|
BLACK COHOSH AND LIVER CONCERNS
Recently, there has been a lot of concern about black cohosh causing liver disorders.
So much so that Australia, the UK and Canada are now requiring black cohosh
products to carry warning labels. (stay tuned, they may very well reverse these
warnings) There continues to be a lot of development on this issue as scientific
evidence to the claim is very questionable. Just this past week a US court
dismissed a case that claimed black cohosh caused liver disorder.
I first took notice of this when a few
cases came out of Australia in 2004. At the time I
was able to locate the cases Australia was referring to. I
remember that these women had been older, on several pharmaceutical
drugs with histories of various serious illnesses over long
periods of time. How they came to the conclusion that
it was black cohosh that caused the liver toxicity seemed
to me, quite frankly, a big stretch.
But since then, Australia has had 9 complaints
about liver damage associated with black cohosh - and sited
47 worldwide. Although extremely rare, could it be
that it takes millions of women to take something before
we know that it could cause liver damage? The
Australian government also pointed out the rarity of the
occurrence. Are they even sure that it was black cohosh
causing the damage, with any clue to amounts or concentrations? Or
perhaps because it's so rare, black cohosh is not a cause
but a coincidence or correlation? What process
did the government go through to establish this? In
the end, liver toxicity is serious and we must take an honest,
hard look at it.
That is what the NIH did in late 2004. In
response to these concerns, the NIH held a one day workshop
considering liver toxicity claims as well as those about
the safety of black cohosh for women with a history of breast
cancer. The link to the write up is listed below. There has
been a lot of on-going research on the herb - and it was
interesting to review the progress. They first
went through how they believe black cohosh works - and once
again stressed that no studies show any estrogenic activity. Studies
continue to confirm that it is safe for women with breast
cancer. While no one is sure how black cohosh
works, the experts hypothesized that one way may be through
the serotonin receptors, specifically binding in two receptor
subtypes SHT-1A and 5HT-7. Both of these receptors
are associated with the hypothalamus, which is involved in
body thermoregulation. They also theorized that black
cohosh may have a positive effect on other systems as it
is found to have antioxidant activity.
But I'm drifting here a little… they
also looked to see if there was anything in the plant that
could be identified as potentially harmful to the liver. Catechols
were identified as a possible source but were dismissed because
they were not absorbed into the intestines. Therefore
at this time there is no known mechanism in the plant or
extract that would cause an adverse effect to the liver. Later,
a leading black cohosh German scientist who has headed several
clinical studies over the year (black cohosh has been
used regularly by Germans for 40 years) summarized
that since hepatotoxicity is always a serious health concern,
he routinely screens for liver function. He has never
identified an adverse effect. This year Dr. Farnsworth,
Professor of Pharmacology at University of Illinois, was
quoted as saying that during a current clinical trial on
black cohosh he's been monitoring liver enzymes in women
for over a year and has found no increase in enzyme levels.
The attention then turned in depth to some
individual cases -- two cases from the US and two from Australia. Each
case raised some very serious doubts whether black cohosh
was really the cause of the damage. In one case the
patient remembered seeing "black cohosh" on the
label but couldn't remember the product name. In the
other, the patient had been to Mexico seven months earlier
and had a history of three medical conditions as well as
depression. This woman was taking Synthroid, Prozac
and Darvocet. Experts agreed that causation was very
difficult to determine. One expert even argued that
it's possible that black cohosh was a protective element
for the liver if women of this population had less incidence
of liver disease than the general population. This
became the most important unanswered question in the workshop
- no one had any baseline data on what the hepatotoxicity
rates are for the general population.
One of the Australian cases that seemed
to be the most serious was a 47 year old woman who took black
cohosh for a week and three weeks later was admitted to the
hospital for liver failure. She eventually had a liver transplant
and remains well four years later. The actual source
of this black cohosh has not been confirmed or independently
tested. This obviously makes it very difficult to
determine whether it was the black cohosh or not. The
other Australian case involved a multi-herbal tincture
made by a pharmacist. It contained only 10% black cohosh
along with other herbs that were more likely to be hepatotoxic
than the black cohosh.
