tag:theconversation.com,2011:/id/topics/complementary-and-alternative-medicine-17307/articlesComplementary and alternative medicine – The Conversation2023-09-19T20:08:42Ztag:theconversation.com,2011:article/2112722023-09-19T20:08:42Z2023-09-19T20:08:42ZLots of women try herbs like black cohosh for menopausal symptoms like hot flushes – but does it work?<figure><img src="https://images.theconversation.com/files/547663/original/file-20230912-17-mabvkn.jpg?ixlib=rb-1.1.0&rect=35%2C26%2C5955%2C3952&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>Menopause is the stage of life where the ovaries stop releasing eggs and menstrual periods cease. Most Australian women go through menopause between <a href="https://www.nature.com/articles/nrdp20154">45 and 55</a> years of age, with the average age being 51 years, although some women may be younger.</p>
<p>Hot flushes and night sweats are <a href="https://www.nature.com/articles/nrendo.2017.180">typical symptoms</a> of menopause, with vaginal dryness, muscle and joint pains, mood changes and sleep disturbance also commonly reported. Up to <a href="https://pubmed.ncbi.nlm.nih.gov/25706184/">75% of women</a> experience menopausal symptoms, with nearly 30% severely affected. </p>
<p>These symptoms can negatively impact day-to-day life and wellbeing. The main therapies available include menopausal hormone therapy (MHT) and non-hormonal prescription therapy. Some women will elect to try complementary and alternative medicines, such as herbal medicines and nutritional supplements. Black cohosh is one of them.</p>
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Read more:
<a href="https://theconversation.com/how-long-does-menopause-last-5-tips-for-navigating-uncertain-times-195211">How long does menopause last? 5 tips for navigating uncertain times</a>
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<h2>What causes hot flushes</h2>
<p>The cause of hormonal hot flushes (also called hot flashes) still isn’t completely understood, but the decline in oestrogen at menopause appears to play a role in a process that involves the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3833827/">area of the brain that regulates temperature</a> (the hypothalamus).</p>
<p>Factors linked to a greater likelihood of hot flushes include <a href="https://pubmed.ncbi.nlm.nih.gov/19675142/">being overweight or having obesity</a> and <a href="https://pubmed.ncbi.nlm.nih.gov/25706184/">smoking</a>.</p>
<p>MHT, previously known as hormone replacement therapy (HRT), usually includes oestrogen and is the <a href="https://pubmed.ncbi.nlm.nih.gov/26444994/">most effective treatment</a> for menopausal symptoms, such as hot flushes. But women may choose complementary and alternative medicines instead – either because they shouldn’t take hormone therapy, for example because they have breast cancer, or because of personal preference. </p>
<p>Close <a href="https://pubmed.ncbi.nlm.nih.gov/26224187/">to 40%</a> of Australian women report using complementary and alternative medicines for menopausal symptoms, and up to 20% using them specifically to treat hot flushes and sweats. </p>
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<h2>A long history</h2>
<p>Complementary and alternative medicines have a long history of use in many cultures. Today, their potential benefits for menopausal symptoms are promoted by the companies that make and sell them. </p>
<p>The <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6419242/">complementary and alternative medicines</a> women often try for menopausal symptoms include phytoestrogens, wild yam, dong quai, ginseng and black cohosh. </p>
<p>Black cohosh (plant name <em>Cimicifuga racemosa</em>) was <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6599854/">traditionally</a> used by Native Americans to treat a variety of health concerns such as sore throat, kidney trouble, musculoskeletal pain and menstrual problems. It is now a popular herbal choice for hot flushes and night sweats, as well as vaginal dryness and mood changes.</p>
<p>There are <a href="https://pubmed.ncbi.nlm.nih.gov/37252752/">many theories</a> for how the active ingredients in black cohosh might work in the body, such as acting like oestrogen, or affecting chemical pathways in the brain. But despite extensive research, the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6599854/">evidence to support these theories remains inconclusive</a>.</p>
<p>It is also not clear whether black cohosh is effective for hot flushes. Results from individual studies are mixed, with <a href="https://pubmed.ncbi.nlm.nih.gov/17565936/">some</a> finding black cohosh improves hot flushes, while <a href="https://pubmed.ncbi.nlm.nih.gov/18257142/">others</a> have found it doesn’t. </p>
<p>A 2012 <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6599854/">review</a> combined all the results from studies of menopausal women using black cohosh to that date and found overall there was no proof black cohosh reduces hot flushes more effectively than an inactive treatment (placebo). <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6599854/">This review</a> also revealed that many studies did not use rigorous research methods, so the findings are hard to interpret. </p>
<p>A more recent <a href="https://pubmed.ncbi.nlm.nih.gov/33021111/">review</a> of clinical trials claimed black cohosh may ease menopausal symptoms, but the included studies were mostly small, less than six months long, and included women with mild symptoms. </p>
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<a href="https://images.theconversation.com/files/547655/original/file-20230912-17-8ycush.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="white flowers on green plant with dark background" src="https://images.theconversation.com/files/547655/original/file-20230912-17-8ycush.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/547655/original/file-20230912-17-8ycush.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/547655/original/file-20230912-17-8ycush.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/547655/original/file-20230912-17-8ycush.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/547655/original/file-20230912-17-8ycush.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/547655/original/file-20230912-17-8ycush.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/547655/original/file-20230912-17-8ycush.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"></a>
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<span class="caption">Black cohosh (Cimicifuga racemosa) in the garden.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
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<p>There is also no meaningful evidence black cohosh helps other symptoms of menopause, such as vaginal symptoms, sexual problems, or poor general wellbeing, or that it protects against bone loss.</p>
<p>Evidence for how black cohosh is absorbed and metabolised by the body is also lacking, and it is not known what dose or formulation is best to use. </p>
<p>More good quality studies are needed to decide whether black cohosh works for hot flushes and other menopausal symptoms. </p>
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Read more:
<a href="https://theconversation.com/hot-flushes-night-sweats-brain-fog-heres-what-we-know-about-phytoestrogens-for-menopausal-symptoms-204801">Hot flushes, night sweats, brain fog? Here's what we know about phytoestrogens for menopausal symptoms</a>
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<h2>Is it safe to try?</h2>
<p>A <a href="https://pubmed.ncbi.nlm.nih.gov/33021111/">review of studies</a> suggests black cohosh is safe to use, although many of the studies have not reported possible adverse reactions in detail. Side effects such as gastrointestinal upset and rashes may occur. </p>
<p>While there have been <a href="https://www.mja.com.au/journal/2008/188/7/liver-failure-associated-use-black-cohosh-menopausal-symptoms#0_i1091948">rare reports of liver damage</a>, there is <a href="https://pubmed.ncbi.nlm.nih.gov/21228727/">no clear evidence</a> black cohosh was the cause. Even so, in Australia, black cohosh manufacturers and suppliers are required to put a warning label for the potential of harm to the liver on their products.</p>
<p>It is recommended black cohosh is not used by women with menopausal symptoms <a href="https://www.canceraustralia.gov.au/cancer-types/breast-cancer/impacted-by-breast-cancer/physical-changes/menopause/treatments-menopausal-symptoms">after breast cancer</a>, as its safety after breast cancer is uncertain. All women should consult with their doctor before using black cohosh if they are taking other medications in case of possible drug interactions. </p>
<p>Many women like to try herbal therapies for hot flushes and other menopausal symptoms. While black cohosh is generally considered safe and some women may find it helps them, at the moment there is not enough scientific evidence to show its effects are any better than placebo. </p>
