A PRELIMINARY PLACEBO-CONTROLLED CROSSOVER TRIAL OF FLUDROCORTISONE FOR CHRONIC-FATIGUE-SYNDROME

Objective: To provide a preliminary assessment of the efficacy and saf ety of fludrocortisone acetate treatment of chronic fatigue syndrome. Design: A placebo-controlled, double-blind, random-allocation crossove r trial of 6 weeks of fludrocortisone. Setting: An outpatient clinical trials unit. Patients: Twenty-five participants with chronic fatigue syndrome (mean age, 40 years; 19 [76%] women; mean duration of illness , 7.0 years) were recruited from a research and clinic registry. Five patients withdrew from the trial. Interventions: all participants were scheduled to receive fludrocortisone acetate (0.1-0.2 mg) or a placeb o for 6 weeks in each treatment. Main Outcome Measures: Self-administe red questionnaires mere completed at the beginning and end of each tre atment arm that asked patients to rate the severity of their symptoms on a visual analogue scale. The Medical Outcomes Study 36-Item Short-F orm Health Survey, a reaction time test, and a treadmill exercise test were used to assess functional status. Blood pressure, heart rate, an d plasma norepinephrine levels were obtained at baseline. Blood pressu re and heart rate were recorded at the end of the exercise test and mo nitored at all subsequent visits. Results: At baseline; the study part icipants reported symptom severity greater than 5 for most symptoms, a nd all had evidence of marked functional impairments. No improvement w as observed in the severity of any symptom or in any test of function for the 20 participants who completed both arms of the trial. Blood pr essure and heart rate readings were unaffected by treatment, and plasm a norepinephrine levels did not differ from those of a healthy control group. The incidence of adverse experiences was similar in the fludro cortisone and placebo arms of the trial. Conclusion: Low-dose fludroco rtisone does not provide sufficient benefit to be evident in a prelimi nary blinded trial of unselected patients with chronic fatigue syndrom e.