Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps (NCT02927834), a randomized na study. The primary outcome is Sinonasal Outcome Test (SNOT 20).

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group study with no masking. It lists three groups: Antibiotic Only, Augmentin With 6 Day Steroid, and Augmentin With 21 Day Steroid. Thus the registered comparison concerns antibiotic treatment alone and antibiotic treatment accompanied by one of two prednisone tapers. The record does not report allocation concealment, the method used to generate the random sequence, or whether any aspect of treatment or outcome assessment was masked.

The antibiotic-only regimen is listed as Augmentin (amoxicillin/clavulanate 875/125mg) taken orally twice a day for 3 weeks. The 6 day steroid group received a prednisone taper alongside Augmentin, starting at 40mg daily for 2 days, followed by 20mg daily for 2 days and 10mg daily for 2 days. The 21 day steroid group received Augmentin with prednisone at 40mg daily for 5 days, then 30mg, 20mg, and 10mg daily for 5 days at each dose level.

The registry lists enrollment as 24 and the study status as completed. The start is recorded as 2015-08 and primary completion as 2018-12. The study is listed as phase NA and sponsored by Loma Linda University. Enrollment is not the same as the number contributing to a particular analysis; the posted outcome lists n values of 7.0 for Antibiotic Only, 6.0 for Augmentin With 6 Day Steroid, and 6.0 for Augmentin With 21 Day Steroid. Reasons for the differences between enrollment and those outcome counts are not reported in the registry record.

The registry summary explains that oral steroids are used in some patients with chronic rhinosinusitis without nasal polyps, while their role in this population is less clear than for patients with nasal polyps. It states that the study aimed to evaluate outcomes with oral steroids and to examine whether a short burst or longer taper makes a difference. The registered primary outcome is symptom score at 4 weeks post treatment.

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

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Sinonasal Outcome Test (SNOT 20), measured over 4 weeks post treatment.

The primary endpoint is the Sinonasal Outcome Test (SNOT 20) score at 4 weeks post treatment. The registry describes the measure as a 20-question assessment of nasal and sinus symptoms. Each question is scored from 0 to 5, with 0 meaning no symptoms and 5 meaning worse symptoms; the total score ranges from 0 to 100. A lower total represents a better symptom outcome.

This is a continuous measure: it represents symptom burden on a score scale rather than a count of events or a yes-or-no outcome. A mean provides a summary of the scores in a group, while a confidence interval describes uncertainty around that estimated mean under the statistical assumptions used. The registry identifies the reported dispersion as a 95% confidence interval. It does not give a standard deviation or participant-level scores.

A symptom questionnaire is used to assess how patients experience nasal and sinus symptoms, rather than relying only on a clinical event count. The chosen time point captures the registered outcome at 4 weeks post treatment. It does not, by itself, describe symptoms at other times or establish how durable any observed score pattern might be. The registry record does not report a threshold for a clinically important change, so the posted means cannot be classified against such a threshold from the record alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The posted endpoint is continuous, so the registry reports a mean score for each treatment group rather than an event count. A mean summarizes the central level of the observed scores. It does not show the spread or shape of individual scores, and it does not tell how many participants improved or worsened. Those details would require participant-level information or additional summaries, which are not reported in the registry record.

What does a confidence interval convey?

A 95% confidence interval expresses uncertainty in an estimated quantity under the assumptions of the statistical procedure used. In repeated applications of a procedure meeting those assumptions, intervals constructed in this way would contain the target quantity at the stated rate. It is not an interval that contains 95% of individual participant scores, and it is not a guarantee that the true value falls inside a particular reported interval. The registry identifies the intervals for the group means as 95% confidence intervals, but does not report the calculation method or assumptions used to obtain them.

The posted intervals are wide, which indicates that the group means are not estimated with high precision in these summaries. However, an interval around a single group mean does not quantify uncertainty in a difference between two means. A comparative analysis would normally estimate the contrast directly and report its uncertainty. The registry record does not report those comparative estimates or a test result. Overlap between separate group-mean intervals is not a substitute for that direct analysis.

Why is a direct treatment contrast important?

The clinical question concerns whether outcomes differ between regimens. To address it statistically, an analysis must define a contrast, such as comparing one registered group with another, and estimate the difference while accounting for the design and the available outcome data. The posted group means describe each group separately. The registry indicates that values are missing or not estimable for a two-arm comparison of this continuous endpoint, and lists 0 analyses. It therefore does not provide a direct contrast to interpret. No p-value or comparative confidence interval should be inferred from the separate summaries.

Randomization is intended to support fair comparisons by assigning participants to treatment groups according to a chance process. The record confirms randomized allocation but does not describe the sequence-generation procedure, concealment, or any adjustment used in analysis. The record also states that masking was none. In an unmasked study, participants and study personnel know the assigned treatment; this can matter for outcomes that depend on reported symptoms, although the record does not report whether or how such effects were assessed. This is a general methodological consideration, not evidence that bias occurred in this study.

