This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Ear Drops for Children With Otitis Media (NCT00622518), a randomized na study. The primary outcome is Resolution of Otitis Media Symptoms.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00622518 |
| Phase | NA |
| Condition | Acute Otitis Media |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 119 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
Children 6 months–11 years old with acute otitis media were the intended population. The registry says that the primary-outcome analysis included children whose data diaries were returned and who had data for an assessment; the number contributing therefore varied by assessment.
Intervention
The intervention was Hyland's earache drops, described as homeopathic ear drops given in addition to standard care for otitis media.
Comparator
The comparison group received standard care without ear drops. The registry does not describe the details of standard care.
Primary question
The primary question was whether symptom scores on the Ear Treatment Group-5 scale differed between the groups over the stated 5 days. The registry record does not report the group scores or a statistical comparison, so it does not establish the direction, size, or precision of any difference.
The study description also proposed examining whether children using drops had more rapid symptom resolution and needed fewer antibiotics. Those statements describe the rationale, not results. The listed primary outcome is a symptom score, while the listed secondary outcome concerns side effects of therapy. Antibiotic use is not listed among the reported outcomes in the registry record.
The study was randomized and parallel, with an ear-drop group and a no-ear-drop group. The registry does not report the allocation ratio, the method used to generate or conceal allocation, or whether families or outcome assessors knew the assigned group. Masking is recorded as none. These design details matter when interpreting a subjective symptom scale, but the record does not provide enough information to assess their implementation.
3. Trial Design
The registry describes a randomized, parallel-group trial with no masking. Children were assigned to receive homeopathic ear drops in addition to standard care or standard care alone. The recorded enrollment was 119. The brief study description refers to a total of 120 study patients, so the planned total described there and the recorded enrollment are not the same. The registry does not explain that difference.
The study is listed as completed, with a start date of 2008-02 and a primary completion date of 2009-02. The sponsor was the University of Washington. The phase entry is NA; the registry does not give a more specific phase description.
The primary outcome was mean symptom severity measured with the Ear Treatment Group-5 scale. The outcome timeframe is stated as 5 days, and the scale description says that two assessments were conducted each day. The registry also gives analysis counts for numbered assessments 1 through 7. It does not explain how those numbered assessments relate to the stated timeframe or the twice-daily schedule.
The primary-outcome population was not simply described as all enrolled participants. The registry says that analyses used participants whose diaries were returned and who had data for an assessment. The number of children analyzed differed across assessments. This means the available analysis population could vary over time; the record does not describe a method for handling missing assessments or whether any other analysis population was used.
Although the registry records randomization, it does not report the allocation sequence method, concealment procedure, or a detailed treatment protocol. It also does not report a statistical analysis plan or sample-size justification for the trial. These omissions limit how fully the conduct and analysis can be evaluated from the registry record alone.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Ear Drops Plus Standard Therapy | Standard Therapy Alone |
|---|---|---|
| STARTED | 59 | 60 |
| COMPLETED | 59 | 60 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: 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
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Ear Drops Plus Standard Therapy | Standard Therapy Alone | Total |
|---|---|---|---|---|
| Participants analysed | 59 | 60 | 119 | |
| Age, Categorical: <=18 years | Participants | 59 | 60 | 119 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age Continuous | years | 3.6 (SD 2.5) | 3.4 (SD 2.4) | 3.5 (SD 2.4) |
| Sex: Female, Male: Female | Participants | 30 | 25 | 55 |
| Sex: Female, Male: Male | Participants | 29 | 35 | 64 |
| Region of Enrollment: United States | participants | 59 | 60 | 119 |
6. Primary Endpoint
The registry lists the primary outcome as Resolution of Otitis Media Symptoms, measured over 5 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was resolution of otitis media symptoms, assessed as the mean score on the Ear Treatment Group-5 scale. The scale covers fever, earache or tugging, feeding, irritability, and sleep. Each component is rated 0, 4, or 7 according to symptom severity, with higher scores indicating more severe symptoms. Component scores are added to produce a total score ranging from 0-35.
A symptom scale can give a structured way to compare symptom burden between groups rather than relying only on a broad judgment that a child is better or worse. Repeated assessments can also describe how scores change during follow-up. These are general reasons for using a symptom measure; the registry record does not explain why this particular scale or endpoint was selected.
