Long-Term DHEA Replacement in Primary Adrenal Insufficiency: A Randomized, Controlled Trial
Context: Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone biosynthesis. In Addison’s disease, glucocorticoid and mineralocorticoid deficiencies require lifelong replacement, but the associated near-total failu...
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| Published in | The journal of clinical endocrinology and metabolism Vol. 93; no. 2; pp. 400 - 409 |
|---|---|
| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Bethesda, MD
Oxford University Press
01.02.2008
Copyright by The Endocrine Society Endocrine Society The Endocrine Society |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Context: Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone biosynthesis. In Addison’s disease, glucocorticoid and mineralocorticoid deficiencies require lifelong replacement, but the associated near-total failure of DHEA synthesis is not typically corrected.
Objective and Design: In a double-blind trial, we randomized 106 subjects (44 males, 62 females) with Addison’s disease to receive either 50 mg daily of micronized DHEA or placebo orally for 12 months to evaluate its longer-term effects on bone mineral density, body composition, and cognitive function together with well-being and fatigue.
Results: Circulating DHEAS and androstenedione rose significantly in both sexes, with testosterone increasing to low normal levels only in females. DHEA reversed ongoing loss of bone mineral density at the femoral neck (P < 0.05) but not at other sites; DHEA enhanced total body (P = 0.02) and truncal (P = 0.017) lean mass significantly with no change in fat mass. At baseline, subscales of psychological well-being in questionnaires (Short Form-36, General Health Questionnaire-30), were significantly worse in Addison’s patients vs. control populations (P < 0.001), and one subscale of SF-36 improved significantly (P = 0.004) after DHEA treatment. There was no significant benefit of DHEA treatment on fatigue or cognitive or sexual function. Supraphysiological DHEAS levels were achieved in some older females who experienced mild androgenic side effects.
Conclusion: Although further long-term studies of DHEA therapy, with dosage adjustment, are desirable, our results support some beneficial effects of prolonged DHEA treatment in Addison’s disease. |
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| AbstractList | Context: Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone biosynthesis. In Addison’s disease, glucocorticoid and mineralocorticoid deficiencies require lifelong replacement, but the associated near-total failure of DHEA synthesis is not typically corrected. Objective and Design: In a double-blind trial, we randomized 106 subjects (44 males, 62 females) with Addison’s disease to receive either 50 mg daily of micronized DHEA or placebo orally for 12 months to evaluate its longer-term effects on bone mineral density, body composition, and cognitive function together with well-being and fatigue. Results: Circulating DHEAS and androstenedione rose significantly in both sexes, with testosterone increasing to low normal levels only in females. DHEA reversed ongoing loss of bone mineral density at the femoral neck (P < 0.05) but not at other sites; DHEA enhanced total body (P = 0.02) and truncal (P = 0.017) lean mass significantly with no change in fat mass. At baseline, subscales of psychological well-being in questionnaires (Short Form-36, General Health Questionnaire-30), were significantly worse in Addison’s patients vs. control populations (P < 0.001), and one subscale of SF-36 improved significantly (P = 0.004) after DHEA treatment. There was no significant benefit of DHEA treatment on fatigue or cognitive or sexual function. Supraphysiological DHEAS levels were achieved in some older females who experienced mild androgenic side effects. Conclusion: Although further long-term studies of DHEA therapy, with dosage adjustment, are desirable, our results support some beneficial effects of prolonged DHEA treatment in Addison’s disease. Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone biosynthesis. In Addison's disease, glucocorticoid and mineralocorticoid deficiencies require lifelong replacement, but the associated near-total failure of DHEA synthesis is not typically corrected. In a double-blind trial, we randomized 106 subjects (44 males, 62 females) with Addison's disease to receive either 50 mg daily of micronized DHEA or placebo orally for 12 months to evaluate its longer-term effects on bone mineral density, body composition, and cognitive function together with well-being and fatigue. Circulating DHEAS and androstenedione rose significantly in both sexes, with testosterone increasing to low normal levels only in females. DHEA reversed ongoing loss of bone mineral density at the femoral neck (P < 0.05) but not at other sites; DHEA enhanced total body (P = 0.02) and truncal (P = 0.017) lean mass significantly with no change in fat mass. At baseline, subscales of psychological well-being in questionnaires (Short Form-36, General Health Questionnaire-30), were significantly worse in Addison's patients vs. control populations (P < 0.001), and one subscale of SF-36 improved significantly (P = 0.004) after DHEA treatment. There was no significant benefit of DHEA treatment on fatigue or cognitive or sexual function. Supraphysiological DHEAS levels were achieved in some older females who experienced mild androgenic side effects. Although further long-term studies of DHEA therapy, with dosage adjustment, are desirable, our results support some beneficial effects of prolonged DHEA treatment in Addison's disease. Context: Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone biosynthesis. In Addison’s disease, glucocorticoid and mineralocorticoid deficiencies require lifelong replacement, but the associated near-total failure of DHEA synthesis is not typically corrected. Objective and Design: In a double-blind trial, we randomized 106 subjects (44 males, 62 females) with Addison’s disease to receive either 50 mg daily of micronized DHEA or placebo orally for 12 months to evaluate its longer-term effects on bone mineral density, body composition, and cognitive function together with well-being and fatigue. Results: Circulating DHEAS and androstenedione rose significantly in both sexes, with testosterone increasing to low normal levels only in females. DHEA reversed ongoing loss of bone mineral density at the femoral neck (P < 0.05) but not at other sites; DHEA enhanced total body (P = 0.02) and truncal (P = 0.017) lean mass significantly with no change in fat mass. At baseline, subscales of psychological well-being in questionnaires (Short Form-36, General Health Questionnaire-30), were significantly worse in Addison’s patients vs. control populations (P < 0.001), and one subscale of SF-36 improved significantly (P = 0.004) after DHEA treatment. There was no significant benefit of DHEA treatment on fatigue or cognitive or sexual function. Supraphysiological DHEAS levels were achieved in some older females who experienced mild androgenic side effects. Conclusion: Although further long-term studies of DHEA therapy, with dosage adjustment, are desirable, our results support some beneficial effects of prolonged DHEA treatment in Addison’s disease. Context: Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone biosynthesis. In Addison’s disease, glucocorticoid and mineralocorticoid deficiencies require lifelong replacement, but the associated near-total failure of DHEA synthesis is not typically corrected. Objective and Design: In a double-blind trial, we randomized 106 subjects (44 males, 62 females) with Addison’s disease to receive either 50 mg daily of micronized DHEA or placebo orally for 12 months to evaluate its longer-term effects on bone mineral density, body composition, and cognitive function together with well-being and fatigue. Results: Circulating DHEAS and androstenedione rose significantly in both sexes, with testosterone increasing to low normal levels only in females. DHEA reversed ongoing loss of bone mineral density at the femoral neck ( P < 0.05) but not at other sites; DHEA enhanced total body ( P = 0.02) and truncal ( P = 0.017) lean mass significantly with no change in fat mass. At baseline, subscales of psychological well-being in questionnaires (Short Form-36, General Health Questionnaire-30), were significantly worse in Addison’s patients vs. control populations ( P < 0.001), and one subscale of SF-36 improved significantly ( P = 0.004) after DHEA treatment. There was no significant benefit of DHEA treatment on fatigue or cognitive or sexual function. Supraphysiological DHEAS levels were achieved in some older females who experienced mild androgenic side effects. Conclusion: Although further long-term studies of DHEA therapy, with dosage adjustment, are desirable, our results support some beneficial effects of prolonged DHEA treatment in Addison’s disease. A 12-month study of dehydroepiandrosterone replacement for primary adrenal insufficiency finds improved femoral neck bone mineral density and lean body mass but no significant benefit with fatigue and cognitive or sexual function. Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone biosynthesis. In Addison's disease, glucocorticoid and mineralocorticoid deficiencies require lifelong replacement, but the associated near-total failure of DHEA synthesis is not typically corrected.CONTEXTDehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone biosynthesis. In Addison's disease, glucocorticoid and mineralocorticoid deficiencies require lifelong replacement, but the associated near-total failure of DHEA synthesis is not typically corrected.In a double-blind trial, we randomized 106 subjects (44 males, 62 females) with Addison's disease to receive either 50 mg daily of micronized DHEA or placebo orally for 12 months to evaluate its longer-term effects on bone mineral density, body composition, and cognitive function together with well-being and fatigue.OBJECTIVE AND DESIGNIn a double-blind trial, we randomized 106 subjects (44 males, 62 females) with Addison's disease to receive either 50 mg daily of micronized DHEA or placebo orally for 12 months to evaluate its longer-term effects on bone mineral density, body composition, and cognitive function together with well-being and fatigue.Circulating DHEAS and androstenedione rose significantly in both sexes, with testosterone increasing to low normal levels only in females. DHEA reversed ongoing loss of bone mineral density at the femoral neck (P < 0.05) but not at other sites; DHEA enhanced total body (P = 0.02) and truncal (P = 0.017) lean mass significantly with no change in fat mass. At baseline, subscales of psychological well-being in questionnaires (Short Form-36, General Health Questionnaire-30), were significantly worse in Addison's patients vs. control populations (P < 0.001), and one subscale of SF-36 improved significantly (P = 0.004) after DHEA treatment. There was no significant benefit of DHEA treatment on fatigue or cognitive or sexual function. Supraphysiological DHEAS levels were achieved in some older females who experienced mild androgenic side effects.RESULTSCirculating DHEAS and androstenedione rose significantly in both sexes, with testosterone increasing to low normal levels only in females. DHEA reversed ongoing loss of bone mineral density at the femoral neck (P < 0.05) but not at other sites; DHEA enhanced total body (P = 0.02) and truncal (P = 0.017) lean mass significantly with no change in fat mass. At baseline, subscales of psychological well-being in questionnaires (Short Form-36, General Health Questionnaire-30), were significantly worse in Addison's patients vs. control populations (P < 0.001), and one subscale of SF-36 improved significantly (P = 0.004) after DHEA treatment. There was no significant benefit of DHEA treatment on fatigue or cognitive or sexual function. Supraphysiological DHEAS levels were achieved in some older females who experienced mild androgenic side effects.Although further long-term studies of DHEA therapy, with dosage adjustment, are desirable, our results support some beneficial effects of prolonged DHEA treatment in Addison's disease.CONCLUSIONAlthough further long-term studies of DHEA therapy, with dosage adjustment, are desirable, our results support some beneficial effects of prolonged DHEA treatment in Addison's disease. |
| Author | Pullenayegum, Eleanor M. Curran, Suzanne E. Chatterjee, V. Krishna K. Gurnell, Eleanor M. Herbert, Joseph Conway, Catherine L. Hunt, Penelope J. Compston, Juliet E. Huppert, Felicia A. |
| AuthorAffiliation | Department of Public Health and Primary Care, Centre for Applied Medical Statistics (E.M.P.), Departments of Medicine (E.M.G., S.E.C., J.E.C., V.K.K.C.), Psychiatry (F.A.H.), and Anatomy and Cambridge Centre for Brain Repair (J.H.), University of Cambridge, Addenbrooke’s Hospital, Cambridge CB2 0QQ, United Kingdom; and Department of Endocrinology (P.J.H., C.L.C.), Christchurch Hospital, Christchurch 8140, New Zealand |
| AuthorAffiliation_xml | – name: Department of Public Health and Primary Care, Centre for Applied Medical Statistics (E.M.P.), Departments of Medicine (E.M.G., S.E.C., J.E.C., V.K.K.C.), Psychiatry (F.A.H.), and Anatomy and Cambridge Centre for Brain Repair (J.H.), University of Cambridge, Addenbrooke’s Hospital, Cambridge CB2 0QQ, United Kingdom; and Department of Endocrinology (P.J.H., C.L.C.), Christchurch Hospital, Christchurch 8140, New Zealand |