How should the outcome counts be read?

The group counts accompanying the posted means are 7.0 for Antibiotic Only, 6.0 for Augmentin With 6 Day Steroid, and 6.0 for Augmentin With 21 Day Steroid. These are outcome-summary counts, not a statement that all randomized participants necessarily contributed to every analysis. The registry record does not explain why these counts differ from its listed enrollment of 24, whether observations were missing, or how missing values were treated. It also does not report an analysis population definition, such as an intention-to-treat population or a per-protocol population.

Small analyzed groups tend to yield less precise estimates, all else equal. The observed intervals are consistent with substantial uncertainty around the group means. Precision also depends on the variability of scores and the method of analysis; a standard deviation is not posted. Since there is no reported model or comparative test, it is not possible to assess whether any covariates, repeated measurements, or other features were considered. Such details are not reported in the registry record.

What do planning illustrations mean?

Sample-size planning uses assumptions about the effect to be detected, the statistical threshold, allocation, and analysis method to estimate how many participants might be needed in a future study. The stated planning assumptions for this record describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as fractions of the observed effect. Such outputs are planning illustrations based on the observed effect, not observed power for the completed trial. They do not establish the probability that this trial detected an effect, and they do not replace a comparative result. The registry record does not report the trial's own design justification, and no planning-output values should be treated as results of the enrolled study.

The data do not support recalculating or interpreting treatment contrasts from the posted summaries as if they were the sponsor's analysis. A simple unadjusted recalculation, when available, would have a different status from the sponsor's own analysis; the registry does not post a comparative sponsor analysis. The priority in interpreting these results is therefore the distinction between the descriptive means and the missing comparative inference.

10. Multiplicity, Missing Data and Analysis Populations

The study has three registered groups and one listed primary outcome, the SNOT 20 mean at 4 weeks post treatment. The stated objective also includes assessing whether a short course and a longer course of oral steroids make a difference. Comparing several groups can involve multiple possible pairwise questions. Testing multiple contrasts raises a general risk of false-positive findings unless the analysis plan addresses multiplicity. The registry record does not report a multiplicity adjustment, a prespecified hierarchy of comparisons, or a detailed statistical plan; no adjustment should be assumed.

The record lists 0 analyses and indicates that values are missing or not estimable for a two-arm comparison of the continuous endpoint. It posts group means and confidence intervals but no comparative tests. The registry does not report secondary posted outcomes, with 0 secondary outcomes listed. This does not reveal whether any additional outcomes were collected but not posted; such information is not reported in the registry record.

The registry record does not specify how missing outcome data were handled, whether every randomized participant was included in the endpoint summaries, or the analysis population definition. Reasons for missingness, if any, are not reported in the registry record. Without those details, it is not possible to assess whether the available outcome summaries represent all randomized participants or whether missing observations could affect the comparisons.

These omissions matter because analysis choices can influence both the estimate and its uncertainty. A prespecified analysis plan, defined analysis populations, and transparent reporting of missing observations and comparisons help readers distinguish planned analyses from exploratory ones. The absence of those details does not establish that an analysis was inappropriate; it limits what can be concluded from the registry results.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry reports serious adverse events, other adverse events, and deaths by group. For Antibiotic Only, 0 serious adverse events and 0 other adverse events are reported among the listed at-risk group of 7, with 0 deaths. For Augmentin With 6 Day Steroid, the record lists 0 serious adverse events and 0 other adverse events among 6 at risk, with 0 deaths. For Augmentin With 21 Day Steroid, it lists 0 serious adverse events and 0 other adverse events among 6 at risk, with 0 deaths.

These are the reported event counts for the groups and categories in the registry; they do not demonstrate that no adverse events of any kind occurred, or that all potential safety outcomes were assessed. The registry provides no serious adverse event terms in its list of top terms. The record does not describe the duration or completeness of safety follow-up, the event-collection methods, or whether events were independently adjudicated. Such details are not reported in the registry record.

Zero recorded events in these groups should be interpreted in light of the limited number at risk and the available follow-up information. Event counts alone do not estimate the rate of uncommon harms reliably, and the record does not post a formal comparative safety analysis. These figures describe what is recorded, not a guarantee that treatment is free of risk.

12. What the Result Does, and Does Not, Mean

The registry record provides descriptive symptom-score summaries for three randomized groups: antibiotic treatment alone, Augmentin with a 6 day prednisone taper, and Augmentin with a 21 day prednisone taper. The primary outcome is the mean SNOT 20 score at 4 weeks post treatment, for which lower scores indicate better reported symptoms. The posted means and their confidence intervals show the group-level outcome summaries recorded for that time point.

