New Pharmaceutical to relieve CFS & FM, Pain, fatigue and Sleep Disorders
By John W. Addington

A medication that has been available in Europe for 30 years is now being tested in the U.S. and Europe for the treatment of CFS and fibromyalgia symptoms. Galantamine, a compound derived from various plant species, particularly snowdrops and daffodils, is one in a group of drugs called acetylcholinester-ase inhibitors. These medications stop the natural breakdown of an important neurotransmitter (a chemical that enables brains cells to communicate) called acetylcholine. Galantamine (also spelled ga-lanthamine) is unique among such medications in use: its secondary effect can increase the release of greater amounts of acetylcholine. By thus increasing the available amount of this neurotransmitter, galantamine offers potential benefits in a wide range of therapeutic applications. Galantamine has been employed in Europe for many years in the treatment of post-polio syndrome, myasthenia gravis, to re-verse the effects of certain muscle-relaxants and more recently to treat Alzheimer's Disease (AD).

Since many CFS patients suffer with cognitive difficulties not dissimilar to those described by Alz-heimer's patients, it is hoped that galantamine can effect relief for their symptoms as well. Beyond this, galantamine may have analgesic properties that could relieve the pain often associated with CFS and fibromyalgia. Several years ago a small trial done in Iceland was reported in a 1996 issue of the Journal of Chronic Fatigue Syndrome to test whether galantamine would benefit CFS patients. Of the 33 who completed the eight week trial, the journal noted "…43% reported over 50% decrease in fa-tigue, sleep disturbance and myalgia ... and 70% reported over 30% improvement." The article went to state that the "…most surprising effect was the great decrease in sleep disturbances that occurred in most patients on galantamine: over 60% of patients who finished the study reported over 70% im-provement of sleep deficit."

Because this Iceland study found galantamine to be very useful for managing CFS symptoms but ad-mittedly was not as rigorously controlled as it could have been, Shire decided to proceed with an im-proved, 400-patient study that is currently underway in the U.S. and Europe. The U.S. trial was open to those who had been diagnosed with either CFS or Fibromyalgia within the last seven years. Patients with psychiatric or neurological problems or prior history of depression were excluded. The galan-tamine used in the study is extracted from daffodil bulbs grown specifically for this purpose and the drug meets strict scientific parameters as to purity.

The first stage of this trial was double-blind placebo controlled meaning neither the patients nor those conducting the trial knew whether any given patient was on galantamine or the placebo. Patients from 10 locations throughout the United States participated in this part of the study; the results are yet un-published. Some of the patients in this initial phase of the study were permitted to enter a six-month open label extension of the trial. During this stage, patients were made aware that they were taking the real medication and were encouraged to gradually increase the medication, if necessary, to their opti-mal dosage. While the results from this portion of the trial currently point provide mere anecdotal evi-dence, they are favorable. Of the 10 patients involved to date in this open label stage, most have clearly seen a benefit; several have indicated tremendous improvement in their symptoms. A doctor assisting in coordinating the trial stated that symptoms most relieved by the medication have been related to cognitive difficulties, including improvements in alertness and sleep quality, whereas relief of myalgia has not been as consistent. However, a patient with more fibromyalgia symptoms notes that, in addi-tion to reduced fatigue, normal morning pain and stiffness diminishes significantly after taking the morning dosage of the drug.

Like most medications, galantamine can have some side effects but these are dose dependent and usu-ally dissipate in time or with reduced dosage. The most common side effects of galantamine are nau-sea, vomiting, diarrhea and insomnia. Notwithstanding the low side-effect of insomnia and the possi-bility of increased alertness and energy, galantamine has actually been found to improve sleep quality by reducing the onset and improving the quality of REM sleep in non-CFS patients.

If the yet-unpublished results are positive from Shire's current galantamine studies, further clinical tri-als will begin. Contingent on the continued success of galantamine, Shire intends to request FDA ap-proval for galantamine use in the treatment of CFS. If the FDA's evaluation favors galantamine for CFS care, Shire is hopeful that their "flower power" can be marketed for the management of CFS and fibromyalgia patients from as early as 2001.