Alternative Therapies for Menopause

Do natural hormones work?

By Tracy Gaudet, MD

August, 2004

In 2003, the Women's Health Initiative (WHI — http://www.whi.org) showed an increased risk of breast cancer and heart attack for women on one combination of estrogen and progesterone. This report sent many mid-life women on a quest for alternative ways to deal with menopausal symptoms.

Now, if you ask any group of 50 year old women what they do to combat hot flashes, mood swings and menopausal sleeplessness, you're likely get a wide variety of answers: bioidentical or "natural" hormones, acupuncture, and over the counter herbal preparations like black cohosh.

But do these therapies work? Where does a woman go to find scientific evidence for her treatment choice? Do these approaches pose any dangers?

Studies show that American women often turn to Oriental medicine, herbs and supplements to combat the menopausal symptoms, without seeking medical advice or informing their doctors of these treatments. [1] More than ever women need guidance in evaluating these options. They also need a more integrated approach to their health care.

Surveys reveal that approximately 80 percent of menopausal women are using "non-prescriptive therapies." Researchers in Washington state found similar results: 76 percent of women were using alternative approaches, with the majority using more than one modality: [2]

• Stress-reduction techniques: 43 percent
• Over the counter alternative remedies: 37 percent
• Chiropractic: 32 percent
• Massage therapy: 30 percent
• Dietary soy 23: percent
• Acupuncture 10: percent
• Naturopathic or homeopathic care: 9 percent
• Herabalists: 5 percent

Between 89 and 100 percent of these subjects found these approaches to be somewhat to very helpful. But what do the latest studies reveal?

This article is the first in a series that reviews the current medical literature, exploring the alternative approaches to menopause, fertility and PMS, and female cancers.

A recent study shows that women who are using compounding pharmacies believe that natural hormones are safer, cause fewer side effects, and are equally or more effective for symptom relief than conventional hormones. [3]

This is often an emotional response, based on the assumption that "natural is better." Yet research shows these preparations differ in their effectiveness, may pose risks for certain patient populations, and often little or nothing is known about their long-term use.

In this article, we begin with one of the most-studied natural remedies: black cohosh.

Black Cohosh (cimicifuga racemosa)

The data on black cohosh is encouraging. A remedy for both PMS and menopause, this herb has been used by the Native American population for centuries, and in Germany since 1950. Its most studied form is a brand called Remifemin®.

Black cohosh compares favorably to estrogen in regard to symptom relief. Initially, it was felt that black cohosh was estrogenic. But studies now show that it does not contain phytoestrogens nor does it have an estrogenic effect on vaginal cells. Additionally, there are no changes in hormone levels in women taking black cohosh.

In laboratory studies, black cohosh actually suppresses rather than stimulates breast cells. [4]

A randomized controlled trial in 1987 compared 80 women on 0.625 mg of Premarin with those taking 8 mg of black cohosh and placebo for 12 weeks. The group taking black cohosh showed significant improvement in menopausal symptoms, anxiety, and vaginal epithelium, and the herb was well tolerated. [5] That same year, another study compared estrogen injections to black cohosh. This time, 82 percent of women reported good-to-very-good relief of their symptoms, with no side effects. [6]

In 1988, researchers compared conjugated estrogens, estrogen-progestagen sequential therapy, estriol, and black cohosh. The results with black cohosh were comparable to the hormonal therapies. [7]

In a study of 629 women who underwent six to eight weeks of treatment with black cohosh, 80 percent of women had improvements in hot flashes, fatigue, irritability, and vaginal dryness. At eight weeks, 50 percent of women were symptom free. [8]

In a recent double blind, placebo-controlled trial, black cohosh (40 mg) was compared to conjugated estrogen (0.6mg) and placebo. Sixty-two women were enrolled and followed for three months. Black cohosh was found to be as effective as conjugated estrogen (CE) and superior to placebo in decreasing climacteric symptoms. Both black cohosh and CE had beneficial effects on bone metabolism. Black cohosh had no effect on endometrial thickening as measured by vaginal ultrasound, unlike CE, which had a significant increase in endometrial thickening. Additionally, both black cohosh and CE increased the vaginal epithelial cells. The authors propose that black cohosh may act as a selective estrogen reuptake modulator (SERM), meaning that it acts like estrogen on some tissues, but blocks the effect of estrogen on others. [9] In summary, while many of the above studies have design weaknesses and more research is clearly needed, black cohosh appears to be safe and efficacious for the treatment of menopausal symptoms.

