TCM has a long history of use in China, Korea, Japan, and other countries, where it is part of mainstream medicine and covered by insurance.
TCM practice does not focus only on the disease or individual organs. Rather, it addresses establishing and maintaining the balance of yin-yang (two opposite-but- complementary forces) the homeostasis of organ systems in the body, and interactions with the environment. The treatment promotes self-healing.
Treatment may be similar if patients have similar symptoms, but usually it is customized for each patient. For example, a “classic” Chinese herbal formulation is a mixture of many herbs, but it can be modified for individual patients depending on the initial combination of symptoms and progress over time.
United States regulators define TCM as a “Whole Medical System” by United States regulators—National Institutes of Health (NIH) and the National Center of Complementary and Alternative Medicines (NCCAM)
TCM is also beginning to play an important role in the US, along with other alternative therapies. Acupuncture needles have been approved by the FDA as medical devices, and are covered by some insurance. Herbal medicines are viewed as dietary supplements and their cost is not covered. However, this is changing. In 1998, the NCCAM/NIH began providing grants to support clinical and basic research on CAM. In 2004, the FDA provided guidance for investigating botanical drug products, including complex formulas containing several herbs, focusing on safety, efficacy, and consistency. Therefore, some dietary supplements may be classified as drugs after completing the clinical trials. In the interim, Flexible Spending Accounts, tax-exempt health care savings accounts, may allow expenditures for alternative medicine.
The regulatory changes described above created a unique situation. Some investigators began to use Western standard methods to investigate some Chinese herbal medicines with the goal of developing botanical drugs. In parallel with the research, some of these medicines continue to be used in clinical practice as supplements, but they use different names to distinguish them.
Investigational drugs registered with the federal government for research are somewhat different than the herbal formulations used in TCM practices as dietary supplements. The ongoing development process for an investigational drug, or any dietary supplement to gain approval as a drug, is time consuming and very expensive.
In recent years, an increasing number of publications, including those by Dr. Xiu-Min Li and her colleagues, showed that some constituents of the Chinese herbal medicine formulas suppress IgE production, mast cell and basophil activation, histamine release, and produce beneficial immunomodulatory effects on Th1 and Th2 responses. In animal models of peanut allergy, the herbal treatment produced full protection after 7 weeks of treatment, which is the mouse equivalent of 2-4 years of human treatment, and full protection lasted for six months. In the clinic, some multiple food allergic patients passed food challenges one by one after 2-3 years of treatment, and once they passed the challenges they do not relapse with or without regular ingestion.
However, while it must be noted, these are anecdotal observations, not part of any study, there is ample theoretical reason to believe that the relevant T-helper cells, Th1 and Th2, which govern the immune system, can be re-educated under appropriate conditions and thus effect a “cure.”
Th1 is normally the dominant immune response, which protects the individual against bacterial and viral infections and controls the counterpart Th2 response. Th2 promotes IgE production, and activates mast cells/basophils that release histamine and other chemicals that cause allergic symptoms, including anaphylaxis. In food-allergic individuals, Th2 responses become abnormally dominant towards food proteins, leading to over-production of IgE. In general, the severity of reactions in an individual depends upon the amount of food antigen exposure and the extent of mast cell/basophil histamine release. The persistence of food allergy depends on the memory Th2 cells and memory IgE producing B cells/plasma cells.
Therefore, a safe and effective therapy should suppress mast cells/basophil activation and also lower IgE levels, which will reduce reactions. A curative therapy will require re-establishing a Th1 balance that in turn controls the Th2 response and restores a normal immune system, which requires longer treatment.
Does it work? The book Food Allergies: Traditional Chinese Medicine, Western Science, and the Search for a Cure, contains several case histories from Dr. Li’s clinic, including one about a girl who used to be so sensitive to multiple nuts and had many ER visits, but she is now able to eat them after TCM treatment, and many months after the cessation of treatment.
