Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

Overview

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.

Full Title of Study: “Echinacea Purpurea and Cranial Osteopathic Manipulative Treatment in Children With Recurrent Otitis Media: a Randomized Controlled Trial.”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Factorial Assignment
  • Primary Purpose: Prevention
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: September 2002

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.

Interventions

• 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.

Arms, Groups and Cohorts

• Placebo Comparator: 1
  • Osteopathic sham treatment plus placebo “Echinacea” drops
• Active Comparator: 2
  • Active Echinacea drops plus sham osteopathic treatment
• Active Comparator: 3
  • Active osteopathic manipulation plus placebo “Echinacea” drops
• Active Comparator: 4
  • Active osteopathic manipulation plus active Echinacea drops.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: 60 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • University of Arizona
• Collaborator
  • National Center for Complementary and Integrative Health (NCCIH)
• Provider of Information About this Clinical Study
  • Richard Wahl, MD, Department of Pediatrics, University of Arizona
• Overall Official(s)
  • Richard A Wahl, MD, Principal Investigator, University of Arizona
  • Michael B Aldous, MD, MPH, Principal Investigator, University of Arizona

References

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.