<p>Women experiencing troublesome menopausal symptoms, such as hot flushes, should talk to their doctor about the best treatment options for them.</p><img src="https://counter.theconversation.com/content/211272/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>Many women choose alternative medicines over hormone therapy because they have a higher risk of breast cancer. Should they give black cohosh a try?Sasha Taylor, Research fellow, Chronic Disease & Ageing, Monash UniversitySusan Davis, Chair of Women's Health, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2054012023-05-16T02:59:48Z2023-05-16T02:59:48ZIllegal, occasionally deadly, and not much fun. What is the frog toxin Kambô and why do people use it?<figure><img src="https://images.theconversation.com/files/526073/original/file-20230515-175760-zv2sde.jpg?ixlib=rb-1.1.0&rect=58%2C0%2C6463%2C4305&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>Kambô is an oozy substance harvested from the defensive skin secretions of the Amazonian giant monkey tree frog. In the traditional medicine of <a href="https://www.pnas.org/doi/abs/10.1073/pnas.89.22.10960">some indigenous peoples of the Amazon</a>, Kambô is applied to superficial burns on the skin of participants to produce an intense purging effect. </p>
<p>In the past decade, Kambô use has also been <a href="https://abcnews.go.com/International/amazonian-tree-frogs-poison-part-latest-super-cleanse/story?id=46431345">on the rise</a> in neo-shamanic or complementary medicine in Western countries. Many users say they experience positive after-effects, but bad outcomes ranging from prolonged vomiting to seizures and even death have also been reported.</p>
<p>In Brazil, it’s <a href="https://www-bbc-com.translate.goog/mundo/noticias/2016/04/160425_salud_kambo_veneno_sapo_amazonico_medicina_polemica_lv?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=wapp">illegal to sell or market Kambô</a>. In Australia, where <a href="https://www.theguardian.com/australia-news/2023/may/13/alternative-reality-two-kambo-deaths-spark-soul-searching-in-australias-counter-culture-capital">two deaths after Kambô rituals</a> have led to coronial inquests, it was <a href="https://www.theguardian.com/society/2021/oct/06/kambo-a-lethal-frog-mucous-used-in-shamanic-rituals-banned-by-tga-after-reports-of-deaths">listed by the Therapeutic Goods Administration in 2021 as a Schedule 10 poison</a>: “a substance of such danger to health as to warrant prohibition of sale, supply and use”.</p>
<p>Despite government bans and several fatalities, Kambô use in Western countries still seems to be going strong. So what does Kambô do, and what do users get out of it?</p>
<h2>The Kambô ritual</h2>
<p><a href="https://journals.openedition.org/pontourbe/2384">Kambô comes from the giant monkey tree frog</a> (<em>Phyllomedusa bicolor</em>) which lives in the Upper Amazon rainforest. The frogs are captured and their limbs are tied with thread to four vertical twigs, to enable harvesting of their secretions by gentle scraping. The frogs are then released, physically unharmed.</p>
<p>The clear mucus-like secretion is typically spread onto bamboo sticks and air-dried for storage and transport. The Kambô is then prepared by reconstituting with water before application.</p>
<p>Kambô contains a <a href="https://journals.sagepub.com/doi/full/10.1177/23978473221085746">range of biologically active molecules</a> that most likely provide the frogs with defences against predators.</p>
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<a href="https://images.theconversation.com/files/526064/original/file-20230515-167825-t81es0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A photo showing a frog stretched out between some sticks while a person runs another stick along its body." src="https://images.theconversation.com/files/526064/original/file-20230515-167825-t81es0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/526064/original/file-20230515-167825-t81es0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/526064/original/file-20230515-167825-t81es0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/526064/original/file-20230515-167825-t81es0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/526064/original/file-20230515-167825-t81es0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/526064/original/file-20230515-167825-t81es0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/526064/original/file-20230515-167825-t81es0.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">To harvest Kambô, the defensive secretions of the frog are scraped off before the frog is released, unharmed.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
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<p>In the ritual, superficial burns are first made on the recipient’s skin, then Kambô is applied to the burns using a short length of rainforest vine. Next, the thick red sap of the “dragon’s blood” tree (<em>Croton lechleri</em>) is applied to the burns as an antiseptic.</p>
<p>Traditionally, among the indigenous Amazonian tribes that use Kambô, there is virtually no ceremony involved. It plays more of a role in their traditional medicine and hunting practices than in informing their cosmology.</p>
<p>In Kambô rituals catering to Westerners, the practice is often carried out in a ceremony involving songs, musical instruments, burning of incense, and prayers.</p>
<p>Traditionally, three to five small burns are made with a smouldering stick on the upper arm or lower leg of the recipient. </p>
<p>In Western neo-shamanic practice, however, Kambô is often applied to a larger number of burns. The burns may be located elsewhere on the body, including the neck, upper back, chest, and the Yogic chakra locations.</p>
<h2>What Kambô does to the body</h2>
<p>Following introduction via the small burns, the active ingredients of the Kambô pass rapidly into the body. They move through the lymphatic system – essentially the body’s drainage system, running parallel to the blood circulatory system – and thence into the bloodstream.</p>
<p>As a result, participants experience a short, intense purgative experience. The <a href="https://www.clinmedjournals.org/articles/iacp/international-archives-of-clinical-pharmacology-iacp-4-017.php?jid=iacp">physiological effects are complex</a>, rapid and sometimes paradoxical.</p>
<p>Typically, the first symptoms reported are an initial rush of heat and redness of the face. Nausea and vomiting are often experienced within several minutes, accompanied by general malaise, racing heart, dizziness and swelling of the face, and sometimes an urge to defecate.</p>
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<a href="https://images.theconversation.com/files/526065/original/file-20230515-163795-uqhdtl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A photo of a person's shoulder with four dark dots on a patch of reddened skin." src="https://images.theconversation.com/files/526065/original/file-20230515-163795-uqhdtl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/526065/original/file-20230515-163795-uqhdtl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/526065/original/file-20230515-163795-uqhdtl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/526065/original/file-20230515-163795-uqhdtl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/526065/original/file-20230515-163795-uqhdtl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/526065/original/file-20230515-163795-uqhdtl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/526065/original/file-20230515-163795-uqhdtl.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">Kambô is typically applied to superficial burns, which are then covered with an antiseptic sap.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
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<p><a href="https://www.peertechzpublications.com/articles/OJPM-2-107.php">Further effects</a> include the feeling of a lump in the throat or difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, runny nose and tears, swollen lips, eyelids or face, and occasionally a swollen tongue or throat.</p>
<p>These physiological effects are generally expected, and indeed sought, by those performing and undergoing the Kambô ritual.</p>
<p>Aside from the range of physiological effects discussed above, Kambô is not regarded as exerting any direct psychedelic or hallucinogenic effects. Nor is it known to be used by anyone for this purpose.</p>
<h2>What can go wrong?</h2>
<p>The duration of the physical effects is usually 15–30 minutes. However, individual responses vary considerably and, on occasion, the symptoms may last several hours.</p>
