tag:theconversation.com,2011:/africa/topics/complementary-medicines-1988/articlesComplementary medicines – The Conversation2022-05-09T20:00:05Ztag:theconversation.com,2011:article/1822202022-05-09T20:00:05Z2022-05-09T20:00:05ZCan taking vitamins and supplements help you recover from COVID?<figure><img src="https://images.theconversation.com/files/461709/original/file-20220506-12965-zm9rtl.jpg?ixlib=rb-1.1.0&rect=19%2C9%2C6410%2C3711&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://image.shutterstock.com/image-photo/supporting-immune-system-season-flu-600w-1835540941.jpg">Shutterstock</a></span></figcaption></figure><p>Australia’s <a href="https://www.abc.net.au/news/2020-03-17/coronavirus-cases-data-reveals-how-covid-19-spreads-in-australia/12060704">surge in COVID cases</a> this year has seen many people looking for ways to protect themselves or boost their immunity and recovery. An upswing in sales of dietary supplements has followed.</p>
<p>In Australia, the Therapeutic Goods Administration includes vitamins, minerals, amino acids, enzymes, plant extracts and microbiome supplements under the term “<a href="https://www.tga.gov.au/node/4233">complementary medicine</a>”.</p>
<p>The supplement industry’s <a href="https://www.globenewswire.com/news-release/2020/07/29/2069678/0/en/Global-Dietary-Supplements-Industry.html">global estimated worth</a> was about US $170 billion (A$239 billion) in 2020. Australian complementary medicines revenue was estimated at A$5.69 billion in 2021 – <a href="https://www.cmaustralia.org.au/page-1859595">doubling in size</a> over the past decade. The latest data shows 73% of Australians <a href="https://www.statista.com/statistics/1285506/australia-leading-complementary-medicines-purchased/">bought complementary medicines</a> in the previous year, with vitamins featuring in more than half of purchases.</p>
<p>But how likely are these purchases to be effective in preventing COVID or treating it?</p>
<h2>Fear, avoidance and laboratory studies</h2>
<p>Historically, the public has purchased supplements from sources that also provide health-care advice. Lockdowns and blanket health messages about social distancing and personal hygiene have created a new normal. So people are doing more shopping online for supplements and turning to the internet, friends or social media for vitamin recommendations. For some, this has led to an unhealthy fear of COVID (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7474809/">coronaphobia</a>) and negative impacts on daily life.</p>
<p>As with any medicine, consumers should seek information from reliable sources (doctors, pharmacists or evidence-based peer-reviewed articles) about the potential benefits and harms of supplements before purchase. Strong evidence <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2119451">supports</a> vaccination as effective against the acute respiratory symptoms of COVID. <a href="https://pubmed.ncbi.nlm.nih.gov/32334392/">Researchers</a> have also looked at whether supplements may prevent or reduce the duration and severity of this viral infection by boosting the immune response.</p>
<p>Deficiencies in essential nutrients that support immune function (vitamin C, vitamin D, zinc and selenium) <a href="https://pubmed.ncbi.nlm.nih.gov/35063248/">have been shown</a> to increase susceptibility to infection, including COVID. But there is <a href="https://pubmed.ncbi.nlm.nih.gov/34626488/">little evidence</a> supplementation in a healthy person prevents respiratory infections such as COVID. An evidence gap <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2776299">exists</a> between a supplement’s action in laboratory or animal studies and findings from well designed and conducted clinical trials. </p>
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<a href="https://images.theconversation.com/files/461710/original/file-20220506-23-ez6sya.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="couple browse vitamin aisle in supermarket" src="https://images.theconversation.com/files/461710/original/file-20220506-23-ez6sya.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/461710/original/file-20220506-23-ez6sya.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/461710/original/file-20220506-23-ez6sya.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/461710/original/file-20220506-23-ez6sya.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/461710/original/file-20220506-23-ez6sya.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/461710/original/file-20220506-23-ez6sya.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/461710/original/file-20220506-23-ez6sya.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">The dietary supplementary industry has doubled in size over the last decade.</span>
<span class="attribution"><a class="source" href="https://image.shutterstock.com/image-photo/couple-doing-their-groceries-supermarket-600w-573335551.jpg">Shutterstock</a></span>
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<h2>A pandemic ‘infodemic’</h2>
<p>Ready access to supplements without a prescription from a myriad of online and shopfront sources and the <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0266705">uncontrolled spread of claims</a> that supplements can prevent or treat COVID symptoms, has created an “<a href="https://www.who.int/health-topics/infodemic#tab=tab_1">infodemic</a>”. </p>
<p>These claims are fuelled by supplement manufacturers being able to <a href="https://www.tga.gov.au/node/4233">“list” their products</a> on the Australian Register of Therapeutic Goods, with limited evidence of safety or effectiveness. This appearance of official approval tallies with the common <a href="https://www.tandfonline.com/doi/abs/10.3109/13697139909025568">misperception</a> that “natural” means “safe”. </p>
<p>Supplements can cause <a href="https://www.tandfonline.com/doi/abs/10.3109/13697139909025568">harm</a> in the form of adverse effects, drug interactions and expense. They also add to a patient’s <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6165107/#:%7E:text=The%20concept%20of%20%E2%80%9Cmedication%2Drelated,19%2C20%2C21%5D.">medication burden</a>, may delay more effective therapy, or give false hope to the vulnerable.</p>
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<h2>Vitamins A to zinc</h2>
<p>The recent <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2776305">COVID A to Z Study</a> illustrates some of the challenges involved. </p>
<p>It was designed to test the effectiveness of high-dose zinc, vitamin C, and a combination of both, to shorten the duration of COVID-related symptoms compared with usual care in adult outpatients with confirmed infection. </p>
<p>These nutrients <a href="https://pubmed.ncbi.nlm.nih.gov/32334392/">were chosen</a> because:</p>
<ul>
<li>vitamin C studies in mice showed this antioxidant to be essential for antiviral immune responses against the influenza A virus, especially in the early stages of the infection</li>
<li>deficiency of zinc, an essential trace element, has been associated with increased susceptibility to viral infections.</li>
</ul>
<p>The authors planned to include 520 patients but the safety monitoring committee recommended the study be stopped early, due to low likelihood of detecting significant outcome differences between the groups. There were also more adverse effects (nausea, diarrhoea, and stomach cramps) reported in the supplement groups than those receiving usual care.</p>
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<h2>Little evidence of benefits</h2>
<p>Despite the large variety of complementary medicines marketed, most clinical trials to date have studied the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8873042/">impact of vitamin D</a>, <a href="https://clinicalnutritionespen.com/article/S2405-4577(22)00002-X/fulltext">vitamin C or zinc</a> to reduce the risk of contracting COVID, improve rates of hospitalisation or death. </p>
<p>Even with high treatment doses, results have been <a href="https://ods.od.nih.gov/factsheets/COVID19-HealthProfessional/#h2">generally disappointing</a>. Vitamin D, zinc and some probiotics <em>may</em> be beneficial to <em>prevent</em> viral infections. Vitamins D, C, A, zinc, calcium and some probiotics <em>may</em> be beneficial to <em>treat</em> viral infections. But other supplements studied (including copper, magnesium, selenium and echinacea) are unlikely to be beneficial or are not supported by sufficient data. </p>
<p>However, supplements may be beneficial when individuals are <a href="https://pubmed.ncbi.nlm.nih.gov/32334392/">unable to achieve</a> a balanced and varied diet.</p>
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<h2>Potentially harmful</h2>
<p>High doses or chronic use of COVID supplements have also been linked with <a href="https://pubmed.ncbi.nlm.nih.gov/20040703/">adverse effects</a>: vitamin D with muscle pain and loss of bone mass; vitamin A with elevated liver function tests and blurred vision; vitamin E with bleeding risk; plant extracts, magnesium with gastrointestinal effects; and selenium with hair loss and brittle nails.</p>
<p>So, the evidence is not convincing that taking vitamins and supplements will prevent you catching COVID or help you recover from the infection, unless you have a known nutrient deficiency or a poor diet.</p>
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Read more:
<a href="https://theconversation.com/vitamins-and-minerals-arent-risk-free-here-are-6-ways-they-can-cause-harm-165399">Vitamins and minerals aren't risk-free. Here are 6 ways they can cause harm</a>
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<img src="https://counter.theconversation.com/content/182220/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Treasure McGuire does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Sales of vitamins are booming in pandemic times. But is there any evidence that vitamin and mineral supplements can protect you from COVID or help you recover from infection?Treasure McGuire, Assistant Director of Pharmacy, Mater Health SEQ in conjoint appointment as Associate Professor of Pharmacology, Bond University and Associate Professor (Clinical), The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1653992021-08-03T07:08:23Z2021-08-03T07:08:23ZVitamins and minerals aren’t risk-free. Here are 6 ways they can cause harm<figure><img src="https://images.theconversation.com/files/414243/original/file-20210803-23-g195ze.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C4928%2C3260&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>One reason dietary supplements are so popular is the perception they’re harmless.</p>
<p>But like all drugs, there are many potential dangers from taking vitamins and minerals.</p>
<p>The problem is that, unlike conventional medicines, dietary supplements aren’t required to provide warnings to consumers of their potential risks.</p>
<p>Nor are they required to submit extensive documentation of their risks to Australia’s drug regulator, the Therapeutic Goods Administration (TGA), when they’re licensed for marketing, leaving us all uninformed.</p>
<p>This week, I published a paper <a href="https://www.nps.org.au/australian-prescriber/articles/the-safety-of-commonly-used-vitamins-and-minerals">in Australian Prescriber</a> identifying six possible harms of taking vitamin and mineral supplements. </p>
<h2>What do we mean by supplements?</h2>
<p>Dietary supplements are natural health products such as vitamins, minerals, amino acids, enzymes, plant extracts, and algae used to augment people’s diets <a href="https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements">rather than treat disease</a>.</p>
<p>Although these products are more commonly referred to as complementary medicines in Australia, particularly by the TGA, the term “dietary supplement” is frequently used by consumers and in the research literature. </p>
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<p>Dietary supplements dominate the complementary medicines industry in Australia. </p>
<p>Sales reached A$4.9 billion in 2017, having <a href="http://www.cmaustralia.org.au/resources/Documents/Australian%20Complementary%20Medicines%20Industry%20snapshot%202018_English.pdf">doubled over the preceding ten years</a>.</p>
<p>Complementary medicines are widely used in Australia. A <a href="https://www.nature.com/articles/s41598-018-35508-y">national survey published in 2018</a> showed 63% of people use them regularly.</p>
<p>Supplements containing vitamins and minerals were the most popular type of complementary medicine, reportedly used by <a href="https://www.nature.com/articles/s41598-018-35508-y">47% of respondents</a>. Examples include vitamin D, vitamin C, calcium, magnesium and vitamin A.</p>
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<h2>6 potential harms of dietary supplements</h2>
<p>People often say they’ve never heard of harms of dietary supplements. This isn’t surprising, given their marketing is largely based on benefits with little, if any, mention of potential harms.</p>
<p>What’s more, consumer information leaflets are never provided, and few products carry warnings on their packaging of potential serious effects.</p>
<p>Nonetheless, there are <a href="https://www.cambridge.org/core/journals/proceedings-of-the-nutrition-society/article/one-is-okay-more-is-better-pharmacological-aspects-and-safe-limits-of-nutritional-supplements/01840971F2C3DEC4E11DA59333A5058D">well-recognised</a> <a href="https://www.nccih.nih.gov/health/vitamins-and-minerals">harms</a> from the <a href="https://academic.oup.com/ajcn/article-abstract/49/2/358/4732772">ingredients</a> of dietary supplements, which anyone who has studied pharmacology would know, especially when these substances are consumed in high doses.</p>
<p>For these reasons, some higher-dose vitamin A and selenium products are legally regulated by the TGA as Schedule 2 (pharmacy only), Schedule 3 (pharmacist only) and Schedule 4 medicines (prescription only) products.</p>
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<p>When contemplating the possible harms that could arise with dietary supplements, most people just think of side effects.</p>
<p>However, as with any medicine, there are at least six types of harm that can occur <a href="https://www.nps.org.au/australian-prescriber/articles/the-safety-of-commonly-used-vitamins-and-minerals">which I identified in my research</a>:</p>
<ul>
<li><p><strong>Side effects</strong>. Side effects from vitamins and minerals can occur from short- or long-term use. Typically side effects emerge from doses that are too high, but not always. They can also cause new disease or upset existing conditions. There are risks from certain supplements during pregnancy and breastfeeding too</p></li>
<li><p><strong>Drug interactions</strong>. Interactions with other drugs, certain foods, and some diseases can make other drugs more toxic or less effective</p></li>
<li><p><strong>Cost</strong>. The cost of dietary supplements can impact on people’s finances and their ability to afford treatment or other essential items</p></li>
<li><p><strong>Delay more effective therapy</strong>. Time spent taking ineffective products may delay more effective interventions, waste valuable time and allow a disease to progress</p></li>
<li><p><strong>False hope or fraud</strong>. Falling for fraudulent claims offering false hope can be demoralising and depressing, which for some can make the difference between continuing to manage a health condition and giving up</p></li>
<li><p><strong>Medication burden</strong>. As the number of medicines and supplements increases, so too does the chance of something going wrong. This includes the risk of side effects, drug interactions, or making a mistake.</p></li>
</ul>
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<h2>The key to safety is the dose</h2>
<p>Many dietary supplements are used safely for medical purposes. Women are prescribed folic acid and iodine in pregnancy, for example, or vitamin and minerals supplements are given for deficiencies, such as iron. </p>
<p>The key to using them safely is the dose, which is determined from research demonstrating the benefits outweigh the risks. </p>
<p>This isn’t the case when people self-medicate with products purchased on the open market. Consumers rarely consider the effective or safe dose and often just take the dose recommended on the label – which could be useless – or whatever they guess is right.</p>
<p>Many people neglect the risk of overdosing on the same ingredient such as vitamin B6 or vitamin A, which is most likley when taken via multiple products.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/new-vitamin-supplement-study-finds-they-may-do-more-harm-than-good-97246">New vitamin supplement study finds they may do more harm than good</a>
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<p>For people to make informed decisions about using dietary supplements, details about the benefits and harms should be evidence-based and readily available. People need to know not only where to look for this information, but also how to critique it. </p>
<p>Health professionals can assist people by openly discussing the risks and benefits of dietary supplements, explain why dose is important for both efficacy and safety, and direct them where to go for good quality information that goes beyond what’s on the manufacturer’s label.</p>
<p>Manufacturers should be required to make this information more readily available.</p>
<p>When assessing the potential benefits and risks of supplements, it’s vital to look beyond the main or well-known ingredient. Identify the exact product being used, all its ingredients, the dose being taken, and the potential for cumulative overdose from repeated ingredients in multiple products.</p>
<p>As with all medicines, if you have any side effects or problems after taking dietary supplements, <a href="https://www.tga.gov.au/reporting-problems">report them to the TGA</a>.</p><img src="https://counter.theconversation.com/content/165399/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Geraldine Moses does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Manufacturers of dietary supplements aren’t required to provide warnings to consumers about their potential risks. Here’s what to look out for.Geraldine Moses, Adjunct Associate Professor, School of Pharmacy, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/808962017-07-20T20:10:01Z2017-07-20T20:10:01ZNew complementary medicine health claims lack evidence, so why are they even on the table?<figure><img src="https://images.theconversation.com/files/178771/original/file-20170719-13534-1g6r575.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The Australian drugs regulator is overhauling the health claims made by suppliers of complementary medicines, including homeopathic therapies. And some curious options are up for discussion.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/557763373?src=IytjhciZWcCOoNS_bLGpyw-1-61&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p>Australia’s drugs regulator seems to be endorsing pseudoscientific claims about homeopathy and traditional Chinese medicine as part of its <a href="https://theconversation.com/which-supplements-work-new-labels-may-help-separate-the-wheat-from-the-chaff-73189">review</a> of how complementary medicines are regulated.</p>
<p>In the latest proposed changes, the Therapeutic Goods Administration (TGA) is looking at what suppliers (also known as sponsors) can claim their products do, known as “<a href="http://www.tga.gov.au/draft-list-permitted-indications">permitted indications</a>”. An example of a “low level” permitted indication might be “may relieve the pain of mild osteoarthritis”.</p>
<p>If approved, the suppliers can use this permitted indication to market its listed product, one of about 11,000 listed complementary medicines on the <a href="https://www.tga.gov.au/australian-register-therapeutic-goods">Australian Register of Therapeutic Goods</a> (indicated by “Aust L” on packaging).</p>
<p>However, the spreadsheet of <a href="http://www.tga.gov.au/sites/default/files/draft-list-permitted-indications.xlsx">1,345 draft permitted indications</a> includes many that seem to lack evidence to back them.</p>
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<a href="https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=236&fit=crop&dpr=1 600w, https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=236&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=236&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=297&fit=crop&dpr=1 754w, https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=297&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/178602/original/file-20170718-22000-1r98mlz.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=297&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Complementary medicines are the subject of the latest TGA review of permitted health claims.</span>
<span class="attribution"><span class="license">Author provided</span></span>
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<p>For instance, despite the Therapeutic Goods Advertising Complaints Resolution Panel upholding complaints of a lack of evidence that <a href="http://www.tgacrp.com.au/complaint-register/?_search=magnesium">magnesium</a> (and <a href="http://www.tgacrp.com.au/complaint-register/?_search=restless+legs&_id=3101">homeopathy</a>) “relieves muscle cramps (and restless legs)”, this permitted indication is on its draft list.</p>
<p>Other examples include “supports transport of oxygen in the body”, “regulates healthy male testosterone levels”.</p>
<p>The list contains around 140 traditional Chinese medicine indications, such as “Harmonise middle burner (Spleen and Stomach)”, “Unblock/open/relax meridians”, “Balance Yin and Yang”.</p>
<p>There are also around 900 additional indications for unspecified “traditions”. These include, “Renal tonic”, “Helps healthy liver regeneration”, “Emmenagogue”, “Vermifuge” and “Vulnerary”.</p>
<h2>Endorsing traditional medicines without evidence they work</h2>
<p>Australia is a multicultural society, and it’s appropriate we <a href="https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cam001_complementary_medicine_resource_clinicians_140409.pdf">respect and have some knowledge</a> of complementary medical traditions.</p>
<p>Some observations made in these traditions have led to valuable, efficacious medicines, such as <a href="https://theconversation.com/is-the-2015-nobel-prize-a-turning-point-for-traditional-chinese-medicine-48643">Artemisinin derivatives</a> isolated from a herb used in traditional Chinese medicine.</p>
<p>However, scientific investigation has not substantiated many other aspects of such traditions, such as the <a href="https://theconversation.com/no-evidence-homeopathy-is-effective-nhmrc-review-25368">homeopathic principles</a> of “like cures like” and <a href="https://theconversation.com/are-traditional-chinese-medicines-safe-and-legal-6373">traditional Chinese medicine</a> concepts of meridians through which the life-energy known as “qi” flows.</p>