This is not an easy question to answer for stand-alone food allergies because it is neither feasible to challenge for food allergies in the short run, nor with any frequency thereafter. Furthermore, it isn’t practical to test IgE (allergic antibody) levels often; nor are these tests strictly reliable because they measure blood (or serum) IgE levels, not IgE attached to mast cells and basophils, which are the ones responsible for triggering a reaction. However, it is still possible to infer progress if any more visible allergy symptoms are being treated concurrently. For example, relief from eczema is an indicator of diminished allergic activity as is improvement of asthma symptoms.
Other markers to look for: Reduced frequency and severity of reactions. For example, some patients who report frequent reactions, 50 or more, to random exposures, despite careful avoidance. After TCM treatment, the reactions become less severe and less frequent and some patients even have no reactions. Dr. Li says the happiest thing is hearing parents say, “We have nothing to report, everything is quiet”. This is a very good sign of improvement.
Food allergies and other immune disorders are quality-of-life conditions [QOL], and any evidence that QOL is improving can be taken as favorable. For example, some children concurrently have asthma and environmental allergies. Improvement of these conditions is also a good sign. Mood; the child becomes happier. Improvement of indigestion, stomachaches, and improve bowel movement. Better overall health, with fewer colds, and other viruses, and sinus infections.
It is also important to understand that while first-year IgE levels may not be totally reliable, if blood IgE levels come down to normal or close to the normal levels and are consistent in the following years, you can work with your allergist to do a new round of skin tests and then oral challenges.
The skin is a very efficient organ for absorbing and distributing the active ingredients throughout the body. Oral dosing has its special role, but when digestion is impaired, as it often is with food-allergic people, the job of processing these compounds is incomplete. Both bath and cream also lower mast cell activity in the skin, which is the largest organ in the body and the primary protection against environmental and infectious toxins. It is uniquely vulnerable to allergen exposure, both by contact and by ingestion. The wide distribution of mast cells throughout this large organ is an important part of the protective effect, but also presents a problem when the immune system has problems as it does with allergies. Finally, the daily oral consumption of a full dose of a variety of herbal medicine can be burdensome, especially for children. It is sometimes difficult to achieve a therapeutic dose. Herbal baths and creams can augment and complement the oral dosing.
This varies according to the individual. It depends on many things, such as age, degree of physical maturity, general health apart from allergies, and many more factors, but a 2-4 year range is a good estimate. As with any medicine, it should not be discontinued at first signs of relief, but Dr. Li has a protocol for tapering off dosage and frequency.
After initial intake, office visits should optimally be scheduled monthly, particularly if acupuncture and/or acupressure are part of the treatment. However, depending on the distances involved—faraway states or countries—the revisits can be arranged typically at 2, 3, 6, or at most 12 months. If long distances aren’t involved, approximately every month there should be another consultation, either in person or by phone. Email and other non-scheduled consultations are also encouraged, although they should be done judiciously out of respect for Dr. Li’s time.
Total and allergen-specific IgE will be done annually. Complete blood count (CBC) and chemistry tests will be done every six months after reaching full dosing.
Dr. Li’s principal concern is that treatment be safe and potentially beneficial. Although TCM therapy itself provided by Dr. Li is very safe, no one can say it is absolutely safe for every patient. Since treatment for immune disorders is a long-term process, Dr. Li likes to see the evidence of safety data. Hence, the CBC and Chemistry lab data at baseline and regular follow-up, because the liver enzyme testing (AST and ALT) can be influenced by behavior and illness. For example, vigorous exercise may increase AST levels. Many medicines such as antibiotics and pain relievers may affect liver enzyme levels. Any abnormalities will elicit more extensive history taking as to activity and illness, and may entail retesting in a few weeks. This does not mean that Dr. Li will not take the patients who have abnormal enzyme levels. If the liver enzyme confirmed to be abnormal, but consistent and there is no underlying condition, she will develop a special TCM protocol to help improve the enzyme levels.
Kidney and liver function are done in the beginning to ascertain whether there are conditions that should be treated on a priority basis, and to avoid the chance, however remote, that the herbal treatments will aggravate them. Because these treatments have a long history of safe use, it is unlikely that they will hurt any organs. Furthermore, the baseline measurements not just of kidney and liver function but other tests will contribute to the body of data accessible to retrospective analysis. After initial panels, they will be done every 6 months.
