Vasomotor Symptoms Associated With Menopause Clinical Trial
Official title:
Herbal Alternatives for Menopause Symptoms: A Randomized Trial
Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms
including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the
medical community for these symptoms is hormone replacement therapy, which is estrogen and
sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is
known about how well these products work, or their safety. Few have undergone the kind of
rigorous testing required of prescription drugs and little is known about their long-term
effectiveness in relieving symptoms.
The purpose of this study is to compare several over-the-counter herbal remedies to hormone
replacement therapy. Our primary aim is to look at the effects of these remedies on your
self-reported menopausal symptoms. We will also be measuring their effects on other factors
known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density,
vaginal cell structure, and blood clotting.
Hormone replacement therapy (HT: estrogen and progestin) remains the treatment of choice for
women with vasomotor symptoms, and long-term HT has been recommended for prevention
purposes. The demand for alternatives to HT, and the availability and use of
over-the-counter products including dietary phytoestrogen supplements, and naturopathic
medicines has grown dramatically. Few of these products have faced the rigors of randomized
trials and none have been tested to evaluate their effects on long-term outcomes.
The purpose of this 4-year, randomized controlled trial is to evaluate the efficacy and
safety of three alternative approaches utilizing phytoestrogens to treat vasomotor symptoms
in peri- and postmenopausal women. The treatments were chosen because of the scientific
evidence supporting a possible benefit, the availability of products with adequate quality
control, their frequency of use in naturopathic medicine, and our ability to blind
participants to the intervention. The 5 proposed treatment arms are: 1) conjugated equine
estrogen with or without medroxyprogesterone acetate in women with or without an intact
uterus respectively; 2) a single herbal product, black cohosh; 3) a multibotanical
preparation; 4) a combination regimen that includes the same multibotanical preparation plus
soy diet counseling; and 5) placebo. Our primary aim is to compare the effects of three
alternative treatments, HRT and placebo on the frequency and intensity of vasomotor symptoms
measured by The Wiklund Menopause Symptom Checklist and a daily Vasomotor Symptom Diary. Our
secondary aims are to compare the effects of three alternative treatments, HRT and placebo
on: 1) vaginal cytology (vaginal maturation index); 2) serum lipids (total cholesterol, HDL
and LDL cholesterol, triglycerides); 3) bone mineral density (hip and spine dual energy
x-ray absorptiometry scan); 4) glucose metabolism (insulin, fasting blood glucose); and 5)
coagulation factors (fibrinogen, PAI-1).
Our hypotheses are that compared to placebo, the three alternative treatments tested in this
proposal will; reduce frequency of hot flashes and night sweats, improve vaginal maturation
and decrease vagina atrophy as measured by maturation index, lower total cholesterol and LDL
with no effect on HDL, reduce the rate of decline in bone mineral density (BMD), and have no
effect on glucose metabolism or clotting factors.
To accomplish our specific aims we will: 1) recruit and randomize approximately peri- and
post-women to one of 5 treatment arms for one year; 2) collect measurements of primary and
secondary outcomes at baseline, 3, 6, and 12 months; and 3) compare changes in outcomes in
the groups taking alternative treatments to those in the HRT and placebo groups.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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