<p>We also cannot assume traditional medicines are safe, as <a href="https://www.ncbi.nlm.nih.gov/pubmed/22374080">emerging data</a> highlights how common adverse reactions and drug interactions really are.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=300&fit=crop&dpr=1 600w, https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=300&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=300&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=377&fit=crop&dpr=1 754w, https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=377&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/178194/original/file-20170714-14315-3dbel0.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=377&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Just because complementary medicines are based on long-held traditions doesn’t mean they work or are safe, as international data show.</span>
<span class="attribution"><span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>For example, Hyland’s homeopathic baby teething products were recalled by the <a href="https://www.fda.gov/safety/recalls/ucm552934.htm">US Food and Drug Administration</a> and then <a href="https://www.tga.gov.au/alert/hylands-baby-homeopathic-teething-tablets">the TGA</a>. This was because lack of quality control over potentially toxic ingredients – belladonna alkaloids – associated with <a href="https://www.scientificamerican.com/article/hundreds-of-babies-harmed-by-homeopathic-remedies-families-say/">adverse events in hundreds of babies</a>. </p>
<p>In China, out of the 1.33 million case reports of adverse drug event reports received by the National Adverse Drug Reaction Monitoring Center in 2014, <a href="http://www.sda.gov.cn/WS01/CL0078/124407.html">traditional Chinese medicine represented around 17.3%</a> (equivalent to around 230,000 cases).</p>
<h2>What we propose</h2>
<p>Listed medicines, like those mentioned, are meant to contain pre-approved, relatively low-risk ingredients. They should be produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed.</p>
<p>So, to safeguard shoppers, consumer representatives (of which I was one), suggested the proposed list of permitted indications should be short and only contain modest claims such as, “may assist” or “may help”.</p>
<p>We also argued that, for consumers to make an informed purchase, claims based on “traditional use” should always have a disclaimer along the lines of what the <a href="https://www.ftc.gov/system/files/documents/federal_register_notices/2016/12/homeopathic_drugs_frn_12-13-2016.pdf">US Federal Trade Commission uses for homeopathic products</a>. </p>
<p>For example, “This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works”.</p>
<p>However, industry representatives <a href="http://www.asmi.com.au/media/30081/asmi_response_to_cm_de-regulation_review__april_2015_.pdf">argued</a> they needed a long list of permitted indications to allow consumers to tell the difference between one product and another. They also argued that disclaimers for traditional medicines were unnecessary. Their wishes made it to the draft list, rather than ours.</p>
<p>While we welcome moves to <a href="https://theconversation.com/which-supplements-work-new-labels-may-help-separate-the-wheat-from-the-chaff-73189">better regulate</a> complementary medicines in Australia, this current list of permitted indications, without disclaimers, represents a government endorsement of pseudoscience.</p>
<p>Worse, it will encourage consumers to purchase often ineffective and sometimes dangerous products.</p><img src="https://counter.theconversation.com/content/80896/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ken Harvey has represented Choice (the Australian Consumers’ Association) on TGA consultations about regulatory reform of complementary medicines. He is also an executive member of Friends of Science in Medicine and a member of the Australian Skeptics Victorian Branch.</span></em></p>Would you trust a complementary medicine described as “vermifuge”, “vulnerary” or “emmenagogue”? That’s what new labelling proposes and not everyone’s happy about it.Ken Harvey, Associate Professor, School of Public Health and Preventive Medicine, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/731892017-02-20T19:24:29Z2017-02-20T19:24:29ZWhich supplements work? New labels may help separate the wheat from the chaff<figure><img src="https://images.theconversation.com/files/157255/original/image-20170217-4236-nzd71a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">How do you really know if vitamin and mineral supplements really 'help your heart' or 'boost your mood'?</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/517627717?src=_bg7SZGmIYpr6LlUowfYLw-3-39&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p>New proposals from Australia’s drug regulator should give you a better idea if your complementary medicines do what they say on the packet.</p>
<p>One change proposed by the Therapeutic Goods Administration (TGA) is a “stamp of approval” on the packaging and promotional material of some vitamins, minerals, herbs and other supplements to tell you there is enough evidence to back health claims.</p>
<p>Other proposals include reducing the number of often unsubstantiated indications that manufacturers of complementary medicines currently make on their TGA application, which are then used as the basis for advertising claims. </p>
<p>The TGA also proposes incentives for companies to develop and market products with new active ingredients, or make new claims based on research.</p>
<p>The proposed changes, <a href="http://www.tga.gov.au/consultation/consultation-reforms-regulatory-framework-complementary-medicines-assessment-pathways">which are out for public consultation</a>, follow the recent <a href="http://www.abc.net.au/4corners/stories/2017/02/13/4616948.htm">ABC Four Corners program</a>, which highlighted long-standing problems with the way complementary medicines are currently regulated.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/TKyHvYgP_ZE?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">ABC Four Corners’ documentary “Swallowing it” highlights the shortcomings of how complementary medicines are regulated in Australia.</span></figcaption>
</figure>
<h2>What’s the problem?</h2>
<p>The TGA’s proposals are urgently needed to fix three major shortcomings of the current regulatory system.</p>
<p>First, consumer organisations and health professionals have lost confidence in the complementary medicines industry’s ability to regulate its own advertisements, and in the TGA’s ability <a href="https://theconversation.com/dodgy-claims-for-complementary-medicines-heres-how-the-drug-watchdog-could-have-more-bite-69488">to apply adequate sanctions</a> when companies don’t follow the rules.</p>
<p>Second, there is little incentive for the manufacturers of complementary medicines to research new innovative products or prove existing ones work.</p>
<p>There are about 11,000 listed complementary medicines on the <a href="https://www.tga.gov.au/australian-register-therapeutic-goods">Australian Register of Therapeutic Goods</a> (indicated by Aust L on packaging). Listed medicines are meant to contain pre-approved, relatively low-risk ingredients, produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed; post-marketing surveillance and upheld complaints show <a href="https://theconversation.com/dodgy-claims-for-complementary-medicines-heres-how-the-drug-watchdog-could-have-more-bite-69488">high levels of regulatory non-compliance</a>. </p>
<p>But there are only 35 <a href="https://www.tga.gov.au/list-evaluated-registered-complementary-medicines">registered complementary medicines</a> (indicated by Aust R on packaging) the TGA says have been thoroughly assessed for safety, quality and efficacy (there is also debate about whether many of these older products should still be on this TGA list). There are fewer products on this list because research to meet registration requirements is expensive, the public doesn’t understand the subtleties between an <a href="https://www.tga.gov.au/community-qa/whats-medicine-label">Aust L and Aust R product</a> and a better return on investment comes from promotional hype and celebrity endorsement of listed products. </p>
<p>Third, the TGA provides only limited transparency about companies and products that fail post-marketing evaluation or have complaints upheld. This information is currently regarded as commercial-in-confidence, fuelling the perception the TGA is more concerned with helping industry than protecting consumers.</p>
<h2>How could the new measures help?</h2>
<p>The proposal to restrict companies to only making pre-approved, “low-level” indications and claims for a product, such as, “may relieve the pain of mild osteoarthritis”, will minimise the risk of misleading consumers. But it is not yet clear how the list of allowed indications will be established nor how a specific product will be matched with an appropriate allowed indication.</p>
<p>The regulator also proposes manufacturers apply for “intermediate-level” health claims falling outside the permitted list (outlined above). An example might be, “our formulation of cranberry reduces the frequency of recurrent urinary infections in women”. For this, the TGA would have to assess the evidence substantiating the claim for a particular product. If the evidence stacks up (and there’s a debate about the type of evidence needed), the product could then carry a TGA “stamp of approval” on the label and any promotional material. But it is not clear what this “stamp of approval” will be. Is it text, a symbol or both?</p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=588&fit=crop&dpr=1 600w, https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=588&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=588&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=739&fit=crop&dpr=1 754w, https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=739&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/157407/original/image-20170218-10217-n5s5fr.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=739&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Not everyone agrees a TGA ‘stamp of approval’ should be in the form of a symbol, like this.</span>
<span class="attribution"><span class="source">(Unofficial mock-up created by Ken Harvey)</span></span>
</figcaption>
</figure>
<p>In preliminary TGA stakeholder consultations, consumer representatives supported a prominent visual identifier (like a logo or symbol) because of the failure of the existing Aust L and Aust R labelling to inform consumers. But industry representatives were concerned a highly visible identifier for a small number of evidence-based complementary medicines might affect sales of the bulk of listed products without one.</p>
<p>The TGA’s proposals encourage innovation because they will stimulate companies to engage in research to qualify for a TGA “stamp of approval”. The proposal also suggests companies that develop a TGA approved evidence-based claim would be awarded a three-year period of data protection to stop others freeloading on their research. </p>
<p>But the proposed changes do not yet address the need for greater transparency in the regulatory process. For instance, it is not clear whether the TGA’s assessment of evidence to back higher-level health claims for complementary medicines will be publicly available, as they are for <a href="https://www.tga.gov.au/australian-public-assessment-reports-prescription-medicines-auspars">prescription medicines</a>.</p>
<h2>What happens next?</h2>
<p>These proposed changes, which are out for public consultation until March 28, 2017, sit alongside <a href="https://theconversation.com/dodgy-claims-for-complementary-medicines-heres-how-the-drug-watchdog-could-have-more-bite-69488">other recommendations</a> aimed at improving the advertising complaints system. </p>
<p>If the TGA implements this package of recommendations, Australia will be a world leader in how complementary medicines are regulated. Despite the substantial and increasing use of supplements, no other country has developed a system that helps consumers and health professionals separate the evidence-based wheat from the chaff, improves confidence in the industry, stimulates more evidence-based products and has the potential to boost exports.</p><img src="https://counter.theconversation.com/content/73189/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ken Harvey has represented Choice (the Australian Consumers’ Association) on discussions about regulatory reform during TGA stakeholder consultations.
He is also an executive member of Friends of Science in Medicine.</span></em></p>If the Therapeutic Goods Administration implements new proposals to regulate complementary medicines, you can be more confident they actually do what they say on the packet.Ken Harvey, Adjunct Associate Professor, School of Public Health and Preventive Medicine, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/677842016-10-27T23:52:03Z2016-10-27T23:52:03ZWhat will consumers gain from research into complementary medicines?<figure><img src="https://images.theconversation.com/files/143405/original/image-20161027-11275-wdgqfp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Consumers want to know if their complementary medicines are safe and effective. But are links between science and manufacturers the answer?</span> <span class="attribution"><span class="source">from www.shutterstock.com.au</span></span></figcaption></figure><p>A <a href="http://www.smh.com.au/technology/sci-tech/swisse-and-csiro-sign-multimilliondollar-research-deal-20161025-gsaq6a.html">new multimillion dollar deal</a> between Swisse Wellness and CSIRO has raised questions about the integrity of Australia’s premier scientific research organisation and the motivations behind the deal. Another important question is whether consumers will benefit from such partnerships.</p>
<p>Swisse manufactures complementary and alternative medicines, which are <a href="https://nccih.nih.gov/research/statistics/2007/camsurvey_fs1.htm">widely</a> used by <a href="https://www.mja.com.au/journal/2006/184/1/continuing-use-complementary-and-alternative-medicine-south-australia-costs-and">different populations</a>. <a href="https://www.ncbi.nlm.nih.gov/pubmed/9605899">Research has shown</a> people like complementary medicines because they find natural alternatives to be in line with their values and beliefs.</p>
<p>Complementary or natural medicines have often been around for centuries, but <a href="http://theconversation.com/do-over-the-counter-weight-loss-supplements-work-53167">frequently research supporting their efficacy</a>, particularly for the treatment of obesity, is weak or lacking.</p>
<h2>Are alternative therapies and science a good mix?</h2>
<p>Although complementary medicines have received <a href="http://www.abc.net.au/news/2016-03-01/supplements-linked-to-at-least-6-australian-organ-transplants/7207472">a lot of attention</a> recently due to <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4848993/">safety risks</a>, there are a number of complementary medicines that are beneficial for physical health conditions.</p>
<p>Some complementary medicines show potential but require further investigation on a larger scale and over a longer time period. One such example are capsaicinoids, the active components in chilli peppers, <a href="http://www.nature.com/ijo/journal/v40/n8/full/ijo2015253a.html">which has been shown</a> to have a biologically plausible mechanism of action for weight loss. But rigorous studies with bigger sample sizes are needed to evaluate <a href="http://www.nature.com/ijo/journal/v40/n8/full/ijo201682a.html">how effective it is long-term</a> and whether the benefits outweigh the risks. </p>
<p>Likewise, <a href="https://www.hindawi.com/journals/njos/2014/674684/">ginger extract and gingerols</a> show potential for preventing type 2 diabetes but must be investigated further in more human studies. Fibre supplements appear to have the <a href="http://www.ncbi.nlm.nih.gov/pubmed/23505169">best supporting evidence</a> and best potential so far for the management of obesity and associated metabolic disease.</p>
<p>There are also a range of natural medicines <a href="https://www.mja.com.au/journal/2002/176/10/effectiveness-complementary-and-self-help-treatments-depression?0=ip_login_no_cache%3D12ed3c6e9462369977a72dbb31847ec7">that show potential</a> for improving mental health conditions. Curcumin, which is the active ingredient of the Indian spice turmeric, has been compared in head-to-head studies with the antidepressant fluoxetine. It has been shown to <a href="https://www.ncbi.nlm.nih.gov/pubmed/23832433">work as well as the pharmaceutical drug</a>, in proof-of-concept research. Similar findings have been shown with extracts from the spice <a href="https://www.ncbi.nlm.nih.gov/pubmed/17174460">saffron</a> and <a href="https://www.ncbi.nlm.nih.gov/pubmed/10759336">St John’s wort extract</a>, although definitive research is needed. </p>
<p>But there’s also a significant number of complementary medicines with no proven efficacy or often the data that supports their claims has come from <a href="http://onlinelibrary.wiley.com/doi/10.1038/oby.2010.185/abstract">poor quality studies</a> with small sample sizes.</p>
<p>There’s also the potential for deception when manufacturers of alternative medicines use research evidence to back up claims for products that may contain similar ingredients to products tested for efficacy, but aren’t in fact the same. A deal like this provides Swisse with the opportunity to <strong>further validate</strong> their specific products.</p>
<h2>People are taking it, so we need to know if it works</h2>
<p>Complementary medicines have shown some potential in treating physical and mental illnesses but rigorous research is desperately needed.</p>
<p>Deals like this one between Swisse Wellness and CSIRO have the potential to further address the gap in information where complementary and alternative medicines are concerned. But this must be on the basis this research is objective and peer reviewed.</p>
<p>In a challenging funding environment, industry support is playing an even greater role but there is a risk of bias when the research is not conducted independent of the industry partner or when results are not disseminated to the public.</p>
<p>Collaborations between industry and leading institutions should be encouraged to support research and development into complementary medicines around product safety and the evidence supporting their claims, so long as the research undertaken adheres to strict academic standards.</p>
<p>Complementary medicine may have a greater role to play, especially when taking into consideration the fact people like to take it, and they stick to it. The continuation of good quality research will tell us if the money spent on complementary medicines is money wasted or well spent.</p><img src="https://counter.theconversation.com/content/67784/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nick Fuller has received research grants for clinical trials funded by Australian Egg Corporation, Arnotts Biscuits, SOHO Flordis International Research, Sanofi-Aventis, Novo Nordisk, Allergan, Roche products, MSD, and GlaxoSmithKline.</span></em></p><p class="fine-print"><em><span>Colman Taylor is an employee of Optum which provides consultancy services for pharmaceutical and medical device companies and the Australian Government. He has previously received government funding in the form of a NHMRC PhD scholarship and is listed as an investigator on NHMRC Project Grants. He is a member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Australia Chapter Committee. </span></em></p>A new multimillion dollar deal between Swisse Wellness and CSIRO has raised questions about the integrity of Australia’s premier scientific research organisation and the motivations behind the deal.Nick Fuller, Research Fellow, Clinical Trials Development & Analysis, University of SydneyColman Taylor, Research Fellow, Critical Care & Trauma Division & Conjoint Senior Lecturer, Sydney Medical School, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/592492016-05-16T02:09:06Z2016-05-16T02:09:06ZSupplements are an expensive and potentially toxic lucky dip<figure><img src="https://images.theconversation.com/files/122607/original/image-20160516-12583-1pwb2np.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Some supplements contain hidden ingredients.</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-136160099/stock-photo-traditional-chinese-medicine-herbs-and-remedies-in-jars.html?src=T-EDfbx8W_IVyRn4R8sCzg-4-37">Yaping/Shutterstock</a></span></figcaption></figure><p>The vitamin and supplement industry is big business in Australia. An <a href="http://www.theguardian.com/world/2013/jun/11/vitamins-take-australia-hollywood-names">estimated</a> 75% of the population use some form of complementary medicines, including vitamins, minerals, herbs, aromatherapy and homeopathic products. </p>
<p>But some vitamin supplements and protein powders at best don’t work and, at worst, can cause harm. </p>
<p>Tonight, ABC’s Four Corners program will air a PBS Frontline investigation exploring the complex issues surrounding supplements in North America. It’s an eye-opening report that details a web of lobbying and legislation designed to protect the industry, but which ultimately leaves consumers at risk. </p>
<p>The issue of harm is covered upfront with a group of patients in Hawaii who suffered liver failure following the ingestion of a dietary supplement. Many required transplants. </p>
<p>At the other extreme is the <a href="http://www.nytimes.com/2013/11/05/science/herbal-supplements-are-often-not-what-they-seem.html?_r=0">revelation</a> that 60% of supplements analysed for the active ingredients didn’t contain what was stated on the label. </p>
<p>In a <a href="http://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-11-222">random sample</a> of 44 popular herbal supplements purchased from North American stores and analysed for their DNA fingerprints, one-third showed outright substitution, meaning there was no trace of the plant advertised on the bottle. </p>
<p>Others contained undisclosed fillers such as soybean, wheat and rice. Gingko biloba supplements, promoted as memory enhancers, were mixed with fillers and black walnut, a potentially deadly hazard for people with nut allergies.</p>
<p>These findings make it very difficult to have any faith in the usefulness of supplements. </p>
<p>But even in the case of unadulterated supplements, scientists and doctors warn, in the absence of a medically diagnosed deficiency, we are taking too many. A recent <a href="http://www.theguardian.com/society/2015/apr/21/vitamin-supplements-increase-risk-cancer-heart-disease-research">study</a> reports that taking extra vitamins and minerals can do more harm than good and may even increase cancer risk rather than reduce it. </p>
