Black Cohosh V Hrt Safety: The Awful Truth

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18th July 2008, 08:02am - Views: 1406





MENOPAUSAL women may have been left wondering what to do, after papers published in

medical journals exposed the dangers of hormone replacement therapy (HRT), then a wave of

adverse publicity cast doubt on a natural alternative, black cohosh, which has been accused of

causing liver damage.

The published science shows that even if every claim made against black cohosh was justified,

it would still be much safer than HRT and just as effective in relieving the hot flushes, night

sweats and anxiety that accompany menopause

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.

Adverse media publicity given to black cohosh has resulted in sales of natural medicines that

contain the herb collapsing by as much as 50 per cent according to industry sources, but an

examination of the facts shows that the fear created by the media coverage is not justified by

the evidence.

Black cohosh is the common name for a North American member of the buttercup family

known as Cimicifuga racemosa.

An extract of its root is used for the temporary relief of the symptoms of menopause, as an

alternative to HRT. It became hugely popular after 2002 when HRT trials in the United States

were cancelled mid-term after it became apparent that HRT was killing the subjects through an

increased incidence of breast and ovarian cancer and heart disease.

1, 2, 3, 4, 5, 6, 7

The published science shows that thousands of women have died of cancer and heart disease as

a result of using HRT, yet according to the World Health Organisation (WHO) and the

American Botanical Council (ABC) there has not been one verifiable case of harm caused by

black cohosh.

8, 9, 10

The adverse publicity began in earnest last year when an Adelaide woman, Marie Furler,

appeared on national television and blamed a black cohosh extract for her liver failure and

subsequent transplant operation.

The media appeared to accept what she and her doctors at the Flinders Medical Centre had to

say at face value and ran with the story.

The product involved was Australia’s top-selling black cohosh preparation, Remifemin, which

is made by the German phytomedicine company Schaper & Brummer and marketed by Sci-Nat

Australia.

SciNat’s managing director, John Waitzer, was highly critical of the standard of journalism

involved.

Mr Waitzer said that the television current affairs reporter who did the story did not get in

contact with SciNat until 4pm of the day that the story was to be put to air and then only in

response to repeated attempts by SciNat to contact the reporter.

He said that the reporter knew nothing of the legally required process for reporting adverse drug

reactions, or the science involved. It seemed to him that little to nothing had been done on the

story other than to interview Mrs Furler and her doctors.

On 5 May this year, the Medical Journal of Australia (MJA) published a paper by the doctors

who performed the transplant surgery on Marie Furler. The paper did not name the woman

involved in the reported case, but the age and other details made it extremely unlikely that it

could have been anyone other than Mrs Furler.

One would expect an article published in the MJA to have undergone a rigorous peer-review

process, but how good was the science in this paper . . . really?

The paper by Flinders Medical Centre doctors Elizabeth C-Y Chow, Marcus Teo, John A. Ring

and John W. Chen reported a case of liver failure in a 51-year-old woman.

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The article in the MJA received extensive coverage in the mainstream media, none of which

took a critical look at the quality of the evidence offered in the paper.

According to Schaper & Brummer, the authors of the paper published in the MJA left

unanswered important questions about what might have caused the woman’s liver failure, then

pointed their collective finger at black cohosh without offering the necessary evidence to

support their claim.

Schaper & Brummer has asked the Flinders Medical Centre and the four doctors to supply it

with evidence to support the claims made in the MJA article, so that it can comply with its duty

of pharmacovigilance as required by the Therapeutic Goods Act.

The requested evidence has not been forthcoming, which has put Schaper & Brummer in a

legally impossible situation.

In addition, there are also significant contradictions between the facts as claimed in the paper

and an adverse reaction report about what was almost certainly the same case that was lodged

with the Therapeutic Goods Administration on 25 July 2006.

Schaper & Brummer has delivered to the MJA for publication a detailed critique of the

published paper, which takes the authors of the article to task over the quality of the science

involved.

The published paper stated that the patient had no history of ‘significant alcohol consumption’,

yet the report lodged with the TGA said that the woman consumed ‘three to four units of

alcohol per day, two alcohol-free days per week’.

The report to the TGA also stated that the patient had taken multivitamins, however no specific

information was provided about the nature, duration, or dose of the multivitamins. This is

important because vitamin A, when taken in conjunction with alcohol, has been shown to

damage the liver.

In addition to alcohol, many medicines and toxins that can be consumed with food are known to

do harm to the liver.

