Investigators Discover Potential Indicator for Chronic Fatigue Syndrome

CHRONIC FATIGUE SYNDROME (CFS) IS A DEBILITATING DISORDER THAT CAUSES UNEXPLAINABLE TIREDNESS OR LACK OF ENERGY. CFS symptoms affect more than 14 million Americans, occurring mainly in adults aged 20 to 40 years and in twice as many women as men.

The most commonly encountered features in patients with CFS are fatigue, impairments in concentration and short-term memory, musculoskeletal pain and sleep disorders. The syndrome is characterized by profound debilitating fatigue lasting at least six months, often beginning after a viral infection and not meeting the criteria for other medical or psychiatric disorders.

The Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, have defined criteria for the diagnosis of CFS. The CDC have established that unexplained debilitating fatigue of at least six months duration must be present along with four or more of the following symptoms including neurocognitive dysfunction, myalgias, sore throat, headache, postexertional malaise, joint pain, sleep disturbances or swelling and tenderness of lymph nodes. The majority of all CFS sufferers complain about an overall lack of energy.

The biochemical substrate of energy stored in our body's cell structure is called adenosine triphosphate (ATP). It has been demonstrated by the technique of MRI spectroscopy that CFS patients exhibit an ATP deficiency, in particular after even a low level of physical exercise. NADH (the reduced form of nicotinamide adenine dinucleotide), is also known as Coenzyme I and is the biological form of hydrogen which reacts with the oxygen we breathe to produce energy in the form of ATP.

It is a biochemical fact that one mol of NADH will form three mols of ATP. Furthermore, NADH itself can be regarded as an energy-rich compound which releases energy as soon as it dissolves in water. In as much as the human body consists of approximately 80 percent water, NADH can continue to increase cellular energy production once it is absorbed. Since the development of ENADA Registered Trademark (the only stabilized, absorbable oral form of NADH), several clinical trials have substantiated its beneficial effect in patients with ailments such as Parkinson's disease, depression and Alzheimer's disease. Even highly conditioned athletes such as competition level cyclists benefit from ENADA Registered Trademark NADH in terms of energy enhanced performance. These applications/observations provided the rationale for a study to evaluate the efficacy of ENADA NADH in patients with CFS.

The study was performed at the Georgetown University Medical Center after an investigative new drug (IND) application was approved by the FDA. Based on this approval, the institutional review board (IRB) of Georgetown University Medical Center gave approval for the study. A total of 26 eligible patients who fulfilled the Centers for Disease Control and Prevention criteria for CFS completed the study. Medical history, physical examination, laboratory studies and questionnaires were obtained at baseline four, eight and 12 weeks. Subjects were randomly assigned to receive either 10 mg of ENADA NADH or placebo for a four-week period followed by a four-week washout period during which the subjects received neither ENADA nor placebo. Subjects were then crossed over to the alternative regimen for a final four-week period in which the group receiving ENADA in the first period received placebo and the placebo group now received ENADA. Overall the key finding in the study is that over 31 percent of the patients responded favorably to ENADA NADH by showing significant improvements in their symptoms. This results in ENADA actually being four times more effective than placebo. Additionally, in the longer term, open-label phase of the study, 72 percent of the patients continued to report an improvement of their symptoms after six months of 10 mg ENADA NADH daily. After approximately one year of taking ENADA the research doctors are reporting up to 81 percent of the patients continue to benefit from ENADA. These findings suggest that long-term ENADA therapy can lead to continued improvements, especially in energy and mental/ cognitive status.

With CFS it should be noted that both dosage level and overall body weight have an influence on the effectiveness of ENADA. Overweight people may need higher dosages of ENADA. In a number of overweight CFS subjects cases, researchers have found that 30 mg of NADH (six ENADA 5 mg tablets per day) leads to an improvement of CFS symptoms in four to six weeks. However, if some of these patients reduce the daily dosage to 10 mg, symptoms of CFS reappear. Based on our experience with CFS subjects, we recommend taking 10 mg NADH (2 tablets ENADA 5 mg) on a daily basis, in the morning and always on an empty stomach with at least a half glass of water. If CFS suffers do not experience an improvement after four weeks of continuous usage, they should increase their dose to a third tablet either in the morning or early afternoon. They may also increase the daily dosage even further to four or five tablets, depending on their body size and weight and the severity of their symptoms. In other words, the optimum effective dosage of ENADA can vary by each individual's own unique biochemistry and body make-up.

