicillin is the first-choice antibiotic for treating acute otitis media, with amoxicillin-clavulanic acid as a second-choice option.

Key Considerations

• For children under 2 years old or those with severe symptoms, a 10-day course of amoxicillin is recommended, while older children with mild to moderate disease may be treated for 5-7 days.
• In patients with penicillin allergy, alternatives include azithromycin or clarithromycin.
• For patients who have taken antibiotics in the past 30 days or have treatment failure, amoxicillin-clavulanate is recommended.
• Pain management is essential and can include acetaminophen or ibuprofen.
• Watchful waiting may be appropriate for children over 2 years with mild symptoms and no fever.

Rationale

The recommendation for amoxicillin as first-line therapy is based on its effectiveness against common bacterial pathogens such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis 1. The use of amoxicillin-clavulanic acid as a second-choice option is also supported by the literature, which suggests that it is effective in cases where amoxicillin is not sufficient 1.

Additional Evidence

Previous studies have also supported the use of amoxicillin as first-line therapy for acute otitis media, with recommendations for dosage and duration of treatment varying depending on the patient's age and severity of symptoms 1. However, the most recent and highest quality study available 1 provides the strongest evidence for the recommended treatment approach.

From the FDA Drug Label

From the perspective of evaluating pediatric clinical trials, Days 11 to 14 were considered on-therapy evaluations because of the extended half-life of azithromycin. The clinical success rate (i. e., cure plus improvement) at the Day 11 visit was 88% for azithromycin and 88% for the control agent (amoxicillin/clavulanate potassium). For the 521 patients who were evaluated at the Day 30 visit, the clinical success rate was 73% for azithromycin and 71% for the control agent The combined clinical success rate (i.e., cure and improvement) at the Day 11 visit was 84% for azithromycin. For the 122 patients who were evaluated at the Day 30 visit, the clinical success rate was 70% for azithromycin. The incidence of treatment-related adverse events, primarily gastrointestinal, in all patients treated was 9% with azithromycin and 31% with the control agent. One U.S./Canadian clinical trial was conducted which compared 45/6. 4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassium for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium for 10 days in the treatment of acute otitis media. The clinical efficacy rates at the end of therapy visit (defined as 2 to 4 days after the completion of therapy) and at the follow-up visit (defined as 22 to 28 days post-completion of therapy) were comparable for the 2 treatment groups, with the following cure rates obtained for the evaluable patients: At end of therapy, 87% (n = 265) and 82% (n = 260) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively. At follow-up, 67% (n = 249) and 69% (n = 243) for 45 mg/kg/day every 12 hours and 40 mg/kg/day every 8 hours, respectively.

The best treatment for acute otitis media is either amoxicillin-clavulanate or azithromycin.

• Amoxicillin-clavulanate has a cure rate of 87% at the end of therapy and 67% at follow-up when given every 12 hours, and 82% at the end of therapy and 69% at follow-up when given every 8 hours.
• Azithromycin has a cure rate of 88% at Day 11 and 73% at Day 30. Both treatments have been shown to be effective, but azithromycin has a lower incidence of treatment-related adverse events, primarily gastrointestinal, with an incidence of 9% compared to 31% for amoxicillin-clavulanate 2, 3.

From the Research

Treatment Options for Acute Otitis Media

The best treatment for acute otitis media (AOM) typically involves the use of antimicrobial agents. According to various studies 4, 5, 6, 7, 8, the following are key points to consider:

• First-line treatment: Amoxicillin is widely recommended as the first-line drug for treating uncomplicated AOM due to its efficacy, safety, and relatively low cost 4, 5, 6, 7.
• Second-line treatments: For cases where amoxicillin fails or is not suitable, alternative antibiotics such as amoxicillin/clavulanate, cefuroxime axetil, cefprozil, cefpodoxime proxetil, and intramuscular ceftriaxone are recommended 6, 7, 8.
• Considerations for antibiotic selection: When choosing an antibiotic, factors such as in vitro activity (especially against drug-resistant Streptococcus pneumoniae), pharmacokinetics, adverse events, palatability of the suspension, cost, and the physician's clinical experience should be taken into account 7.
• Management of amoxicillin failure: In cases of amoxicillin treatment failure, considerations should include the likely pathogens and their susceptibility patterns, as well as antibiotic issues like clinical efficacy, adverse reactions, dosing schedules, and cost 8.
• Additional interventions: For patients with recurrent infections or chronic middle ear effusion, interventions such as antibiotic prophylaxis, myringotomy with insertion of a tympanostomy tube, or adenoidectomy may be considered 4, 6.