On the 9th of July 2002 a press release announced that the National
Institutes of Health (NIH) had stopped a major clinical trial investigating
risks and benefits of combined estrogen and progestin in healthy menopausal
women. The planned duration of the trial was 8.5 years. After a follow-up
at 5.2 years it was decided that the health risks outweighed the benefits.
An independent data and safety monitoring board recommended stopping
the trial because it found an increased risk of invasive breast cancer
(in fact the number of cases of breast cancer had reached a prespecified
The study also found increases in coronary heart disease, stroke and
pulmonary embolism among study participants receiving the combined estrogen
compared to women receiving placebo. The trial results was published in the
Journal of the American Medical Association together with an editorial (JAMA
2002; 288: 321-333, 366-8) and both are freely available from its website (www.jama.com) – go
to the Past Issues section, July 17, 2002 link.
Hot on the heels of the estrogen plus progestin trial the National Cancer Institute
released the results of a trial studying estrogen alone. The study was also
published in JAMA (JAMA 2002; 288: 334-341) but is not freely available from
its website. This observational study investigated the association between
estrogen-only hormone replacement therapy and ovarian cancer. More than 44,241
postmenopausal women were included in the study which spanned approximately
20 years (1979-1998). The mean age at the start of follow-up was 56.6 years.
Women who used estrogen-only HRT for 10 or more years had a significantly greater
risk of developing ovarian cancer than women who did not use HRT. The risk
increased with length of estrogen use.
The impact of these studies and the parallel recommendation from various health
authorities around the world are still reverberating through our communities.
As a phytotherapist I am receiving many more enquiries from patients or potential
patients about herbal alternatives for the relief of menopausal symptoms. My
experience as a clinician is that herbs can be successfully prescribed in the
majority of cases for the alleviation of symptoms such as hot flashes, sweating,
mild depression and irritability.
The recommendation now coming through is that HRT is only suitable for short-term
treatment in most women. However, it could be argued that this approach to
using HRT in fact only briefly delays menopausal symptoms. When the patient
stops HRT after 6 or 12 months she will likely experience all the symptoms
of estrogen withdrawal once again. There seems to be little point in delaying
the inevitable by just 6 or 12 or even 18 months.
In contrast, the aim of herbal therapy is to assist with the adjustment to
this important change, particularly to the estrogen withdrawal. It is often
the case that herbs will need to be taken for a few years, but eventually the
patient will adjust to her new estrogen levels and will be free of symptoms
even when the herbs are withdrawn.
Many OTC herbal products are being promoted in the media and there is a particular
emphasis now on black cohosh because its efficacy has been supported by clinical
trials. But herbalists select from a much wider range of herbs than just black
cohosh for menopausal symptoms. In fact, I find many of the other herbs that
I recommend in my clinic are much more effective than black cohosh.
In particular, herbs containing steroidal saponins such as in wild yam, Tribulus
and false unicorn root are very effective. The compounds in these herbs may
exert estrogenic effects by binding with estrogen receptors in the hypothalamus,
which are part of the negative feedback mechanism of estrogen control. In the
low estrogen environment of peri- and postmenopause, such herbs might alleviate
symptoms of estrogen withdrawal through the binding of their steroids to vacant
receptors in the hypothalamus. Because some menopausal symptoms are thought
to be initiated via the hypothalamus (especially hot flashes), this selective
binding could be sufficient to reduce symptoms by convincing the body that
more estrogen is present in the bloodstream than there actually is.
The oral application of wild yam must be clearly differentiated from its use
in creams. The use of such creams appears to have arisen from the confusion
between the phytochemicals in wild yam and the hormone progesterone. This
in turn follows from the fact that yams (Discorea species) are industrially
used as a source of progesterone precursors.
Many species of Dioscorea have been cultivated for the industrial manufacture
of steroidal hormones. Diosgenin is manufactured from the dioscin in the herb
and then undergoes a series of reactions to produce progesterone or hydrocortisone.1 Despite this well-known industrial process, there is no evidence to suggest
that diosgenin is metabolized in the body to produce these steroidal hormones,
particularly progesterone. Moreover, diosgenin does not normally occur in untreated
wild yam rhizome.
Analysis of saliva samples from women who were using wild yam cream or tablets
indicated that their progesterone levels, DHEA levels and total progestin activities
were no different from those of untreated women. The women tested were taking
products that did not contain added hormones and for the most part the specimens
were collected within 12 to 24 hours of product usage assay.2
A trial published in 2001 found a wild yam cream to have little effect on menopausal
symptoms. Twenty-three women completed treatment in this randomized, double-blind,
placebo-controlled, crossover trial. After a 4-week baseline period, each woman
was given active cream and matching placebo for 3 months each. Salivary progesterone
levels did not on any occasion exceed the detection limit of the assay.3
One of the best-researched examples of the use of a steroidal-saponin containing
herb is Tribulus. Tribulus terrestris leaf is a popular herb in Europe for
the treatment of menopausal symptoms. Like wild yam and false unicorn, the
leaf of this plant is rich in steroidal saponins.4
In an open study, 98% of 50 menopausal women experienced symptom improvement
after Tribulus treatment, but not after placebo. Fifty-two percent of patients
were experiencing natural menopause and 48% had postoperative symptoms after
removal of their ovaries. Predominant symptoms included hot flashes, sweating,
insomnia and depression. The dosage prescribed varied, but generally a maintenance
dose of 500–750 mg/day of a standardized extract (corresponding to 20
to 30 g of original leaf) was reached after higher initial doses. Treatment
did not result in significant changes in FSH, LH, prolactin, estradiol, progesterone
and testosterone, although FSH tended to be lower.5 There are several other
important uses of this wonderful herb which have been supported by clinical
research, most notably its effects on both male and female infertility.
