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This interview was conducted with Dr. Xiu-Min Li via phone and email.

Healing Hacker: Can you discuss the results of the human efficacy trials with Food Allergy Herbal Formula-2
(FAHF-2)? Does it work if compliance is good? How do you know it works? Can you talk about the clinical
trials of FAHF-2? What results are forthcoming?

Dr. Li: I can only discuss the published studies. We


published a study in annals of Allergy Asthma and
Immunology that showed FAHF-2 is a very safe
treatment that modulates the immune system. We
found it had immune-modulating effects on Th1, and T-
regulatory cells that inhibit allergic immune response as
well as Th-2 cells, which are associated with allergies.
We actually saw the immune system response switch
from allergic to non-allergic. This is promising. If you
can modulate the T-cells so that they dont produce IgE,
the allergic antibody, you will eventually see a clinical
improvement.

We did a 6-month open-label study (not a control study)


but much shorter than the mouse study, which required
two years to produce results. Our second six-month trial
found similar high safety profile; and this time we had
an opportunity to look at the immunological response of
the basophils, which produce histamine. We were able
to suppress the histamine production of these cells,
which produced a favorable clinical effect. So that was
the second trial.

The third trial we finished in 2014. The results were


mixed. We did see consistent safety data and some
immunomodulatory effects. However, we have not
demonstrated efficacy yet with the protocol used. The
compliance level was a big issue. You know this as well
as everyone else. (HH: my son took herbs with Dr. Li for
about a year and compliance was difficult for us - swallowing between 30-40 pills a day because I was
crushing them and putting into small capsules for him to swallow.)

There are still a lot of things to learn from this trial. We think the product itself needs to be improved - if we
can reduce the number of pills we can increase compliance and optimize the product.

This is an obstacle for traditional herbal medicine - we know its safe, it has potential benefits, but its very
difficult to conduct a trial because the amount of pills is an issue. And also the protocol design is not where
after a couple weeks you see the effect. This protocol requires quite a long time and much effort. In private
practice when we treat things like eczema and asthma, patients can see and feel improvements, which gives
them an incentive to continue treatment for the invisible problem, food allergies.

Interestingly, the preliminary data showed that if the individual had high enough blood concentration of the
bioactive compound marker, they had positive clinical outcomes. This supports our in vitro study data that
showed that human immune cells directly exposed to FAHF-2 extract experienced beneficial
immunomodulatory effects. There are gaps of knowledge between TCM human use experience, in vivo

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animal model study, human in vitro study, and then finally to human in vivo study trials. Our continued work
will help us fill in the gaps.

The good news is that we have developed a purified product which requires just 1/5 of the previous dosage
that has successfully combatted peanut allergy in mice.

HH: This is B-FAHF-2?

Dr. Li: Yes, B for butanol, a form of alcohol. Weve achieved FDA approval and received funds for the clinical
trials but we havent started yet. Were updating the protocol and preparing the refined version of B-FAHF-2
that will be used for the trial.

The design of this trial is different than the previous trials. Treatment time will be 26 months closer to a real
timeframe where you can see strong results. Previous study times were too short to allow the full
immunological changes to occur. Persistent allergy is associated with abnormal memory immune cells--T
cells, B cells and mast cells/basophils--which are very stubborn. Taking IgE production as an example - as
youve seen in your life, youve been avoiding peanut, but still the peanut specific IgE is more than 100.

HH: Its more than 100 still, yes.

Dr. Li: Why is that? Its because of the memory B cells. Once those cells form, they have longevity and
continue to reproduce. Knocking them out takes a long time.

HH: How do the herbs operate? What are the


We actually saw the immune herbs doing that are affecting the immunological
markers?
system response switch from Dr. Li: We started to look at which herb
allergic to non-allergic. compounds affect IgE. We just published in 2014
but the work has been done over many years. We
demonstrated that human memory B-cell lines
This is promising. that produce IgE could remain very high, even if
they are not stimulated. You just put them in a
good nutrition medium and they will grow and
produce IgE.

In that study we compared effects of FAHF-2 and B-FAHF-2 on IgE production. Both significantly reduced IgE,
but B-FAHF-2 requires nearly 9 times less concentration.

