Eur J Endocrinol
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European Journal of Endocrinology (2010)
Copyright © 2010 by European Society of Endocrinology
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Table 3 Randomized controlled trials on DHEA replacement in women.
Reference Subjects Study design Dose and duration Outcome (measure)

Studies in women with adrenal insufficiency
Arlt et al. (41); Callies et al. (55) Women with primary (n = 14) and secondary adrenal insufficiency (n = 10) (23–59 yrs) Randomized, double-blind, placebo-controlled, crossover study DHEA 50 mg/day vs placebo for 4 months each (n = 24) Increased well-being and mood, specific improvements in anxiety and depression; increased sexual interest and satisfaction; HDL {downarrow}, LDL ->, Trigl. -> , Lpa ->; fasting glucose ->, fasting insulin ->, serum leptin {downarrow}; BC -> (bioimpedance); exercise capacity -> (incremental cycling test); serum osteocalcin {uparrow}, urinary crosslinks ->
Hunt et al. (44) Women with primary adrenal insufficiency (26–59 yrs) (n = 24) Randomized, double-blind, placebo-controlled, crossover study DHEA 50 mg/day vs placebo for 3 months each (n = 24) Self-esteem {uparrow}, mood {uparrow}, fatigue {downarrow}, cognition ->, no change in sexual function; no change in BC and BMD (DXA); HDL ->, LDL ->, Trigl. ->; insulin sensitivity -> (fasting glucose, insulin, (HOMA);
Johannsson et al. (45) Women with secondary adrenal insufficiency due to hypopituitarism (25–65 yrs) (n = 38) Randomized, double-blind, placebo-controlled, crossover study DHEA 20–30 mg/day vs placebo for 6 months each (n = 38) (20 mg > 45 yrs; 30 mg < 45 yrs) Alertness {uparrow}, stamina {uparrow}, initiative {uparrow}, improved sexual relations (validated partner questionnaire); no change in BMD (DXA); HDL {downarrow}, ApoA1 {downarrow}
Lovas et al. (56) Women with primary adrenal insufficiency (n = 39) Randomized, double-blind, placebo-controlled, parallel study DHEA 25 mg/day (n = 19) vs placebo (n = 20) for 9 months No change in subjective health status, fatigue and sexuality; HDL ->; sweat odor {uparrow}, scalp itching {uparrow}
Dhatariya et al. (50) Women with adrenal insufficiency (n = 28) Randomized, double-blind, placebo-controlled, crossover study DHEA 50 mg/day vs placebo for 12 weeks each (n = 28) Insulin sensitivity {uparrow} (euglycemic-hyperinsulinemic clamp); plasma lipid profile (HDL {downarrow}, LDL {downarrow}, Trigl. {downarrow})
Studies in healthy peri- and postmenopausal women
Morales et al. (57) Healthy women (40–70 yrs) (n = 17; 15/17 menopausal, 8/15 on HRT) Randomized, double-blind, placebo-controlled, crossover study DHEA 50 mg/day vs placebo for 3 months each (n = 17) Improved self-reported well-being {uparrow} (caveat: no assessment with validated questionnaires); no change in libido; no change in BMI and body fat (bio-impedance); insulin sensitivity -> (ivGTT + MINMOD); HDL {downarrow}
Yen et al. (58); Morales et al. (59) Women with physiological menopause (40–70 yrs) (n = 8; 7/8 on HRT) Randomized, double-blind, placebo-controlled, crossover study DHEA 100 mg/day vs placebo for 6 months each (n = 8) Basal metabolic rate -> (indirect calorimetry) fasting insulin ->; fasting glucose ->, HDL {downarrow}, ApoA1 {downarrow} ; no change in BC and BMD (DXA); urinary crosslinks ->; no change in muscle strength (isometric testing)
Casson et al. (60) Women with physiological menopause (n = 13) and low serum DHEAS Randomized, double-blind, placebo-controlled, parallel study DHEA 25 mg/day (n = 7) vs placebo (n = 6) for 6 months No change in BC and BMD (DXA); urinary crosslinks ->; insulin sensitivity -> (iv insulin tolerance test + MINMOD); LDL ->, Trigl. ->, HDL {downarrow}, ApoA1 {downarrow}
Barnhart et al. (46) Perimenopausal women (45–55 yrs) reporting impaired well-being (n = 60) Randomized, double-blind, placebo-controlled, parallel study DHEA 50 mg/day (n = 30) vs placebo (n = 30) for 3 months No change in mood, self-perceived quality of life, cognitive function and perimenopausal symptoms
Baulieu et al. (49) Postmenopausal women (60–79 yrs) (n = 140) Randomized, double-blind, placebo-controlled, parallel study DHEA 50 mg/day (n = 70) vs placebo (n = 70) for 12 months BMD {uparrow} in women > 70 yrs (DXA), osteocalcin -> libido {uparrow} in women > 70 yrs (visual analog scale); skin sebum secretion {uparrow} in women 60–79 yrs
Lasco et al. (61) Women with physiological menopause and low DHEAS (n = 20) Randomized, double-blind, placebo-controlled, parallel study DHEA 50 mg/day (n = 10) vs placebo (n = 10) for 12 months HDL {uparrow}, LDL {downarrow}, Trigl. {downarrow}; oGTT ->; insulin sensitivity {uparrow} (euglycemic hyperinsulinemic clamp)
Villareal & Holloszy (51) Postmenopausal women (65–78 yrs) (n = 28) Randomized, double-blind, placebo-controlled, parallel study DHEA 50 mg/day (n = 14) vs placebo (n = 14) for 6 months Decrease in both visceral and subcutaneous abdominal fat (MRI); oGTT; AUC insulin {downarrow}, AUC glucose ->, insulin sensitivity {downarrow}


BC, body composition; BMD, bone mineral density; DXA, dual-energy x-ray absorptiometry; oGTT, oral glucose tolerance test; ivGTT, intravenous glucose tolerance test; AUC, area under the curve; HDL, high density lipoprotein; LDL, low density lipoprotein, Trigl., triglycerides; LPA, lipoprotein a; HOMA, homeostasis model of assessment; ApoA1, apolipoprotein A1; HRT, hormone replacement therapy; BMI, body mass index; MINMOD, Bergman minimal model.





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