Effects of standard glucocorticoid replacement therapies on subjective
well-being: a randomized, double-blind, crossover study in patients with
secondary adrenal insufficiency.
Author(s): Benson S, Neumann P, Unger N, Schedlowski M, Mann K, Elsenbruch S, Petersenn S.
Affiliation(s): Institute of Medical Psychology and Behavioural Immunobiology, Essen, Germany.
Publication date & source: 2012, Eur J Endocrinol. , 167(5):679-85
OBJECTIVE: For secondary adrenal insufficiency (SAI), established biochemical
parameters for dosage control are lacking and no optimal substitution dosage and
daily distribution have been determined yet. Therefore, in clinical practice, the
individual total dose is often adjusted based on patients' subjective well-being.
DESIGN: Effects of three standard glucocorticoid replacement regimens on
psychological variables were assessed in patients with SAI based on a randomized
double-blind study design.
METHODS: SAI patients (n=18) were treated with three different established
glucocorticoid replacement regimens in a randomized, double-blind, crossover
study (treatment A, hydrocortisone 10 mg-placebo-5 mg-placebo; treatment B,
hydrocortisone 10 mg-5 mg-placebo-5 mg; and treatment C, prednisone 5
mg-placebo-placebo-placebo). Following each 4-week replacement regimen, quality
of life (SF-36) and emotional distress (brief symptom inventory (BSI)) were
assessed along with diurnal changes in current well-being (Bf-S) and alertness
(Stanford Sleepiness Scale (SSS)) using validated questionnaires, and
additionally compared with patient (patients with pituitary disease and adrenal
sufficiency) and healthy control groups.
RESULTS: SAI patients showed improvements in physical quality of life (i.e. SF-36
physical function, P<0.05; physical role function, P<0.05) and current well-being
(at 1800 h, P<0.05) under treatment A (hydrocortisone 10-0-5-0 mg) compared with
the other replacement regimens. Quality of life and current well-being were
significantly impaired compared with healthy controls but did not differ from
CONCLUSIONS: Although the observed improvements in psychological parameters were
comparatively small, our results indicate beneficial effects of a 10-0-5-0 mg
hydrocortisone replacement regimen. Nevertheless, treatment effects were
insufficient to restore subjective health compared with healthy controls,
indicating the need for improved replacement regimens and supportive psychosocial
interventions in SAI patients.