Physician CFS Study Abstract
NADH A NEW THERAPEUTIC APPROACH IN CHRONIC FATIGUE SYNDROME (CFS)
L.M. Forsyth, M.D.; A.L. MacDowell-Carnciro, M.D.; G.D. Birkmayer, M.D.; Ph.D.; H.G.
Preuss, M.D.; and J.A. Bellanti, M.D.; Departments of Pediatrics and
Microbiology-Immunology and the Immunology Center, Georgetown University Medical Center,
Washington, D.C.
Background: Chronic fatigue syndrome (CFS) is a disorder of unknown etiology, consisting
of prolonged, debilitating fatigue, and a multitude of symptoms including neurocognitive
dysfunction, flu-like symptoms, myalgia, muscle weakness, arthralgia, low-grade fever,
sore throat, headache, sleep disturbances, and swelling and tenderness of lymph nodes. No
effective treatment for CFS is known.
Objective: The purpose of the study was to evaluate the efficacy of the reduced form of
nicotinamide adenine dinucleotide (NADH) administered orally in a randomized,
double-blind, placebo-control, crossover study in patients with CFS. NADH is known to
trigger energy production through ATP generation, which may form the basis of its
potential effects. The study drug is ENADA® NADH the only stabilized absorbable oral form
of NADH a nutritional supplement product.
Methods: Twenty-six evaluatable patients who fulfilled the CDC criteria for CFS completed
the study. Medical history, physical examination, laboratory studies and questionnaire
were obtained at baseline, 4, 8 and 12 weeks. Subjects were randomly assigned to receive
either 10 mg of NADH (ENADA®) or placebo at week 0 for a four-week period, followed by a
four-week wash-out period, followed by a final four-week period in which subjects were
crossed to an alternative regimen.
Results: No adverse effects were observed related to the study drug. Within this cohort of
twenty-six patients, four times more patients responded to NADH (ENADA®) compared to
placebo.
Conclusion: Collectively, the results of this preliminary study indicate that NADH
(ENADA®) may be an effective therapy in the management of the Chronic Fatigue Syndrome
and suggest that further clinical trials be performed to establish its efficacy in this
clinically perplexing disorder.
The study was published in the February 1999 issue of Annals of Allergy, Asthma and
Immunology.
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