Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

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

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.

Study Overview

• Status: Completed
• Conditions: Otitis Media
• Intervention / Treatment: Procedure: Sham osteopathic manipulative treatment; Dietary supplement: "Echinacea purpurea" placebo; Dietary supplement: Echinacea purpurea; Procedure: Cranial osteopathic manipulative treatment.

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Pediatric Osteopathic Center
    • Tucson, Arizona, United States, 85719
      • KateCare Osteopathic Center
    • Tucson, Arizona, United States, 85724-5073
      • Pediatric Clinic, Arizona Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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	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; 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.
Active Comparator: 3; Active osteopathic manipulation plus placebo "Echinacea" drops	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.; 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).
Active Comparator: 4; Active osteopathic manipulation plus active Echinacea drops.	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: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The occurrence of a first episode of acute otitis media during the study period.	Six months

Secondary Outcome Measures

Outcome Measure	Time Frame
The total number of episodes of diagnosed acute otitis media during the study period.	Six months

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 1999
• Primary Completion (Actual): September 1, 2002
• Study Completion (Actual): October 1, 2002

Study Registration Dates

• First Submitted: May 30, 2008
• First Submitted That Met QC Criteria: May 30, 2008
• First Posted (Estimate): June 3, 2008

Study Record Updates

• Last Update Posted (Estimate): June 3, 2008
• Last Update Submitted That Met QC Criteria: May 30, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Otitis media; Osteopathic Medicine; Echinacea
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: Arizona HSC #98-83; NIH P50 HL61212-01