We screened nine herbs from B-FAHF-2 and found three of them directly suppressed IgE. Other herbs have no
direct effect on IgE, but some of them suppress inflammation and histamine release while others enhance
protective immune responses such as IgG. But this study only focused on identifying the constituents in vitro
(in a test tube, Petri dish, outside the body - as opposed to in vivo, which means given to a living animal or
human).

We focused on one of the IgE inhibitory herbs, identified and isolated the active compounds, and published.
The mechanism operates thusly: memory cells do not need a strong stimulus, sometimes none at all. They
settle in the bone marrow where they wait until theyre ready to produce IgE. We discovered the compound
that regulates IgE does so through the modulation of one of the critical transcription factors that control IgE
synthesis from memory cells.

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HH: It suppresses that transcription factor?

Dr. Li: Yes, thats the key - antibody production thats where we use the term switch. The antibody
producing B-cells can be switched in a different direction. The same cells can produce IgG or IgE, controlled
by these transcription factors. They tell this cell what to produce. And so therefore, you dont have to kill the
cells; you just have to initiate the signals to control what they produce.

HH: So youre not killing those cells, you are switching what they are producing.

Dr. Li: Right. That is a unique finding for a natural product. They are not killing the cells. The cells can still be
there, but just not produce the IgE. Also, sometimes with immunomodulation, the IgE levels are still there,
only theyre dormant. Then when the body needs them, they can reactivate, when you encounter an intestinal
parasite, for example.

Normally the immune system can distinguish between the different proteins - food protein is very different
from bacteria. Bacteria pathogens are very different from other microbes. The cells can tell. So therefore
when you get a bacterial infection, your B-cells automatically start to produce IgG. Most of the time probiotics
stimulate your immune system to produce IgG. Once your immune system encounters this type of stimulus, it
has the capability to produce IgG to protect the individual. But with allergies, the allergen stimulates
production of IgE by B cells.

HH: Why do allergic individuals have this? Are they missing some key windows of immune education? Are
they missing nutrients? Is there toxicity? I understand that the herbs are working on the cellular level, but
why - why does it exist at all? I dont know if you know the answer to this

Dr. Li: (Laughs) - Some kids have asked me why do we need allergy. We are not absolutely certain yet. But
you can summarize it as several things - perhaps its a single factor or combination but it has to do with
exposure to microbials. There is a short window when the fetus is in the moms uterus when the immune
system is skewed towards Th2 - but then after birth they need to gain quickly and switch to Th1 dominance
through exposure to the microbials. So microbials or a type of microbial exposure is a major factor. Another
theory holds that the mother or the post-natal infant is exposed to food too early or too late. This was the
prevailing theory for 10 - 15 years, but has been recently rejected. See we avoided the peanut early and the
prevalence of peanut allergy has doubled. So that has not been the peanut. So now there is no peanut
restriction on mothers- but now the peanut prevalence allergy has tripled. We still have no consensus.

Another thing is the allergic march from when children are very little - they have a little eczema or allergy but
as they grow they develop asthma or persistent food allergy. We are just beginning epigenetic studies. The
genes are switched on and off by certain triggers such as chemicals in the environment. The environment is
important, food is important, microbials and pathogens are important, antibiotics are important because they
wipe out good microbes as well as bad

So we are studying epigenetics - the genes are all normal and present. Its how they are regulated that may
cause a baby to be born with a pre-existing, allergy-prone condition. We just had a publication in a very
important journal using the mouse model. We induced an allergy in some of the mothers and their babies had
a very strong tendency to develop allergies, an allergy bias. But conditions still must be favorable for allergies
to develop. So both factors play a role: susceptibility (active allergen genes) and environment.

With this epigenetic mechanism - the good thing is that its dynamic. So, you can modify it.
Thats why we are working hard to develop a treatment. We believe that this epigenetic mechanism not only
underlies why its easier for some people to develop allergies, but it also provides an opportunity for

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treatment and dietary modification. For example, taking vitamin C and other things - may reprogram these
genes from allergy to non-allergy. But these epigenetic changes in vivo (in body) take quite a long time. In
vitro studies, through exposing the cells, provide good information about product efficacy. When working in
vivo its crucial to have a sufficient dose the more bioactive ingredients the better the treatment at the
expected concentration range.

