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- This was the largest prospective controlled study
specifically focused on long term health outcomes
after treatment of early Lyme disease in North America.
This was a unique study because it was done prospectively,
starting at the time of early diagnosis and treatment,
and was controlled with non-Lyme infected patients
for comparison.
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The results of the study were quite striking.
Even in patients with early, well diagnosed
and ideally treated Lyme disease,
14% of the patients when examined six months later
continued to have persistent symptoms.
And this really fits into what we've suspected,
that the rates would be somewhere between 10 and 20%,
consistent with other studies done,
both in the United States and Europe,
and these persistent symptoms were significant
on well validated instruments.
So this wasn't just the mild fatigue
and pain of everyday living.
These were significant levels of fatigue and pain
that impacted the patient's quality of life.
It's very important to know that this 14% number
was able, then, to be compared to the controls,
and when we applied the same criteria to the controls,
these levels of fatigue and pain were only present
in 4% of the control population without Lyme disease.
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The symptoms in our patients are very real
and again caused by the Lyme disease
despite early diagnosis and treatment.
It impacts the patients' quality of life
and it impacts a significant number of patients.
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The results of our study that 14% of patients
with early Lyme disease
developed Post Treatment Lyme Disease
looked at ideally diagnosed patients
with the earliest stages of Lyme disease
and treated ideally right at the time of early diagnosis.
It's likely an underestimate of the true rates,
possibly more like 20 to 30% rates in complicated patients,
such as those that don't get diagnosed and treated
until they've developed neurologic disease
or other later manifestations of Lyme disease.
In the real world, patients often don't get diagnosed
at the first stage.
Patients often go for weeks or months or even years
before their diagnosis and first treatment of Lyme disease.
In the real world, patient populations
are much more complicated.
Patients have less ideal diagnosis and treatment.
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Our current paper does not tell us
what causes the prolonged symptoms,
but other studies we're conducting now
look at the potential causes or etiologies.
These range from a persistent infection hypothesis
to persistent Borrelia antigens, to persistent immune
and inflammatory responses to the initial infection,
to rewiring of neural networks and neural pathways,
and potentially all of those mechanisms
in different patients or in different combinations.
And understanding those will come out
of our ongoing research that looks
at the biologic specimens, the blood samples
that were collected as part of the study.
They're the key to understanding the mechanism
of what drives these persistent symptoms.
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Our current study has direct implications
for other related illness, such as long haul COVID,
chronic fatigue syndrome.
These associated illnesses share a lot of similarities,
and our studies suggest that, again,
infections trigger these illnesses that share a lot
of the same patient attributes of the illness,
fatigue, pain, cognitive dysfunction.
This phenomenon can be triggered by several types
of infectious diseases, Lyme disease,
COVID, Epstein-Barr virus.
There's something about these infections
that can trigger long lasting health problems
that are very real and very impactful in the patients.
The impact on brain neurophysiology,
the mechanisms of inflammation
and its impact on autonomic nervous system function
may be one of the critical pathways
that causes the chronic symptoms we see in our patients.
There may be common mechanisms
that underlie these illnesses.
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Our study, in combination with the other studies,
really should end the controversy
about whether Post Treatment Lyme Disease is a real illness.
Chronic symptoms occur
after Lyme disease and other infections.
This has been validated now firmly in the literature
with this study that we've published,
and it's a very significant percentage, 14%,
and severity of the symptoms.
It's also very consistent with studies
coming out of long haul COVID that suggest
that infections can trigger very real illnesses.
Very importantly, our study was controlled
with non-Lyme infected controls,
showing that this is not just the baseline rate
of symptoms in the general population.
Very importantly, our study is controlled
for mental health disorders,
depression, traumatic life events.
We're very confident that the symptoms
in our patients are very real.
They're not, quote, just in our patients' head.
These are not psychosomatic symptoms
and not symptoms of depression, the real outcome
of their initial infection with Lyme disease.
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