Overall, the panel noted the weakness in
the claim that black cohosh was really the cause of hepatotoxic
effects in these cases. In fact, it was stressed that
if black cohosh is taken by the millions of women that trade
groups are reporting, any adverse effects of the herb are
incredibly low. Having said that, a really good
point was made by a digestive and kidney disease expert. He
pointed out that studies are not powered to detect rare events
and only after thousands of people take a product can such
a thing as hepatotoxicity be detected. And the more
cases of this, the harder it becomes to dismiss. It can be
life threatening.
That sounds correct to me - as long as
the cases are being evaluated with good scientific sense. Hepatotoxicity
covers a spectrum of liver disease. According to this
expert, the cause can be determined in 90% of cases. It
is also the most common basis for pharmaceutical drugs being
pulled from the market or not being approved. The most
common cause of acute liver failure is the use of acetaminophen
(Tylenol). Many hepatotoxicity cases involve people taking different
drugs and OTC's as well as herbs. So, this must be sorted
out and obviously can be if 90% of the cases can be determined.
In my opinion, this is where Australia,
the UK and Canada dropped the ball. In February of
this year, the Australian Therapeutic Goods Administration
(TGA) issued a policy for a new warning label required on
all herbal products containing black cohosh. The label
is to read, "Warning: Black cohosh may harm the liver
in some individuals. Use under supervision of a healthcare
professional." Later in the year, the UK followed
suit with a similar rule and Canada issued a safety statement. The
problem is, as many herbalists have pointed out, none of
these agencies have detailed the process or criteria they
used to determine this harm. It appears that they read
published cases but as we've seen from the NIH workshop,
when analyzed they don't hold up.
The American court system agrees. Just
last week one of two big cases believed to show causation
was dismissed with a preliminary judgment. The plaintiff
developed autoimmune hepatitis and required a liver transplant
just months after starting to use black cohosh. A lot
of inconsistencies emerged between the case write up and
court testimony. Most notably was the fact that the
woman drank alcohol, took ibuprofen and had been prescribed
Valtrex, a drug that lists liver enzyme abnormalities and
hepatitis as adverse reactions. In the case report the patient
did not drink or take any other medications, including herbals. The
patient's physician was one of the authors of the published
case and later an expert witness. The court found another
expert witness, a toxicologist, lacked expertise as he testified
that there was a causal link that could be tested but he
had not conducted animal or human tests on black cohosh toxicity.
"In fact, the research has consistently
held to the contrary, that black cohosh is non hepatotoxic," said
the court ruling.
The defense motioned for these two witnesses
to be excluded and later for a summary judgment. Both
were granted and the complaint was dismissed. This
dismissal of this case has prompted trade organizations to
approach Australia, UK and Canada to reconsider their rulings. So
far, the UK has agreed to reconsider.
As for Oöna and taking our products,
this is what I think. I know you know this about us,
but it warrants repeating… we take every step possible
to make sure that what goes into our products are the correct
species in the amounts that we say. We do independently
test each batch to make sure that we have reliable efficacy. I
am concerned about some adulterate products out there - so
sincerely, don't buy cheap. You know that we are extremely
careful about the source of our products.
And while I don't believe that black cohosh
is the cause of hepatotoxicity - if you are on pharmaceutical
drugs or have liver disease - please have your liver enzymes
regularly tested and read the fine print on those inserts. Consult
your physician or other health care professional about adding
Oona. I also love Alpha Lipoic Acid for the health
of the liver - but again, do check with your health care
professional.
What are the signs that your liver may
not be working properly?
Jaundice
- yellowing of the skin or whites of the eyes
Dark urine
Nausea/vomiting
Diarrhea
Fatigue
Weight and/or
appetite loss
Fever
Bloated
abdomen or abdominal pain
We're here for you and your health and
will continue to update on this issue.
http://nccam.nih.gov/news/pastmeetings/blackcohosh_mtngsumm.pdf#know
http://www.herbalgram.org/herbalgram/articleview.asp?a=3010
http://www.nutraingredients-usa.com/news/ng.asp?n=70068-black-cohosh-health-canada
http://www.imt.ie/displayarticle.asp?AID=11360&NS=1&CAT=18&SID=1
http://www.nutraingredients-usa.com/news/ng.asp?n=70681
-black-cohosh-liver
http://www.ahpa.org/Default.aspx?tabid=69&aId=318&zId=1
http://www.tga.gov.au/cm/blkcohosh.htm
Newsletter
Fall 2006
MORE WOMEN TURN TO HERBS FOR MENOPAUSE
In a survey conducted at Stanford University Medical School
and published in “Menopause:
The Journal of the North American Menopause Society” are some notable
experiences of 781 women aged 40-60.
