Reprinted from ANNALS OF ALLERGY, ASTHMA, IMMUNOLOGY, February 1999, Volume 82, Number 2
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., ENADA 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 ENADA 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 ENADA 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.
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.