Science or Snake Oil: will horseradish and garlic really ease a cold?

Horseradish hasn’t been studied, and studies on garlic found it probably does nothing. from http://www.shutterstock.com

Ken Harvey, Monash University

Some of us may have heard that horseradish and garlic supplements help ease cold and flu. Blooms High Strength Horseradish and Garlic Complex claims it has

a soothing antimicrobial action that helps fight off the bugs that can cause colds and flu and provides symptomatic relief from upper respiratory tract infections.

Others, such as those promoted by Swisse and Blackmores, claim to be “traditionally used in Western Herbal Medicine to provide symptomatic relief of sinusitis, hay fever and upper respiratory tract infections”. And the Swisse and Blackmores products (and many others) add additional ingredients, commonly vitamin C, which is claimed to be beneficial for “immune health”.

There are two categories of “evidence” allowed by the Therapeutic Goods Administration (TGA) to validate indications or claims made for complementary medicines: scientific or traditional.

Scientific evidence is based on the scientific literature, such as trials in humans. Traditional evidence is based on theories outside modern conventional medicine, such as Western herbal medicine, traditional Chinese medicine and homeopathy.

---

Read more – Science or Snake Oil: can turmeric really shrink tumours, reduce pain and kill bacteria?

---

So, what does the research say?

A search of the medical journal database PubMed failed to find any clinical trials on the combination of horseradish (Armoracia rusticana) and garlic (Allium sativum), with or without vitamin C. Nor were any clinical trials found on horseradish alone.

The authors of a 2014 Cochrane review concluded there was insufficient clinical trial evidence supporting garlic in preventing or treating the common cold. A single 2001 trial (from the Garlic Centre in the UK) suggested garlic may prevent the common cold, but more studies were needed to validate this finding. Claims of effectiveness appear to rely largely on poor-quality evidence.

A 2013 Cochrane systematic review explored whether taking vitamin C (0.2g a day or more) reduced the incidence, duration or severity of the common cold. The 29 trial comparisons involving 11,306 participants found taking vitamin C regularly failed to reduce the incidence of colds in the general population.

Supplements can claim they’re a traditional medicine, meaning they don’t have to prove they’re effective. Screenshot, Author provided

Regular supplementation had a modest effect in reducing the duration of common cold symptoms by a few hours. The practical relevance of this finding is uncertain. The authors felt this level of benefit did not justify long-term supplementation. Finally, taking vitamin C at the onset of cold symptoms was not effective.

Vitamin C deficiency can impair immune function, but this is uncommon in Australia and best prevented by eating fruit and vegetables.

---

Read more – Monday’s medical myth: vitamin C prevents colds

---

The TGA accepts a traditional indication if that use has been recorded in internationally recognised traditional sources for a period of use that exceeds three generations (75 years). Traditional indications or claims don’t mean a product actually works – that requires scientific evidence.

What’s the verdict?

Products such as Blooms High Strength Horseradish & Garlic Complex claim they fight off bugs, but those claims that lack scientific validation. This breaches many provisions of the Therapeutic Goods Advertising Code 2015.

Products such as Swisse Ultiboost High Strength Horseradish + Garlic + Vitamin C, claiming horseradish and garlic have been “traditionally used in Western Herbal Medicine”, have correctly invoked the TGA’s “traditional paradigm”. But it’s important to remember this doesn’t mean these products work.

What’s the implication?

Recently, more and more purveyors of complementary medicine have been making “traditional” claims for their products.

If consumers are to make an informed choice about medicines claiming traditional use, a mandatory statement is required on the label and on all promotion explaining what this means. It should be explained to consumers the “tradition” is not in accordance with modern medical knowledge, and there is no scientific evidence the product works.

Without such a disclaimer, consumers will be misled and the TGA will be seen to be endorsing pseudoscience. But to date, industry, the TGA and government have refused to take on-board such proposals.

---

Read more: Which supplements work? New labels may help separate the wheat from the chaff

---

Ken Harvey, Associate Professor, School of Public Health and Preventive Medicine, Monash University

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.

Which supplements work? New labels may help separate the wheat from the chaff

Ken Harvey, Monash University

New proposals from Australia’s drug regulator should give you a better idea if your complementary medicines do what they say on the packet.

One change proposed by the Therapeutic Goods Administration (TGA) is a “stamp of approval” on the packaging and promotional material of some vitamins, minerals, herbs and other supplements to tell you there is enough evidence to back health claims.

