Acute Otitis Media
Conditions
Keywords
otitis media, children
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. A total of 120 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
Standard Homeopathic Company
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
* Presenting to participating clinic with otitis media * Diagnosed with acute otitis media * Parents rate symptoms as a moderate problem or more
Exclusion criteria
* Diagnosis of otitis media within preceding 30 days * Receipt of antibiotics within 2 days * Perforated ear drum or bullous lesion * Receipt of homeopathic treatment within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Otitis Media Symptoms | 5 days | Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day. |
Secondary
| Measure | Time frame |
|---|---|
| Side Effects of Therapy | 5 days |
Countries
United States
Participant flow
Recruitment details
patients were recruited from 2/4/08 through 2/23/09 at a pediatric primary care clinic at the time of a visit for acute otitis media
Participants by arm
| Arm | Count |
|---|---|
| Ear Drops Plus Standard Therapy homeopathic ear drops in addition to standard care for otitis media | 59 |
| Standard Therapy Alone No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen | 60 |
| Total | 119 |
Baseline characteristics
| Characteristic | Standard Therapy Alone | Ear Drops Plus Standard Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 60 Participants | 59 Participants | 119 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 | 3.4 years STANDARD_DEVIATION 2.4 | 3.6 years STANDARD_DEVIATION 2.5 | 3.5 years STANDARD_DEVIATION 2.4 |
| Region of Enrollment United States | 60 participants | 59 participants | 119 participants |
| Sex: Female, Male Female | 25 Participants | 30 Participants | 55 Participants |
| Sex: Female, Male Male | 35 Participants | 29 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 29 / 44 | 37 / 50 |
| serious Total, serious adverse events | 0 / 59 | 0 / 60 |
Outcome results
Primary
Resolution of Otitis Media Symptoms
Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.
Time frame: 5 days
Population: Data were analyzed on participants from whom data diaries were returned and who had data for an assessment. Data were analyzed on the following number of children at each assessment: 1- 50 standard care (SC),40 ear drop (ED) 2- 40SC 35ED 3- 49SC 37ED 4- 40SC 36ED 5- 44SC 35ED 6- 42SC 34ED 7- 44SC 34ED 8- 43SC 31ED 9- 44SC 33ED 10- 44SC 29ED
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ear Drops Plus Standard Therapy | Resolution of Otitis Media Symptoms | Assessment 7: day 4, am | 3.8 units on a scale | Standard Deviation 6.1 |
| Ear Drops Plus Standard Therapy | Resolution of Otitis Media Symptoms | Assessment 5: day 3, am | 6.1 units on a scale | Standard Deviation 6.6 |
| Ear Drops Plus Standard Therapy | Resolution of Otitis Media Symptoms | Assessment 1: day 1, am | 14.2 units on a scale | Standard Deviation 8.2 |
| Ear Drops Plus Standard Therapy | Resolution of Otitis Media Symptoms | Assessment 2: day 1, pm | 7.5 units on a scale | Standard Deviation 10.5 |
| Ear Drops Plus Standard Therapy | Resolution of Otitis Media Symptoms | Assessment 8: day 4, pm | 3.3 units on a scale | Standard Deviation 5.1 |
| Ear Drops Plus Standard Therapy | Resolution of Otitis Media Symptoms | Assessment 4: day 2, pm | 6.7 units on a scale | Standard Deviation 6 |
| Ear Drops Plus Standard Therapy | Resolution of Otitis Media Symptoms | Assessment 9: day 5, am | 2.8 units on a scale | Standard Deviation 5.7 |
| Ear Drops Plus Standard Therapy | Resolution of Otitis Media Symptoms | Assessment 3: day 2, am | 6.1 units on a scale | Standard Deviation 6.7 |
| Ear Drops Plus Standard Therapy | Resolution of Otitis Media Symptoms | Assessment 10: day 5, pm | 2.3 units on a scale | Standard Deviation 4.1 |
| Ear Drops Plus Standard Therapy | Resolution of Otitis Media Symptoms | Assessment 6: day 3, pm | 5.2 units on a scale | Standard Deviation 6.3 |
