hayfever

Allergy relievers: red light nonsense

Its just about coming into allergy season again, so today I am turning my attention to a product I’ve seen for sale in a few pharmacies I’ve locumed at of late: The Allergy Reliever Device. These things are sold under some pharmacy chain’s own names, or under brand names like Kinetik.

An allergy reliever display spotted on a Tesco pharmacy counter by @TheWholeT00th. 

An allergy reliever display spotted on a Tesco pharmacy counter by @TheWholeT00th. 

It’s yet another medical device. These things seem to be hitting the pharmacy shelves more and more often these days, giving them a level of respectability which personally I don’t think they deserve. At least this device makes it clear that it is a device though, unlike things like Prevalin which pretend to be real medicine.

According to Kinetik, it uses “red light therapy to suppress the cells that release histamine, thereby relieving the symptoms of hayfever and allergic rhinitis.”

So, essentially shoving some Christmas tree lights up your nose then. Well I must admit that’s a new one on me. It’s pretty hard to sniff out (geddit?) the theory behind this one too.  The manufacturers of these things don’t give any explanation as to why red light would suppress mast cells, and several Google searches later I’m none the wiser. I have managed to dig out one published paper in rats, where the authors seem to be suggesting that red light changes the redox state of cells, which might cause some changes within the cell. Even these others say that they’re not quite sure what’s happening though, and that further investigation is required.

Armed with a few unsuccessful Google Searches, I delved into the medical literature. I tried every which way I could think of to search for evidence that this thing works, but ended up drawing a total blank. I think this may well be the least successful search for evidence I’ve done so far, and that’s saying something. Even the manufacturers can’t be bothered with listing any sources instead they go wild with the clipart, giving us a Generic Smiley White Coated Person and Happy Photostock Chef alongside some very random recipes and general lifestyle advice.

And it looks like this thing really isn't very pleasant or practical to use. You're supposed to shove the probes up your schnozz as far as you comfortably can, then keep them there for three minutes. Not the most dignified of poses. And you're supposed to do this three or four times a day. That's a lot of inconvenience. Seems like prime Use Once Then Put In A Dark Cupboard territory for me, especially since taking a one a day antihistamine tablet is no hassle at all. 

In short, I wouldn’t waste your money. There’s no basis to these things, and it saddens me that they are not only being sold in pharmacies, but are being sold under pharmacy brand names. The more we associated our profession with such nonsense, the less trustworthy we become to other healthcare professionals and patients alike.

Hxxx

Advert Annoyances Vol 1: Senokot

Welcome to the first installment in what is likely to be a very sporadic series. As you've probably guessed by now, I have a tendency to be irrationally annoyed by small things, especially when it comes to medicines. Adverts for OTC meds can be a prolific  source of cringes. Even leaving aside the requests for "you know, that one on the telly, where there is a guy and a dog and its a blue box", there will occasionally be a little phrase or image used in these adverts that makes me stop and seethe a little.

The current one at the moment, is Senokot. I can't find a link to the new advert, but when I do, I shall pop it in here so you can see for yourself.

There's all sorts of naturalistic fallacies going on, but that's not what annoys me the most. It's the phrase " works in harmony with your body" that i'm finding hard to stomach (geddit?)

Put simply, senna works by irritating your bowel. Your bowel notices that it is being hurt by something, therefore starts contracting and producing secretions to hastily get rid of the thing hurting it.  This then might make you poo, but from your bowel's point of view that's a side issue- its just trying to protect itself from harm.

That doesn't really sound to me like "working in harmony". You might as well say that fire works in harmony with human skin to make you walk faster- in actual fact, one is just out to hurt the other, meaning something else happens as an unintended- but sometimes useful- consequence. 

Hxxx

 

The Society of Homeopaths and what they pass off as evidence

So today has seen some great news for rationality, science, and above all patients. The ASA has announced this ruling, leading to the Society of Homepaths taking down a rather large chunk of their website- the bit about what homeopathy can be used for.