<p>In addition, some commercially available preparations of fish oil have been <a href="http://www.nature.com/articles/srep07">shown</a> to be rancid, as a result of poor processing procedures. This can trigger inflammatory pathways in our cells – the exact opposite of what they are designed to do. </p>
<p>If you’re thinking that “what happens in North American doesn’t affect me”, you might be wrong. Herbal supplements bought online have been <a href="http://www.abc.net.au/news/2016-03-01/supplements-linked-to-at-least-6-australian-organ-transplants/7207472">linked to at least six Australian organ transplants</a> since 2011. </p>
<p>This includes the recent <a href="http://www.abc.net.au/news/2016-02-14/man-faced-death-after-taking-popular-weight-loss-product/7162378">case of a Perth man</a> who was given two weeks to live and required an emergency liver transplant after taking a protein powder containing green tea extract and a supplement containing garcinia cambogia. Such was his emergency that he had no choice but to accept a liver infected with hepatitis B. </p>
<p>Australia’s regulatory authorities <a href="http://www.abc.net.au/news/2016-02-14/man-faced-death-after-taking-popular-weight-loss-product/7162378">responded</a> by saying they’re “continuing to investigate the report” and “the results will be made public if there is sufficient evidence of a safety issue”. But Australia’s regulations when it comes to supplements are also woefully inadequate. </p>
<p>First of all, if a product is intended to be used as a supplement, it must be listed with the <a href="https://www.tga.gov.au/australian-register-therapeutic-goods">Therapeutic Goods Administration</a> (TGA). The process of <a href="https://www.tga.gov.au/community-qa/listed-medicines-role-australias-medicines-regulator">listing a product</a>, however, only requires the registrant to fill out an online form, choose from a list of pre-approved ingredients (indicating low risk and tested for safety in isolation) and state they hold information to substantiate their product’s claims. They are not required to present it. </p>
<p>What is missing from this picture is testing each batch of supplement for the concentration and safety of indicated ingredients that are actually in the bottle. </p>
<p>Importantly, the ingredients should be tested for safety in combination, since we know that a mix of herbs or plants can be more potent when combined. </p>
<p>What’s also missing is checks that the claims made on the bottle can be substantiated prior to the product going on sale. While compliance checks do occur, each review covers only a fraction of the <a href="https://www.tga.gov.au/australian-register-therapeutic-goods">total products</a> listed on the Australian Register of Therapeutic Goods (ARTG). Each time, dozens of products are <a href="https://www.tga.gov.au/complementary-medicines-cancellations-artg">cancelled</a> for reasons ranging from unsubstantiated claims on the label, to unacceptable quality, safety or efficacy of the goods.</p>
<p>And that doesn’t even cover products that are not listed on the ARTG, such as traditional Chinese medicine products that <a href="http://www.sbs.com.au/news/article/2015/12/11/whats-your-herbal-medicines">have been found</a> to be contaminated with pharmaceuticals such as paracetamol, antihistamines, antibiotics and blood-thinners, as well as significant levels of toxic heavy metals such as arsenic, cadmium and lead. </p>
<p>Meanwhile, Australian supplement manufacturers are required to adhere to <a href="https://www.tga.gov.au/good-manufacturing-practice-overview">good manufacturing practice</a>. Their sites are also inspected and licensed by the TGA. </p>
<p>But, beyond that, does the product do what it says? Is there any active ingredient in the bottle? You many never know. </p>
<p>Consumers can easily be lulled into a false sense of security, especially if a product is stamped with an official-looking number and sold beside evidence-based medicines in a pharmacy. But they’d be wrong and this is simply not good enough. </p>
<p>Like North America, we also have a vocal supplement lobby with connections to powerful people, but shouldn’t we be putting consumer safety above profits? Most definitely we should, but until that happens I would steer clear of over-the-counter supplements. Buyer beware. </p>
<p><em><a href="http://www.abc.net.au/tv/programs/four-corners/">Supplements and Safety: The hidden dangers of vitamins and health supplements</a> airs tonight at 8.30pm on ABC TV and iview.</em></p><img src="https://counter.theconversation.com/content/59249/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rachael Dunlop has a patent pending for L-serine use as a supplement in the treatment of neurodegenerative disorders. She receives funding from the Institute for Ethnomedicine, Jackson. WY. She is co-Vice President of Australian Skeptics Inc. </span></em></p>Vitamin supplements and protein powders at best don’t work and, at worst, can cause harm. So why do 75% of Australians take them?Rachael Dunlop, Visiting associate, Macquarie UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/536372016-01-27T02:49:40Z2016-01-27T02:49:40ZGluten- and casein-free diet makes a meal of autism science<figure><img src="https://images.theconversation.com/files/109119/original/image-20160125-425-ucexga.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Diet modification is one of the most prominent alternative autism therapies.</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-20927107/stock-photo-joyful-breakfast-of-little-boy.html?src=NSRei_7o3YNSf4WWDwjRHA-4-104">Larisa Lofitskaya/Shutterstock</a></span></figcaption></figure><p>From the moment a child is diagnosed with autism, their family enters the unknown. Conference halls are lined with salespeople, letterboxes are stuffed with pamphlets, and life is transformed into a whirlwind tour of a fantastical array of therapies and potions that are positioned as the “cure all” for their child’s difficulties.</p>
<p>Diet modification is one of the most prominent alternative therapies. A diet free of gluten (found in wheat, rye and barley) and casein (the main protein in dairy products) attracts more attention than any other and is estimated to be given to <a href="http://www.ncbi.nlm.nih.gov/pubmed/16977497">approximately 40%</a> of individuals with autism spectrum disorder (ASD). </p>
<p>In some cases, clinicians recommend diets; in others, they’re instigated by parents eager to find anything that may help their child. But there is currently little scientific evidence the gluten-free, casein-free (GFCF) diet has beneficial effects for children with autism.</p>
<h2>The theory</h2>
<p>The theory most commonly associated with the use of the GFCF diet relates to proposed differences in the functioning of the gut of individuals with autism.</p>
<p>Our bodies extract nutrition from food through the intestines, which is where small molecules cross the mucosal lining and enter our bloodstream. It is thought that some individuals with autism have a “leaky gut” – that is, their intestines are more permeable than normal – and this may allow molecules to enter the bloodstream that should not otherwise be there. </p>
<p>The GFCF diet is based on the <a href="http://www.ncbi.nlm.nih.gov/pubmed/12223079">theory</a> that opioid peptides, formed from the incomplete breakdown of foods containing gluten and casein, may enter the bloodstream due to the increased intestinal permeability. From there they cross the blood–brain barrier and disrupt brain development and functioning.</p>
<p>On the face of it, this theory has some plausibility.</p>
<p>The gut has its own nervous system, called the enteric nervous system, which is how we know when we are hungry and when we need to go to the toilet. The enteric nervous system is closely related to the development of the central nervous system, including the brain. </p>
<p>Extensive research has also shown that a significant minority of individuals with autism – perhaps <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2747040/">around 30%</a> – experience considerable difficulties with gut functioning at some stage in their lives. </p>
<p>The assumptions here are that the gut difficulties experienced by individuals with autism are causally related to the differences in brain development. By using the GFCF diet, gut problems are reduced and autistic symptoms should improve.</p>
<p>This is a neat theory, but unfortunately there are some evidence gaps that need to be plugged.</p>
<h2>The problems</h2>
<p>The first problem relates to testing the underlying theory itself. If an inability to break down gluten and casein leads to an excess in opioid peptides, then we would expect to find high levels of these molecules in children with autism. </p>
<p>However, <a href="http://adc.bmj.com/content/93/9/745.short">three studies</a> <a href="https://www.ncbi.nlm.nih.gov/pubmed/12578238">have found</a> <a href="http://www.ncbi.nlm.nih.gov/pubmed/17520243">no evidence</a> of excessively high levels of opioid peptides in the urine of children with autism. Other <a href="http://www.ncbi.nlm.nih.gov/pubmed/24339339">studies</a> have questioned the existence of a “leaky gut” altogether.</p>
<p>The second problem is the results of studies that have tested the effectiveness of GFCF diets with children with autism. A 2014 <a href="http://www.ncbi.nlm.nih.gov/pubmed/24789114">systematic review</a> found major methodological limitations of studies in this area. These included lack of a control group, poor definitions of inclusion criteria, and very small sample sizes.</p>
<p>The studies that found a positive effect of GFCF diets on the behaviours of children with autism had the most significant flaws. Conversely, the studies that were considered to be most methodologically rigorous tended to find no benefits from the use of GFCF diets.</p>
<p>The third problem relates to the question of “what’s the harm?” This argument goes: “Despite there being no evidence for the effectiveness of GFCF diets, nor the theory underpinning it, what’s the harm in families trying this on the odd chance that it may be beneficial for their child?”</p>
<p>Unfortunately, some question marks remain over the safety of GFCF diets. Several studies have reported that a GFCF diet is associated with reduced bone density in both children <a href="http://www.ncbi.nlm.nih.gov/pubmed/17879151">with</a> and <a href="http://www.ncbi.nlm.nih.gov/pubmed/17516020">without</a> autism. </p>
<p>Others have suggested it’s unethical to recommend a diet that has significant logistical and financial implications for families who are already stretched to <a href="http://www.ncbi.nlm.nih.gov/pubmed/24339339">capacity</a>. </p>
<h2>The future</h2>
<p>Currently, there is not sufficient scientific evidence that GFCF diets can be beneficial for children with ASD. </p>
<p>Furthermore, given the uncertain safety profile, only when there is a clear intolerance or allergy to the foods that a GFCF diet eliminates would it be prudent to recommend the diet.</p>
<p>The key determiner to changing or strengthening this conclusion is the findings from well-designed treatment trials. It is completely understandable for parents to have a burning desire to do anything that may help their child. It is because of this that we, as scientists, must do better in providing solid evidence to guide parental and clinical decision-making.</p>
<p>The quality of autism intervention science has increased significantly over the past decade, and it is critical that alternative therapies are also tested as part of this agenda.</p><img src="https://counter.theconversation.com/content/53637/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andrew Whitehouse receives funding from the NHMRC, the ARC and the Autism CRC.</span></em></p>In some cases, clinicians recommend special diets; in others, they’re instigated by parents eager to find anything that may help their child.Andrew Whitehouse, Winthrop Professor, Telethon Kids Institute, The University of Western AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/521442015-12-10T20:09:27Z2015-12-10T20:09:27ZWhat’s in your herbal medicines?<figure><img src="https://images.theconversation.com/files/105183/original/image-20151210-7428-j8b0yp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The most concerning finding was leopard DNA.</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-72466159/stock-photo-traditional-chinese-medicine-herbs-and-remedies-in-jars.html?src=HIr8BTFSvoXmoCsud7eENg-1-14">Elena Elisseeva/Shutterstock</a></span></figcaption></figure><p>by Ian Musgrave and <a href="https://theconversation.com/profiles/michael-bunce-8333">Michael Bunce</a></p>
<p>Many people take herbal medicines, including traditional Chinese medicine (TCM) thinking they are doing something positive for their health. Ironically, in many cases they may be doing just the opposite.</p>
<p>Have you ever wondered what is actually in the herbal medicine products you buy? Has the herb on the label been replaced with another herb? Have pharmaceuticals been snuck in? </p>
<p>Making sure that a tablet claiming to have 500 milligrams of paracetamol really does contain 500 milligrams of paracetamol is relatively easy, there are established assays to measure paracetamol routinely. But how do you test for herbs? </p>
<p>Most herbal medicines are pills or powders that have removed all trace of structure we would normally use to identify plants, and many plants have no chemical signature that is able to definitively identify them. And what about all the other possible contaminants and adulterants that could hide in the complex brew of chemicals from herbal medicines?</p>
<p><a href="http://www.nature.com/articles/srep17475">Our research</a>, which has just been published in the journal <a href="http://www.nature.com/srep/">Nature Scientific Reports</a>, goes a long way to answering that.</p>
<p>For the first time, our group of researchers from <a href="http://www.curtin.edu.au/">Curtin University</a>, <a href="http://www.murdoch.edu.au/">Murdoch University</a> and the <a href="http://www.adelaide.edu.au/">University of Adelaide</a> have combined some of the most cutting-edge and sensitive analytical techniques to screen a set of traditional Chinese medicines available in Australia. </p>
<p>We used a three-pronged approach, combining DNA sequencing, toxicology and heavy metal testing to elucidate the true composition of 26 TCMs purchased at random from the Adelaide Markets; most were either for colds and flu’s or for general wellness. </p>
<h2>What did we find?</h2>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/105221/original/image-20151210-7442-7b1atq.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/105221/original/image-20151210-7442-7b1atq.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/105221/original/image-20151210-7442-7b1atq.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=544&fit=crop&dpr=1 600w, https://images.theconversation.com/files/105221/original/image-20151210-7442-7b1atq.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=544&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/105221/original/image-20151210-7442-7b1atq.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=544&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/105221/original/image-20151210-7442-7b1atq.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=684&fit=crop&dpr=1 754w, https://images.theconversation.com/files/105221/original/image-20151210-7442-7b1atq.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=684&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/105221/original/image-20151210-7442-7b1atq.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=684&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Summary of the contaminants in traditional Chinese medicines (TCMs) tested in this study that contained toxic metals, undeclared or illegal contents as determined by DNA, toxicological, and heavy metal screening methods. Each TCM tested is represented in the diagram as a tablet; blue shading on tablets indicate AUST L listed medicines, red shading are not-listed with the TGA regulatory body. TCMs deemed non-compliant.
for DNA (green), toxicology (pink) and heavy metals (yellow) or a combination thereof, are represented within the Venn diagram.</span>
<span class="attribution"><span class="source">Coglan et al.,Sci Reports 2015</span></span>
</figcaption>
</figure>
<p>Nearly nine in ten of these medicines had some form of undeclared substance in them as either adulteration or contamination. Sixteen of TCM’s had more than one contaminant or adulterant. </p>
<p>While around half of these medicines were not listed with the <a href="http://www.tga.gov.au/index.htm">Therapeutic Goods Administration</a> (TGA), and should not have been available for purchase, contaminants were found in both TGA-listed and non-listed medicines. These adulterants/contaminants included pharmaceuticals and toxic heavy metals. </p>
<p>Plant and/or animal DNA from species not listed on the labels were also found. The most concerning finding was snow leopard DNA (snow leopards are an endangered species), which was detected in one medicine. DNA from pit viper, frog, rat, cat and dog was also detected in several medicines. </p>
<p>Among the pharmaceuticals found were paracetamol, antihistamines, anti-inflammatories and antibiotics, and stimulants such as pseudoephedrine. Of particular concern were drugs such as warfarin, which have significant potential for harm if not taken under medical supervision, and ephedrine, which is banned in Australia.</p>
<p>Significant levels of toxic heavy metals such as arsenic, cadmium and lead were found in over half the medicines. In at least four of these medicines following the directions on the label would expose you to over ten times the TGA’s regulatory limit for heavy metals in medicines.</p>
<h2>What does this mean?</h2>
<figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/105222/original/image-20151210-7431-1oi14lx.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/105222/original/image-20151210-7431-1oi14lx.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=513&fit=crop&dpr=1 600w, https://images.theconversation.com/files/105222/original/image-20151210-7431-1oi14lx.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=513&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/105222/original/image-20151210-7431-1oi14lx.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=513&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/105222/original/image-20151210-7431-1oi14lx.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=645&fit=crop&dpr=1 754w, https://images.theconversation.com/files/105222/original/image-20151210-7431-1oi14lx.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=645&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/105222/original/image-20151210-7431-1oi14lx.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=645&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Herbal Medicines.</span>
<span class="attribution"><span class="source">Megan Coglan</span></span>
</figcaption>
</figure>
<p>Are the levels of undeclared materials in these products adulteration or contamination? In <em>adulteration</em>, the material is added deliberately. In <em>contamination</em>, the material is added inadvertently, for example, through unclean workplaces or herbs grown on contaminated soil. </p>
<p>Whether a compound is a result of deliberate adulteration or contamination has different regulatory implications. It can mean the difference between banning a substance or cleaning up the workplace. </p>
<p>It can be tricky to decide which is which. In TCM materials, for instance, <a href="http://www.cnbc.com/id/100992436">heavy metals</a> or <a href="http://www.ncbi.nlm.nih.gov/pubmed/12866383">toad venom</a> may be added as part of the treatment. However, by looking at the patterns of materials we found, we can get some hints. </p>
<p>One TCM claiming to enhance weight gain with appetite stimulation contained pharmaceutically relevant levels of the drug <a href="https://en.wikipedia.org/wiki/Cyproheptadine">cyproheptadine</a>, a known appetite enhancer. </p>
<p>In another, <a href="https://en.wikipedia.org/wiki/Ephedrine">ephedrine</a> was found without any evidence of DNA from plants of the <a href="https://en.wikipedia.org/wiki/Ephedra_sinica">Ephedra</a> genus, suggesting that in both cases the drug was deliberately added. </p>
<p>Intriguingly, high levels of arsenic were often found with similar levels of lead. <a href="https://www.lead.org.au/lanv10n3/lanv10n3-7.html">Lead arsenate</a> has been used as a pesticide, and the high levels may come from persistently contaminated soils.</p>
<p>What this means is that you should be very careful about choosing and purchasing TCMs. Definitely avoid any medicine that does not have an <a href="https://www.ebs.tga.gov.au/">ARTG listing</a> (it should have a number like AUST L 123456 on the front of the bottle). But even medicines with these AUST L labels are no guarantee of safety.</p>
<p>This also highlights the importance of informing your health practitioner if you are taking TCMs as adulterants might interact with conventional medication to cause adverse effects. </p>
<h2>What are the regulatory implications?</h2>
<p>Unlike countries such as the United States, where many herbal medicines are regulated as dietary supplements, in Australia, herbal medicines are regulated through the TGA as medicines.</p>
<p>TGA-regulated medicines can be approved as either <a href="https://www.tga.gov.au/registered-and-listed-medicines">“registered” or “listed”</a>. Most herbal medicines are classified as <a href="https://www.tga.gov.au/listed-medicines">“listed”</a>. Unlike registered medicines such as paracetamol and <a href="http://www.nps.org.au/medicines/heart-blood-and-blood-vessels/anti-clotting-medicines/for-individuals/anticoagulant-medicines/for-individuals/active-ingredients/warfarin">warfarin</a>, the evidence required for approval is much less stringent. </p>
<p>In many ways it is an honour system, where the herbal medicines sponsor says there’s no evidence of harm, and they hold documentation that shows this. Mostly, the evidence is historical, claiming that people have been using it for generations without evidence of harm. As well, if the compounds are on the TGA’s list of “generally recognised are safe” materials extensive safety testing is not required.</p>
<p>The TGA uses post marketing follow-up to check for compliance with the “listed” medicine regulations. This follow-up consists of <a href="http://www.anao.gov.au/Publications/Audit-Reports/2011-2012/Therapeutic-Goods-Regulation-Complementary-Medicines/Audit-brochure">random surveys as well as targeted surveys</a> from concerns raised by consumers. </p>
<p>In Australia, nearly 2,000 new herbal medicines are registered each year.