| Author_xml | – sequence: 1 givenname: Eleanor M. surname: Gurnell fullname: Gurnell, Eleanor M. organization: 2Departments of Medicine (E.M.G., S.E.C., J.E.C., V.K.K.C.), University of Cambridge, Addenbrooke’s Hospital, Cambridge CB2 0QQ, United Kingdom – sequence: 2 givenname: Penelope J. surname: Hunt fullname: Hunt, Penelope J. organization: 5Department of Endocrinology (P.J.H., C.L.C.), Christchurch Hospital, Christchurch 8140, New Zealand – sequence: 3 givenname: Suzanne E. surname: Curran fullname: Curran, Suzanne E. organization: 2Departments of Medicine (E.M.G., S.E.C., J.E.C., V.K.K.C.), University of Cambridge, Addenbrooke’s Hospital, Cambridge CB2 0QQ, United Kingdom – sequence: 4 givenname: Catherine L. surname: Conway fullname: Conway, Catherine L. organization: 5Department of Endocrinology (P.J.H., C.L.C.), Christchurch Hospital, Christchurch 8140, New Zealand – sequence: 5 givenname: Eleanor M. surname: Pullenayegum fullname: Pullenayegum, Eleanor M. organization: 1Department of Public Health and Primary Care, Centre for Applied Medical Statistics (E.M.P.), University of Cambridge, Addenbrooke’s Hospital, Cambridge CB2 0QQ, United Kingdom – sequence: 6 givenname: Felicia A. surname: Huppert fullname: Huppert, Felicia A. organization: 3Department of Psychiatry (F.A.H.), University of Cambridge, Addenbrooke’s Hospital, Cambridge CB2 0QQ, United Kingdom – sequence: 7 givenname: Juliet E. surname: Compston fullname: Compston, Juliet E. organization: 2Departments of Medicine (E.M.G., S.E.C., J.E.C., V.K.K.C.), University of Cambridge, Addenbrooke’s Hospital, Cambridge CB2 0QQ, United Kingdom – sequence: 8 givenname: Joseph surname: Herbert fullname: Herbert, Joseph organization: 4Department of Anatomy and Cambridge Centre for Brain Repair (J.H.), University of Cambridge, Addenbrooke’s Hospital, Cambridge CB2 0QQ, United Kingdom – sequence: 9 givenname: V. Krishna K. surname: Chatterjee fullname: Chatterjee, V. Krishna K. email: kkc1@mole.bio.cam.ac.uk organization: 2Departments of Medicine (E.M.G., S.E.C., J.E.C., V.K.K.C.), University of Cambridge, Addenbrooke’s Hospital, Cambridge CB2 0QQ, United Kingdom |
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| Copyright | Copyright © 2008 by The Endocrine Society 2008 Copyright © 2008 by The Endocrine Society 2008 INIST-CNRS Copyright © 2008 by The Endocrine Society 2008 |
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| Keywords | Endocrinopathy Obesity Nutrition Nutrition disorder Metabolic diseases Replacement Long term Randomized controlled trial Dehydroepiandrosterone Randomization Adrenal insufficiency Adrenal gland diseases Primary Clinical trial Endocrinology Nutritional status |
| Language | English |
| License | CC BY 4.0 |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 ObjectType-Undefined-3 Address all correspondence and requests for reprints to: Professor Krishna Chatterjee, Department of Medicine, Level 5, Box 157, Addenbrooke’s Hospital, Hills Road, Cambridge CB2 0QQ, United Kingdom. E-mail: kkc1@mole.bio.cam.ac.uk. |
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| PublicationTitle | The journal of clinical endocrinology and metabolism |
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| Publisher | Oxford University Press Copyright by The Endocrine Society Endocrine Society The Endocrine Society |
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| Snippet | Context: Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone... CONTEXT:Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone... Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone biosynthesis. In... Context: Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are the major circulating adrenal steroids and substrates for peripheral sex hormone... |
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| SubjectTerms | Absorptiometry, Photon Addison Disease - blood Addison Disease - drug therapy Adrenals. Adrenal axis. Renin-angiotensin system (diseases) Adult Aged Androstenedione Biological and medical sciences Blindness Body composition Body Composition - drug effects Body fat Bone composition Bone density Bone Density - drug effects Bone mass Bone mineral density Cognition - drug effects Cognitive ability Dehydroepiandrosterone Dehydroepiandrosterone - therapeutic use Dehydroepiandrosterone sulfate Dehydroepiandrosterone Sulfate - blood Double-Blind Method Endocrinopathies Fatigue Feeding. Feeding behavior Female Females Fundamental and applied biological sciences. Psychology Hormone Replacement Therapy - methods Humans Male Medical sciences Middle Aged Non tumoral diseases. Target tissue resistance. Benign neoplasms Original Prospective Studies Quality of Life Sex hormones Statistics, Nonparametric Steroid hormones Surveys and Questionnaires Testosterone Vertebrates: anatomy and physiology, studies on body, several organs or systems Vertebrates: endocrinology |
| Title | Long-Term DHEA Replacement in Primary Adrenal Insufficiency: A Randomized, Controlled Trial |
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