However, using their search function, you can still find some of the nonsense they are promoting. I stumbled across this article, for example, entitled "Homeopathy Offers Alternative Relief for hay fever sufferers". I'd be very surprised if this article doesn't get taken down soon also, to be honest. It really should, given part of the ASA's ruling relates to their claims over the efficacy of homeopathy for hay fever. 

That use of the word alternative (as opposed to complementary) is interesting. That in itself suggests that the Society of Homeopaths are advocating patients not using conventional medicines in favour of their homeopathic products.

One thing that I have learnt about homeopaths is that, despite the fact that they often claim that randomised controlled trials (and indeed science in general) can't explain their wondrous treatment because of its individualised nature and quantum nanoparticles blah blah all the other words that they're clinging onto, they like to cite trials. A lot.

Homeopaths will often spout names of trials and provide links to PubMed abstracts with abandon, even when the trials say little about the clinical use of homeopathy in humans. In vitro or animal trials are favourites, and on the odd occasion where I have been sent a human trial, the result usually show that homeopathy is no better than placebo, and in some cases actually worse than placebo. At best, I'm guessing this is just ignorance- maybe they have misread the results of the trial? At worst (and more realistically), its a pretty obvious and petty method of obfuscation, and a pretty rubbish one at that. Presumably they think I will be so vowed by the fact that a trial exists that I wont bother to check the actual results of what the trial is saying.

This hayfever page overs a great example of this:

"A number of research trials have shown that homeopathic treatment can produce a significant improvement in hay fever symptoms,(4-7) but what does this involve?"

 Let's have a look at the "number of research trials", shall we?  

  • Reilly DT, Taylor MA, McSharry C, Aitchison T. Is homeopathy a placebo response?  Controlled trial of homeopathic potency, with pollen in hayfever as a model. Lancet,1986;2: 881-6.

This is a trial from 1986. Really, that's the best they can do, in 2013? The abstract of this trial appears impressive: "The homoeopathically treated patients showed a significant reduction in patient and doctor assessed symptom scores", but neglects to mention the most important part of a study like this: blinding. How can we assess the placebo effect in a study that isn't blinded? especially when the results rely on only reported outcomes. We can tick this one off the list as being a pretty rubbish effort at a trial. Must try harder. 

  •  Kleijnen J, Knipschild P, ter Riet G. Clinical trials of Homeopathy. Br Med J, 1991; 302:316-22.

Ahh, the early nineties. We're getting thoroughly modern and hip now, eh? This is a meta-analysis. hay fever isn't mentioned in the abstract at all, and the conclusion of the paper is that studies performed in homeopathy are rubbish, and better ones need to be done. Hardly a conclusive statement that homeopathy works for hay fever. We can tick this one off the list too.

We're now left with two trials to back up that statement above. To me, two trials is not "a number" of trials, even at this point. Even if these two trials were massive, robust, good quality randomised controlled trials, I still wouldn't be entirely convinced: I'd want to see the result replicated in as many different trials as possible. Anyway, we shalll soldier on, in the hopes of being dazzled by the brilliance of these two references. 

  • Launsø L, Kimby CK, Henningsen I, Fønnebø V. An exploratory retrospective study of people suffering from hypersensitivity illness who attend medical or classical homeopathic treatment. Homeopathy, 2006; 95: 73-80.

Oh dear. A retrospective study. So not a controlled trial at all then? The results? "The two groups of patients were similar in respect of their health at the start of the treatment, 57% of the patients who consulted a CH experienced an improvement of their state of health compared to 24% of the GP patients." well, that's all very well and good, but there is no blinding here whatsoever, and only 88 patients completed the study. means nothing at all, except for- as even the authors put it- as an exploratory study, maybe to try to find ways of how to conduct as more robust actual trial in the future.

That's it, down to the final trial. I'm expecting great things.  

  • Kim LS, Riedlinger JE, Baldwin CM, Hilli L, Khalsa SV, Messer SA, Waters RF. Treatment of Seasonal Allergic Rhinitis Using Homeopathic Preparation of Common Allergens in the Southwest Region of the US: A Randomized, Controlled Clinical Trial. Ann Pharmacother, 2005; 39(4): 617-24.

