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A preliminary placebo-controlled crossover trial of fludrocortisone for Chronic Fatigue Syndrome (CFS)

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OBJECTIVE: To provide a preliminary assessment of the efficacy

and safety of fludrocortisone acetate treatment of chronic

fatigue syndrome.

DESIGN: A placebo-controlled, double-blind,

random-allocation crossover trial of 6 weeks of


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 placebo for 6 weeks

in each treatment.

MAIN OUTCOME MEASURES: Self- administered

questionnaires were completed at the beginning and end of each

treatment arm that asked patients to rate the severity of

their symptoms on a visual analogue scale. The Medical

Outcomes Study 36-Item Short-Form Health Survey, a reaction

time test, and a treadmill exercise test were used to assess

functional status. Blood pressure, heart rate, and plasma

norepinephrine levels were obtained at baseline. Blood

pressure and heart rate were recorded at the end of the

exercise test and monitored at all subsequent visits.


At baseline, the study participants reported symptom severity

greater than 5 for most symptoms, and all had evidence of

marked functional impairments. No improvement was 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

pressure and heart rate readings were unaffected by treatment,

and plasma norepinephrine levels did not differ from those of

a healthy control group. The incidence of adverse experiences

was similar in the fludrocortisone and placebo arms of the


CONCLUSION: Low-dose fludrocortisone does not provide

sufficient benefit to be evident in a preliminary blinded

trial of unselected patients with chronic fatigue syndrome.

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