Clinical Trial vs Private Treatment #FAREcon

I had the privileged of volunteering at the FARE National Food Allergy Conference this past weekend, which allowed me to attend many fantastic presentations. Over the next few blog posts, I will summarize some of the research presented.

Out of my swirling my, one fact stood out. Dr. Baker, the CEO of FARE stated that the FDA had told DBV, the maker of the Viaskin Peanut Patch and ARC, the maker of CODIT, that they each needed studies of 8,000 people in order to get approval of their products.

8,000!

Staggering.

The LEAP Study, which was fairly widely commended for its size had 640 infants enrolled. In 2014, DBV announced results of its IIb study, "the largest clinical trial in peanut allergy desensitization ever completed" - 221 patients.

How will they ever get 8,000 patients each?

Why We Chose Private Practice

We briefly considered enrolling in a clinical trial. James qualified to be evaluated for a clinical trial for OIT to wheat at Stanford. My husband, in particular, was interested in considering this route. So, why did we decide against it?

1.  As I shared in my first post, we chose a different treatment. My husband, like many, had heard of OIT through the news. The trial, for us, opened the conversation, but OIT was not the right treatment for our family. I would not recommend choosing a treatment only because a trial is available.
2. We would have had to travel to Stanford every other week, for two years, about a 6-7 hour drive. Unless you think no one would ever be willing to do this, you should read this article of people who did a drive of the same time for the same reason.
3. The placebo. I will admit that I didn't want the risk of James being administered the placebo. We were told upfront that we would be offered what they could at the end of the trial for treatment. I don't know what that means, because I did not investigate the trial any further.

Benefits of a Clinical Trial

1. You have access to some of the best medical care and minds. 
2. You have access to treatments and testing that aren't yet available outside of trials.
3. You are helping to advance science and the community as a whole.

8,000 Patients

I have so much respect and appreciation for those families that do participate in clinical studies. Despite the perception that it is "free," because they don't pay for the medicine, the saying, "there is no free ride," certainly applies - time off for appointments, traveling, stress, emotional wear and tear. Thank you.

Daily Protocol for Treatment of Food Allergies with TCM

I hesitate to post this, not because I hesitate to share the information, but I don't want to give out any mis-information. This is a snapshot in time for one patient. By the very nature of Dr. Li's practice, she works with each patient as an individual. James's protocol has changed nearly every month. What the protocol is for James, I'm sure is very different for a patient of a different age, condition, and response. There are patients with no pills and patients with many more pills. So, please don't look at this and assume that if you or your child were to see Dr. Li, this would be your protocol.

That said, as of today, and at least until my next phone consult, this is James's daily routine:

After eating  (breakfast and dinner), he starts taking pills. He takes them in the order I have shown (although the capsules are mixed together, I've only separated them for the photo. He takes 5 at a time, mixed). He sets a timer for 1/2 an hour, takes the next set (he calls them M&M pills, for visual reasons only, there are 15), sets the timer for 1/2 an hour again, and takes the final 5 capsules. We have found if he doesn't take them spaced out this way, they make him sick (nauseous and heartburn). It's definitely the capsules that cause the upset. He's able to take the Mei Huang 4 without any issues. Dr. Li suggested spacing the dosages out and, as long as he sticks to it, he does fine.

So, each day total, he takes 50 pills over a 3 hour period. This is actually the part of the protocol he doesn't mind, assuming he leaves enough time between doses that  he doesn't get sick.

For those wondering what the pills are for, I can only speak to use for my son and my understanding as it's been explained. Different people may have the same pills prescribed by Dr. Li for different things.

Good Mood Tea: To help anxiety, he hates the name whereas it makes me want to sneak some every now and then

Mei Huang Tea 4: To lower IgE/help with food allergies

Shi Zhen Tea 1A: To help his skin/itchiness/hives

After he's had all his pills, before bed, he showers and then his dad puts Cream III-VB on him.