HURRAH!!! It's double-blind! We've gotten there! We've gotten some good, robust evidence tha- oh hang on, its only got 40 participants in it. It's just a wee ickle study that's far too small to draw any conclusions from.

So there you have it. This page is still up there on their website, using crappy references that don't back up their claims. The Society of Homeopaths- and quacks in general- need to realise that, no matter how hard they try, just trying to shoehorn poor excuses for studies in wherever they like isn't good enough.

Here's how it should go: you look at the evidence, you evaluate the evidence, and you make your claim on the basis of that evidence. Not: "I shall claim this, then try desperately to find something that vaguely looks like it backs me up, and I'll just hope for the best that no-one else bothers reading it. It seems the Society of Homeopaths are going in for the latter, and good on the ASA for pulling them up on it.

"We told the Society of Homeopaths not to discourage essential treatment for conditions for which medical supervision should be sought, including offering specific advice on or treatment for such conditions. We also told them not to make health claims for homeopathy unless they held sufficiently robust evidence of efficacy." -ASA ruling


Hxxx

Nose gunk strikes again: Nasalguard AllergieBLOCK

What is it with people trying to produce "Revolutionary" new versions of rubbing vaseline on your nose whilst charging vastly over the odds for the privilege? Someone, somewhere has obviously decided that our noses just aren't greasy enough. Thanks to my friend Paul for bringing this to my attention.

Enter the new kid on the over-the-counter hayfever market block (see what I did there?): Nasalguard AllergieBLOCK. Firstly, how am I supposed to trust a product that can't even manage to spell allergy properly? Secondly, is that Comic Sans font that I spy on the packaging?! Okay, so it seems like the UK packaging is different, but that doesn't matter. The damage is done, and the use of Comic Sans is an unforgivable crime.

Font against humanity. 

Font against humanity. 


Thirdly, on trying to find the UK site, it seems that this is yet another company who has taken to giving free stuff to people so that they will say on their personal blogs how very marvellous it is. This sort of publicity just doesn't wash with me. It feels grimy and seedy and smells faintly of desperation. I therefore imagine this is also what Allergieblock gel smells of.

Let's have a look at what the manufacturer's say:

"NasalGuard AllergieBLOCK® Regular is a revolutionary topical gel based upon patented technology containing cosmetic grade ingredients. The FDA-approved gel creates a positive charge which blocks negatively charged allergens on contact before they enter the nasal passages."

Right, it's really not revolutionary, is it? It's hardly going to free the downtrodden masses from the grips of the evil dictatorship of pollen. It's exactly the same principle as Prevalin and Haymax, and of course good old Vaseline. I've said it before in the Prevalin post, but the idea of putting vaseline on your nostrils to reduce hayfever symptoms is as old as the hills. There's nothing revolutionary about this. This positive charge thing is new, however. It sounds like something that a bunch of marketers sat in an office having a "thinkstorm" session would come up with as being suitably science-y to wow the masses. 

But surely this can't possibly be the case, not when there is a heart-warming "Inventor's Story" on the website:


"About 20 years ago, New Jersey Professional Engineer Ashok Wahi's daughter Aikta frequently suffered from allergies after exposure to her friend's cat. He wanted her to be relieved from the constant sneezing, runny nose and congestion without taking drugs.  The conventional over-the-counter remedies made her sleepy at school, he got motivated to create a drug-free solution for his daughter that wouldn’t cause drowsiness, dry mouth and similar side effects.

The project's goal was to prevent the inhalation of allergens rather than treating the allergy symptoms after the fact.

With this in mind, Wahi put his engineering skills to work and developed a unique gel that blocks allergens on contact, therefore alleviating allergy symptoms. Hence the birth of NasalGuard® technology."


So its taken this dude 20 years to reinvent the wheel and come up with a fancy version of Vaseline. Shame really, he could have saved himself the effort if he had only spoken to a decent pharmacist or GP. Whilst I'm sure being a "Professional Engineer" is awesome and all, I'd really rather like it if people who are trying to improve my health have some sort of background or training in healthcare, thank you very much. 

