Otitis Media
Conditions
Keywords
otitis media, children, homeopathy
Brief summary
The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media in whom the health care provider has recommended that antibiotics not be immediately administered. A total of 150 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.
Interventions
3-4 drops in affected ear 3 times a day as needed for up to 5 days
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 11 Years
Healthy volunteers
No
Inclusion criteria
* Age 6 months - 11 years old * Diagnosed with otitis media by clinician at participating clinic * Clinician determines that a watch and wait antibiotic prescription treatment plan is optimal management
Exclusion criteria
* Antibiotic treatment during past 7 days * Homeopathic treatment within past 30 days * History of serious chronic illness (e.g. diabetes, autoimmune disease, cystic fibrosis * Perforated tympanic membrane * Immediate antibiotic treatment plan decided by examining clinician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Symptoms of Otitis Media | 15 days | Ear Treatment Group - 5 scores. Parent rated severity of otitis media symptoms including fever, earache, irritability, feeding and sleeping. Each symptom rated 0, 4 or 7. Total scores range 0 (least symptoms) to 35 most symptom. ETG-5 scores collected 12-15 days after enrollment |
| Administration of Antibiotics | 15 days | Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects From Study Remedy | 15 days | Any other symptoms reported by parents in logbooks. Logbooks were returned by 72/105 participants randomized to the homeopathic ear drops group and 78 of those randomized to standard therapy alone. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Homeopathic Ear Drops Commercially available homeopathic ear drops
Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days | 105 |
| Standard Therapy standard therapy for otitis media, no ear drops | 105 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Standard Therapy | Homeopathic Ear Drops | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 105 Participants | 105 Participants | 210 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.2 years STANDARD_DEVIATION 2.6 | 3.9 years STANDARD_DEVIATION 2.8 | 4.1 years STANDARD_DEVIATION 2.7 |
| Region of Enrollment United States | 105 participants | 105 participants | 210 participants |
| Sex: Female, Male Female | 77 Participants | 51 Participants | 128 Participants |
| Sex: Female, Male Male | 28 Participants | 54 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 58 / 104 | 88 / 102 |
| serious Total, serious adverse events | 0 / 104 | 0 / 102 |
Outcome results
Primary
Administration of Antibiotics
Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.
Time frame: 15 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Homeopathic Ear Drops | Administration of Antibiotics | 28 participants |
| Standard Therapy | Administration of Antibiotics | 42 participants |
Primary
Severity of Symptoms of Otitis Media
Ear Treatment Group - 5 scores. Parent rated severity of otitis media symptoms including fever, earache, irritability, feeding and sleeping. Each symptom rated 0, 4 or 7. Total scores range 0 (least symptoms) to 35 most symptom. ETG-5 scores collected 12-15 days after enrollment
Time frame: 15 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Homeopathic Ear Drops | Severity of Symptoms of Otitis Media | 2.0 units on a scale | Standard Deviation 4.5 |
| Standard Therapy | Severity of Symptoms of Otitis Media | 2.0 units on a scale | Standard Deviation 3.8 |
Secondary
Side Effects From Study Remedy
Any other symptoms reported by parents in logbooks. Logbooks were returned by 72/105 participants randomized to the homeopathic ear drops group and 78 of those randomized to standard therapy alone.
Time frame: 15 days
Population: The number of participants analyzed includes only those whose parents returned logbooks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Homeopathic Ear Drops | Side Effects From Study Remedy | hyper behavior | 6 participants |
| Homeopathic Ear Drops | Side Effects From Study Remedy | other symptom reported | 14 participants |
| Homeopathic Ear Drops | Side Effects From Study Remedy | diarrhea | 5 participants |
| Homeopathic Ear Drops | Side Effects From Study Remedy | decreased hearing | 1 participants |
| Homeopathic Ear Drops | Side Effects From Study Remedy | headache | 9 participants |
| Homeopathic Ear Drops | Side Effects From Study Remedy | plugged ears | 1 participants |
| Homeopathic Ear Drops | Side Effects From Study Remedy | rash | 3 participants |
| Homeopathic Ear Drops | Side Effects From Study Remedy | redness around ear with drops | 1 participants |
| Homeopathic Ear Drops | Side Effects From Study Remedy | lethargy | 15 participants |
| Homeopathic Ear Drops | Side Effects From Study Remedy | ear popping | 1 participants |
| Homeopathic Ear Drops | Side Effects From Study Remedy | vomit | 4 participants |
| Standard Therapy | Side Effects From Study Remedy | ear popping | 0 participants |
| Standard Therapy | Side Effects From Study Remedy | vomit | 5 participants |
| Standard Therapy | Side Effects From Study Remedy | rash | 11 participants |
| Standard Therapy | Side Effects From Study Remedy | diarrhea | 6 participants |
| Standard Therapy | Side Effects From Study Remedy | hyper behavior | 10 participants |
| Standard Therapy | Side Effects From Study Remedy | headache | 10 participants |
| Standard Therapy | Side Effects From Study Remedy | lethargy | 23 participants |
| Standard Therapy | Side Effects From Study Remedy | other symptom reported | 23 participants |
| Standard Therapy | Side Effects From Study Remedy | decreased hearing | 0 participants |
| Standard Therapy | Side Effects From Study Remedy | plugged ears | 0 participants |
| Standard Therapy | Side Effects From Study Remedy | redness around ear with drops | 0 participants |