Effects of Acupuncture in the Treatment of Infant Colic: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effects of Acupuncture in the Treatment of Infant Colic (NCT00907621), a randomized phase 2 study. The primary outcome is Change in Crying Time Per 24 Hour Period..

2. Clinical Question

3. Trial Design

The registry identifies NCT00907621 as a completed, randomized, parallel-group phase 2 study titled “Effects of Acupuncture in the Treatment of Infant Colic.” Its official title describes a prospective, multi-center, single-blinded randomized controlled study. The sponsor is the University of Oslo. The registry lists enrollment as 90 and the study start as 2009-09, with primary completion in 2012-12.

The study summary says the investigators intended to include 130 patients, with 65 in each group. The enrolled total recorded in the registry is 90. The record does not explain the difference between the intended and recorded enrollment, and does not report whether recruitment stopped early or whether a different enrollment target was adopted.

The summary describes work at thirteen locations in Norway by general-practice specialists trained in acupuncture. The intervention description specifies bilateral needle insertion at St36 for 30 seconds on 3 consecutive working days. The control description is cut off and does not establish what control participants received. Although the study is described as single blinded, the record does not say which participants or personnel were blinded, how blinding was maintained, or whether it was assessed.

Randomization is recorded, but the sequence-generation method, allocation concealment, and any stratification factors are not reported in the registry record. The record also does not report the protocol, planned statistical analysis, or the rationale for the sample-size target. These omissions prevent a fuller assessment of how the groups were assigned and how the planned design was to be implemented.

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: 113 pasients were recruited. 23 were excluded beacuse of spontanous improving of symptoms, transportation problems, change of mind regarding participation.90 patients were randomized. 79 crying diaries and 84 interviews were analysed.

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.

Population: We analyzed 79 crying diaries and 84 interviews. The baseline characteristics, except crying time is based on the 84 interviews where we had complete data. The crying time is based on the 79 crying diaries

6. Primary Endpoint

The registry lists the primary outcome as Change in Crying Time Per 24 Hour Period., measured over 6 time points measured: First, second and third intervention day, one day after last intervention, one week after last intervention and one month after last intervention. All time points measured in 24 hours..

The primary endpoint is change in crying time per 24 hour period, measured in minutes. Crying time is a continuous outcome: it can take a range of values rather than being limited to categories such as improved or not improved. The registry specifies a mean as the summary measure and a 95% confidence interval as the dispersion measure. It describes crying time at baseline and after treatment, with six stated time points: the first, second and third intervention day, one day after the last intervention, one week after the last intervention and one month after the last intervention.

As a general statistical consideration, repeated measurements can describe both the course of an outcome during treatment and its persistence after treatment. A mean gives a group-level summary, while a confidence interval conveys uncertainty about the estimated quantity under the assumptions of the analysis. The record does not give the actual means, changes, confidence intervals, or a single selected time-point comparison. It therefore does not show how crying time changed in either group or how precisely any between-group difference was estimated.

The registry also lists “Parents Evaluation of Benefit to the Child” as a secondary outcome. That measure may capture parents’ assessment rather than minutes of crying, but its definition and results are not reported in the registry record. The distinction matters: a subjective evaluation and a time-based measure describe different aspects of the study question and should not be treated as interchangeable.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, parallel-group study. In general, random assignment is intended to make treatment groups comparable at the point of allocation, including with respect to factors that were not measured. A parallel design assigns participants to one group for the study rather than having each participant receive both study conditions in sequence. These design labels do not by themselves show whether allocation was concealed or whether groups remained comparable after enrollment. The method used to generate the random sequence and the allocation procedure are not reported in the registry record.

What does a mean describe?

The primary outcome is a mean of a continuous measure: minutes of crying per 24 hour period. In general, a mean summarizes the observed values across participants, but it does not reveal how widely individual values vary or whether the distribution is unusually skewed. The registry identifies a 95% confidence interval as the measure of dispersion for the primary outcome, but it does not provide the interval or explain whether it applies to a group mean, a change, or a between-group contrast. Those details are necessary to interpret the estimate precisely.

How should repeated measurements be understood?

