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Reprinted from ANNALS OF ALLERGY, ASTHMA,
IMMUNOLOGY, February 1999, Volume 82, Number 2
Physician CFS Study Abstract
NADH A NEW THERAPEUTIC APPROACH IN CHRONIC FATIGUE SYNDROME (CFS)
L M Forsyth, MD; H G Preuss, Md; A L MacDowell, MD; L Chiazze,
JR, ScD; G D Birkmayer, MD, PhD; and J A Bellanti, MD; Departments of Pediatrics and
Microbiology-Immunology and the Immunology Center, Georgetown University Medical Center,
Washington, DC
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, 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) i.e., Co-E1 administered orally in a
randomized, double-blind, placebo-controlled crossover study in patients with CFS.
Nicotinamide adenine dinucleotide is known to trigger energy production through ATP
generation, which may form the basis of its potential effects. The study nutritional
supplement is Co-E1 NADH, the only stabilized, patented absorbable oral form of NADH.
Methods: Twenty-six eligible patients who fulfilled the Center for Disease Control
and Prevention 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 10mg of NADH or placebo at week 0
for a 4-week period, followed by a 4-week washout period, then followed by a final 4-week
period in which subjects were crossed to the alternate 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 Co-E1 compared
to placebo.
Conclusion: Collectively, the results of this pilot study indicate that NADH may be
a valuable adjunctive 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.
Open-Label Study:
During a follow-up, open label, pilot study, it was observed that 73% of the subjects
achieved marked improvement over time. Therefore, based upon these encouraging results, we
have decided to continue the open-label study in a larger cohort of participants.
Copyright 1999 Co-E1 NADH
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