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WITH almost three-quarters of older, healthy Australians using complementary medicines, should there be more regulation of this multibillion-dollar industry?
That is a question being asked after the MJA published a revealing research letter about complementary medicine usage in older Australians.
The research analysed data from the ASPirin in Reducing Events in the Elderly (ASPREE) Longitudinal Study of Older Persons (ALSOP). It assessed self-reported use of complementary medicines such as fish oil, glucosamine, ginkgo, coenzyme Q10, calcium, zinc, vitamins B, C, D and E, multivitamins, Chinese or herbal medicines by healthy people over 70 years of age.
The authors found that 74.3% of the respondents reported using complementary medicines either daily or occasionally, with fish oil (44.5%), vitamin D (33.8%), glucosamine (26.7%), and calcium supplements (24.7%) being the most frequently reported items.
Although it’s known that complementary medicine use is increasing, the study’s authors were surprised by how common it was in older Australians.
“The sheer number of patients or the number of participants who were taking these medications either regularly or occasionally, really did surprise us,” senior author Associate Professor Ingrid Hopper said in an exclusive podcast.
According to co-author Dr Alice Owen, speaking in an exclusive podcast, it was particularly concerning, as often older Australians have a fixed income and are investing vast amounts of money into medicines that often have no proven benefits.
“The issue (is they’re) being bought over the counter, and that raises the question about whether or not people are getting the benefits for the out-of-pocket health expense that is incurred when they purchase these complementary medicines,” Dr Owen said.
For some complementary medicines, such as vitamin D and calcium, they may supplement a proven deficiency and are beneficial. However, studies have previously found that many people don’t have a concrete reason for taking other complementary medicines.
Dr Owen said: “When you ask them why they are taking complementary medicines, the most common reason given was for general health, which is hard to quantify”.
Dr John Maddison, President of the Australian and New Zealand Society for Geriatric Medicine, agreed that it was hard to show the benefits for these types of medications because the data aren’t there.
“It’s hard at times to know whether any medication is working in a single individual, which is why we do large randomised, double-blind, controlled trials, to find out if medications are working in people. When looking at these alternative medications, where there are the data, there is little or no evidence of efficacy,” Dr Maddison told InSight+.
“If someone takes one of these medications and their arthritis feels a bit better the next day, they’ll attribute it to the medication, whereas it’s almost certainly a false attribution.”
Most complementary medicines are Therapeutic Goods Administration (TGA) “listed medicines”. This means they include low risk ingredients and, although they need to be safe and of high quality, the TGA doesn’t assess them for efficacy.
“A lot of medications in this category are relatively benign in terms of low rates of side effects. I explain to patients that the low rate of side effects probably means they’re not doing much biologically either,” said Dr Maddison.
Associate Professor Danijela Gnjidic, President of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, said that sometimes complementary medicines might lead to drug interactions.
“For example, if glucosamine is taken with warfarin blood thinning agents, we think it could cause some issues. But we need more evidence.”
One of the greatest concerns is that many older Australians don’t tell their doctor when they’re taking these complementary medicines.
“Half of them don’t tell their doctor,” said Associate Professor Hopper, a clinical pharmacologist and general physician with Monash University.
“So, we may not have a good, clear idea of the drug interactions.”
The research authors said individual physicians should focus on patient education.
According to Dr Maddison, the first thing was to take a full history of the patient.
“It’s important that anyone who is taking history or prescribing takes considerable effort to take a history of complementary medicine usage by patients,” he said.
“Some patients might be reluctant to disclose they are using it, particularly if you’re hurried or don’t have a good rapport. You need to be particularly empathetic about why they’re taking these medicines and don’t become judgemental.”
Doctors also need a broader understanding of what these complementary medicines are and what they do, which Associate Professor Gnjidic admitted could be challenging.
“We often hear that GPs feel they aren’t equipped to deal with these questions regarding these products. We have so many diverse ranges of products. Keeping on top of that evidence can be quite tricky. Do we provide appropriate reliable information to doctors and consumers as well and ensure that is regulated?”
