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I hope you all had a nice summer. I certainly did
- although it was a lot of effort. As you probably
know, I had a baby girl in late 2005, but you might not know
that I am a single mom. I also have a beautiful Standard
Poodle (black) named Coco. So, how do we get from
the beach to the car? It took me a while to figure
it out, but that's what Moms do! I got one of
those "buggies" that you can load and then pull.
(BIG mistake to overload it, keep it light or it won't steer) I
strapped the baby on me with an advanced snuggly kind of
thing (she's a hearty little girl) - clipped the dog on the
leash, grabbed the bar of the buggy and prayed for the best. Once
we got to our spot, we were quite okay - the umbrella
goes up, the dog goes to the ocean with her ball, the baby
combs the beach pulling seaweed clusters apart and I keep
watch. Apparently we were the entertainment for everyone
within a 100 ft radius - we would catch them looking up from
their books. Our saviors were the grandmothers
who could feel my pain even if I couldn't - they would declare
their "grandmother hood of X many" and offer to
watch the troops while I dipped in the ocean. Coco was the
star as she pranced up and down looking for ball throwers. I
didn't get to sit in the lounge chair once, but brought it
every time thinking, "I bet she'll nap in her little
tent." It was just too exciting - the only naps
were on the ride home. The highlight was when a kind
stranger helped us pull the buggy. Once we got to
the car he asked, "Do you do this regularly?" I
burst out laughing - "I know, it's nuts, right?"
But I can't say I'm glad it's over
- I love summer and it goes so quickly. I want my
daughter to enjoy the beach, the ocean, the sunshine and
summer folks.
So on to the business at hand. I'm
going to devote this newsletter entirely to an important
issue that has been reported a lot recently - is black
cohosh harmful to the liver?
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.
In good health,
Valerie Otto
President
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
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
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