medical devices

Is SoreFix a sore loser?

Cold sores truly are the devil's work. The pesky little blighters make a habit of cropping up at the worst moment, crushing your self confidence within a mere matter of hours. 

Given that cancelling everything and holing yourself up in a darkened room until it has gone away tends not to be all that practical for most of us, It's no surprise that folk are desperate for something that really works, and fast. I've already written about several other new cold sore products on this here blog, neither of which are the miracle cures they're marketed as. 

Enter Sorefix, a product selling itself as a new all-round product to both treat and prevent cold sores. Interestingly, the manufacturers claim that it even works after the cold sore has come out, which if true would make it a really useful product. 

In case you are too late to prevent a cold sore, SoreFix relieves symptoms such as itching, burning and the blisters on or around the lips and it speeds up the healing process. So prevent feeling embarrassed and choose SoreFix!
— http://www.sorefix.com/sorefix-cold-sore/

Medicine vs Medical Device? 

Once again, this product isn't a medicine. It seems that nearly every new OTC product these days is actually a medical device masquerading as a medicine, and this is no exception. It might look like a medicine, it might be sold in pharmacies, and the manufacturers might even make claims that make it sound like a medicine, but nay, it is in fact a medical device. Essentially, this means that the need for good quality, robust evidence of efficacy before marketing is virtually non-existent. Le sigh.

The evidence   

Usually, the first step in finding evidence for how a product works is to find out what is actually in the product. This is proving quite difficult for Sorefix, as all I can find is some vague statements about "two zinc salts". hmph. Ah well, I shall have to make do with what I can. What i am particularly interested in is the claim that Sorefix can reduce healing times for a cold sore once it is already out. 

The manufacturers themselves don't bother with providing any cursory clinical trial data. This is unusual, and sort of  refreshing in a way; at least they aren't trying to palm off some nonsense animal studies as irrefutable evidence. It does, however, leave me with even less of a start than I normally would have for these sorts of posts. 

A quick Google search found nothing whatsoever, so I delved into the medical literature in a Medline and Embase search to see if there is any studies looking at the effects of zinc on cold sores. As I can't find which exact zinc salts are in the product, I just did a search for zinc. I found a grand total of three results, none of which were relevant. 

I did manage to find some information about the topical use of zinc in a trusted database. It seems that there is some, very limited data which suggests that some specific zinc-containing products, none of which are Sorefix, may reduce the duration of symptoms by a grand total of 1.5 days, and that's only if used within 24 hours of onset. There is also some evidence that zinc isn't effective for recurrent infections, which is probably going to be pretty much everyone. 

So it seems that I can find nothing at all to back up any of the manufacturers claims at this point. I've contacted them to see if they have any further information, and it'll be really interesting to see if I ever get anything back. 

Safety

Safety-wise, it's very difficult to comment on without knowing what exactly is actually in it. The manufacturers say you shouldn't use it if you are very sensitive to any of the ingredients, though of course they don't tell you what they are. Helpful much :S

The practicalities

The key with cold sore treatments is that you need to start using them before they appear, and you need to use them regularly. Despite what the manufacturers seem to be saying, it would appear that this product is no different. It doesn't contain an antiviral, but the limited amount of evidence looking at the effects of zinc for cold sores suggest that it needs to used every two hours in order to have an effect. That's a lot of applications per day, and I think it's unlikely that most people will be able to keep up with it for any reasonable amount of time. It's worth noting that, because cold sores can worsen quickly, this probably does include overnight too.

I really like the idea of having something to use for prevention, but its hard to remember to apply something at the best of times.  Its even harder if you haven't got a throbbing mass of evil reminding you of its presence constantly.  Given the lack of evidence for prevention, there is no specific guidance on how often you are supposed to use it in order to prevent a cold sore, but I suspect its going to have to be very regularly. 

The cost

It costs £7.47 for a jar or tub of this stuff. Although that's quite similar to other new products for cold sores, it's waaay more expensive than generic aciclovir or plain old vaseline. 

So, is it worth a shot? 

At this time, no. I can't see anything to suggest it's any better than existing treatments. I'll be interested to see if I get anything back from the manufacturers, but I can't see any reason why this product would work, and there is certainly no evidence to back up their claims.

Unfortunately, when it comes to cold sores, time is the best healer, especially once they are out and proud.  If it hurts, then use painkillers like paracetamol or ibuprofen. If its still at the tingling stage, go for topical aciclovir, but make sure you get a cheap generic version rather than Zoivirax: its exactly the same stuff. It's not going to make much difference once its already taken hold though, and at this point you're better off just using something like vaseline to keep it as supple as possible. 

Hxxx

 

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.