For many reasons, it is preferable for patients to work with their own physicians for things like blood work. On a very practical level, it is easier to get the work reimbursed. For another thing, we welcome collaboration with local physicians to help impart knowledge of TCM that will in the long run contribute to the dissemination of knowledge and achieve the model of integrative medicine. Anyone who needs help persuading a personal physician should contact Dr. Li via the private clinic.
Most crucially, because the number of pills is large and because many parents and children have no experience in handling TCM pills, Dr. Li has develop a special protocol for newcomers to further enhance the safety, tolerability and ease.
Yes. These medicines are meant to be ingested as teas, and in the case of some individual ingredients, such as ginger root, are staples of diets throughout the world. They are highly adaptable and can be added to liquids and soft foods. The most important thing is that any mixture be consumed in its entirety. It can be as simple as adding the contents of a capsule or a crushed pill to a couple of ounces of water and a bit of honey for flavor. The most important thing is that these are not chemically delicate medicines, so improvise to suit your child’s taste.
Take as directed. The most important thing is to space the doses by four hours. If the morning dose is missed, it can still be made up by an afternoon and evening dose. However, if you somehow miss two doses by evening, do not take two together before bedtime. Just take one and try to get back on schedule the following day.
As mentioned above, digestion is often impaired in those with food allergies. In fact, the most allergenic proteins in foods, such as peanuts, are the hardest to digest and are thus most likely to be absorbed intact into the body where they appear to the immune system as threatening invaders. Leaving aside standard diet and medical treatments for the time being, many American digestive systems are in need of repair, and the digestion teas have long track records for achieving this. The tea also helps with constipation, diarrhea, stomachaches, and pains unrelated to allergies.
There are no particular side effects, although some patients do have gastric discomfort. This could be the result of adjustment to unfamiliar substances. If these effects persist, they should be described to Dr. Li for possible adjustment of dosing. One of the statistics researchers are most proud of with FAHF-2 is that not a single adverse effect could be attributed to the drug. This is as safe as it gets. There may be other health effects coincident with taking these treatments but they are likely the result of other factors, such as viruses.
No. Dr. Li has seen hundreds of patients, from infants on up, and as long as the protocols are being followed she has seen no complications.
It is only necessary to continue to avoid pertinent allergens for the initial phases of treatment. Activities are permissible, since the whole point of treatment is to achieve a normal existence.
In the case of viruses and bacterial infections that involve vomiting, oral treatment can be suspended, since there’s no point in taking medicine that won’t stay down. As for baths and creams, it is probably not a good idea to treat the immune system when it is working overtime to fight infection. However, as long cold symptoms and coughing are not accompanied by fever, there’s no reason to stop treatment, and the creams and baths may enhance your child’s comfort.
If a patient must undergo surgery, however, discontinue herbs for one week before and after the procedure.
No. Keep in mind that the medicines use herbs in refined form.
Cornstarch is used to bind the active ingredients. Without some form of starch, it would be impossible to manufacture pills. Some people are concerned that they will react to this substance. True corn allergy is very rare. Corn is low in protein to begin with and refining removes almost any conceivable trace of it. For those who have trouble with the starch, special provisions can be made.
This is a long-term process so missing a few doses here and there, particularly in the case of illness, doesn’t make a significant difference. However, patients should endeavor to stick with their schedules.
The duration of active treatment won’t be the same for everyone, and will probably not be “forever”. Whether there will be any “boosting” necessary remains to be seen. In mouse trials, diminished protection following cessation of treatment was easily remedied by additional administration of medication. Patients with multiple allergies may see cessation with some faster than with others.
Always discuss other medications with all your doctors! Herbal medications do contain active ingredients, and sometimes react with mainstream drugs. Please advise Dr. Li and your physician about all medications, and consult the NIH website: www.nlm.nih.gov/medlineplus/druginformation.html
With some medicines, there can be synergistic effects. Antihistamines complement the herbal medicines because they block receptors on the IgE attached to mast cells, which inhibits allergic response, while the herbs inhibit production of IgE itself and block histamine release. The combination may be more effective than the herbs alone.
