Amber teething beads revisited

Darcy Cowan takes another look at a subject that just won’t go away.

The page views for my amber teething necklace post (printed in NZ Skeptic 100) are about to pass the 20,000 mark. Interest in the article has just kept increasing over the last year or so, 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, 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 based on personal experience that have no hope of working; why should this one get more credibility?

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 any personal trial I made just another anecdote – something I don’t accept from others, so what would make my own experience any more valid? I realise that for most people this sort of reasoning is at best foreign and at worst incomprehensible. The general thinking appears to be: “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 the placebo effect seems now to be the ‘go-to’ explanation for all things unexplained. It started off being understood as simply the improvement seen in the control group for clinical studies. Therefore by definition the placebo response was what happened when people weren’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. More recently there has been some work to see if there is a real change due to people thinking they are getting an active treatment, the so-called ‘placebo response/effect’. Results have been mixed. It is true that people will report less pain and their brains will show less activation in pain-related areas. But people are susceptible to what they are told. 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 of asthma showed that while people reported feeling better while taking a 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 amber beads don’t have any active ingredient, and
2. don’t make any difference to the underlying condition.
ie, they do nothing.

Now notice in my original piece this is not what I said. I merely pointed 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 is: “If you think it works then it does”. I would counter by asking why not use something that we know works, 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, so 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 it was completely untrue (the TGA has an on-line register of such devices). Not only that but there were suppliers (www.allaboutamber.com.au) admitting that they couldn’t claim therapeutic benefits because they were not on the register. This company still promotes the therapeutic benefits of Hazelwood Jewellery, however:

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.

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

A complaint was made against one supplier for making claims for the product and this was upheld by the Therapeutic Products Advertising Complaints Resolution Panel, 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 they could be sure that an actual benefit is occurring. And that brings 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 at the end of September last year. 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, I am not intending 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.
Darcy Cowan lives in Hamilton, where he works at an environmental chemical testing laboratory and writes the Scepticon blog.

Amber teething beads: something to chew on

A ‘natural’ way to manage teething pain has no plausible mechanism.

Parents, especially new parents like myself, are a vulnerable group. We tend to be full of anxiety that we are doing the ‘right thing’ by our children. Wherever you find a vulnerable group like this you also tend to find those who prey on such fears.

Being a new parent and a skeptic I have been on guard regarding dubious advice and practices, but so far I have actually been pleasantly surprised: I have not, as far as I’ ve noticed, been subjected to any dubious advice. But recently I was confronted by a practice of a fellow new parent that I found a little disturbing. I’ m taking about using necklaces of amber beads to reduce the pain of teething for babies.

Teething can be an especially stressful time for parents and children. The child may be experiencing pain as the new teeth break through the gums; this means an irritable child and frazzled parents. Anything that promises to relieve or prevent this harrowing time is gratefully embraced.

On to the amber beads. This practice disturbs me for several reasons. First is safety. The necklace, if left on the baby for long periods, may pose a strangling hazard if it becomes caught on something. Most advertise that they are made to break easily to prevent this and that the beads are individually knotted onto the necklace to prevent scattering on breakage. However, this still seems to leave a broken string of beads in reach of a baby, and as most people know – anything a baby can get its hands on goes straight into the mouth. So choking is also a concern.

Now, I’m not one to be a worry wart over every little potential hazard; used correctly under parental supervision I suspect that the likelihood of a tragedy of this kind is low. But not zero. This, coupled with the low probability that the necklace actually does anything, is what worries me. The second disturbing thing is that parents are accepting that the necklaces work via word of mouth, and apparently not consulting their doctors before subjecting their child to an intervention of unknown safety and efficacy.

I have three main points I believe parents should consider before trying these beads (in addition to the physical safety above). The first relates to basic plausibility. There are several explanations for how the beads are supposed to work floating around the intertubes, many of the tinfoil hat brigade variety ([… it generates pain relieving magnetic field[). Only one explanation I have found makes biological sense so that’s the one I’ll be focusing on.

