Therapeutic effects of oral NADH on the symptoms of patients with chronic fatigue syndrome

Background: Chronic fatigue syndrome (CFS) is a disorder of unknown etiolog y, consisting of prolonged, debilitating fatigue, and a multitude of sympto ms including neurocognitive dysfunction, flu-like symptoms, myalgia, weakne ss, 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 red uced form of nicotinamide adenine dinucleotide (NADH) ie, ENADA(R) the stab ilized oral absorbable form, in a randomized, double-blind, placebo-control led crossover study in patients with CFS. Nicotinamide adenine dinucleotide is known to trigger energy production through ATP generation which may for m the basis of its potential effects. Methods: Twenty-six eligible patients who fulfilled the Center for Disease Control and Prevention criteria for CFS completed the study. Medical histor y, physical examination, laboratory studies, and questionnaire were obtaine d at baseline, 4, 8, and 12 weeks. Subjects were randomly assigned to recei ve 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 fbr 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 NA DH in contrast to 2 of 26 (8%) to placebo. Based upon these encouraging res ults we have decided to conduct an open-label study in a larger cohort of p atients. Conclusion: Collectively, the results of this pilot study indicate that NAD H may be a valuable adjunctive therapy in the management of the chronic fat igue syndrome and suggest that further clinical trials be performed to esta blish its efficacy in this clinically perplexing disorder.