The following is my latest interview with the Xiu-Min Li.

Xiu-Min Li, Gina Clowes

I have had the good fortune to get to know some amazing doctors and researchers and without hesitation, Dr. Li is at the top of my list. She is determined to find a way to help allergic children recover their health.   

If you are not familiar with the Food Allergy Herbal Formula, you may want to read my earlier interview here.  

Gina Clowes: I'm grateful to talk with you today. Let's start by talking about how you've been working to refine the herbal formal FAHF-2. 

Dr. Xiu-Min Li:  It's called butanol-purified FAHF-2, or B-FAHF-2.

We've decreased the number of tablet dose by 80% by concentrating the active ingredients, and this is very significant.

Gina: Because it's hard to take so many pills.

Dr. Li: Right. This affects compliance in our trials--especially with the children.

Gina:  So for those who are not familiar, FAHF-2 is an herbal therapy which can prevent anaphylaxis in peanut allergic mice and has been shown to be safe for adults and children. 

For the treatment to work well, the patient has to take quite a few of these herbal tablets and capsules.

Dr Li:  Now, with FAHF-2, adults need to take about 36 pills per day.  With the new, refined B-FAHF-2, adults need only 6-8 pills a day. Kids need 1-2 pills a day of B-FAHF-2.

Gina: That sounds very doable. 

Dr. Li: I have FDA approval for research with this B-FAHF-2.  We will do an abbreviated safety trial first, and then we will look at efficacy.

That will be a longer term study. We want to treat for two years, without a control.

Gina:  I love that. No one gets left out.

I know parents who are reluctant to have their kids participate in a clinical trial, knowing that after all it entails, they may have been treated with a placebo. 

Dr. Li: Yes. We know the formula is safe but compliance can be an issue. We keep refining the formula but the treatment-it takes time.

Gina: And is so worth it!  (My son Daniel is a patient of Dr. Li's at her private clinic.)

Daniel's skin is clear, he's no longer contact sensitive to latex, milk or anything and we're adding foods to his diet like apples and ice cream! 

Dr. Li: Daniel is doing so well!  

Gina: Would you tell us the research you're about to publish? 

Dr. Li: We have published our research results on B-FAHF-2 for treating peanut allergy in the animal model. B-FAHF-2 also directly suppresses IgE production of human memory 

B cells and peripheral blood mononuclear cells nine times more potently than FAHF-2 (manuscript submitted).

 Importantly, we are ready to submit our new research for publication of B-FAHF-2 in combination with peanut/tree nut oral immunotherapy in the animal model. The abstract has accepted for oral presentation at the Annual meeting of American Academy Allergy Asthma and Immunology.   

In this study, we treated peanut and tree nut allergic mice with peanut/ tree nut OIT (oral immunotherapy) alone, and then tested a second set of mice who were treated with B-FAHF-2 first and then peanut/ tree nut/OIT.  

 B-FAHF-2 dramatically reduced  allergic reactions during  the dosing protocol and also had a longer-term effect on preventing reactions post therapy.

Gina: That is amazing. It's interesting that a subset of the mice had an elevation of IgE and some did not.  

Many of us are looking forward to more research with multiple tree nuts. Do you have other research in the works?

Dr. Li: In addition to test B-FAHF-2 alone, we are planning research combining B-FAHF-2 with OIT [Oral Immunotherapy] with and without Xolair (anti-IgE) in a new trial with the team members (Drs. Sampson, Julie Wang and I)  at Mount Sinai.  

I've have been discussing this with Kari Nadeau at Stanford University. The patient would take the B-FAHF-2 with or without Xolair for a while first. Then move on to the OIT while continuing the B-FAHF-2 with the goal of reducing or eliminating OIT induced reactions and generate a long-term protection. Gastrointestinal adverse reactions are common during OIT. Dr. Wesley Burks group just published an abstract in JACI reporting that pre-treatment with anti-IgE does not protect gastrointestinal adverse effect related to OIT.

In addition, my laboratory has established protocols to look at the in vitro immune responses at the cellular levels. For example, we can determine activation of basophils (the cells that release histamine upon antigen stimulation). I plan to work protocols to study TCM treatment effects on immune responses at the cellular level. My lab can also determine bioavailability (the amount of presence of active ingredients in blood circulation). These data will provide understanding of how TCM may improve immune response over time. These in vitro studies may help us to design a "real life" and "personalized" clinical study of TCM for allergies in the future.