90% of women in this age group have experienced
some sort of menopause symptom in the past with 79% of them
experiencing symptoms now. The most prevalent are headaches,
sleeplessness, mood swings and weight gain. (Notice
the absence of hot flash on the list.)
Interestingly, more women are now using
an herbal or soy remedy than hormone replacement therapy
(HRT) to address their menopause symptoms. 37% of women
use HRT, while 31% of women use herbs with another 13% using
soy.
Of the women taking an herbal remedy, almost
two-thirds of them find it effective. 70% of former users
did not feel herbs helped. I only looked at reviews
of this research and did not see the actual number of women
who stopped taking herbs because they didn’t work.
Overall, only 29% of women were aware of
the results of the Women’s Health Initiative study
that pointed to the risks of HRT - primarily increased risk
of heart attacks, stroke and breast cancer.
Yet, 55% of women said they used an herbal
remedy because they had concerns about HRT. 45% said
they preferred something natural. Of women who stopped taking
hormone therapy, three-quarters (74%) were not taking any
other kind of treatment. This suggests that women are
either in one camp or the other and are swaying more to the
natural route.
Only about half of women taking herbal
supplements tell their primary physicians – although
71% of women said that they consider their doctor to be their
most trusted source of information. 45% of these women
said the information provided by their doctors was conflicting
and confusing and 20% said their doctors had not given them
adequate information about alternative therapies for menopausal
symptoms.
The most interesting point to me in this
whole thing is that we women are in fact doing the research
and have enough knowledge to know when our physicians aren’t
up to speed when it comes to alternatives. I’m
certainly not suggesting that we don’t tell our physicians
what we are doing but my hope is that they will stop discounting
the value of alternatives. Obviously, women are experiencing
the value.
One last note – this survey is funded
by GlaxoSmithKline the pharmaceutical company. They
had no input in the method of the study, etc. but I wonder
if the researcher, Dr. Jun Ma has an affiliation to the firm
because of her tone, which I took out and just presented
the facts. It may certainly be her opinion, but she
really makes it sound, once again, that herbs are completely
unsafe etc. etc. I did not see any affiliation through
a Google search but they did fund her study.
http://www.nytimes.com/2006/06/20/health/20meno.html?ex=
1152244800&en=8a5a731d424fa001&ei=5070
http://www.medpagetoday.com/Endocrinology/Menopause/tb/3561
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=
Retrieve&dopt=Abstract&list_uids=16735949&query_hl=5&itool=pubmed_docsum
Newsletter
Summer 2006
BIOIDENTICAL HORMONES
Women often ask me what I think of these and I do like them
better than conventional hormones, but only if all else
fails. Keep in mind that it has
been estimated that 85% of women can find relief during this transition we
know as peri menopause/menopause by using one or a combination of lifestyle,
nutiritonal and/or herbal supplementation.
As a refresher, we produce three different
strengths of estrogen. From strongest to weakest they
are estradiol, estrone and estriol. Estradiol is most
prevalent in reproductive years as it plays a major role
in follical (or egg) development, estrone is more prevalent
in menopausal years and estriol is prevalent throughout your
life but most dominant during pregnancy. (see http://www.oonahealth.com/peri.html for
a full explanation and click on "estrogen")
The definition of bio-identical hormones
is what the name implies -they are made from plant sources
and modified to identically match the chemical structure
of hormones made naturally by our bodies. Synthetic
hormones, while we often think of Premarin and horse's urine,
may also come from plant sources. The difference is
that these are not processed to match human hormones and
tend to be much stronger.
