Related Terms

• ALS, amyotrophic lateral sclerosis, antioxidants, autism, The Detoxx Book, the Detoxx System, glutamate, glutathione, intravenous therapy, Lou Gehrig's disease, muscular dystrophy, neurodetoxification, neurologic disorders, nutritional supplements, oxidative stress, Parkinson's disease, PC, PhosChol, phosphatidylcholine, PK protocol, targeted nutritional intervention.

Background

• The Patricia Kane protocol, often called the PK protocol, is a three-part program to treat amyotrophic lateral sclerosis (ALS) and other neurological disorders. It includes multiple daily infusions of intravenous (IV) phosphatidylcholine (often referred to as PC or PhosChol) and glutathione, a special nutrient-dense diet that limits the intake of carbohydrates and oral supplements.

• Patricia Kane, Ph.D., has claimed that this protocol "successfully reverses" ALS and has improved symptoms connected with other neurological problems, such as microbial infections, chronic fatigue immune dysfunction syndrome (CFIDS), Lyme disease, fibromyalgia, autism, mood disorders, Parkinson's disease, Alzheimer's disease, and multiple sclerosis.

• Patricia Kane specializes in treating metabolic disorders and lipid disturbances with targeted nutritional intervention. (There is a lack of information about the area in which Kane earned her Ph.D.) She and her husband, Edward Kane, promote their New Jersey-based business, BodyBio, which provides nutritional diagnostic reports to healthcare providers. The company also manufactures and sells vitamins, minerals, and supplements to providers and consumers. Information on this site states that Kane's primary interest is in fatty acids, nutritional biochemistry, cell membrane function, and neurological disturbances and that she has long been interested in seizure disorders, autism, traumatic brain injury, multiple sclerosis (MS), ALS, Parkinson's, CFIDS, and heavy metal toxicity.

• Patricia Kane, with coauthors Neal Speight, M.D., and John S. Foster, has written two books: one version for healthcare providers and one version for patients. Both are titled The Detoxx Book: Detoxification of Biotoxins in Chronic Neurotoxic Syndromes.

• According to some secondary sources, Patricia Kane may have practiced at the Haverford Wellness Center in Havertown, Penn.

• ALS is a progressive disorder that is characterized by a gradual degeneration of the nerve cells in the central nervous system that control voluntary muscle movement. The Over time, ALS causes muscle weakness and atrophy, eventually paralyzing the muscles. It becomes increasingly difficult to perform everyday activities, such as eating and breathing. ALS almost always results in death, often within 2-5 years from the time of diagnosis, because there is no cure. The ALS Association notes that fewer than one-quarter of all ALS patients live for five or more years after diagnosis, and 10% live longer than 10 years.

• ALS is a type of movement disorder. Examples of movement disorders include Huntington's disease, muscular dystrophy, cerebral palsy, Parkinson's disease, Alzheimer's disease, metabolic diseases, Gaucher's disease, and epilepsy.

• According to the ALS Association (ALSA), about 5,600 Americans are diagnosed with ALS annually, and as many as 30,000 Americans have ALS at any given time. Worldwide, an estimated 350,000 may have ALS. More than half of those with ALS in the ALSA database are men, and 93% are Caucasian. Most people with ALS are diagnosed between ages 40 and 70. Annually, ALS is responsible for an estimated two deaths per 100,000 people in the United States.

• One type of ALS is familial or inherited, although it only accounts for 5-10% percent of cases in the United States. Most cases are called sporadic ALS.

• Current conventional treatment of ALS involves the use of the drug riluzole (Rilutek©), and other drugs, such as ceftriaxone, minocycline, ONO-2506, and IGF-1 polypeptide (or Myotrophin). Riluzole is given to provide symptomatic relief, prevent complications, and help patients function and maintain quality of life as long as possible.

• Some ALS patients also take vitamins and supplements, including vitamin E, creatine, ginseng, and soy isoflavones, as part of their therapy. According to ALSA, antioxidants (such as vitamin E), and supplements (such as creatine, ginseng, and soy isoflavones) were beneficial in an ALS mouse model, but it does not include information on how.

• Researchers are focusing on other CAM methods for understanding and eventually treating ALS. One National Center for Complementary and Alternative Medicine (NCCAM) Research Centers program is researching several antioxidants (alpha-lipoic acid, vitamin C, and vitamin E, among others) in the hope that they may become part of ALS therapy in the future.

• Targeted nutritional intervention is a relatively new approach, used by some to treat Down syndrome and autism. It involves giving patients nutritional supplements that contain vitamins, minerals, and antioxidants. In one 2008 study, targeted nutrition was linked with an improvement in behavior and cognitive skills.

Technique

• Patricia Kane, Ph.D., has not made the details of her PK protocol available to the general public. Her staff states that it is only available to medical doctors.