<p>Kambô has caused harm in only a very limited number of documented cases, although the documented harms <a href="https://onlinelibrary.wiley.com/doi/10.1111/1556-4029.13641">have included death</a>. A handful of case reports describe incidents of hepatitis, psychosis, prolonged vomiting, hyponatremia (low blood sodium), seizure, rupture of the oesophagus and cardiac arrest.</p>
<p>Those extreme consequences are particularly few relative to the presumably large number of administrations globally, in both the traditional indigenous and the recent Western contexts.</p>
<p>Accurate figures about usage are impossible to obtain, but <a href="https://neip.info/texto/o-kambo-na-rede-divulgacao-de-uma-pratica-tradicional-indigena-na-internet/">one academic source</a> notes over 6,000 members of various closed Facebook groups devoted to Kambô, and the International Association of Kambô Practitioners’ Facebook page has over 2,500 followers.</p>
<h2>What are the perceived benefits of Kambô?</h2>
<p>Despite the documented harms, the great majority of users of Kambô <a href="https://juniperpublishers.com/jojcs/JOJCS.MS.ID.555739.php">anecdotally report</a> positive physical, emotional and spiritual after-effects.</p>
<p>In Western societies, including Australia, the use of Kambô for healing or wellness has risen rapidly in recent years. The rise has coincided with the emergence of a subculture that questions the merits of the Western medical model and embraces alternative modes of health and medicine.</p>
<p>However, there is <a href="https://www.nature.com/articles/s41598-020-78527-4">limited evidence</a> of the directly measurable health benefits of Kambô in the peer-reviewed academic literature. The putative benefits claimed by the Kambô community largely remain to be substantiated by clinical research.</p>
<p>The actual or potential health benefits conferred by Kambô treatment can be difficult to distinguish from the anticipated or perceived benefits related to psychological effects. These psychological effects in turn may relate to the belief or faith systems that may be involved.</p>
<p>One important aspect of the Kambô experience is purging, particularly by way of vomiting but also defecation. </p>
<p>Many advocates see purging as representing a means of personal transformation through cleansing or detoxification. Purging may also be thought to expel various harmful, negative or generally undesirable aspects of both an emotional and a spiritual nature.</p>
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Read more:
<a href="https://theconversation.com/ayahuasca-the-shamanic-brew-that-produces-out-of-body-experiences-52836">Ayahuasca: the shamanic brew that produces out-of-body experiences</a>
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<p>Participants may also feel a benefit from the overall “ordeal” or “challenge”. In this regard, significant parallels may be drawn between the purging elicited by Kambô and that associated with <a href="https://doi.org/10.1016/j.socscimed.2019.112532">the psychoactive brew ayahuasca</a>.</p>
<p>To understand what people gain from Kambô, we may need to move into the domain of philosophical speculation. However, the concepts of personal transformation and spiritual growth are very real to many adherents, and their role in Kambô’s perceived benefits should not be discounted.</p><img src="https://counter.theconversation.com/content/205401/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Martin Williams 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>People have died after taking the banned frog secretion Kambô, and even when things go right there’s a lot of vomiting.Martin Williams, Research fellow, Swinburne University of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1983452023-02-02T12:23:35Z2023-02-02T12:23:35ZVitamins and supplements: what you need to know before taking them<figure><img src="https://images.theconversation.com/files/507046/original/file-20230130-20-x1ljxi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Supitcha McAdam/Shutterstock </span></span></figcaption></figure><p>If you were to open your medicine cabinet right now, there’s a fair chance that you’d find at least one bottle of vitamins alongside the painkillers, plasters and cough syrup.</p>
<p>After all, people are definitely buying vitamins: in 2020, the global market for complementary and alternative medicines, which includes multivitamin supplements, had an estimated value of <a href="https://www.grandviewresearch.com/industry-analysis/complementary-alternative-medicine-market">US$82.27 billion</a>. The use of natural health products such as minerals and amino acids has <a href="https://journals.lww.com/nutritiontodayonline/Abstract/2007/03000/Why_People_Use_Vitamin_and_Mineral_Supplements.4.aspx">increased</a> – and continues to rise, partly driven by consumers’ buying habits during the COVID-19 pandemic.</p>
<p>People <a href="https://www.businesslive.co.za/bd/companies/healthcare/2021-02-08-native-sales-of-sas-vitamins-and-nutritional-supplements-boom/">sought out</a> vitamins C and D, as well as zinc supplements, as potential preventive measures against the virus – even though the <a href="https://www.health.harvard.edu/blog/do-vitamin-d-zinc-and-other-supplements-help-prevent-covid-19-or-hasten-healing-2021040522310">evidence</a> for their efficacy was, and <a href="https://pubmed.ncbi.nlm.nih.gov/35888660/#:%7E:text=Concluding%2C%20available%20data%20on%20the,trials%20(RCTs)%20are%20inconsistent">remains</a>, inconclusive. </p>
<p>Multivitamins and mineral supplements are easily accessible to consumers. They are often marketed for their health claims and benefits – sometimes unsubstantiated. But their potential adverse effects are not always stated on the packaging.</p>
<p>Collectively, vitamins and minerals are known as micronutrients. They are essential elements needed for our bodies to function properly. Our bodies can only produce micronutrients in small amounts or not at all. We get the bulk of these nutrients <a href="https://www.iprjb.org/journals/index.php/IJF/article/view/1024">from our diets</a>. </p>
<p>People usually buy micronutrients to protect against disease or as dietary “insurance”, in case they are not getting sufficient quantities from their diets. </p>
<p>There’s a common perception that these supplements are harmless. But they can be dangerous at incorrect dosages. They provide a false sense of hope, pose a risk of drug interactions – and can delay more effective treatment. </p>
<h2>Benefits</h2>
<p>Vitamins are beneficial if taken for the correct reasons and as prescribed by your doctor. For example, folic acid supplementation in pregnant women has been shown to prevent neural tube defects. And individuals who reduce their intake of red meat without increasing legume consumption require a vitamin B6 supplement. </p>
<p>But a worrying trend is increasing among consumers: intravenous vitamin therapy, which is often punted by celebrities and social media marketing. Intravenous vitamins, nutrients and fluids are administered at pharmacies as well as beauty spas, and more recently “<a href="https://www.health.harvard.edu/blog/drip-bar-should-you-get-an-iv-on-demand-2018092814899">IV bars</a>”. Users believe these treatments can quell a cold, slow the effects of ageing, brighten skin, fix a hangover or just make them feel well. </p>
<p>Intravenous vitamin therapy was previously only used in medical settings to help patients who could not swallow, needed fluid replacements or had an electrolyte imbalance. </p>
<p>However, the evidence to support other benefits of intravenous vitamin therapy is limited. No matter how you choose to get additional vitamins, there are risks. </p>
<h2>Warning bells</h2>
<p>Most consumers use multivitamins. But others take large doses of single nutrients, especially vitamin C, iron and calcium. </p>
<p>As lecturers in pharmacy practice, we think it’s important to highlight the potential adverse effects of commonly used vitamins and minerals: </p>
<ul>
<li><p><a href="https://www.hsph.harvard.edu/nutritionsource/vitamin-a/">Vitamin A/retinol</a> is beneficial in maintaining good eye health. But it can cause toxicity if more than 300,000IU (units) is ingested. Chronic toxicity (hypervitaminosis) has been <a href="https://www.ncbi.nlm.nih.gov/books/NBK532916/">associated</a> with doses higher than 10,000IU a day. Symptoms include liver impairment, loss of vision and intracranial hypertension. It can cause birth defects in pregnant women.</p></li>
<li><p><a href="https://www.hsph.harvard.edu/nutritionsource/niacin-vitamin-b3/">Vitamin B3</a> is beneficial for nervous and digestive system health. At moderate to high doses it can cause peripheral vasodilation (widening or dilating of the blood vessels at the extremities, such as the legs and arms), resulting in skin flushing, burning sensation, pruritis (itchiness of the skin) and hypotension (low blood pressure). </p></li>
