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Editor's Note:
The recent PAN recall, triggered by the faulty manufacture of an orthodox medication, eventuated in one of those accidents of history where a large component of the recall involved complementary medicines.
This latter aspect of the recall was then translated by various politicians, the media, and those of the medical/pharmaceutical professions opposed to the use of complementary medicines in any form, into a full scale investigation into complementary medicines.
How a breach of good manufacturing practice takes on this format involves a quantum leap in imagination, and those people decrying the "lack of evidence" for complementray medicines in the form of a "broad brush", need to review the "evidence" which has led them into joining what can only be described as a form of mass hysteria.
In the interest of fairness I contacted the Complementary Healthcare Council (CHC), the very professional organisation which represents complementary medicines and practitioners in Australia.
I offered them a page in this publication so that an educative process can occur in regard to this industry. Ben Farrell has responded on behalf of the CHC.
There is a body of evidence to support complementary medicines, and it is progressively expanding.
If any person reading this material wishes to debate the pros and cons, then please feel free to respond.
It is my belief that complementary medicines are effective in varying degrees, and it is quite possible that the efficacy of some individual products may prove to be doubtful.
But doesn't this also apply to orthodox medicine?
For example, how valid was the "evidence" that allowed synthetic hormonal combinations on the market in the form of HRT?
Is HRT safe?
Some of the "evidence" seems to indicate that it is not.
Is this being investigated?

Black cohosh (Cimicifuga racemosa) is a herb native to North America where it was used by indigenous populations for a number of conditions, including gynaecological conditions. Over the last 50 years, standardised preparations of the herb have been studied clinically for the treatment of menopausal symptoms, and black cohosh is now one of the most popular herbs in Western herbal medicine.

One preparation alone has been used by more than 1.5 million European women since its introduction (1), and more than 1 billion tablets of that preparation have been sold
worldwide (2). The product is sold in Australia, where its efficacy has been demonstrated in trials at the Royal Hospital for Women, Randwick.

There are 160 products containing black cohosh on the Australian Register of Therapeutic Goods (154 are listed, 6 are registered) (3).While some products contain the herb as the sole active ingredient, the majority of products contain the herb in combination with other herbs and nutrients.

Black cohosh has a long history of safe use in traditional medicine, and in modern herbal medicine (more than 60 years) in Europe. Observational studies in the 1950s indicated that ethanolic extracts of black cohosh roots were beneficial for the treatment of menopausal symptoms. Since that period there have been an increasing number of trials of the effectiveness of standardised extracts. By 1962, at least 14 clinical studies/reports involving more than 1,500 patients had been published, and results showed improvements in menopausal symptoms such as hot flashes and depressive moods (1).

A 1964 review of 135 cases of premenstrual syndrome by Schildge et al showed an improvement in mood swings, mild depression and general well-being over a period of three to six months (1).

An open, retrospective, multicentre study by Stolze et al in 1982, involving 704 menopausal women, showed an improvement in symptoms in 80% of women after four weeks, while there was complete removal of symptoms in some participants after six to eight weeks (1).

Stephen Foster's review of clinical studies utilising standardised extracts (providing 4mg triterpene glycosides daily) reveals improvements in menopausal symptoms in a number of sub-groups in a variety of situations e.g. women with reduced ovary function following hysterectomy, with at least one ovary intact; women converting from hormone injection therapy to black cohosh over a six month period; patients with menopausal complaints for which hormone therapy was contraindicated, or who refused hormone treatment (1).

More recently, a randomised, placebo-controlled trial was designed to look at the effect of black cohosh extract on menopausal symptoms in women with a history of breast cancer. In the study, 59 of the participants (out of a total of 85 women) were using tamoxifen. Black cohosh significantly reduced excessive sweating, but not hot flashes (4).

However, a new study on mice, not yet published, has found that black cohosh might have increased the chance of a pre-existing cancer spreading in the test animals. The study needs to be put into context, particularly with regard to the relevance of results of animal experiments that are extrapolated to women.

Leading herbalist Kerry Bone has said that, at a time when there were increasing questions among women as to the safety of pharmaceuticals such as HRT, it was important to question the relevance of these animal studies involving herbs and that funding should be made available for more appropriate studies into natural medicines.

"For instance, as black cohosh is approved for use in Australia, any research should have been conducted in humans, not mice, and should be focused on understanding the efficacy of the herbal treatment. The artificial nature of this experiment makes it of little relevance to the day-to-day use of black cohosh," said Mr Bone. "We welcome research into the use of natural health care products, but we want that research to be appropriate to the remedies in question."

"More funding for appropriate studies will help to back up the evidence of thousands of years of traditional use with modern clinical data, thus allowing consumers to make informed decisions about their health care choices. In the case of black cohosh there is already a substantial body of research, mainly from Europe, to support its safety and efficacy, but more research is still needed."

The confusion about the safety of drugs such as HRT has also shown the importance of a holistic approach to healthcare. "We should not consider any particular medicine to be a magic bullet for any particular condition," said Mr Bone, "especially when it comes to a life-event such as menopause, where the treatment must be tailored to the individual woman."

"There are many clinically proven natural alternatives available for the treatment of menopausal symptoms, and women should discuss their individual circumstances with their practitioner to find the right treatment," Mr Bone said.

Remedies such as Korean ginseng for exhaustion and depression, sage for excessive sweating, soy for hot flushes and tribulus for symptoms of oestrogen withdrawal provide a range of safe and effective options for women. Used in conjunction with lifestyle and diet measures, these natural products can form part of a holistic approach to dealing with the symptoms of menopause. And importantly, unlike HRT, they do not need to be taken indefinitely to help control menopausal symptoms.

References:
1.Foster, S. Black Cohosh: A Literature Review. Herbalgram No. 45, pp 35-50
2.SmithKlineGlaxo/ Remifemin North American website
3.ARTG search by TGA Listing Unit
4.Jacobson JS et al. Journal of Clinical Oncology. 2001;19:2739-45