Regarding ENADA side effects and product safety the Georgetown University Medical Center study was a FDA approved clinical trial, therefore, any side effects or adverse reactions must be carefully and totally documented. None of these were observed by the doctors or reported by the patients. Also no side effects were reported in another study with 880 parkinsonian patients who were treated with 10-25 mg of NADH orally or parenterally for at least six months. In a depression study with 205 patients NADH has been found to improve symptoms of depression with no reported side effects. Although ENADA NADH is classified as a dietary supplement, the FDA requires safety data be presented before human trials can be scheduled. Therefore, toxicology safety studies performed on ENADA NADH show that the maximum tolerated dosage of NADH is 500 mg per kg body weight per day. The dosage applied to CFS patients was 10 mg per patient per day and is regarded as a totally safe and acceptable therapeutic dosage. Based on the safety data, the maximum tolerated human dosage is more than 3500 times higher than the 10 mg dosage given to the CFS subjects. The majority of patients have been taking between 10 and 30 mg ENADA NADH on a daily basis for over four years. In other words, NADH is an extremely safe substance.

In conclusion, since many CFS suffers are now taking ENADA NADH, it will effectively improve two major CFS symptoms--debilitating fatigue and lack of mental clarity/focus with no significant side effects experienced.

A free copy of the actual published Georgetown CFS study in the Annals of Allergy, Asthma, and Immunology, February 1999 is available at www.enada.com or call 1-800-636-8261.

Clinical Urinary Test May Indicate Chronic Fatigue Syndrome
Researchers at Georgetown University Medical Center in Washington D.C. believe that high urinary levels of 5-HIAA, a metabolite of serotonin, may be a predictive marker for chronic fatigue syndrome. Dr. Joseph Bellanti presented his team's preliminary findings at the annual meeting of the American College of Allergy, Asthma and Immunology in Chicago.

In a previous study, Dr. Bellanti and colleagues administered the nutritional supplement nicotinamide adenine dinucleotide hydride (NADH) to a group of patients with chronic fatigue syndrome to boost glucose metabolism and production of a number of neurotransmitters, including serotonin. In the study presented, which was conducted in a subgroup of 20 patients from that study--10 on active treatment and 10 on placebo--the Georgetown team measured urinary 5-HIAA levels both pre- and post-treatment.

Results of the original study showed that patients on active treatment were four times more likely to experience an improvement in symptoms than patients on placebo. Dr. Bellanti reported that at baseline, urinary concentrations of 5-HIAA were elevated in 10 of the 20 patients. The researchers found that urinary levels of 5-HIAA returned to normal in seven to 10 patients who received NADH.

These findings are significant in that"... 5-HIAA may be a predictive marker of disease activity and may be a useful measurement of the efficacy of therapy." Dr. Bellanti told Reuters Health: "We may be able to develop a urine test that is easily performed and reliable to identify chronic fatigue syndrome."

PHOTO (COLOR): Chronic Fatigue Syndrome

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By Georg D. Birkmayer, M.D., Ph.D.

Adapted by M.D., Ph.D.

Professor Georg D. Birkmayer, M.D., Ph.D. is a world-renowned bio-chemical researcher who was the first to identify the importance of NADH in cellular development and energy transmission for all bodily functions and organs. He is the medical director of the Birkmayer Institute for Parkinson's Therapy which has treated thousands of patients suffering from Parkinson's disease, Alzheimer's disease and depression. He is the founder and chairman of Birkmayer Pharmaceuticals and the Birkmayer Laboratories (Vienna, Austria). Dr. Birkmayer is the author of more than 150 major research papers and more than 100 scientific articles in the areas of cancer diagnosis, neurochemistry and neuropharmacology related to Parkinson's and Alzheimer's diseases

He is a professor at the University of Graz in Austria, heading its Division of Neurochemistry at the Department of Medical Chemistry. He is also a visiting professor at the University of Beijing and Canton, China and secretary general of the International Academy of Tumor Marker Oncology in New York. He is the European editor of the Journal of Tumor Marker Oncology and a member of the editorial board of the Journal.

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I've been having an aching pain in my lower back, oblique and upper abdominal region. I'm thinking it may be CFS, but I don't have a lot of the symptons of it (I don't have any flu like symptons or swollen glands. I work out every day and I don't notice any lethargy (not more than usual hah). I've been working out my abs (I use one of those stupid contour belt things so you know what i'm talking about. That could possibly explain the aching in the abdominal section, but it doesn't account for the obliques and my back.