Ultimately, regulation of these products and the way they’re marketed is something all experts agreed needs further debate.
“It’s a big industry. It’s making a lot of money and there are certainly arguments from some that in light of that, how they’re regulated should be changed,” Dr Owen said.
Dr Maddison agreed.
“These types of products are aggressively marketed on television with prominent sports stars all advocating their features. It’s difficult to battle that kind of marketing as a GP sitting in the suburbs.”
Comment was sought from the TGA for this article, but they were unavailable.
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Oh Dear,
Anonymous says “If you are looking after any patient with one or more chronic conditions, and if you want to get them better, I invite you to do a course …………… real Evolution of Medicine. It’s happening now.”
In fact you feel so strongly about you have made two similar posts.
No wonder you remain anonymous, I wouldn’t put my name to calls for doctors to reject science and evidence in favour of made up, expensive placebo’s with grand titles like “Integrative Medicine”. This of course means actual medicine mixed with vaginal jade eggs, vinegar cleanses and excluding wheat and dairy on spurious grounds. Tell me “Dr” do you advocate Rhino horn for erectile problems? After all the Traditional Chinese Medicine practitioners claim it’s better than Viagra.
Guess what I call alternative medical products that actually work? Medicine. I don’t care what you claim it is. Put it to the test in large,blinded, placebo, multi-centered trials over a period of time. If it works, is safe, has a rational explanation of how and why its effective and is well tolerated, then Ill prescribe it.
Dear Josef Goldbaum,
The sponsors of complementary medicines that are listed with the TGA (designated (L)) do not have to prove efficacy. The claims are restricted to general health and general conditions. The sponsor, for example, cannot claim that their listed product is effective for RA.
Assessed listed products are assessed for efficacy, but safety and quality are self-certified.
Registered products (designated (R)) are fully assessed by TGA for efficacy, quality and safety.
I cannot search by complementary medicine, but it seems that most complementary medicine items are listed products – not registered products – on TGA and ARTG (Australian Register of Therapeutic Goods).
I wonder if consumers understand (or care about) the differences between L and R (and I don’t mean the differences between left and right).
We can’t lump (or dump) all complementary medicine products into one single pile and label this as ‘rubbish’. Some items may have therapeutic value. I have found the National Centre for Complementary and Integrative Health’ website to be useful for monographs and descriptions of uses and interactions. https://www.nccih.nih.gov/
Consumers are voting with their feet (and with their wallets/credit cards/digital wallet services/etc). Orthodox medical practitioners need to acknowledge this. Why is the patient choosing to take this product?
Acknowledgement in no way implies endorsement or support for the use of such products. The use of complementary medicines may be relevant to presenting symptoms and interactions.
These “complementary” medicines are already highly regulated by the TGA and the industry itself.
Only proven claims can be made for their effectiveness and efficiency. Research into these medicines and nutritional supplements is ongoing and reported in peer reviewed journals.
Interactions with other complementary medicines and pharmaceutical medicines are well documented.
The overall safety profiles are exceptionally high and have been so for decades.
The benefits proven to scientific satisfaction.
Who are we to tell the intelligent consuming public that their positive experiences are not real and that they are wasting their money. They are obviously deriving benefits from their consumption ,even if some of the benefits are due to placebo.
I think it is the regulators that need regulating and that the doubting professionals expand their spheres of knowledge to incorporate what their patients are taking and why.
Look out for the potential roll-out of a complementary medicine bonanza for community pharmacies with the COVID-19 vaccine roll-out.
What will people do while they are waiting and physically distanced in the Pharmacy? What will people do while they are waiting for a period of 15 minutes after vaccination?
They can browse the aisles for vitamins, minerals, and herbal preparations which may improve energy, wellbeing, brain function, bowel function, joint pain, and heart health.
To ensure that people get the chance to take advantage of the products on offer, the advertising and marketing can be clicked up a notch or two.