The study describes measurement at six time points, spanning the intervention and follow-up. Repeated measurements on the same infant are related: a participant’s crying time at one time point may be associated with that participant’s crying time at another. As a general statistical matter, an analysis that accounts for within-participant correlation can differ from a series of independent comparisons. The registry record does not describe the analysis method, how the repeated measurements were modeled, or whether one time point was designated as the primary comparison. It also does not state how baseline values were incorporated into the analysis.

A result at one time point would answer a different question from a summary of the overall trajectory. A trajectory analysis can use the pattern across follow-up, while a single-time-point analysis focuses on a particular visit. The registry’s listing of several time points does not establish which approach was planned or used. No estimates are posted for any of the time points.

What does a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimate using a procedure with a stated coverage property under its assumptions. A narrower interval indicates greater precision than a wider interval for the same estimand and method. A confidence interval does not describe the range of individual participants’ outcomes, and it does not establish that an effect is clinically important. Here, the record names a 95% confidence interval but supplies no interval limits or estimate to which the interval can be attached. Precision therefore cannot be evaluated.

What can the planning assumptions tell us?

The registry describes a sample-size planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. This is a planning illustration, not evidence of the trial’s original design rationale. The registry does not report its own sample-size justification, target effect, or assumptions used when the trial was planned. No sample-size values are listed in the record, so the illustration cannot be used to infer how many participants were needed or what the study could reliably detect.

In general, power is a design property under specified assumptions, not a measure of whether a particular study result is true. A planning illustration based on an observed effect should not be interpreted as observed power or as a substitute for reading an effect estimate and confidence interval. Because the primary outcome estimate is not reported, no recalculation of its uncertainty or planning implications can be made from the registry record.

Why can over-dispersion matter?

General statistical methods for counts or event rates may rely on a specified relationship between the average and the variability. Over-dispersion means that the observed variability is greater than the model assumes; if ignored, uncertainty can be understated. The primary endpoint in this study is a continuous measure of crying minutes, and the registry does not identify a count model or report a dispersion assessment. Over-dispersion should therefore not be asserted as a feature of this trial’s primary analysis. The general concept is relevant only if a model with assumptions about outcome variability is used, and the record does not state which model was used.

Finally, the record’s blank analysis listing means there is no reported basis for checking model assumptions, handling of repeated observations, adjustment for baseline values, or sensitivity analyses. These are not details that can be reconstructed from the design labels or outcome description alone.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome with six measurement time points and one secondary outcome, Parents Evaluation of Benefit to the Child. It does not say which time point or summary across time points was designated as the primary test, or how comparisons across time were to be handled. It also does not report whether any adjustment for multiple comparisons was planned. Without a defined analysis plan and posted results, the risk that several outcome comparisons could affect interpretation cannot be assessed.

Missing-data procedures are not reported in the registry record. It does not state how many participants had outcome measurements at each time point, how incomplete follow-up was handled, or whether any sensitivity analyses assessed the influence of missing observations. The record also does not give a flow of participants from assignment through follow-up.

Analysis populations are not described. In particular, the record does not say whether the primary analysis included all randomized participants, only those who received treatment, or participants with available outcome data. The 45 participants at risk listed for each group in the adverse-event information cannot establish the number included in the primary outcome analysis. Interim analyses and stopping rules are not reported in the registry record. These omissions limit assessment of multiplicity, attrition, and the population to which any primary outcome result would apply.

11. Safety Results

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

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 0 of 45 participants at risk in the acupuncture group and 0 of 45 at risk in the control group. It also reports other adverse events for 2 of 45 at risk in the acupuncture group and 8 of 45 at risk in the control group. Death counts are not reported in the registry record. No serious adverse event terms are listed.

These counts should be read as event information recorded in the registry, not as a complete safety comparison. The record does not define the “other” event category, provide descriptions of those events, or explain how events were collected, classified, or attributed. It also does not report follow-up duration for safety or whether every participant completed safety monitoring. Counts alone do not establish why events occurred or whether the groups differed in risk. They should not be treated as evidence that a treatment is safe or unsafe.

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

The registry record describes a randomized, parallel-group investigation of standardized acupuncture for infant colic and identifies crying time as its primary outcome. Its design information includes a stated intervention, a control group, six crying-time measurement points, and enrollment recorded as 90. It also lists adverse-event counts. These details help define what the study was intended to examine.