Sadly, many Tribulus products on the world market will not be effective for
these uses because they are from the wrong plant part (fruit or root instead
of leaf) and do not contain the required composition of steroidal saponins.6 This is despite what might be claimed on the label in terms of active or marker
compounds. Inappropriate methods of analysis have been used and rigorous testing
using HPLC will show the absence of protodoiscin and related steroidal saponins
in many Tribulus products.
The value of soy products for treating menopausal symptoms has been questioned,
but two recent clinical trials have provided positive evidence. One study
examined the change in menopausal symptoms and cardiovascular risk factors
in response to 4 months of 100 mg per day of soy isoflavones. The study found
a decrease in menopausal symptoms and total cholesterol from soy intake when
compared with the placebo group.7 In the other study a tofu which was high
in isoflavones was compared against placebo for the relief of menopausal
symptoms. A statistically significant improvement was observed in 12 of the
15 variables examined. Hot flashes decreased in 76% of treated patients versus
19% of those on the placebo. Significant decreases were also noted for palpitations
(77% versus 17%), sleep disturbances (69% versus 16%) and nervousness (56%
versus 14%). These results were achieved without any changes in the hormonal
profile of patients or in the endometrial thickness.8
The safety of soy is controversial. In 2000, two US writers published concerns
about the safety of soy in the Townsend Letter.9,10 Such
concerns were also picked up by the media. These issues were adequately countered
by Nancy Beckham,
who in her published letter in the Townsend Letter wrote: "This article
contains incorrect referencing, misrepresentation, misunderstanding, quotes
out of context, fractional truths and extreme bias… I have found 43 'misrepresentations'
in this particular paper…".11
Phytotherapists also select other herbs for treating menopausal symptoms such
as sage for sweating and St John’s wort for mild depression. The value
of St John's wort standardized extract in treating the psychological and
vegetative symptoms of menopause was recently assessed in an uncontrolled
trial.12 Substantial improvements in these symptoms were observed and sexual
well-being also improved. These results need to be confirmed in a controlled
The use of chaste tree berry (Vitex agnus castus) to treat menopausal symptoms
is popular amongst English herbalists.13 I have found this herb to be particularly
useful for the alleviation of exaggerated PMS symptoms which can occur in the
perimenopausal time period.
It should also be stressed that the aim of all herbal treatment is to ensure
a comfortable adaptation to the lower levels of female hormones which accompany
the climacteric. As such, these treatments are not recommended for indefinite
use. Typical treatment times vary from 6 to 18 months, but treatment may be
necessary for a few years in some cases.
What is now needed are properly designed clinical trials to objectively investigate
the value of the traditional herbal treatments for menopause, particularly
the steroidal-saponin-containing herbs. The generation of such evidence will
provide a tremendous boost for naturopathic medicine in terms of meeting the
need in the community created by the justified demise of HRT as a first line
treatment for menopausal symptoms.
1. Bruneton J. Pharmacognosy, Phytochemistry, Medicinal Plants. Lavoisier
Publishing, Paris, 1995.
2. Dollbaum C. Townsend Letter for Doctors and Patients 1996; 159: 104
3. Komesaroff PA, Black CV, Cable V et al. Climacteric 2001; 4(2): 144-150
4. Stuthe J, Fletcher M, Lambert L, Penman K, Lehmann R, Kitching W,
De Voss J. Chemical Constituents of Chamaelirium luteum. Poster presented
at 50th Conference Society of Medicinal Plant Research (GA) in Barcelona,
Spain. Sept 2002
5. Zarkova S. Tribestan: Experimental and Clinical Investigations. Chemical
Pharmaceutical Research Institute, Sofia, Bulgaria.
6. Lehmann R, Halloran K, Ozarko L, Penman K. Poster presented at 50th
Conference Society of Medicinal Plant Research (GA) in Barcelona, Spain.
7. Han KK, Soares JM Jr, Haidar MA et al. Obstet Gynecol 2002; 99(3):
8. Yoles I, Kaplan B, Seidman DS et al. Obstet Gynecol 2002; 99(4 Supp
9. Fallon S, Enig M. Townsend Letter for Doctors and Patients 2000; 204:
10. Fallon S, Enig M. Townsend Letter for Doctors and Patients 2000;
11. Beckham N. Townsend Letter for Doctors and Patients 2001; 219: 100-103
12. Grube B, Walpart A, Wheatley D. St John's Wort extract: efficacy
for menopausal symptoms of psychological origin. Adv Ther 1999, 16(4):
13. Christie S, Walker AF. Vitex agnus castus. A review of its traditional
and modern therapeutic use, current use from a survey of practitioners.
Eur J Herb Med 1997/1998; 3(3): 29-45