Otitis Media
Conditions
Keywords
Otitis media, Echinacea, Osteopathic Medicine
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.
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
PROCEDURECranial 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_SUPPLEMENTEchinacea 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.
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_SUPPLEMENTEchinacea 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
National Center for Complementary and Integrative Health (NCCIH)
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 60 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of a first episode of acute otitis media during the study period. | Six months |
Secondary
| Measure | Time frame |
|---|---|
| The total number of episodes of diagnosed acute otitis media during the study period. | Six months |
Countries
United States
Outcome results
None listed