In a <a href="http://www.tga.gov.au/behind-news/complementary-medicines-compliance-reviews-2013">TGA survey in 2012-2013</a>, 145 complementary medicines were tested. Around 83% of complimentary medicines surveyed were deemed to be non-compliant, with 6% failing due to product composition, formulation or manufacturing.</p>
<p>Using a combination of new molecular approaches, our survey found a much higher level of adulteration and contamination in TCMs than found in the TGA’s surveys. Adding DNA ingredient screening to the TGA’s armoury of analytical methods would help ensure that undeclared ingredients are not included in the herbal medicines we consume. </p>
<h2>And Finally:</h2>
<p>The herbal medicine industry is a billion dollar international industry, with products travelling all over the world. </p>
<p>Globally, we need a better auditing “toolkit” to ensure consumers of herbal medicines, as well as people testing their efficacy, are not being misled. </p>
<p>This research, we think, provides a roadmap to more effective regulation of the herbal medicine sector. </p>
<p><em>* The results of our screening have been passed on to the TGA, which is following this up.</em></p><img src="https://counter.theconversation.com/content/52144/count.gif" alt="The Conversation" width="1" height="1" />
<h4 class="border">Disclosure</h4><p class="fine-print"><em><span>Ian Musgrave and Michael Bunce receive funding from the National Health and Medical research Council to study adulteration and Contamination of herbal medicine. Ian Musgrave is a board member of the Australasian Society of Clinical and Experimental Pharmacology and Toxicoloy</span></em></p>Making sure that a tablet claiming to have 500 mg of paracetamol really does contain 500 mg of paracetamol is relatively easy. But how do you test for herbs?Ian Musgrave, Senior lecturer in Pharmacology, University of AdelaideLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/424152015-05-27T04:44:37Z2015-05-27T04:44:37ZWhat if Sydney University’s complementary medicine research shows it’s useless?<figure><img src="https://images.theconversation.com/files/83051/original/image-20150527-25080-9lborb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The Faculty would do well to appoint an external audit committee.</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-88025923/stock-photo-close-up-of-medical-capsules.html?src=Xr2HlOAk7yJXOEiSwWKSsg-1-26">kubais/Shutterstock</a></span></figcaption></figure><p>The Faculty of Medicine at the University of Sydney has just announced A$1.3 of funding from Blackmores, the complementary medicine manufacturer, for a Chair in Integrative Medicine (a blending of evidence-based conventional and complementary medicine). It will be named after the company’s owner, Maurice Blackmore.</p>
<p>The Dean of the Faculty, Bruce Robinson, has given a <a href="http://www.abc.net.au/am/content/2015/s4243099.htm">coherent and persuasive account</a> of why research in this area is of importance to modern medical practice. Nearly <a href="http://www.ncbi.nlm.nih.gov/pubmed/21806735">a quarter</a> of Australians with chronic health problems use complementary and alternative medicine (CAM) and the bewildering range and often changing nature of these products are often of unknown efficacy, and may have important adverse or beneficial interactions with prescribed medicines.</p>
<p>Still, more of the “worried well” regularly use unnecessary vitamins and other dietary supplements, often achieving little other than the generation of expensive urine in consumers and handsome profits in manufacturers.</p>
<p>Robinson is correct in arguing that medical practitioners and students know little about what a significant proportion of their patients are using and about whether these preparations help, harm, generate only placebo effects or simply waste patients’ money. And he is absolutely correct in making it clear from the beginning that the relationship will be at “arm’s length”, with Blackmores having no say in the research projects selected, in vetting the results produced, or in any post-publication researcher communications about those results.</p>
<p>But there is already a great deal of evidence about a large number of complementary and alternative medicine preparations being useless, and about how faith in their magical properties can too often cause people with serious health problems to stay away from “conventional” evidence-based treatments of known effectiveness.</p>
<p>Complementary and alternative medicine manufacturers continue to produce and promote many of these substances, paying no heed to the evidence for their uselessness.</p>
<p>Conventional medicines (so-called “ethical pharmaceuticals”) have to pass through onerous regulatory hurdles to prove both safety and efficacy. With the exception of the United States and New Zealand, prescribed medicines cannot be advertised directly to consumers. While the complementary and alternative medicine industry has to satisfy concerns about safety and toxicity, it does not have to satisfy standards of efficacy and can promote useless products in often quasi-mystical and vague language.</p>
<p>The University of Sydney needs to be extremely careful that its association with Blackmores does not turn into a “CAM-wash” exercise, where any adverse research findings on efficacy or interactions are ignored by the company, with the products not being withdrawn or the promotional language unchanged.</p>
<p>There are social and financial costs in the mass consumption of unnecessary and ineffective “medicines”. The pages of medical journals routinely expose such drugs in the conventional medicines area. Many are highly sceptical that far too many players in the complementary and alternative medicine industry are the historical siblings of snake-oil medicine. For the Blackmores-University of Sydney association to repudiate that concern, it will be important to see evidence that the evidence-based and ethical principles at the heart of medical research are both shared and acted upon by the company.</p>
<p>In view of the sensitivities involved over potential reputational damage, the Faculty would do well to appoint an external audit committee to periodically review the relationship and to provide the Faculty with a report on the impact of the research program on the way Blackmores responds to the research it will have supported.</p>
<p><strong><em>Editor’s note: please ensure your comments are <a href="https://theconversation.com/au/community-standards">courteous and on-topic</a>.</em></strong></p><img src="https://counter.theconversation.com/content/42415/count.gif" alt="The Conversation" width="1" height="1" />
<h4 class="border">Disclosure</h4><p class="fine-print"><em><span>Simon Chapman is professor of public health in the Faculty of Medicine at the University of Sydney and a member of Friends of Science in Medicine. He was the 2013 Australian Skeptic of the Year.</span></em></p>The Faculty of Medicine at the University of Sydney has just announced A$1.3 of funding from Blackmores, the complementary medicine manufacturer, for a Chair in Integrative Medicine (a blending of evidence-based…Simon Chapman, Professor of Public Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/423482015-05-26T20:10:08Z2015-05-26T20:10:08ZViewpoints: should universities accept funding from industry?<figure><img src="https://images.theconversation.com/files/82919/original/image-20150526-24748-bbccw1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Direct links between universities and industry funders pose significant risks – but can they be managed?</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/shannonkringen/5182061073/">Shannon Kringen/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>The University of Sydney has just announced it’s establishing a new research position in integrative medicine funded by a A$1.3 million donation from the Blackmores Institute. It says the Maurice Blackmore Chair in Integrative Medicine (a blending of evidence-based conventional and complementary medicine) will add to the university’s current research in the field. </p>
<p>But does the move give rise to questions about whether research linked to industry will be compromised? In this Viewpoints, Paul Komesaroff argues working with industry doesn’t have to be a problem for universities while Ken Harvey says there’s a better way.</p>
<hr>
<p><strong>Paul Komesaroff</strong>: The propriety of industry support for research in universities has long been debated. During the Vietnam War, for instance, controversy was generated in the United States about the role of universities in developing chemical and anti-personnel weapons. And, more recently, relationships with pharmaceutical companies have come under close scrutiny. </p>
<p>The issue has become still more complicated by the transformations universities have been forced to undergo over the last few decades. </p>
<p>For better or for worse, universities are not ivory towers and researchers are not disinterested searchers after truth. Scientists are motivated as much by personal ambition and advancement as they are by the pursuit of knowledge and derive their incomes from ever-shrinking grant sources that are themselves controlled by government and subject to partisan social policies. </p>
<p>Universities now operate as businesses and have limited commitment to the traditions of radical critique. And there’s no doubt direct links between universities and industry funders pose significant risks. These include the possibility of the research agenda being distorted in favour of commercial interests, of unpopular viewpoints being suppressed for fear of offending benefactors, and of the very concept of free inquiry and possibility of independent scholarship being placed under challenge from crudely commercial managerial imperatives. </p>
<p>Indeed, there’s ample evidence that all of these possibilities have to some extent been realised. But this doesn’t amount to an argument that all relationships between industry and universities should be proscribed. </p>
<p>What it means is that such relationships must be carefully regulated according to clearly defined values. There must be irrefragable guarantees of independence, both from industry funders and from university management themselves. There must be vigorous debate about where the limits to external support should be set and which industries should be excluded altogether. </p>
<p>Universities should adopt clear charters and codes of ethics that guarantee their founding ethos, which should be genuinely enforceable. </p>
<p>The case of complementary medicine raises special issues. Mainstream medicine remains well represented in the universities while only limited research funds are made available for complementary medicines, in spite of the fact that a high proportion of Australians use these products on a daily basis. The conduct of high-quality research in this area is undoubtedly in the public interest. Risks can be mitigated if the guidelines suggested here are followed. </p>
<p>Universities are not pure centres of thought, and nor should they be. Constructive engagement between educational institutions and industry is desirable, but it needs to be subject to rigorous controls. This applies to all research partnerships, including those with the pharmaceutical and complementary medicine industries, and other commercial entities. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/82922/original/image-20150526-24745-1iyc8pp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/82922/original/image-20150526-24745-1iyc8pp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=300&fit=crop&dpr=1 600w, https://images.theconversation.com/files/82922/original/image-20150526-24745-1iyc8pp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=300&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/82922/original/image-20150526-24745-1iyc8pp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=300&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/82922/original/image-20150526-24745-1iyc8pp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=377&fit=crop&dpr=1 754w, https://images.theconversation.com/files/82922/original/image-20150526-24745-1iyc8pp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=377&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/82922/original/image-20150526-24745-1iyc8pp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=377&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Integrative Medicine is a blending of evidence-based conventional and complementary medicine.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/genphys/17308685382/">General Physics Laboratory (GPL)/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>Regulatory processes should include clearly articulated principles that define what is acceptable and what is not, along with mechanisms for public scrutiny and effective enforcement. The task may be a complex one, but there is no reason why it’s unachievable.</p>
<hr>
<p><strong>Ken Harvey</strong>: It’s my view that this question cannot be answered without first addressing fundamental problems in the Australian regulatory system of complementary medicines, which is what is at stake in this instance. The vast majority of complementary medicines on the Australian market are listed by the Therapeutic Goods Administration (TGA) rather than registered. Listed products are not evaluated by the TGA to see if they work.</p>
<p>While the product’s sponsors, which are usually its manufacturers or licensed local distributors, are meant to hold evidence of efficacy, this is often found to be unsatisfactory when <a href="http://www.tgacrp.com.au/index.cfm?pageID=13&special=complaint_single&complaintID=2678">complaints are made</a>. Or when the TGA conducts limited <a href="https://www.tga.gov.au/complementary-medicines-compliance-reviews-outcomes-2014">post-marketing reviews</a>. In addition, there are no effective sanctions to deter such behaviour.</p>
<p>The end result is a market flooded with products of dubious efficacy promoted <a href="https://www.youtube.com/watch?v=12ww26sQF7E&feature=youtu.be">with hype and celebrity endorsement</a> rather than scientific research. Indeed, <a href="http://www.health.gov.au/internet/main/publishing.nsf/content/Expert_Review_Submissions-container1/$FILE/Flordis%20submission.pdf">a company</a> that has financed the research necessary to produce evidence-based (TGA registered) complementary medicines complain they haven’t garnered a useful return on their investment as the public doesn’t understand the difference between listed and registered products. </p>
<p>But what does this mean for the incumbent of the Maurice Blackmore Chair in Integrative Medicine? First of all, she will need to be aware that the majority of complementary medicine products in the Australian marketplace are not evidence-based. And that includes those of the company funding her chair. </p>
<p>This could cause a number of potential conflicts of interest. The company concerned may have expectations that the research conducted will validate its products, which it may not do; there may be subtle pressures on researchers from vice chancellors and university business managers to not be critical of complementary and alternative medicine products so as not to upset the funder; researchers may be tempted to game their work to produce pleasing results by, for instance, testing the effect of multivitamins on cognition by performing numerous psychometric tests on small numbers of subjects. This increases the likelihood that one or two will prove “statistically significant” by random chance.</p>
<p>And then there’s the danger that the funder may magnify or cherry-pick positive results – or both – without waiting to see if these can be replicated. </p>
<p>Companies may also refuse permission to publish negative results. They will almost certainly use their association with the university for marketing purposes. And this may cause problems for the university if <a href="http://www.tgacrp.com.au/index.cfm?pageID=13&special=complaint_single&complaintID=2678">the company’s views on marketing differs from those of regulators</a>.</p>
<p>Most of these potential problems can be minimised by clear agreement that the university will be in complete control of the research questions, the methodology, and ethics approval and publication rights. But <a href="http://www.dailymail.co.uk/news/article-2918600/Top-scientist-claims-lost-job-Prince-Charles-wanted-silence-criticising-report-alternative-medicine-commissioned-royal.html">Professor Edward Ernst’s experience at Exeter University</a> provides a cautionary tale of the problems that can emerge. </p>
<p>From 1993, Ernst held the first chair of complementary medicine in the United Kingdom. His research showed that while some complementary modalities worked, many more didn’t. In 2005, Ernst dismissed as “complete misleading rubbish” a report commissioned by the Prince of Wales, which claimed complementary and alternative medicine was cost-effective. His university investigated him after a complaint about his early disclosure of the report’s contents and his funding dried up despite the lack of findings against him. He retired early and his department was closed. </p>
<hr>
<p><strong>Paul Komesaroff</strong>: I agree with many of the concerns about the regulation of complementary medicines expressed by Ken Harvey. The current system encourages the sale of products that have been subjected to inadequate testing and tolerates inaccurate or even false promotional claims about them. And the distinction between listing and regulation of medicinal products has generated perverse incentives that operate against public interest. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/82923/original/image-20150526-24740-1efcsol.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/82923/original/image-20150526-24740-1efcsol.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/82923/original/image-20150526-24740-1efcsol.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/82923/original/image-20150526-24740-1efcsol.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/82923/original/image-20150526-24740-1efcsol.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/82923/original/image-20150526-24740-1efcsol.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/82923/original/image-20150526-24740-1efcsol.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Australia’s current regulatory system encourages the sale of products that have been subjected to inadequate testing and tolerates inaccurate or even false promotional claims about them.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/healthgauge/10134733936/">Health Gauge/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>But surely this is an argument for more research, not less - for increased support for the generation of high-quality data, and for open, critical reflection and debate. It’s an argument in favour of bringing complementary medicines in from the cold so they can be subject to the same standards and scrutiny as pharmaceuticals and other fully regulated medicinal products. </p>
<p>I also agree that research funding poses risks, including those associated with conflicts of interests, pressure on researchers and the institutions themselves. And there’s the risk that funders may use their support to bolster commercial activities, and may even seek to suppress unfavourable research outcomes. </p>
<p>These risks are real but they are all also foreseeable. And in each case, it is possible to devise effective strategies to avert them. </p>
<p>It’s in the public interest for complementary medicines to be subjected to rigorous research and for reliable, trustworthy information to take the place of exaggerated and unsubstantiated claims. One of the most effective ways in which this can be achieved is through careful, properly regulated, fully transparent relationships between industry and academia. </p>
<p>If the chair at the University of Sydney satisfies these criteria it should receive our full support. </p>
<hr>
<p><strong>Ken Harvey</strong>: The best way for a company to sponsor high-quality research into complementary medicine without any possible conflict of interest is for them to provide a hands-off, anonymous donation to the National Health and Medical Research Council (NHMRC) that would add to the existing (small) pool of money provided for competitive, peer-reviewed research grants in this area. </p>
<p>The NHMRC has already researched <a href="https://www.nhmrc.gov.au/health-topics/complementary-medicines/homeopathy-review">some complementary medicine modalities</a> and has also provided <a href="https://www.nhmrc.gov.au/health-topics/complementary-medicines/talking-your-patients-about-complementary-medicine-resource-cl">educative material</a> for medical students and practitioners. </p>
<p>And the report of the <a href="http://www.health.gov.au/internet/main/publishing.nsf/Content/phi-natural-therapies">Review of the Australian Government Rebate on Private Health Insurance for Natural Therapies</a> (currently with the health minister) will provide additional information on the evidence base of many more complementary or natural therapies. </p>
<p>Hands-off industry support to the NHMRC is a better way to proceed than financing an eponymous chair because it still ensures we’re researching complementary medicines but mitigates all the risk that the latter entails.</p><img src="https://counter.theconversation.com/content/42348/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Paul Komesaroff is a former colleague of Dr Lesley Braun who is now Director of the Blackmore Institute. </span></em></p><p class="fine-print"><em><span>Dr Harvey has accepted travel expenses only to talk about problems of complementary medicine regulation to pharmaceutical companies and industry associations. He has also been paid travel expenses and sitting fees for his involvement with government inquiries and working groups concerning the promotion and regulation of complementary medicines. He is regarded by some section of industry as a serial complainant.</span></em></p>The University of Sydney’s announcement of a role funded by the Blackmores Institute raises perennial questions about whether industry-funded research can be truly independent.Paul Komesaroff, Professor of Medicine, Monash UniversityKen Harvey, Adjunct Associate Professor, School of Public Health and Preventive Medicine, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/367702015-02-05T19:37:41Z2015-02-05T19:37:41ZKrill oil marketing: a case study of Australia’s broken regulations<figure><img src="https://images.theconversation.com/files/71181/original/image-20150205-28589-oqqydp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Complementary medicines such as krill oil don't always have the science to back up their claims.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/oter/6108414083">Jo Christian Oterhals/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span></figcaption></figure><p><a href="http://cmaustralia.org.au/Resources/Documents/Technical-Alerts/2015/Complementary%20Medicines%20Australia%20Pre-Budget%20Submission%202015-16.pdf">Two out of three Australians</a> regularly use complementary medicines, which constitute a A$3.5 billion domestic market. But the industry’s marketing strategies are a source of ongoing controversy and pose a significant challenge for regulators.</p>
<p>Products containing containing krill oil provide a good example of the kinds of extravagant claims made by supplement manufacturers. The oil is derived from a tiny, shrimp-like crustacean and, like fish oil, contains omega-3 fatty acids. </p>
<p>Company claims include krill oil’s capacity to “relieve arthritic symptoms [of osteoarthritis and rheumatoid arthritis] within a short period of 7 to 14 days”, as well as its “superior absorption” and the curiously ambiguous “9x [strength]” of the less expensive fish oil. Such claims are found on product packs and manufacturers’ websites, as well as the websites of third-party stockists.</p>
<p>Few companies provide links to research supporting such claims. What research does exist is not easily accessible to most consumers, who, at any rate, can rarely assess its validity.</p>
<h2>Claims and science</h2>
<p>The widely used claim that krill oil relieves the symptoms of arthritis within seven to 14 days appears to be based on <a href="http://www.naturinstitut.info/docs/krilloel-arthritis.pdf">a small 2007 study</a>. The research focused on one specific formulation of krill oil, produced by a Canadian company. Possible <a href="http://www.icmje.org/recommendations/browse/roles-and-responsibilities/author-responsibilities--conflicts-of-interest.html">conflicts of interest</a>, including the source of funding for the study, are notably absent from the paper.</p>
<p>The study recruited 90 people with a confirmed diagnosis of one or more of cardiovascular disease, rheumatoid arthritis (ten people) and osteoarthritis (30 people). They were compared to placebo groups of 12 and 26. Three patients pulled out of the trial before completion, and 12 didn’t have a diagnosis of either osteoarthritis or rheumatoid arthritis. </p>
<p>While some results at seven and 14 days were deemed statistically significant, the meagre number of people involved raises questions about the <a href="https://theconversation.com/the-problem-with-p-values-how-significant-are-they-really-20029">clinical significance</a> of its conclusions. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/71178/original/image-20150205-28605-14bvgqy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/71178/original/image-20150205-28605-14bvgqy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/71178/original/image-20150205-28605-14bvgqy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=518&fit=crop&dpr=1 600w, https://images.theconversation.com/files/71178/original/image-20150205-28605-14bvgqy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=518&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/71178/original/image-20150205-28605-14bvgqy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=518&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/71178/original/image-20150205-28605-14bvgqy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=650&fit=crop&dpr=1 754w, https://images.theconversation.com/files/71178/original/image-20150205-28605-14bvgqy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=650&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/71178/original/image-20150205-28605-14bvgqy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=650&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Snake oil for what ails you? Speedy fixes sound great, but don’t be taken in by claims on labels.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/tim_and_selena/5052201329">Tim & Selena Middleton/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
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</figure>
<p>Regardless of this and other details of the report that suggest only people with very severe cases of illness were included, the findings of this early and isolated study can, at best, be considered preliminary. And a search of a <a href="http://www.ncbi.nlm.nih.gov/pubmed">comprehensive research database</a> found no evidence that the results had been replicated independently. </p>
<p>The claim of krill oil having “superior absorption” is also dubious and not supported by research evidence. A <a href="http://www.lipidworld.com/content/13/1/137">2014 review of krill oil absorption</a> actually concluded there was no evidence for krill oil being more easily absorbed by the human body. </p>