Compare the experience in a general practice. What to do while waiting? Watch some health information videos? Read some tired old magazines? Play games on your phone? Listen to SmoothFM? There may be some free take-away health information leaflets and brochures, but there is nothing to buy that will improve your health.
Maybe I’ll go to the local Pharmacy to get my jab. The complementary experience is complimentary.
Regulation in this sector has been gutted by the coalition government. As of last year, pre-clearance of advertising of complementary medicine was changed from regulation by the TGA to ‘self-regulation’.
see https://www.tga.gov.au/media-release/pre-approval-no-longer-required-ads-specified-media
Unsurprisingly, we now see widespread breaches of the standards that make at times quite outrageous claims. Seems big business and the mighty dollar win again, at the cost of the health of Australians.
Simply rubbish peddled by crooks to poor suckers
Reply to Anonymous, February 1, 2021 at 6:45 pm
Professor Avni Sali AM, Professor Ian Brighthope, Dr Penny Caldicott, Professor Sydney-Smith, and Dr Tim Ewer, could submit articles on Integrative Medicine to Insight+
Thank you for this article. It is an important reminder for clinicians about their patients’ use of complementary medicines. The numbers do not surprise me. I assume that all patients are taking one or more complementary medicines until proven otherwise – although I do not have any evidence to support this. Patients may not volunteer this information, so direct questioning is required (‘What medicines/drugs/medications are you taking? Prescribed/OTC/Illicit/CAMs?’). The article refers to elderly patients, but I suspect (without evidence) that the use of complementary medicines applies to patients of any age.
It would not be a good idea to proscribe complementary medicines, or to push them ‘underground’. It is really important for patients to tell their GP and other clinicians what complementary medicines they are taking because the medicines may be relevant to symptoms, harm, and interactions.
Some complementary medicines are L(A) – assessed listed medicines. These can include ‘TGA Assessed’ on their labels. This means that the medicine has been assessed for efficacy as claimed. However, most complementary medicines are L – listed medicines (not assessed for efficacy).
It is not necessary to increase regulation for complementary medicines. People should have the right to choose to spend a sum of money on a product that has no evidence for efficacy. A poor choice, perhaps, but it’s the person’s choice. However, I believe that parents should not give complementary medicines to their children. Children should be protected from treatment with unproven and untested complementary medicines.
There should be more regulation around advertising and the use of testimonials in the promotion of complementary medicines.
This goes beyond the scope of this article, but on a related issue, what about non-medicine complementary therapies? What about regulation for claims for efficacy for – eg chiropractic, osteopathy, yoga, reiki, cupping, aromatherapy, acupuncture (for which there is some evidence of efficacy for some conditions) etc? I do not wish to offend practitioners, but it is reasonable to ask for evidence of efficacy. Are chiropractic and osteopathy ‘complementary and/or alternative’ therapies, or do they belong with orthodox medicine? Or do they sit within the ‘integrative medicine’ domain?
“…. the data aren’t there.” and “When looking at these alternative medications, where there are the data, there is little or no evidence of efficacy,” This is the standard, tedious, steriotyped output from the Friends of Scientism in Medicine. It’s nothing to do with science, or medicine. Most of us know this and don’t buy it.
If you are looking after any patient with one or more chronic conditions, and if you want to get them better, I invite you to do a course with the Australasian College of Nutritional and Environmental Medicine (ACNEM), or the Australasian Integrative Medicine Association (AIMA), or the Australasian Institute for Medical Nutrition (AIMN) or the National Institute for Integrative Medicine (NIIM). I would invite “Insight” to interview Prof Avni Sali, Prof Ian Brighthope, Prof Sydney-Smith, Dr Penny Caldicott or Dr Tim Ewer. Let’s hear about the real Evolution of Medicine. It’s happening now.
Calling anything a ‘complementary’ medicine allows those profiting from its sale to claim exemption from providing any evidence of efficacy.
It is time to say that there are only medicines, divided into those that have acceptable and adequate evidence of safety and efficacy, and others that don’t have acceptable and adequate evidence of safety and efficacy.