The stated timeframe is 5 days, and the description says that two assessments were conducted each day. However, the registry does not report group means, standard deviations, changes in score, or a between-group estimate for the primary endpoint. It also does not specify which assessment or summary across assessments was used for the primary comparison. Consequently, the endpoint's definition is available, but the posted results do not show the observed symptom-score comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a randomized comparison and defines a continuous primary outcome, but it does not report the numerical primary-outcome results. No group means, standard deviations, treatment-effect estimate, confidence interval, or p-value for symptom scores are reported in the registry record. Without those results, the direction and magnitude of the observed difference cannot be described, and its statistical precision cannot be assessed.
The analysis counts show that different numbers of children contributed data at different numbered assessments. For assessment 1, the record lists 50 standard-care children and 40 ear-drop children; for assessment 2, 40 and 35; for assessment 3, 49 and 37; for assessment 4, 40 and 36; for assessment 5, 44 and 35; for assessment 6, 42 and 34; and for assessment 7, 44 and 34. These are assessment-specific counts, not outcome scores. They cannot establish whether symptoms improved, whether one group changed more, or whether any difference was clinically important.
In general, a confidence interval describes the range of effect estimates compatible with the data under the analysis assumptions. A narrow interval indicates greater precision than a wide interval, while an interval that includes no difference may leave substantial uncertainty about the direction of an effect. Those concepts cannot be applied to this primary outcome without a reported estimate and interval.
The safety entries report zero serious adverse events among 59 participants at risk in the ear-drops-plus-standard-therapy group and among 60 at risk in the standard-therapy-alone group. Other adverse events are reported for the listed at-risk groups, but those counts do not answer the primary symptom question. The safety entries also do not establish whether an event was caused by treatment.
The registry's purpose statement says that the study was intended to assess symptom reduction and discusses a hypothesis about faster resolution and antibiotic use. A stated purpose or hypothesis is not evidence that the expected result occurred. The posted registry information is insufficient to conclude whether symptom scores differed between groups or how precisely any difference was estimated.
9. Statistical Methods Explained
The reported primary measure is continuous: it is a numerical score assembled from symptom ratings. The registry specifies that the outcome was summarized as a mean with standard deviation. In general, a mean describes the central level of scores, while a standard deviation describes how spread out individual scores are around that mean. Reporting both can help readers understand the observed group data, but the registry record does not include the primary-outcome means or standard deviations.
What does a between-group estimate describe?
In general, a treatment-effect estimate for a continuous outcome expresses how far apart the groups' mean scores are under a specified analysis. Its interpretation depends on the scale's direction: this scale assigns higher values to more severe symptoms. The estimate also needs a clearly defined time point or summary period. Here, the record states a 5-day timeframe and describes two assessments each day, but it does not say which time point or combined summary was used for the primary comparison. No primary between-group estimate is reported.
Why does the analysis model matter?
General statistical practice distinguishes an unadjusted comparison of group means from models that account for additional features of the data. Repeated scores from the same child are related rather than independent observations. A suitable repeated-measures analysis can account for that within-child relationship and can use the pattern of scores over time; other approaches may instead define a single summary per participant. The registry record does not report which approach was used, what covariates were included, or how dependence among repeated assessments was handled. No particular model should therefore be attributed to this study.
In general, the assumptions behind an analysis affect how its uncertainty is calculated. For mean-based methods, the distribution of scores, the spread of scores, and the independence structure matter. If variability differs across groups or observations are related, a method that ignores those features may give misleading uncertainty. The registry provides the scale definition and assessment counts, but does not report diagnostic checks or enough outcome data to assess these assumptions.
How should significance and precision be read?
A p-value, when reported, measures how incompatible the observed data are with a specified null model under the analysis assumptions; it is not the probability that a treatment has no effect. A confidence interval is generally more informative about the range and precision of an estimated effect. Neither a p-value nor an interval for the primary endpoint is reported in the registry record. The registry also does not report an analysis plan that would identify the primary statistical test or explain how the outcome was modeled.
The study description notes multiple assessments during follow-up, and the registry lists more than one outcome measure. In general, making multiple comparisons can increase the chance of a result appearing unusual by chance if every comparison is treated as a separate test. A prespecified hierarchy or an adjustment for multiplicity can address some of that concern, but the registry record does not report whether a strategy was planned or used. It is also unclear whether the numbered assessments were analyzed separately, combined, or treated as repeated observations in one model.
What do the planning illustrations mean?