Other proposals include reducing the number of often unsubstantiated indications that manufacturers of complementary medicines currently make on their TGA application, which are then used as the basis for advertising claims.

The TGA also proposes incentives for companies to develop and market products with new active ingredients, or make new claims based on research.

The proposed changes, which are out for public consultation, follow the recent ABC Four Corners program, which highlighted long-standing problems with the way complementary medicines are currently regulated.

ABC Four Corners’ documentary “Swallowing it” highlights the shortcomings of how complementary medicines are regulated in Australia.

What’s the problem?

The TGA’s proposals are urgently needed to fix three major shortcomings of the current regulatory system.

First, consumer organisations and health professionals have lost confidence in the complementary medicines industry’s ability to regulate its own advertisements, and in the TGA’s ability to apply adequate sanctions when companies don’t follow the rules.

Second, there is little incentive for the manufacturers of complementary medicines to research new innovative products or prove existing ones work.

There are about 11,000 listed complementary medicines on the Australian Register of Therapeutic Goods (indicated by Aust L on packaging). Listed medicines are meant to contain pre-approved, relatively low-risk ingredients, produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed; post-marketing surveillance and upheld complaints show high levels of regulatory non-compliance.

But there are only 35 registered complementary medicines (indicated by Aust R on packaging) the TGA says have been thoroughly assessed for safety, quality and efficacy (there is also debate about whether many of these older products should still be on this TGA list). There are fewer products on this list because research to meet registration requirements is expensive, the public doesn’t understand the subtleties between an Aust L and Aust R product and a better return on investment comes from promotional hype and celebrity endorsement of listed products.

Third, the TGA provides only limited transparency about companies and products that fail post-marketing evaluation or have complaints upheld. This information is currently regarded as commercial-in-confidence, fuelling the perception the TGA is more concerned with helping industry than protecting consumers.

How could the new measures help?

The proposal to restrict companies to only making pre-approved, “low-level” indications and claims for a product, such as, “may relieve the pain of mild osteoarthritis”, will minimise the risk of misleading consumers. But it is not yet clear how the list of allowed indications will be established nor how a specific product will be matched with an appropriate allowed indication.

The regulator also proposes manufacturers apply for “intermediate-level” health claims falling outside the permitted list (outlined above). An example might be, “our formulation of cranberry reduces the frequency of recurrent urinary infections in women”. For this, the TGA would have to assess the evidence substantiating the claim for a particular product. If the evidence stacks up (and there’s a debate about the type of evidence needed), the product could then carry a TGA “stamp of approval” on the label and any promotional material. But it is not clear what this “stamp of approval” will be. Is it text, a symbol or both?

Not everyone agrees a TGA ‘stamp of approval’ should be in the form of a symbol, like this.
(Unofficial mock-up created by Ken Harvey)

In preliminary TGA stakeholder consultations, consumer representatives supported a prominent visual identifier (like a logo or symbol) because of the failure of the existing Aust L and Aust R labelling to inform consumers. But industry representatives were concerned a highly visible identifier for a small number of evidence-based complementary medicines might affect sales of the bulk of listed products without one.

The TGA’s proposals encourage innovation because they will stimulate companies to engage in research to qualify for a TGA “stamp of approval”. The proposal also suggests companies that develop a TGA approved evidence-based claim would be awarded a three-year period of data protection to stop others freeloading on their research.

But the proposed changes do not yet address the need for greater transparency in the regulatory process. For instance, it is not clear whether the TGA’s assessment of evidence to back higher-level health claims for complementary medicines will be publicly available, as they are for prescription medicines.

What happens next?

These proposed changes, which are out for public consultation until March 28, 2017, sit alongside other recommendations aimed at improving the advertising complaints system.

If the TGA implements this package of recommendations, Australia will be a world leader in how complementary medicines are regulated. Despite the substantial and increasing use of supplements, no other country has developed a system that helps consumers and health professionals separate the evidence-based wheat from the chaff, improves confidence in the industry, stimulates more evidence-based products and has the potential to boost exports.

Ken Harvey, Adjunct Associate Professor, School of Public Health and Preventive Medicine, Monash University

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.

Can the ACCC ‘target the source’ of misleading labelling?

Michael Vagg, Barwon Health

Regular readers of this column will know that I’ve been less than complimentary about the effectiveness of the Therapeutic Goods Administration (TGA) in its efforts to regulate advertising of non-prescription products.

I am therefore delighted to give some credit when good news breaks. The Australian Consumer and Competition Commission (ACCC) has succeeded in a Federal Court action to have misleading packaging of Nurofen products banned.