HH: In vitro is the herb exposed to the cells - but in vivo the herbs have been processed and digested - can
you talk about that?

Dr. Li: That is why I now tell the patients, if you want to start the herbal protocol, you need to use a good dose
over a long period of time. Otherwise I dont think it will work.

HH: It sounds like what youre talking about is achieving a certain level of cellular saturation.

Dr. Li: Yes, youre right. This all has science behind it.

HH: And so, let me go back to - youre talking about this next round of trials that will be 26 months and the
mouse models - and in a perfect world if what youve seen in the mouse models translates to humans - what
does someones path to reprogramming their genes from allergic to tolerogenic look like? What does the path
to heal through B-FAHF-2 look like - how long does it take? Are we on it for our entire lives? What is the
dosage?

Dr. Li: It still depends on the individual. So thats why parents are very supportive of us. Were moving in a
more practical direction, but with minimum expenditures, as opposed to the millions spent on the earlier trial.
This new study will require $2-3 million but it can only take 17 patients in active and 17 patients in placebo.
Why? Because when you want to do a double blind placebo trial with the challenges, its extremely expensive
medicines, nurses, doctors, tests, managing reactions.

sometimes with But then another new study we are setting up will
be a small practice-based study. That is, it will be
done through day-to day practice under real
immunomodulation, the IgE world conditions instead of intensely controlled
clinical trial conditions. I want to use biomarkers -
levels are still there, only IgE as well as basophilsto see if we can
measure progress without challenges.
theyre dormant.
In mice, basophils activation shows a very strong
correlation with clinical reaction. And then Ill use epigenetics to look at the T-cells and determine whether
they are switched or not switched, and how long they take to make the transition (Additional information: The
epigenetic biomarker becomes more important now. For example, some of my patients passed a peanut or
treenut challenges. If their tolerogenic epigenetic biomarker maintains even after reduction and
discontinuation of treatment, plus normalized basophil activity, their tolerance will highly likely be sustained.)

I cannot stress strongly enough - these trials - no one has done them but us. We are pioneers. Its not perfect
yet. There are several knowledge gaps. In addition to continuing double blind placebo controlled trials, we will
also conduct the practice based-study, which is more cost effective, so that we can design an even better trial
in the near future. (Additional Information: Although randomized controlled trials (RCT) are the gold standard
in assessing treatment efficacy and safety of newly developed drugs, their results can be limited when applied
to real-world clinical settings. Practice based evidence (PBE) studies are an alternative to RCT, and well suited
to determine what works best for specific patient types in day-to-day

clinical practice. They provide a holistic picture of patients, treatments, and outcomes seen in real-world
clinical settings. PBE studies can uncover better practices more quickly than randomized controlled trials,

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while achieving many of the same advantages. TCM is inherently an individualized approach to Chinese herbal
medicines as well as acupuncture and acupressure; PBE studies are well suited for the preliminary TCM
therapy to define what TCM therapies will be the best for the specific group of patients with food allergies.

There are three requirements for the individuals in the study. They have to have a history of reactions and
their peanut specific IgE has to be over 100. Or, if the peanut IgE is not over one hundred, but the two-year IgE
figures are very high and increasing, those patients can also qualify. The third group will be made up of people
who have a history and very frequent reactions. You know sometimes children are so sensitive they dont even
have to eat the offending food, they just smell it or touch it and they have a reaction. They will also qualify.
This is a patient friendly protocol.

You know Ive really learned a lot from mothers. I started to work on my case reports because a mother said,
You know you have so many good results, why dont you publish them? Do a small study not a big trial study
and publish it. Ive got medical students helping me organize the data. One case report was just accepted
for publication that shows positive effects of an herbal treatment combination. We dont know which one is
essential. I think that each one made some contribution therefore making the combination better. I used
cream and internal tea and it really quieted the patients reactions and lowered the IgE.

