Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Otitis Media

Intervention / Treatment
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* Procedure: Cranial osteopathic manipulative treatment.
* Dietary Supplement: Echinacea purpurea
* Procedure: Sham osteopathic manipulative treatment
* Dietary Supplement: Echinacea purpurea placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Osteopathic sham treatment plus placebo Echinacea drops | Procedure: Sham osteopathic manipulative treatment<br>* 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.<br>Dietary Supplement: Echinacea purpurea placebo<br>* 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.<br>|
| Active Comparator: 2<br>Active Echinacea drops plus sham osteopathic treatment | Dietary Supplement: Echinacea purpurea<br>* 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.<br>Procedure: Sham osteopathic manipulative treatment<br>* 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.<br>|
| Active Comparator: 3<br>Active osteopathic manipulation plus placebo Echinacea drops | Procedure: Cranial osteopathic manipulative treatment.<br>* 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).<br>Dietary Supplement: Echinacea purpurea placebo<br>* 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.<br>|
| Active Comparator: 4<br>Active osteopathic manipulation plus active Echinacea drops. | Procedure: Cranial osteopathic manipulative treatment.<br>* 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).<br>Dietary Supplement: Echinacea purpurea<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Otitis media, Echinacea, Osteopathic Medicine