The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery (NCT02562924), a randomized na study. The primary outcome is Change in Lund-Kennedy Endoscopic Scores.

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group clinical study at the University of Vermont Medical Center. It records the study as completed, with an enrollment of 40, and lists the study phase as not applicable. The study concerns people with chronic sinusitis and nasal polyposis following functional endoscopic sinus surgery. Its stated aim is to assess postoperative mucosal healing and polyp recurrence with MEDIHONEY® rinses, alone or combined with intranasal corticosteroids, compared with intranasal corticosteroid rinses.

Three groups are represented in the primary-outcome results: budesonide rinse, MEDIHONEY® rinse alone, and MEDIHONEY® with budesonide rinse. The registry describes the budesonide and MEDIHONEY® regimens in stages, including an initial postoperative period and subsequent rinse schedules. It also describes conditional changes to the regimen after day 91. These are regimen descriptions, not evidence that each participant followed every element as planned.

There is an inconsistency in how masking is described. The registry lists the study as double-masked, while the official title calls it open-label. The registry record does not explain this difference, so the masking arrangement cannot be resolved from the record alone. Allocation is listed as randomized, but details of sequence generation, concealment, or implementation are not reported in the registry record.

The main outcome is change in Lund-Kennedy Endoscopic Score at 119 days. Its reported analysis population consists of participants with day 119 data, which is smaller than the enrollment in each group. The registry record does not report the full protocol, a sample-size justification, or a detailed statistical analysis plan.

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.

Before assignment: All subjects were enrolled prior to surgery (day 0). Days 0-7 all subjects were treated with oral prednisone once daily, nasal saline irrigation four times daily, and nasal saline misting hourly while awake. Assignment to each arm occurred on day 7. Three enrolled subjects withdrew prior to assignment because they elected to not undergo surgery.

Overall Study

Analysis population for the primary outcome, as defined in the registry: The population analyzed for this outcome is the population of participants for which we had data points at day 119. Please note that this is different than the number of participants that completed the study (Budesonide: 13 enrolled, 11 analyzed; MEDIHONEY: 12 enrolled, 6 analyzed; MEDIHONEY and budesonide: 12 enrolled, 9 analyzed).

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 Change in Lund-Kennedy Endoscopic Scores, measured over 119 days.

The primary endpoint is change in Lund-Kennedy Endoscopic Score from baseline to day 119. The score is based on endoscopic assessment of features of the left and right sinonasal cavities, including polyps, edema, discharge, scarring, and crusting. The two sides are scored and their scores are combined. The registry describes a scale from 0 to 20 and states that higher scores indicate worse outcomes.

This endpoint is used to measure changes in visible sinonasal disease and healing after surgery. Because the scale captures several endoscopic features, it provides a structured way to record findings over time rather than relying only on a general impression. The registry says that the primary comparison concerns the average unit change between baseline and day 119 across the three groups.

The posted outcome is a mean change with a standard deviation for each group. The mean describes the average change among participants included in that group’s analysis; the standard deviation describes variation in individual changes around that average. A negative mean indicates a decrease in score over the measurement period. The registry does not provide a confidence interval for each mean or for differences between groups, nor does it report a threshold for interpreting the clinical importance of a change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: it is a numerical score, and the registry reports its mean change and standard deviation. These summaries describe different aspects of the results. The mean change gives the average direction and size of change in each analyzed group. The standard deviation describes how dispersed the individual changes were around that group mean. Neither statistic alone establishes the precision of a between-group contrast.

What does a standard deviation tell the reader?

A standard deviation is a measure of variability among observations. A larger value means that individual changes were more spread out around the mean; a smaller value means they were more closely clustered. It is not the same as a standard error, a confidence interval, or a measure of treatment effect. In particular, the reported standard deviations do not tell the reader how uncertain a difference between two group means is without a suitable comparative analysis.

The endpoint is defined as change from baseline to day 119. Change scores focus on how a participant’s score differs between the two measurement occasions, rather than presenting only the score at follow-up. The registry says the comparison of interest is the average unit change across the three groups. However, it does not provide the baseline and follow-up group means separately, nor a model describing how baseline scores were incorporated into inference.

Why is a between-group estimate important?

In a randomized study, the research question usually concerns whether outcomes differ between assigned groups, rather than whether scores changed within each group. A change within one group can reflect many influences, including the course of recovery over time, concurrent care, or measurement variability. A comparative estimate expresses the difference in outcome between groups and should be accompanied by a measure of uncertainty, such as a confidence interval. General statistical principle: a confidence interval describes a range of values compatible with the data and analysis assumptions; it is not a guarantee that the true effect lies within that range.

The registry record does not report an estimable two-group comparison for this continuous endpoint. It therefore does not supply a comparative estimate, confidence interval, or p-value for the treatment-group contrasts. The record says values are missing or not estimable for a two-arm comparison. Without those comparative results, the three reported means should be read as descriptive group summaries, not as evidence that one regimen is superior to another.

