Abstract
BackgroundRecurrent otitis media is a common problem in young children. Echinacea and osteopathic manipulative treatment have been proposed as preventive measures, but have been inadequately studied. This study was designed to assess the efficacy of Echinacea purpurea and/or osteopathic manipulative treatment (OMT) for prevention of acute otitis media in otitis-prone children.MethodsA randomized, placebo-controlled, two-by-two factorial trial with 6-month follow-up, conducted 1999 – 2002 in Tucson, Arizona. Patients were aged 12–60 months with recurrent otitis media, defined as three or more separate episodes of acute otitis media within six months, or at least four episodes in one year. Ninety children (44% white non-Hispanic, 39% Hispanic, 57% male) were enrolled, of which 84 had follow-up for at least 3 months. Children were randomly assigned to one of four protocol groups: double placebo, echinacea plus sham OMT, true OMT (including cranial manipulation) plus placebo echinacea, or true echinacea plus OMT. An alcohol extract of Echinacea purpurea roots and seeds (or placebo) was administered for 10 days at the first sign of each common cold. Five OMT visits (or sham treatments) were offered over 3 months.ResultsNo interaction was found between echinacea and OMT. Echinacea was associated with a borderline increased risk of having at least one episode of acute otitis media during 6-month follow-up compared to placebo (65% versus 41%; relative risk, 1.59, 95% CI 1.04, 2.42). OMT did not significantly affect risk compared to sham (44% versus 61%; relative risk, 0.72, 95% CI 0.48, 1.10).ConclusionIn otitis-prone young children, treating colds with this form of echinacea does not decrease the risk of acute otitis media, and may in fact increase risk. A regimen of up to five osteopathic manipulative treatments does not significantly decrease the risk of acute otitis media.Trial registrationClinicalTrials.gov Identifier: NCT00010465
Highlights
Recurrent otitis media is a common problem in young children
One survey of parents at an urban pediatric emergency department reported an overall incidence of Complementary and alternative medicine (CAM) use of 15%
A survey of pediatric clinic patients in Quebec revealed that ear, nose, and throat problems accounted for 24% of child visits to alternative medicine practitioners [5], and a survey of parents at a British pediatric otolaryngology clinic found that 29% reported CAM use, with echinacea and manipulative treatments frequently cited [6]
Summary
Recurrent otitis media is a common problem in young children. Echinacea and osteopathic manipulative treatment have been proposed as preventive measures, but have been inadequately studied. In children with recurrent otitis media, conventional approaches to decreasing the risk of further episodes include prophylactic antibiotic therapy and surgical insertion of tympanostomy tubes to prevent accumulation of middle ear effusion. The effectiveness of these approaches is limited and controversial [2,3]. A survey of pediatric clinic patients in Quebec revealed that ear, nose, and throat problems accounted for 24% of child visits to alternative medicine practitioners [5], and a survey of parents at a British pediatric otolaryngology clinic found that 29% reported CAM use, with echinacea and manipulative treatments frequently cited [6]
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