<h2>Regulatory challenges</h2>
<p>Companies that market <a href="https://www.tga.gov.au/community-qa/whats-medicine-label">complementary medicines</a> in Australia are legally required to comply with standards set by the Therapeutic Goods Administration (TGA). These standards relate to both the quality of the product and advertising claims. </p>
<p>But manufacturers self-certify their compliance with TGA requirements. Limited, as well as poorly targeted, post-market surveillance of complementary products means they can contravene standards without fear of reprisal. Then there’s the lack of effective penalties to deter companies from breaching TGA regulations. </p>
<p>In <a href="http://www.tgacrp.com.au/index.cfm?pageID=13&special=complaint_single&complaintID=2250">May 2013</a>, the Therapeutic Products Advertising Complaint Resolution Panel determined claims such as “9x stronger” and “reduce[s] pain, stiffness and inflammation caused by arthritis, within a short period of 7 to 14 days” breached a number of sections of the Therapeutic Goods Advertising Code 2007.</p>
<p>It said such statements:</p>
<blockquote>
<p>ought to be supported by a wide body of scientific evidence involving a number of independent studies. </p>
</blockquote>
<p>But the claims continue to be made, even by companies asked to withdraw them.</p>
<p><a href="http://www.tga.gov.au/sites/default/files/consult-advertising-ris-130531.pdf">Numerous reports</a> over the last decade have recommended that the lack of effective penalties for offending companies be redressed. But it seems unlikely any changes will be implemented any time soon as both the <a href="http://www.foodnavigator-asia.com/Policy/Deregulating-complementary-medicines-would-save-A-70m-a-year">industry</a> and <a href="http://health.gov.au/internet/main/publishing.nsf/Content/regulation-and-red-tape-reduction">government</a> support a deregulation agenda. </p>
<p>Meanwhile, consumers continue to be ripped off by products that cannot deliver on the promises they make.</p><img src="https://counter.theconversation.com/content/36770/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr Harvey has accepted travel expenses only to talk about problems of complementary medicine regulation to pharmaceutical companies and industry associations. He has also been paid travel expenses and sitting fees for his involvement with government inquiries and working groups concerning the promotion and regulation of complementary medicines. He is regarded by industry as a serial complainant</span></em></p><p class="fine-print"><em><span>This article is based on a Monash Summer Research Project that Aaron Kovacs completed under Dr Harvey's supervision.</span></em></p><p class="fine-print"><em><span>This article is based on a Monash Summer Research Project that Grace Jackel completed under Dr Harvey's supervision.</span></em></p>Two out of three Australians regularly use complementary medicines, which constitute a A$3.5 billion domestic market. But the industry’s marketing strategies are a source of ongoing controversy and pose…Ken Harvey, Adjunct Associate Professor, School of Public Health and Preventive Medicine, Monash UniversityAaron Kovacs, Medical Student, Monash UniversityGrace Jackel, Biomedicine and Commerce Student, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/234182014-02-21T03:52:44Z2014-02-21T03:52:44ZIndustry has a role in funding alternative medicine research<figure><img src="https://images.theconversation.com/files/42146/original/4wpjvmj3-1392952805.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Researchers working with alternative medicines have an obligation to report negative or null findings.</span> <span class="attribution"><a class="source" href="http://www.flickr.com/photos/ringai/3174641354/sizes/l/">hit thatswitch/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span></figcaption></figure><p><em><a href="https://theconversation.com/topics/testing-alternative-therapies">TESTING ALTERNATIVE THERAPIES</a> - La Trobe University’s decision to accept funding from Swisse for a new centre to research alternative medicines has sparked controversy.</em></p>
<hr>
<p>There’s been a fair bit of debate recently over the role of industry funding in research into complementary and alternative medicines, <a href="https://theconversation.com/topics/testing-alternative-therapies">including on this site</a>. Much of it has argued that research funded by industry is inherently compromised, but it doesn’t have to be.</p>
<p>There are limited government funding options in Australia for complementary medicine research so it’s important that industry supports such research. It’s equally important that there are mechanisms in place to ensure the research is conducted at a high level, with checks on quality, such as trial registration and peer review of papers.</p>
<h2>Show me the money</h2>
<p>In Australia, there are two major government bodies that fund research – the National Health and Medical Research Council (NHMRC) and the Australian Research Council (ARC). </p>
<p>Since 2012, the ARC <a href="http://www.arc.gov.au/applicants/md_research.htm">no longer funds</a> health or medical research at all, while the NHMRC largely restricts its funding of clinical trials to those investigating medical and health conditions. </p>
<p>If we wish to find out whether or not a dietary supplement improves some aspect of health among people without a defined medical condition, the choice is effectively between industry-supported research or no research. </p>
<p>Indeed, in my experience, it’s not unheard of to receive feedback for grant applications saying although the science is sound, the research should be supported by industry! This suggests that there is a reasonably common belief that such support, when available, is more appropriate for these kinds of studies.</p>
<p>Even if this position changed, competition for research support is so high that, last year, for instance, the NHMRC funded around 16% of applications for its highly-regarded project grants. So it’s likely industry will play an increasingly valuable role in supporting Australian research.</p>
<p>But researchers don’t just undertake industry-funded research because of the lack of other funding. The motivation for scientific investigation is the same for any academic – to increase our understanding and knowledge. </p>
<h2>Ensuring research integrity</h2>
<p>Industry-funded research is subject to the same peer-review processes as any other. Peer reviewers are made aware of funding sources and judge research on its merit. If it’s of a high enough quality, the research is published in well-regarded international journals.</p>
<p>The gold standard for testing the efficacy of any health intervention is the clinical trial – a controlled study involving human volunteers. Like studies of pharmaceutical drugs, research into the health effects of nutritional supplements relies on clinical trials.</p>
<p>The requirements for research to support health claims from nutritional interventions and supplements have varying levels of stringency in the <a href="http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm111447.htm">United States</a>, <a href="http://www.efsa.europa.eu/en/topics/topic/nutrition.htm">Europe</a> and <a href="http://www.tga.gov.au/pdf/cm-evidence-claims.pdf">Australia</a>, but all trials should be conducted to the standards of <a href="http://www.australianclinicaltrials.gov.au/node/36">good clinical practice</a>. </p>
<p>This involves registering the study on a public clinical trials registry, such as the <a href="http://www.anzctr.org.au/">Australian New Zealand Clinical Trials Registry</a>, to ensure the research is transparent.</p>
<p>Industry-sponsored trials also routinely use statisticians not associated with the researchers, who follow a pre-determined statistical plan. </p>
<p>Typically, studies are monitored by independent auditors to ensure all data are recorded and entered into the database accurately. This database is “locked” prior to analysis, which is performed using codes so the statistician cannot tell the active treatment data set from the placebo data set.</p>
<p>These processes are time consuming, resource-heavy and not always pleasant but most scientists welcome the rigour they add to their work. Interestingly, most studies funded by national grant funding schemes are not subject to the same level of scrutiny.</p>
<h2>Growing sophistication</h2>
<p>It is difficult to know whether researchers unconsciously put a positive spin on industry-sponsored studies by exaggerating certain outcomes to ensure continued funding. </p>
<p>But is there any reason to think the reporting of research funded by other sources cannot also be (unconsciously) spun to avoid being among of 84% applicants who don’t get funding the next time around?</p>
<p>In order to maintain rigour, researchers working with alternative medicines have an obligation to report negative or null (when the intervention does harm or does nothing) findings. In my experience, this is always written into the research contract.</p>
<p>Of course, statements made for the purposes of marketing can be appallingly misleading. But this is completely independent of the science undertaken to evaluate the efficacy of products, and could be avoided by consultation with the researchers involved.</p>
<p>The funding landscape in Australia is becoming increasingly sophisticated and, as with other areas, industry support for alternative medicines has its place.</p>
<p><strong><em>This is the final article in our series about complementary and alternative therapies. Click on the links below to read the others:</em></strong></p>
<ul>
<li><p><a href="https://theconversation.com/heres-why-we-should-research-alternative-therapies-19436">Here’s why we should research alternative therapies</a></p></li>
<li><p><a href="https://theconversation.com/herbal-medicines-toxic-side-effects-and-drug-interactions-23118">Herbal medicines – toxic side effects and drug interactions</a></p></li>
<li><p><a href="https://theconversation.com/alternative-medicine-research-must-be-publicly-funded-23293">Alternative medicine research must be publicly funded</a></p></li>
</ul>
<p><strong><em>Can we scientifically test herbal medicines?</em></strong></p>
<ul>
<li><p>Yes: <a href="https://theconversation.com/quality-research-of-herbal-medicines-is-possible-23139">Quality research of herbal medicines is possible</a></p></li>
<li><p>No: <a href="https://theconversation.com/why-we-cant-have-reliable-evidence-for-herbal-therapies-22882">We can’t have reliable evidence for herbal therapies</a></p></li>
</ul><img src="https://counter.theconversation.com/content/23418/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andrew Scholey consults to the food and supplement industry. He has received funding from the Biotechnology and Biological Sciences Research Council (UK), the European Union Framework scheme, the Australian Research Council, the National Health and Medical Research Council, the British Psychological Society, Abbott Nutrition/CNLM Grand Challenge scheme (USA), the Australian Wine Research Institute, Bayer Healthcare (Switzerland), Cognis (Germany), Cyvex (USA), GlaxoSmithKline Nutrition (UK), Masterfoods (USA), Martek (USA), Naturex (France), Nestlé (Switzerland), Neurobrands (USA), Sanofi and Wrigley (USA).</span></em></p>TESTING ALTERNATIVE THERAPIES - La Trobe University’s decision to accept funding from Swisse for a new centre to research alternative medicines has sparked controversy. There’s been a fair bit of debate…Andrew Scholey, Professor and director of the Centre for Human Psychopharmacology, Swinburne University of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/180072014-02-13T03:32:12Z2014-02-13T03:32:12ZTrick or treat? Alternative therapies for menopause<figure><img src="https://images.theconversation.com/files/40961/original/s4m5ggcs-1391731842.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">What really works to alleviate hot flushes and other symptoms of menopause?</span> <span class="attribution"><span class="source">splityarn/Flickr</span></span></figcaption></figure><p>During menopause, estrogen levels drop, leading to a number of unpleasant symptoms.</p>
<p>The transition to menopause can significantly affect women’s quality of life, with many willing to try anything to alleviate the hot flushes, night sweats, decline in libido, backaches and other symptoms that result from their drop in oestrogen levels. </p>
<p>Hormone replacement therapy (HRT) is the most effective treatment for the relief of menopause symptoms and works by topping up declining oestrogen levels with synthetic version of the hormone. It’s <a href="https://theconversation.com/hormone-replacement-therapy-and-cancer-lets-get-the-facts-straight-4975">effective</a> around 80% to 90% of the time. </p>
<p>HRT comes with a <a href="https://theconversation.com/hormone-replacement-therapy-and-cancer-lets-get-the-facts-straight-4975">small increase</a> in the risk of breast cancer and blood clots. But due to the severity of the menopausal symptoms, many women believe the benefits of HRT outweigh the relatively small risks associated with the treatment. Being overweight, for instance, carries a far higher risk of developing breast cancer compared with the risks associated with taking HRT for less than five years. </p>
<p>A <a href="http://www.ncbi.nlm.nih.gov/pubmed/12117397">large clinical trial</a> published a decade ago sparked widespread fears that HRT could cause cancer, stroke and heart disease. While the risks are now considered to have been <a href="https://theconversation.com/hormone-replacement-therapy-and-cancer-lets-get-the-facts-straight-4975">overstated</a>, they led to a dramatic decline in the use of hormone therapy. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/40974/original/fhb3dh5d-1391734021.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/40974/original/fhb3dh5d-1391734021.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=897&fit=crop&dpr=1 600w, https://images.theconversation.com/files/40974/original/fhb3dh5d-1391734021.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=897&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/40974/original/fhb3dh5d-1391734021.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=897&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/40974/original/fhb3dh5d-1391734021.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1127&fit=crop&dpr=1 754w, https://images.theconversation.com/files/40974/original/fhb3dh5d-1391734021.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1127&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/40974/original/fhb3dh5d-1391734021.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1127&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Just because products are natural, doesn’t mean they’re risk-free.</span>
<span class="attribution"><a class="source" href="http://www.flickr.com/photos/sanzibar/2611481094/sizes/l/">sanzibar/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span>
</figcaption>
</figure>
<p>As many as 60% of women between the age 50 to 60 now <a href="http://www.ncbi.nlm.nih.gov/pubmed/21631851">use complementary and alternative</a> treatments. </p>
<p>But while manufacturers are quick to claim to provide a wide array of benefits to menopausal women, in many instances, there’s <a href="http://benthamscience.com/ebooks/Sample/9781608054534-sample.pdf">little scientific evidence</a> to show they work. Let’s look at what the science has to say about the safety and efficacy of these products.</p>
<h2>Phytoestrogens</h2>
<p>Phytoestrogens are plant-derived compounds with a similar structure to human oestrogen, but are not as potent as the synthetic hormones used in HRT. </p>
<p><strong>Isoflavones</strong></p>
<p>Isoflavones are a class of phytoestrogens widely consumed by women to treat menopausal symptoms, especially hot flushes. They’re found in soy beans, soy-based foods such as tofu, lentils, alfalfa sprouts and chickpeas. </p>
<p>Studies have shown isoflavones in soy <a href="http://www.ncbi.nlm.nih.gov/pubmed/17593379">may be beneficial</a> for reducing cardiovascular disease and <a href="http://www.ncbi.nlm.nih.gov/pubmed/20452475">improving</a> bone strength. But there is conflicting evidence on their effectiveness for treating menopausal symptoms. <a href="http://www.ncbi.nlm.nih.gov/pubmed/16675169">One study</a>, for instance, suggested that isoflavone treatment may be effective only when the number of flushes experienced daily is relatively high. </p>
<p>Overall, it seems that soy in the diet of menopausal women may be beneficial and is unlikely to do harm. </p>
<p><strong>Red clover</strong></p>
<figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/40968/original/jq8zmybv-1391733100.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/40968/original/jq8zmybv-1391733100.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=878&fit=crop&dpr=1 600w, https://images.theconversation.com/files/40968/original/jq8zmybv-1391733100.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=878&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/40968/original/jq8zmybv-1391733100.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=878&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/40968/original/jq8zmybv-1391733100.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1103&fit=crop&dpr=1 754w, https://images.theconversation.com/files/40968/original/jq8zmybv-1391733100.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1103&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/40968/original/jq8zmybv-1391733100.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1103&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Red clover.</span>
<span class="attribution"><a class="source" href="http://www.flickr.com/photos/randihausken/2590899732/sizes/l/">randihausken/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>Red clover is a plant compound that contains four different isoflavones (formononetin, biochanin A, daidzein, and genistein). It is available as a tablet, tea, or in liquid form and is widely used by menopausal women.</p>
<p>The data is mixed on the effectiveness of red clover to reduce menopausal symptoms. <a href="http://www.ncbi.nlm.nih.gov/pubmed/11910671">Some studies</a> suggest it delivers no improvement over placebo while <a href="http://www.ncbi.nlm.nih.gov/pubmed/12851275">others report</a> decreased frequency of hot flushes. </p>
<p>There have been no reported safety issues with taking red clover.</p>
<h2>Herbal remedies</h2>
<p>Herbal remedies have been used throughout the world as a traditional medicine for centuries, either in tea, tablet or powder forms. </p>
<p><strong>Black cohosh</strong></p>
<p>Black cohosh is an American perennial plant which has been used for hundreds of years to alleviate menopausal symptoms. It is the most studied herbal supplement, however, no researchers have identified its active constituent nor its mode of action. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/40967/original/dvx5k63b-1391732754.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/40967/original/dvx5k63b-1391732754.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/40967/original/dvx5k63b-1391732754.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/40967/original/dvx5k63b-1391732754.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/40967/original/dvx5k63b-1391732754.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/40967/original/dvx5k63b-1391732754.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/40967/original/dvx5k63b-1391732754.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Black cohosh.</span>
<span class="attribution"><a class="source" href="http://www.flickr.com/photos/8583446@N05/2694055172/sizes/l/">milesizz/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>Studies have demonstrated that black cohosh is mildly effective for alleviating <a href="http://www.ncbi.nlm.nih.gov/pubmed/17179056">hot flushes</a> and <a href="http://www.ncbi.nlm.nih.gov/pubmed/15863547">mood swings</a>.</p>
<p>It’s safe to use for up to six months, although there have been <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Lontos+S%2C+Jones+RM%2C+Angus+PW%2C+Gow+PJ.+Acute+liver+failure+associated+with+use+of+herbal+preparations+containing+black+cohosh.+Med+J+Aust+2003%3B+179%3A+390-91">case reports</a> of liver failure in women using black cohosh for longer periods. </p>
<p>Further studies are required to clarify whether black cohosh may work to alleviate symptoms by mimicking estrogen.</p>
<p><strong>Maca</strong></p>
<p>Maca, a biennial herbaceous plant native to Peru has been used historically used for its putative fertility-enhancing and aphrodisiac properties. </p>
<p>Maca is marketed based on reported benefits in relieving menopause symptoms, though there is scant published scientific data show it is effective and exerts any estrogenic activity.</p>
<p><strong>Evening primrose oil</strong></p>
<p>Evening primrose oil is obtained from the seeds of a biennial plant native to the United States. It contains high levels of omega-6 essential fatty acids and is widely used for skin disorders, rheumatoid arthritis, multiple sclerosis, chronic fatigue, asthma and gastrointestinal disorders.</p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/40966/original/qzfvzmwd-1391732603.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/40966/original/qzfvzmwd-1391732603.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=489&fit=crop&dpr=1 600w, https://images.theconversation.com/files/40966/original/qzfvzmwd-1391732603.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=489&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/40966/original/qzfvzmwd-1391732603.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=489&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/40966/original/qzfvzmwd-1391732603.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=614&fit=crop&dpr=1 754w, https://images.theconversation.com/files/40966/original/qzfvzmwd-1391732603.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=614&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/40966/original/qzfvzmwd-1391732603.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=614&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Evening primrose plant.</span>
<span class="attribution"><a class="source" href="http://www.flickr.com/photos/wanderingnome/8111318834/sizes/l/">wanderingnome/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>Women have also been using primrose oil for decades for alleviating breast pain, endometriosis, and symptoms of menopause such as hot flushes. </p>
<p>As with other herbal supplements, the precise mechanism of action is not fully clear and the <a href="http://www.healthline.com/natstandardcontent/evening-primrose-oil">efficacy</a> of evening primrose oil for relieving symptoms in menopausal women is not conclusive.</p>
<p><strong>Dong quai</strong></p>
<p>Dong quai is also prepared from the root of a perennial aromatic herb, this one native to China and Japan. Dong quai has long been used in traditional Chinese medicine to regulate menstrual cycle and alleviate menopausal symptoms. </p>
<p>Scientific <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Hirata+JD%2C+Swierz+LM%2C+Zell+B%2C+et+al.+Does+dong+quai+have+estrogenic+effects+in+postmenopausal+women%3F+A+double-blind%2C+placebo+controlled+trial.+Fertility+and+Sterility+1997%3B+68%3A+981-6">evidence</a> suggests it is ineffective for relieving menopausal symptoms. But when used in combination with other herbs (such as black cohosh, chasteberry, milk thistle, chamomilla and Siberian ginseng) <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=Wong+VC%2C+Lim+CE%2C+Luo+X%2C+Wong+WS.+Current+alternative+and+complementary+therapies+used+in+menopause.+Gynecological+Endocrinology+2009%3B+25%3A166%E2%80%9374">appears to be useful</a> in controlling hot flushes and other menopausal symptoms.</p>
<p><strong>Ginseng</strong></p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/40965/original/dyypjq8z-1391732419.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/40965/original/dyypjq8z-1391732419.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=391&fit=crop&dpr=1 600w, https://images.theconversation.com/files/40965/original/dyypjq8z-1391732419.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=391&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/40965/original/dyypjq8z-1391732419.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=391&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/40965/original/dyypjq8z-1391732419.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=491&fit=crop&dpr=1 754w, https://images.theconversation.com/files/40965/original/dyypjq8z-1391732419.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=491&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/40965/original/dyypjq8z-1391732419.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=491&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Ginseng.</span>
<span class="attribution"><a class="source" href="http://www.flickr.com/photos/centralasian/3259345993/sizes/o/">Cea./Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p><a href="http://www.herbs-for-menopause.com/ginseng/ginseng-benefits.htm">Gingeng</a>, a root native to Chinese medicine has been used for centuries for a number of ailments. However, few studies have examined the effects of ginseng on menopausal symptoms. </p>
<p>Ginseng does not have estrogenic effects, suggesting it does not exert any hormone replacement-like effects. But it has <a href="http://www.ncbi.nlm.nih.gov/pubmed/17593379">been reported</a> to alleviate some menopausal symptoms. </p>
<h2>Other complementary therapies</h2>
<p>Homeopathy is a system of alternative medicine, where substances that cause symptoms of disease in healthy subjects would cure such symptoms in sick subjects. Active ingredients are used and repeatedly diluted in alcohol or distilled water until no molecules of the original substance remains. </p>
<p>Studies <a>show</a> homoeopathy is no more effective as a menopause treatment than a placebo, and since the ingredients are extensively diluted, it is unlikely to have any side effects. </p>
<figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/40971/original/c2x8qpxn-1391733413.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/40971/original/c2x8qpxn-1391733413.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=897&fit=crop&dpr=1 600w, https://images.theconversation.com/files/40971/original/c2x8qpxn-1391733413.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=897&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/40971/original/c2x8qpxn-1391733413.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=897&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/40971/original/c2x8qpxn-1391733413.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1127&fit=crop&dpr=1 754w, https://images.theconversation.com/files/40971/original/c2x8qpxn-1391733413.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1127&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/40971/original/c2x8qpxn-1391733413.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1127&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The evidence for accupuncture is mixed.</span>
<span class="attribution"><a class="source" href="http://www.flickr.com/photos/rocketlass/4716251954/sizes/l/">rocketlass/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span>
</figcaption>
</figure>