There is another important difference -
as there are conventional (pharmaceutical) hormones that
are bio-identical. Conventional therapy either supplies
just one of the two strongest hormones - estradiol or estrone
- or, more recently, a set combination of the two. Bio-identical
treatment includes all three estrogens and is made specifically
for you based on a blood or saliva test. Prescribed
by a healthcare professional, bio-identical are then made
up at a Compounding Pharmacy. (Compounding pharmacies are
not regular pharmacies)
Compared to conventional hormones, it is
believed and shown that bio- identical hormones are metabolized
closer if not the same as our own hormones and therefore
produce the same effects with less adverse effects. And
while there are European studies that show they are indeed
safer, there are no long term studies that prove it either
way. It is assumed that bio-identical and conventional
pose the same risks - risks such as breast cancer and blood
clots.
One of the main criticisms of bio-identical
hormones is that they are unregulated and therefore somehow
dangerous as it is generally believed that they are safer. If
they are compounded in a reputable pharmacy, of which there
are many, this criticism in my opinion is unfounded. It
must be taken into consideration that only conventional or
synthetic hormones can be patented - these companies have
a lot invested in making us believe that only their products
are safe.
However, there are questions that don't
seem to have clear answers. The procedure for this
regime is to get a saliva or blood test that tests your hormone
levels. There are differing opinions about which test
is more accurate, which leads me to believe that neither
is reliably accurate. Some say saliva testing is better
because it tells how much estrogen is available to be absorbed. Apparently,
blood tests can't tell you that. Others say blood tests
are better because saliva tests can differ so greatly at
different times of the month or even day. Then there
is the question about what level you should be obtaining? If
you don't have a baseline from your late 30's early 40's,
it would seem to me, very difficult to determine. The
going consensus is to just add the least amount of hormones
to obtain relief. If three estrogens are being compounded,
it seems like a difficult balance to obtain without a baseline. However,
if you compare this procedure to conventional treatment that
personalizes very little if at all, this does seem better.
Oöna works very well for me - however, if nothing worked
and I was miserable, I would try bio-identical for a shortest
period of time. I think that Dr. Susan Love makes an
important point - it is not safe for us to maintain reproductive
amounts of hormones for our whole lives. This is why
we go through menopause. Respecting nature and tampering
with this biological process A LITTLE seems okay - but how
much is too much and how long is too long? It's becoming
more and more apparent that the answer is an individual answer. At
least, in my opinion, bio-identical hormones are a step in
the right direction.
So how do you find a health care professional
that will work with you on this? Besides asking around,
I would work backwards. You can call a Compounding
Pharmacy in your area or find one by contacting The International
Academy of Compounding Pharmacists at 800-927-4227. Ask
for a reference to an MD or other healthcare professional
that uses their services.
My favorite on the subject - the first
one is selling a program of some nature but offers a great
explanation.
http://www.womenshealth.com/patientinfo/NHRT.pdf
http://www.drnorthrup.com/menopause-2.php
http://susanlovemd.com/community/questions/question020812.htm
Mostly con-bioidentical.
http://www.minniepauz.com/bio-identical-hormones.html
http://news.yahoo.com/s/nm/20051031/hl_nm/hormonetherapy_dc
http://www.healthywomen.org/Documents/BioidenticalHormones.pdf
Newsletter
November/December 2005
MENOPAUSE NEWS
Sometimes, I just don’t get it. A National Institute of Health (NIH)
consensus panel came to the conclusion on March 24th that Menopause is not a
disease (hello) and that women with symptoms that are not severe should just “wait
it out”, insinuating to me anyway that women are over-reacting. They
can’t seem to agree which symptoms are “menopause” and which
are “aging” but they do agree that if symptoms are moderate to severe,
women should go on a low dose HRT regiment. Who are these “experts” and
where have they been? Do they see women? This is three years after HRT
was pulled from the market with several follow up studies pointing to greater
risk of all sorts of diseases including Alzheimer’s and we still haven’t
steered the discussion away from HRT? They go on to say that there needs
to be more research on alternatives, they can’t comment on whether they
are safe or effective or not -- have they considered research that’s going
on at other arms of the NIH? I guess they’re too busy. I’m not anti-HRT,
(I only believe it shouldn’t be the first thing we try) but I find this
discussion an insult and an obvious lack of concern for women’s health.
Let them take HRT and we’ll check back in 2020.
