November 21, 2008 (New Orleans, Louisiana) — Custom-compounded plant-derived hormone cream may not only improve menopausal symptoms, including depression, anxiety, and pain, it may also provide an anti-inflammatory effect without increasing blood-clot formation, a small study suggests.
Researchers at the University of Texas Health Science Center, in Tyler, found promising 1-year safety and efficacy results in 75 peri- and postmenopausal women who received individually formulated hormone-replacement therapy applied as a cream to the skin.
"The 1-year findings are pretty encouraging," lead author Kenna Stephenson, MD, told Medscape Psychiatry. "We thought compounded transdermal hormones would relieve menopausal symptoms, but we didn't anticipate that they would also have a favorable effect on inflammatory, hemostatic, and cardiometabolic pathways."
The study was presented here at the American Heart Association 2008 Scientific Sessions.
Unproven Safety and Efficacy
In the United States, about 15 million women are currently peri- or postmenopausal and, as such, have an increased risk for cardiovascular disease, said Dr. Stephenson.
Since the Women's Health Initiative study showed an increased risk for breast cancer, stroke, and dementia with conventional hormone therapy, more women have been seeking alternative treatments for menopausal symptoms, such as hot flashes, night sweats, disrupted sleep, and irritability.
"We've seen an increase in the use of compounded transdermal hormone therapies among this population, but the safety and efficacy of these formulations have not been studied," she said.
To evaluate the hemostatic and anti-inflammatory effects of a compounded transdermal hormone-replacement therapy, the researchers recruited 150 peri- and postmenopausal women, aged 30 to 70 years.
Half were assigned to usual care and the rest were assigned to the compounded cream. Usual care was defined as conventional hormone therapy of conjugated equine estrogens and medroxyprogesterone.
The transdermal hormonal therapy consisted of plant-derived estrogen, progesterone, and sometimes testosterone and dehydroepiandrostenedione (DHEA).
Subjects in the transdermal-cream group were prescribed individualized therapy on the basis of their hormone levels. The women applied the cream to the skin once or twice daily to receive the target dose.
Although progesterone and DHEA are available over the counter in the United States, the doses of prescribed therapy, such as those used in the study, are much higher.
At 12 months, the subjects who received the study treatment had:
Significant decreases in depression and anxiety, as assessed by the Hamilton Depression Scale and the Hamilton Anxiety Scale
Significant improvements in quality of life and menopausal symptoms, such as hot flashes and night sweats, as assessed by the Greene Climacteric Scale
No harmful hemostatic effects, as indicated by significant decreases in fibrinogen and factor VII, and no significant changes in factor VIII or plasminogen activator inhibitor type I.
No harmful anti-inflammatory effects, as shown by significant decreases in C-reactive protein (CRP), and no significant changes in interleukin-6
Beneficial cardiometabolic effects, as shown by significant decreases in systolic blood pressure, pulse pressure, fasting glucose, and fasting triglycerides.
Still Early Days
"All hormones are not equal, and all hormone preparations are not equal," said Dr. Stephenson. "There are distinctly different risks and effects on inflammatory and thrombotic factors and cardiovascular biomarkers."
In this study, CRP and triglycerides decreased in women who received transdermal plant-derived compound hormones, whereas other studies have shown increased CRP and triglycerides in women receiving conventional equine and synthetic hormone therapy, she added.
However, "larger clinical trials are needed to determine whether this therapy is a good alternative to conventional hormone-replacement therapy," she said.
"Patients Like It"
"Many perimenopausal and postmenopausal women with mood symptoms may be given antidepressant therapy or antianxiety therapy, but by treating the underlying cause — hormonal changes — we see a statistically significant improvement in dysphoria," said Dr. Stephenson.
She added that patients in her clinical practice who receive compounded transdermal hormone-replacement therapy like it because it is easy, there are few adverse effects, it is very well tolerated, and it is effective for mood symptoms and hormone-related symptoms, such as vaginal dryness and night sweats."
It is important, she added, that a trained compounding pharmacist prepare transdermal hormone-replacement therapy. The International Academy of Compounding Pharmacists, which helped fund the study, lists such pharmacists on its Web site. Other information is available from the Professional Compounding Centers of America (PCCA) and the PCCA Canada Web sites.
The study was partly funded by the Progesterone Foundation and the International Academy of Compounding Pharmacists. The study authors have disclosed no relevant financial relationships.
American Heart Association (AHA) 2008 Scientific Sessions: Abstract 5071. Presented November 11, 2008.
Medscape Medical News © 2008 Medscape
Cite this: Marlene Busko. AHA 2008: Hormone Cream May Aid Menopausal Symptoms Without Increasing Thrombotic Risk - Medscape - Nov 21, 2008.