Those summaries do not establish whether adding prednisone changes the outcome compared with antibiotic treatment alone, or whether the two prednisone schedules differ. The registry does not post a direct treatment contrast, comparative confidence interval, or p-value, and it indicates that two-arm values are missing or not estimable for this endpoint. A reader should not treat the ordering of the means or overlap of the separate intervals as a formal test of treatment effect.

The record also does not report a clinically important difference threshold, detailed participant eligibility criteria, missing-data handling, analysis populations, or the statistical plan. These omissions limit assessment of clinical relevance, generalizability, and robustness. The group counts listed with the endpoint are smaller than the listed enrollment, and reasons for that are not given.

More generally, a study's observed estimates are not the same as proof of benefit or absence of benefit. Imprecise estimates can be compatible with a range of possible underlying effects. Here, the lack of a posted comparison is an additional barrier: the means alone do not quantify how much one regimen differs from another or how uncertain that contrast is. The registry results are best read as descriptive outcome and safety summaries, with comparative conclusions remaining unresolved in the posted record.

13. Why This Trial Matters Statistically

This trial addresses a statistical question that is more complex than comparing one treatment with a control. It has an antibiotic-only group and two antibiotic-plus-steroid regimens, so the stated purpose includes both the role of oral steroids and the comparison of a shorter course with a longer taper. Those objectives call for clearly defined contrasts and transparent reporting of how they were analyzed.

The posted endpoint is a patient-reported symptom score, which captures a different aspect of outcome from a count of clinical events. Its interpretation depends on the scale direction, timing, group summaries, and uncertainty. The registry identifies the score range and explains that lower scores indicate better outcomes. It also posts confidence intervals, making the degree of uncertainty visible, even though a comparative analysis is absent.

For biostatistical interpretation, the distinction between descriptive results and comparative evidence is central. Random assignment is an important design feature, but causal interpretation also depends on adequate outcome capture, a well-defined analysis population, and appropriate analysis and reporting. The registry confirms randomized allocation and no masking, but does not provide enough detail to evaluate these other elements fully.

The record therefore illustrates why a numerical difference between group means is not, on its own, a treatment-effect estimate with known precision. Readers need the direct contrast, its uncertainty, and the analysis context. The limited outcome counts and missing comparative analysis mean that the posted data can inform what was recorded in each group, while leaving the central between-group statistical question unanswered.

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.

Several limitations specific to this record constrain interpretation. Although the design is described as randomized, the record does not report how the random sequence was generated or whether allocation was concealed. It lists masking as none. Because the primary outcome is based on reported symptoms, lack of masking is relevant as a general source of possible measurement or reporting influence, but the record does not establish whether such influence occurred.

The registry reports an enrollment of 24, while the outcome summaries list n values of 7.0, 6.0, and 6.0. It does not explain the relationship between those figures, report participant flow, or describe missing outcomes. The outcome analysis population and any missing-data method are not reported in the registry record. These gaps make it difficult to assess whether the posted summaries reflect the originally randomized groups.

The primary endpoint is accompanied by group means and 95% confidence intervals, but no two-arm comparison is posted. The record lists 0 analyses and says the comparative values are missing or not estimable. Consequently, the core treatment contrasts and their uncertainty cannot be evaluated from the registry results. The registry also does not report standard deviations, detailed analysis methods, multiplicity handling, or secondary posted outcomes.

The score scale is stated as 0 to 100, yet the Antibiotic Only confidence interval extends to -2.21. This is a feature of the reported interval estimate; it does not make negative individual scores possible on the stated scale. The registry does not give details needed to assess the interval calculation or explain its relation to the bounded score.

Finally, the record does not describe a clinically important difference threshold, full eligibility criteria, or the trial's own sample-size justification. These omissions limit judgments about clinical meaning, applicability, and study planning. They do not show that the trial's conduct was deficient, but they restrict conclusions based on the registered results.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps — NCT02927834.
• Registry record last updated 2020-12-29; status last verified 2020-12.
• Results first posted 2020-12-29.
• 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.

18. Record Summary

NCT02927834 is a completed randomized, unmasked, parallel-group study sponsored by Loma Linda University. The registry lists enrollment of 24, a start of 2015-08, and primary completion in 2018-12. It compares Augmentin alone with Augmentin plus either a 6 day or 21 day prednisone taper in chronic rhinosinusitis without nasal polyps.

The primary outcome is the mean SNOT 20 score at 4 weeks post treatment; lower scores indicate better reported symptoms. The record posts group means with 95% confidence intervals and outcome counts, along with zero reported serious adverse events, other adverse events, and deaths in each listed group. It does not post a two-arm comparative analysis, and the record indicates that comparison values are missing or not estimable. Details of missing-data handling, analysis populations, and the statistical plan are not reported in the registry record.