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Low-dose hydrocortisone for treatment of Chronic Fatigue Syndrome (CFS): a randomized controlled trial

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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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