Over the week or so I expect the page views for my amber teething necklace post to top 20,000 over the two blogs. Interest in the article has just kept increasing over the last year or so of it being up, as opposed to the majority of my posts which slip into internet obscurity within days. In anticipation of the occasion I thought I’d cover some of the comments that this post has gathered over the last few months.

Many of the comments are along the lines of “It worked for me” and “Try it yourself”.

To the first, I don’t really have much to say. I can’t peer inside the inner workings of your child and determine what is going on. But at the same time a bunch of individuals making claims of efficacy without adequate control for bias, natural history and various other contingencies is not a compelling argument to me. Plenty of others swear by practices that have no hope of working*, why should this one get more credibility based on personal experience?

As to the second, three words for you: Anecdote and Confirmation bias. I know enough to realise that I am not immune to the wiles of confirmation bias, which would make my trial just another anecdote – something I don’t accept from others so what would make my own experience any more valid? I also realise that for most people this sort of reasoning is at best foreign and at worst incomprehensible. The general thinking appears to go something like “If I try something and it seems to work, then it works – QED”.

No.

Related to this point are appeals to the “Placebo Effect”, the idea being that simply trying something helps, somehow. This may be true. But I’ll expand on the faulty reasoning behind this assertion.

The placebo effect as this seems now to be the “go-to” explanation for all things unexplained so it might be a good idea to dwell on this concept on it’s own for a bit. First off with regard to talking about the placebo effect, it depends on what you mean. The placebo effect started off being simply the improvement seen in the control group for clinical studies. It was the group that was given everything except the active treatment. Therefore by definition the placebo response is what happens when people aren’t treated. It was the catch all for everything that could affect the outcome that wasn’t due to the treatment itself: poor method design, confirmation bias, reporting bias, observer effect on the patients, regression to the mean, natural history of the disease, etc, etc.

Recently there has been some work done to see if there is a real change in people that is due to thinking they are getting an active treatment, the so called “Placebo response/effect”, this has been mixed. It is true that people will report less pain and their brain will show less activation in pain related areas. But people are susceptible to what they are told, it turns out if you tell people a cheap wine is expensive they will enjoy it more. Is there a placebo wine effect? possibly, but the wine didn’t change and neither did any underlying physiology in relation to placebo medical treatments.

In fact recent studies in asthma showed that while people reported feeling better while taking placebo their ability to perform on objective measures remained the same, while those on active medications improved. If you feel better while still having a life threatening condition are you better? I don’t think so.

So in appealing to the placebo effect you have to concede that 1. the beads don’t have any active ingredient, and 2. don’t make any difference to the underlying condition.
i.e. They do nothing.
Now notice in my original piece this is not what I say, I merely point out there is no good reason to think they are doing anything, not that they definitely aren’t. A subtle distinction I admit.

In essence the argument becomes: “If you think it works then it does”, well I would counter with why don’t you use something that we know does work and then you can capitalise on both effects: You will think it works and it will actually work too. Double goodness.

One poster asserted that amber necklaces were registered with the Therapeutic Goods Administration in Australia as a Medical Device. Arguing that this must mean they have therapeutic properties.

This one was my favourite as it was almost laughably easy to dismantle. After only a few minutes I found that this was completely untrue (you can search the TGA resister here). Not only that but there were suppliers admitting** that they couldn’t claim therapeutic benefits because they were not on the register:

“Amber Teething Necklace Information – TGA Australia

Due to regulations of the Therapeutic Goods ACT, policed by the Therapeutic Goods Administration (TGA), whose register does not recognise the claimed healing and theraputic[sic] properties of Amber we are unable to offer any detailed information on Amber Teething necklaces or Amber in general in a theraputic[sic] advisory capacity.

Therapeutic goods are defined in the Act to include goods that are represented in any way to be for therapeutic use. Therapeutic use is defined to include use in or in connection with influencing, inhibiting, or modifying a physiological process in persons.

In all amber related cases that we have seen, the TGA Panel note “that the advertisement appeared likely to breach section 42DL(1)(g) of the Act, which prohibits the publication of advertisements for therapeutic goods that are not included in the Register“” [Emphasis added]

A complaint was made against a supplier for making claims for the product and this was upheld in part because the necklaces are not on the register.

“The Panel noted, without making any formal finding, that the advertisement appeared likely to breach section 42DL(1)(g) of the Act, which  prohibits the publication of advertisements for therapeutic goods that are not included in the Register.

The website involved changed their wording to get around the regulations, spot the difference:

OLD: “natural pain relief provided by Amber works by placing the necklace on your body, this allows your skin to warm the amber beads, releasing healing oils which are then absorbed into the blood stream.