But back to this practice-based study, which will


answer your question. Well do three courses of From this we know that
treatment; one course of treatment is one year. I
believe well see changes in biomarkers in the first
year for some such as reduction of basophil activity.
tolerance has increased.
But for others it may take two or three years. Maybe
someone after one year will see effects. If the IgE is
more than 100, in one or two years youll start to see it drop - but it may not drop to the level where its so low
that they can go for a challenge. Other biomarkers will help to monitor progress. You have to separate when
the effects are first visible and there is tolerance from the child outgrowing the allergy which may take
longer.

HH: That makes sense. Its about adjusting expectations to the time frames youre talking about. Even
though, when we took the herbs, you told us to have a vision spread out over 3 years - it was still a lot to wrap
my mind around. I think now I have a little bit more time stamina.

Dr. Li: I know. I sometimes tell the patients if you are seeking an immediate cure, I cannot help you. But if
you have a long-term effort really concentrating - you will see, given time, gradually it will help your sons or
daughters immune system. But some respond sooner. Thats why I said it depends on the individual. We
give a choice - you can do one course and then two or three courses. After one course of treatment we can
also combine with other therapies. I am collaborating with other allergists to combine the therapies such as
SLIT provided by Dr. Mary Morris.

HH: For that practice-based study are you doing it multi-center or only out of New York?

Dr. Li: First we will just start in New York collaborating with a mainstream allergy practice. Since its practice
based, the regulation level is different than for a placebo-controlled trial. Its not called a trial - its a study.
Everyone gets treated. We will use the individuals that come to the clinic and get an annual check up but they
dont want to get treated as controls (sometimes this is also called community study). Well

just collect their blood samples. Since they are checking their blood levels anyway we just use that as a
control, but they dont take a placebo. And then no one will get a challenge. I have a team working with two
other allergists that are helping me evaluate. Ill provide the treatment and then they will evaluate. This will
make it more objective not just my opinion.

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And then after two or three years we will most likely see the epigenetics change - the basophils reduced,
and/or the IgE changed. However, even if the IgE remains high - but we may be able to predict that they have
built up a new level of tolerance. Sometimes people will still have a high IgE, it cannot be reduced to the
baseline normal, but they can tolerate the foods to which they used to have reactions.

For example, weve taken blood and mixed it with peanut protein - two nanograms a very low dosage.
Before treatment the cells produce 60-90% activation, meaning 60-90% of the cells released histamine. This
shows that the patient is very sensitive. Then after treatment, weve done the same blood sample mixed with
two nanograms of peanut protein, and seen 20% of the basophil cells release histamine. From this we know
that tolerance has increased (non-allergic people also have basophil activation, about 10-20%). So that gives
us a quantitative measurement, but the individual does not have to go for a challenge. We use the cell level
to predict the individuals sensitivity If patients biomarkers are dramatically improved compared to baseline,
and if the family is interested in introducing certain foods, allergists will determine clinical tolerability by oral
challenge based on the clinical practice standard for assessing food allergy outgrowth.

All these methods for biomarkers are being used in my lab. We dont require a food challenge at baseline for
this highly sensitive group of patients. But if you dont do a challenge sometimes people think that you dont
have an allergy. So we want to use biomarkers to predict sensitivity. As Ive said before, there is a strong
correlation between the biomarkers and clinical reactivity. If you look at the cells, instead of the clinical
endpoints, you can get critical information about allergic vs. tolerogenic status. But many times we separate
the clinical symptoms and the immunological basis. We see the clinical symptoms and forget that everything
has an immunological and physiological foundation. What we observe in clinic originates in the cells. And so
predictive information, not necessarily diagnostic information, can be drawn without the dangers of
challenges.

HH: Challenges can be traumatic. I think that clinicians see a reaction from the outside. But our children
experience these reactions and so while challenges can be life changing if you get a new food they can
also be extremely terrifying for the children especially if theyve failed challenges in the past.

Dr. Li: Yes. Thats why many kids are very, very careful. And some kids can still be careful, but avoidance is
not enough for them. Theres about 10-14% of the allergic children who react to inhaled allergens and/or skin
contact. In fact, my recent publication of three cases in one instance focuses on skin contact and inhalation
causing severe reactions.