Those that lack evidence of safety should not be allowed to be marketed. Those that lack acceptable evidence of efficacy should be required to state this prominently in all advertising and on the packaging.
Quite a number of the people in this research may have been advised to take vitamin D and/or vitamin B12 supplements, for example by their doctor. Isn’t it a bit of a stretch to classify these as ‘complementary medicines’ if they are being used to address a deficiency?
I believe we as patients have the right to choose and that are rights are being eroded.
I don’t accept that the Medical Profession, the Drug Companies or the Government have a right to dictate to the patient what’s in our best interest.
These bodies are only looking to control the income generated from alternative options and not the welfare or wellbeing of the patients / consumers
We have a right to have options and make our own decisions –
Until the Medical Profession & all other related organisations recognise that the patient knows their own body better than anyone else and that we are not morons or Neanderthals.
I vehemently resent being treated this way and I will fight ’til the day I day for these fundamental rights
I love the automatic assumption that all medicines prescribed are actually useful, given that The Lancet editor suggests that up to 75% of trials funded by pharmaceutical companies may be inaccurate, at the least, in their recommendations.
I write anonymously as so many doctors are brainwashed by the pharmaceutical companies as to the benefits of mainstream medicines, which OBVIOUSLY have no side effects, and I have no wish to be branded as a sceptic or denier, merely for being open-minded.
Correct nutrition would solve a lot of problems, without requiring expensive and possibly unnecessary medications.
The adverse effects that can arise from using some so called Complementary “Medicines” simultaneously with some prescription items are of real concern.
I refer to drug interactions.
Quoting only one example. If a patient is on ciprofloxacin and takes a calcium or a magnesium tablet or an antacid containing aluminium at the same time they will bind to the antibiotic as they are covalent metals and the bioavailability of the ciprofloxacin will drop dramatically and in fact will be clinically ineffective.
Many herbals too can be issues with their non regulated active contents and the doses being used. There is little evidence based studies as to their usefulness and to substantiate the claims made for them.
Ben Goldberg (Retired Pharmacist)
A large range of these products are bought in supermarkets, so there is no oversight for what many (most?) people may be taking. Many are also sold online, often at exorbitant prices and with glowing ‘testimonials’ from untraceable people. There is virtually no control over these products or sales.
Patients’ medication history & medication reconciliation including all complementary medicines is part of Pharmacists profession for more than a decade not only in hospital/clinical setting but community pharmacies as well. Medication history/reconciliation is something that pharmacists workforce are involved with, especially at a time of pts admission to hospitals.
Evidence based practice regarding complementary medicines are part of training at many School of Pharmacy within country & world.
I agree that more research, regulations are required.
One of the excellent textbooks guide for Pharmacists is L Braun M Cohen, Herbs and Natural Supplements, 2-Volume set : An Evidence-Based Guide among the other textbook
https://www.bookdepository.com/Herbs-and-Natural-Supplements-2-Volume-set-Lesley-Braun/9780729553841?redirected=true&selectCurrency=AUD&w=AF45AU9SSQQKHJA8VR1X&pdg=pla-295092701166:cmp-6919946397:adg-82581721111:crv-389775188388:pos-:dev-c&gclid=EAIaIQobChMItfu4paHH7gIVFA4rCh2rqgNtEAYYBiABEgJH0fD_BwE
Best Regards
Jasminka
Jasminka N Sarunac
Lead/Senior Pharmacist Investigational Drug Unit /Clinical trials| Pharmacy Department
John Hunter Hospital Lookout Rd, New Lambton Heights NSW 2305
Tel 02 4921 3635 | Fax 02 4921 3354 | jasminka.sarunac@health.nsw.gov.au
Opening Hours: 9am-5pm Mon-Frid
I still don’t understand why we persist in calling these pills and potions “Complementary medicine,” as rarely are they medicine or complimentary. Something truly descriptive such as “So-Called Alternative Medicines,” or SCAM, would be much more appropriate.