conventional medicines

Unicough: Sadly not as good as unicorns.

Another day and another new cough medicine has mysteriously appeared on pharmacy shelves.  It’s called Unicough® (Infirst), and it claims to work by:

addressing the hypersensitivity of the cough reflex, which makes it suitable for dry, tickly and chesty coughs
— http://www.chemistanddruggist.co.uk/news/new-cough-syrup-pharmacy-only#sthash.toAK6A2l.dpuf (subscription required)
source: http://www.infirst.co.uk/were-working-on/unicough

source: http://www.infirst.co.uk/were-working-on/unicough

Riiiight. Regular readers will by now know that most cough medicines are absolute nonsense, with little to no evidence of effectiveness. I’m particularly suspicious of products (like this one and Bronchostop, for example), which claim to be able to work on any type of cough. Chesty and dry coughs happen through different mechanisms, so a product that claims to treat all types seems more likely to not work for any. An exception to this would be a simple demulcent like simple linctus, which acts just by coating the throat for a little while. 

Am I right to be suspicious about this product? Well dear friends, lets take a deep, objective breath and dive into the evidence, hoping beyond hope that maybe this time… this time… it might not be a nonsense product. 

Is it actually a medicine? Or is it just pretending? 

Unlike most new over the counter products which all turn out to be medical devices masquerading as real medicines, this product is actually, genuinely a Real Life Medicine. It even has a Real Life License, for the symptomatic relief of common coughs associated with upper respiratory tract congestion. What larks! What a time to be alive!

This means that the manufacturer will have proven three broad things in order to receive the license: safety, efficacy, and quality. We’re not out of the woods yet, by any means, but this is probably the most promising start to an OTC medicines review I’ve done so far.

It contains diphenhydramine 14 mg (an antihistamine, which as a side effect will make you sleepy), ammonium chloride 135 mg (irritates the airways, therefore is supposed to loosen up any mucus and help you cough it up- aka an expectorant), and levomenthol 1.1mg (minty, therefore feels a bit soothing and cooling). Despite Infirst’s hopes that Unicough will “reshape the approach to acute common coughs”, there are no exciting or revolutionary technologies here. All of these drugs are old as the hills, and very similar products (Benylin Chesty Cough Original) have been widely available for pretty much forever.  

Furthermore, it is a totally irrational combination of drugs. You’ve got an antihistamine, which acts to dry up secretions, nestling up alongside an expectorant, which is supposed to promote loosening up secretions. Those two actions work against each other and cancel each other out, rendering the whole thing pretty darn pointless. 

If it's licensed, that means that there is evidence that it works though, right?

Ummm… no. It seems that it’s managed to get its license on the basis of being exactly the same (save for flavouring) as another product called Histalix®. That product got its license in 1999, seemingly on the basis of thin air. It’s safe to say that back then licensing for OTC products was rather less rigorous than these days, and “but it’s been around for a while now” used to be a legitimate reason to grant a license. Now, I can’t find the information that the manufacturers of Histalix® presented at the time, but I’m guessing it’s probably not a whole suite of robust, well designed trials.

An article about the product in Chemist+Druggist magazine gave some vague details about a trial:

A randomised study of 163 patients co-ordinated by King’s College Hospital, London, found that the cocoa-based formulation was more effective at reducing the frequency of coughs and the disrupted sleep caused by coughs than simple linctus, Infirst Healthcare said
— http://www.chemistanddruggist.co.uk/news/new-cough-syrup-pharmacy-only#sthash.toAK6A2l.dpuf

This trial, however, doesn’t appear to be published anywhere. I contacted the manufacturers asking for more information about it and was, perhaps predictably, met with silence. Without knowing how the trial was designed, and what the results were, we will have to just discount it; it’s the medical equivalent of being told that no, this Rolex watch someone wants to sell you for £20 is definitely not a fake, honest guvnor. It’s worth noting too that the comparator they used, simple linctus, is no better than placebo itself. 

