A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials of DHEA Treatment Effects on Quality of Life in Women with Adrenal Insufficiency

Al-Katib, Ayad; Cosma, Mihaela; Elamin, Mohamed B.; Erickson, Dana; Swiglo, Brian A.; Erwin, Patricia J.; Montori, Víctor M.

doi:10.1210/jc.2009-0672

Cited by 127 publications

(56 citation statements)

References 22 publications

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“…In this study, the daily co-administration of 50 mg DHEA did not give rise to safety concerns, as supported by data from the literature [54][55][56][57][58][59][60][61]. As demonstrated also in this study…”

Section: Accepted M Manuscriptsupporting

confidence: 88%

Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II. Clinical effects

Zimmerman¹,

Foidart²,

Pintiaux³

et al. 2015

Contraception

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Source of fundingThe study was financially supported by Pantarhei Bioscience Conflict of interestYZ is an employee of Pantarhei Bioscience (PRB), the company developing the Androgen RestoredContraceptive concept for contraception. JMF has no conflict of interest in the course of this study.AP shares expertise as a lecturer, member of advisory boards, and/or consultant, with Bayer, Amgen, Gedeon Richter and Teva/Theramex, without personal gain. JMM has nothing to declare. KC has nothing to declare. BF has received fees and grant support from the following companies (in alphabetic order); Andromed, Ardana, Euroscreen, Ferring, Genovum, Merck (MSD), Merck Serono, Organon, Ovascience, Pantharei Bioscience, PregLem, Schering, Schering Plough, Serono, Uteron Pharma, Watson Pharmaceuticals and Wyeth. HCB is the CEO and a shareholder of PRB.After publication of the paper, PRB will make the clinical study report available upon request. The authors alone are responsible for the content and the writing of the paper. Clinical Trial Registration Number: ISRCTN06414473A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPT AbstractObjectives: Combined oral contraceptives (COCs) decrease androgen levels, including testosterone (T), which may be associated with sexual dysfunction and mood complaints in some women. We have shown that co-administration of dehydroepiandrosterone (DHEA) to a drospirenone (DRSP) containing COC restored total T levels to baseline and free T levels by 47%. Here we describe the effects on sexual function, mood and quality of life of such an intervention. Study design:This was a randomized, double-blind, placebo-controlled study in 99 healthy COC starters. A COC containing 30 µg ethinylestradiol (EE) and 3 mg DRSP was used for 3 cycles, followed by 6 cycles of the same COC combined with 50 mg/day DHEA or placebo. There were no statistically significant differences between groups for the MSFQ and Q-LES-Q scores. DHEA co-administration resulted in an acceptable safety profile. DHEA negated the beneficial effect of the COC on acne according to the subjects' self-assessment. A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPTConclusions: Co-administration with DHEA did not result in consistent improvements in sexual function, mood and quality of life indicators in women taking EE/DRSP.Retrospectively, the 50 mg dose of DHEA may be too low for this COC.Implications A well-balanced judgment of the clinical consequences of normalizing androgens during COC use may require complete normalization of free T.

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Section: Accepted M Manuscriptsupporting

confidence: 88%

Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II. Clinical effects

Zimmerman¹,

Foidart²,

Pintiaux³

et al. 2015

Contraception

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“…Patients on replacement therapy reproducibly selfreport impairment in particular dimensions of general well-being questionnaires such as SF-36 (8,29,30,31,32,33,34,35,36). General health and vitality perception are low for all patient subgroups, although the reductions are particularly pronounced for patients with concomitant type-1 diabetes (T1D).…”

Section: Health-related Quality Of Lifementioning

confidence: 99%

MANAGEMENT OF ENDOCRINE DISEASE: Epidemiology, quality of life and complications of primary adrenal insufficiency: a review

Bensing

Hulting

Husebye

et al. 2016

European Journal of Endocrinology

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In this article, we review published studies covering epidemiology, natural course and mortality in primary adrenal insufficiency (PAI) or Addison's disease. Autoimmune PAI is a rare disease with a prevalence of 100-220 per million inhabitants. It occurs as part of an autoimmune polyendocrine syndrome in more than half of the cases. The patients experience impaired quality of life, reduced parity and increased risk of preterm delivery. Following a conventional glucocorticoid replacement regimen leads to a reduction in bone mineral density and an increase in the prevalence of fractures. Registry studies indicate increased mortality, especially evident in patients diagnosed with PAI at a young age and in patients with the rare disease autoimmune polyendocrine syndrome type-1. Most notably, unnecessary deaths still occur because of adrenal crises. All these data imply the need to improve the therapy and care of patients with PAI.

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“…82 It plays a role in modulating neuroendocrine and immune homeostasis and influences monoaminergic and glutaminergic neurotransmission. 83 Dosage of DHEA commonly used in research ranges from 30 to 450 mg/day, with treatment lasting 6 to 8 weeks.…”

Section: What Is Dhea? How Effective Is Dhea For the Treatment Of Mdd?mentioning

confidence: 99%

Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 5. Complementary and Alternative Medicine Treatments

Ravindran¹,

Balneaves²,

Faulkner³

et al. 2018

FOC

127

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Methods: Using the question-answer format, we conducted a systematic literature search focusing on systematic reviews and meta-analyses. Evidence was graded using CANMAT-defined criteria for level of evidence. Recommendations for lines of treatment were based on the quality of evidence and clinical expert consensus. ''Complementary and Alternative Medicine Treatments'' is the fifth of six sections of the 2016 guidelines. Results: Evidence-informed responses were developed for 12 questions for 2 broad categories of complementary and alternative medicine (CAM) interventions: 1) physical and meditative treatments (light therapy, sleep deprivation, exercise, yoga, and acupuncture) and 2) natural health products (St. John's wort, omega-3 fatty acids; S-adenosyl-L-methionine [SAM-e], dehydroepiandrosterone, folate, Crocus sativus, and others). Recommendations were based on available data on efficacy, tolerability, and safety. Conclusions: For MDD of mild to moderate severity, exercise, light therapy, St. John's wort, omega-3 fatty acids, SAM-e, and yoga are recommended as first-or second-line treatments. Adjunctive exercise and adjunctive St. John's wort are second-line recommendations for moderate to severe MDD. Other physical treatments and natural health products have less evidence

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A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials of DHEA Treatment Effects on Quality of Life in Women with Adrenal Insufficiency

Cited by 127 publications

References 22 publications

Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II. Clinical effects

Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II. Clinical effects

MANAGEMENT OF ENDOCRINE DISEASE: Epidemiology, quality of life and complications of primary adrenal insufficiency: a review

Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 5. Complementary and Alternative Medicine Treatments

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