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., ENADA the
stabilized oral absorbable form, 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.
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 10 mg of
NADH or placebo for a 4-week period. Following a 4-week
washout period, subjects were crossed to the alternate regimen
for a final 4-week period.
RESULTS: No severe adverse effects
were observed related to the study drug. Within this cohort of
26 patients, 8 of 26 (31%) responded favorably to NADH in
contrast to 2 of 26 (8%) to placebo. Based upon these
encouraging results we have decided to conduct an open-label
study in a larger cohort of patients.
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.
Forsyth LM, Preuss HG, MacDowell AL, Chiazze L Jr, Birkmayer GD,