Searches of the medical literature found a great deal of nothing, either. I searched for both Unicough® and Histalix® too, as well as the combination of ingredients, to no avail. Yes, it might help you get to sleep at night thanks to the antihistamine side effects, but I wish they would be honest about that in their marketing. You’ll sleep because you’ve been knocked out by drugs, not because its made any difference to your cough. 

Is it safe? 

On the whole, there probably aren't any major safety concerns here. Drowsiness is going to be the main problem with it, and as with all things that can cause drowsiness there is a possibility of dependence. Other effects could be dry mouth and urinary retention. It can interact with a few different medicines. Of course there is always the potential issue of self-treatment of a persistent cough, and masking of symptoms that could suggest a more malignant cause. 

The practicalities

Any product which causes drowsiness is going to be severely limited in its usefulness through the day. If you drive, work, or even just don’t want to be asleep all day, then you’re going to have to avoid this product, or you might even end up having to buy two lots of pointless medicines; one for day and this one for night. Additionally, antihistamine-induced sleep can often leave you feeling still quite drowsy the next morning, and some people can even feel quite hungover. It’s not going to be ideal if you have to be up early for work, or if you drive early in the morning.

The unique selling point of this product is the taste. It's cocoa-based, which I'm sure is pleasant, but it aint going to make a blind bit of difference to your cough. I even wonder whether a pleasant taste might have a detrimental effect on any placebo effect: if it doesn't taste like medicine, then you might get less of a response. 

Is the cost reasonable?

Whoah, £8.85 for 150 mL? Give over! There is absolutely, categorically no way that this product is worth that amount. 

TL:DR! Is it worth a punt? 

Nope. There’s no evidence it works, and the combination of ingredients in it makes no sense. Save your money and invest in some cheap simple linctus or glycerine, honey and lemon to soothe your throat instead. The best cure for a post-infective cough is time. Look after yourself, rest, drink plenty, and eat well. If your cough doesn’t go away after about three weeks, get yourself checked over. I know that coughs can be awful, annoying, embarrassing, and exhausting, but –and I’m sorry to have to tell you this- nothing will get rid of it instantaneously, or even any quicker than using nothing at all, so you might as well save your pennies. 

A Mahoosive Thank You

Last month, in a drunken moment of possible madness, I decided to set up a Patreon page. I did so hoping that even setting the page up might work as a driver to overcome the writer's block that has been cursing me for too long. I set the target amount as a dollar, and limited paid posts to these OTC product reviews, because I think there is a real gap in the market for them, and ultimately they will hopefully help people save money. 

To my utter astonishment, four kindly patrons stepped up and made pledges. I doff my cap to you and can't thank you enough. 

Shaun Sellars
Alex Brown
Jack Wright
Bevin Flynn

If you enjoy these sorts of posts, find them useful, and have more money than sense, then I'll just leave this here

Literature Search terms:

Embase: unicough (freetext, ti.ab) Histalix (freetext, ti.ab) *Diphenhydramine AND *Menthol AND *Ammonium chloride

References: http://www.infirst.co.uk/were-working-on/unicough https://www.medicines.org.uk/emc/medicine/31365 https://www.medicines.org.uk/emc/medicine/11171 http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con553668.pdf http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1445576593772.pdf

Is Herpatch Mouth Ulcer Gel worth a shot?

Mouth ulcers can be very unpleasant little blighters. They’re often really painful and can be rather distracting, especially when eating. And, if you ask me, anything that makes eating difficult makes life more miserable. They tend to be self-limiting, but for those most painful moments, there aren’t that many treatment options available over the counter. There’s a new product available in Boots currently called Herpatch mouth ulcer gel, so I thought I’d cast an eye over it to see whether it’s worth spending your hard earned cash on.

What's in a name? Mainly confusion in this case

Its actually been quite hard to find manufacturer’s information on this product due to some brand name issues. It would seem that the Herpatch range is being marketed elsewhere in Europe as two products for cold sores, a preventer and a treatment “serum”. The same manufacturers also market a product called Aphtgel, which is for mouth ulcers.