Even with no or reduced consumption of alcohol, or the use of other substances that are toxic to

the liver, in more than 30 per cent of liver disease cases the cause of the condition remains

unclear.

12

An extensive laboratory investigation was claimed in the paper published in the MJA, however

no information was offered as to whether or not liver diseases such as Morbus Wilson, hepatitis

E, or porphyry had been excluded as possible causes of the liver failure.

The patient was also at a statistically greater risk of liver disease as a result of obesity, for

which she underwent a gastric-bypass procedure 10 years before the liver failure occurred. The

relationship between obesity, gastric bypass surgery and non-alcoholic fatty liver disease has

been reported extensively in scientific literature for some time.

13, 14

Whether the patient’s history of gastric-bypass surgery at the age of 40 played a role in the

woman’s liver failure remains unclear. In the paper, the authors admitted that they could not

exclude a causal relationship.

In the view of Schaper & Brummer, the information about the case published in the MJA did

not allow for a valid assessment and did not constitute credible evidence of probable harm.

“It cannot be excluded that the patient’s history of obesity and bariatric surgery was

complicated with liver injury. Idiopathic reason and rarely occurring or unclear liver diseases

should also be considered as possible causes,” a statement by Schaper & Brummer said.

The Furler case was not the first time in recent history that a doctor had pointed the finger at

black cohosh, so various government regulators around the world commissioned research into

the herb.

A scientific panel convened by the American Botanical Council (ABC) to look at the safety of

black cohosh reported to the United States Pharmacopeia on 31 October, last year, that there

was no scientific evidence that black cohosh posed any risk.

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“The widespread and historical use of black cohosh products, coupled with the lack of

scientific evidence of toxicity, suggest strongly that there is no attributable risk associated with

the use of properly manufactured black cohosh preparations,” a statement issued by the ABC on

15 February this year said.

“In recent workshops on black cohosh safety, sponsored by the National Institutes of Health,

international experts have noted that no scientific evidence has been reported that implicates

any chemical, pharmacological, or clinically verifiable mechanism to support concerns related

to the poorly-documented cases where there has been alleged black cohosh associated

hepatotoxicity.”

The report was authored by ABC founder and executive director Mark Blumenthal; Professor

Norman R. Farnsworth PhD of the University of Illinois at Chicago, director of the UIC Centre

for Botanical Dietary Supplement Research; Professor Richard Kingston, PharmD, of the

University of Minnesota, president and senior toxicologist of Safety Call International Poison

Centre; and Professor Tom Kurt, MD, of the University of Texas Southwestern Medical Centre.

The World Health Organisation (WHO) Collaborating Centre for International Drug

Monitoring database does not have any record of verifiable evidence of liver problems caused

by black cohosh.

10

A safety assessment conducted by the Natural Health Products Directorate of Health Canada,

which was published on 28 March last year, put the adverse incident risk of black cohosh at one

in 10 million, or fewer.

8

So, if a menopausal woman is worried about a possible risk to her liver from black cohosh,

would she be at less risk if she opted for HRT prescribed by her doctor?

The answer, according to the published science, is a resounding no.

Even if all the claims made against black cohosh were found to be true, the evidence shows that

HRT is much more dangerous.

The increased risk of breast and ovarian cancer and heart disease posed by HRT has been

documented in papers published in various medical journals.

In the 2 June edition of the Medical Journal of Australia

16

a paper was published which showed

that a 40 per cent decline in the use of HRT between 2001 and 2003 coincided with a 6.7 per

cent decrease in the incidence of breast cancer among women aged 50 years or older.

The authors concluded that: “While other factors may have contributed to a recent reduction in

breast cancer incidence among Australian women aged more than 50 years, the available

evidence suggests that much of the decrease is due to the recent fall in use of HRT.”

The Australian experience tallies with medical data from elsewhere in the world.

For example, a study published in the New England Journal of Medicine

5

showed that there

was also a 6.7 per cent decrease (age adjusted) in new breast cancer cases during 2003, which

the authors linked to a decline in the use of HRT. During that time prescriptions for the two

most commonly used HRT drugs declined from 61 million in 2001 to 21 million in 2004.

A paper published in the Journal of the National Cancer Institute of Britain found that breast

cancer survivors who used HRT had more than a two-fold increase in the risk of recurrence, or

the appearance of another form of cancer.

6

A study published in no less a journal than The Lancet found that between 1991 and 2005 an

extra 1,000 women in Britain died of ovarian cancer that was attributed to HRT.

7

The same study, which was called the Million Women Study, also found that HRT users were,

on average, 20 per cent more likely to develop ovarian cancer and die from it.