Baltic amber is known to contain between three and eight percent succinic acid. According to proponents this is released from the beads and into your baby. The succinic acid then allegedly has an analgesic effect and so reduces the pain of teething. Here is where my first point regarding plausibility comes in.

Amber is tough. Really tough. This is a material that has persisted for thousands and in some cases millions of years unchanged. Suffering through innumerable climatic cycles of heating and cooling. Yet this same tough unchanging material will happily give up its chemical components upon the gentle heating it receives on being placed next to your baby’s skin? Colour me unconvinced. I found a 2010 paper on volatile degradation products from Baltic amber that doesn’t mention succinic acid as an identified component. Related to this point, amber has a hardness on the Mohs scale of between 1 and 3. Baltic amber, which is usually touted as the therapeutic variety (because of the high succinic acid content), is at the high end of this scale at 2 – 2.5. To put this in perspective, Tin has a hardness of about 1.5 and Gold is 2.5-3. But let’s say for argument’s sake that clinically relevant amounts of succinic acid are released by the amber and absorbed by your baby’s skin.

My second point then, relates directly to the claims made for succinic acid. Succinic acid is made in the body (and in plants) as part of the citric acid cycle (aka the Krebs cycle). It is also used in the food and beverage industry as a food acid (additive #363 to be precise). Interestingly, in this capacity there are recommendations from some quarters to avoid the substance ([avoid it, banned in some countries[, warnswww.foodreactions.org).

Even so, apart from its early use as a topical treatment for rheumatic pain, there is no evidence that I could find (searching Pubmed at least, where I would expect a decent study to be referenced) that it is effective as either an anti-inflammatory or general analgesic. Let me be clear on that. I don’t mean low-quality evidence, I don’t mean small, poorly designed trials with equivocal effects, I mean nothing. Zip. Nada. In fact if anyone knows of any let me know because I find this complete lack quite surprising. I’m open to the idea that I was looking in the wrong place or was using incorrect search terms. So, unless there is late breaking news, it fails on that count as well. But what do we care about evidence of efficacy anyway? Let’s throw this point out too, and move on to my final point to consider.

Let’s say that (a): the beads do indeed release succinic acid into your baby and (b): this succinic acid has an analgesic effect once it enters your baby’s body. Doesn’t the very fact that an unknown amount of a drug is being put into your baby’s body bother you? (If it has biologic activity that can be used in a therapeutic fashion, it’s a drug, no quibbling on that point please.)

What is that I hear? It’s natural? Oh, well, that’s okay then. No wait, it’s not. I don’t care what the origin of a compound is, the question is what are its effects on the body and do the benefits outweigh the risks. Let’s replace succinic acid with some other naturally occurring substance, salicylic acid. This is a compound with known anti-inflammatory properties. Would you be happy with a product that introduced unknown levels of this compound into your baby? What if I said that overdoses with this compound could lead to a one percent chance of death (emedicine.medscape.com/article/818242-overview#a0199)? It’s natural; it’s also the precursor to acetylsalicylic acid, otherwise known as Aspirin.

Now, lest I be accused of unnecessary fear-mongering and drawing false comparisons I would like to admit that at present there is no evidence to suggest that succinic acid is hazardous, nor even that it is potentially hazardous. This does not detract from my main point however. It isn’t whether this particular compound is safe or not but that the reasoning around its use (ie [It’s got to be good, it’s natural[) is faulty and cannot be used as a substitute for evidence.

Based on the complete lack of plausibility on any level of efficacy any potential for harm, however small, must tip the balance of the equation away from the use of this product. But don’t trust me; talk to your doctor. I suspect though that given the complete lack of reliable information on this topic they will be left to rely on their own philosophy of harm vs benefit. In the final analysis, there are not always clear answers, but developing good critical thinking skills will at least provide you with a small light in the darkness.