It seems that in the UK, however, the picture is less clear. From what I’ve managed to cobble together, only two products are being marketed, and they’re both doing so under the Herpatch brand. There is a mouth ulcer gel, which appears to be the same as Aphtgel, as well as the cold sore preventer product. The serum doesn’t appear to be available over here yet. The brand name makes little sense for the mouth ulcer product- there’s no patches, it has nothing to do with herpes, and it ends up sounding gender specific, which is nonsense.

What is it?

Aphtgel Remesense is based on Sylphar’s film forming technology. Upon application, it will form a transparent, thin muco-adhesive film on the mouth ulcer. This film will protect and isolate the injured mouth area affected by the ulcer.
— http://www.sylphar.com/sites/default/files/productfiles/111085Aphtgel_Psheet_UK00.pdf

This actually seems like a very reasonable mode of action. Forming a cover over the ulcer may in theory reduce pain, as well as reducing the likelihood that a secondary bacterial infection can creep in and make itself comfortable. It’s also useful to cover over an ulcer whilst it heals, but its obviously very difficult to stick a plaster in your gob, so a product like this certainly does have an important role, at least in theory. It’s not a new concept, but refreshingly it also doesn’t seem to be marketed as such. A product called Orabase used to do a similar sort of job, though its no longer available.

The main active ingredient is hyaluronic acid, which is naturally abundant in skin and cartilage, along with a few other bits and pieces like xanthan gum and cellulose. Basically, it contains a collection of gloopy, sticky stuff that probably won’t dissolve immediately when in contact with saliva. 

Medicine vs Medical Device?

As with many new Over the Counter products, Herpatch gel isn’t actually a medicine. Instead, it is classed as a medical device- a fact that is fairly difficult to deduce unless you do a fair bit of poking about on the manufacturer’s website. This means that the product doesn’t have to go through the rigorous testing that a medicine would, and it shouldn’t have any direct pharmacological effect- in this case it forms a physical barrier, but isn’t absorbed greatly and doesn’t produce any other effects on the body.

Does it work? 

Wonders will never cease, but it seems that there is actually some half-decent evidence that this product works. There are some actual, real life trials for gingivitis, periodontitis, and a similar product is already licensed for chemotherapy-induced mucositis. There’s not much evidence, admittedly, but the published stuff seems to suggest a decent effect size. It’s worth noting that most trials and evidence include people with recurrent or more severe ulcers, which might skew the results somewhat- most of the folk buying it over the counter will be using it for the occasional ulcer rather than for a more serious, recurrent problem.

Is it safe? 

Evidence seems to suggest that topical hyaluronic acid is well tolerated and there aren’t really any safety concerns that I can see think of with this product. One problem could be indirect harm caused by lengthy self-treatment of an ongoing problem. If an ulcer persists for more than 3 weeks, there’s a possibility that it could be something more suspicious.

The practicalities

Using the product might be a bit onerous. The aforementioned Orabase used to be a claggy, gritty paste which felt pretty unpleasant in your mouth. Being a gel, I’d imagine that Herpatch might feel a bit better, but there’s still a possibility that it might feel weird. You’re supposed to wait for 30 minutes before eating and drinking and avoid rubbing the area with your tongue. That seems… unlikely. We’ve all got that little masochistic streak in us that means you can’t quite leave it alone. I’m therefore not sure how long the barrier will stay in place for.

The cost.

This product isn’t cheap, coming in at £7 a pack. That seems pretty steep to me, especially for something that is self-limiting and will probably resolve in two or three days.

To summarise

Not a medicine as such, but a product that has some prior plausibility and some evidence suggesting it may work. Pretty pricey, but I guess if you’re going out for an important curry or something, you might decide it’s worthwhile. There aren’t that many other options available that aren’t hokum or placebos, so I’d actually-for once- be fairly happy to recommend this product to some patients over the counter.

 

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