Anyway, all of this is by-the-by, because of course there is going to be a wealth of good quality clinical trial evidence to say that it works, right? Dear readers, you probably know the drill by now. There's some testimonial videos on the website, a grand total of 4 of them. With Prevalin, the manufacturers tried to pass off two methodologically poor trials about products that bore no relation to Prevalin at all off as clinical proof that it works. These guys don't even bother going to that amount of effort. There is no mention anywhere on the website about any trials at all. They don't even bother cursorily referencing the Principles and Technology bit:

 "NasalGuard AllergieBLOCK® uses patented technology that works on a simple principle of electrostatic charges: opposite charges attract each other.
AllergieBLOCK gel has a slight positive charge which attracts negatively charged allergens. Allergens like pollen, ragwort/ragweed, hay, dust mites, pet dander and house dust all carry a slightly negative charge. The allergens are blocked on contact. You do not inhale allergens, which means you don’t suffer from allergic reactions"

Now, it does seem to be the case from this PLoS One study that allergens are negatively charged whereas non-allergens are more likely to be postively charged. But until there's some evidence that a mixture of "Dl Water, Polyquats, Propylene Glycol, Octoxynol-9, Glycerin, other cosmetic grade ingredients and preservatives" can definitely produce some sort of nasal forcefield against the nasty pollen, and the manufatcurers can demonstrate an ability to spell properly, I'm not interested.

I'd also rather not apply something to my face which is going to actually attract the very things I am expressly trying to keep away it, thank you very much. Without evidence to the contrary, there is nothing to say that all of those positively-charged allergens which are supposedly now attracted to the gunk on your nose will get stuck on the gunk. A few allergens with probably make it through, given that nostrils are relatively big holes in comparison to how small the allergens are. So if anything, there is a potential that you end up with more allergens than you would have done had you not bothered applying it in the first place. Imagine Justin Bieber in a young girl's school, with only one or two bouncers for protection. a fair proportion of the screaming pre-pubescent youngsters are likely to get through the bouncers to plant a kiss or two on the fresh-faced child-adonis. (If I'm honest, I have only a vague knowledge of who Justin Bieber is, but I understand he's the Jason Donovan of modern time)

How much does it cost? oh, only the princely sum of £11.99 for 3g at Boots. ELEVEN POUNDS AND NINETY NINE PENCE for THREE GRAMS!!! Think of all the other things you could buy for £11.99.

Save your money, people.

Prevalin: Pollen & Prevarication

There's yet another shiny new product on the pharmacy shelves this spring. In plenty of time for the hayfever season, Prevalin(TM) (which, as someone has already pointed out sounds like a bad name for HRT, not a hayfever medicine) promises us "Fast allergy relief at the onset of symptoms. Acts 5 times faster than hayfever tablets"

It's being advertised by a real-life Pharmacist, Mr Nick Kaye, who appears, resplendent in a white coat, in the advert, in front of a photo-shopped sign saying "Effective Hayfever Treatments". In the still from the video on the website, Mr Kaye looks less than happy and indeed even a tad embarrassed to be there. Having had a good look at the website for the product, I don't blame him.

So sad. 

So sad. 

First things first: this is not a medicine. It takes quite a bit of digging, but you can just about find on the website where it says in small letters that its a medical device. You can also tell by the trademark, and the "clinically proven" claims splashed liberally all over the website (real medicines don't tend to point out that they're clinically proven as the very fact they have a license does that).

So what is it supposed to do? According to the advert, it has a unique thixotropic formula. That sounds science-y and cool, eh? It basically means that when you shake it, it becomes a liquid, therefore it can be easily sprayed. It'll then thicken up at rest, i.e. on the inside of your nostrils. It's supposed to form a barrier on the inside of your nose to stop the nasty allergens getting through. According to the website, this is a unique approach, the next generation of hayfever treatment. This is totally untrue: for many, many years we've been advising to put Vaseline on your nostrils as a barrier. A product called HayMax which has been around for years claims to be a "natural balm that acts as a barrier to pollen, dust and dander.". This is, in no way, shape or form, a new concept or breakthrough.