HH: Skin contact causing systemic anaphylactic reactions?

Dr. Li: Yes. Well skin contact-induced reactions dont happen with everyone, only a small portion of allergic
individuals.

HH: With the mouse model - the mice were 100% compliant - so how many of the mice were successfully
protected from anaphylaxis? Did it protect all the mice that took it?

Dr. Li: Yes. Thats what was so impressive. Since I started working on the food allergy research we tested
many novel therapies that we thought would be effective against food allergies. The first time we used the
herbal treatment we saw that the mice were protected. They were all protected. It was

beautiful. If we can reach the dose and duration of the mice (100%), we have a good chance. Its just that
persuading our patients to use a full dose over an extended period of time is a big job. We are hoping that the
refined product will make our and their efforts easier. In my practice-based study we are going to use the
refined product that Im working on.

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HH: I understand that youre preparing to publish the data of the most recent FAHF-2 study - and with the
practice-based study youre hoping to perfect the protocol and process - and so talking about what things look
like is difficult. But if you look at the mouse model and translate to the human model, what kind of
projections can you make? Do we take the herbs at a full dose for three years? And then what happens?

Dr. Li: Then youll get protection, even if your IgE may not be at a normal level. That is my prediction.
Reactions dont only involve IgE, but also additional types of cells such as mast cells and basophils. The
protection is not only due to reduction of IgE, but also induction of other antibodies such as IgA and IgG.

In the animal study, before treatment, the mice had a similar IgE level as post treatment. But in the middle,
before treatment with the herbs commenced, we gave a boosting dose to drive their IgE levels very high. In
mice, we dont do More than 100 we do a real level - for example, 2500 or 2000 - to ensure at that time of
the challenge they have a reaction. Following the boosting, their IgE levels can reach 5000 or more. But after
the herbal treatment, the IgE level of 5000 can drop to around 2000. And even with that level at the time of
the challenge they dont have any reactions. So, after treatment the IgE level is lower than the post-boost
level. But it never gets as low as normal, sometimes not even to the level before we boosted them.

With very high IgE levels, if you are able to drop it to a certain level, I think you do not need it to be normal.
After treatment, you may build up a new level of tolerance. In Chinese medicine, they talk about balance - so I
think - the treatment just brings a new level of balance. You cannot go back to baseline, like a new baby
before theyve been exposed to the allergens. But, you can affect a switch that starts to build up a good
protective immune response and bring new balance The children are still healthy. They dont have
reactions. But their IgE level is not zero.

HH: IgE becomes less an indicator at that point, because the whole system has realigned itself.

Dr. Li: Right. You can still have IgE. But you also have lots of IgG, IgA, and many other protective antibodies.
That is very good. These antibodies circulate. And for example, if you have peanut protein that gets in, they
grab the protein and dont give it a chance to bind to IgE. These other antibodies are also specific so they can
do that. This protects the individual from having a reaction. The protection happens in many ways, not just
dropping the IgE.

HH: And then after the three years - there is protection - there is a new balance. How do the next 10 years
look? Are there periods of time where were back on herbs for a month, a year? Is it half the year? Not at all?

Dr. Li: That is a very good question. Many allergists who do research dont believe that food allergies,
particularly persistent food allergies, can be cured. Thats because they see how stubborn the cells are.
Everything involves cellular memory - memory basophils cells, memory B-cells, memory T-cells

Thats why the new study is around the effect of polysensitization (sensitization to more than one allergen
family). You can lower this sensitization. You can build up a higher level of tolerance. You can bring a new
balance. This is an epigenetic concept (relating to or arising from nongenetic

influences on gene expression) - you can reprogram. You still have the potential to have good protection.

Many children have multiple food allergies: 30-50% of them. Another part that is so scary, from the literature,
is the growing number of children with multiple food allergies and multiple allergic diseases. In my patient
population, almost 100% have many things - food allergies, asthma, and eczema. Many of them had been on
daily anti-histamine for many years for their allergies in addition to other medications. They have several
foods with IgE levels that are over 100. Other people have come to me and they dont write down how many
foods they are allergic to as one mother told me, Let me tell you how many foods we can eat. Maybe thats
simpler. (Additional information: I just had a phone consultation last week with this mother, this child started

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to add back some foods already. We added the foods back to his diet first from the foods that he lost the
latest).