Gina: Would you share a few success stories?

Dr. Li: We've seen some very impressive results at my clinic. Remarkable outcomes.

I had one 14 year old girl. So severely allergic to milk. She reacted to touching a trace of milk. She reacted to inhalation of dairy. She could not walk into a pizza parlor.

Her reactions were so severe that she needed two shots of epinephrine to control these reactions. Not just one.

She left school and was home-schooled because her reactions were so frequent.      

She lived across the country and her parents were so dedicated to getting her help that they drove for three days to come to New York to see me. She could not fly fly because of the concern of exposure to traces of dairy containing food by inhalation or contact.

We started with the treatment with the herbs. They came every six months. Never missed an appointment. Within six months she was starting to feel a little better. She still had some reactions though less severe and less frequent than before. 

I added acupuncture and more herbs as she could tolerate them. Finally, I added an herb tea that is pretty strong. I warned her about the taste. She said "I don't care.I want to get better."

Within a year the reactions that were once so frequent, really started to come down.

After two years on the treatment, she was getting much better. They took a plane to New York!        

She went back to school. She got a job working as a life guard at a swimming pool! Things she never imagined.

She can smell pizza now. She can't eat it yet but she can be around it. 

Gina: Her whole world opened up!

Dr. Li: I have another teenage patient from Canada. Her severe reactions started when she was in a grocery store. She was so severely allergic to peanut and tree nuts.  The mother is an ER doctor, so she knows what a true emergency is.    

This child was in the ER for anaphylaxis more than 10 times within 2 years.  She was on multiple medications, including daily use of two types of anti-histamine drugs, antidepressants and missing tons of school. 

They came to see me and were very compliant with the treatment. Gradually, her reactions became much less frequent. 

She was able to go off of the antihistamines and some of the other medications she was taking. 

After about a year, the girl was exposed to peanut and tree nuts on a trip. She consumed them a lot accidentally.  She found she had no problem!

The mother said "I evidenced it myself!" 

They decided to do a peanut challenge and she passed! She can continue to eat peanut and tree nuts and she is off all of the herbs now. Six months after stopping the herbs, her mother emailed me and said "We are still cured'

These patients and families start to provide support for the other patients who have the similar conditions.

Gina: That is so wonderful!

 I've heard from parents that some doctors discount or make light of contact or inhalation reactions. 

You seem to take these reports seriously. Would you comment on that?

Dr. Li: I respect the patient's information. If this is what patient or parent reports to me, I respect that their sensitivity level is that high. They know when they have a reaction and whether or not they were eating anything at the time. Although not common, contact reactions as well as inhalation reactions have been reported in the medical journals. 

Gina: I love that about you!  So let's talk about the anxiety that allergic children experience. It can be difficult for an adult to manage the range of emotions let alone children. 

You are always so careful about what you say in front of the kids.   

Dr. Li: The anxiety is understandable of course. We see this with the food allergies and asthma.  Anxiety can exacerbate reactions and can cause the release of inflammatory chemicals and cytokines.

Gina:  Another reason to make sure that their environment at school and other places accommodates their unique needs. 

Can adrenal fatigue be a factor as well?

Dr. Li: Yes. There can be a connection, if they have chronic inflammation. Even more so with asthma.  I have  published information on this in a clinical asthma study. Some TCMs can help normalize adrenal function.

When they have compromised adrenal function, they don't handle stress as well. Chronic and high dose exposure to steroids can make this worse.

Gina: Interesting. I know acupressure and acupuncture can help with these issues. How important are these treatments for your patients?

Dr. Li: Very important.  Acupressure is helpful.  Acupuncture will have a much stronger effect than acupressure. 

There are publications that show a suppression of basophil histamine release and other inflammatory markers with these treatments.  It's very impressive. Acupuncture and acupressure help reduce stress and anxiety, which has been reported in medical journals.

I like to do acupuncture and acupressure for my patients if possible. More than one third of my patients come from out of state so that is not always possible.

Dr. Xiu-Min Li

Gina: That sounds wonderful. How long can someone safely stay on the formula?

Dr. Li: That is a good question.

There is a principle in Traditional Chinese Medicine [TCM] that is that chronic conditions require longer treatment. Therefore safety and tolerability is critical.  