<p>Complementary methods such as acupuncture, moxibustion (a traditional Chinese medicine treatment that involves burning a herb called <a href="http://www.cancer.org/treatment/treatmentsandsideeffects/complementaryandalternativemedicine/herbsvitaminsandminerals/mugwort">Mugwort</a>) and reflexology are popular methods used to treat symptoms of various disease, including menopausal symptoms. </p>
<p>Again, there are contradictory studies, which <a href="http://www.ncbi.nlm.nih.gov/pubmed/10853874">some indicate</a> that such complementary methods alleviate menopausal symptoms to some extent, while <a href="http://www.ncbi.nlm.nih.gov/pubmed/20207087">other studies demonstrate</a> no benefit.</p>
<h2>So, what’s the verdict?</h2>
<p>Although some complementary and alternative therapies may have been used for many years with reports of great success, there is little scientific data to prove their efficacy. </p>
<p>And when studies have been undertaken, they’re of varying quality. Differences in findings across studies of the same product may be due to less-than-optimal trial design, variation in products and composition of products used, inadequate dosing, the length of treatment and small population size.</p>
<p>There’s no doubt that more clinical trials are required to ascertain the effectiveness of such methods in treating menopausal symptoms. In the meantime, exercise caution when taking complementary therapies and talk to your doctor about how they’ll interact with other medications you’re taking. </p>
<p>Just because they’re natural, doesn’t mean they’re risk-free.</p><img src="https://counter.theconversation.com/content/18007/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>During menopause, estrogen levels drop, leading to a number of unpleasant symptoms. The transition to menopause can significantly affect women’s quality of life, with many willing to try anything to alleviate…Lily Stojanovska, Professor and Acting Director Centre for Chronic Disease Prevention and Management, Victoria UniversityVasso Apostolopoulos, Adjunct Professor and Sessional Academic, Victoria UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/194362014-02-11T19:36:03Z2014-02-11T19:36:03ZHere’s why we should research alternative therapies<figure><img src="https://images.theconversation.com/files/41227/original/9r7jtdzd-1392090466.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Acupuncture is one of a suite of alternative therapies almost two-thirds of Australians use every year.</span> <span class="attribution"><span class="source">KayVee.INC/Flickr</span></span></figcaption></figure><p><em>TESTING ALTERNATIVE THERAPIES - La Trobe University’s decision to accept funding from Swisse for a new centre to research alternative medicines has sparked controversy. This series looks at how the evidence behind alternative medicines can be assessed, and the ethics of such links between industry and research institutions.</em></p>
<hr>
<p>Acupuncture, chiropractic, herbal medicines, massage, and
other therapies known collectively as complementary and alternative medicine, are big business in Australia, as elsewhere. </p>
<p>About <a href="http://www.anao.gov.au/Publications/Audit-Reports/2011-2012/Therapeutic-Goods-Regulation-Complementary-Medicines/Audit-brochure">two-thirds of Australians</a> use such products and practices over the course of a year. Nonetheless, the debate around these therapies remains dominated by emotive and political commentary – on both sides.</p>
<h2>Doing the right kind of research</h2>
<p>Like all other areas of health-care practice and consumption, complementary therapies need to be underwritten by rigorous scientific investigation. The gold standard of such work is the randomised controlled trial, which aims to establish whether a treatment or medicine is clinically efficacious. </p>
<p>This type of research is to be applauded and encouraged. But the current popularity of alternative therapies highlights the immediate need for parallel public health and health-services research. </p>
<p>What we need is a broad range and mix of methods and approaches that are essential to understanding the place and use of complementary therapies within contemporary health care.</p>
<p>Such an approach provides findings of direct benefit to practice and policy. It would be in the interest of patients, practitioners, and those managing and directing health policy to address critical questions such as why, when, and how alternative therapies are currently consumed and practiced. </p>
<p>Studies along these lines help provide a factual platform for ensuring safe, effective health care. And it’s important to note that such investigations are neither for complementary medicine nor against it.</p>
<p>Rather, the work is undertaken in the spirit of critical and rigorous empirical study that charts a path free from the emotion we have become accustomed to on this topic.</p>
<h2>A burgeoning body of work</h2>
<p>A number of recent Australian projects have started to do just this kind of research, to explore the use and practice of alternative therapies from a critical public health and health-services research perspective. </p>
<p>Research drawing on a large, nationally representative sample of 1,835 pregnant women, for instance, has shown that complementary therapies are popular for pregnancy-related conditions. The <a href="http://www.ncbi.nlm.nih.gov/pubmed/23231765">researchers found</a> nearly half (49.4%) of the women they studied had consulted an alternative-therapy practitioner at the same time as a maternity-care provider for a pregnancy-related condition. </p>
<p>Similarly, <a href="http://www.biomedcentral.com/1472-6882/12/98">another study found</a> 40% of Australian women with back pain who were surveyed had consulted a complementary-therapy practitioner, as well as a health provider for back pain. </p>
<p><a href="http://www.biomedcentral.com/1472-6882/11/85/">Other Australian research</a> has found that women in rural areas are statistically more likely to use alternative medicine than their counterparts in urban Australia. </p>
<p>And use has been <a href="http://bmjopen.bmj.com/content/3/4/e002292.abstract">identified as high</a> among <a href="http://www.biomedcentral.com/1472-6882/12/34">older Australian men and women</a> as well as among people with depression, cancer, and a range of chronic conditions. </p>
<p>In these and other areas of health-seeking behaviour and utilisation, the core issues requiring further examination include how people make the decision to use complementary therapies, and how they seek information and engage with them. </p>
<h2>Uncovering use</h2>
<p>The use of alternative therapies is often a hidden activity within the community and, in many cases, distanced from both formal care and health-care providers (and, in some cases, divorced from complementary therapists as well). This raises a number of potential risks around safety, efficiency, and coordination of care. </p>
<p>While many people condemn complementary and alternative therapies because of a lack of clinical evidence, this doesn’t constitute a scientific platform for ignoring or denying research on the subject. </p>
<p>In fact, it’s the opposite case. If we accept that most complementary therapies have at best emerging, weak, or no clinical evidence, then it surely becomes necessary to try and more fully understand what drives people to use them, in what manner and setting they use them, and what information they draw upon to decide whether they’ll use them.</p>
<p>At a time when health-care funding is stretched by our ageing population and rise of chronic illnesses, it’s imperative that research-based assessments of future practice, policy and financial planning include consideration of all health treatments. </p>
<p>Such research will not only help produce a critical, non-partisan platform for better understanding complementary and alternative therapies, it will also provide a rigorous and broad evidence-base with which to help people, practitioners, and policymakers on this significant component of Australians’ health care. </p>
<p><strong><em>This is the first article in our series about complementary and alternative therapies. Click on the links below to read the others:</em></strong></p>
<ul>
<li><a href="https://theconversation.com/herbal-medicines-toxic-side-effects-and-drug-interactions-23118">Herbal medicines – toxic side effects and drug interactions</a></li>
</ul>
<p><strong><em>Can we scientifically test herbal medicines?</em></strong></p>
<ul>
<li><p>Yes: <a href="https://theconversation.com/quality-research-of-herbal-medicines-is-possible-23139">Quality research of herbal medicines is possible</a></p></li>
<li><p>No: <a href="https://theconversation.com/why-we-cant-have-reliable-evidence-for-herbal-therapies-22882">We can’t have reliable evidence for herbal therapies</a></p></li>
</ul><img src="https://counter.theconversation.com/content/19436/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Professor Jon Adams receives funding from NHMRC and ARC for his research program.</span></em></p>TESTING ALTERNATIVE THERAPIES - La Trobe University’s decision to accept funding from Swisse for a new centre to research alternative medicines has sparked controversy. This series looks at how the evidence…Jon Adams, Professor of Public Health, University of Technology SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/124812013-03-07T19:41:15Z2013-03-07T19:41:15ZCAM or sham? Let’s get the facts straight on vitamins and supplements<figure><img src="https://images.theconversation.com/files/20998/original/2x9dwqh9-1362539898.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">How can you tell what products might be of use and which ones will only lighten your wallet?</span> <span class="attribution"><span class="source">Image from shutterstock.com</span></span></figcaption></figure><p>Australia’s complementary and alternative medicine (CAM) industry is worth about <a href="http://www.ibisworld.com.au/industry/default.aspx?indid=1914">A$4 billion annually</a>. Around <a href="http://www.anao.gov.au/Publications/Audit-Reports/2011-2012/Therapeutic-Goods-Regulation-Complementary-Medicines/Audit-brochure">two thirds</a> of Australians use CAM – which includes therapies such as chiropractic and naturopathy, traditional Chinese medicine, vitamins, minerals, nutritional supplements, as well as homoeopathic and aromatherapy products – and there appears to be no sign of this declining. </p>
<p>In many cases, the evidence for CAMs having significant beneficial effects is scant. And recent studies have even found that some <a href="http://heart.bmj.com/content/98/12/895.extract">supplements can be harmful</a>.</p>
<p>Though this is not true for all CAMs and, as a critic, I must be careful not make sweeping generalisations about efficacy – each CAM modality must be examined at face value. It is now well accepted, for example, that <a href="http://www.nlm.nih.gov/medlineplus/folicacid.html">folic acid</a> can prevent some birth defects and <a href="http://nccam.nih.gov/health/stjohnswort/sjw-and-depression.htm">St John’s Wort</a> is effective for mild to moderate depression.</p>
<p>But, as a consumer, how can you tell what products might be of use and which ones will only lighten your wallet? The task of sorting the wheat from the chaff is not made easy by unscrupulous pharmacies <a href="https://theconversation.com/want-to-try-the-latest-fad-diet-just-ask-your-local-pharmacist-4098">selling</a> what is essentially <a href="http://scepticsbook.com/2009/03/14/request-to-pharmacists-to-stop-selling-ear-candles-reaches-the-mainstream-media/">snake oil</a> alongside drugs for which efficacy is well established.</p>
<p>Can you trust the government to regulate products and only license those that work? You’d think so, but you’d be wrong. Indeed, the government is largely to blame for misleading consumers when it comes to CAMs.</p>
<h2>How are medicines registered?</h2>
<p>In Australia more than 10,000 drugs and medical devices are listed on the <a href="http://www.tga.gov.au/industry/artg.htm">Australian Therapeutics Goods Register</a> (ATRG). There are two arms to the ARTG: </p>
<ol>
<li><p>Listed products. These products are considered low risk and include complementary medicines such as herbs, minerals, vitamins and sunscreens. Listed products are identified with an “AustL” number.</p></li>
<li><p>Registered products. These products are high risk because they have a known effect and include prescription drugs and painkillers. Registered products are identified with an “AustR” number. </p></li>
</ol>
<p>The degree of assessment and regulation required to gain registration (AustR) is rigorous – sponsors are required to provide comprehensive safety, quality and efficacy data. </p>
<p>This is not the case for AustL. Under the current system, you can get your CAM product stamped with an official-looking number by simply applying online. You should hold evidence that your product works as described and you can explain this in a “free text” box which is provided when you apply for listing. </p>
<p>And therein lies the problem. Back in 2010, TGA auditors conducted a spot check on about 400 AustL products and <a href="http://www.smh.com.au/lifestyle/diet-and-fitness/watchdog-crackdown-on-alternative-medicines-20101228-199bo.html">found</a> nine out of ten breached regulations. </p>
<p>The breaches were largely relating to false claims of curative powers on labels and as a result, a “significant number” of products were removed from the ARTG. Which products were removed and precisely why, was not revealed by the TGA.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/20990/original/p7r4p8v2-1362537763.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/20990/original/p7r4p8v2-1362537763.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/20990/original/p7r4p8v2-1362537763.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/20990/original/p7r4p8v2-1362537763.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/20990/original/p7r4p8v2-1362537763.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/20990/original/p7r4p8v2-1362537763.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/20990/original/p7r4p8v2-1362537763.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The TGA does not check any AustL products to see if they work or even if they are safe.</span>
<span class="attribution"><span class="source">Clean Wal Mart</span></span>
</figcaption>
</figure>
<h2>Time for change</h2>
<p>Recently, the TGA announced it was finally putting a stop to the “free text” option when applying to list a product. As TGA manager Dr John Skerritt <a href="http://parlinfo.aph.gov.au/parlInfo/download/committees/estimate/e907ffd9-0ff7-48fb-b2d1-21555ab645ed/toc_pdf/Community%20Affairs%20Legislation%20Committee_2013_02_13_1707.pdf;fileType=application%2Fpdf#search=%22committees/estimate/e907ffd9-0ff7-48fb-b2d1-21555ab645ed/0001%22">told a Senate estimates committee</a>, this is supposed to be part of “the most sweeping reforms of complementary medicines regulations for many years in this country”. The proposed changes mean sponsors will have to select from a list of indications, the aim being to prevent spurious claims of cures or miracle treatments.</p>
<p>But this is not the first time the TGA has announced an overhaul of the CAM listing system. In 2012, it proposed the introduction of an <a href="http://scepticsbook.com/2012/06/03/more-hollow-legislation-from-the-tga/">Expert Report</a> that would require sponsors to conduct a review of the scientific literature in support of their product’s claims. </p>
<p>Following a call for public consultations, this proposal was quietly scrapped, apparently as a result of pressure from the CAM industry which protested it was prohibitively expensive and would force many small suppliers to close down. Or maybe it was the lack of published evidence for their claims that was worrying them. Curiously, it appears this idea was recently resurrected with a <a href="http://www.tga.gov.au/newsroom/consult-cm-argcm-partb-130121.htm">second round</a> of consultations on the same issue closing on February 18, 2013.</p>
<p>The removal of the free text option is also not new, being first proposed following a <a href="http://www.tga.gov.au/newsroom/review-tga-transparency-1101-call-for-input-101222.htm">transparency review</a> commissioned in 2010 by the Honourable Catherine King. </p>
<p>But even if these changes are implemented (and there’s some suggestion that in an election year, there may not be enough time to modify the relevant legislation) they miss the point, in my opinion. What consumers should be made aware of is that the TGA does not check any AustL products to see if they work or even if they are safe. This needs to be stamped on the side of all AustL products in great big letters.</p>
<p>And while consumers are free to make complaints about what they believe to be false or misleading claims made by AustL products, don’t expect anything to happen, even if the TGA rules in your favour. In approximately 30% of cases, orders to publish disclaimers or remove misleading material are <a href="http://www.abc.net.au/lateline/content/2010/s2867990.htm">ignored</a> by sponsors and the TGA has never in its history prosecuted a sponsor for non-compliance. Ever. </p>
<p>Adding a warning to a product may not change consumer behaviour, but it at least increases transparency, thus enabling consumers to make an informed decision about what they purchase. Although homoeopathy doesn’t always come under the ARTG (because some preparations are <a href="http://www.tga.gov.au/industry/cm-basics.htm">too dilute</a> to be considered of any risk), a sticker saying “this is not medicine” or “there is no evidence this works better than placebo” would make me think twice about handing over my 20 bucks. </p>
<p>So, the TGA can jump up and down all it likes and make announcements about proposed changes and new legislation, but until it actually instigates meaningful change, then it’s just lip service. While I was encouraged to see the <a href="http://www.tga.gov.au/industry/cm-cancellations-cr.htm">removal</a> of several products from the ARTG recently, much more needs to be done. </p><img src="https://counter.theconversation.com/content/12481/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rachael Dunlop receives funding from The Institute for Ethnomedicine, WY. She is a Vice President of Australian Skeptics Inc.</span></em></p>Australia’s complementary and alternative medicine (CAM) industry is worth about A$4 billion annually. Around two thirds of Australians use CAM – which includes therapies such as chiropractic and naturopathy…Rachael Dunlop, Post-doctoral fellow, University of Technology SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/84822012-12-17T03:29:44Z2012-12-17T03:29:44ZMonday’s medical myth: take a vitamin a day for better health<figure><img src="https://images.theconversation.com/files/18609/original/sk85c74k-1355290056.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Up to one in three Australians take vitamin supplements, but few healthy people need them.</span> <span class="attribution"><span class="source">Brian Gaid</span></span></figcaption></figure><p>Forget an apple a day, vitamin manufacturers would have you believe it’s important to take daily vitamins to boost your health. </p>
<p>And a surprising proportion of Australians do. Data from the last National Health survey (back in 1995) showed that up to <a href="http://www.abs.gov.au/ausstats/abs@.nsf/2f762f95845417aeca25706c00834efa/8281b681f03a73e0ca2570ec00192aa3!OpenDocument">30% of Australians</a> had recently taken vitamin or mineral supplements – mostly for preventive health reasons. </p>
<p>More recently, the <a href="http://www.45andup.org.au">45 and Up study</a> of more than 100,000 Australian adults found that 19% of men and 29% of women reported taking vitamin or mineral supplements. </p>
<p>But most healthy people don’t need to take vitamins. A better safeguard for your health would be to spend the money you save from <em>not</em> buying supplements, on buying more vegetables and fruit.</p>
<p>The <a href="http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pubhlth-strateg-food-guide-index.htm">Australian Guide to Healthy Eating</a> (AGHE) translates the <a href="http://www.eatforhealth.gov.au/sites/default/files/files/public_consultation/n55_draft_australian_dietary_guidelines_consultation_121003.pdf">national dietary guidelines</a> into recommended daily food serves to help Australians eat better, without the need for vitamins or mineral supplements. </p>
<p>In a nutshell, the aim is for adults to have a minimum daily intake of: </p>
<ul>
<li>two serves of fruit </li>
<li>four to five serves of vegetables</li>
<li>four to six serves of wholemeal or wholegrain breads and cereals </li>
<li>two serves of reduced fat dairy products</li>
<li>one serve of lean protein</li>
<li>a small amount of healthy fats. </li>
</ul>
<p>The problem is, we just don’t follow the advice in the dietary guidelines, or eat like the patterns suggested in the AGHE.</p>
<p>The last <a href="http://www.abs.gov.au/websitedbs/d3310114.nsf/4a256353001af3ed4b2562bb00121564/b5243fb56a17a812ca2572030023fdd3!OpenDocument">National Nutrition Survey</a> of dietary intakes in adults (from 1995 – this is currently being updated) found that we had inadequate intakes of vegetables, fruit, wholegrain cereals and dairy products. We also consumed too much fat, especially saturated fat and over a third of our daily energy intake came from energy-dense nutrient-poor foods, aka “junk” foods.</p>
<p>So what do we do: turn to vitamin and mineral supplements to make up the shortfall? Or try harder to encourage Australians to eat better?</p>
<figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/18611/original/jsykdnhx-1355290136.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/18611/original/jsykdnhx-1355290136.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/18611/original/jsykdnhx-1355290136.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/18611/original/jsykdnhx-1355290136.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/18611/original/jsykdnhx-1355290136.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=504&fit=crop&dpr=1 754w, https://images.theconversation.com/files/18611/original/jsykdnhx-1355290136.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=504&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/18611/original/jsykdnhx-1355290136.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=504&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Most healthy people don’t need to take vitamins.</span>
<span class="attribution"><span class="source">Andreas Feldl</span></span>
</figcaption>
</figure>
<p>I vote for the second approach because taking supplement is not without risks. </p>
<p>Take <a href="http://www.ncbi.nlm.nih.gov/pubmed/17209217">lung cancer</a>, for example. Epidemiological research indicated that eating more fruit and vegetables was associated with a reduced risk of lung cancer. After this relationship was recognised, a number of clinical trials then gave people supplements of <a href="http://www.nlm.nih.gov/medlineplus/druginfo/natural/999.html">beta-carotene</a>, given it’s a major <a href="http://www.ncbi.nlm.nih.gov/pubmed/10511324">carotenoid</a> (pigment) in vegetables and fruit. </p>
<p>But the supplements had the opposite effect and actually <a href="http://www.ncbi.nlm.nih.gov/pubmed/18429004">increased the risk of lung cancer</a> in smokers. </p>
<p>Medical problems that arise due to excessive intakes of vitamins and minerals are almost always due to intakes of supplements. To develop toxicity from vitamins in food you’d have to eat excessive amounts of specific foods such as carrots (which could make your skin turn yellow) or liver (vitamin A toxicity would leave you with blurred vision, dizziness, nausea and headaches).</p>
<p>There are, however, people with health conditions or in a particular life stage when they really need vitamins. This includes people with chronic medical problems (such as cystic fibrosis, coeliac disease, pancreatitis), people on restrictive diets to achieve rapid weight loss, those with conditions that interfere with their ability to eat properly.</p>
<p>Women planning a pregnancy also require additional nutrients. <a href="http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/Folate_for_women?open">Folic acid</a> supplements are strongly recommended in early pregnancy to reduce the risk of having a baby with neural-tube defects such as spina bifida.</p>
<p>Let’s leave vitamin supplements to those who need them, and call this myth busted. </p>
<hr>
<p><strong>Are you getting enough vitamins and minerals in your diet?</strong> </p>
<p>Take the <a href="http://healthyeatingquiz.com.au/">Five Minute Healthy Eating Quiz</a>. Developed by my colleagues and I at the University of Newcastle, the quiz compares your current eating habits against the Australian Dietary Guidelines. It also provides advice on how to improve the variety and nutritional quality of your usual diet. </p><img src="https://counter.theconversation.com/content/8482/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Clare Collins is a coauthor of the Healthy Eating Quiz <a href="http://healthyeatingquiz.com.au/">http://healthyeatingquiz.com.au/</a>
</span></em></p>Forget an apple a day, vitamin manufacturers would have you believe it’s important to take daily vitamins to boost your health. And a surprising proportion of Australians do. Data from the last National…Clare Collins, Professor in Nutrition and Dietetics, University of NewcastleLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/105272012-11-14T03:29:30Z2012-11-14T03:29:30ZReflexology: panacea or placebo?<figure><img src="https://images.theconversation.com/files/17404/original/x4kwrz6y-1352351405.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">It's unclear whether reflexology provides any therapeutic benefits beyond those of a generic foot massage.</span> <span class="attribution"><span class="source">Paul Bence</span></span></figcaption></figure><p>Reflexology is a form of manual therapy based on the principle that specific locations on the feet, hands and ears have connections to the rest of the body. By applying pressure to these locations using various massage techniques, reflexology is thought to stimulate the body’s natural healing processes.</p>
<p>A very broad range of conditions are treated with reflexology, including headache, asthma, premenstrual syndrome, irritable bowel syndrome, dementia, incontinence, diabetes, low back pain and cancer-related pain. The <a href="http://www.reflexology.org.au/home2/index.php?option=com_content&view=article&id=20:reflexology-and-you&catid=2:modern-practice&Itemid=9">Reflexology Association of Australia</a> states that “all body systems benefit from reflexology”.</p>
<p>A <a href="http://www.ncbi.nlm.nih.gov/pubmed/17718647">population-based survey</a> of 1,067 Australians in 2005 found that 4% had received reflexology in the previous 12 months.</p>
<h2>History</h2>
<p>The history of reflexology has not been thoroughly documented, although practises resembling reflexology have been identified from ancient Egyptian, Greek, Chinese, Indian and Native American sources. </p>
