Research News

NADH study reports long-term gains
A nutritional supplement, NADH may be a valuable adjunctive therapy for CFS, according to a published report by a team of researchers at Georgetown University Medical Center in Washington, D.C. In a double-blind, placebo-controlled, crossover study of 26 patients with CFS, Dr. Joseph Bellanti and colleagues reported that eight patients improved during the four weeks they were on NADH, while only two patients improved while on placebo. In a continuation of the study in which all the volunteers were knowingly taking the supplement, 72% (18 of 25 patients) reported significant improvement of their fatigue with no severe adverse effects from the supplement.
 
NADH (the reduced form of nicotinamide adenine dinucleotide) is a co-enzyme that triggers energy production in cells by generating ATP (adenosine triphosphate), which stores energy in cells. If cellular levels of NADH are depleted, brain and muscle cells lose their ability to function effectively. The theory is that as NADH levels rise in the body, the cells become more energized, making the body feel stronger and more energized.
 
This trial used a dosage of 10 mg per day (two tablets, taken 45 minutes before breakfast) of a patented, oral form of NADH manufactured under the brand name Enada by the European company Menuco.
 
This study was small, with just 26 patients, but it does appear to have been carefully controlled. The study protocol was approved by the Food and Drug Administration (FDA), which does not regulate the distribution of nutritional supplements but does regulate medical claims made for such products. This was the equivalent of a Phase II safety and efficacy trial.
 
Subjects were 17 women and nine men, ranging in age from 26 to 57, and they had experienced fatigue for an average of seven years (ranging from one to 16 years). One patient was African-American; 25 were Caucasian. All had fatigue, neurocognitive difficulties and sleep disturbances, and nearly all experienced postexertional malaise, headaches, muscle weakness, arthralgia, myalgias and a history of allergy. Eighteen had swollen or tender lymph nodes. There was no correlation between a specific symptom pattern or laboratory test results and response to treatment. Response was measured primarily by a subjective questionnaire, with at least a 10% improvement required to be considered a favorable response.
 
One of the subjects reported being overly stimulated, and the researchers suggested that patient's dosage could have been decreased. Other non-responders may have benefited from an increased dosage. Dosages were not adjusted for weight in this study.
 
The study was published in the February 1999 issue of Annals of Allergy, Asthma and Immunology. A larger open-label study is planned at Georgetown. NADH also is being studied as a potential treatment for persons with Alzheimer's disease and Parkinson's disease.

Editor's note: Many people have called the Resource Line inquiring about where to get Enada. It is available through a number of sources, one of which is The CFIDS and Fibromyalgia Health Resource.

Hydrocortisone revisited 
Treatment with extremely low doses of hydrocortisone was found more effective than placebo in alleviating fatigue in CFS with little or no side effects, according to research conducted by a group of psychiatrists in London led by Anthony J. Cleare and published in the Feb. 6, 1999, issue of The Lancet. This result differs from a recent study by the National Institutes of Health, which found that hydrocortisone appeared to be an effective treatment for CFS but had the dangerous side effect of suppressing the adrenal system (Nov./Dec. 1998 Chronicle, page 19). The NIH study concluded that the risk to the adrenal system outweighed any potential benefit of hydrocortisone treatment. The London study, which found no such side effect, used much lower doses of the treatment, 5-10 mg instead of the 25-35 mg used in the NIH study.

Test finds new antibodies in fibromyalgia
 
A New Orleans biotechnology company has reported that it found a previously unknown anti-polymer antibody in the blood of many fibromyalgia patients. The research, led by Russell B. Wilson, PhD, president of Autoimmune Technologies, used a patented blood test to identify the antibodies in about half of patients who were diagnosed with fibromyalgia. The percentage was somewhat higher in more severely ill fibromyalgia patients and lower in persons diagnosed with diseases such as rheumatoid arthritis, lupus and scleroderma.
 
In a press release, the company touted the finding as a potential marker for fibromyalgia, but independent researchers responded more cautiously, noting that more research is needed to confirm the specificity of the test. The research itself was published in the February 1999 issue of The Journal of Rheumatology.

Toxins linked to British vets illness 
An extensive study of British veterans of the Gulf War verified what had been previously reported about U.S. and Canadian veterans-that service in the Gulf War posed an exceptionally high risk of a long illness. Those who served were more than twice as likely as other military cohorts to report chronic fatigue, irritability, headache and other symptoms, as well as higher levels of psychological distress. Furthermore, the study led by Catherine Unwin and published in the Jan. 16, 1999, issue of The Lancet, found that the risk of illness correlated significantly with exposures to potentially harmful substances. Among those factors were vaccination against plague and anthrax before deployment.
 
The study suggested that the increased stress associated with being deployed to a war zone might have predisposed troops for a unusual response to those toxic exposures. In the same issue of The Lancet, Khalida Ismail and colleagues used factor analysis, a complex statistical method, to identify the symptoms that most clearly defined Gulf War illness. The results-fatigue, muscle pain, insomnia, cognitive problems-were very similar to that found in the United States. The British researchers said the pattern of symptoms suggested that the illness reported by Gulf War veterans was not a novel or unique disease.
 
An accompanying editorial by Stephen E. Straus of the National Institutes of Health suggested that there are limited means of preventing chronic illness in future wars. Therefore, "troops must be prepared both physically and emotionally for combat, be provided with routine health surveillance afterward, and be given a commitment for all necessary care for war-related illness," Straus wrote. He said military scientists need to undertake prospective studies to define pre-existing clinical condition of individuals and the specific experiences that might contribute to the risk of long-term illness, as the outcomes of such studies should benefit the civilian population that suffers from similar illnesses.

FDA approves new Lyme test 
A new test for Lyme disease can be performed immediately in a doctor's office, avoiding the delay of sending samples to a lab and potentially speeding up the treatment of the tick-borne illness. The test, approved in February by the FDA, is manufactured by Chembio Diagnostic Systems in Medford, N.Y. The test has been shown to correctly diagnose Lyme in 72% to 95% of all  cases. It has a low rate of false positive results; however, the CDC recommends that a positive result be confirmed with laboratory tests.

Twins study continues 
A study of twins in which one or both has CFS or fibromyalgia is continuing at the University of Washington. More than 250 sets of twins are currently enrolled in the study, which is examining the immunologic, virologic, and genetic differences between twins. To participate or for more information, write Dedra Buchwald, MD, Harborview Medical Center, 325 Ninth Ave., Box 359780, Seattle, WA 98104 or call 206-521-1935 and speak with Megan Belcourt.

Clinical trials

Nutritional supplement to be studied
Preventive Therapeutics Inc. of Athens, Ga., plans to cooperate with Nova Southeastern University in Fort Lauderdale, Fla., to conduct a double-blind, placebo-controlled trial of its nutritional supplement with CFS patients. The company's product, Dr. Burgstiner's Complete Thymic Formula and Vitamin/Mineral Complex, is described as "a blend of herbs, vitamins, minerals, glandulars, antioxidants, enzymes and whole food extracts designed to strengthen the immune system."
 
Nutritional supplements are not currently regulated by the FDA and clinical trials are not required, although manufacturers of such products are beginning to see such studies as important to support the health claims they make, and they are anticipating possible FDA regulation.
 
Cheryl Feingold, PhD, Director of Clincal Research at Nova Southeastern University, said preparations are being made for the trial using FDA guidelines. Persons in the Fort Lauderdale area who are diagnosed with CFS and who would like to participate in the trial may contact her office at 954/262-1235. Names of potential subjects will be kept on file to be contacted when the trial is ready to begin.