Population, and Was Primarily Aimed

¶ … population, and was primarily aimed at measuring the efficacy of two different pharmacological interventions. The focus of the research question was further enhanced by the multitude of outcomes generated through randomization.

This randomization also made the study quite clearly a randomized controlled trial, in both its original conception and in its carrying out. The trial was both randomized and double-blind, allowing researchers to effectively address the research question without bias. Further investigation is definitely worthwhile.

The study's crossover design allowed for true randomization in allocation, in that all participants eventually underwent all phases of the study -- control, placebo, and various intervention combinations. This also minimized group and individual differences, balancing the groups and providing greater statistical relevance. The group was comprised predominantly of white males, which was not a part of the study's design that was purposeful, though age was a specific eligibility factor.

4)

All participants on the study, form the primary researchers to the staff to the patients themselves, were kept unaware of the patients' status throughout all phases of the trial. Recordkeeping and pharmaceutical administration was conducted in a manner that allowed for this blindness without sacrificing the effectiveness of the trial or the validity of its findings.

5)

Though sixty participants were initially recruited, only 47 completed the study; the others left for various reasons and were accounted for though not counted in the final results. As each group eventually went through every iteration that took place in the study, analysis based on original group is irrelevant to the study at hand, and the validity is secure.

6)

Again, all groups were by the end of the study essentially the same in that they had each served as controls, placebo recipients, and recipients of either one or two interventional medicines. The same periods of medication and testing were utilized for all participants in all groups of the study throughout the period during which the research took place.

7)

According to the researchers, the completion of a crossover study such as this by forty-five participants is equivalent to 80% power at 5% statistical significance that the results could be extrapolated to the wider population. Though a higher level of certainty could be desired, this study's findings are still worthwhile.

8)

The results are presented as average rates of the effects of the varying interventions (or lacks thereof) among the participants during the different phases of the trial. The differences between these averages were compared as different levels of efficacy.