Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

Not Applicable

Completed

• Conditions: Otitis Media
• Interventions: Procedure: Sham osteopathic manipulative treatment; Procedure: Cranial osteopathic manipulative treatment.; Dietary Supplement: Echinacea purpurea; Dietary Supplement: "Echinacea purpurea" placebo

• Registration Number: NCT00689468
• Lead Sponsor: University of Arizona

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1999-07
• Primary Completion: 2002-09
• Study Completion: 2002-10
• Status Verified: 2008-05
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-05-30
• Last Update Submitted: 2008-05-30
• Study First Posted: 2008-06-03
• Last Update Posted: 2008-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Sham osteopathic manipulative treatment	Osteopathic sham treatment plus placebo "Echinacea" drops
4	Cranial osteopathic manipulative treatment.	Active osteopathic manipulation plus active Echinacea drops.
4	Echinacea purpurea	Active osteopathic manipulation plus active Echinacea drops.
3	Cranial osteopathic manipulative treatment.	Active osteopathic manipulation plus placebo "Echinacea" drops
1	"Echinacea purpurea" placebo	Osteopathic sham treatment plus placebo "Echinacea" drops
2	Sham osteopathic manipulative treatment	Active Echinacea drops plus sham osteopathic treatment
2	Echinacea purpurea	Active Echinacea drops plus sham osteopathic treatment
3	"Echinacea purpurea" placebo	Active osteopathic manipulation plus placebo "Echinacea" drops

Primary Outcome Measures

Name	Time	Method
The occurrence of a first episode of acute otitis media during the study period.	Six months

Secondary Outcome Measures

Name	Time	Method
The total number of episodes of diagnosed acute otitis media during the study period.	Six months

Trial Locations

Locations (3)

KateCare Osteopathic Center; 🇺🇸 Tucson, Arizona, United States

Pediatric Osteopathic Center; 🇺🇸 Tucson, Arizona, United States

Pediatric Clinic, Arizona Health Sciences Center; 🇺🇸 Tucson, Arizona, United States