1. Simon Strauss Simon Strauss Australia says:

    "The sample size problem
    Twelve patients, six responders, six non-responders. With n=6 per arm, you have almost no statistical power. A difference in microRNA profiles or anti-inflammatory assay results between two groups of six could easily be noise, batch effects, or donor-specific idiosyncrasies. Correlation at this scale is hypothesis-generating, not predictive.
    The control group problem
    There is none. KOA has a massive placebo response, and natural fluctuation in symptoms over 24 months is common. Without a sham-injection arm, claiming the stem cells caused the 50% response rate is unwarranted. The responders might have improved regardless.
    The circularity problem
    They defined responders by symptom improvement, then hunted for biological differences between the two groups they just created. This is data dredging. Finding 14 microRNAs that differ between six responders and six non-responders, after testing a panel, is exactly what you would expect by chance. It needs validation in an independent cohort — which they do not have."

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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