Six months physiological DHEA substitution in female adrenal failure: impact on quality of life and sexual parameters.
Jens J Christiansen1, Mimi Mehlsen1, Anna Maria Geraldi2, Claus Gravholt1, Jens O Jørgensen1 & Jens S Christiansen1
Female adrenal failure involves impaired DHEA secretion and very low circulating androgens. To address the impact of a daily physiological substitution dose of capsule DHEA 50 mg on quality of life and sexual parameters, we performed a 6 month trial in a randomised, crossover and placebo controlled design. The trial was approved by the local ethical committee and conducted according to GCP guidelines. Ten patients were enrolled. Seven patients reported seborrhoic side effects in the DHEA treatment period. On this background two patients left the study.
Short Form 36 (SF36) and Female Sexual Function Index (FSFI) were obtained before and after each period. Delta values on physical function (pf), role-physical (rp), bodily pain (bp), general health (gh), vitality (vt), social functioning (sf), role-emotional (re), mental health (mh) were all positive in the DHEA treatment period but failed to reach statistical significance separately. Delta value on FSFI total score was not differently influenced by the treatments (delta placebo −2.1±2.0, delta DHEA −3.2±0.6; P=0.598), neither were subheadings as desire, arousal, lubrication, orgasm, satisfaction and pain. A spousal questionnaire handling 15 questions recorded 15, 67, 7 (positive, neutral, negative observations) after placebo treatment and 32, 53, 5 after DHEA treatment. After both treatment periods, an interview was performed by a clinical psychologist. Topics as knowledge to DHEA and expectations to treatment effects were handled as well as side effects and clinical effects. In summary, this blinded study in a well-motivated group of patients recorded a high frequency of side effects due to DHEA treatment and no significant effects on quality of life or sexual parameters.