The drug galantamine (used for treatment of mild to moderate dementia) did not demonstrate a clinical benefit in treating chronic fatigue syndrome when compared with placebo, according to a study in the September 8 issue of JAMA.
Chronic fatigue syndrome (CFS) is a complex disorder characterized by long-term disability, according to background information in the article. There is no established pharmacological treatment for the core symptoms of CFS. Galantamine hydrobromide has pharmacological properties, including improving sleep quality, that researchers have speculated may benefit CFS patients. A pilot trial with CFS patients suggested that the drug might be helpful in CFS.
C.V. Russell Blacker, F.R.C.Psych., M.D., of the University of Exeter, England, and colleagues conducted a study to determine the efficacy and tolerability of galantamine hydrobromide in patients with CFS. The randomized, double-blind trial was conducted from June 1997 through July 1999 at 35 outpatient centers in Western Europe and the U.S. The study included 434 patients with a clinical diagnosis of CFS. A total of 89 patients were randomly assigned to receive 2.5 mg of galantamine hydrobromide; 86 patients, 5.0 mg; 91 patients, 7.5 mg; and 86 patients, 10 mg (these patients received medicine in the tablet form three times per day); a total of 82 patients received matching placebo tablets three times per day.
The researchers found that after 16 weeks there was no statistically significant differences between any of the galantamine or placebo groups in clinical condition, as measured by various tests and surveys.
“The lack of effect of galantamine on cognitive performance was surprising given the extent of the patients’ cognitive impairment at baseline,” the authors write. “In conclusion, in this study, galantamine did not provide a significant clinical benefit in the treatment of patients with CFS.”