• According to secondary sources, the protocol appears to be a three-part program. Part one is an organic diet that includes fresh vegetables, berries, and natural meats. Part two is an oral supplement program that consists of certain oils and supplements. Part three includes intravenous (IV) doses of phosphatidylcholine (10mg two times daily), leucovorin (0.05cc twice daily), and glutathione (10cc twice daily). The IV doses are delivered a total of 10 times weekly in conjunction with a sodium phenylbutyrate drip (25cc) twice weekly. Dr. Kane has not made available any more detailed information on the diet and treatment plan, although it could be speculated that the call for organics has something to do with avoiding potential toxins.

• According to some amyotrophic lateral sclerosis (ALS) organizations, some suggest that there may be a connection between diet and how the body handles lipids. ALS patients commonly lose a lot of weight. It has been proposed that a high-fat, low-carbohydrate diet might slow the progression of ALS, and there has been a call for animal studies in the area.

• Dr. Ross Hauser, coauthor of The Hauser Diet, credits Dr. Kane for her use of phosphatidylcholine (PC), which is used in conventional medicine to treat arteriosclerosis and plaque. Hauser states that Dr. Kane, along with Domenick Braccia, D.O., medical director of Haverford Wellness Center in Havertown, Penn., used PC as a neurodetoxifier and to treat diseases such as ALS, multiple sclerosis (MS), and others. He describes the PK protocol as an IV push of a lower dose of PC, which is called Essential -N® (an imported brand of PC). Dr. Hauser uses Essential -N® in his Illinois practice. Hauser's Web site states that PC may stabilize cells that are malfunctioning as a result of coronary artery disease. It is thought to strengthen cell membrane structure and also balance fatty acids.

• Other secondary sources suggest that part of the PK protocol involves taking a product called E-Lyte®, a concentrated product containing electrolytes that is added to drinking water.

• There is a lack of published data on this protocol.

Theory

• There is a lack of available scientific data on the Patrician Kane (PK) protocol.

• The Haverford Wellness Center, located in Haverton, Penn., where Domenick Braccia, D.O., formerly worked in partnership with Patricia Kane, Ph.D., refers to the PK protocol as a safe detoxification system that works through a combination of targeted nutrition and intravenous (IV) therapy. Targeted nutritional intervention is a relatively new approach, used by some to treat Down syndrome and autism. It involves giving patients nutritional supplements that contain vitamins, minerals, and antioxidants. It is not clear why IV therapy is used to deliver these nutrients.

• Some secondary sources suggest that the PK protocol may work by supporting cell membranes in the body, although this theory has not been confirmed.

• Oxidative stress is thought to play a key role in cell dysfunction in some disorders, including ALS. Oxidative stress may lead to the loss of motor neurons, although the mechanism is still unclear. Researchers are looking for ways to prevent oxidative stress in the hope of stemming motor neuron damage.

• Glutamate is an amino acid that acts as a messenger between nerve cells and organs. Researchers theorize that glutamate may send prolonged messages that overwhelm the nerve cells, causing toxicity, and that this malfunction may hold a key to understanding ALS.

• Researchers are also investigating whether immune-inflammatory responses contribute to ALS and other neurodegenerative diseases, such as Parkinson's disease and Alzheimer's disease. There is some evidence of a link between microglial activation and immune response.

Safety

• There is a lack of available scientific data on the Patrician Kane (PK) protocol.

• A qualified healthcare provider should be consulted before making decisions about therapies and/or health conditions.

• Patients with amyotrophic lateral sclerosis (ALS) or other neurological disorders should consult their healthcare providers before taking vitamins or supplements.

Author Information

• This information has been edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).

Bibliography

Natural Standard developed the above evidence-based information based on a thorough systematic review of the available scientific articles. For comprehensive information about alternative and complementary therapies on the professional level, go to www.naturalstandard.com. Selected references are listed below.

1. ALS Association. www.alsa.org

2. Ellis JM, Tan HK, Gilbert RE, et al. Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial. BMJ. 2008 Mar 15;336(7644):594-7. Epub 2008 Feb 21. View Abstract

3. Lakshmi K T, Surekha R H, Srikanth B, et al. Serum cholinesterases in Down syndrome children before and after nutritional supplementation. Singapore Med J 2008; 49(7): 561-564. View Abstract

4. Mehta S, Fawzi W. Effects of vitamins, including vitamin A, on HIV/AIDS patients. Vitam Horm. 2007;75:355-83. View Abstract

5. Muscular Dystrophy Association, www.mda.org

6. National Institute of Neurological Disorders and Stroke (NINDS). www.ninds.nih.gov

7. Natural Standard: The Authority on Integrative Medicine. www.naturalstandard.com