This interview was conducted with the world renowned immunologist and Chinese Herbalist Dr. Xiu-Min Li via phone and email discussing the latest in her proprietary Chinese Herbal Formulas for asthma and food allergies. Dr Li is the originator of FAHF-2 (food allergy herbal formula) and ASHMI (anti-asthma herbal medicine intervention).
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This is a relatively in depth article and takes about 20 minutes to read (longer if you want to really digest). If you don't have time (or patience), here are the distilled takeaways:
- Herbs work, but there's a high level of commitment necessary - time (several years) & dosage (prepare to swallow more than one pill a day). If you can't bring it (commitment that is), herbs may not be for you.
- IgE is not necessarily be-all/end-all of allergic reaction - on herbal protocol IgE may remain constant or not, and yet tolerance can occur. Basophil activation measured via blood draw is strongly correlated with tolerance/reactivity. Dr Li discusses this blood test as a safe prelude to food challenge. We've made inroads in reducing our IgE levels, but I am now even more aware that this as a singular strategy isn't a "cure." Other immune cells need to be addressed as well. I think Chinese herbs can really shine in addressing a spectrum of immune cells - quieting reactions.
- Herbs switch the immune system from allergic to non-allergic by rebalancing the immune system. As mentioned above, the IgE levels may or may not change, but previously reactive individual may be able to tolerate foods/pollens..., because other parts of immune system are mediating.
- Results are totally individual. Some people can do treatment and then be off completely; others will need to pulse on and off (6 months on, 6 months off).
If you want the full-on details from which the above has been distilled, pull up a chair, grab a snack, and READ ON!
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 don’t 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 it’s safe, it has potential benefits, but it’s 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 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. We’ve achieved FDA approval and received funds for the clinical trials but we haven’t started yet. We’re 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 you’ve seen in your life, you’ve been avoiding peanut, but still the peanut specific IgE is more than 100.
HH: It’s more than 100 still, yes.
Dr. Li: Why is that? It’s because of the memory B cells. Once those cells form, they have longevity and continue to reproduce. Knocking them out takes a long time.
“We actually saw the immune system response switch from allergic to non-allergic. This is promising.”
HH: How do the herbs operate? What are the herbs doing that are affecting the immunological markers?
Dr. Li: We started to look at which herb 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 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 they’re 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.
HH: It suppresses that transcription factor?
Dr. Li: Yes, that’s the key - antibody production – that’s 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 don’t have to kill the cells; you just have to initiate the signals to control what they produce.
HH: So you’re 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 they’re 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 don’t 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 it’s 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 mom’s 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. It’s 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 it’s dynamic. So, you can modify it.
That’s why we are working hard to develop a treatment. We believe that this epigenetic mechanism not only underlies why it’s easier for some people to develop allergies, but it also provides an opportunity for 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 it’s 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 don’t think it will work.
HH: It sounds like what you’re talking about is achieving a certain level of cellular saturation.
Dr. Li: Yes, you’re right. This all has science behind it.
“…sometimes with immunomodulation, the IgE levels are still there, only they’re dormant.”
HH: And so, let me go back to - you’re talking about this next round of trials that will be 26 months and the mouse models - and in a perfect world if what you’ve seen in the mouse models translates to humans - what does someone’s 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 that’s why parents are very supportive of us. We’re 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, it’s extremely expensive – medicines, nurses, doctors, tests, managing reactions.
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 world” conditions instead of intensely controlled clinical trial conditions. I want to use biomarkers - IgE as well as basophils—to see if we can measure progress without challenges.
In mice, basophils activation shows a very strong correlation with clinical reaction. And then I’ll 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. It’s 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, 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 don’t 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 I’ve 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 don’t you publish them? Do a small study not a big trial study and publish it.” I’ve 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 don’t 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 patient’s reactions and lowered the IgE.
But back to this practice-based study, which will answer your question. We’ll do three courses of treatment; one course of treatment is one year. I believe we’ll see changes in biomarkers in the first year for some such as reduction of basophil activity. 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 you’ll start to see it drop - but it may not drop to the level where it’s 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. It’s about adjusting expectations to the time frames you’re 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 son’s or daughter’s immune system. But some respond sooner. That’s 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.