What does the planning illustration represent?

Any sample-size planning illustration based on the observed effect is a planning exercise, not an observed result and not observed power. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a fraction of the observed effect. General statistical principle: such calculations illustrate the number of participants that might be required under specified assumptions, but they do not show the probability that the completed study detected an effect. In this study, there are three groups, and the reported outcome counts are unequal. The registry record does not report the trial’s own sample-size justification or establish that the planning illustration matches its design or analysis.

Interpretation of a planning calculation also depends on what is assumed about the outcome distribution, variability, target effect, and analysis. If the assumed effect is based on a small or imprecise observed estimate, the planning result can be unstable. A planning value should not be mistaken for a group result, a treatment comparison, or proof that the study had adequate precision. The particular planning values are not reported in the registry record.

What can be learned from missing comparative results?

The absence of a posted comparison is not the same as a finding of no difference. It means that the registry record does not provide an estimable contrast and its uncertainty for this outcome. A result can be inconclusive because information is limited, because the analysis was not reported, or for other reasons; the registry record does not state which explanation applies. General statistical principle: a non-significant test, if one were reported, would also not prove equivalence. Equivalence requires a prespecified margin and an analysis designed to assess whether the uncertainty is sufficiently narrow within that margin. Neither is reported in the registry record.

Finally, group-level summary statistics conceal the distribution of individual changes. They do not show whether changes were similar across participants or driven by a small number of observations. They also cannot establish whether the score change was important to patients. The posted numerical summaries are useful for describing the analyzed groups, but fuller interpretation would require participant flow, a prespecified analysis approach, and comparative estimates with uncertainty.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Budesonide Rinse Group", "MEDIHONEY® Rinse Alone Group", "MEDIHONEY® and Budesonide Rinse Group")
n   <- c(11, 6, 9)
m   <- c(-8, -1.5, -6.9)
sp  <- c(3.1, 4.6, 3.9)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Budesonide Rinse Group  11  -8.000  3.100  -10.083  -5.917
CARM  MEDIHONEY® Rinse Alone Group  6  -1.500  4.600  -6.327  3.327
CARM  MEDIHONEY® and Budesonide Rinse Group  9  -6.900  3.900  -9.898  -3.902

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 3 secondary outcomes in addition to the primary outcome. These include nasal drainage cultures, change in SNOT-22 questionnaire score, and change in SNOT-22 nasal symptom scores. The record lists 4 outcome measures and 0 posted analyses. It does not report how many hypotheses were planned, which comparisons were considered primary among the secondary outcomes, or whether any adjustment for multiple testing was planned or performed. When many outcomes or comparisons are examined, the chance of at least one apparently notable result can increase; general statistical principle, not a finding about this study.

The primary-outcome analysis population is described as participants for whom day 119 data were available. The reported group counts are 11 for budesonide, 6 for MEDIHONEY® alone, and 9 for MEDIHONEY® with budesonide. The registry notes that these numbers differ from the numbers who completed the study. Reasons for missing outcome data, the number and timing of withdrawals, and whether missing values were imputed are not reported in the registry record.

The record does not state whether the primary analysis followed intention-to-treat principles, used a per-protocol population, or applied another analysis population definition beyond availability of day 119 data. It also does not report a sensitivity analysis assessing how missing data might affect the findings. These details matter because an analysis restricted to people with observed follow-up can be affected if availability of data is related to outcome or group assignment.

Details of the statistical model, covariate adjustment, handling of baseline scores, and planned treatment contrasts are not reported in the registry record. Interim analyses and stopping rules are also not reported in the registry record. Consequently, the posted summaries cannot establish whether the reported analysis followed a prespecified plan or how multiplicity and missing observations were addressed.

12. 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.

Most frequent non-serious adverse event terms

The registry reports serious adverse events for participants at risk in each group. There were 0 serious adverse events among 13 participants at risk in the budesonide rinse group, 0 among 12 in the MEDIHONEY® rinse alone group, and 0 among 12 in the MEDIHONEY® and budesonide rinse group. The registry lists no serious adverse-event terms.

For other, non-serious adverse events, the registry reports 1 affected participant among 13 at risk in the budesonide group, 2 among 12 at risk in the MEDIHONEY®-alone group, and 0 among 12 at risk in the combination group. Deaths are reported as 0, 1, and 0 in those groups, respectively. The registry does not provide a cause of death or explain whether the death was considered related to a study intervention.

These are descriptive safety counts. They do not establish that an event was caused by a treatment, and the record does not report event details sufficient to assess causality, timing, or severity beyond the serious/non-serious classification. The number of participants at risk differs from the analyzed counts for the primary endpoint; safety and efficacy populations should not be assumed to be identical. With these counts alone, the registry record does not provide a comparative safety estimate or a measure of uncertainty.