In light of the evidence of the danger posed by HRT and the lack of evidence against black

cohosh, it is worth noting that the Australasian Menopause Society does not mention black

cohosh when it offers advice to menopausal women on its web site.

Instead, the Australasian Menopause Society’s web site states: “for women aged 50 to 59, HRT

remains the first line and most effective treatment for menopausal symptoms.”

Australian Menopause Society president Alice MacLennan said that the society’s

recommendation was based on the evidence.

“At this stage the AMS does not endorse the use of black cohosh for menopause symptoms due

to the lack of efficacy,” Ms MacLennan said.

“Many of the earlier trials were short term and had a lower than expected placebo effect.

“ The recent HALT trial

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gives the most conclusive evidence that black cohosh is not effective

above placebo in controlling the hot flushes of menopause.

“The AMS recommends actions or treatments based on evidence based on research and we

endeavour to update this advice as new research is published.”

1. Hulley S., Grady D., Bush T., Furberg C., Herrington D., Riggs B., Vittinghoff E.

Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease

in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research

Group. JAMA 1998; 280(7):605-13.

2. Grady D., Herrington D., Bittner V., Blumenthal R., Davidson M., Hlatky M., Hsia J., Hulley

S., Herd A., Khan S., Newby L. K., Waters D., Vittinghoff E., Wenger N.; HERS Research

Group. Cardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and

Estrogen/progestin Replacement Study follow-up (HERS II). JAMA 2002; 288(1):49-57.

3. Manson J., Hsia J., Johnson K. et al. Estrogen plus progestin and risk of coronary heart

disease. New Engl J of Med 2003; 349:523-534.

4. U.S. Department of Health and Human Services and the National Institutes of Health. Facts

on Menopausal Hormone Therapy, June 2005.

5. Ravdin Peter M., Cronin Kathleen A., Howlader Nadia, Berg Christine D., Chlebowski

Rowan T., Feuer Eric J., Edwards Brenda K., Berry Donald A. The decrease in breast cancer

incidence in 2003 in the United States. New England Journal of Medicine 2007 356: 1670-

1674.

6. Holmberg L. et al. Increased risk of recurrence after hormone replacement therapy in breast

cancer survivors. Journal of the National Cancer Institute 2008; 100: 475-482

7. Valerie Beral and the Million Women Study Collaborators. Ovarian cancer and hormone

replacement therapy in the Million Women Study. The Lancet DOI:10.1016/SO140-

6736(07)605534-0


grappes_fact-fiche_e.html#skipall

9. Hudson T. Women’s health update: black cohosh concerns and controversies. Alternative

Complementary Therapies. April 2007: 102-106

10. World Health Organisation Collaborating Centre. Adverse reactions to drugs: Cimicifuga

racemosa, Cimicifuga racemosa root, Cimicifuga racemosa extract. Welwyn Garden City, UK:

ECRI (formerly Emergency Care Research Institute)

11. Liver failure associated with the use of black cohosh for menopausal symptoms. Elizabeth

C-Y Chow, Marcus Teo, John A. Ring and John W. Chen. Medical Journal of Australia 2008;

188 (7): 420-422

12. . Walker AM, Post Marketing Surveillance 6 (1992),107-117

13. Beymer C., Kowdley K. V., Larson A., et al. Prevalence and Predictors of Asymptomatic

Liver Disease in Patients Undergoing Gastric Bypass Surgery. Arch Surg 2003 Nov; 138:1240-

4

14. Silvestre V., Ruano M., García-Lescún M. C., et al. Morbid obesity, non-alcoholic fatty

liver disease, metabolic syndrome and bariatric surgery] Nutr Hosp. 2007 Sep-Oct;22(5):602-6.

15. Hudson T. Women’s health update: black cohosh concerns and controversies. Alternative

Complementary Therapies. April 2007: 102-106.

16. Canfell K., Banks E., Moa A. M., Beral V. Decrease in breast cancer incidence following a

rapid fall in use of hormone replacement therapy in Australia. Medical Journal of Australia

2008; 188 (11): 641-644.

17. Osmers R. MD PhD et al. Efficacy of isopropanolic black cohosh extract for climacteric

symptoms. Journal of the American College of Obstetrics & Gynaecology 2005; 105: pp 1074-

83.

18. Newton K. M., Reed S. D., LaCroix A. Z., Grothaus L. C., Ehrlich K., Guiltinan J.

Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy,

hormone therapy, or placebo: a randomised trial. Annals of Internal Medicine 2006; 145: 869-

879.








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