Professor Charlie Xue says bad reactions to herbal medicines are generally because of misuse.
If many herbal medicines have at best only a placebo effect, why are they still so popular?
PROFESSOR Alastair MacLennan is head of obstetrics and gynaecology at Adelaide University and a man with strong opinions and a deft way with words. Both qualities came together in June this year when he gave a presentation at the International Menopause Society’s symposium in Rome titled ”Death from Natural Causes”.
Its subject was the rise in popularity of complementary and alternative medicines, and where the professor stands on that subject was starkly evident in his speech’s subtitle – ”Potions, Poisons and Placebos”.
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Some of the many herbal supplements available in pharmacies and health shops. Photo: Craig Abraham
About two out of three Australians use some form of traditional or alternative medicine – from vitamins and minerals to fish oils, homoeopathic concoctions, and herbs such as St John’s wort and evening primrose – and with 10,000 such medicines available it is now a $1.2 billion-a-year business. but according to MacLennan, much of alternative medicine is ”basically a religion without an evidence base”. in Rome, he said the public needed to be protected from its ”false claims and unproven and possibly dangerous therapies”.
Marcus Blackmore is a trained naturopath and chairman of Blackmores, market leader in vitamin, herbal and mineral supplements. last week the company announced a deal with the Pharmacy Guild of Australia in which almost 5000 pharmacies will start recommending a range of Blackmores products to patients when they pick up prescriptions for antibiotics, blood pressure drugs, cholesterol medicine and proton pump inhibitors.
Potentially applying to 58 million prescriptions a year, it sounded like a win/win for both the company and the pharmacists. but it seems to have backfired dramatically – in part because of Blackmores chief executive Christine Holgate’s junk food analogy, that the deal would add ”the Coke and fries” to prescription drugs – and by the end of the week Blackmore was feeling beleaguered.
The media reaction had unleashed public ”vitriol” against pharmacists, Blackmore said, and ”an important program to support the healthcare of patients on some leading pharmaceutical drugs has ended up as an attack on complementary medicine”.
In fact, alternative medicine and associated therapies such as chiropractic and homeopathy have been under an increasingly critical microscope, much of it centred on a report last month by the Australian National Audit Office (ANAO) and audits by the Therapeutic Goods Administration (TGA).
The more than 200 audits of complementary medicines, conducted between June 2009 and December 2010, found hundreds of instances where treatments failed to comply with regulations and sparked a wave of news reports, opening something like this: ”Many vitamins, herbs and Chinese medicines make false claims and don’t work.”
Late last year the Department of Health and Ageing reported that as many as 90 per cent of such products were found to be non-compliant with regulatory requirements. The audit office said the TGA had failed for years to counter widespread use of deceptive and misleading advertising and claims about their safety and efficacy.
Research has shown that more than half of Australians incorrectly believe alternative medicines are independently tested by the TGA before being allowed on sale. That is true of only a small number.
Under the TGA’s ”light touch” regulatory system, based on the relatively low risk of such products if properly used, they can be electronically listed or approved using computer-based assessment. This relies heavily on information provided by applicants and industry self-assessment. while the TGA has conceded some companies could be entering false information, no checks have been introduced.
MacLennan is colourfully scathing: ”You can mow your grass tonight and put the grass in little bottles, in a sterile fashion, and you can go online for about $370 and list your herbal grass cuttings,” he says. ”And you can make low-level claims – you can’t say it cures cancer but you can say it helps your immune system, will reduce menopausal symptoms or help you lose weight. You can do all of that and get a listed number and stick it on your bottles. It’s very strange that in a society where even toys, mattresses, bicycles and washing machines undergo governmental inspection, few consumers comprehend that alternative medicines do not.”
The TGA says it is now actively considering requiring all such remedies to carry a disclaimer on their labels, saying ”Untested”. such a radical proposal will be heavily resisted by the industry.
”There’s always room for improvement, but that doesn’t mean there’s no evidence and to state these products are untested for efficacy is misleading,” says Dr Wendy Morrow, chief executive of the Complementary Healthcare Council. ”The argument is how much evidence we need to satisfy ourselves that they have the result that the advertising states they do.”
Professor Charlie Xue, head of the school of health sciences at RMIT and chair of the Chinese Medicine Board of Australia, agrees labelling is critical, but argues that simply stating ”untested” will stop people using herbal medicines altogether. ”But if the labelling provides sufficient information about contra-indications, side effects or interactions with other drugs, it would be really useful.”
