CM - AT is touted as the hopeful new treatment for those within the autism spectrum. CM - AT utilizes active ingredients that seem to already be available without prescription; digestive enzymes are not new. CM - AT does represent they have an enzyme with a proprietary delivery system that is supposed to help digest proteins on another site (link). The key is that either the delivery or the ingredients of CM - AT is somehow new and proprietary, and therefore it might become an FDA approved pharmaceutical.
From Curemark: CM-AT, which has received Fast Track status from the FDA, is based on Curemark's research that showed enzyme deficiencies in autistic children, resulting in an inability to digest protein. The inability to digest protein affects the availability of amino acids, the building blocks of chemicals essential for brain function. If approved, CM-AT will be one of the first therapies to address the underlying physiology of autism.
CM - AT appears to be delivered in powder form three times daily, and the study is exclusive to those autism spectrum children between 3 - 8 years of age; it lasts for 90 days. Not really a long enough period to justify conclusion about if the treatment is actually beneficial due to the known ebb and flow of autism features that might occur from month to month anyway. Any person that has had to chart behaviors for longer periods knows this...
The developer of CM - AT does contend that the use of digestive enzymes might result in the development of better neural underpinnings for those youngest autism spectrum individuals. She also represents that ..."an early observational study of CM - AT, an orally ingested powder that delivers protein-digesting protease, showed significant improvements".
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Dr. Peter Lipson says there is a whole lot of bad science behind the CM - AT endeavor. He questions the fact that Dr. Fallon has previous to CM - AT ...applied for a patent to use the commonly available laxative lactulose to treat autism. He marvels at the fact that she has found a way to patent delivery of digestive enzymes in his writing - New Autism Study: Science or Nonsense?
One paper points out some guidelines required in order to avoid harm while starting treatment...(from Karen DeFelice)
One guideline is to start enzymes gradually with a low-protease enzyme product. This is an excellent workaround to situations such as gastritis or serious gut injury. The higher quantities of proteases in most enzyme products can cause discomfort when they come into contact with inflamed or exposed nerve tissue in an injured gut. Starting with a very low-protease product means you do not have to give up all the other enzymes just to get the protease levels down.
After one to three weeks using the low-protease product, a high-protease product usually can be gradually added without problem. The first product allowed gentler, more comfortable healing initially before the stronger proteases were introduced. The proteases can be considered the real workhorses in healing on many levels, so being able to use them is important...
In an older study to do with benefits of digestive enzymes (link) there was much that needed to be considered when applying enzyme type and dosage. Simply put there may need to be significant variations in order to provide efficacy. 17 of 46 subjects dropped out from the study to do with ENZYM-ED. Some did benefit from the application of ENZYME-ED.
...Patients who stopped the study in the first few weeks, reported a number of reasons including: need to start other therapies; family illness; personal issues; changed physicians; did not tolerate the taste of the supplement and/or no change in symptoms. Additionally, there were six patients who had "adverse responses" including hyperactivity/increased aggression, increased stimming (one), diarrhea/loose stools (two), provocation of red ears and cheeks (one), increased hunger (one), and stopped eating (one). Approximately 40% (data not shown) of the participants were following a gluten-free and casein-free diet but all were instructed not to change their diet during the treatment.
I have personally seen digestive enzymes give my daughter comfort as far as less tummy troubles. I do hope that Dr. Fallon is right in alluding that her treatment will improve neural underpinnings, because if a simple thing like using her proprietary digestive enzyme can address the underlying physiology of autism - that would help a lot of families.