Release Date: November 12, 1999
Contact: Jo Ann Faber (847) 427-1200

Investigators Discover Potential Indicator for Chronic Fatigue Syndrome

Chronic fatigue syndrome (CFS) is a debilitating disorder that causes unexplainable tiredness or lack of energy. It affects more than 14 million Americans, occurring mainly in adults aged 20 to 40 years and in twice as many women as men.

"Currently, the diagnosis of CFS involves a lengthy procedure of eliminating other possible causes of severe fatigue lasting more than six consecutive months," said ACAAI Past President Joseph A. Bellanti, M.D., of Georgetown University Medical Center in Washington, D.C. "Hopefully this data will provide a predictive marker of CFS which will help unravel the diagnosis and treatment of this perplexing disorder."

Investigators used data from a double blind placebo controlled study published February 1999, in the ACAAI'S scientific journal, "Annals of Allergy, Asthma and Immunology." The study reported subjects taking a nutritional supplement ENADA® - a stabilized oral absorbable form of nicotinamide adenine dinucleotide (NADH) - were four times more likely to show an improvement in CFS symptoms than those taking a placebo.

According to Dr. Bellanti, the follow-up study testing urinary concentrations in 20 of the CFS patients found that 75 percent showed elevated levels of a major breakdown product of serotonin, known as 5-HIAA. When treated with NADH, 70 percent of the patients returned to normal range, whereas in the placebo subjects, 70 percent retained elevated or increasing levels.

"The results of this study suggest that the measurement of urinary 5-HIAA may not only serve as a useful predictive marker of disease activity in CFS patients, but also may provide an objective measure of improvement following therapy with NADH," said Dr. Bellanti.

The Centers for Disease Control and Prevention (CDC) defined criteria for the diagnosis of chronic fatigue syndrome. Unexplained, debilitating fatigue of at least six month duration must be present, along with four or more of the following symptoms: neurocognitive dysfunction, muscle pain, sore throats, headaches, feeling of being sick or of physical discomfort after exertion, joint pain, sleep disturbances, or swelling and tenderness of lymph nodes.

FOR IMMEDIATE RELEASE:
Contact: Prof. Birkmayer Health Products USANovember 12, 1999 Bill Armstrong
New York, NY 1.760.438 2755

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New Diagnostic Tool
for Chronic Fatigue Syndrome (CFS)
Presented to Annual Meeting of American College of Allergy,
Asthma and Immunology

CHICAGO, IL, Nov. 12, 1999, New data presented to the Annual Meeting of the American College of Allergy, Asthma and Immunology suggests the discovery of a potential diagnostic tool and therapeutic measurement for CFS.
The Centers for Disease Control and Prevention, report that chronic fatigue symptoms affect more than 14 million people between the ages of 17-69 and in twice as many women as men. "Currently, the diagnosis of CFS involves a lengthy procedure of eliminating other possible causes of severe fatigue lasting more than six consecutive months," said Dr. Joseph Bellanti, M.D., and Director of the International Center for Interdisciplinary Studies of Immunology at Georgetown University Medical Center, who identified a simple-to-test for urinary marker in CFS patients.

Last month a study published in the American Medical Association's The Archives of Internal Medicine reported that the incidence of CFS is significantly more prevalent than previous data suggests. The study reported women are 20 times more likely to develop CFS than breast cancer and more than 15 times more likely to contract CFS than lung cancer.
CFS patients suffer a debilitating illness that drastically affects their ability to work and live normal lives. CFS patients are often unable to complete the simplest of tasks without being exhausted. "Dr. Bellanti's work may represent a major breakthrough that will help doctors provide earlier diagnosis and better treatment," said Dr. Georg Birkmayer, M.D., Ph.D., the researcher who first discovered the therapeutic application of NADH in cellular development and energy transmission. NADH is a naturally occurring coenzyme that activates bodily energy production.

The Georgetown University Medical Center doctors' groundbreaking CFS research involved the use of ENADA® NADH a dietary supplement. Results of a double-blind, placebo-controlled cross-over study published in the February 1999 issue of Annals of Allergy, Asthma and Immunology found that CFS patients taking ENADA, a dietary supplement, were four times more likely to show improvements compare to those taking a placebo. A follow-up open label study showed 72% of the patients taking ENADA achieved continued marked improvement over time. After more than 18 months of using ENADA more than 80% of the CFS patients continue to experience improvement in their condition.

Dr. Bellanti's current study evaluated 20 of the original CFS test subjects and found that 75 percent showed elevated levels of a major breakdown metabolite product of serotonin, 5-HIAA which appears in urine. When treated with NADH, 70 percent of the patients returned to the normal range. In subjects taking a placebo, 70 percent retained elevated or increased levels of 5-HIAA.

Dr. Bellanti is founder and director of Georgetown University Medical Center's International Center for Interdisciplinary Studies of Immunology. He is a professor of pediatrics and microbiology. Dr. Bellanti has served on the Maternal and Child health Study Section of the National institutes of Child Health and Human Development (NICHD) and the Allergy and Immunology Research Committee of the National Institute of Allergy and Infectious Diseases NIAID). He has published more than 400 scientific papers, abstracts and books. He is the author of the widely renowned textbook on immunology, now in its third edition.
Prof. Birkmayer Health Products USA's mission is to develop and market safe, reliable and effective nutritional supplement products, which are designed to improve the quality of life for all people. Prof. Birkmayer Health Products USA's ENADA is the only patented, stabilized, absorbable, oral form of NADH. ENADA is the result of a decade of research and extensive toxicology and safety studies, culminating in the filing and issuing of an Investigational New Drug application (IND). The IND, issued in 1996, is number 49,635. The original code name of ENADA was Birmadil.