They recalibrate an unbalanced immune system towards normal. They do this by moderating the production of allergenic antibodies. Th2 cells, the T-helper cells associated with production of allergic antibodies, or IgE, are “down-regulated” without over-stimulating or damaging other immune function (as is often the case with excessive use of steroidal immune suppressants).
By repairing the digestive system, the herbal treatments make it less likely that allergenic proteins will be absorbed into the system, removing perceived threats, and by down-regulating Th2 IgE output, they reduce reactivity to current allergens. These twin effects make it less likely that new foods will become allergens.
There is no problem in principle because TCM modulates the immune system, instead of desensitizing it to particular allergens, which is the goal of OIT and the patch. It may be that these two processes can complement one another, although that remains to be studied. As a practical matter, however, patients in clinical trials can’t do TCM because it will compromise the study data. Currently, the patch is exclusively being done in trials, and many OIT studies are ongoing. However, patients who are doing OIT in private practice are welcome, provided they are doing it with the cooperation of their treating doctor. For patients who participated in OIT, but stopped because of frequent adverse reactions such as gastrointestinal problems, TCM may be a helpful option.
Curative therapy or persistent protection have not been established and the studies of FAHF-2, or a refined version, will carry on. Dr. Li’s team continues to make effort and to improve the herbal product for the clinical studies. They developed refined FAHF-2 named B-FAHF-2 (Butanol purified FAHF-2 or B version of FAHF-2). It increases the potency and requires only 1/5 of current FAHF-2 dose to produce complete protection in lab animal model of peanut allergy. For instance, the current version of FAHF-2 requires 36 pills a day for a 12 year old and an adult research subject, but will only need 6 pills of B-FAHF-2 to do the same job. For young child, it will only need 1-2 pills. This refined product will significantly increase the ease of clinical trial. A refined version will be available for clinical practice after an abbreviated safety trial. The refining process will make her clinical TCM supplement products easier to use over a long period of time, reducing the probability of “medication fatigue” and encouraging use for a long enough time with the goal to calibrate the Th1 and Th2 balance and build a healthier immune system.
The answer is no, for two reasons. First, this has been tried and the technology just isn’t sufficient. The transmission is halting and not conducive to a fluid conversation. It is not a good use of Dr. Li’s time or clinic facilities, especially when there is a waiting room full of patients who have made the trip. Second, the effectiveness of any non-surgical medical therapy is dependent in part on a bond of trust between the patient and doctor. This is especially true in the case of a highly individualized and probably unfamiliar therapy like TCM, which requires daily compliance with a regimen that may include a combination of pills, drinks, baths, and creams. The problem is compounded if acupuncture and/or acupressure are deemed part of the therapy. Skype is just not conducive to establishing the spirit of collaboration among patient, doctor, and parent that comes from face-to-face meetings. While flying has been a source of anxiety for many families, with proper precautions, the risks have been very successfully mitigated by thousands of families. For information on flying with food allergic symptoms, FARE has detailed procedures.http://www.foodallergy.org/managing-food-allergies/traveling
As mentioned, TCM treats the whole patient. The goal is to achieve a healthy, balanced immune system that does not react to allergens introduce via food, contact, or inhalation. Different symptoms in specific organs do not exist in insolation from the rest of body, and many organs can contribute to a single symptom. Dr. Li chooses not to treat one thing now and another later, unlike Western practitioners who often seek to treat acute problems in isolation from the larger picture. Eczema, or atopic dermatitis, is a prime example. Topical steroids help with inflammation, but without treating the underlying immune system, it will likely return. The same with wheezing and coughing associated with asthma.