<li><p><a href="https://www.hsph.harvard.edu/nutritionsource/vitamin-b6/">Vitamin B6</a> is essential for brain development and in ensuring that the immune system remains healthy. But it can result in damage to the peripheral nerves, such as those in the hands and feet (causing a sensation of numbness and often referred to as pins and needles) at doses over 200mg/daily.</p></li>
<li><p><a href="https://www.hsph.harvard.edu/nutritionsource/vitamin-c/">Vitamin C</a> is an antioxidant and assists in the repair of body tissue. Taken in high doses it can cause kidney stones and interactions with drugs, such as the oncology drugs doxorubicin, methotrexate, cisplatin and vincristine. </p></li>
<li><p><a href="https://www.hsph.harvard.edu/nutritionsource/vitamin-d/">Vitamin D</a> is essential for bone and teeth development. At high doses it can cause hypercalcaemia (calcium level in the blood is above normal) that results in thirst, excessive urination, seizures, coma and death.</p></li>
<li><p><a href="https://www.hsph.harvard.edu/nutritionsource/calcium/#:%7E:text=Calcium%20is%20a%20mineral%20most,heart%20rhythms%20and%20nerve%20functions">Calcium</a> is essential for bone health, but can cause constipation and gastric reflux. High doses can cause hypercalciuria (increased calcium in the urine), kidney stones and secondary hypoparathyroidism (underactive parathyroid gland). It can have drug interactions with zinc, magnesium and iron. </p></li>
<li><p><a href="https://www.hsph.harvard.edu/nutritionsource/magnesium/">Magnesium</a> is important for muscle and nerve functioning. At high doses it can cause diarrhoea, nausea and abdominal cramping, and can interact with tetracyclines (antibiotics).</p></li>
<li><p>Zinc <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7781367/">can impair</a> taste and smell, and doses over 80mg daily have been <a href="https://link.springer.com/article/10.1007/s10654-022-00922-0#:%7E:text=Zinc%20supplementation%20of%20more%20than,zinc%20supplements%20among%20adult%20men.">shown</a> to have adverse prostate effects.</p></li>
<li><p><a href="https://www.hsph.harvard.edu/nutritionsource/selenium/">Selenium</a> can cause hair and nail loss or brittleness, lesions of the skin and nervous system, skin rashes, fatigue and mood irritability at high doses.</p></li>
<li><p><a href="https://www.sciencedirect.com/science/article/pii/S0098299720300364#:%7E:text=Expert%20guidelines%20for%20oral%20iron%20supplementation&text=Traditionally%2C%20the%20recommended%20daily%20dose,iron%20(Brittenham%2C%202018).">Iron</a> at 100-200mg/day can cause constipation, black faeces, black discoloration of teeth and abdominal pain.</p></li>
</ul>
<h2>Recommendations</h2>
<p>People need to make <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8377299/">informed decisions</a> based on evidence before consuming health products. </p>
<p>Regular exercise and a well-balanced diet are more likely to do us good, as well as being lighter on the pocket.</p>
<p>Seeking advice from a healthcare professional before consuming supplements can reduce the risk of adverse effects.</p>
<p>Be aware of the potential adverse effects of vitamins and seek a healthcare professional’s guidance if you have symptoms.</p><img src="https://counter.theconversation.com/content/198345/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>There’s a common perception that supplements are harmless. But they can be dangerous at incorrect dosages.Neelaveni Padayachee, Senior Lecturer, Department of Pharmacy and Pharmacology, University of the WitwatersrandVarsha Bangalee, Associate Professor, Pharmaceutical Sciences, University of KwaZulu-NatalLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1653772021-08-05T12:41:37Z2021-08-05T12:41:37ZOlympic athletes excel at their sports but are susceptible to unproven alternative therapies<figure><img src="https://images.theconversation.com/files/414386/original/file-20210803-25-khztso.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5000%2C3532&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Cupping, K-tape and cryotherapy are a few alternative therapies commonly used by athletes.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/massage-and-spa-for-men-male-torsos-in-the-royalty-free-illustration/1268389138">juliawhite/iStock via Getty Images Plus</a></span></figcaption></figure><p>Australian Olympic swimmer Kyle Chalmers earned a silver medal and his personal-best time in the 100-meter freestyle event at the 2021 Tokyo Games. While most of the world focused on his thrilling performance, others were equally interested in the <a href="https://www.independent.co.uk/life-style/health-and-families/olympics-cupping-circles-swimmers-backs-b1892490.html">conspicuous, circular bruises</a> on his back and shoulders. Similar marks were seen on <a href="https://well.blogs.nytimes.com/2016/08/08/what-are-the-purple-dots-on-michael-phelps-cupping-has-an-olympic-moment/">Michael Phelps</a> in 2016 when he added six medals to his tally to cement his title as history’s most successful Olympian.</p>
<p>Those blemishes were the work of <a href="https://doi.org/10.1016/S2005-2901(11)60001-0">cupping</a>, an alternative therapy in which small glass cups are placed on the skin at sites of injury or soreness, and used to create suction that stimulates “energy flow.” One form of cupping – wet cupping – involves piercing the skin to bleed the area and remove stagnant blood and toxins.</p>
<p><div data-react-class="InstagramEmbed" data-react-props="{"url":"https://www.instagram.com/p/7djtuUyx7j","accessToken":"127105130696839|b4b75090c9688d81dfd245afe6052f20"}"></div></p>
<p>As an <a href="https://scholar.google.com/citations?user=F8Gr-jAAAAAJ&hl=en">exercise physiologist</a> who studies critical thinking, I can’t help but wonder how an athlete’s unwitting endorsement of alternative therapy might influence the progression of a sport. This is because cupping is fairly characteristic of <a href="https://www.who.int/health-topics/traditional-complementary-and-integrative-medicine#tab=tab_1">alternative therapy</a> that, by definition, hasn’t been accepted by conventional science and medicine. When tested in <a href="https://doi.org/10.1016/S2005-2901(11)60001-0">controlled studies</a>, cupping doesn’t work. </p>
<p>In fact, all alternative therapies exist on a spectrum, from treatments with some merit to scientifically disproven nonsense. And interventions like cupping, that masquerade as science without fulfilling its robust methodology, are known as <a href="https://www.scientificamerican.com/article/what-is-pseudoscience/">pseudoscience</a>.</p>
<h2>Alternative therapies are rife in sport</h2>
<p>When it comes to unproven alternative therapies, cupping is just the tip of the iceberg. Other such practices in sport include <a href="https://pubmed.ncbi.nlm.nih.gov/21952385/">chiropractic spinal manipulation</a>, <a href="https://doi.org/10.1007/s00405-020-06202-5">nasal strips</a>, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3737916/">hologram bracelets</a>, <a href="http://dx.doi.org/10.1136/bjsm.2006.028936">oxygen drinks</a>, <a href="https://pubmed.ncbi.nlm.nih.gov/25835541/">reiki (healing hands)</a>, <a href="https://pubmed.ncbi.nlm.nih.gov/26383887/">cryotherapy</a> and <a href="https://doi.org/10.1177%2F0269215520963846">kinesiology tape or K-tape</a>. </p>
<p>While an estimated <a href="https://www.cdc.gov/nchs/data/nhsr/nhsr012.pdf">40% of Americans have used alternative therapies</a>, approximately 20% have used alternative therapies to enhance <a href="https://pubmed.ncbi.nlm.nih.gov/28987072/">athletic performance</a>. <a href="https://doi.org/10.3810/psm.1998.06.1066">Studies</a> <a href="https://doi.org/10.1177%2F1012690205057199">in</a> <a href="https://doi.org/10.1097/00042752-200605000-00008">amateur</a> and <a href="https://doi.org/10.1155/2021/5572325">elite</a> <a href="https://doi.org/10.1159/000511247">athletes</a> show a higher prevalence of 50% to 80%.</p>
<p>A detailed discussion of the evidence – or lack thereof – underpinning each practice can be found in <a href="https://doi.org/10.4324/9780429446160">books and scientific journals</a>. However, most alternative therapies generally have three things in common:</p>
<p>1) They’re sold on strong claims and weak evidence.</p>
<p>2) They invoke scientific-sounding terms like “energy,” “metabolites” and “blood flow” to feign scientific legitimacy.</p>
<p>3) They’re based on low-quality studies that are poorly controlled and have small samples sizes. This makes it impossible to distinguish the real benefits of the treatment from perceived or imagined ones.</p>
<h2>Why do some athletes love alternative therapies?</h2>
<p>Despite scientific consensus on their poor efficacy, alternative therapies appear to be more popular among athletes than the general population. So what makes them so popular?</p>