General sample-size planning asks how many participants would be needed to detect a defined effect with a chosen significance level and power, subject to assumptions about variability and the analysis. The planning assumptions associated with this trial use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect framed as a fraction of the observed effect. These assumptions describe planning illustrations, not the trial's original design justification. The registry record does not report the trial's own sample-size calculation or the numerical effect and variability inputs needed to assess such planning. Any planning estimate is not observed power and is not evidence that the trial detected an effect.
In general, observed power calculated after a study from its estimated effect largely restates the observed result and does not resolve uncertainty. Interpretation should instead focus on the estimate, its confidence interval, the analysis population, and the analysis assumptions. Since the registry does not report the primary estimate or interval, those features cannot be evaluated for this trial.
The registry records one analysis, but that count alone does not identify the statistical procedure, the analysis population, or whether the analysis was prespecified. It also does not establish that only one comparison was performed. Further details about the analysis methods are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry describes repeated symptom assessments and lists side effects of therapy as a secondary outcome in addition to the primary symptom outcome. Multiple time points and outcomes can raise multiplicity questions: in general, the more comparisons considered, the greater the opportunity for chance findings if no plan governs interpretation. The registry record does not report whether a primary time point was selected in advance, whether the repeated assessments were combined, or whether any adjustment or testing hierarchy was used. It therefore does not support a conclusion about how multiplicity was handled.
Missing data are relevant because the primary-outcome analysis population is described as participants with returned diaries and data for an assessment. The number analyzed varied across numbered assessments: assessment 1 lists 50 standard-care and 40 ear-drop participants; assessment 2 lists 40 and 35; assessment 3 lists 49 and 37; assessment 4 lists 40 and 36; assessment 5 lists 44 and 35; assessment 6 lists 42 and 34; and assessment 7 lists 44 and 34. These counts describe available observations but do not explain why data were absent or whether missingness was related to symptoms or treatment.
In general, excluding participants without an observed assessment can affect a comparison if those participants differ systematically from those with data. Methods such as imputation or likelihood-based analyses may address missing outcomes under stated assumptions, but the registry record does not report whether such methods were used. It also does not report a complete-case definition beyond the diary-and-assessment description, a sensitivity analysis, or a separate intention-to-treat analysis population. The effect of missing data on the results cannot be assessed without those details and the outcome estimates.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Ear Drops Plus Standard Therapy | 0 | 59 | 0.0% |
| Standard Therapy Alone | 0 | 60 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ear Drops Plus Standard Therapy | 29 of 44 |
| Standard Therapy Alone | 37 of 50 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ear Drops Plus Standard Therapy | Standard Therapy Alone |
|---|---|---|---|
| other | General disorders | 19 of 44 | 22 of 50 |
| lethargy | General disorders | 13 of 44 | 25 of 50 |
| vomiting | Gastrointestinal disorders | 5 of 44 | 10 of 50 |
| diarrhea | Gastrointestinal disorders | 3 of 44 | 12 of 50 |
| "hyper" behavior | General disorders | 3 of 44 | 11 of 50 |
| headache | General disorders | 7 of 44 | 6 of 50 |
| rash | Skin and subcutaneous tissue disorders | 3 of 44 | 5 of 50 |
The registry reports zero serious adverse events among 59 participants at risk in the ear-drops-plus-standard-therapy group and zero among 60 participants at risk in the standard-therapy-alone group. No serious adverse-event terms are listed. Deaths are not reported in the registry record.
For other adverse events, the registry lists 29 affected participants among 44 at risk in the ear-drops-plus-standard-therapy group, and 37 affected participants among 50 at risk in the standard-therapy-alone group. These are the recorded counts; they are not a comparison adjusted for differences in follow-up or other factors. The at-risk counts for other events differ from the serious-event at-risk counts, so the denominators should be read as reported for their respective entries.
In general, an adverse event is not necessarily caused by the treatment under study. The registry's counts do not identify whether events were judged related to the ear drops, how events were defined or collected, or whether follow-up was complete for all participants. The absence of reported serious events in these entries should be read as a description of the registry data, not as proof that no serious event occurred outside the recorded information or that the treatment is safe.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized comparison was conducted between homeopathic ear drops plus standard care and standard care alone for children with acute otitis media. It also gives a detailed definition of the symptom scale, a stated outcome timeframe, assessment-specific analysis counts, and safety counts. These details help describe the intended question and some aspects of the recorded study.
