Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

• ClinicalTrials.gov Identifier: NCT00689468
• Recruitment Status: Completed
• First Posted: June 3, 2008
• Last Update Posted: June 3, 2008
• Sponsor: University of Arizona
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by: University of Arizona

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Otitis Media	Procedure: Cranial osteopathic manipulative treatment.; Dietary Supplement: Echinacea purpurea; Procedure: Sham osteopathic manipulative treatment; Dietary Supplement: "Echinacea purpurea" placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, 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.
• Study Start Date: July 1999
• Actual Primary Completion Date: September 2002
• Actual Study Completion Date: October 2002

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. The occurrence of a first episode of acute otitis media during the study period. [ Time Frame: Six months ]

Secondary Outcome Measures :

1. The total number of episodes of diagnosed acute otitis media during the study period. [ Time Frame: Six months ]

Eligibility Criteria

• Ages Eligible for Study: 12 Months to 60 Months (Child)
• Sexes Eligible for Study: All
• 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

Locations

United States, Arizona

Pediatric Osteopathic Center

Tucson, Arizona, United States, 85712

KateCare Osteopathic Center

Tucson, Arizona, United States, 85719

Pediatric Clinic, Arizona Health Sciences Center

Tucson, Arizona, United States, 85724-5073

Sponsors and Collaborators

University of Arizona

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Richard A Wahl, MD; University of Arizona
• Principal Investigator: Michael B Aldous, MD, MPH; University of Arizona

More Information

Publications:

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. doi: 10.1177/000992280104000505.

• Responsible Party: Richard Wahl, MD, Department of Pediatrics, University of Arizona
• ClinicalTrials.gov Identifier: NCT00689468
• Other Study ID Numbers: Arizona HSC #98-83; NIH P50 HL61212-01
• First Posted: June 3, 2008
• Last Update Posted: June 3, 2008
• Last Verified: May 2008

Keywords provided by University of Arizona:

Otitis media; Echinacea; Osteopathic Medicine

Additional relevant MeSH terms:

Otitis; Otitis Media; Ear Diseases; Otorhinolaryngologic Diseases