<p>Humans evolved to take mental shortcuts called <a href="https://doi.org/10.1126/science.185.4157.1124">heuristics</a> that lead to rapid but imperfect solutions, particularly when making <a href="https://doi.org/10.3389/fpubh.2019.00006">health and fitness decisions</a>. Proponents of some alternative therapies exploit the economy heuristic by offering grand rewards for comparatively little investment. Athletes are always chasing the extra 1% and may be particularly susceptible to extravagant claims.</p>
<p>In some instances, a lack of scientific evidence for a given alternative therapy may be the very reason that someone is drawn to it in the first place. The last decade has seen an upswing in <a href="https://doi.org/10.1371/journal.pbio.3000683">anti-science movements</a> and unprecedented attacks on scientists around the world. An individual may turn to alternative treatments due to dissatisfaction or distrust in conventional science, <a href="https://doi.org/10.1136/bmj.321.7269.1133">rejection of societal norms</a>, or both. A therapy may become popular simply because it defies the established order.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"426647061870956544"}"></div></p>
<p>Sponsorship is another factor. American athletes only win between <a href="https://www.cnbc.com/2021/07/29/tokyo-olympics-how-much-athletes-earn.html">$15,000 and $37,500 for an Olympic medal</a>, while British athletes receive no prize money whatsoever. Many have <a href="https://www.goodhousekeeping.com/life/money/news/g3797/how-olympians-make-money/">regular jobs</a>, while some earn the bulk of their income from <a href="https://www.forbes.com/sites/oliviaevans/2021/07/31/what-do-some-us-olympic-athletes-spend-and-how-much-can-they-make-going-for-gold/?sh=439e4cfc1f00">paid advertising</a>. Marketing companies are shrewd: <a href="https://www.researchgate.net/publication/312116633_Consuming_rationally_How_marketing_is_exploiting_our_cognitive_biases_and_what_we_can_do_about_it">They understand our biases better than we do</a>. A company can increase product sales by sponsoring an athlete and affiliating itself with success, fitness and beauty. It’s a win-win because athletes are able to leverage their hefty social media followings into an advertising base. Seemingly innocuous <a href="https://doi.org/10.1080/16184742.2020.1806897">Instagram posts</a> must not be taken at face value.</p>
<p>Finally, some products like <a href="https://sciencebasedmedicine.org/olympic-pseudoscience-tokyo-edition/">K-tape</a> boost their sales through visibility. This phenomenon, where consumers prefer products they’re more familiar with, is called the <a href="https://doi.apa.org/doi/10.1037/h0025848">exposure effect</a>. Increased visibility leads to increased popularity in an ongoing, reciprocal relationship.</p>
<p>Importantly, none of these factors speak to the effectiveness of a product.</p>
<h2>How do alternative therapies benefit athletes?</h2>
<p>It’s not all squandered time and money, however, and there are benefits to some alternative therapies. <a href="https://doi.org/10.1016/j.jad.2020.09.134">Meditation</a> has been used to successfully improve anxiety, depression and psychological well-being, and <a href="https://doi.org/10.1016/j.ypmed.2016.03.013">yoga</a> is a valid means of weight loss. Moreover, <a href="http://dx.doi.org/10.1136/bjsm.32.3.212">massages</a> and other soft tissue therapies appear to reduce muscle soreness and possibly prevent injury. </p>
<p>A distinction can be made between these and unproven alternative therapies based on the data. Care should be taken not to confound plausible claims like weight loss and relaxation with implausible ones like physical healing and detox. </p>
<p><iframe id="Prqt8" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/Prqt8/3/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>Even without a quantifiable mechanism of action, many alternative remedies claim efficacy based on <a href="https://doi.org/10.2165/00007256-200939040-00004">placebo effects</a>. The placebo effect manifests when a product improves performance via a positive psychological outcome, attributable to an individual’s belief in the product’s effectiveness. The outcome can be powerful. For instance, <a href="https://doi.org/10.1097/00005768-200009000-00019">one study</a> administered flavored water to competitive cyclists and told them it was a glucose supplement. They saw performance improve by 4% relative to a second group, which was told they’d received a placebo.</p>
<p>In Olympic sport, where gold and silver can be decided by less than a half-second, it’s understandable why sports teams may condone use of placebos, particularly when <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3778695/">athletes believe in the powerful effects</a>.</p>
<h2>Are there risks of alternative therapies in sport?</h2>
<p>The downside is that, yes, there are clear risks associated with certain alternative therapies. For instance, there are numerous reports of serious injury and even death following both <a href="https://doi.org/10.1111/j.1742-1241.2010.02352.x">chiropractic spinal manipulation</a> and <a href="https://doi.org/10.3233/JRS-2010-0503">acupuncture</a>. Moreover, skin burns are a common side effect of <a href="https://doi.org/10.5694/mja17.00230">cupping therapy</a>. </p>
<p>Of course, all medical procedures carry risk. But in conventional medicine, physicians make treatment decisions based on a <a href="https://doi.org/10.1016/s0197-2456(96)00092-x">risk-to-benefit ratio</a>. When the benefit of alternative therapy hinges on a placebo, the potential risks become hard to justify, especially given the possible loss of training time due to injury or other negative outcome that results from an alternative treatment.</p>
<p>The broad and indiscriminate use of alternative therapies in sport may also have downstream consequences for clinical practice. This is because it’s impossible to restrict placebo use only to minor ailments and sports performance. A sincere belief in the effectiveness of an alternative therapy that isn’t backed by science will lead to its inevitable use by some individuals to treat a potentially <a href="https://www.independent.co.uk/news/world/americas/parents-found-guilty-letting-baby-son-die-meningitis-a7003866.html">serious</a> <a href="https://doi.org/10.1136/bmj.j4006">condition</a>, sometimes with <a href="http://whatstheharm.net/index.html">fatal consequences</a>.</p>
<h2>Is there a place for alternative therapy?</h2>
<p>Might alternative treatments complement those endorsed by science? Perhaps. But safe practice requires drawing a clear line in the sand to restrict alternative therapies to minor ailments and sports performance, not replace modern medicine.</p>
<p>Pseudoscience is a major barrier to both <a href="https://dx.doi.org/10.1016%2Fj.optom.2017.08.001">evidence-based practice</a> and <a href="https://doi.org/10.1002/(SICI)1098-237X(199806)82:3%3C407::AID-SCE6%3E3.0.CO;2-G">science education and literacy</a>. That’s why it’s a potential burden in sport, and why education programs are needed to help people <a href="https://plato.stanford.edu/entries/pseudo-science/">distinguish science from pseudoscience</a>. Not just in sport, but in all facets of society.</p>
<p>And despite what you may hear in Olympics coverage, <a href="https://news.berkeley.edu/2018/05/23/rehabilitating-lactate-from-poison-to-cure/">lactic acid does not cause fatigue</a>.</p><img src="https://counter.theconversation.com/content/165377/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nicholas B. Tiller is a board member of the Pulmonary Education and Research Foundation (PERF). </span></em></p>Many elite athletes turn to alternative therapies to improve performance and enhance recovery. But are these treatments helping or hindering their quest for sporting success?Nicholas B. Tiller, Research Fellow (exercise physiology/respiratory medicine), University of California, Los AngelesLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/596692016-07-13T01:08:27Z2016-07-13T01:08:27ZUnderstanding the NDIS: how does the scheme view music therapy?<p><em>On July 1 2016, the National Disability Insurance Scheme (NDIS) moved from a trial phase to a full national roll-out. This is the last article in our <a href="https://theconversation.com/au/topics/understanding-the-ndis">Understanding the NDIS</a> series where we explore how the scheme works, why Australia needs it, and the issues to be addressed before eligible Australians, such as Indigenous people with disability, can receive the benefits they are entitled to.</em></p>
<hr>
<p>It is challenging to work out how the new <a href="https://theconversation.com/understanding-the-ndis-how-does-the-scheme-work-and-am-i-eligible-for-funding-58726">National Disability Insurance Scheme (NDIS)</a> works. As an an <a href="http://www.austmta.org.au/content/what-music-therapy">allied health professional</a> who is also the <a href="http://mcm.bespoke.unimelb.edu.au/study/degrees/master-of-music-therapy/overview">Head of Music Therapy</a>, I attempt to anticipate and influence policy changes, conduct research that challenges and tests new directions and teach how music therapy practice needs to evolve in response. </p>