Click here for the Associated Press piece
http://www.cbsnews.com/stories/2005/03/24/health/main682816.shtml
Newsletter
April 2005
THE TESTOSTERONE PATCH
The big news this month had to do with the testosterone patch
from P&G getting on the fast track with the FDA and then
getting turned down. The testosterone patch has been touted
in the media as the woman's Viagra. They've even come up with
a new fancy clinical name for women with low sex drives, it's
called hypoactive sexual desire disorder (HSDD) - the problem
is that women's sex drives are a lot more complicated then
men's. Further, it is not an issue exclusive to the 40s and
50s set - according to an Australian researcher, 28% of women
in their 20s are unable to reach orgasm. (birth control pills
can flatten out the rising estrogen levels, diminishing drive)
According to JAMA, 43% of women 18-59 experience sexual dysfunction
(5 million women)…it's 31% for men.
So what's with the patch? First, it's important
to note that the role of androgenic hormones (hormones produced
in our adrenal glands such as testosterone and DHEA) in women
has only just begun to be studied recently, mostly in the
'90s, although its importance was noted as far back as 1939.
Testosterone is needed during our fertile years to build the
lining in our uterus in preparation for pregnancy as well
as energy and healthy muscles and bones. It's especially prevalent
during puberty. Associated with sex drive in adult women,
testosterone is also a precursor to estrogen, meaning that
it can be converted to estrogen.
So from what I can gather (Nurses, MD's,
please correct me if I'm wrong) our ovaries produce both estrogen
and testosterone (about 1/10 of that in men) - and testosterone
is also excreted through our adrenal glands along with DHEA,
another precursor to estrogen. At menopause, the ovaries continue
to excrete both estrogen and testosterone but at much lower
levels, specifically 70-80% and 50% of what they were. Women
with ovaries continue to produce testosterone at this 50%
level at least 4 years into menopause; women with no ovaries
they lose this 50% level - although they do produce through
their adrenal glands. The reason these androgenic hormones
are so important is that they are precursors to estrogen -
in other words the body converts them to estrogens.
Most physiological sexual issues with post
menopausal women have to do with a loss of estrogen to the
genitals - this can manifest as vaginal dryness, painful sex
and also decreased desire.
So the theory as I see it (again, you can
correct me) is that the patch delivers testosterone in amounts
that provide the body enough to covert to estrogen and a decent
sex drive. And because the body is converting them to estrogen,
it is assumed that it would only convert what it needs and
therefore reduce the risks associated with estrogen replacement.
The P&G folks were playing it safe in that they are only
recommending it for women with ovaries removed - these woman
obviously have an androgen deficiency and will most likely
benefit. The benefits become a lot more obscure if there is
an absence of androgen deficiency. (see bmj piece below) Word
on the street is that when it works, testosterone can really
make a dramatic difference, in about 50% of women.
Then there's the risks… we do know
that too much progesterone can cause acne and hair growth,
anger, weight gain and liver disease. But the FDA turned it
down for now because it may have cardio vascular effects as
well as breast cancer risks.
And as noted women's sexuality is much more
complicated than one hormone - and encouraging this before
a woman understands what's happening to her body and psyche,
is really a disservice. As quoted in the Wall St. Journal,
"No single hormone determines sexual function,"
notes Susan R. Davis, professor of women's health at Monash
University in Melbourne and a principle investigator for the
Vivus spray (another similar remedy). "It won't change
anything for a woman who doesn't like the look of her partner
or if she's desperately unhappy, depressed or worried about
money."
P.S. The herbs in Oöna for menopause
as well as getting enough protein and exercise can help in
this arena.
More on the subject:
British Medical Journal
http://bmj.bmjjournals.com/cgi/content/full/329/7477/1255
http://bmj.bmjjournals.com/cgi/content/full/329/7477/1294
Susan Love, MD on the patch
http://susanlovemd.com/community/flashes/hotflash001027.htm
Various press reports
http://aca.ninemsn.com.au/stories/1782.asp
http://my.webmd.com/content/article/95/103428.htm
http://www.medicalnewstoday.com/medicalnews.php?newsid=16979
http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees
/Reproductive+Health+Drugs/120204_Intrinsa/120204_IntrinsaR.htm
Newsletter
December 2004
MENOPAUSE GENE?