| Standard Therapy Alone | Resolution of Otitis Media Symptoms | Assessment 10: day 5, pm | 3.4 units on a scale | Standard Deviation 5.7 |
| Standard Therapy Alone | Resolution of Otitis Media Symptoms | Assessment 5: day 3, am | 7.0 units on a scale | Standard Deviation 8.3 |
| Standard Therapy Alone | Resolution of Otitis Media Symptoms | Assessment 2: day 1, pm | 14.1 units on a scale | Standard Deviation 7.4 |
| Standard Therapy Alone | Resolution of Otitis Media Symptoms | Assessment 3: day 2, am | 10.8 units on a scale | Standard Deviation 8.1 |
| Standard Therapy Alone | Resolution of Otitis Media Symptoms | Assessment 4: day 2, pm | 8.7 units on a scale | Standard Deviation 7.8 |
| Standard Therapy Alone | Resolution of Otitis Media Symptoms | Assessment 6: day 3, pm | 7.3 units on a scale | Standard Deviation 8.7 |
| Standard Therapy Alone | Resolution of Otitis Media Symptoms | Assessment 7: day 4, am | 5.8 units on a scale | Standard Deviation 7.8 |
| Standard Therapy Alone | Resolution of Otitis Media Symptoms | Assessment 8: day 4, pm | 3.7 units on a scale | Standard Deviation 5.7 |
| Standard Therapy Alone | Resolution of Otitis Media Symptoms | Assessment 9: day 5, am | 3.7 units on a scale | Standard Deviation 5.7 |
| Standard Therapy Alone | Resolution of Otitis Media Symptoms | Assessment 1: day 1, am | 16.5 units on a scale | Standard Deviation 8.2 |
p-value: 0.002linear mixed model
Secondary
Side Effects of Therapy
Time frame: 5 days
Population: Specific side effects were collected on patients whose parents returned study diaries (44 from ear drop group and 50 from standard care only group). In addition, parents were telephoned and asked about any serious side effects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ear Drops Plus Standard Therapy | Side Effects of Therapy | vomiting reported at least once in diary | 5 participants |
| Ear Drops Plus Standard Therapy | Side Effects of Therapy | hyper behavior reported at least once in diary | 3 participants |
| Ear Drops Plus Standard Therapy | Side Effects of Therapy | Any side effect reported in diary | 29 participants |
| Ear Drops Plus Standard Therapy | Side Effects of Therapy | headache reported at least once in diary | 7 participants |
| Ear Drops Plus Standard Therapy | Side Effects of Therapy | rash reported at least once in diary | 3 participants |
| Ear Drops Plus Standard Therapy | Side Effects of Therapy | lethargy reported at least once in diary | 13 participants |
| Ear Drops Plus Standard Therapy | Side Effects of Therapy | other symptom reported at least once in diary | 19 participants |
| Ear Drops Plus Standard Therapy | Side Effects of Therapy | serious side effect reported | 0 participants |
| Ear Drops Plus Standard Therapy | Side Effects of Therapy | diarrhea reported at least once in diary | 3 participants |
| Standard Therapy Alone | Side Effects of Therapy | serious side effect reported | 0 participants |
| Standard Therapy Alone | Side Effects of Therapy | Any side effect reported in diary | 37 participants |
| Standard Therapy Alone | Side Effects of Therapy | vomiting reported at least once in diary | 10 participants |
| Standard Therapy Alone | Side Effects of Therapy | rash reported at least once in diary | 5 participants |
| Standard Therapy Alone | Side Effects of Therapy | diarrhea reported at least once in diary | 12 participants |
| Standard Therapy Alone | Side Effects of Therapy | hyper behavior reported at least once in diary | 11 participants |
| Standard Therapy Alone | Side Effects of Therapy | headache reported at least once in diary | 6 participants |
| Standard Therapy Alone | Side Effects of Therapy | other symptom reported at least once in diary | 22 participants |
| Standard Therapy Alone | Side Effects of Therapy | lethargy reported at least once in diary | 15 participants |