However, the registry does not report the mean symptom scores or a statistical comparison between groups. It therefore does not show whether the groups had similar or different symptom scores, the size of any difference, or the precision of an estimate. The study's stated hypothesis about symptom resolution is not a result, and the record does not report antibiotic-use results.
In general, a randomized design can support a comparison between assigned groups when the randomization and analysis are implemented appropriately. But design labels alone do not establish that the groups were comparable in all relevant respects, that outcome data were complete, or that an analysis was unbiased. The registry does not include enough information about allocation procedures, analysis methods, missing-data handling, or the primary results to judge those features fully.
Safety counts should also be interpreted within their reporting limits. The recorded serious and other adverse-event counts describe what the registry lists for the stated groups; they do not by themselves determine causation or provide a complete assessment of treatment risks.
Accordingly, the appropriate reading is limited: the registry describes the trial question and some design and safety information, but it does not provide the primary efficacy results needed to assess the observed symptom-score comparison. No conclusion about whether the drops changed symptoms can be drawn from the posted registry data alone.
13. Why This Trial Matters Statistically
This trial illustrates why a registry record needs both a clear outcome definition and the numerical results for that outcome. The Ear Treatment Group-5 scale is described in detail, including its symptom components, scoring direction, and total-score range. Yet without group scores and an estimated between-group difference, the endpoint definition cannot answer the comparative question on its own.
It also illustrates the importance of defining the time point or summary used for a repeated outcome. The registry describes two daily assessments over a stated 5-day timeframe and gives counts for numbered assessments 1 through 7. The relationship among those details is not explained, and no primary analysis method is reported. Readers therefore cannot tell how the repeated measurements were combined or how their dependence was handled.
The varying assessment counts make the analysis population important to interpretation. A count of participants with observed data at each assessment does not explain why data are missing or how missing observations were treated. In general, these choices can affect both the estimated group difference and its uncertainty.
Finally, the record shows the distinction between a trial's rationale and its evidence. The description states that the study was intended to test a symptom hypothesis, but the primary-outcome results are not reported. Reporting the estimate and its precision, along with the analysis choices and missing-data approach, is essential for readers to evaluate what the trial observed rather than infer findings from its aim or design.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important limitation of the available record is that it does not report the primary symptom-score results. Group means, standard deviations, an effect estimate, a confidence interval, and a p-value are not reported in the registry record. This prevents assessment of the observed direction, magnitude, or precision of the primary comparison.
The primary outcome is described as measured over 5 days, with two assessments each day, but the analysis counts are presented for numbered assessments 1 through 7. The record does not explain how those numbered assessments align with the timeframe or which assessment or summary was used for the primary analysis. The statistical model and handling of within-child repeated measurements are also not reported.
The record says that primary-outcome analyses included participants whose diaries were returned and who had assessment data. The number contributing varied across assessments, but reasons for missing data and methods for handling it are not reported. The record does not describe a separate intention-to-treat analysis or sensitivity analyses.
Additional design details are not reported, including the allocation sequence method, concealment procedure, and details of standard care. Masking is recorded as none. The registry does not give a statistical analysis plan, a trial-specific sample-size justification, or information about multiplicity procedures. The brief description refers to 120 study patients, while recorded enrollment is 119; the record does not explain the difference.
Finally, the safety entries do not report deaths, event definitions, relatedness assessments, or details of adverse-event collection. These omissions limit interpretation of both the clinical outcome and safety information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Ear Drops for Children With Otitis Media — NCT00622518.
- Registry record last updated 2010-12-02; status last verified 2010-11.
- Results first posted 2010-12-02.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed randomized, parallel-group study sponsored by the University of Washington. It enrolled 119 children with acute otitis media, comparing homeopathic ear drops plus standard care with standard care alone. Masking is recorded as none. The recorded study dates are 2008-02 to 2009-02.
The primary outcome was mean symptom severity on the Ear Treatment Group-5 scale, with a stated timeframe of 5 days. The registry gives the scale's components and scoring but does not report the primary group results or their statistical comparison. Analysis counts vary across numbered assessments, and the method for handling repeated observations or missing data is not reported.
The registry lists side effects of therapy as a secondary outcome and reports serious and other adverse-event counts. It does not report deaths. The primary symptom findings, trial-specific sample-size justification, analysis plan, and multiplicity approach are not reported in the registry record.