This is an interesting preliminary finding. Scientist have
believe they have located the gene that regulates the rate
of egg production. The discovery was made with mice but may
have positive implications for women. The gene is called Foxo3a
and mice that are lacking the gene use up all their available
eggs earlier in life. They also had fewer and smaller litters
than those with the gene. The hope is that researchers may
be able to develop contraception that delays the activation
of a woman's eggs until she wants to become fertile at the
age she chooses. Now that's science. For more info go to:
http://www.betternutrition.com/view.asp?issue=Oct03&article=485
and scroll down until you see "Hot News Flash" or
http://www.sciencemag.org/content/vol301/issue5630/index.shtml
under "Reports" Science Magazine is pay per article
Newsletter
December 2003
MENOTYPE?
You knew it had to happen right? But actually, this is an
interesting article that was published in Canada's Alive Magazine
about the different categories of menopause symptoms. It doesn't
separate out different symptoms for different body types or
anything trite like that, it looks at the degree of discomfort.
What I particularly liked about this was the solutions they
offered. I hope you find it as helpful if you are looking
for further relief.
http://www.alivepublishing.com/home/index.php?page_type
=article&topic_id=144753&article_id=6528&site_id=24&go_id=2&take_id=6
Newsletter
October 2003
NEW UPDATED WEBSITE AT MENOPAUSE RX
Our friends at menopauserx.com have just updated their website
with some great information that includes a new tool for a
"perimenopausal assessment" and also one for osteoporosis.
To check out these features, go to
http://www.menopauserx.com/health_center/assessment.htm
Newsletter
May 2003
MENOPAUSAL BONE LOSS MAY BE CONNECTED
TO HIGH BLOOD PRESSURE
An interesting study was published last month in JAMA. It
theorizes that when a perimenopausal or menopausal woman loses
bone mass, there is an increase in the amount of skeletal
lead in our bodies. Lead exposures have been linked to hypertension
and high blood pressure in older men. It is now suggested
the same is most pronounced in post-menopausal women. For
more information
http://jama.ama-assn.org/cgi/content/abstract/289/12/1523
Newsletter
April 2003
HOLD THE SCAPLE
Tara Parker-Pope of the Wall St. Journal (Tuesday February
25, 2003, Personal Journal) reported some very important news
concerning hysterectomies. While a hysterectomy is almost
always a necessary operation for women with certain cancers
and pre-cancer conditions, the most common reason for the
procedure is to treat heavy bleeding, usually caused by fibroids.
(non-cancerous uterine growths) Based on a study by the Journal
of Obstetrics & Gynecology, as many as 70% of the 500
women they followed received hysterectomies that may have
been avoided. Alternative options include surgical removal
of the fibroids, using heat to destroy the uterine lining,
a method that cuts off the fibroid blood supply, focused ultra
sound, and the drug RU-486. Ladies, know your options and
get second and third opinions. Although this is a paid service
at the Wall St. Journal, it may be worth it if you are suffering.
www.wsj.com
Perhaps if you email Ms. Parker-Pope at healthjournal@wsj.com,
she'll reply.
Newsletter
March 2004
HMMMMM....
There has always been wide spread speculation that the pharmaceutical
industry has sponsored the creation of new "diseases"
- arguably menopause being one of them. The British Medical
Journal has published an article using sexual dysfunction
in women as a clear example about how drug companies look
to build markets and race to create medicines. For some interesting
fireside reading, go to http://bmj.com/cgi/content/full/326/7379/45
Newsletter
February 2003
FOR THOSE WHO WONDER HOW TO GET OFF HRT:
Many of us women look to Susan Love, MD not only for her research
but for her honest and open advice. Click here for her suggestions
about how to get off HRT. http://www.susanlovemd.com
Newsletter
January 2003
ALTERNATIVE TREATMENTS FOR MENOPAUSE
46% women in the United States treat their menopausal symptoms
by using alternative therapies, such as herbal supplements.
Among the various herbs on the market, black cohosh was considered
to be the most effective for the treatment of hot flashes
and other menopausal symptoms. Because it does not bind to
estrogen or progesterone receptors, black cohosh received
high marks for not increasing a woman's risk to breast cancer.
Newsletter
September 2002
That's it for this month! As always,
check out our website for lots more information at www.oonahealth.com. In Good Health,
The Oöna Team
Questions or comments? Write valerie@oonahealth.com
|
