03/16/2026    Robert Kornfeld, DPM

The Timely Death of the RCT in Health and Healing

For decades in functional medicine, we have had to
defend the meta-analysis as the gold standard for
protocol evaluation, as opposed to RCTs that
cannot be performed in a functional medicine
approach since it is not the one, but the many
arms of the protocol that drives salutogenesis,
along with the unique characteristics of the
patient being treated. This quote, taken from a
very well-written article, says it all. “An
analogy of the approach mainstream medical science
has operated with could be like someone trying to
understand how the rainforest works by studying
one leaf at a time in a petri dish in a lab under
fluorescent lights, for 12 weeks - then publishing
a field guide for every ecosystem on Earth.
Randomized controlled trials isolate a single
variable, measure a handful of endpoints over
months, and declare a verdict for billions of
people.”. Enej Kuscer - Co-Founder & CEO at NU,
Co-Founder and Director at ACIES BIO

We have truly been missing the forest for the
trees. So much about the human body needs to be
revealed on a patient-specific basis owing to the
unique epigenetics and genetics of the patient and
the interplay between the environment, lifestyle,
diet with the genes of each patient. Our biology
is a dynamic system of hundreds of thousands of
interacting pathways, genes, and cellular
responses, all shaped by how you live, what you
eat, how you sleep, how you breathe, and what
you’re exposed to. The future of health science
isn’t bigger trials with more participants. It’s a
longitudinal, systems-biology N-of-1 approach
where each individual becomes the unit of
experimentation, discovery, and optimization.

While I admit I’m just a novice with AI, there are
things on the horizon that will blow the roof off
the traditional single agent/placebo driven
studies that have created narrow fields of vision.
The power in a multi-omics, patient-specific
analysis spread across populations will eventually
be the gold standard for health and healing
globally.

Those doctors who embrace this and become well-
educated in a functional medicine approach to
health and healing will prosper along with their
patients. Exciting times ahead.

Robert Kornfeld, DPM, New York, NY

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