Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00689468
First received: May 30, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Otitis Media
Procedure: Cranial osteopathic manipulative treatment.
Dietary Supplement: Echinacea purpurea
Procedure: Sham osteopathic manipulative treatment
Dietary Supplement: "Echinacea purpurea" placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Echinacea Purpurea and Cranial Osteopathic Manipulative Treatment in Children With Recurrent Otitis Media: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • The occurrence of a first episode of acute otitis media during the study period. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The total number of episodes of diagnosed acute otitis media during the study period. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: July 1999
Study Completion Date: October 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Osteopathic sham treatment plus placebo "Echinacea" drops
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.
Active Comparator: 2
Active Echinacea drops plus sham osteopathic treatment
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.
Active Comparator: 3
Active osteopathic manipulation plus placebo "Echinacea" drops
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" 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.
Active Comparator: 4
Active osteopathic manipulation plus active Echinacea drops.
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.

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.

  Eligibility

Ages Eligible for Study:   12 Months to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689468

Locations
United States, Arizona
Pediatric Clinic, Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5073
KateCare Osteopathic Center
Tucson, Arizona, United States, 85719
Pediatric Osteopathic Center
Tucson, Arizona, United States, 85712
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Richard A Wahl, MD University of Arizona
Principal Investigator: Michael B Aldous, MD, MPH University of Arizona
  More Information

Publications:
Responsible Party: Richard Wahl, MD, Department of Pediatrics, University of Arizona
ClinicalTrials.gov Identifier: NCT00689468     History of Changes
Other Study ID Numbers: Arizona HSC #98-83, NIH P50 HL61212-01
Study First Received: May 30, 2008
Last Updated: May 30, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Otitis media
Echinacea
Osteopathic Medicine

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 20, 2014