The manufacturer Reckitt Benckiser (Australia) Pty Ltd has three months to remove all its misleadingly packaged Nurofen products from shelves. This outcome has taken five years from the time CHOICE magazine awarded Nurofen a Shonky Award for the labelling. The TGA first ordered them to withdraw the claim in 2011.

Following a final TGA review in 2012 which backed up the original finding, Reckitt Benckiser effectively dared the TGA to force them to change their ways. It was announced in March this year that following the failure of the TGA to get an outcome, the ACCC would pursue it using their consumer protection powers.

Today’s outcome is entirely predictable, from a scientific point of view. There was never any merit to the claim that ibuprofen could in any way be said to “go straight to the site of pain” any more than a sprinkler system in a high-rise building goes straight to the cause of a fire.

So why didn’t Reckitt Benckiser change their branding when ordered to?

My guess (and I emphasise this is speculation) is that they understood that there has never been a prosecution by TGA under the Therapeutic Goods Act 1989 because the derisory penalties aren’t worth paying good public money to enforce.

Once Reckitt Benckiser have paid their lawyers and costs, I’m guessing they will be well in front after selling the offending products for four years longer than they were supposed to. They have also had four extra years to gather marketing data and optimise their plan for rebranding.

It was inevitable that they were going to have to change their indefensible labelling, but why jump until you’re about to be savagely pushed?

Another example of the contempt in which the TGA is held was in 2013 when Swisse vitamins had an “appetite supressant” product banned by TGA only to re-register the exact same pills as a “hunger control” product. They only made the change after the TGA threw everything they had at them. Yet it was as easy as that to shrug off all the bluster the regulator could work up.

The example Reckitt Benckiser has set in defending its misleading and unfair consumer strategy with Nurofen will be noted by other companies, and the lesson will not be lost on them if they are next in the ACCC’s sights. The tactic is to fight in the courts for as long as the ACCC has the will to spend taxpayers’ money in order to buy time to plan the exit strategy and get a few more months or years of benefit from the dodgy claims. Milk the cash cow until the law closes in, then cop it sweet and move on.

Australian consumers will continue to be ripped off and fleeced as long as we are represented by a TGA which has not been given the tools to do its job. Neither side of politics is very interested in legislative change because the big players are just fine with it how it is. The real problem is that the same legislation that makes the TGA a tough-but-fair sheriff as far as prescription drugs and devices go also renders it flabby and supine enough to be unable to seriously hamper the sales targets of the non-prescription sector.

The foxes of the health-care industry may not be directly in charge of the hen house, but no holes in the wire are getting fixed without them giving the nod.

Michael Vagg, Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist, Barwon Health

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.

 

What’s in your herbal medicines?

by Ian Musgrave and Michael Bunce

Many people take herbal medicines, including traditional Chinese medicine (TCM) thinking they are doing something positive for their health. Ironically, in many cases they may be doing just the opposite.

Have you ever wondered what is actually in the herbal medicine products you buy? Has the herb on the label been replaced with another herb? Have pharmaceuticals been snuck in?

Making sure that a tablet claiming to have 500 milligrams of paracetamol really does contain 500 milligrams of paracetamol is relatively easy, there are established assays to measure paracetamol routinely. But how do you test for herbs?

Most herbal medicines are pills or powders that have removed all trace of structure we would normally use to identify plants, and many plants have no chemical signature that is able to definitively identify them. And what about all the other possible contaminants and adulterants that could hide in the complex brew of chemicals from herbal medicines?

Our research, which has just been published in the journal Nature Scientific Reports, goes a long way to answering that.

For the first time, our group of researchers from Curtin University, Murdoch University and the University of Adelaide have combined some of the most cutting-edge and sensitive analytical techniques to screen a set of traditional Chinese medicines available in Australia.

We used a three-pronged approach, combining DNA sequencing, toxicology and heavy metal testing to elucidate the true composition of 26 TCMs purchased at random from the Adelaide Markets; most were either for colds and flu’s or for general wellness.

What did we find?

Summary of the contaminants in traditional Chinese medicines (TCMs) tested in this study that contained toxic metals, undeclared or illegal contents as determined by DNA, toxicological, and heavy metal screening methods. Each TCM tested is represented in the diagram as a tablet; blue shading on tablets indicate AUST L listed medicines, red shading are not-listed with the TGA regulatory body. TCMs deemed non-compliant
for DNA (green), toxicology (pink) and heavy metals (yellow) or a combination thereof, are represented within the Venn diagram. Coglan et al.,Sci Reports 2015

Nearly nine in ten of these medicines had some form of undeclared substance in them as either adulteration or contamination. Sixteen of TCM’s had more than one contaminant or adulterant.