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

The results show that mean Lund-Kennedy Endoscopic Scores decreased from baseline to day 119 in all three analyzed groups. The mean changes were -8.0 with budesonide rinse, -1.5 with MEDIHONEY® rinse alone, and -6.9 with MEDIHONEY® plus budesonide rinse. The scoring description says that higher values indicate worse outcomes, so a negative change corresponds to a lower score at follow-up on average. These summaries describe the participants with available day 119 data in each group.

They do not, on their own, answer whether the groups differed. The registry does not report an estimable two-group comparison for the continuous endpoint, or comparative confidence intervals or p-values. A difference in the observed group means cannot be interpreted as a reliable treatment effect without a suitable comparative analysis and an assessment of uncertainty. The record also does not report a threshold for a clinically important change, so the practical importance of the observed mean changes cannot be determined from these summaries alone.

The findings do not establish how results would differ in other populations, under other postoperative care, or at other follow-up times. They concern the stated postoperative setting and the day 119 endpoint. The primary outcome is an endoscopic score; it is not itself a direct measure of every symptom, quality-of-life outcome, or recurrence outcome. Although the registry lists secondary outcomes, it does not provide analyses for them in the posted results described in the record.

Nor do the data establish equivalence, non-inferiority, or absence of an effect. Such conclusions require specific comparative methods and prespecified criteria, which are not reported in the registry record. The most defensible reading is descriptive: the analyzed groups had the reported average changes, with the reported variation, and the record leaves comparative effectiveness and precision unresolved.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of the distinction between within-group change and a randomized comparison. The registry reports a mean change for each group, but the principal question concerns differences between assigned regimens. Group summaries can describe what happened among analyzed participants; they cannot replace an estimate of the contrast between groups and its uncertainty.

The endpoint counts also highlight the importance of defining an analysis population. Enrollment was 40, while the primary outcome summaries include 11, 6, and 9 participants in the respective groups. The registry states that the outcome population consists of participants with day 119 data and differs from those who completed the study. Transparent reporting of participant flow and missing-data methods is necessary to understand how observed results relate to the randomized groups.

The discrepancy between the registry’s double-masked design label and the official title’s open-label wording is another reporting detail relevant to interpretation. Masking can affect conduct, measurement, and expectations, but the record does not resolve which description applies. The score is based on endoscopic assessment, making clear reporting of assessment procedures particularly useful for readers judging the risk of measurement bias.

Finally, the absence of comparative analyses and a reported statistical plan limits inference even though group-level means and variability are available. The record supports description of the endpoint summaries, not a definitive ranking of the three regimens. These distinctions are central to reading small clinical studies responsibly: numerical results need to be paired with analysis methods, uncertainty, and transparent accounting of missing observations.

15. 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 main limitation for interpreting the primary outcome is the absence of a reported between-group estimate and its uncertainty. The registry provides group means and standard deviations, but says values are missing or not estimable for a two-arm comparison. This prevents assessment of the precision of contrasts among the three groups and means that the descriptive means should not be treated as a tested comparison.

Only participants with day 119 data are included in the primary endpoint summaries. The group counts are 11, 6, and 9, and the registry notes that these differ from the numbers who completed the study. The reasons for missing outcome data and their potential relationship to outcomes are not reported in the registry record. The reported summaries may therefore not fully represent all randomized participants.

The registry does not report a detailed statistical analysis plan, a sample-size justification, handling of missing data, or multiplicity procedures. It also does not report baseline score summaries alongside the change results, confidence intervals for group means, or a threshold for clinically important change. The number of posted analyses is 0, so the listed secondary outcomes cannot be interpreted through posted analytic results in this record.

There is also a design-description inconsistency: the registry lists double masking, while the official title describes an open-label study. The record does not clarify this. Details of randomization procedures, outcome assessor masking, and adherence to the described regimens are not reported in the registry record. These gaps do not negate the posted descriptive data, but they constrain assessment of bias, precision, and generalizability.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery — NCT02562924.
• Registry record last updated 2019-10-16; status last verified 2019-09.
• Results first posted 2019-10-16.
• 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.

19. Record Summary

The registry record describes a completed, randomized, parallel-group study of postoperative rinse regimens for chronic rhinosinusitis with nasal polyposis. It reports an enrollment of 40 and lists three groups: budesonide rinse, MEDIHONEY® rinse alone, and MEDIHONEY® with budesonide rinse. The primary endpoint is change in Lund-Kennedy Endoscopic Score at 119 days, with higher scores indicating worse outcomes.

Mean changes were -8.0, -1.5, and -6.9, respectively; the corresponding standard deviations were 3.1, 4.6, and 3.9. The analysis counts were 11, 6, and 9. These are descriptive results for participants with day 119 data. The registry does not report an estimable two-group comparison for the endpoint, and it does not report comparative uncertainty or a detailed analysis plan.

The registry lists 3 secondary outcomes and 0 posted analyses. Its design description also conflicts with the official title on masking. These reporting gaps limit conclusions about comparative effects, missing data, and the interpretation of the study’s other outcomes.