Trial Outcomes & Findings for Ear Drops for Children With Otitis Media (NCT NCT00622518)
NCT ID: NCT00622518
Last Updated: 2010-12-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
5 days
Results posted on
2010-12-02
Participant Flow
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
Participant milestones
| Measure |
Ear Drops Plus Standard Therapy
homeopathic ear drops in addition to standard care for otitis media
|
Standard Therapy Alone
No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
60
|
|
Overall Study
COMPLETED
|
59
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ear Drops for Children With Otitis Media
Baseline characteristics by cohort
| Measure |
Ear Drops Plus Standard Therapy
n=59 Participants
homeopathic ear drops in addition to standard care for otitis media
|
Standard Therapy Alone
n=60 Participants
No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
59 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
3.6 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
3.4 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
3.5 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
60 participants
n=7 Participants
|
119 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: 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
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.
Outcome measures
| Measure |
Ear Drops Plus Standard Therapy
n=44 Participants
homeopathic ear drops in addition to standard care for otitis media
|
Standard Therapy Alone
n=50 Participants
No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
|
|---|---|---|
|
Resolution of Otitis Media Symptoms
Assessment 1: day 1, am
|
14.2 units on a scale
Standard Deviation 8.2
|
16.5 units on a scale
Standard Deviation 8.2
|
|
Resolution of Otitis Media Symptoms
Assessment 2: day 1, pm
|
7.5 units on a scale
Standard Deviation 10.5
|
14.1 units on a scale
Standard Deviation 7.4
|
|
Resolution of Otitis Media Symptoms
Assessment 3: day 2, am
|
6.1 units on a scale
Standard Deviation 6.7
|
10.8 units on a scale
Standard Deviation 8.1
|
|
Resolution of Otitis Media Symptoms
Assessment 4: day 2, pm
|
6.7 units on a scale
Standard Deviation 6.0
|
8.7 units on a scale
Standard Deviation 7.8
|
|
Resolution of Otitis Media Symptoms
Assessment 5: day 3, am
|
6.1 units on a scale
Standard Deviation 6.6
|
7.0 units on a scale
Standard Deviation 8.3
|
|
Resolution of Otitis Media Symptoms
Assessment 6: day 3, pm
|
5.2 units on a scale
Standard Deviation 6.3
|
7.3 units on a scale
Standard Deviation 8.7
|
|
Resolution of Otitis Media Symptoms
Assessment 7: day 4, am
|
3.8 units on a scale
Standard Deviation 6.1
|
5.8 units on a scale
Standard Deviation 7.8
|
|
Resolution of Otitis Media Symptoms
Assessment 8: day 4, pm
|
3.3 units on a scale
Standard Deviation 5.1
|
3.7 units on a scale
Standard Deviation 5.7
|
|
Resolution of Otitis Media Symptoms
Assessment 9: day 5, am
|
2.8 units on a scale
Standard Deviation 5.7
|
3.7 units on a scale
Standard Deviation 5.7
|
|
Resolution of Otitis Media Symptoms
Assessment 10: day 5, pm
|
2.3 units on a scale
Standard Deviation 4.1
|
3.4 units on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: 5 daysPopulation: 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.
Outcome measures
| Measure |
Ear Drops Plus Standard Therapy
n=59 Participants
homeopathic ear drops in addition to standard care for otitis media
|
Standard Therapy Alone
n=60 Participants
No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
|
|---|---|---|
|
Side Effects of Therapy
rash reported at least once in diary
|
3 participants
|
5 participants
|
|
Side Effects of Therapy
Any side effect reported in diary
|
29 participants
|
37 participants
|
|
Side Effects of Therapy
vomiting reported at least once in diary
|
5 participants
|
10 participants
|
|
Side Effects of Therapy
diarrhea reported at least once in diary
|
3 participants
|
12 participants
|
|
Side Effects of Therapy
"hyper" behavior reported at least once in diary
|
3 participants
|
11 participants
|
|
Side Effects of Therapy
headache reported at least once in diary
|
7 participants
|
6 participants
|
|
Side Effects of Therapy
lethargy reported at least once in diary
|
13 participants
|
15 participants
|
|
Side Effects of Therapy
other symptom reported at least once in diary
|
19 participants
|
22 participants
|
|
Side Effects of Therapy
serious side effect reported
|
0 participants
|
0 participants
|
Adverse Events
Ear Drops Plus Standard Therapy
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Standard Therapy Alone
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ear Drops Plus Standard Therapy
n=44 participants at risk；n=59 participants at risk
homeopathic ear drops in addition to standard care for otitis media
|
Standard Therapy Alone
n=50 participants at risk；n=60 participants at risk
No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
|
|---|---|---|
|
Gastrointestinal disorders
vomiting
|
11.4%
5/44 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
20.0%
10/50 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
|
Skin and subcutaneous tissue disorders
rash
|
6.8%
3/44 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
10.0%
5/50 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
|
Gastrointestinal disorders
diarrhea
|
6.8%
3/44 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
24.0%
12/50 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
|
General disorders
"hyper" behavior
|
6.8%
3/44 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
22.0%
11/50 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
|
General disorders
headache
|
15.9%
7/44 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
12.0%
6/50 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
|
General disorders
lethargy
|
29.5%
13/44 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
50.0%
25/50 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
|
General disorders
other
|
43.2%
19/44 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
44.0%
22/50 • 2 weeks
The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place