Research article

Echinacea purpurea and osteopathic manipulative treatment in children with recurrent otitis media: a randomized controlled trial

Richard A Wahl^{* 1} , Michael B Aldous^{* 2} , Katherine A Worden^{* 3} and Kathryn L Grant^{* ^ 4}

¹Department of Pediatrics, University of Arizona, Tucson, Arizona, USA

²Department of Pediatrics, Saltzer Medical Group, Nampa, Idaho, USA

³Department of Osteopathic Manipulative Medicine, Midwestern University, Glendale, Arizona, USA

⁴Department of Pharmacology, University of Arizona, Tucson, Arizona, USA

author email corresponding author email^Deceased * Contributed equally

BMC Complementary and Alternative Medicine 2008, 8:56doi:10.1186/1472-6882-8-56

Published:	2 October 2008

Abstract

Background

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. 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.

Methods

A 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.

Results

No 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).

Conclusion

In 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 registration

ClinicalTrials.gov Identifier: NCT00010465