FDA-Approved Trial Heralds Promising NADH Supplement for Treating Chronic Fatigue Syndrome
by Kyle Roderick

Results of a FDA-approved study conducted at Georgetown University Medical Center in Washington, D.C., indicate that a nutritional supplement called NADH may be a valuable adjunctive therapy in the management of chronic fatigue and immune dysfunction syndrome (CFIDS). These research findings were presented at the November 9, 1997 meeting of the American College of Allergy, Asthma and Immunology in San Diego. The positive nature of these findings also suggests that more clinical trials be performed to further establish NADH's efficacy. "We're pleased with the results," says Joseph Bellanti, M.D., a co-director of the study who heads the Immunology Center at Georgetown University Medical Center. "We feel they have proved useful in understanding the clinically perplexing disorder of chronic fatigue."

CFIDS is a disorder of unknown cause for which no effective treatment exists. The incidence of CFIDS, as diagnosed using the Centers for Disease Control and Prevention (CDC) criteria, is between 0.8% and 1.6% in the United States and could be much higher. About 80 percent of reported cases are women. The constellation of CFIDS symptoms includes persistent, disabling fatigue which causes a substantial reduction in activity level. Other symptoms include recurrent infections, sleep disturbances, neurocognitive dysfunction or "brain fog," flu-like episodes, muscle pain and weakness, low- grade fever, sore throat, headache, swelling and tenderness of lymph nodes, and bowel disorders.

NADH enjoys a privileged position in medical history. In fact, NADH is the first nutritional supplement ever approved for testing by the FDA for potential use as a medical treatment. (Until now, FDA approved testing has been confined to drugs and medications.) A naturally-occurring coenzyme found in all living cells, NADH is known to trigger energy production through ATP generation, which may account for its potential effects. A coenzyme is a non-protein, organic substance that usually contains a vitamin or mineral and combines with a specific protein to create an active enzyme system. (Enzymes help facilitate biological processes and also create the molecules which we need to survive). The patented nutritional supplement form of NADH was formulated after a decade of research on NADH's effect on the body's production of a brain chemical which affects muscle coordination and control.

NADH is the abbreviation for nicotinamide adenine dinucleotide; the "H" in its name stands for hydrogen. The "H" also indicates that the substance is the reduced form of coenzyme #1, which is the body's most important coenzyme. If cellular levels of NADH are depleted, brain and muscle cells lose their ability to function effectively. NADH supplies cells with energy, so the more NADH a cell can use, the more energy the cell can produce. Thus, the theory goes that as NADH levels rise in the body, the cells become more energized, making the body feel stronger and more vitalized.

Another director of the NADH trial was Harry Preuss, M.D., Director of the Department of Nephrology at Georgetown University. Medical Researchers began using NADH to treat patients with CFIDS in April, 1996, and the preliminary results were so positive that Drs. Preuss and Bellanti recruited more patients for a follow-up study. Twenty-three patients who fulfilled the U.S. Centers for Disease Control criteria for chronic fatigue were enrolled. Medical history, physical examination and laboratory studies were performed at baseline, 4, 8 and 12 weeks. Subjects were randomly assigned to receive either 10 mg of NADH or a placebo at week 0 for a 4-week period, followed by a 4-week wash-out period, followed by a final 4- week period in which subjects were crossed to an alternate treatment regimen.

The study found NADH never caused any adverse effects. The preliminary results of this ongoing study suggest that 6 of 23 (26%) patients responded to the NADH and showed a marked improvement in physical, psychological, and neurocognitive measures. Significantly, 8 of 11 (73%) study patients enrolled in a longer, open label follow-up study showed significant improvement in clinical symptomatology and energy levels.

Georgetown's FDA-approved NADH study was a double-blind, placebo-controlled clinical trial, which means that physicians, researchers and patients were unaware of who received NADH and who did not. Sponsored by Birkmayer Pharmaceuticals of Vienna, Austria, the trial used the European oral tablet form of NADH. According to Dr. Preuss, co- director of the NADH study, "This FDA-approved trial for treating chronic fatigue syndrome patients is a first, significant step down a long road to investigate the many potential benefits of this natural co-enzyme called NADH." A recent European clinical study tested 100 chronic fatigue syndrome patients. Participants took the NADH oral tablets and all of them reported relief from their fatigue, increased strength and endurance, and a significant energy boost. No negative side effects were reported. Other clinical studies in Europe have also shown NADH to be a promising treatment for Alzheimer's and Parkinson's Disease.

Dr. George Birkmayer of Vienna, Austria, who co-created and patented NADH, suggests that CFIDS patients follow a specific routine when taking the supplement to maximize its efficacy. He recommends that the CFIDS patient remain upright or walk around for at least 20 minutes after taking the NADH tablet or tablets. Birkmayer's clinical observations indicate that remaining upright seems to facilitate the absorption and activation of the substance. Whenever possible, walking for 20 minutes after ingestion of NADH is also recommended.

"The results of the FDA's NADH trial appear to hold some promise for treating chronic fatigue patients, depressed people, and other patients who have special energy needs," says Dr. Stephen Sinatra, a cardiologist at the New England Heart Center in Manchester, CT. Editor of the cardiology health newsletter, Heart Sense, and author of books such as Optimum Health and Heartbreak & Heart Disease, Sinatra says, "NADH merits further research so we can more accurately identify and understand its potential value to patients and physicians." Sinatra himself uses NADH supplements. "When I feel exhausted from pushing myself too hard," he says, "NADH helps me feel energized."

FDA approval testing for NADH will most likely be completed in late 1998 or early 1999. After this, it is expected that NADH will be officially named as a vitamin.