Evidence table 6-4. Key Question 3C DHEA

Specific Characteristics of PopulationTreatmentOutcomes
Study/YearNStudy designCompari-sonLength of TrialPopulationInclusion/Exclusion CriteriaMeasures UsedHyster-ectomy (#/n)Bilateral Oophorec-tomy (#/n)Premature Ovarian Failure (#/n)Breast Cancer (#/n)Use of SERMS (#/n)Behavior or Lifestyle Factors (#/n)Recent discontin-uation of HRT (#/n)High or Low BMI (#/n)Main Drug type; dose; regimenOther Drugs type; dose; regimenHot FlashesVaginal DrynessSleepMoodCognitiveSomaticUrinaryUterine BleedingSexual Dysfunc-tionQuality of LifeOther OutcomesWithdrawalsWithdrawals due to AEsAdverse EffectsComments
Barnhart, 199960 in 2 groupsDBP3 monthsPerimenopausal women with altered mood and well-being. Mean age 48 (45–55)Inclusion:DSR (0–4 scale), Profile of Mood Scale, Ham-D, SmithKline Beecham Quality of Life Self-Report Questionnaire, Buschke Immediate Recall and Delayed Recall, Symbol Copying and Digit Symbol Substitution TestsNRNRNRNRNRNRNRNRDHEA 50 mg/day oralPlaceboNo significant difference between study groupsNo significant difference between study groupsNo significant difference between study groupsNo significant difference between study groupsNo significant difference between study groupsNo significant difference between study groupsNo significant difference between study groupsNRNo significant difference between study groupsNo significant difference between study groupsSex hormones and lipids63Rash (placebo)Subjects from both study groups had decreased total perimenopausal symptoms and improvements in components of health-related quality of life, p<0.01.
RCT1. Perimenopausal womenAbdominal pain/fatigue (placebo)
2. 45–55 years oldParesthesia (DHEA)
3. Symptoms include fatigue, lack of energy, anxiety, tension, irritability, depression, insomnia, forgetfulness, concentration difficulties, decreased libido, or global reports of a decreased sense of well-being
Exclusion:
1. Any contraindication to HRT
2. Exposure to injectable or implantable sex steroid within 6 months or systemic steroid within 90 days of treatment
3. Used antidepressants and/or antianxiolitics
4. Current diagnosis of major psychiatric disorder, diabetes mellitus, hypercholesterolemia, or cardiovascular disease
5. Abnormal renal or liver function
Stomati, 199922 in 3 groupsRCTHH3 monthsPostmenopausal women (50–55 years)Inclusion:Kupperman (0–3 scale, where 0=none and 3=marked)NRNRNRNRNRNRNRNRDHEAs 50 mg/day oralDHEAs 50 mg/day + Estradiol 50 mg/day trans or Estradiol 50 mg/dayNRNRNRNRNRNRNRNRNRNRNR00NRSimilar significant progressive improvement in Kupperman score with all treatment groups (p<0.01). Specific components of Kupperman score not reported individually.
1. Postmenopausal women
2. 50–55 years old
3. Climacteric complaints
4. Normal body mass index
5. Basal plasma DHEA levels < 5 ug/ml
Exclusion:
1. Previous or current estrogen-dependent neoplasia, thromboembolic disease, liver, pancreatic or renal disease, and diabetes mellitus

Key/Abbreviations

BMI = Body mass index

DB = Double blind

DHEA = Dehydroepiandrosterone

DSR = Daily Symptom Rating Calendar

HAM-D = Hamilton Depression Rating Scale

HH = Head to head

HRT = Hormone replacement therapy

NR = Not reported

P = Placebo

RCT = Randomized controlled trial

SERMs = Selective Estrogen Receptor Modifiers

From: Appendix F. Evidence Tables

Cover of Management of Menopause-Related Symptoms
Management of Menopause-Related Symptoms.
Evidence Reports/Technology Assessments, No. 120.
Nelson HD, Haney E, Humphrey L, et al.

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