Blackmore is scornful. ”Where are all the people dying in the street from complementary medicines?” he asked last month.
HERBAL medicines have been with us for millenniums, and many are now the basis of our most common and effective mainstream pharmaceuticals. The World Health Organisation says at least 25 per cent of all modern medicines are derived, either directly or indirectly, from medicinal plants.
Cinchona tree bark was long used by Peruvian Indians to treat malaria but it wasn’t until 1820 that chemists isolated its active component and gave the world quinine. Willow bark was used against pains and fevers for centuries, based on its active ingredient salicin. but that compound in pure form is toxic and it wasn’t until scientists transformed it into a related molecule, acetylsalicylic acid, that we had aspirin. Now it is estimated that about 95 per cent of modern painkillers are based on it or (poppy-derived) opium.
Similarly, the anti-cancer drug taxol comes from the Pacific yew tree; artemisinin, used against malaria, is based on the artemisia shrub, and penicillin, of course, was discovered through a humble mould.
A number of the so-called alternative medicines have also been shown to be beneficial to certain degrees. one of the most popular is St John’s wort, used for centuries against everything from arthritis and diarrhoea to sciatica – and later, and more effectively, against depression. in the mid-1990s, a meta-analysis of 23 studies into the plant concluded there was evidence its extracts were ”more effective than placebo for the treatment of mild to moderately severe depressive disorders”. a later review came to a similar conclusion but added that they had minimal benefit for major depression.
As Simon Singh and Edzard Ernst point out in their book Trick or Treatment: The Undeniable Facts About Alternative Medicine, such scientific evidence-based research has made St John’s wort one of the biggest sellers in the worldwide multibillion-dollar herbal remedy market and a number of other popular products have also been shown to be effective.
Trials have proved Harpagophytum procumbens (or devil’s claw) helps treat musculoskeletal pain; echinacea may reduce the length of common colds; garlic can help with high cholesterol; and kava with anxiety.
But others have been shown to have minimal effect or be next to useless – such as the ”cure-all” chamomile; lavender, recommended for anxiety and insomnia; aloe vera, used for herpes, wounds and skin injuries; and evening primrose oil, promoted as a treatment for a range of problems from eczema and PMS to asthma and psoriasis – yet they remain popular and high-profile.
Many have mild to dangerous side effects. Australian research last year identified 39 reports of adverse events associated with such products, including four deaths in the previous two years.
Even St John’s wort has significant drawbacks. as well as side effects – fewer and less serious than conventional antidepressants, but including dizziness, confusion and gastro-intestinal problems – it stimulates liver enzymes that can block or destroy other drugs a user might be taking, including for HIV and cancer. given that about half of cancer patients may be using an alternative supplement and more than half of those may not inform their doctors, according to a London study, this can have dire consequences.
Others are more perilous. Ephedra, extracted from a Chinese plant Ma Huang and used to lose weight and improve physique, was linked in 2005 to severe reactions in 19,000 people worldwide, including at least 164 deaths. a Chinese herbal slimming regime, using birthwort or aristolochia, was shown in the mid-1990s to cause kidney failure, with at least 30 fatal cases, and later linked to multiple tumour cancers.
Xue says the deaths in both cases came from misuse. Ma Huang is recommended to treat cold symptoms, but because it increases metabolism and perspiration it was wrongly promoted for weight loss, in large and subsequently toxic doses. ”If you use it properly, three to five grams of raw herbs for three days for a common cold, it will not kill anybody,” he says.
Yet alternative medicines remain incredibly popular – even the dangerous ones: the Medical Journal of Australia this year reported a 75-year-old man who suffered kidney failure after using mail-ordered aristolochia.
One reason might be that they are promoted as ”natural”, which users interpret as ”safe”. in 2011 the World Health Organisation emphatically rejected this assumption: ”The idea that just because traditional medicine products come from natural sources they are completely safe is dangerously false.” It quoted a survey that found just 46 per cent of herbal medicine users in Australia were even aware there could be potential risks.
Because of the lack of proper safety testing or monitoring, the risks of herbal medicines have not been fully assessed, but many have been noted, from allergic reactions to interference with other medications, including anticoagulants, blood pressure drugs and contraceptives.
