This study was designed to evaluate the efficacy of the herb Echinacea purpurea and of cranial osteopathic manipulative treatment to prevent otitis media (middle ear infections) in young children.

The use of complementary and alternative therapies by parents of young children remains common despite the lack of clinical trials demonstrating either the efficacy or safety of these treatments. Two of the more common complementary therapies used in young children with a history of recurrent otitis media are preparations of the herb Echinacea purpurea and cranial osteopathic manipulative treatment. This study represents one of the first double-blinded, placebo controlled trials of each approach in a population of young children who presented with three or more recent episodes of acute otitis media.

Inclusion Criteria:

• 3 or more separate episodes of acute otitis media within a 6 month period, or
• 4 episodes of acute otitis media in one year,

Exclusion Criteria:

• Congenital malformations of the ears, nose, or throat
• Known or suspected allergy to echinacea
• Immune deficiency including HIV infection
• Tuberculosis
• Current use of prophylactic antibiotics
• Tympanostomy tubes in place
• Unwillingness of child to participate