So what does life look like after 3 years of treatment? It depends on how severe the individuals food allergies
were to start. For the most severe, with many IgE counts more than 100 - maybe we can help introduce some
new foods. With treatment, plus lifestyle changes, plus other dietary modifications - when the IgE level is low -
they get a chance to introduce new foods. And many patients are cured. But for others we still need to work.
In these groups of children who have multiple allergic conditions, their asthma and eczema will be improved
first and environmental allergy can also be improved so some of them can wean off the steroids and daily anti-
histamine. They are healthier as individuals (including both physical and mental health). But their IgE
sensitization improvement may be seen later. That is why the clinical phenotype and IgE levels are not always
correlated. However, it is not easy to establish this concept/practice because these are no other in vitro
immunological measures available yet at routine practice, most of the new biomarker measures are still in
research status

This is an epigenetic concept I helped several mothers; they started to


introduce one food after another after another. I
(relating to or arising from dont claim this is all my success, because the
patients are children. Children have a strong
natural capacity to outgrow. The treatment just
non-genetic influences on helps them to develop that capacity. If they have
20 or 30 or 10 even (food allergies) to outgrow,
gene expression) - you can that may take a longer time. And it seems that
after they outgrow certain foods, its quite stable,
reprogram. the allergies dont return. Im not saying 20-30
foods all of a sudden are all cured. Its different
levels. Some are more stubborn. Some are
easier. But once you can introduce more foods, the idea is to improve this individuals quality of life.

HH: Now going back to the mouse model - for some people they might need to do intermittent periods of
herbs and for others they just go off and they are done.

Dr. Li: Youre right. In the mouse model, we stopped treatment after six months. But in human time, that is a
quarter of their life (HH NOTE: because mice live an average 2 years). If ten mice are used, you stop once
they build up full protection. Then about two or three mice will start to show some symptoms after you stop
treatment for six months. Then we give another course of treatment and they are fully protected again. But
the other seven or eight mice continue to be fully protected even without further herb courses.

I think it is still a good protocol even if the individual passes the challenge - maybe each year or every two
years they do the herbal treatment for three months or six months. I use this protocol for asthma patients.

I have asthma patients who were chronically steroid dependent. When they were on steroids they still had
symptoms. They got better on the herbs and eventually they were off all inhaled steroids. In these cases they
stop the herbs for six months and go back on herbs for six months thats the protocol (Most of time I start
with a one-month alternating protocol). Maybe eventually they will only need three months per year treatment.
Im happy when theyre able to wean off the steroids; Im also very happy that they can stop TCM as well, AND
their conditions are still very well controlled.

HH: And what percentage of the patients were able to do that?

Dr. Li: Asthma patients?

HH: Yes

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Dr. Li: Asthma patients are very interesting. When they come to me, most of the time, they are very chronic.
They are the extremely tough asthma cases. I have quite a few, but I dont have a percentage. Computing
percentages doesnt mean as much in one practice as it does with a bigger study base. Since this work
involves clinical practice, not a study population, I would be very reluctant to use percentages routinely.

HH: The one thing we didnt cover, which Im curious about. You noticed similarity between parasite infection
and allergy at the start of your research. How do Chinese medicine principles enter into the herbal tinctures
that you are working with?

Dr. Li: It would take a while to connect the TCM principles to the research. You know TCM to the U.S. is a new
concept. Many people dont know about it. For many years I havent used TCM interpretation or language to
connect to our medicine because its very difficult to have a common language. Its very hard to talk about
that.

When I started my off-site clinic, I didnt start with people with food allergies. I started with patients with
eczema. They were so bad - and the standard therapy couldnt help them. They were dubbed give up
patients by the referring physicians. These doctors sent their patients to me, and I helped their eczema. And
then when the eczema was better they wanted me to help their food allergies.

