LOW-DOSE HYDROCORTISONE FOR TREATMENT OF CHRONIC-FATIGUE-SYNDROME - ARANDOMIZED CONTROLLED TRIAL

Context.-Chronic fatigue syndrome (CFS) is associated with a dysregula ted hypothalamic-pituitary adrenal axis and hypocortisolemia. Objectiv e.-To evaluate the efficacy and safety of low-dose oral hydrocortisone as a treatment for CFS. Design.-A randomized, placebo-controlled, dou ble-blind therapeutic trial, conducted between 1992 and 1996. Setting. -A single-center study in a tertiary care research institution. Patien ts.-A total of 56 women and 14 men aged 18 to 55 years who met the 198 8 Centers for Disease Control and Prevention case criteria for CFS and who withheld concomitant treatment with other medications. Interventi on.-Oral hydrocortisone, 13 mg/m(2) of body surface area every morning and 3 mg/m(2) every afternoon, or placebo, for approximately 12 weeks . Main Outcome Measures.-A global Wellness scale and other self-rating instruments were completed repeatedly before and during treatment. Re sting and cosyntropin-stimulated cortisol levels were obtained before and at the end of treatment. Patients recorded adverse effects on a ch ecklist. Results.-The number of patients showing improvement on the We llness 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 i n Wellness score on more days than did placebo recipients (P<.001). St atistical evidence of improvement was not seen with other self-rating scales. Although adverse symptoms reported by patients taking hydrocor tisone 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 ass ociated with some improvement in symptoms of CFS, the degree of adrena l suppression precludes its practical use for CFS.