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ENADA - A Nutritional Supplement for Healthy Individuals Desiring More Natural Energy

A Clinical Trial Reports Proven Energy Enhancement Using Strict FDA Testing Guidelines to Alleviate Symptoms of Chronic Fatigue Syndrome

WASHINGTON, DC, (February 23, 1999) - - Menuco Corporation announced today that ENADA®, a natural energy-enhancing nutritional supplement, tested by researchers at Georgetown University Medical Center, has achieved significant improvement in relieving the symptoms of people suffering from Chronic Fatigue Syndrome (CFS). CFS is a debilitating disorder caused by unexplainable tiredness or lack of energy, and has no known cure. According to the Centers for Disease Control, over 14 million people in the U.S. experience chronic fatigue symptoms. The Georgetown clinical trials focused on people diagnosed with CFS; however, ENADA is also a nutritional supplement for healthy individuals who desire additional energy.

ENADA is one of the first nutritional supplements to be tested using strict guidelines to determine its safety and effectiveness. Georgetown doctors found that 31% of the patients who took ENADA achieved significant improvement in the relief of their symptoms. In a follow-up study, 72% of the patients achieved positive results over a longer period of time. The double-blind, placebo-controlled human clinical trial results have recently been published in a prominent medical peer-reviewed journal called "Annals of Allergy, Asthma and Immunology." The findings of these clinical trials are being presented at the February 23, 1999 press conference at Georgetown University Medical Center.
"Eighty percent of Americans state that fatigue is their number one health complaint. We to demonstrate through sound scientific studies, not marketing hype, that ENADA is both safe and effective in providing energy enhancement to alleviate the symptoms of CFS, a debilitating disorder which affects half a million Americans," said Matt Fitzsimmons, president, Menuco Corporation. "Dr. Bellanti and his research colleagues at Georgetown University Medical Center have successfully demonstrated ENADA's effectiveness in increasing energy," says Fitzsimmons.

For years, research scientists have known that NADH a natural coenzyme plays an important role in the body's cellular energy producing function. NADH occurs naturally in the muscle tissue of fish, poultry and cattle - key food sources in the human diet. However, the human body absorbs miniscule amounts of NADH ingested from food sources. Also it is known that the more NADH a cell has, the more energy it can produce; therefore, the more energy a person has.

In 1996, ENADA received an Investigative New Drug (IND) acceptance allowing ENADA to begin a human double-blind, placebo-controlled, crossover study following strict pharmaceutical and drug testing guidelines. The study was conducted at the prestigious Georgetown University Medical Center in Washington, DC. (The IND number is 49,635 and the original working name of the product was Birmadil.)

FOR IMMEDIATE RELEASE:
Contact: Prof. Birkmayer Health Products USA
March 10, 1998 Bill Armstrong
New York, NY 760-438 2755

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NUTRITIONAL SUPPLEMENT OFFERS RELIEF FOR CHRONIC FATIGUE SYNDROME (CFS)

New York, N.Y. -- In a clinical trial conducted at Georgetown University Medical Center have discovered that the use of a naturally occurring coenzyme may alleviate the major symptoms such as significant energy loss associated with Chronic Fatigue Syndrome (CFS).

A double-blind, placebo-controlled clinical study conducted at Georgetown University Medical Center found that 31 percent of the patients, who took the nutritional supplement ENADA® the stabilized oral form of the coenzyme NADH, achieved significant improvement in symptoms compared to eight percent of the subjects who took a placebo. The 12-week study included four weeks on 10 mg. of ENADA® or a placebo, four weeks off any medication, and then four weeks on 10 mg. of ENADA® or placebo.

Additionally, in a follow-up preliminary open-label study, 73 percent of the patients achieved marked improvement over time. Researchers identified no adverse effects from taking ENADA® and no interactions with antidepressants or antihistamines.

"We have found from other studies that patients with Chronic Fatigue Syndrome have lower levels of ATP, the chemical that gives the body energy," says Joseph A. Bellanti, MD, director of Georgetown's International Immunology Center and the study's co-principal investigator. "We believe that ENADA® works by increasing the levels of the body's energy fuel."

"In this carefully controlled scientific study, we were able to show a significant benefit from ENADA®," Bellanti adds. "We were very impressed with the beneficial effects of this nutritional supplement."

Chronic Fatigue Syndrome (CFS) is a debilitating disorder with no known cause or cure. More than 600,000 people are affected with the disease, and more than 2 million people believe they suffer from chronic fatigue. The primary symptom of CFS is a general, unexplainable lack of energy.

NADH occurs in all living cells and plays a central role in the body's energy-producing capacity. It occurs naturally in the muscle tissue of fish, poultry and cattle, (key parts of the human diet), and in yeast food products.
"This trial in chronic fatigue patients is a first but significant step in investigating the many potential benefits of this coenzyme," says Harry Preuss, MD, a Georgetown nephrologist and the study's other co-principal investigator. "Georgetown's scientists are conducting nutritional supplement research to determine scientifically the efficacy of these natural substances in preventing and treating a number of disorders."

Birkmayer Laboratories of Vienna, Austria, and MENUCO Corporation of New York sponsored the CFS study using ENADA®, the only stabilized, absorbable oral form of NADH. The oral supplement results from a decade of research at the Birkmayer Institute on NADH's ability to stimulate the body to produce naturally the key brain chemicals responsible for energy production and muscle coordination. Though studies are not required for nutritional supplements, this study followed all guidelines for drug research.

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