Trial Outcomes & Findings for Homeopathic Ear Drops for Otitis Media Study (NCT NCT01003210)
NCT ID: NCT01003210
Last Updated: 2018-06-08
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
210 participants
Primary outcome timeframe
15 days
Results posted on
2018-06-08
Participant Flow
Participant milestones
| Measure |
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
|
Standard Therapy
standard therapy for otitis media, no ear drops
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
105
|
|
Overall Study
COMPLETED
|
104
|
102
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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
|
Standard Therapy
standard therapy for otitis media, no ear drops
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Homeopathic Ear Drops for Otitis Media Study
Baseline characteristics by cohort
| Measure |
Homeopathic Ear Drops
n=105 Participants
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
|
Standard Therapy
n=105 Participants
standard therapy for otitis media, no ear drops
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
105 Participants
n=93 Participants
|
105 Participants
n=4 Participants
|
210 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
3.9 years
STANDARD_DEVIATION 2.8 • n=93 Participants
|
4.2 years
STANDARD_DEVIATION 2.6 • n=4 Participants
|
4.1 years
STANDARD_DEVIATION 2.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
128 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=93 Participants
|
105 participants
n=4 Participants
|
210 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 15 daysEar 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
Outcome measures
| Measure |
Homeopathic Ear Drops
n=101 Participants
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
|
Standard Therapy
n=99 Participants
standard therapy for otitis media, no ear drops
|
|---|---|---|
|
Severity of Symptoms of Otitis Media
|
2.0 units on a scale
Standard Deviation 4.5
|
2.0 units on a scale
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: 15 daysNumber of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.
Outcome measures
| Measure |
Homeopathic Ear Drops
n=104 Participants
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
|
Standard Therapy
n=102 Participants
standard therapy for otitis media, no ear drops
|
|---|---|---|
|
Administration of Antibiotics
|
28 participants
|
42 participants
|
SECONDARY outcome
Timeframe: 15 daysPopulation: The number of participants analyzed includes only those whose parents returned logbooks.
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.
Outcome measures
| Measure |
Homeopathic Ear Drops
n=72 Participants
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
|
Standard Therapy
n=78 Participants
standard therapy for otitis media, no ear drops
|
|---|---|---|
|
Side Effects From Study Remedy
vomit
|
4 participants
|
5 participants
|
|
Side Effects From Study Remedy
rash
|
3 participants
|
11 participants
|
|
Side Effects From Study Remedy
diarrhea
|
5 participants
|
6 participants
|
|
Side Effects From Study Remedy
"hyper" behavior
|
6 participants
|
10 participants
|
|
Side Effects From Study Remedy
headache
|
9 participants
|
10 participants
|
|
Side Effects From Study Remedy
lethargy
|
15 participants
|
23 participants
|
|
Side Effects From Study Remedy
other symptom reported
|
14 participants
|
23 participants
|
|
Side Effects From Study Remedy
decreased hearing
|
1 participants
|
0 participants
|
|
Side Effects From Study Remedy
"plugged" ears
|
1 participants
|
0 participants
|
|
Side Effects From Study Remedy
redness around ear with drops
|
1 participants
|
0 participants
|
|
Side Effects From Study Remedy
ear popping
|
1 participants
|
0 participants
|
Adverse Events
Homeopathic Ear Drops
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Standard Therapy
Serious events: 0 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Homeopathic Ear Drops
n=104 participants at risk
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
|
Standard Therapy
n=102 participants at risk
standard therapy for otitis media, no ear drops
|
|---|---|---|
|
Gastrointestinal disorders
vomit
|
3.8%
4/104 • Number of events 5
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
4.9%
5/102 • Number of events 8
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
|
Skin and subcutaneous tissue disorders
rash
|
2.9%
3/104 • Number of events 8
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
10.8%
11/102 • Number of events 22
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
|
Gastrointestinal disorders
diarrhea
|
4.8%
5/104 • Number of events 14
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
5.9%
6/102 • Number of events 15
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
|
Psychiatric disorders
"hyper" behavior
|
8.7%
9/104 • Number of events 22
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
9.8%
10/102 • Number of events 16
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
|
General disorders
Headache
|
8.7%
9/104 • Number of events 22
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
9.8%
10/102 • Number of events 16
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
|
General disorders
lethargy
|
14.4%
15/104 • Number of events 27
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
22.5%
23/102 • Number of events 58
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
|
General disorders
Others
|
13.5%
14/104 • Number of events 48
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
22.5%
23/102 • Number of events 83
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
|
Ear and labyrinth disorders
decreased hearing
|
0.96%
1/104 • Number of events 4
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
0.00%
0/102
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
|
Ear and labyrinth disorders
ear plugging
|
0.96%
1/104 • Number of events 2
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
0.00%
0/102
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
|
Ear and labyrinth disorders
ears popping
|
0.96%
1/104 • Number of events 1
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
0.00%
0/102
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
|
Skin and subcutaneous tissue disorders
redness around ear
|
0.96%
1/104 • Number of events 2
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
0.00%
0/102
Adverse data were not collected on 4 children including 1 randomized to the ear drop group and 3 receiving standard therapy alone.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place