Let's look at what's actually in it, shall we? This is actually very difficult to find, as it doesn't appear to tell you anywhere at all on their website. At first I thought it was cellulose-based, given that most of the references they cite for it being "Clinically proven" are about cellulose powder.  However, according to Netdoctor, it contains "mixture of inactive ingredients, including bentonite (a form of purified clay), xanthan gum, glycerol stearate and sesame seed oil." So, basically, gunky stuff then. gunky stuff that becomes a bit less gunky so it can be sprayed, but that will dry to be more gunky in your nose (although given the inside of noses are actually fairly moist, it's probably, I should imagine, unlikely to dry completely, which would presumably lessen its ability to form a full barrier). It's basically like PVA glue for your nose and it apparently feels like wallpaper paste when its up there, according to @ianthunderroad. Mmmm, sounds lovely.

The "evidence" they show on their website as proof that it works is frankly laughable. Check out this chart:

 

'% of patients experience improvement' it reads. Well, how many patients? What do they mean by improvement? Hopefully we'll find the answers in the accompanying text:

"Prevalin™'s efficacy has been proven in 2 clinical studies, where over 9 out of 10 people experienced significant improvement of their allergic symptoms6,7."

Two studies? that's all? Even if they were pretty big studies, I'd be happier if there were more than two of them. What is "over 9 out of 10 people"? Surely that would be 10 people then? Given a person is a discrete being, you can hardly have 9.25 people experiencing significant improvements. And what do they mean by significant- statistically? or, what we would be more interested in, clinically? 

The referencing on this page is very odd to say the least. I'm expected a reference for two studies, presented in the usual, standard (formerly Vancouver, or similar) format. I'm presented with this:

 6,7. Efficacy of thixotropic nasal spray for seasonal allergic rhinitis assessed by a 4-hour and 3-hour allergen challenge in an environmental exposure unit.

 No authors, no information about date, or where it is published, etc etc. A quick google search finds what I assume to be the paper, although I have no way of confirming that due to the very poor referencing. Even the article itself tells you how to reference it, but the makers of Prevalin have happily ignored this

Luond-Valeskeviciute I, Haenggi B, Gruenwald J. Efficacy Of Three Thixotropic Nasal

Spray Preparations On Seasonal Allergic Rhinitis Assessed By Allergen Challenge In An Environmental Exposure Unit . WebmedCentral ALLERGY 2010;1(10):WMC00993

 


So let's have a look at the three nasal sprays being used in this study then, they are referred to as IQM 11, IQM12, and IQM 13. The first study is a pilot, which uses IQM11. The other two are used in the second study.

Here's the ingredients for IQM 11: liquid paraffin, gylcerol, emulsifier (Glucate SS and Glucamate SSE-20), and water.

It's pretty unclear what the ingredients of the other two are, as they're not fully described. However I think the inference is that they have the same ingredients except for the emulsifier.

See any bentonite in there? any xanthan gum? any of the other ingredients that appear in Prevalin at all? No, me neither. There are other methodological problems with the studies too, but to be honest its not worth going into them now because they are unrelated to the product they are supposed to prove efficacy for.

So in summary: the two studies that the manufacturer's quote are actually the same study, poorly conducted and poorly written up, and about completely different products.

Would I buy this product if I had hayfever? Probably yes initially, because the nice trustworthy pharmacist man on the telly said its good and it works. Would I buy it having looked at the appallingly shaky evidence base for it? abso-blummin-lutely not. This is a shoddy effort, if you ask me, and at a cool £9.95 there is absolutely no way that its worth it.

If any patients ask me whether it works on my locum shifts, I will be very clearly telling them to put their money away and use the vaseline they've probably already got in the house instead. 

UPDATE: 10/05/13 I'm reliably informed by a friend who is using this product out of desperation (and in spite of my ranting about it) that this product has an inconvenient habit of dripping back out of your nose at inopportune moments without much warning. Doesn't sound great, does it? In fact it reminds me a bit of the 'flatulence with oily seepage' side effect you can get with orlistat, only from your nose. Distinctly unpleasant.