Posted by apgaylard on June 20, 2008
I’ve been talking to Trading Standards and Lloyds Pharmacy about the claims that the latter have been making for their “Allergy Reliever”. This is a ‘medical device’ that allegedly uses phototherapy to relieve the symptoms of allergic rhinitis. Put simply: it shines a red light up your nose.
The claim “Clinically proven” appeared on their website and still appears on the product packaging (see image). Scratching the surface revealed that this claim is based on a single, un-replicated, small, decade-old and deeply flawed trial.
On that basis I am contesting the claim to be “Clinically proven”; Trading Standards have referred the issue to the MHRA and I’m waiting to see what the outcome will be.
In the meantime Lloyds Pharmacy very kindly offered me an “Allergy Reliever” for free. I accepted on the basis that they understood that it does not constitute an endorsement of the product; and that it will not hold me back from making critical observations.
So, Operation Rudolph was born: a home experiment aiming to illustrate what I consider to be one of the major flaws in the trial that underpins the claims made for the product: the design of the placebo, or “sham” treatment.
In my discussions with Trading Standards one of the most difficult things to get across has been my contention that the trial was, in effect, un-blinded by a poorly chosen placebo. So I hope that the pictures in this piece make the point more clearly.
One of the most important features of a placebo is that it is, “indistinguishable from the therapy being evaluated.” Otherwise the patient will know that they are not being treated and are unlikely to experience the benefits of a placebo response. They may even drop out of the trial; they may not see any value in ‘wasting their time’ not getting a therapy for a condition that may be very troubling. These influences will tend to bias the trail in favour of the therapy being tested – making it look more effective than it really is.
Another consequence of a placebo that is not indistinguishable from the therapy being tested is that the people delivering the therapy may be able to see who is being ‘treated’ and who is not. This may introduce biases into their dealings with the trial subjects and their interpretation of the results. Again, this will tend to favour the therapy under test.
A good placebo enables a trial to be designed so that it is ‘blind’, from both the researcher’s and subject’s perspective: the subjects don’t know whether they are getting the therapy or the placebo and neither do the researchers. This is the ‘double-blind‘ methodology that lies at the heart of all fair trials.
So, what about the clinical trial that Lloyds Pharmacy, and others, are relying on? The sham, or placebo, used in the trial was a similar device with its light emitting diodes “internally disconnected“. This means that anyone in the control group was ‘treated’ with a device that emitted no light.
How indistiguishable is this from the treatment? Just have a look at the results from my home experiment (below) The noses in the picture belong to me (I’m sporting my usual post-holiday beard!) and a glamorous female assistant. Now it may be that other people’s noses don’t exhibit the Rudolph Effect to the same degree (age, skin pigmentation and natural variation in the thickness of the structures of the nose could all have a bearing), but this shows that a “no light” placebo is a waste of time. Our red noses are clearly visible to anyone nearby. Importantly, both of us could see our own noses glow red.
So it is clear that when you use a device like this your nose lights up like the proverbial Reindeer; you can see it and so can anyone else nearby. The “no light” placebo is very easily distinguished from the treatment.
Anyone participating in this trial would have known whether they were being treated or not; anyone observing them would also know. It is not clear from the paper whether the participants were ‘treated’ at home, away from the researchers, or in a clinical setting. In the latter case the chances of the researchers knowing who was being treated and who was not is increased.
If the participants were administering the ‘treatment’ themselves then just switching on the device prior to insertion, out of curiosity (and who wouldn’t) would reveal what part of the study they belonged to: treatment or control (See the last image above).
If the device tested in the clinical trail was similar to Lloyds Pharmacy’s product, and one should hope that it is given that this trial is their sole evidence of efficacy, then light leakage through the nose and along the probes will have the same effect.
That the authors did not go to the trouble of developing a proper placebo raises concerns about the general quality of the trail. Accepting what is in a published paper requires a degree of trust; when the work is this sloppy that is undermined.
Does this mean that this device doesn’t work? No, but in the absence of good quality trials all claims for this product should be treated with extreme scepticism.
Conflict of Interest
As disclosed in this piece I am now in the pay of ‘big quacka’, having received an alternative medical device worth £13.49 for free. Having sold my soul for such a princely sum, any future endorsements that I may make of CAM modalities should be seen in this context.
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