Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

Otitis Media Clinical Trial

Official title:

Echinacea Purpurea and Cranial Osteopathic Manipulative Treatment in Children With Recurrent Otitis Media: a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689468
• Other study ID #: Arizona HSC #98-83
• Secondary ID: NIH P50 HL61212-
• Status: Completed
• Phase: N/A
• First received: May 30, 2008
• Last updated: May 30, 2008
• Start date: July 1999
• Est. completion date: October 2002

Study information

• Verified date: May 2008
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2002
• Est. primary completion date: September 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 60 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

Procedure:
• Cranial osteopathic manipulative treatment.
A series of five cranial osteopathic manipulative treatment sessions scheduled over three months, and provided by osteopathic physicians whose practices are limited to osteopathic manipulative treatment. Treatment modalities were limited to cranial osteopathy, balanced membranous/ligamentous tension, and/or myofascial release (applied directly or indirectly).

Dietary Supplement:
• Echinacea purpurea
1:1 weight-to-volume 50% ethanol liquid extract of the fresh roots and dried mature seeds of Echinacea purpurea. Dosage: 0.5 ml orally 3 times daily for 3 days at the onset of cold symptoms, followed by 0.25 ml orally 3 times daily for 7 more days.

Procedure:
• Sham osteopathic manipulative treatment
Sham osteopathic treatment consisted of a series of five osteopathic examinations only (palpation of the cranial bones and muscles and other structures) without treatment maneuvers.

Dietary Supplement:
• "Echinacea purpurea" placebo
An identically labeled placebo contained 50% ethanol, 45% filtered water, food coloring and thickeners. Dosage: 0.5 ml orally 3 times daily for 3 days at the onset of cold symptoms, followed by 0.25 ml orally 3 times daily for 7 more days.

Locations

Country	Name	City	State
United States	KateCare Osteopathic Center	Tucson	Arizona
United States	Pediatric Clinic, Arizona Health Sciences Center	Tucson	Arizona
United States	Pediatric Osteopathic Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mark JD, Grant KL, Barton LL. The use of dietary supplements in pediatrics: a study of echinacea. Clin Pediatr (Phila). 2001 May;40(5):265-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of a first episode of acute otitis media during the study period.		Six months	No
Secondary	The total number of episodes of diagnosed acute otitis media during the study period.		Six months	No