<p>A <a href="http://upload.wikimedia.org/wikipedia/commons/d/d5/Akmanthor.jpg">wall painting in the tomb of Ankhmahor</a> (c 2,330BC) in Saqqara, Egypt is often cited as one of the earliest depictions of reflexology, although it is unclear whether the image merely represents massage as opposed to reflexology.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/17402/original/qfj9rqzs-1352351181.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/17402/original/qfj9rqzs-1352351181.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=316&fit=crop&dpr=1 600w, https://images.theconversation.com/files/17402/original/qfj9rqzs-1352351181.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=316&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/17402/original/qfj9rqzs-1352351181.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=316&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/17402/original/qfj9rqzs-1352351181.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=397&fit=crop&dpr=1 754w, https://images.theconversation.com/files/17402/original/qfj9rqzs-1352351181.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=397&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/17402/original/qfj9rqzs-1352351181.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=397&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Akmanthor.</span>
<span class="attribution"><span class="source">Wikimedia Commons</span></span>
</figcaption>
</figure>
<p>An early form of reflexology (zone therapy) was introduced to the United States in 1913 by <a href="http://www.reflexologyinstitute.com/reflex_fitzgerald.php">Dr William Fitzgerald</a>, an ear, nose and throat specialist. Fitzgerald proposed that there were ten vertical zones in the body. By stimulating the appropriate locations on the soles of the feet, bioelectrical energy flows could be altered, leading to pain relief in other body regions.</p>
<p>The modern practice of reflexology is primarily influenced by the work of Eunice Ingham, a nurse and physiotherapist whose 1938 text <a href="http://www.worldcat.org/oclc/9867508">Stories the Feet Can Tell</a> contained detailed maps of the “reflex” areas of the sole of the foot corresponding to the rest of the body, including internal organs.</p>
<p>Reflex areas do not correspond to either the nervous system or to acupuncture meridians, and published maps demonstrate <a href="http://www.ncbi.nlm.nih.gov/pubmed/22789788">several inconsistencies</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/17410/original/939kn28v-1352352322.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/17410/original/939kn28v-1352352322.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/17410/original/939kn28v-1352352322.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=364&fit=crop&dpr=1 600w, https://images.theconversation.com/files/17410/original/939kn28v-1352352322.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=364&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/17410/original/939kn28v-1352352322.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=364&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/17410/original/939kn28v-1352352322.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=457&fit=crop&dpr=1 754w, https://images.theconversation.com/files/17410/original/939kn28v-1352352322.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=457&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/17410/original/939kn28v-1352352322.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=457&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">There are many incosistencies between published maps.</span>
<span class="attribution"><span class="source">Stacy Simone</span></span>
</figcaption>
</figure>
<h2>Mechanism</h2>
<p>There is no clear consensus among reflexologists as to how the therapy “works”. Several mechanisms have been proposed, including the unblocking of energy fields, the removal of toxins, the breakdown of crystalline deposits in the lymphatic system, the release of endorphins, alteration of electromagnetic fields, and the increase of blood flow to internal organs.</p>
<p>Many of these mechanisms are inconsistent with mainstream physiological principles and are therefore unmeasurable with conventional scientific methods. </p>
<p><a href="http://www.ncbi.nlm.nih.gov/pubmed/23072265">Four trials</a> have demonstrated some evidence of a reduction in systolic blood pressure and heart rate in individuals undergoing reflexology. However, these studies did not adequately control for non-specific (placebo) effects, so it is not possible to delineate the benefit of stimulating reflex areas from the beneficial effects of simply lying down and receiving a relaxing foot massage.</p>
<h2>Reflexology to aid diagnosis</h2>
<p>Some reflexologists claim that the identification of tenderness at specific locations on the foot can assist in the diagnosis of medical conditions. Two studies have explored this by asking reflexologists to examine patients of whom they had no previous knowledge.</p>
<p>In both studies, the <a href="http://www.ncbi.nlm.nih.gov/pubmed/11068346">level of agreement between reflexologists was very low</a>, as was the level of agreement between the reflexologists’ diagnoses and the known medical history of the patients. There was also evidence of <a href="http://www.ncbi.nlm.nih.gov/pubmed/9528375">over-diagnosis</a> by the reflexologists. Therefore, the reflexology approach to diagnosis cannot be considered valid.</p>
<h2>Does reflexology work?</h2>
<p>The most recent and comprehensive <a href="http://www.ncbi.nlm.nih.gov/pubmed/21111551">systematic review</a> on the effectiveness of reflexology found 23 trials where reflexology had been compared to no treatment, usual care, or a placebo/sham treatment. The methodological quality of these trials was generally poor, with few studies adequately controlling for non-specific (placebo) effects or blinding the assessors documenting the outcome measurements. </p>
<figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/17408/original/gs2pfdhw-1352351911.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/17408/original/gs2pfdhw-1352351911.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=800&fit=crop&dpr=1 600w, https://images.theconversation.com/files/17408/original/gs2pfdhw-1352351911.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=800&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/17408/original/gs2pfdhw-1352351911.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=800&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/17408/original/gs2pfdhw-1352351911.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1005&fit=crop&dpr=1 754w, https://images.theconversation.com/files/17408/original/gs2pfdhw-1352351911.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1005&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/17408/original/gs2pfdhw-1352351911.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1005&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">There’s no consensus about how reflexology ‘works’ but some believe it removes toxins.</span>
<span class="attribution"><span class="source">countrygal</span></span>
</figcaption>
</figure>
<p>The review concluded that there is insufficient evidence to demonstrate that reflexology is an effective treatment for any medical condition.</p>
<p>It needs to be acknowledged, however, that conducting high quality trials of reflexology is inherently difficult. <a href="http://www.ncbi.nlm.nih.gov/pubmed/23072264">Possible solutions</a> to the problems of inconsistent reflexology maps and difficulties controlling for placebo effects have recently been proposed, but have not yet been implemented.</p>
<h2>Is reflexology safe?</h2>
<p>There appears to be very few adverse effects associated with reflexology treatment itself. However, reflexology, like many other complementary therapies, could potentially be life threatening if used in the place of orthodox medicine for treating serious conditions (such as <a href="http://www.ncbi.nlm.nih.gov/pubmed/8200209">patients with diabetes using alternative treatments</a> in preference to taking insulin).</p>
<h2>The verdict</h2>
<p>Reflexology is a popular form of manual therapy. The basic underlying premise of reflexology has no sound scientific basis, reflexology maps exhibit several inconsistencies, and there is no convincing evidence that reflexology assessment can identify underlying medical conditions. </p>
<p>Several low quality trials have been conducted, so it remains unclear as to whether reflexology confers any therapeutic benefits beyond those provided by generic foot massage.</p>
<p><strong><em>This is the seventh article in our series Panacea or Placebo. Click on the links below to read the other instalments:</em></strong></p>
<ul>
<li><p><a href="https://theconversation.com/western-herbal-medicine-panacea-or-placebo-7474">Western herbal medicine</a></p></li>
<li><p><a href="https://theconversation.com/aromatherapy-panacea-or-placebo-9270">Aromatherapy</a></p></li>
<li><p><a href="https://theconversation.com/chiropractic-therapy-placebo-or-panacea-8104">Chiropractic</a></p></li>
<li><p><a href="https://theconversation.com/colonic-therapy-panacea-or-placebo-9926">Colonic therapy</a></p></li>
<li><p><a href="https://theconversation.com/modern-acupuncture-panacea-or-placebo-8102">Modern acupuncture</a></p></li>
<li><p><a href="https://theconversation.com/myotherapy-panacea-or-placebo-9183">Myotherapy</a></p></li>
</ul><img src="https://counter.theconversation.com/content/10527/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Professor Hylton B Menz receives funding from the National Health and Medical Research Council of Australia.</span></em></p>Reflexology is a form of manual therapy based on the principle that specific locations on the feet, hands and ears have connections to the rest of the body. By applying pressure to these locations using…Hylton B Menz, Professor; NHMRC Senior Research Fellow , La Trobe UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/91832012-10-03T04:31:40Z2012-10-03T04:31:40ZMyotherapy: panacea or placebo?<figure><img src="https://images.theconversation.com/files/16071/original/td22dpqn-1349143513.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Some of the techniques that form the armamentarium of myotherapy are supported by some positive evidence.</span> <span class="attribution"><span class="source">o5com</span></span></figcaption></figure><p><em>PANACEA OR PLACEBO – A weekly series assessing the evidence behind complementary and alternative medicines.</em></p>
<p>Myotherapy was developed by American <a href="http://en.wikipedia.org/wiki/Bonnie_Prudden">Bonnie Prudden</a> in the 1970s as a system of treating painful and dysfunctional muscles and soft tissue. The term is also used more generally to describe a suite of soft tissue and massage techniques. </p>
<p>Myotherapists are concerned with treating <a href="http://www.mayoclinic.com/health/myofascial-pain-syndrome/DS01042">myofascial pain</a>. This term was coined by <a href="http://en.wikipedia.org/wiki/Janet_Travell">Janet Travell</a> and <a href="http://www.dgs.eu.com/fileadmin/documents/Obituary_DGS_BMJ.pdf">David Simons</a> to refer to pain that arises from areas within muscles and ligaments that are both spontaneously painful and also capable of causing referred pain in predictable patterns. </p>
<p>They were a fascinating and formidable pair: Travell was best known as JFK’s personal physician; Simons was a pioneer of stratospheric flight and the first man to observe the curvature of the earth from the edge of space. Their <a href="http://books.google.com.au/books/about/Travell_Simons_Myofascial_Pain_and_Dysfu.html?id=sU0XupX7DGsC&redir_esc=y">Trigger Point Manual</a> has become a standard reference for clinicians interested in myofascial pain. </p>
<p>Bonnie Prudden was an early leader in promoting physical fitness for the masses, and became interested in the work of Travell and Simons in the early 1970s. She published her book <a href="http://www.getcited.org/pub/102067234">Pain Erasure</a> in 1980 and devoted the rest of her life to teaching and expanding myotherapy from her base in Tucson, Arizona.</p>
<h2>Techniques and evidence</h2>
<p>Trigger points and myofascial pain remain a controversial area of medicine. Few clinicians who see large number of patients with musculoskeletal pain would argue against the idea that painful areas exist in the locations described in the Trigger Point Manual. </p>
<p>As a pain specialist, I have certainly been able to help sort out dozens of patients referred by colleagues with otherwise inexplicable pain by applying the general principles of Travell and Simons. </p>
<p>But nearly half a century after the terms trigger points and myofascial pain were coined, the scientific understanding of them, and the best means of treating the latter remain sketchy. This is largely due to the slow progress of basic science research into muscle and soft tissue pain. </p>
<p>Manual techniques including massage, focused pressure from hands, fingers, knuckles or elbows and the use of modalities such as heat, cold, electrical stimulation and sticking acupuncture needles into the trigger points form the bulk of what myotherapists are trained to do. They also give advice about posture and prescribe exercise programs to remediate the biomechanical imbalances that caused the trigger points to form in the first place. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/16078/original/qkrwxmjk-1349155922.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/16078/original/qkrwxmjk-1349155922.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/16078/original/qkrwxmjk-1349155922.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/16078/original/qkrwxmjk-1349155922.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/16078/original/qkrwxmjk-1349155922.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/16078/original/qkrwxmjk-1349155922.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/16078/original/qkrwxmjk-1349155922.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Myotherapists use manual techniques to alleviate tissue and muscle pain.</span>
<span class="attribution"><span class="source">www.shutterstock.com</span></span>
</figcaption>
</figure>
<p>Some of the techniques that form the armamentarium of myotherapy are supported by some positive evidence. Trigger-point injections with local anaesthetic, dry needling and even botulinum toxin have good supporting evidence of short- to medium-term benefit. <a href="http://www.aafp.org/afp/2002/0215/p653.html">This article</a> from the American Family Physician journal gives a comprehensive summary of what is understood about treatment approaches for myofascial pain.</p>
<p>But published studies in the peer-reviewed literature of specific <a href="http://www.bonnieprudden.com/">Bonnie Prudden-approved manual techniques</a> are completely lacking. If you search myotherapy in <a href="http://www.ncbi.nlm.nih.gov/pubmed">Pubmed</a> you find very little: the papers published in the medical literature are merely case reports of a German technique for treating painful jaw muscles.</p>
<h2>Training and practice</h2>
<p>In Australia, Victoria has all the tertiary courses in Myotherapy apart from one. Qualifications from an Advanced Diploma of Remedial Massage (Myotherapy) to a Bachelor-level degree in Myotherapy are available through RMIT University, Australian College of Sports Therapy, Northern Melbourne Institute of TAFE, Southern School of Natural Therapies, Chisholm Institute, Holmesglen Institute and Endeavour College. </p>
<p>Completion of one of these courses is required for membership of the Institute of Registered Myotherapists of Australia (IRMA), but the term “myotherapist” is not a protected professional title. </p>
<p>Most myotherapists work in small individual practices or as part of a multidisciplinary team of allied health clinicians. Many massage therapists also incorporate myotherapy into their practice.</p>
<h2>My verdict</h2>
<p>There is a lingering impression of a cult of personality about myotherapy in general, considering the charismatic individuals involved in pioneering it, and the lack of follow-up development of an evidence base. </p>
<p>Myotherapy is, however, founded on rational principles and does not tend to make claims of benefit beyond the myofascial realm of treatment. </p>
<p>Attending a myotherapist for muscular pain may well have a positive result if your pain is due to trigger points and remains amenable to manual treatments.</p>
<p>It seems a reasonable precaution to prefer a therapist who is a member of the <a href="http://www.myotherapy.org.au/home">IRMA</a>, which represents around 500 therapists, or the <a href="http://aamt.com.au/">Australian Association of Massage Therapists</a>, since these organisation require their members to carry indemnity insurance and participate in ongoing professional development activities.</p>
<p>You can find a consumer guide to attending a myotherapist at the Victorian government’s <a href="http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/Myotherapy">Better Health Channel</a> website. </p>
<p><strong><em>Read the second instalment of panacea of placebo:</em></strong></p>
<ul>
<li><a href="https://theconversation.com/modern-acupuncture-panacea-or-placebo-8102">Acupuncture</a></li>
</ul><img src="https://counter.theconversation.com/content/9183/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Michael Vagg has a professional subscription to the Journal of Musculoskeletal Pain, which is published by the International Myopain Society.</span></em></p>PANACEA OR PLACEBO – A weekly series assessing the evidence behind complementary and alternative medicines. Myotherapy was developed by American Bonnie Prudden in the 1970s as a system of treating painful…Michael Vagg, Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist, Barwon HealthLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/91582012-08-30T03:56:37Z2012-08-30T03:56:37ZSwisse vitamins’ sweetener to doctors: complaint resolution<figure><img src="https://images.theconversation.com/files/14782/original/8936fyzm-1346292853.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The CHC Complaints Resolution Committee did not consider a $675 gift to be "undue influence, pressure or unfair tactics".</span> <span class="attribution"><span class="source">Bradley Stemke</span></span></figcaption></figure><p>In April 2012 Swisse made the following offer to GPs, “For those who on-sell full sized Swisse Practitioner products, Swisse will sponsor the full cost for you or one of your staff members to complete an online course in Health and Complementary Medicine by the National Institute of Integrative Medicine (NIIM), valued at $675”. </p>
<p>The offer <a href="http://theconversation.com/swisse-vitamins-highlights-the-failure-of-industry-self-regulation-6535">raised a number of concerns</a>. </p>
<p>First, it contained a financial inducement to doctors to specifically recommend the products of a particular company. What’s more, encouraging doctors to “on-sell” products to patients (presumably at a lucrative mark-up) runs the risk of encourage unnecessary or inappropriate prescribing. It also violates the traditional (and ethical) separation of prescribing from dispensing. </p>
<p>Third, this promotion appears to violate Section 9.12 of <a href="http://medicinesaustralia.com.au/code-of-conduct/">Medicines Australia Code of Conduct</a> which says, “No gift, benefit in kind or pecuniary advantage shall be offered or given to healthcare professionals or to administrative staff as an inducement to recommend, prescribe, dispense or administer a Company’s product(s)”.</p>
<p>But Swisse is <a href="http://medicinesaustralia.com.au/about-us/our-members/">not a member</a> of Medicines Australia. Instead, the company is a member of the <a href="http://www.chc.org.au/">Complementary Health Care Council of Australia</a> (CHC). Neither the existing 2005 <a href="http://www.chc.org.au/CHC-Codes-of-Practices">CHC Code</a> nor its initial <a href="http://www.chc.org.au/Resources/Documents/Codes%20and%20Guidelines/DRAFT%20Code%20of%20Practice%20for%20the%20Marketing%20of%20Complementary%20Medicines%20%20Health%20Food%20Productsjuly.pdf">2012 “consultation draft”</a> contains a clause similar to that in Medicines Australia code. </p>
<p>But the <a href="http://www.chc.org.au/Resources/Documents/CHC_Code_of_Practice_for_the_marketing_of_Complementary_Healthcare_and_Healthfood_Products.pdf">2005 code</a> does contain a clause (4.1.1) that states, “Members should not engage in any unfair or unconscionable conduct or commercial practice”. </p>
<p>Accordingly, on April 18 2012, I submitted a complaint to the CHC arguing that the Swisse promotion subjected doctors to “undue influence, pressure or unfair tactics” especially when such conduct is not allowed by Medicines Australia code. I also asked the CHC to add Medicines Australia Code S 9.12 to the consultation draft of their new code and increase the maximum penalties available from $20,000 to $200,000.</p>
<p>On August 28 2012, I received the determination of the CHC Complaints Resolution Committee. The Committee found that the offer of a $675 gift did not constitute “undue influence, pressure or unfair tactics”. It acknowledged the value of education in allowing doctors to confidently and appropriately integrate nutritional and herbal medicines into their practice. The committee went on to say, “However, the offer of a valuable consideration as an inducement to stock a product range does not fit within the spirit of the Code of Practice”. No penalty or sanction was applied. </p>
<p>The new consultation draft of the CHC Code (July 2012) was recently published for comment. As requested, it has the exact words from the Medicines Australia code of conduct as a new section (8.14.1). And it has raised the maximum fine available for code breaches to $40,000. </p>
<p>The draft also suggests increasing transparency by stating the outcomes of all complaints received will be published on the CHC website as and when complaints are finalised (currently, only summary details are published in the CHC annual report). It has incorporated some, but not all, of the high-level principles contained in the report of the government’s <a href="http://www.health.gov.au/internet/main/publishing.nsf/Content/Consultation:+Position+Paper+on+the+Promotion+of+Therapeutic+Goods">Working Group on Promotion of Therapeutic Products</a>, which was tasked with aligning self-regulatory codes of conduct. </p>
<p>But the latest CHC consultation draft code has left out the following high-level statement of principle that the working group recommended be included in all therapeutic industry codes:</p>
<blockquote>
<p>“The Australian therapeutic products industry promotes the concept of good health incorporating the quality use of therapeutic products which is based on genuine consumer health needs and supported by the ethical conduct of all parties. The quality use of therapeutic products means: selecting diagnostic and treatment options wisely based on the best available evidence and the consumer’s needs; choosing suitable therapeutic products if this is considered necessary, and using therapeutic products safely and effectively.”</p>
</blockquote>
<p>Critics argue that the complementary medicines industry produces many products that don’t meet genuine consumer health needs and are not promoted in accordance with quality use of medicines principles. So it’s important to ensure that the working group’s statement is incorporated in the next draft of the CHC code.</p>
<p>The CHC consultation draft code states (Section 4.4), “Non-members will be invited to submit to the Code’s processes if a complaint is received, with refusal of this invitation resulting in the complaint being referred to the relevant Government authority e.g. TGA, ACCC, NSW Food Safety Authority”. </p>
<p>While this may be appropriate for complaints about promotion to consumers, it does nothing to resolve complaints about promotion to health professionals by non-members. The government (and the TGA) continues to insist that these must be dealt with by self-regulation. But self-regulation can only work if the government adopts the recommendation of their working group that compliance with a self-regulatory code must be made a condition of TGA marketing approval. Otherwise there’s no inducement for bodies such as CHC and Medicines Australia to ensure self-regulation is not simply self-serving.</p><img src="https://counter.theconversation.com/content/9158/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr Harvey has accepted travel expenses only to talk about problems of complementary medicine regulation to pharmaceutical companies and industry associations. He has also been paid travel expenses and sitting fees for his involvement with government inquiries and working groups concerning pharmaceutical promotion and the regulation of complementary medicines. He is regarded by industry as a serial complainant.</span></em></p>In April 2012 Swisse made the following offer to GPs, “For those who on-sell full sized Swisse Practitioner products, Swisse will sponsor the full cost for you or one of your staff members to complete…Ken Harvey, Adjunct Associate Professor of Public Health, La Trobe UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/82322012-07-16T05:12:53Z2012-07-16T05:12:53ZComplementary vs western medicine – both have a role in universities<figure><img src="https://images.theconversation.com/files/13004/original/bsh7f2rr-1342408045.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Universities should be protected as sites where unpopular ideas and theories can be examined.</span> <span class="attribution"><span class="source">uonottingham</span></span></figcaption></figure><p>Medicine has long been the subject of vigorous debate about the control of social resources. The formation of modern medicine in the mid-19th century was itself the result of a century long fight for legitimacy among many contending groups. At that time, those who won out – the physicians, the surgeons and those who prepared and sold medicines – had no more evidence to support them than those they defeated. They succeeded on the basis of politics, not of evidence.</p>
<p>Since then, western medicine has grown into a key social institution supported by an elaborate scientific infrastructure. But the battle to defend its status, authority and access to wealth continues unabated.</p>
<p>On the one hand, doctors and their professional organisations are engaged in regular disputes with government about the control of fees and budgets, disciplinary practices and accreditation and the extent of their decision-making power. On the other hand, there is a persistent need to defend the boundaries against opposing forms of health care - so-called “complementary” medicine. The latter haven’t died out, despite the undisputed success of medicine. Indeed, estimates show that in most developed countries, including Australia, about half the population regularly use health practices outside the mainstream.</p>
<p>By and large, most people would agree that this is unproblematic and regard it as just part of the rough and tumble of democratic life. What’s more, the current arrangements are regarded as broadly satisfactory. The ability of individuals to choose their own forms of health care is maintained, subject to some limits on what practitioners can do: in the case of complementary therapists, for example, there are rules – admittedly, not always enforced - to protect vulnerable people from unscrupulous, unfounded and dangerous practices and restrictions on the kinds of claims that can be made in advertising and promotional materials.</p>
<h2>Western vs complementary medicine</h2>
<p>Debates about complementary medicine’s place in society have traditionally been vigorous, but reasoned, with the proponents of medicine calling on the authority of science, and their opponents either appealing to their own evidence, which may be derived from traditional practices, or to philosophical theories, or drawing attention to perceived limitations of western medicine.</p>