“From this we know that tolerance has increased.”
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 it’s practice based, the regulation level is different than for a placebo-controlled trial. It’s not called a trial - it’s a study. Everyone gets treated. We will use the individuals that come to the clinic and get an annual check up but they don’t want to get treated as controls (sometimes this is also called community study). We’ll just collect their blood samples. Since they are checking their blood levels anyway we just use that as a control, but they don’t 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. I’ll provide the treatment and then they will evaluate. This will make it more objective not just my opinion.
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, we’ve 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, we’ve 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 individual’s 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 don’t require a food challenge at baseline for this highly sensitive group of patients. But if you don’t do a challenge sometimes people think that you don’t have an allergy. So we want to use biomarkers to predict sensitivity. As I’ve 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 they’ve failed challenges in the past.
Dr. Li: Yes. That’s why many kids are very, very careful. And some kids can still be careful, but avoidance is not enough for them. There’s 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 don’t 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. That’s 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. It’s 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 I’m working on.
HH: I understand that you’re preparing to publish the data of the most recent FAHF-2 study - and with the practice-based study you’re 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 you’ll get protection, even if your IgE may not be at a normal level. That is my prediction. Reactions don’t 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 don’t 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 don’t 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 they’ve 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 don’t 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 don’t 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 we’re 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 don’t believe that food allergies, particularly persistent food allergies, can be cured. That’s because they see how stubborn the cells are. Everything involves cellular memory - memory basophils cells, memory B-cells, memory T-cells…
That’s 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 don’t 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 that’s simpler.” (Additional information: I just had a phone consultation last week with this mother, this child started 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 individual’s 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 (relating to or arising from non-genetic influences on gene expression) - you can reprogram."
I helped several mothers; they started to introduce one food after another after another…. I don’t claim this is all my success, because the patients are children. Children have a strong natural capacity to outgrow…. The treatment just helps them to develop that capacity. If they have 20 or 30 or 10 even (food allergies) to outgrow, that may take a longer time. And it seems that after they outgrow certain foods, it’s quite stable, the allergies don’t return. I’m not saying 20-30 foods all of a sudden are all cured. It’s different levels. Some are more stubborn. Some are easier. But once you can introduce more foods, the idea is to improve this individual’s 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: You’re 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 – that’s the protocol (Most of time I start with a one-month alternating protocol). Maybe eventually they will only need three months per year treatment. I’m happy when they’re able to wean off the steroids; I’m 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
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 don’t have a percentage. Computing percentages doesn’t 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 didn’t cover, which I’m 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 don’t know about it. For many years I haven’t used TCM interpretation or language to connect to our medicine because it’s very difficult to have a common language. It’s very hard to talk about that.
When I started my off-site clinic, I didn’t start with people with food allergies. I started with patients with eczema. They were so bad - and the standard therapy couldn’t 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 couldn’t 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. I’m not saying that other TCM practitioners are not reliable. But we focus on food allergies, allergies, asthma… We started to build. We’re 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, I’ve 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 that’s why I developed a treatment called digestive tea. To help the kids rebuild their GI system. That’s really a TCM concept. They have this concept that they focus for children on enhancing the GI system.
Normally I don’t want to interpret anything with TCM terminology. It’s not necessary to use the same language and terminology. Some mothers read the TCM books. Some don’t. And if you say, “you have a spleen Qi deficiency,” they get very scared.
HH: Yes, I’ve read about TCM and if I heard that, I’d get scared.
Dr. Li: Right. If you say, you have a kidney Qi deficiency. They say, “What’s that?”
That’s why I don’t use that terminology. Patients and families rarely ask about the TCM terminology/mechanisms and I don’t offer them. Interestingly, some of allergists and clinical fellows who work 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 I’ve 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 concentrations…we 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 we’ll 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 don’t have solid funding, you won’t reach your goal. That’s the difference when you are a pharmaceutical company. We have to struggle. This is a critical factor that you can’t 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 funding—the heavy lifting—but it allows concerned parents and patients to contribute to science on behalf of their own children’s 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.
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