<p>Music therapy is different from music entertainment. It is a <a href="https://theconversation.com/explainer-what-is-music-therapy-20154">research-based practice</a> and profession where music is used to actively support people to improve their health and overall well-being. Music therapists are musicians trained at university to understand how music can affect behaviours and how people feel and think.</p>
<p>Theoretically, music therapy is a support funded under the NDIS, that includes funding for “therapeutic supports including behaviour support”. A spokesman from the National Disability Insurance Agency – the organisation implementing and overseeing the scheme – told us:</p>
<blockquote>
<p>Under the scheme, music therapy must be delivered in a program designed by a qualified music therapist and delivered by a music therapist or therapy assistant with experience in music therapy. If it is delivered by a therapy assistant, the program must be monitored by a music therapist. Like any therapeutic intervention, a music therapy program is regarded as a capacity building support with goals and measurable outcomes.</p>
</blockquote>
<p>But it is still unclear how music therapy will be funded under the NDIS. While the spokesman said funding for music therapy would be assessed on a case-by-case basis, <a href="http://www.austmta.org.au/brochure/ndis-white-paper">anecdotal reports</a> suggest assessment for funding varies greatly between regions, rather than individual cases.</p>
<h2>The value of the arts</h2>
<p>The NDIS was established to reflect a <a href="http://www.pwd.org.au/student-section/the-social-model-of-disability.html">social model of disability</a> which means it recognises people with disabilities are part of our community and supports the social changes necessary to accommodate their needs. It’s an <a href="http://www.un.org/disabilities/convention/conventionfull.shtml">internationally accepted model</a> that emphasises inclusion, equity and autonomy. </p>
<p>Music therapy provides accessible opportunities for participation in the arts and is also an allied health profession, along with 17 others represented by the national <a href="http://www.ahpa.com.au/">Allied Health Professions Association</a>.</p>
<p>We conducted research with disability service providers such as <a href="http://www.scopevic.org.au/news-event/calling-writers-artists/">Scope</a>, which have arts programs that aim at both community inclusion and the provision of traditional allied health services in their centres. We found participants enthusiastic about accessing music programs tailored to their needs and keen to be involved in new opportunities provided by qualified music therapists.</p>
<p><a href="http://www.ndis.gov.au/participants/planning-process">NDIS planners</a> are the gatekeepers of the new funding process, assessing plans submitted by families. So the key question becomes: what understanding do planners have of the value of arts participation in the scheme? </p>
<p>According to our <a href="http://www.austmta.org.au/brochure/ndis-white-paper">most recent research project</a> this is variable. Service users in the New South Wales region, where a pilot has been rolling since 2015, say some requests for music therapy services have been rejected. In some instances, families have been advised to just seek services from speech pathologists who are musical, and told that music therapy just sounds like instrumental lessons. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/124428/original/image-20160530-859-2m8g8a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/124428/original/image-20160530-859-2m8g8a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/124428/original/image-20160530-859-2m8g8a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=427&fit=crop&dpr=1 600w, https://images.theconversation.com/files/124428/original/image-20160530-859-2m8g8a.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=427&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/124428/original/image-20160530-859-2m8g8a.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=427&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/124428/original/image-20160530-859-2m8g8a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=536&fit=crop&dpr=1 754w, https://images.theconversation.com/files/124428/original/image-20160530-859-2m8g8a.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=536&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/124428/original/image-20160530-859-2m8g8a.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=536&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A newborn baby in a Slovakian hospital listens to music. The hospital uses music as therapy for babies separated from their mothers.</span>
<span class="attribution"><span class="source">Petr Josek Snr</span></span>
</figcaption>
</figure>
<p>Further anecdotal evidence suggests those unhappy with the progress of their plans are unable to change them directly, but instead have been advised to formally request a review, which can take months. Although the NDIS is still being trialled and piloted, anecdotal reports from NSW are that participants will only have limited access to funded arts participation under the scheme. </p>
<p>This hasn’t been the case everywhere. In the Barwon region of Victoria for instance, music therapists have been funded to deliver therapeutic programs; as well as being asked to oversee programs run by non-qualified, community music colleagues to ensure relevant issues are taken into account. </p>
<p>This inconsistency between trial sites has made it difficult to efficiently develop the kinds of programs that will best support participants of the scheme. And the overlap of medical and social models of therapy has compounded that confusion. </p>
<h2>A social model of therapy</h2>
<p>We developed <a href="http://www.salvationarmy.org.au/Global/News%20and%20Media/Reports/2008/7-who-says-i-cant-sing.pdf">a practical model of music participation back in 2008</a> that is similar to the one of therapists and assistants highlighted by the NDIS. But this assumed people’s right to access ongoing and regular participation in music programs.</p>
<p>The NDIS is currently exploring allied health provision through a medical lens with an emphasis on words such as “treatment” and suggestions of short-term “interventions”. These words imply an <a href="https://voices.no/index.php/voices/article/view/787/664">individualised, expert focus</a> where the trained professional holds the skills to fix a client’s pathology.</p>
<p>In a social model, <a href="https://voices.no/index.php/voices/article/view/786/657">disability is seen as part of human diversity</a> and therapy aims to change structures and promote empowerment. A program designed with these values is therefore very different from one aligned with the medical model. </p>
<p>The underlying, social philosophy of the NDIS demands a new kind of service provision. Indeed, the change to the scheme has been driven by members of the disability sector who are sick of being pathologised. In anticipation of the new scheme, community music therapy scholars have been establishing a research basis for understanding music <a href="https://voices.no/index.php/voices/article/view/784/655">as a social practice</a> and challenging the ways our profession has previously aligned with <a href="https://voices.no/index.php/voices/article/view/801/666">medicalisation of people with disabilities</a>.</p>
<p>Our research shows <a href="http://jid.sagepub.com/content/early/2016/05/24/1744629516650128.full.pdf?ijkey=Z94SesIeGvTwK7B&keytype=finite">a need for a shift in thinking</a> about the provision of community-based music programs before services are ready to provide what people need and deserve from a social model. This will take support and funding, and while a program designed to <a href="http://www.ndis.gov.au/sites/default/files/ILC-Policy-Framework.pdf">build community capacity</a> is due to be trialled in the Australian Capital Territory next year, its scope and methods are still unclear. </p>
<p>The money certainly isn’t going to be coming from community arts organisations, whose <a href="https://theconversation.com/carnage-in-the-arts-experts-respond-to-the-australia-council-cuts-59368">funding has been slashed</a> across the sector by the current government. </p>
<p>The NDIS has excellent intentions. Its agenda of inclusion emphasises the rights of all people to access mainstream community services. But will people be able to find what they need and deserve through the new funding scheme?</p>
<hr>