 This is the part he doesn't like. Previously he used Cream IIIB, which had a texture similar to Aquaphor™, and it stank. In my opinion, it smelled strongly like dirt. I was physically repelled by the smell. He put it on himself. 

Dr. Li wanted to be sure he was getting the cream applied adequately, which meant by someone else. She felt he would be more receptive to this with a second version that has the same medicinal properties but a different base. It's much lighter, both in texture and smell. James says it smells like lemons; I can't smell it. It's a water based cream, so it goes on much more smoothly and lightly.

But, he hates having someone else put cream on him and he hates the green tinge on his clothes and his skin. He doesn't like when Darren affectionately calls him the Hulk.

Cream III-VB: to help lower iGe/food allergies

A month of this protocol (for a 12 year old who is 5'6" and just over 100 lbs) is nearly $800. It is a commitment, both financially for the family and for James, daily dedication.

Why Traditional Chinese Medicine for Food Allergy Treatment

Why seek treatment at all

For a year after James's diagnosis, we followed the allergist's advice, which was to avoid his allergens, carry an epi-pen and come back in a year for a food challenge. When he failed a food challenge at the first dose, requiring epinephrine, I began to go into research overdrive. And, I was convinced that he should seek treatment.

James, on the other hand, wanted no part of it. And, age 11 at the time, I respected that he needed to want treatment. I won't say I dropped it, but we weren't going to enroll him in something against his wishes.

June 30, 2014 

James had a two system reaction to a new food (it turned out to be honeydew melon, although it was diagnosed by Urgent Care as mango - always seek treatment from a Board Certified Allergist!). We did not have an action plan from the first allergist we saw. However, having done tons of research by this point, I knew enough that James need to use an epi-pen, which he administered himself. Being diagnosed with a new food (ultimately two, honeydew and tomatoes, although OAS, rarely anaphylactic, 1-2%. James tends to get GI symptoms in addition to throat tightness so we avoid raw forms strictly), convinced James that he was ready to seek treatment. At this point, it took a few weeks and a therapy visit for him to convince me, because I did not want him to decide under the stress of a reaction.

Why Traditional Chinese Medicine (and Dr. Li)

James has a complex allergic history

July 4th, 2004, 3 days after he turned 3, we brought James in after watching fireworks and soon he was covered in head to toe hives the size of my husband's palm. They lasted (controlled by medication) for the next 3 years. This condition is know as chronic idiopathic urticaria (chronic hives, cause unknown). Even when he outgrew it, he still does occasionally get hives from overheating or from the wrong environmental allergen.

The goal of TCM is to heal the immune system. Although there is no correlation between having chronic urticaria and food allergies, in one person, it indicates to me a  basic issue with his immune system. It's the underlying healing that I am focused on.

James does not want to ingest his allergens

Ultimately, that is the goal. However, with OIT, you ingest them while still allergic. There seems to be debate about how common reactions are during OIT. It is generally agreed that most reactions are not severe. For the purpose of this post, I'm going to use this quote: "Wasserman (a private OIT doctor) says that about 15 percent of his patients drop out of OIT for reasons including severe reactions; stomachaches or vomiting hours after dosing; an aversion to the foods to which they are allergic; and anxiety." 

Whatever the rate and whomever you believe, I believe James would have been one of the percentage to drop out, for the anxiety if not the actual reactions. His journey with TCM has not been completely reaction free (GI upset and shortness of breath) but he is able to both tolerate it and work past it, which I don't think he could have done eating his allergens.

Dr. Li

Dr. Li is the only TCM practitioner/researcher/western Dr. in the U.S. that is researching the effects of TCM on allergic conditions. In addition, all of her herbs are tested for safety, both by a WHO lab in China and her lab at Mt. Sinai. You quite simply won't find another Dr. like her.

For more information on TCM and Dr. Li, please read Henry Ehrlich's book (affiliate link). 

And more

While there are many more differences between the multiple treatment options, our decision boiled down to those two main factors. The following chart includes some of the factors I considered. You might read the evidence and come to entirely different conclusions, so please understand the chart is based on my opinion, not meant to replace your own research!