Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

University of Arizona

Status: Completed

Conditions: Otitis Media

Treatments: Dietary Supplement: Echinacea purpurea; Dietary Supplement: "Echinacea purpurea" placebo; Procedure: Cranial osteopathic manipulative treatment.; Procedure: Sham osteopathic manipulative treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00689468

NIH P50 HL61212-01

Arizona HSC #98-83

Details and patient eligibility

About

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 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.

Enrollment: 90 patients

Sex: All

Ages: 12 to 60 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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90 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Osteopathic sham treatment plus placebo "Echinacea" drops

Treatment:

Procedure: Sham osteopathic manipulative treatment

Dietary Supplement: "Echinacea purpurea" placebo

2

Active Comparator group

Description:

Active Echinacea drops plus sham osteopathic treatment

Treatment:

Dietary Supplement: Echinacea purpurea

Procedure: Sham osteopathic manipulative treatment

3

Active Comparator group

Description:

Active osteopathic manipulation plus placebo "Echinacea" drops

Treatment:

Procedure: Cranial osteopathic manipulative treatment.

Dietary Supplement: "Echinacea purpurea" placebo

4

Active Comparator group

Description:

Active osteopathic manipulation plus active Echinacea drops.

Treatment:

Dietary Supplement: Echinacea purpurea

Procedure: Cranial osteopathic manipulative treatment.