Clinicians should begin recommending doses of 20-40 mg orally, twice a day, standardized to 2.5 triterpenes.

Patients should be informed that it might be four to eight weeks before they notice an improvement. Side-effects are rare and include GI upset, headache, weight gain, and dizziness. The Physicians' Desk Reference for Nonprescription Drugs and Dietary Supplements recommends using for no longer than six months. This time-frame was cited due to the fact that the longest study in the literature lasted six months. There is no indication that longer use is unsafe. Studies with use for two years are currently underway.

Black cohosh and breast cancer

Multiple studies show that in vitro black cohosh has an inhibitory effect on estrogen-sensitive breast cancer cells.

In the one placebo-controlled study to date that looked at the effectiveness of black cohosh in reducing menopausal symptoms for breast cancer patients, both the placebo group and the group receiving black cohosh had a 27 percent reduction in number and intensity of hot flashes. A placebo effect is common in this patient group. However, women on black cohosh reported a more significant reduction in sweating. [10]

More studies are needed in this population. It is useful to know that black cohosh is not estrogenic, and does not need to be avoided from a safety perspective. However, its efficacy in this patient group has not yet been established.

Notes

1 Eisenberg, 1998

2 Newton, 2002

3 Adams, 2001

4 Amato, 2002

5 Stoll, 1987

6 Petho, 1987

7 Lehmann-Willenbrock, 1988

8 Stolze, 1982

9 Wuttke, 2003

10 Jacobson, 2001

General References

Adams C, Cannell S. Women's beliefs about "natural" hormones and natural hormone replacement therapy. Menopause. 2001 Nov-Dec;8(6):433-40. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11723417

Amato P, Christophe S, Mellon PL. Estrogenic activity of herbs commonly used as remedies for menopausal symptoms. Menopause. 2002 Mar-Apr;9(2):145-50. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11875334

Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9820257

Jacobson JS, Troxel AB, Evans J, Klaus L, Vahdat L, Kinne D, Lo KM, Moore A, Rosenman PJ, Kaufman EL, Neugut AI, Grann VR. Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer. J Clin Oncol. 2001 May 15;19(10):2739-45. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11352967

Lehmann-Willenbrock E, Riedel HH. [Clinical and endocrinologic studies of the treatment of ovarian insufficiency manifestations following hysterectomy with intact adnexa] [Article in German] Zentralbl Gynakol. 1988;110(10):611-8. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=2841818

Newton KM, Buist DS, Keenan NL, Anderson LA, LaCroix AZ. Use of alternative therapies for menopause symptoms: results of a population-based survey. Obstet Gynecol. 2002 Jul;100(1):18-25. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12100799

Petho A. Menopausal complaints: change-over of a hormone treatment to a herbal gynecological remedy practicable? Arztliche Prax Gynakol 1987;38, 47:1551-1553.

Stoll W. Phytopharmacon influences atrophic vaginal epithelium: double-blind study: Cimicifuga vs estrogenic substances. Therapeutika . 1987;1:23-31.

Stolze H. An alternative to treat menopausal complaints. Gyne. 1982;3:14-16.

Wuttke W, Seidlova-Wuttke D, Gorkow C. The Cimicifuga preparation BNO 1055 vs. conjugated estrogens in a double-blind placebo-controlled study: effects on menopause symptoms and bone markers. Maturitas. 2003 Mar 14;44 Suppl 1:S67-77. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12609561