NEW: “Amber is believed to soothe naturally, when Amber is worn next to the skin it is warm and it is reputed to release natural oils that can care for the skin.”

What a difference a few words make.

At the time the comment was made alleging the necklaces were on the register I suspected that intended therapeutic benefits would be enough to fulfil the therapeutic benefits category.

This is supported both in the declaration of the supplier above and from the wording from the complaint, just prior to the excerpt above it states:

Therapeutic goods are defined in the Act to include goods that are represented in any way to be for therapeutic use. Therapeutic use is defined to include use in or in connection with influencing, inhibiting, or modifying a physiological process in persons.

In representing the advertised products to have an “active ingredient”, to release “healing oils which are then absorbed into the blood stream”, and to relieve teething in infants, the advertisement clearly constituted an advertisement for therapeutic goods.” [Emphasis added]

Lets say though that the product had been registered with the TGA or will sometime in the near future, I would note that unless the administration was in possession of studies that are not published elsewhere there is no way that they could be sure that an actual benefit is occurring. Bringing us right back where we are now.

As an extra note on the activities of the Australian government on this topic I found it amusing to see that the Australian Competition and Consumer Commission issued a safety warning about Amber teething beads end of September last year (see here and here and here).

I say amusing because, while it’s not impossible, I do find it unlikely that one branch of the government is condoning their use while another warns against them. Luckily this is not actually the case.

Finally, this post is not intended to address every conceivable objection to my arguments, merely a survey of what has been proffered so far. I am not really convinced by anything I have yet seen but I remain open to changing my mind so long as the evidence is of good quality. It doesn’t have to be much, a good start would be something that suggests succinic acid has the analgesic properties attributed to it. Then we could address whether succinic acid is released from the beads at ambient/skin temperature. Finally we would need to tackle whether the succinic acid is absorbed topically in any significant dose (decent dose response curves could be obtained at stage one of this theoretical research programme).

All three of these items would need to be looked at in order to state that amber beads have good plausibility for what they are marketed for.

[Update 29/4/13: Apparently there is a chain email circulating blaming amber beads for a case of SIDS. This seemed implausible to me and a very brief check seems to back up my gut feeling. There is no reason to think that amber beads contribute to SIDS at all. For a more thorough break-down go here: http://www.hoax-slayer.com/amber-teething-necklace-sids.shtml . I am not one who feels we need to latch onto any reason to vilify our intellectual opponents and spreading misinformation (especially easily debunked misinformation) is a big no-no in my book.]

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*Not that I think this product has “no hope” of working, it could as far as I know. We just can’t make that determination on the basis of anecdote and there are no trials that I’m aware of.

** Argh, this site seems to have removed any trace of of this page. Should have archived it. It has essentially been replaced with this (archive):

In keeping with Australian Fair Trading guidelines no therapeutic claims are made and no medical advice is offered. The material provided on allaboutamber.com.au is for information and educational purposes only and is not a substitute for medical treatment or diagnosis. We assume no responsibility for treatment or cure of any illness or disease. If you have a health problem we recommend seeking medical advice from your qualified natural/health professional. This information is strictly a source of general information and is not intended for use as a tool for self-diagnosis. All About Amber provides this information for you to make your own decisions, if you want to use them on your own family, we believe they work for us and please read the reviews to gather many other peoples opinions.

Which seems to me to be saying “We can’t claim the beads have any healing powers directly, but they really do.”

They haven’t yet learned this lesson for Hazelwood jewellery (archive)though:

How does hazelwood jewellery work?

Hazelwood products are believed to help to create an alkaline environment in your body, which may help, precent[sic] and appease many of the symptoms caused by being to acidic. Hazelwood, being an alkaline wood, has the natural property of absorbing and neutralizing the body’s acidity through contact with the skin. By doing so, the necklaces can also help with digestion, constipation, eczema, migraines, acid reflux, heart burn, nausea, arthritis, skin problems, etc. If you suffer from one of these issues, it is highly probable that you are suffering from an acidity imbalance, and hazelwood may be able to help you alleviate these symptoms in a natural way.  Most people who suffer from an unbalanced pH are unbalanced towards the acidic. This condition forces the body to borrow minerals—including calcium, sodium, potassium and magnesium—from vital organs and bones to buffer (neutralize) the acid and safely remove it from the body.

Hhhhm, perhaps another post is in order. And a complaint.

As a brief aside, as it seems there are quite a few parents out there hungry for this information if you know of a good parenting or early childhood publication that would be willing to print the original article (probably in an altered form) then let me know.

And I’ll stop there before the footnotes become longer than the post.

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