Context There is no established pharmacological treatment for the core symptoms
of chronic fatigue syndrome (CFS). Galantamine hydrobromide, an acetyl cholesterone
inhibitor, has pharmacological properties that might benefit patients with
Objective To compare the efficacy and tolerability of galantamine hydrobromide
in patients with CFS.
Design, Setting, and Patients Randomized, double-blind trial conducted June 1997 through July 1999
at 35 outpatient centers in the United Kingdom (n = 17), United States (n
= 14), the Netherlands (n = 2), Sweden (n = 1), and Belgium (n = 1) involving
434 patients with a clinical diagnosis of CFS (modified US Centers for Disease
Control and Prevention criteria).
Interventions 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 3 times per day);
a total of 82 patients received matching placebo tablets 3 times per day.
Main Outcome Measures The primary efficacy variable was the global change on the Clinician
Global Impression Scale after 4, 8, 12, and 16 weeks of treatment. Secondary
outcomes were changes in core symptoms of CFS on the Chalder Fatigue Rating
Scale, the Fibromyalgia Impact Questionnaire, and the Pittsburgh Sleep Quality
Index; changes in quality of life on the Nottingham Health Profile; and assessment
of plasma-free cortisol levels and cognitive performance on a computer-based
battery of tests.
Results After 16 weeks, there were no statistically significant differences
between any of the galantamine or placebo groups in clinical condition on
the Clinician Global Impression Scale, or for any of the secondary end points.
Exploratory regression analysis failed to detect any consistent prognostic
factor that might have influenced the primary or any secondary outcome measures.
Conclusion This trial did not demonstrate any benefit of galantamine over placebo
in the treatment of patients with CFS.