Additionally, patients with asthma also began to come to me for help. I had many who couldnt continue the
steroids because they developed terrible adverse effects from having been on them so many years. This led
me to present the idea of establishing an alternative medicine or integrative medicine center to Mount Sinai in
order to help the patients. That way if the patients wanted to use the alternative medicine at least they would
have reliable sources. Im not saying that other TCM practitioners are not reliable. But we focus on food
allergies, allergies, asthma We started to build. Were half way. There are a lot of things that need to be
worked on that are difficult.

Seeing the patients with the multiple food allergies spurred me to understand this more using the TCM
concept. I read and researched intensively. The symptoms described in the formula for parasites are very
much like a food allergy reaction.

Now in my practice, I do incorporate the TCM concept. For example, a particular group of patients, children
who when they were little, only had a few allergies; but, as they grow, they acquire more and more food
allergies. They develop environmental allergies as well. For them, I see that the digestive system is not
functioning properly - in addition to the immune system and IgE. For these patients, Ive begun to deepen the
treatment with great TCM principles not simply using a formula that matches the symptoms.

Sometimes we forget the physiological function of digestion. So thats why I developed a treatment called
digestive tea. To help the kids rebuild their GI system. Thats really a TCM concept. They have this concept
that they focus for children on enhancing the GI system.

Normally I dont want to interpret anything with TCM terminology. Its not necessary to use the same language
and terminology. Some mothers read the TCM books. Some dont. And if you say, you have a spleen Qi
deficiency, they get very scared.

HH: Yes, Ive read about TCM and if I heard that, Id get scared.

Dr. Li: Right. If you say, you have a kidney Qi deficiency. They say, Whats that?
Thats why I dont use that terminology. Patients and families rarely ask about the TCM
terminology/mechanisms and I dont offer them. Interestingly, some of allergists and clinical fellows who work

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with me began to use TCM terminology even in their presentations. I think in the future, more people will be
willing or interested in the TCM terminologies.

HH: Yes. And I have a bare bones understanding - yes it can be frightening to hear that.
Is there anything that Ive missed?

Dr. Li: Yes. I feel that the conditions of food allergies, asthma, eczema, environmental allergies that can
occur in one individual make the situation very difficult. They are different conditions, but they can and do
occur together in one individual.

So the vision of the treatment should be different depending on the individual. And herbal medicines give us a
promising, safe starting point, to retrain the immune system either before it goes wrong, or after. If we expose
the memory B cells to the bioactive compounds at sufficient concentrationswe can basically shut down the
memory cells from producing IgE. That means you have to expose as many memory cells to these ingredients
as possible through many routes.

Now since memory cells, as I said, usually settle in the bone marrow, it is a real challenge to reach them in
vivo. Which will be most effective? Through the skin or through ingestion? Probably a combination. We
understand which molecules may be the key for IgE, key for basophils, key for good T-cells.... The active
compounds can switch the epigenetics from allergic to tolerogenic - so well use this knowledge to also help us
to advance the TCM products. That is my immediate goal.

The clinical trial is a long way off. There is a huge effort needed. It requires a good design for the patients and
the investigators - and then the funding is an issue. You can have great ideas, but if you dont have solid
funding, you wont reach your goal. Thats the difference when you are a pharmaceutical company. We have
to struggle. This is a critical factor that you cant ignore in the success of clinical trials.

Then in line with that the practice-based biomarker study of TCM that is the beginning of new methodology
to help TCM clinical studies move forwards. If we gain more information, it will help us to advance the science
before spending millions of dollars, and design bigger studies with more precision.

Susan Weisman and another mother, Selena Bluntzer, worked through the Icahn Medical School at Mount
Sinai school to set up a crowd funding website. That site discusses the practice-based biomarker study. This
is not a substitute for government or big institutional fundingthe heavy liftingbut it allows concerned
parents and patients to contribute to science on behalf of their own childrens future. I would also like to
thank Winston Wolkoff Integrative Medicine for Allergies and Wellness, and our supporters, the Winston,
Wolkoff, Sherbakova, and Pichugov families for their contributions.

To read and donate to Chinese Medicine for Food Allergy go here:

https://www.crowdrise.com/chinesemedicineforfa/fundraiser/tcmforfoodallergies

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