In our laboratory studies, we treat the mice for 7 weeks. That is the human equivalent of 3-4 years.  With my patients, I've found that after 1-2 years of full treatment, we can usually reduce the dose and still see continuous improvement for some patients.

For many patients, 2-3 years of treatment is required and by then, some will be able to add new foods. 

Some patients can gradually reduce the dosages after that time. Some patients can stop altogether. 

Although there is no definite amount of time the patients should stay on the treatment, it can be used chronically. For some patients, it is possible to stop the herbal therapy once their conditions were improved or resolved, but for others maintenance of treatment may be needed. It is very individual.

All herbs used in my practice have been well documented in the Pharmacopeia of People Republic China as safe herbal medicines and have thousand years of human use experience. All medicinal herbs used are carefully tested for quality and absence of pesticide or heavy metal contamination. The patients also follow up with their primary care doctors on CBC, liver and kidney function testing. There is strong evidence that this herbal therapy has excellent safety profile. 

Gina: One of the many things that I like about you is that you are open to working with other doctors.

Dr Li:  Yes, of course. I have a patients now who are sent to me by their doctors because they cannot tolerate OIT (oral immunotherapy). Most of them have stomach issues on OIT. Some of them also have anaphylactic reactions  requiring epinephrine. For the patients who are still on OIT, I use TCM as supportive treatment to improve their stomach issues.

I have also been working with the other allergists, who practice sublingual immunotherapy (SLIT) and we see promising results.  

This combination approach seems to be a welcome approach. Some allergists are comfortable to encourage their patients to come to me to get TCM therapy first before they introduce OIT or SLIT.

My treatment is aimed at enhancing the digestion system.

If they do not have a good digestive system, it may affect the treatment. Publications show that using antacid drugs increases the risk to develop food allergy. Thus, indigestion plus "leaky gut" may cause sensitization in a susceptible individual.  

This concept also is supported by scientific evidence.  In our lab experiments, in order to make mice sensitized to peanut, we will have to neutralize stomach pH and to increase gastrointestinal permeability by adding sodium bicarbonate alcohol, and cholera toxin to peanut sensitization regimen.   

Gina: Interesting about stomach pH and leaky gut. And it's wonderful that patients who have not been able to tolerate OIT can go back to it after working with you. 

Dr. Li: Yes. Their digestive system sometimes needs work before they can tolerate the dose. There may be other issues. I personalize the approach for them. 

Gina: Your private practice is bustling, and I know there are many others who would love to come to see you. Since your practice is individualized, what do you tell new patients when you see them? 

Dr. Li: I am very objective.  I am confident in this but it takes time. 

I tell new patients that it is very safe and also require them to have periodic liver and kidney function tests.  I am very involved in quality control of the herbal products. There may be a benefit, however I can't predict the outcome for an individual patient. 

Gina:  I know I speak for many allergy moms and dads out there when I say that I am grateful for your work. Thank you for all that you do! 

Dr. Li: Thank you Gina. 

(c) 2014 Gina Clowes www.AllergyMoms.com  

 

 If you would like to support Dr. Li's research at Mount Sinai's Jaffe Food Allergy Institute, you can do so in 
one of the following three ways:   

 

Credit Card Online: 

Visit https://philanthropy.mountsinai.org/jaffe.  

In the "designation" field select "other",
then type  "Dr. Li - TCM Research".          

 Credit Card by Phone:
Contact Jacqueline Leitzes
Associate Director of Development in Children's Health Mount Sinai at 212-731-7430.   

Check:
Write check to "Icahn School of Medicine at Mount Sinai" and in the memo portion write "Dr. Li - TCM Research".  
Mail to:  
  Jacqueline Leitzes 
  Office of Development
  Mount Sinai Medical Center
  One Gustave L. Levy Place
  Box 1049, New York, NY 10029. 

                                                                                                   For more information on the science behind Dr. Xiu-Min Li's

work, see Food Allergies: Traditional Chinese Medicine, Western Science, and the Search for a Cure by Henry Ehrlich. 

Take a look behind the scenes at a physician and researcher who bridges two great traditions in her search to win the fight against disease. Born and educated in China, Dr. Xiu-Min Li trained in both traditional Chinese medicine and Western medicine.   

This "love letter to science" documents the moment when Dr. Li decided to devote herself to researching food allergies, followed by detailed accounts of the science that shows food allergies can be conquered.