<p><em>You can read other pieces in the NDIS series <a href="https://theconversation.com/au/topics/understanding-the-ndis">here</a>.</em></p><img src="https://counter.theconversation.com/content/59669/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Katrina McFerran receives funding from the Australian Research Council and is a member of the Australian Music Therapy Association. </span></em></p>The NDIS has laudable aims but how much funding will be available to enable participation in arts therapy?Katrina McFerran, Professor and Head of Music Therapy, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/521392015-12-14T06:32:35Z2015-12-14T06:32:35ZDon’t believe the hype – your complementary medicines are unlikely to deliver<figure><img src="https://images.theconversation.com/files/105348/original/image-20151211-8314-wfel0p.png?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">'Clinically proven' to shorten your cold? Not quite.</span> <span class="attribution"><a class="source" href="http://www.easeacold.com.au/">Screen shot from http://www.easeacold.com.au/</a></span></figcaption></figure><p>We recently submitted a complaint about the promotion of <a href="http://www.easeacold.com.au/">Ease-a-Cold</a> products, which claim to be “clinically proven” to shorten your cold. The complaint highlights a number of long-standing problems with the regulation of <a href="https://www.tga.gov.au/overview-regulation-complementary-medicines-australia">complementary medicines</a>. </p>
<p>The results of the Ease-a-Cold trial mentioned in the ads are unpublished and unavailable. And the ingredients used in the trial also appear to be different to those in the products promoted. This casts doubt on the relevance of the trial to the claims made, regardless of the results. </p>
<p>Even if our complaint is upheld, it can take years before misleading and deceptive claims are removed. The Federal Court finally ordered <a href="https://www.accc.gov.au/media-release/court-finds-nurofen-made-misleading-specific-pain-claims">Reckitt Benckiser to remove</a> its pain-specific Nurofen products from the shelves because of misleading claims. But this occurred four years after the first complaint. </p>
<h2>What’s wrong with the current system?</h2>
<p>The current system is based on <a href="http://www.health.gov.au/internet/main/publishing.nsf/content/Expert_Review_Submissions-container1/$FILE/Bandiera%20submission.pdf">trust</a>. Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), does not assess the claims of the vast majority of complementary medicines (labelled AUST L) before they go to market. Rather, the company simply promises that it holds evidence to support any health claims it makes.</p>
<p>Companies also promise that the product only contains ingredients the TGA regards as relatively safe and that production follows good manufacturing practice.</p>
<p>The TGA only <a href="https://www.tga.gov.au/sites/default/files/half-yearly-performance-reports-july-december-2014.pdf">occasionally</a> checks if the companies’ promises can be confirmed by post-marketing reviews. In the last six months of 2014, the TGA listed 1022 new products but only initiated 72 post-marketing reviews. In the same period, 60% of reviews found manufacturers weren’t compliant. </p>
<p>Each year, more than 100 complaints sent to the Therapeutic Goods Advertising Complaint Resolution Panel (TGACRP) are upheld. But the TGACRP and the TGA lack the power to adequately respond: they can’t issue substantial fines or order manufacturers to take out corrective advertisements. So there is little to deter companies from making misleading claims. </p>
<h2>Blueprint for change</h2>
<p>Last week, industry, consumers and health care professionals met to respond to an <a href="https://www.health.gov.au/internet/main/publishing.nsf/Content/8ADFA9CC3204463DCA257D74000EF5A0/$File/Review%20of%20Medicines%20and%20Medical%20Devices_Stage%20Two%20Report_Accessible.pdf">independent review</a> of the current regulatory system. </p>
<p>There was general agreement that the current system is broken. The market is flooded with more than 12,000 products for which the claims made are rarely supported by the evidence available. </p>
<p>Consumers are put at risk because they are unable to make an informed choice about the benefits and <a href="https://theconversation.com/whats-in-your-herbal-medicines-52144">risks</a> of complementary medicines. </p>
<p>Companies currently get a better return from investing in <a href="https://www.youtube.com/watch?v=MTa_ccZBvEg">promotional hype</a> and <a href="http://www.news.com.au/entertainment/celebrity-life/nicole-kidman-to-lead-health-supplement-company-swisses-world-push/story-fn907478-1226461998896">celebrity endorsement</a>, rather than research aimed at new innovative products. </p>
<p>The review panel proposed an integrated package of measures to fix these problems. </p>
<p>First, it recommends eliminating the free text option in the listing process that allows companies to creatively add their own product indications such as CoQ10, “<a href="https://www.blackmores.com.au/products/coq10-150mg?gclid=COvWq5CN0MkCFQsQvQodfiUI4A">supports a healthy cardiovascular system</a>”, and probiotics, “<a href="http://www.ethicalnutrients.com.au/Products/Product?groupkey=IHC">help improve general well-being</a>”.</p>
<p>Instead, the TGA should establish a limited list of evidence-based “permitted indications” which companies can use. An example might be, “glucosamine sulphate may relieve joint pain”.</p>
<p>Second, the review panel wants companies to publish the evidence they hold to support the indications made. And where the company has made its own assessment of the evidence for their product, the panel wants a prominent disclaimer to be added to all promotional materials that states: “efficacy claims for the product have not been independently assessed”. </p>
<p>Third, the panel recommends increasing the number of post-marketing reviews and making them more transparent; and that the complaint process be revamped and current investigative and enforcement powers be broadened.</p>
<p>To encourage research and innovation, the review panel recommends the TGA provide a new listing pathway, which would allow companies to submit clinical trial data to the TGA to get a higher level claim approved. An example might be, “clinical trials show that DONA® glucosamine sulphate provides symptomatic relief of osteoarthritis”.</p>
<p>This would be a less rigorous path than product registration. It would also allow a company to claim that the efficacy of its product had been independently assessed for that particular use.</p>
<h2>Hurdles to overcome</h2>
<p>The industry is concerned that eliminating the free text option will limit its ability to differentiate competing products in the marketplace. It is also concerned that requiring companies to publish the evidence supporting an indication would allow free-loading by copy-cat competitors. </p>
<p>However, we agree with the <a href="http://www.who.int/ictrp/results/reporting/en/">World Health Organisation</a> and <a href="http://www.alltrials.net/find-out-more/why-this-matters/">others</a> that all clinical trial results should be in the public domain. </p>
<p>Finally, a number of the failings of the current system have resulted from inadequate resourcing of the TGACRP and the TGA. This has been noted in most of the 16 consultations and inquiries since 2002. The benefits from revamping the system will only eventuate if greater resources are committed. </p>
<p>So what happens next? </p>
<p>The Department of Health will soon deliver its recommendations to health ministers Sussan Ley and Fiona Nash. Their response presents an historic opportunity for the government to show that Australia leads the world in complementary medicine regulation and consumer protection, industry innovation and export opportunities.</p><img src="https://counter.theconversation.com/content/52139/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 numerous government inquiries and working groups concerning the promotion and regulation of complementary medicines. However, he attended the recent Department of Health Forum mentioned in this article at his own expense. He is regarded by industry as a serial complainant.</span></em></p><p class="fine-print"><em><span>Amy Yan and Ned Latham 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>We recently submitted a complaint about the promotion of Ease-a-Cold products, which claim to be “clinically proven” to shorten your cold.Ken Harvey, Adjunct Associate Professor, School of Public Health and Preventive Medicine, Monash UniversityAmy Yan, Health Science & Business Student, Monash UniversityNed Latham, Public Health Summer Research Student, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/457272015-08-27T03:58:52Z2015-08-27T03:58:52ZWhy alternative medicine should be integrated into conventional health care<figure><img src="https://images.theconversation.com/files/93071/original/image-20150826-15407-1lxf8iy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Complementary and alternative medicine has been recognised in South Africa but is not yet fully integrated into the country's health care system.</span> <span class="attribution"><span class="source">shutterstock</span></span></figcaption></figure><p>A proposal to restructure primary health care in South Africa provides the perfect opportunity for complementary and alternative medicine to be formally integrated into the country’s health system.</p>
