By Kathy Franklin
There’s been a great deal of interest in the Food Allergy Herbal Formula Study being conducted at Mount Sinai Medical Center. Many food allergy parents have asked me all sorts of questions about this much-anticipated research trial, so I thought I’d pass along what I know. This is strictly unofficial, from personal experience and word-of-mouth — one food allergy mom’s perspective on a promising therapy.
What is the Food Allergy Herbal Formula? This is the wonderful new Chinese-based therapy that aims to raise the threshold for an allergic response; if it works as hoped, there will be less to fear from tiny amounts of accidental cross-contamination. No one is promising (yet) that your child can eat a whole nut; but indications point to those horrifying “didn’t clean the knife well enough” reactions being less of a concern for those taking the herbal supplements.
The great news is that the Phase Two trials are now underway. They are looking for participants, ages 12 to 45, with an allergy to peanut, tree nuts, fish, shellfish, and/or sesame, and who are interested in taking Chinese herbal medicine tablets for 6 months. Unfortunately, not everyone will qualify, because the FDA imposes very strict rules about who can and cannot be included in research trials; please contact Jaime Ross, Nursing Clinical Research Coordinator, to learn more, and to find out if you or your child is eligible for inclusion. email@example.com or 212-241-6577.
Worried about safety? Don’t be! The Phase I Trials, completed last year, proved that the formula is both safe and well tolerated by allergic patients. (My own son participated; it was a very positive experience.) A food challenge will be required, at the start and the end of the study. This, too, is quite safe.
There’s a common misconception that food challenges are dangerous, or that they require inducing a serious anaphylactic reaction to prove a true food allergy. This is NOT the case. They give such microscopic amounts of the food that not even the most extremely food-allergic individuals react to the early doses. The clinicians gradually increase the amounts, until they induce some hives, or a stuffy nose, or hives plus a cough; perhaps a stomachache, with or without vomiting; or red, itchy eyes. That’s it. They stop as soon as there is a clear sign of an allergic reaction; they’re not producing a severe reaction, just a mild one.
All of this happens under careful medical supervision; usually one dose of antihistamine is all that’s needed to stop the reaction. Sometimes albuterol is used instead, or in addition, depending on the symptoms. Epinephrine is, of course, always available, just in case, but it’s rarely needed. There has never been a death due to a clinical food challenge, ever. Not at Mount Sinai, and not anywhere else in the world.
As a further precaution, they keep you under observation for several hours following the challenges, whether or not you’ve had any reaction. My son actually got quite a bit of schoolwork done there one afternoon — it’s a nice quiet place to study.
I recently read a comprehensive description of food challenges. You can find it here.
If you’re interested in the Herbal study, I urge you to contact Nurse Ross as soon as possible. People have been eagerly awaiting this opportunity, and the limited spots will fill up quickly.
Trials are also being conducted in Little Rock, Arkansas. The contact for that location is Lynn Christie, firstname.lastname@example.org.
There are other promising research studies underway, if you’re not interested in this one, or don’t qualify. The following sites have extensive information about upcoming and ongoing opportunities for participating in a clinical trial, as well as helpful details of what’s involved in research participation:
The Food Allergy Initiative (FAI) click here.
The Food Allergy & Anaphylaxis Network ( FAAN) click here.
The Consortium of Food Allergy Research (CoFAR) click here.
The Mount Sinai School of Medicine click here.
Remember, the benefits of participation are many. You will be making a direct contribution to the search for a cure; you will have access to new treatments years before they become available to non-participants; and you will have face-to-face time with some of the leading food allergy specialists in the world. Another benefit: free parking, even in New York City! I’ve heard that transportation and/or parking expenses will be reimbursed, if needed.
Please feel free to contact us at AsthmaAllergiesChildren.com, as well, if you have any questions or concerns.
Disclaimer: This is not an advertisement. I have no official or unofficial relationship with Mount Sinai, nor any research study. I’m a private citizen, a concerned food allergy mom, sharing this information with those who might benefit from this opportunity. This is a personal interest of mine, to raise awareness of the need for food allergy patients to participate in clinical research so that we can help the researchers find a cure sooner.
For more about Traditional Chinese Medicine, click here.
For more about food allergies at Mount Sinai, click here.