Low-dose hydrocortisone for treatment of Chronic Fatigue Syndrome (CFS): a randomized controlled trial
By McKenzie R, O'Fallon A, Dale J, Demitrack M, Sharma G, Deloria M, Garcia-Borreguero D, Blackwelder W, Straus SE •
September 23, 1998
CONTEXT: Chronic fatigue syndrome (CFS) is associated with a
dysregulated hypothalamic-pituitary adrenal axis and
OBJECTIVE: To evaluate the efficacy and
safety of low-dose oral hydrocortisone as a treatment for CFS.
DESIGN: A randomized, placebo- controlled, double-blind
therapeutic trial, conducted between 1992 and 1996.
single-center study in a tertiary care research institution.
PATIENTS: A total of 56 women and 14 men aged 18 to 55 years
who met the 1988 Centers for Disease Control and Prevention
case criteria for CFS and who withheld concomitant treatment
with other medications.
INTERVENTION: Oral hydrocortisone, 13
mg/m2 of body surface area every morning and 3 mg/m2 every
afternoon, or placebo, for approximately 12 weeks.
OUTCOME MEASURES: A global Wellness scale and other
self-rating instruments were completed repeatedly before and
during treatment. Resting and cosyntropin-stimulated cortisol
levels were obtained before and at the end of treatment.
Patients recorded adverse effects on a checklist.
number of patients showing improvement on the Wellness scale
was 19 (54.3%) of 35 placebo recipients vs 20 (66.7%) of 30
hydrocortisone recipients (P =.31). Hydrocortisone recipients
had a greater improvement in mean Wellness score (6.3 vs 1.7
points; P=.06), a greater percentage (53% vs 29%; P=.04)
recording an improvement of 5 or more points in Wellness
score, and a higher average improvement in Wellness score on
more days than did placebo recipients (P<.001). Statistical
evidence of improvement was not seen with other self-rating
scales. Although adverse symptoms reported by patients taking
hydrocortisone were mild, suppression of adrenal
glucocorticoid responsiveness was documented in 12 patients
who received it vs none in the placebo group (P<.001).
CONCLUSIONS: Although hydrocortisone treatment was associated
with some improvement in symptoms of CFS, the degree of
adrenal suppression precludes its practical use for CFS.
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