Objective: To access the effects of a metabolic supplement on the out-of-control free radicals. These atoms, each with a missing electron, induce an excess of SOD (superoxide dismutase) accumulation within all cells of Down Syndrome patients.
Design: Noncomparative, open case studies were formulated from team data. Teams consisted of multidisciplinary medical staff, primary care physicians, developmental resource personnel, and families. Eleven random samples from a population of 6,000 patients were selected for the study. Six males and five females living across the United States were chosen. All patients have working parents and were in childcare situations prior to four months of age. Age appropriate children attended regular scholastic classes. Growth: Growth charts were standard pediatric Department of Health, Education and Welfare (not DS) charts. Pictures: Profile and full face showed indication of eye and nose changes. Developmental Tests: Denver Developmental, Leiter International Performance Scale, Slosson Intelligence Test - Revised, Wide-Range Achievement Test-R, and Visual Motor Integration. Infection History: Through physical observation of primary care physician (check list), or parent conference with Dr. Warner. Teleconferences also used.
Results: Median age of trial group was 6.7 years. Growth: Growth indicators for the males was a median height in the
32nd percentile at the onset of the program, and a current median in the 48.6th percentile. Females had a median height in the 27.5th
percentile at the onset of the trial, and a current median in the 30th percentile. Male median weight at the onset was in the 29th percentile,
with a current median in the 45.3rd percentile. Females started the trial with a median weight in the 22.5th percentile, and the current median weight is in 45th percentile.
Pictures: Observations of the multidisciplinary team noted changes in DS facies with the development of a typical nose bridge and reduction of the epicanthal folds.
Developmental Tests: Special Note: Limited data because of ages of test group.
Slosson Intelligence Test - Revised: Scoring has a mean of 100 with a standard deviation of 16. Median results for the trial were 99 for verbal and 105 for performance. Infections: Median results for ear infections are .41 per year. Median results for viral infections are .27 per year. Colds were reported at .73 per year. Only one patient had asthma with a history of two episodes the first year on treatment and none currently. One patient had pneumonia and was hospitalized for 1.5 days. No other infections reported currently.
Discussion: The metabolic supplement known as HAP CAPS has recently been copied by a parent whose child was on a Warner program for two years previously. This product is sold through a telemarketing scheme with enormous exposure on the Internet. More copy cats will surface and be used without adequate supervision. There is a grave concern that mistakes will again be attributed to metabolic supplementation when in reality it will be unauthorized "copies" with no accountability and no medical supervision. This is not a multi-vitamin, easily accessible, but a specific formula to decrease the excess SOD interfering with cellular growth. Each child treated is evaluated individually and additional medications and supplements are provided for the medical need of that patient. The Warner House data shows that 72.6 percent of the children treated need additional thyroid medication.
Conclusion: Metabolic supplements with specific doses of antioxidants have a direct effect on the excess SOD levels accumulated within all cells of DS children. Antioxidant modifications control free radicals so that cellular function becomes more appropriate.
Metabolic treatments have come and gone, and come again. Everything from "megadose" to toxic levels, and offering false hope to families with disabled children has been hurled at this type of treatment for too many years.
Doctors have pleaded for any scientific proof that there might be some credibility in the use of metabolic treatments. In 1980, Dr. F. Jack Warner, M.D, F.A.A.P., became interested in what a chemist turned medical doctor, Henry Turkel, M.D., was doing in Southfield, MI, for children with Down Syndrome(1). Through physical observations and histories Dr. Warner was able to detect improvements in DS (Down Syndrome) children being treated by Dr. Turkel. These patients were developing more typically than DS children not taking any supplement.
Two years of research and affiliation with Dr. Turkel contributed to the compounding of HAP CAPS, the Warner House, Inc.'s metabolic supplement. Metabolism is determined as the sum total of all chemical reactions that go on in living cells. Research for the past 25 years has validated the metabolic defect in Down Syndrome(2). Metabolic energy includes all the ways the body obtains and uses energy from food. Nutrients are necessary for energy, organ function, food utilization, and cell growth. The body simplifies nutrients in order to utilize them. When medical professionals voice concern over the long term effects of nutrient supplementation, are they using scientific integrity and accuracy in the consideration of a population already deficient in necessary metabolites?
The study of oxygen metabolism in Down Syndrome has been initiated by the assignment of the SOD-1 gene to chromosome 21.(3) In order to test a gene dosage effect for this enzyme in Trisomy 21, Sinet successfully measured, in erythrocytes, SOD-1 activities and found an increase of about 50% of this enzyme.(4) In a summary of properties, SOD has intracellular localization. There are certain indisputable facts that are now known about the super oxide dismutase enzyme. The gene is located in the area which produces the classical features of Down Syndrome.
