Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

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.

Conditions

• 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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• University of Arizona

  lead OTHER

Principal Investigators

• Richard A Wahl, MD · University of Arizona

• Michael B Aldous, MD, MPH · University of Arizona

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

12 Months

Max Age

60 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

1999-07-31

Primary Completion

2002-09-30

Completion

2002-10-31

Countries

• United States

Study Locations