Combination therapy with hydrocortisone and fludrocortisone does not improve symptoms in chronic fatigue syndrome: a randomized, placebo-controlled, double-blind, crossover study.
OBJECTIVE
Chronic fatigue syndrome has been associated with decreased function of the hypothalamic-pituitary-adrenal axis. Although neurally mediated hypotension occurs more frequently in patients with chronic fatigue syndrome than in controls, attempts to alleviate symptoms by administration of hydrocortisone or fludrocortisone have not been successful. The purpose of this study was to investigate the effect of combination therapy (5 mg/d of hydrocortisone and 50 microg/d of 9-alfa-fludrocortisone) on fatigue and well-being in chronic fatigue syndrome.


METHODS
We performed a 6-month, randomized, placebo-controlled, double-blind, crossover study in 100 patients who fulfilled the 1994 Centers for Disease Control and Prevention criteria for chronic fatigue syndrome. Between-group differences (placebo minus treatment) were calculated on a 10-point visual analog scale.


RESULTS
Eighty patients completed the 3 months of placebo and 3 months of active treatment in a double-blind fashion. There were no differences between treatment and placebo in patient-reported fatigue (mean difference, 0.1; 95% confidence interval [CI]: -0.3 to 0.6) or well-being (mean difference, -0.4; 95% CI: -1.0 to 0.1). There were also no between-group differences in fatigue measured with the Abbreviated Fatigue Questionnaire, the Short Form-36 Mental or Physical Factor scores, or in the Hospital Anxiety and Depression Scale.


CONCLUSIONS
Low-dose combination therapy of hydrocortisone and fludrocortisone was not effective in patients with chronic fatigue syndrome.
Blockmans
Daniel
D
Department of General Internal Medicine, University Hospital Gasthuisberg, Leuven, Belgium. Daniel.Blackmans@uz.kuleuven.ac.be
Persoons
Philippe
P
Van Houdenhove
Boudewijn
B
Lejeune
Marina
M
Bobbaers
Herman
H
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001794:Blood Pressure; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015673:Fatigue Syndrome, Chronic / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005438:Fludrocortisone / Q000008:administration & dosage*; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage*; D008297:Male; D010147:Pain Measurement; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D005438:Fludrocortisone; D006854:Hydrocortisone