Echinacea has been linked with asthma, hives and aching muscles; black cohosh, used in menopause, has been associated with liver damage, as have valerian, kava and willow; evening primrose may trigger epileptic fits; ginseng is linked to problems including insomnia, diarrhoea and hypertension; and devil’s claw with unwanted abortion.
Singh and Ernst warn of other significant risks in untested herbal remedies, including contamination with mercury, lead and even arsenic; deliberately added conventional pharmaceuticals, such as corticosteroids in herbal eczema creams, sedatives in ”natural” sleeping supplements and Viagra in herbal aphrodisiacs; as well as endangered animal products such as rhino horn.
Since 2000, there have been more than 4000 research studies into alternative medicine published worldwide. ”At the more positive end of the scale, herbal medicine can claim a few successes, but the majority of herbs appear to be overhyped,” they write.
”The bottom line is that none of the … treatments is backed by the sort of evidence that would be considered impressive by the current standards of medical research. Those benefits that might exist are simply too small, too inconsistent and too contentious. moreover none of those alternative treatments (apart from a few herbal medicines) compare well against the conventional options for the same conditions.
SO WHY, as the authors put it, do smart people believe in ”wacky therapies”? (And while the second assumption can be fiercely argued, the first is apparently apt. Dr Ken Harvey, adjunct senior lecturer in public health at La Trobe University, says the prime users of alternative medicines are educated middle-class women – ”which conflicts with the fact that you’d expect they’d be the type to assess the evidence”.)
”That demographic is interested in taking charge of their own health,” he says. ”They like the concept that perhaps by taking supplements they can keep themselves well. That’s good, except there’s not a lot of evidence to support it. others have suggested that it’s a reaction to the six-minute medicine of GPs. if you go to people like naturopaths, they sit you down for an hour, they’re very empathetic … People like that they’re listened to and looked after.”
Singh told The Sunday Age from London that possible reasons ranged from lack of effective conventional treatments for some conditions, suspicion of the medical establishment and the pharmaceutical industry, anecdotal evidence and ”a world view that might prefer alternative to mainstream, and prioritise tradition over modernity”.
”However, the key reason why people waste so much money on herbal remedies is that they are being misled,” he says. ”The fact that these products are being sold in apparently responsible outlets misleads patients into thinking they are more effective than the evidence suggests. The fact that many herbalists present bad evidence as good evidence is misleading. The fact that the media often provide a rose-tinted view, including in the health pages, is also misleading.
”Finally, the fact that the regulators do not intervene means that the public is constantly receiving misinformation about herbal remedies.”
MacLennan agrees, citing the lack of TGA pre-market checking. ”People lie. they lie about the ingredients, they lie about good manufacturing practice. It’s absolutely scandalous. You have a trust-based system that’s obviously failed, you have a system that actually encourages shonks to flood the market.”
Understandably, Morrow takes a contrary view. ”People are turning to complementary medicines more and more because they work, they have a low risk of side effects and people are starting to take more control over their own health,” she says.
”For a long time society has dictated that we hand control for our health to someone else. not every disease is a major, chronic illness and those that are self-limiting, like the common cold, are all things that complementary medicine work very well on.”
But there are dangers in uninformed self-medication. Tony Hu, a fourth-generation Chinese medicine practitioner, now dispensing herbs and acupuncture in Smith Street, Collingwood, says he always examines people shopping for remedies and questions them closely about their symptoms and if they are taking conventional pharmaceuticals. GPs have a similar responsibility to ask patients if they are using alternatives, he adds.
MacLennan remains largely dismissive of most herbs and supplements.
”Folic acid is helpful in pregnancy and vitamin D in osteoporosis, but in general the supplements are just giving you expensive urine,” he says.
Though he admits many are relatively harmless, if useless, he says there are still ”four harms of ‘harmless’ therapy”. probably most important is delay in seeking effective therapy, if there is one; increasing evidence of side effects and drug interactions, which are under-reported; a placebo effect that wears off within months and sees people ”becoming disappointed, disillusioned and depressed as they move along the health food shop counter seeking placebo after placebo”; and a multibillion-dollar industry that is a waste of the scarce health dollar, if they’re not doing any real good.
Morrow dismisses the last two: ”Quite frankly, if complementary medicines didn’t work it would have been a fad that was here and gone in the blink of an eye. their increasing use shows they’re not a fad, they do work if used appropriately, and I don’t see that people are going to stop using them.”