One of the questions which can be broached is "If too little SOD is bad, is too much SOD also bad?" Dr. Sinet's report suggests that too much SOD probably has an indirect detrimental effect. Patients at the Warner House have tested with SOD levels as height as 10 times normal prior to any treatment. Presentation features included hypotonia, Down Syndrome facies, lethargy, obesity, epicanthal folds, history of frequent infections, marked gross and find motor delays, and arrested cognitive ability.
Investigative research has detected a marked reduction in the enzyme catalase. Without the proper amount of a catalase, the conversion of SOD will not transfer into the next oxidative state. This deficiency results in an accumulation of SOD in each body cell of a patient with Down Syndrome. The reduction has created a metabolic aggravation of free radicals in each cell. Free radicals are defined as molecules which have an unpaired or odd number of electrons in their outer orbit. These free radicals are missing an important electron and literally "run wild" trying to pick up that elusive electron in order to restore stability. They attract an electron from a nearby cell. That depleted cell attracts from an adjoining cell thus setting up a continual chain reaction until the body's defense system becomes defective. When antioxidant defenses falter, as they do when they are crippled by mutant genes, free radical production rises and tissue damage increases. A discovery by Duke University Medical School researchers headed by Dr. Allen Roses underscored how free radical damage may lead to chronic brain disease and disturbance. Because of the important role of free radicals in causing the brain to malfunction, scientists are attempting to devise a test to measure their activity. It appears that the free radicals generated by the abnormal SOD-1 are targeting glutamate, the protein involved in excitoxicity. The pattern typical of neurodegenerative diseases weaves a deadly web: Free radical damage produces an excitoxic state, which is then followed by programmed cell death.
Various treatment modalities have been recommended for Down Syndrome. For a number of years, Dr. Clemens Benda administered pituitary hormone and thyroid. He discontinued the use of this treatment in 1973 "because the product was not entirely successful." Rosner's discovery that serotonin levels were low in DS led to the hope that supplementary serotonin would improve muscle tone and mentality.(5) However, this treatment showed no improvement for many normal chemicals are reduced because of primary and secondary accumulations. For may years, Dr. Lejeune, the discoverer of the Trisomy abnormality, treated DS patients with some of the same nutrients as Dr. Turkel. For over 20 years the improvement of ameliorative therapy was forestalled by the medical opinion that "failure to cure a disease somehow diminished the importance of a successful treatment."(6) Even today many medical professionals scoff at the validity of Dr. Ruth Harrell's study with nutritional supplements and the important addition of thyroid medication. Dr. Harrell pleaded with her replicators to use exactly the same chemical values of supplements and medications.(7) To date, this still has not been accomplished. For years Down Syndrome was thought to be unrelated to any metabolic disorders because the examined biochemicals seemed to be within the normal range. Since excess wastes are pushed into tissue, investigators do not know what to look for or how to look for it. Many noted medical authorities, even today, fail to understand the concept of the out-of-control free radicals. Antioxidants are added to neutralize these rampant free radicals. This reaction lowers the high SOD levels which activate the enzymes to more functional values. Proper function of the absorptive and transport mechanism is crucial to delivering the nutrient products to individual cells. Derangement of any of these systems, as in Down Syndrome, can result in deficiency and malnutrition of the cellular membranes.
The idea of treating the entire child has always been a tenet of Dr. Warner's medical practice. And, the same precept is true with a DS patient. Many diagnoses are missed under the umbrella of "Down Syndrome." To facilitate the concept of entire care, a multidisciplinary medical staff was originated by the Warner House. All the body systems are evaluated. The typical Warner team consists of a pediatrician, behavioral vision optometrist, physical therapist, massage therapist, speech therapist, clinical child psychologist and a nutritionist. Many doctors throughout the United States, Great Britain and Australia are currently proctoring with Warner staff members and setting up satellite clinics for the proper care and treatment of children with Down Syndrome.
Findings of the Warner House reveal that heart abnormalities, frequent ear and respiratory infections, hypothyroidism, gastroesophageal reflux, hypotonia, flat feet, ankle pronation, low oral motor function, speech deficit disorder and cataracts are prevalent in DS patients.
Careful medical histories and previous records are perused by staff doctors prior to a child being evaluated for treatment. Consultation with family practitioners screens the differentiation between treatment progress and accustomed growth development.
Augmented metabolic supplements do change the enzyme deficiencies and provide nutrition for cellular growth. Dr. Warner is finding a marked lowering of the infection frequencies typical to children with DS - Otis media, ear infections, viral infections and allergic rhinitis. Height and weight are within the average range of typical development. And, like Harrell's results there is normal progress in the neurocognitive abilities of his patients.
Warner is the first to admit that nothing works by itself. It is a synergy of metabolic treatment, thyroid stimulation, and early intervention programs.