The primary outcome data from the reaZin study appear to be consistent with the proposed action of the intervention. The three cognitive and functional measures used for the series of secondary outcomes are appropriate, but the small size of the sample means that the study was underpowered with respect to any clinical outcome measures. The small sample size was probably responsible also for the lack of balance in baseline measures across the randomized groups. Whether one should see the preliminary clinical outcome results as encouraging is a matter of judgment. The poster presentation does not make it clear whether the composite outcome was specified a priori. If not, the meaning of the p-value of 0.15 is hard to discern. In any event, I cannot agree with the authors' conclusion that these results provide a "strong trend toward cognitive benefit favoring the treatment group."
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McGill University Faculty of Medicine
The primary outcome data from the reaZin study appear to be consistent with the proposed action of the intervention. The three cognitive and functional measures used for the series of secondary outcomes are appropriate, but the small size of the sample means that the study was underpowered with respect to any clinical outcome measures. The small sample size was probably responsible also for the lack of balance in baseline measures across the randomized groups. Whether one should see the preliminary clinical outcome results as encouraging is a matter of judgment. The poster presentation does not make it clear whether the composite outcome was specified a priori. If not, the meaning of the p-value of 0.15 is hard to discern. In any event, I cannot agree with the authors' conclusion that these results provide a "strong trend toward cognitive benefit favoring the treatment group."
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