While around half of these medicines were not listed with the Therapeutic Goods Administration (TGA), and should not have been available for purchase, contaminants were found in both TGA-listed and non-listed medicines. These adulterants/contaminants included pharmaceuticals and toxic heavy metals.

Plant and/or animal DNA from species not listed on the labels were also found. The most concerning finding was snow leopard DNA (snow leopards are an endangered species), which was detected in one medicine. DNA from pit viper, frog, rat, cat and dog was also detected in several medicines.

Among the pharmaceuticals found were paracetamol, antihistamines, anti-inflammatories and antibiotics, and stimulants such as pseudoephedrine. Of particular concern were drugs such as warfarin, which have significant potential for harm if not taken under medical supervision, and ephedrine, which is banned in Australia.

Significant levels of toxic heavy metals such as arsenic, cadmium and lead were found in over half the medicines. In at least four of these medicines following the directions on the label would expose you to over ten times the TGA’s regulatory limit for heavy metals in medicines.

What does this mean?

Herbal Medicines. Megan Coglan

Are the levels of undeclared materials in these products adulteration or contamination? In adulteration, the material is added deliberately. In contamination, the material is added inadvertently, for example, through unclean workplaces or herbs grown on contaminated soil.

Whether a compound is a result of deliberate adulteration or contamination has different regulatory implications. It can mean the difference between banning a substance or cleaning up the workplace.

It can be tricky to decide which is which. In TCM materials, for instance, heavy metals or toad venom may be added as part of the treatment. However, by looking at the patterns of materials we found, we can get some hints.

One TCM claiming to enhance weight gain with appetite stimulation contained pharmaceutically relevant levels of the drug cyproheptadine, a known appetite enhancer.

In another, ephedrine was found without any evidence of DNA from plants of the Ephedra genus, suggesting that in both cases the drug was deliberately added.

Intriguingly, high levels of arsenic were often found with similar levels of lead. Lead arsenate has been used as a pesticide, and the high levels may come from persistently contaminated soils.

What this means is that you should be very careful about choosing and purchasing TCMs. Definitely avoid any medicine that does not have an ARTG listing (it should have a number like AUST L 123456 on the front of the bottle). But even medicines with these AUST L labels are no guarantee of safety.

This also highlights the importance of informing your health practitioner if you are taking TCMs as adulterants might interact with conventional medication to cause adverse effects.

What are the regulatory implications?

Unlike countries such as the United States, where many herbal medicines are regulated as dietary supplements, in Australia, herbal medicines are regulated through the TGA as medicines.

TGA-regulated medicines can be approved as either “registered” or “listed”. Most herbal medicines are classified as “listed”. Unlike registered medicines such as paracetamol and warfarin, the evidence required for approval is much less stringent.

In many ways it is an honour system, where the herbal medicines sponsor says there’s no evidence of harm, and they hold documentation that shows this. Mostly, the evidence is historical, claiming that people have been using it for generations without evidence of harm. As well, if the compounds are on the TGA’s list of “generally recognised are safe” materials extensive safety testing is not required.

The TGA uses post marketing follow-up to check for compliance with the “listed” medicine regulations. This follow-up consists of random surveys as well as targeted surveys from concerns raised by consumers.

In Australia, nearly 2,000 new herbal medicines are registered each year.
In a TGA survey in 2012-2013, 145 complementary medicines were tested. Around 83% of complimentary medicines surveyed were deemed to be non-compliant, with 6% failing due to product composition, formulation or manufacturing.

Using a combination of new molecular approaches, our survey found a much higher level of adulteration and contamination in TCMs than found in the TGA’s surveys. Adding DNA ingredient screening to the TGA’s armoury of analytical methods would help ensure that undeclared ingredients are not included in the herbal medicines we consume.

And Finally:

The herbal medicine industry is a billion dollar international industry, with products travelling all over the world.

Globally, we need a better auditing “toolkit” to ensure consumers of herbal medicines, as well as people testing their efficacy, are not being misled.

This research, we think, provides a roadmap to more effective regulation of the herbal medicine sector.

* The results of our screening have been passed on to the TGA, which is following this up.

Ian Musgrave, Senior lecturer in Pharmacology

This article was originally published on The Conversation. (Reblogged by permission). Read the original article.