The record does not report the primary outcome results, the secondary outcome results, or any statistical analyses. It is therefore not possible to tell whether crying time changed differently between groups, how large a difference might have been, or how precisely it was estimated. The absence of a result in this registry record is not a finding of no effect. It also does not establish that an effect was present. Neither direction nor magnitude can be inferred from study design or safety counts.

Even if a treatment contrast were reported, interpretation would depend on the endpoint definition, time point, analysis population, missing-data handling, and uncertainty interval. The registry does not provide those analytical details. The single-blinded label does not reveal who was blinded, and the control-arm description does not specify the control condition. These gaps matter when judging the meaning of a group comparison.

The appropriate conclusion from the record is limited: it documents a completed randomized study and its planned clinical question, but it does not publish the outcome evidence needed to answer that question. A statistical conclusion about the effect on crying time would require the estimates and analysis details, which are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically notable because its primary outcome is measured repeatedly rather than at just one follow-up point. Crying time was assessed across the intervention period and after treatment, so the choice of analysis could shape whether the main focus is a particular time point or the pattern over time. The registry identifies the measurement schedule but does not report the analysis used. This makes the distinction between a planned measurement and a defined primary comparison especially important.

The record also illustrates why registration details and posted results answer different questions. It names the outcome, broad design, and intervention, but does not supply outcome estimates or an analysis plan. A randomized design can support a fair comparison when implemented and analyzed appropriately, but the label alone cannot reveal allocation procedures, missing data, blinding details, or the precision of a treatment estimate.

The enrollment entries also require careful reading: the record lists enrollment of 90, while its summary says the investigators intended 130 participants, 65 per group. The record does not explain this difference. Recognizing that distinction prevents a planned target from being confused with the recorded enrollment or with the number contributing data to an analysis.

Finally, the registry’s safety counts and primary outcome are different forms of information. Event counts do not answer the question about change in crying time, and they do not substitute for outcome estimates. The record is useful for identifying what was studied and what information is missing, while remaining insufficient for statistical conclusions about the primary clinical question.

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 registry record leaves several trial-specific uncertainties. The control-arm description is truncated, so the comparator condition cannot be characterized. The single-blinded designation does not identify who was blinded or how blinding was achieved. The record gives no random-sequence or allocation-concealment method, and it does not provide full eligibility criteria or a description of the enrolled population beyond the general colic definition and infant characteristics included in the arm descriptions.

The primary outcome is described at six time points, but the record does not identify a primary time point, provide a definition of the change calculation, or state how repeated measurements were analyzed. It reports no group means, between-group estimates, confidence intervals, or p-values. The secondary outcome is named but not defined in detail and has no posted result. Consequently, neither the magnitude nor the precision of the clinical comparison can be assessed.

The registry lists 90 enrolled participants, while the summary records an intended total of 130. The reason for this difference is not reported. Participant flow, group allocation totals for the primary outcome, follow-up completeness, and reasons for missing observations are also absent. The record does not describe the analysis population, missing-data methods, multiplicity adjustment, interim analyses, or sensitivity analyses. The sample-size illustration is not the trial’s reported design justification.

Safety reporting is also limited: the record provides counts but no descriptions of the “other” events, event ascertainment details, or death counts. These limitations concern what can be learned from the registry record; they do not establish that the corresponding procedures or analyses were absent from the conducted trial.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Effects of Acupuncture in the Treatment of Infant Colic — NCT00907621.
• Registry record last updated 2015-03-17; status last verified 2015-03.
• Results first posted 2015-03-17.
• 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

NCT00907621 is listed as a completed, randomized, parallel-group phase 2 study sponsored by the University of Oslo. The official title describes a prospective, multi-center, single-blinded randomized controlled study. The record lists enrollment of 90 and a study period beginning 2009-09, with primary completion in 2012-12. The study summary describes an intended enrollment of 130.

The intervention was acupuncture using a Seirin 020x15 mm sterile needle at St36, with bilateral insertion for 30 seconds over 3 consecutive working days. The primary outcome was change in crying time per 24 hour period, measured at six time points. Parents Evaluation of Benefit to the Child was listed as a secondary outcome.

The registry record does not report primary or secondary outcome results, statistical analyses, or the control treatment. Safety counts list 0 serious adverse events in either group and other adverse events in 2 acupuncture participants and 8 control participants, with 45 participants at risk in each group. Death counts are not reported in the registry record.