<p>Complementary and alternative medicine is any practice of medicine that is outside mainstream conventional <a href="http://www.medicinenet.com/script/main/art.asp?articlekey=10981">allopathic</a> medicine. Some of these medicines may be sourced from natural herbs and are referred to as herbal medicines. They are used, among others, as remedies for a variety of ailments like coughs and insomnia and as dietary supplements and weight loss.</p>
<p>In South Africa, as in many other countries, these alternative treatments are used alongside conventional medicines rather than exclusively. They are also chosen by patients rather than prescribed to them, which creates a complementary rather than an alternative practice. </p>
<p>In 2014 the government amended the Medicines and Related Substances <a href="http://www.saflii.org/za/legis/consol_reg/marsa101o1965rangnr510723/">Act</a>. Practitioners of complementary and alternative medicine are now officially recognised and are obliged to register with the Allied Health Professions <a href="http://www.ahpcsa.co.za/">Council</a>. </p>
<p>The amendment has been seen as the government acknowledging complementary and alternative medicines, but it has not translated into their inclusion into health policy. There is still much to be done before there’s symbiosis between these two systems.</p>
<h2>Filling a critical gap</h2>
<p>South Africa’s private health care system is rated among the best in Africa, with facilities said to be comparable to those in <a href="http://www.thesouthafrican.com/which-countries-have-the-best-healthcare-systems-and-where-does-sa-rank/">developed economies</a>.</p>
<p>Against this backdrop it may seem counter-productive to focus on the integration of conventional with complementary health approaches. But the reality is that the population’s health care demands are not being met. This is particularly true in the country’s rural areas, where access to basic conventional health care is extremely limited. </p>
<p>In these rural settings, complementary and alternative medicine practices are <a href="http://www.abpn.org.br/Revista/index.php/edicoes/article/viewFile/533/430">common</a>. The rich diversity of South Africa means there are a variety of alternative medicine approaches. However, current literature provides little information on its use. </p>
<p>Fully including these treatments into the health care programmes would ensure that safety, quality and efficacy studies are available and regulated. This is particularly important given the potential of side effects that the existing health care system may be unaware of or is ill-prepared to manage. </p>
<h2>A global picture</h2>
<p>Across the globe, only a few countries have achieved full integration. These include China, Korea and Vietnam.</p>
<p>But there is more to integrating complementary medicine than using one treatment with another. In an integrated system, complementary health care approaches are officially recognised and incorporated into all aspects of health as well as the national drug policy. Training and treatment measures are registered and properly regulated. Patients can access both conventional and complementary <a href="http://kamome.lib.ynu.ac.jp/dspace/bitstream/10131/6917/3/Payyappallimana.pdf">products and services</a>.</p>
<p>In Equatorial Guinea, Nigeria, Mali, Canada and India, complementary medicine practices are inclusive rather than integrated. This is because the practice is not fully incorporated into all aspects of health. In these countries, complementary medicines are extensively used but are not fully accepted for health care provision. They are also not fully included in the national drug policy. </p>
<p>Many other countries have a “tolerant” system of complementary medicine, which means that allopathy is the major system of care and some complementary approaches are allowed under law. South Africa falls in this subcategory.</p>
<h2>The challenges</h2>
<p>The popularity of complementary and alternative medicine in South Africa has resulted in calls for it to be integrated into the country’s health care and medical education <a href="http://www.biomedcentral.com/1472-6920/14/40">systems</a>. </p>
<p>But there are two problems. Firstly, integrative measures into medical and health schools in South Africa are almost non-existent. Linked to this is a scarcity of studies on the integration of these medicines with conventional ones and their effect on patients. </p>
<p>Secondly, there are challenges in deciding what student trainees should be taught. Adding the “selected content” to the intense schedule of medical, pharmacy, nursing and the allied health professions students will pose considerable challenges. </p>
<p>Valuable lessons could be learnt from countries like Cuba where complementary medicine is integrated into training and practice. Medical students are extensively trained in the theoretical and practical aspects of complementary and alternative medicine. Only duly qualified and certified health professionals are allowed to practice with complementary and <a href="http://www.ncbi.nlm.nih.gov/pubmed/17122478">alternative medicine</a>. This ensures that patients are not exposed to unsafe practices. </p>
<h2>Moving towards a single system</h2>
<p>South Africa’s diversity means there are a variety of complementary health approaches that may differ among different racial, ethnic and cultural groups. This may pose a challenge to inclusion.</p>
<p>As a start, South Africa can create inclusion strategies which will see integration happen over time. These would include quality and efficacy studies and scientific evidence supporting the use of complementary and alternative medicines. </p>
<p>Inclusion strategies may need to be initiated in a specific province, with the full support of government and advisory bodies sanctioned by regulatory authorities. This would focus attention on a smaller area and may limit associated errors.</p>
<p>The strategy would also need to incorporate alternative medicine practices into the training curriculum of medical and health care workers. This would raise awareness of complementary practices among students and expose conventional health practitioners to the benefits and disadvantages. </p>
<p>This strategy would have several benefits, such as successfully incorporating complementary practises into the health system. It would also mean that practitioners could advise patients about medicines and treatments accordingly. Most importantly, it would advance the agenda of health care for all in South Africa.</p><img src="https://counter.theconversation.com/content/45727/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Gail Hughes receives funding from South African National Research Foundation and is an executive committee member for the Public Health Association of South Africa. She is also a member of the American Public Health Association and in the leadership of its integrative complementary and alternative practice group.
</span></em></p><p class="fine-print"><em><span>Ol N M 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>Complementary and alternative medicine could alleviate many of the access problems within primary health care in South Africa’s rural areas if it was fully integrated into the system.Gail Hughes, Professor and Director South African Herbal Science and Medicine Institute (SAHSMI), University of the Western CapeOl N M, Researcher at the School of Pharmacy, University of the Western CapeLicensed 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>
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<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>
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<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>
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<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>
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<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">
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<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>
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<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>
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<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.