A preliminary placebo-controlled crossover trial of fludrocortisone for chronic fatigue syndrome.
OBJECTIVE
To provide a preliminary assessment of the efficacy and safety of fludrocortisone acetate treatment of chronic fatigue syndrome.


METHODS
A placebo-controlled, double-blind, random-allocation crossover trial of 6 weeks of fludrocortisone.


METHODS
An outpatient clinical trials unit.


METHODS
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.


METHODS
All participants were scheduled to receive fludrocortisone acetate (0.1-0.2 mg) or a placebo for 6 weeks in each treatment.


METHODS
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.


RESULTS
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 trial.


CONCLUSIONS
Low-dose fludrocortisone does not provide sufficient benefit to be evident in a preliminary blinded trial of unselected patients with chronic fatigue syndrome.
Peterson
P K
PK
Department of Medicine, Hennepin County Medical Center, Minneapolis, Minn 55415, USA. peter137@maroon.tc.umn.edu
Pheley
A
A
Schroeppel
J
J
Schenck
C
C
Marshall
P
P
Kind
A
A
Haugland
J M
JM
Lambrecht
L J
LJ
Swan
S
S
Goldsmith
S
S
D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D015673:Fatigue Syndrome, Chronic / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005438:Fludrocortisone / Q000627:therapeutic use*; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008901:Mineralocorticoids / Q000627:therapeutic use*; D009638:Norepinephrine / Q000097:blood; D011597:Psychomotor Performance / Q000187:drug effects; D012720:Severity of Illness Index; D016896:Treatment Outcome
D008901:Mineralocorticoids; D005438:Fludrocortisone; D009638:Norepinephrine