I watched the blush rising from her chest to the top of her head. As she fumbled for something in her bag, her complexion radiated a moist sheen and small droplets of perspiration began to trickle down her cheeks. “It will be over in a minute,” she explained and now clenched in her white knuckled hand a small fan was soon working overtime. “What do you know about ‘Maca’?” she asked, “a woman I recently met swears by it - It’s a herb from Peru for menopause. My pharmacist said he’d find out about it for me, but he hasn’t got back to me yet”. So what does and doesn’t work? This month I’m going to talk about complementary medicine claiming to help with Menopausal symptoms.
Now experiencing severe menopausal symptoms, my friend was working her way through the alphabet backwards having already tried Wild Yam cream, Soy, Remifemin (Black Cohosh) and Promensil (Red Clover). She assured me that she had looked up ‘Maca’ on the internet and that it did work for some people, but she would only use it for six weeks to see if it worked for her. Her doctor had suggested she use a Hormone Replacement Treatment (HRT) but she didn’t want to take it. She was convinced that she would get Breast Cancer because she had heard about the research and because it was “made of chemicals”.
I pointed out that none of the plant phytoestrogens work better than placebo (1) & (2). The heavily promoted ingredients such as Red Clover (3) and Black Cohosh not only cannot be recommended, but Black Cohosh (4), for example, was implicated in muscle damage and resulted in a number of liver transplants including three in Queensland and two in South Australia.
So what did the Government do as these women went under the knife? The Therapeutic Goods Administration (TGA) formed a committee to rewrite the labelling (5)!
HRT has had publicity relating to an increased risk of Breast Cancer through long-term use, but there are a number of HRT’s and for short periods they do no harm. There is also evidence that a mild dose of the anti-depressant Venlafaxine (Efexor) has helped some women and this is sometimes recommended to Breast Cancer survivors like myself. I suggested that she should work with her GP who would explain the risks and benefits of what was on offer. She admitted that the HRT had helped her but she preferred to use a natural product if possible.
Does “natural = safe” – of course not! Some of the most potent poisons come out of nature, but that detail seems to get lost in the “traditional is good” hype. Research is now showing that liver and kidney damage (6) may result from the use of herbal remedies, but that information is not getting through either.
Products on pharmacy shelves usually have government approval numbers on them but the labelling fails to mention that they have not been tested. Also most consumers don’t know that the current guidelines for obtaining listing numbers does not require the sponsors to provide any proof of efficacy (7), so it’s a bit of a ‘free for all’ in the herbal remedies department of our pharmacies.
Even when there are claim that scientific research has shown positive results, the study may not have been peer reviewed and may have been on two rats and a guinea pig or the outcome of a publication bias or simply a dodgy trial. With the definition of evidence being traditional OR scientific, (in that order), a sponsor merely states that they have sited the traditional evidence and Bob’s your Uncle! – when the $850 cheque made out to the TGA clears, the AUST L listing number is on its way and new miracle products, complete with a wad of amazing claims on their labels, soon appear on pharmacy shelves.
A particularly vulnerable target group are our Seniors, they trust the Government Regulators are doing their job and more importantly, they trust their pharmacists and trust that products on Pharmacy shelves work. Sadly, the Government has no interest in removing herbal hormone products because not only does the TGA receive over $250,000 on annual fees for the 350+ listed products but that 10% GST on sales keeps rolling in.
I have looked up ‘Maca’. According the Natural Medicines Data Base, ‘Maca’ may help “increase subjective feelings of sexual desire in healthy men”. However, as for those cures for menopausal symptoms, “there is insufficient reliable information available about the effectiveness of MACA for other uses.”
So will it be on the shelf in the future? Possibly not for menopause, but undoubtedly in the men’s pills and potions section next to the Horny Goat Weed, rhino horn and magic mushrooms, because anything claiming to be an aphrodisiac always brings in the bickies to our pharmacies.
1. Treatment of Vasomotor Symptoms of Menopause with Black Cohosh, Multibotanicals, Soy, Hormore Therapy, or Placebo www.annals.org/cgi/content/full/145/12/869
2. Phytoestrogens for Treatment of Menopausal Symptoms: A Systematic Review
3. Phytoestrogen Supplements for the Treatment of Hot Flashes: The Isoflavone Cover Extract (ICE) Study
4. Phytoestrogens for vasomotor menopausal symptoms http://www.cochrane.org/reviews/en/ab001395.html
5. Black Cohosh and liver toxicity – an update
6. Chronic Kidney Disease in Asia.
7. Guidelines for levels and kinds of evidence to support indications and claims www.tga.gov.au/docs/pdf/tgaccevi.pdf