<p>But there is a current tendency in Australia that may have crossed the line from reasoned discussion to the inappropriate use of power and authority. A group referring to itself as the “<a href="http://www.scienceinmedicine.org.au/">Friends of Science in Medicine</a>”, made up of senior doctors and scientists, has set itself up to “counter the growth” of what it regards as “pseudoscience in medicine”, where “true science” is defined as a set of practices characterised by “an experimental, evidence-based approach”.</p>
<p>The strategy of the group is to apply pressure on government and educational institutions through advertisements, the use of the media and sometimes personal criticisms of individuals to withdraw or prohibit funding for complementary health practices. The organisation models itself on groups in the United States and the United Kingdom that have succeeded in having funding removed from certain “alternative medicine” courses.</p>
<p>Philosophically and ethically, the approach of the group is questionable. As any practitioner knows, the role of empirical evidence in determining a particular clinical decision is, at best, partial and tentative. What we do is pose hypotheses on the basis of laboratory or clinical studies, which we then test through careful observation and assessment of outcomes. Each decision is conditioned by the unique circumstances of the individual involved, including his or her personal medical history, goals, values and preferences. It’s about opening up possibilities, not closing them down.</p>
<h2>The role of universities</h2>
<p>The key places in our society where science is conducted are the universities. These should therefore be protected as sites where unpopular ideas and theories can be examined. They must foster criticisms of orthodoxy, especially those embedded in the institutions of power and authority. Both western medical practitioners and scientists - like myself – and their interlocutors must be challenged and called to account for their claims and judgements.</p>
<p>What is objectionable about Friends of Science in Medicine is their lack of respect for the fragile balance on which genuine dialogues about knowledge and ethics depend, and their readiness to resort to the use of power and authority to win an intellectual debate. Of course, the medical research and teaching budgets are in the hundreds of millions of dollars, so the power is on their side. Although they may therefore win the battle, the trouble is that control of wealth and the institutions of authority does not generate truth.</p>
<h2>Clear thinking</h2>
<p>None of this means that there are not problems, either with complementary medicines or with aspects of western medicine. In both cases, vulnerable members of the community need to be protected from exaggerated or misleading claims. In both cases, the evidence – in all its forms – needs to be scrutinised and presented clearly and fairly to patients. And in both cases, the process of communication has to be open, respectful and free of contamination with power or self-interest.</p>
<p>In the spirit and tradition of science, if there is a disagreement, let it be resolved in the crucible of public discourse. We do not need intellectual vigilantes patrolling the corridors of our institutions looking for theories or ideas with which they disagree to drive them out from our midst.</p>
<p><em><strong>Paul Komesaroff’s comment piece, <a href="https://www.mja.com.au/journal/2012/197/2/medicine-and-science-must-oppose-intolerance-and-censorship">Medicine and science must oppose intolerance and censorship</a>, is published in today’s Medical Journal of Australia</strong></em></p><img src="https://counter.theconversation.com/content/8232/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Paul Komesaroff does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Medicine has long been the subject of vigorous debate about the control of social resources. The formation of modern medicine in the mid-19th century was itself the result of a century long fight for legitimacy…Paul Komesaroff, Professor of Medicine, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/55262012-02-23T04:23:01Z2012-02-23T04:23:01ZNew weight-loss claims show TGA reforms aren’t working<figure><img src="https://images.theconversation.com/files/8002/original/4d8s94bd-1329959385.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The TGA is still slow to act on products making dubious weight-loss claims.</span> <span class="attribution"><span class="source">puuikibeach</span></span></figcaption></figure><p>Little seems to have changed inside the Therapeutic Goods Administration (TGA). And that’s despite two years of reviews into the shortcomings of its regulatory processes and the release, late last year, of the government’s <a href="http://www.tga.gov.au/newsroom/btn-cm-framework.htm">blueprint for reform</a>.</p>
<p>Complaints about breaches of the <a href="http://www.tga.gov.au/industry/legislation-tgac.htm">Therapeutic Goods Advertising Code</a> continue to generate a weak response – the latest of which involves the TGA-listed weight-loss product <a href="http://www.undoit.com.au/">Undoit®</a>. Its suppliers claim you can eat “fat-laden, carb-dense snacks” and just pop a pill to “undo” their effects. </p>
<h2>Proposed reforms</h2>
<p>Stakeholders put a ton of effort into submissions that documented problems with the TGA and suggested improvements. But the government’s “reform” document <a href="http://theconversation.com/tga-all-bark-no-bite-as-labor-botches-response-to-a-series-of-reviews-4640">contained</a> only an ounce of movement. </p>
<p>Stakeholders had pointed out, for instance, that numerous reports over the past decade recommended timely and effective sanctions to deter manufacturers or importers of complementary medicines (known as sponsors) from repeated breaches of the <a href="http://www.tga.gov.au/industry/legislation-tgac.htm">Therapeutic Goods Advertising Code</a>. </p>
<p>Yet the reform “blueprint” merely said, “The TGA will develop options for consideration by Government in consultation with stakeholders on … developing a more effective approach to sanctions and penalties for breaches of advertising requirements.” </p>
<p>Many stakeholders had <a href="http://www.tga.gov.au/pdf/submissions/review-tga-transparency-1101-submission-loretta-marron.pdf">expressed concern</a> in the past that the TGA was a “black-hole” of communication. Consumers could submit a complaint about a product but received no communication from the TGA about the outcome of the investigation. </p>
<p>In response to these concerns, the reform “blueprint” said, “the TGA will adopt a strong focus on improving its communication and engagement with the community”. </p>
<p>Following the publication of the government’s reform “blueprint”, several TGA staff have resigned, although these changes are not reflected on the <a href="http://www.health.gov.au/internet/main/publishing.nsf/Content/health-struct.htm">current TGA organisational chart</a>. </p>
<h2>Weight-loss fads</h2>
<p>The sponsors of Undoit® <a href="http://www.undoit.com.au/">claim</a> their pills let you “have the cake without the calories” – it’s “the snack without the guilt” and “the taste without the tummy”. The sponsors <a href="http://www.theaustralian.com.au/national-affairs/health/tga-probes-complaint-about-pills-said-to-block-fatty-food/story-fn59nokw-1226274225139">claim</a> a biscuit can be undone with one tablet, a tub of ice-cream may take two and a Big Mac and fries requires the maximum does of five pills. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/8004/original/mn853wqb-1329959897.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/8004/original/mn853wqb-1329959897.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=800&fit=crop&dpr=1 600w, https://images.theconversation.com/files/8004/original/mn853wqb-1329959897.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=800&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/8004/original/mn853wqb-1329959897.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=800&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/8004/original/mn853wqb-1329959897.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1005&fit=crop&dpr=1 754w, https://images.theconversation.com/files/8004/original/mn853wqb-1329959897.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1005&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/8004/original/mn853wqb-1329959897.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1005&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">You can’t have the cake without the calories.</span>
<span class="attribution"><span class="source">Ned Richapill</span></span>
</figcaption>
</figure>
<p>Each tablet (Aust L 166770) contains Ascorbic acid 7.5 mg, Chitosan 337.5 mg and Phaseolus vulgaris 375 mg. </p>
<p>Another version listed on the Australian Register of Therapeutic Goods (Aust L 193428) adds the laxative Cassia senna 62.5 mg (although the marketing manager of Undoit, Michael Romm, <a href="http://www.smh.com.au/national/health/hunt-for-the-truth-behind-diet-pill-20120217-1tei9.html">says</a> this version “has not been manufactured yet”). </p>
<p>Regardless, there is no scientific evidence that taking five pills containing Ascorbic acid, Chitosan and Phaseolus vulgaris will “undo” the impact of eating a Big Mac and fries. </p>
<p>More worryingly, the dose of Cassia senna contained in just one pill of the second version of the product is potentially dangerous and likely to cause diarrhoea, abdominal pain, cramping, loss of fluids and <a href="http://www.mayoclinic.com/health/low-potassium/MY00760">hypokalemia</a> (low potassium). The usual recommended laxative dose of Cassia senna is 17.2 mg daily, with a maximum of 34.4 mg daily – almost half the dose of a single Undoit® pill. </p>
<p>The claims made for Undoit® exploit the large and vulnerable population of overweight and obese people. They undermine the crucial public health message that reducing the health impact of obesity requires fundamental lifestyle change. In my opinion, they breach numerous sections of the Therapeutic Goods Advertising Code.</p>
<p>Regrettably, Undoit® is just the latest in a <a href="http://www.mja.com.au/public/issues/188_01_070108/har10522_fm.html">long line</a> of ineffective complementary medicine weight loss products listed by the TGA. These include Xantrax, Weight Loss Accelerate, Fat Blaster, Fat Magnet, SensaSlim and Hunger Buster.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/8003/original/n8csmcpg-1329959718.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/8003/original/n8csmcpg-1329959718.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=431&fit=crop&dpr=1 600w, https://images.theconversation.com/files/8003/original/n8csmcpg-1329959718.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=431&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/8003/original/n8csmcpg-1329959718.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=431&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/8003/original/n8csmcpg-1329959718.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=542&fit=crop&dpr=1 754w, https://images.theconversation.com/files/8003/original/n8csmcpg-1329959718.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=542&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/8003/original/n8csmcpg-1329959718.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=542&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Tackling obesity requires lifestyle improvements such as increased exercise.</span>
<span class="attribution"><span class="source">Flickr/Steve H</span></span>
</figcaption>
</figure>
<h2>A reformed TGA? </h2>
<p>So, what happened when a complaint about Undoit® alleging at least eight breaches of the Therapeutic Goods Advertising Code was sent to the new, hopefully more transparent TGA? </p>
<p>The TGA sent the following response (my emphasis added):</p>
<p>“Thank you for your correspondence dated 17 February 2012 in relation to Undoit. The TGA has <em>noted</em> your complaint in relation to this matter. </p>
<p>"The TGA <em>may use</em> this information and conduct investigations in relation to the safety, quality and regulatory status of the goods as part of the TGA’s ongoing regulatory activities. </p>
<p>"Investigations are <em>prioritised upon potential level of risk to public health and safety.</em> </p>
<p>"Please note that you <em>may not be informed of the outcome of any investigations as the information may be confidential to the owner of the medicine</em>. Thank you again for referring this matter to us.” </p>
<h2>Consumer or commercial protection?</h2>
<p>The issue of what should constitute commercial-in-confidence information was a hot topic in the TGA reviews. </p>
<p>Unsurprisingly, the views of consumers and health professionals differed from those of industry. While consumers accepted that genuine trade secrets, such as manufacturing processes, should be commercial-in-confidence, they did not accept that information about product safety or advertising violations should be suppressed. </p>
<p>One problem concerning potentially commercial-in-confidence information, raised by the TGA in the past, is Section 47 of the Freedom of Information Amendment (Reform) Act 2010, which states that a document is an exempt if its disclosure under this Act would disclose:</p>
<p>(a) trade secrets; or</p>
<p>(b) any other information having a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed.</p>
<p>The latter provision (b) is of particular relevance if the TGA determines that a complaint about the efficacy of a product, such as Undoit®, is justified because sponsors can argue that the commercial value of their product would be diminished by such disclosure. </p>
<p>Consumers and health professionals need access to such information but the TGA currently appears to rate the commercial protection of sponsors more highly that the public interest. On this matter, the government’s blueprint for reform merely said, “The TGA will develop and publish a policy on the disclosure of commercial-in-confidence information”. </p>
<h2>Consumer complaints</h2>
<p>The TGA’s website <a href="http://www.tga.gov.au/industry/advertising-reg9.htm">explains</a> its policy is “to publish the outcome of certain investigations into complaints about therapeutic goods advertising directed to consumers which have been referred to the TGA by the Complaints Resolution Panel for follow-up action”. The criteria the TGA use to disclose “certain” investigations have not been made public. </p>
<p>I’m aware of at least 20 complaints referred to the TGA by the Panel over the last 18 months because of sponsor non-compliance. The TGA has yet to report any outcome of their “investigations”. These <a href="http://www.tgacrp.com.au/index.cfm?pageID=13&displayYear=2011">include</a> Nurofen, Homeopathy Plus, FatBlaster Reducta and Fat Magnet, Maqui Berry Capsules, Virility Pills, Energy Slim and Berocca Performance. </p>
<p>So it seems the TGA’s <a href="http://www.tga.gov.au/newsroom/review-tga-transparency-1101.htm">transparency review</a> and <a href="http://www.anao.gov.au/Publications/Audit-Reports/2011-2012/Therapeutic-Goods-Regulation-Complementary-Medicines/Audit-brochure">other reports</a> have yet to make any impact on the organisation. Unfortunately, the TGA remains a “black hole” for reporting advertising complaints.</p><img src="https://counter.theconversation.com/content/5526/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr Harvey has accepted travel expenses only to talk about problems of complementary medicine regulation to pharmaceutical companies and industry associations. He has also been paid travel expenses and sitting fees for his involvement with government inquiries and working groups concerning pharmaceutical promotion and the regulation of complementary medicines.</span></em></p>Little seems to have changed inside the Therapeutic Goods Administration (TGA). And that’s despite two years of reviews into the shortcomings of its regulatory processes and the release, late last year…Ken Harvey, Adjunct Associate Professor of Public Health, La Trobe UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/37802011-12-06T19:38:38Z2011-12-06T19:38:38ZGiving the right teeth to the tiger: creating an effective TGA<figure><img src="https://images.theconversation.com/files/6179/original/nrkcfcbq-1323149556.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Some complementary medicines fill a medical need while others are of no value whatsoever.</span> <span class="attribution"><span class="source">nicholaslaughlin</span></span></figcaption></figure><p>Some complementary medicines are useful while others are just plain quackery so any attempt to regulate the industry requires an understanding of this heterogeneity. What’s more, the regulator of the industry must have real powers to promote useful products and inform the public of the effectiveness and safety of both types.</p>
<p>Discussions of regulatory requirements for complementary medicines often proceed as though they are a homogenous group. They are not. Some fill a medical need while others are of no value whatsoever.</p>
<p>A number of supplements – such as iodine for pregnant and breastfeeding women and, vitamin B12 for pernicious anaemia sufferers and for vegetarians – are known to be efficacious and this use is endorsed by the <a href="http://www.nhmrc.gov.au/">National Health and Medical Research Council (NHMRC)</a>. </p>
<p>But that’s not to say that all vitamin and mineral supplements are of medical value. For healthy normal adults with no special needs, a balanced diet is the best source of vitamins and minerals. </p>
<figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/6180/original/zd6278xb-1323149640.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/6180/original/zd6278xb-1323149640.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=734&fit=crop&dpr=1 600w, https://images.theconversation.com/files/6180/original/zd6278xb-1323149640.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=734&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/6180/original/zd6278xb-1323149640.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=734&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/6180/original/zd6278xb-1323149640.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=923&fit=crop&dpr=1 754w, https://images.theconversation.com/files/6180/original/zd6278xb-1323149640.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=923&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/6180/original/zd6278xb-1323149640.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=923&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">St Johns Wort.</span>
<span class="attribution"><span class="source">Anne Burgess</span></span>
</figcaption>
</figure>
<p>Then, there are complementary medicines that are never likely to have a scientific basis, such as homeopathic remedies. In 2010, the UK <a href="http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/4502.htm">House of Commons Science and Technology Committee</a> concluded that the principle underlying homeopathy was weak and that it should not be funded by the <a href="http://www.nhs.uk/Pages/HomePage.aspx">National Health Service</a>.</p>
<p>Some herbal medicines have been investigated by reputable clinicians, but such studies are of little value without standardisation of the products. A <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD000448.pub3/abstract">2009 review of St John’s Wort</a>, for instance, concluded that the evidence for its efficacy varied according to different research trials. It concluded that “country of origin and precision with effects size complicates the interpretation”. Other influencing factors include country of origin, harvest time, method of processing, part of the plant used, and how long the harvested plant was stored before use in manufacture. </p>
<p>St John’s Wort contains numerous chemical components, some of which have been identified and many of which have not. It’s not known which of these components contribute to antidepresssant activity so they haven’t been tested as a mainstream medicine would be and standardisation of products is next to impossible.</p>
<p>What’s more, it’s highly likely that different batches of a complementary product will contain different chemicals in different ratios and have different profiles for effectiveness, adverse reactions and interactions with other medicines. To suggest, as some do, that numerous minor ingredients have subtle effects that are beyond conventional medicine to define is to indulge in witchcraft. </p>
<p>If the major active ingredient(s) could be identified and formulated as a standardised medicine, and safety and efficacy demonstrated in controlled studies, then St John’s Wort could make a real contribution to human medicine. The same has been done with other substances of vegetable origin, like digoxin from foxglove, morphine from poppies and and artemisinin, the life-saving drug for malaria from Chinese Sweet Wormwood, all of which became medically reliable when standardised and appropriately developed. </p>
<p>But the ethically dubious promotion of some complementary medicines and their extravagant claims must be restrained. So what is it that regulatory government bodies, such as the Therapeutic Goods Administration (TGA), can do about complementary products? </p>
<p>Regulatory options for the TGA include:</p>
<ul>
<li>Publishing its own reviews of the efficacy of complementary medicines in layman’s terms. There’s already a mechanism for doing this via <a href="http://www.nps.org.au/consumers/publications/medicines_talk">Medicines Talk</a>, a part of the <a href="http://www.nps.org.au/">National Prescribing Service</a>. More publicity and perhaps a sexier title would enhance use of this facility. </li>
<li>Monitoring advertising more rigorously. While some companies may advertise appropriately, the notorious case of <a href="http://theconversation.com/sensaslim-and-me-how-criticism-of-a-weight-loss-spray-landed-me-in-court-1911">Sensaslim</a>, described by <a href="http://www.theage.com.au/national/sensaslim-banned-for-advertising-breach-20111124-1nwxk.html">The Age as a “shonky diet nasal spray”</a>, illustrates the depths to which advertising can fall. </li>
<li>Banning payment for items that are represented as “news” in current affairs programs.</li>
<li>Abandoning the requirement that sponsors of complementary medicines must hold data to support their claims but need not submit it to the TGA, and instead adopting a universal standard for all medicinal products. Any product that falls short of this universal standard should not be marketed, except with written TGA approval.
<br></li>
</ul>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/6182/original/6tybrzy8-1323149924.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/6182/original/6tybrzy8-1323149924.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=777&fit=crop&dpr=1 600w, https://images.theconversation.com/files/6182/original/6tybrzy8-1323149924.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=777&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/6182/original/6tybrzy8-1323149924.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=777&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/6182/original/6tybrzy8-1323149924.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=976&fit=crop&dpr=1 754w, https://images.theconversation.com/files/6182/original/6tybrzy8-1323149924.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=976&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/6182/original/6tybrzy8-1323149924.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=976&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">This fax was sent to pharmacists.</span>
</figcaption>
</figure>
<p>Instituting such a standard would require compliance with a set of criteria along the lines of – unless otherwise approved by TGA in writing, no medicine may:</p>
<ul>
<li>contain an active ingredient that’s scheduled as prescription-only, pharmacist-only, or pharmacy-only;</li>
<li>contain a substance that’s on a list of banned substances;</li>
<li>claim efficacy for preventing or treating a serious illness, as defined by TGA;</li>
<li>recommend administration other than via oral or topical routes; </li>
<li>be manufactured at premises that are not TGA-licensed for that type of manufacture;</li>
<li>fail to comply with an applicable official standard published by TGA;</li>
<li>claim to be sterile or free of microbes;</li>
<li>fail to comply with general limits on microbial load, and the absence of defined pathogens, such as pseudomonads (this is already the case for other oral and topical medicines); </li>
<li>fail to comply with general limits on the content of heavy metals and pesticides; </li>
<li>fail to include instructions for patients on the container label or in an enclosed consumer medicines information leaflet; and<br></li>
<li>possibly other requirements after consideration by TGA experts.
<br> </li>
</ul>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/6186/original/qn4zkytp-1323153120.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/6186/original/qn4zkytp-1323153120.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=596&fit=crop&dpr=1 600w, https://images.theconversation.com/files/6186/original/qn4zkytp-1323153120.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=596&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/6186/original/qn4zkytp-1323153120.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=596&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/6186/original/qn4zkytp-1323153120.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=748&fit=crop&dpr=1 754w, https://images.theconversation.com/files/6186/original/qn4zkytp-1323153120.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=748&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/6186/original/qn4zkytp-1323153120.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=748&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Chinese Sweet Wormwood.</span>
<span class="attribution"><span class="source">Ton Rulkens</span></span>
</figcaption>
</figure>
<p>The consequences for the TGA if it adopted these criteria would be:</p>
<ul>
<li>a reduced commitment of resources to the existing “pretend” regulating;</li>
<li>a focus on random and targeted sampling and testing, including review of labelling;</li>
<li>a focus on review of advertising; and </li>
<li>no imprimatur for safety and efficacy of medicines that TGA hasn’t evaluated for these things (perhaps these medicines should be labelled as such).
<br></li>
</ul>
<p>But strong action, including publicity for recalls in the event of non-compliance, would be required to accompany such changes. The consequences of strong TGA action (even if not well handled at the time) for Pan Pharmaceuticals, which collapsed soon after a recall of a large number of products, were dire. It wouldn’t take many such events to have a salutary effect on the whole industry. </p><img src="https://counter.theconversation.com/content/3780/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Susan Walters has been a consultant for the WHO and other similar bodies. She also does work for the technical and training organisation for the Australian pharmaceutical industry (ARCS).</span></em></p>Some complementary medicines are useful while others are just plain quackery so any attempt to regulate the industry requires an understanding of this heterogeneity. What’s more, the regulator of the industry…Susan Walters, Adjunct Associate Professor, UNSW SydneyLicensed as Creative Commons – attribution, no derivatives.