Galantamine Trials
By Gail Kansky

A paper appeared in the 1996 Journal of Chronic Fatigue Syndrome (Vol. 2, 2/3) by Emir Snorrason, M.D., and two other researchers, entitled Trial of a Selective Galantamine Hydrobromide in the Treatment of Chronic Fatigue Syndrome. Two of the authors were from Iceland, and the third was from Boston's Beth Israel Hospital, an affiliate of Harvard Medical School. These doctors had been searching for a way to test their hypothesis that the central feature of CFIDS/ME was a cholinergic defect, which means they were looking for something to inhibit the irritability that this defect caused. They felt this played a large role in the pathogenesis of the illness.

There were 39 patients in this first trial, and 43% reported a 50% improvement in their pain, sleep, and fatigue levels. A huge 70% reported 30% improvement while the placebo group only reported a low 10% improvement. The improvement did not happen overnight. It was a gradual improvement that took over 4 to 8 weeks. Some of the patients experienced side effects from galantamine and the complaint was usually nausea. The physicians found that side effect could be eliminated by changing the dosage. Galantamine Hydrobromide is considered to be relatively safe and the trials are to establish its effectiveness. Those patients that are eligible to take place in the trials must have had CFIDS/ME for less than seven years and not currently be taking antidepressants. Individuals with a diagnosis of CFIDS or FMS will be considered for inclusion as long as they fit the CDC criteria. They will receive either galantamine at titrated levels or a placebo for 16 weeks. The patients are assessed every 4th, 8th, 12th and 16th week and again 4 weeks following the end of their trial. Patients must be 18 years or older. The trials at 12 centers in the country have a planned patient size of 300 and are being sponsored by Shire Pharmaceutical Development Lmtd. One of those on the review board in England is Michael Sharpe, M.D. The locations of these trials was given in the former issue of The National Forum. 

[Ed.Note: I am particularly grateful to Dr. Nelson M. Gantz, M.D., FACP, one of the 
principle investigators, for taking the time to provide information on the trial. Dr. Gantz heads a CFS clinic in Harrisburg, PA at the Polyclinic Hospital, where he is also the Chief of Infectious Disease and a Clinical Professor of Medicine at the Allegheny University of the Health Sciences. He is on a grant review board at the NIH and is helping out with the Wichita Study being done by the CDC. Dr. Gantz said, "I think everyone's goal is to make people feel better who have this horrendous disease."]

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