There is also the challenge presented by the limitation of any single method of dosing. Medicines introduced by swallowing have the problem that digestion will destroy or eliminate a percentage of the active ingredients. Thus, it is necessary to induce additional ones via the skin to achieve a full therapeutic dose. Dr. Li’s research shows that multiple molecules contained in these compounds affect multiple other molecules in the body. In this, it is not very different from the discovery of “off label” uses of Western medicines, as, for example, that a pain reliever like aspirin when used in small doses can stave off clotting and reduce the risk of a heart attack. Thus, FAHF-2 may also prove useful as a treatment for Crohn’s disease because of its ability to inhibit secretion of cytokines found in both food allergies and cytokines.
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 (co-author of Asthma Allergies Children: a parent’s guide and editor of asthmaallergieschildren.com).
All extracts and final products must meet official Chinese standards, which are also recognized by the World Health Organization (WHO) Standards of Import and Export of Green Medicinal Plants and Their Preparations, which The State Administration of Traditional Chinese Medicine of the People Republic of China (http:// www.satcm.gov.cn/English2010/Policy/2010-10-06/156.html), Promulgated by Ministry of Foreign Trade and Economic Cooperation, the People’s Republic of China. Dr. Li uses herbs from areas that are known for purity, and are screened for potency of active ingredients. Medicines are tested by the manufacturers, pharmacies at major hospitals, which make all their own drugs right down to saline solutions. All extracts and final products are tested for microbial, pesticide, and heavy-metal residual levels* (Pony Testing International Group in Beijing, an official WHO collaborative lab). Because the US. Food and Drug Administration accepts their data, Dr. Li also uses this lab for investigational drugs. Finally, the lab in New York tests for batch quality using certain chemicals markers.
*4. Limited Amount Index
4.1. Heavy metal and arsenate
4.1.1. Heavy metal content ≤20.0mg/kg
4.1.2. Lead(Pb) ≤5.0mg/kg
4.1.3. Cadmium(Cd): ≤0.3mg/kg
4.1.4. Mercury(Hg) ≤0.2mg/kg
4.1.5. Copper (Cu): ≤20.0mg/kg
4.1.6. Arsenic(As): ≤2.0mg/kg
“Negative” results do not mean the science is wrong. You learn from them and try something different.
What we said in reporting our results is that the efficacy of FAHF-2 was unproven at the dose and duration in the study. Six months is a very brief period to try to effect the necessary re-education of the immune system to cure food allergies. Recommended treatment is 2-4 years. In addition, the compliance level was very poor. However, the biochemistry was encouraging. FAHF-2 showed very good immune modulating effects in the cultured cells in the lab; i.e. they switched cells from producing allergy-prone cytokines to producing toleragenic cytokines instead.
In retrospect, it was unreasonable to expect patients age 12 through middle age to dutifully take ten pills at each of breakfast, lunch, and dinner. The research is still active. We have successfully refined the herbal medicine to reduce the effective dosage by 80% and we have found a new way to make it even more concentrated. Finally, the investigational new drugs are not identical to the herbal treatments given in private practice. We know from private practice that we are headed in the right direction and we want to create drugs that have similar results.
Stop five days before the procedure and resume five days afterward after the procedure.
All components of Chinese herbal medicine do have powerful medicinal properties, which is why they work. Any potent herb, taken in large quantities, can be dangerous, just as something like aspirin (itself a botanical drug) can damage your stomach if taken too often and to excess. Many patients read about a “super food” or an herb that can boost energy or cure some ailment and they take it on their own with no medical supervision. This can be harmful. However, except in certain circumstances where individual herbs are used, all Dr. Li’s medicines are based on classical formulas that have been used for many years. The fact that they are formulas is important. No herb is over represented. Used together in therapeutic balance they are safe and effective. Used separately and without guidance, they may harm you.
After an acute reaction, the patient may take a 3-5 day break from treatment. When completely recovered, the patient may resume treatment, starting with half doses for 2 days, and then moving to the full dose.
Listen to your doctor! You must treat the emergent condition. The treating physician, whether a primary care doctor, an allergist, or an emergency department attending, is the person in charge. TCM is not an either/or modality. It is part of an ideal called integrative medicine. Patient well-being in the long run depends on a constructive partnership among patients, physicians, and Dr. Li’s team.