Il n'est pas evidence for Salonpas

Firstly, forgive that truly horrific use of French in the title. I'm truly sorry.

Okay, so today I've been having a more in-depth look at the evidence that Salonpas works. And, as predicted, the bottom line is that there seems to be very little. I'm going to tell you where I've looked, in what order, and what I've found and you can see if you agree with this conclusion.

Firstly, the manufacturer's info, the Summary of Product Characteristics. This tells me how it works- it contains methylsalicylate which is converted into salicylic acid (an anti-inflammatory which also irritates the skin), and levomenthol, which causes a local cooling effect and also causes irritation. You might think including ingredients that cause irritation might be weird, but in fact this is partly how most topical rubs and sprays-and even just plain heat- works. Such things are called rubefacients. The irritation basically detracts from the pain and is supposed to distract you from noticing it- replacing one type of  pain with another, almost.

So now we know that we can try to find some proper evidence that this particular product works. So I've done a Medline and Embase search, freetext searching using the brand name. the results? zip. not a sausage. So I tried searching methylsalicylate, and again I found nothing of use. Hmmm.

Eventually I've managed to dig out one study by the manufacturers of Salonpas. I can only get it in abstract form, so I can't really appraise it properly, but its pretty small (n=208) and is limited to patients with mild to moderate muscle strain. Now, if you've ever done any exercise ever, you'll probably know that muscle strain is a self-limiting condition anyway which may well get better itself after a few hours. I also don't know from the abstract whether they controlled the amount of activity in the patients- as you'll know, keeping moving can really help with muscle strain, whereas keeping still can mean you seize up and hurt more. I'm wondering about the blinding of the study as well: what did the placebo contain, because with levomenthol in the active patch it would be easy to distinguish by smell which was which. The results do seem to find a significant difference in pain, but are mainly reported as a per-protocol analysis, so don't account for any patients who have dropped out of the study.

So one study suggests some benefit, but may have some flaws that mean we can't quite accept the results yet.

What about topical rubefacient and anti inflammatory agents as a whole? Well, a Cochrane review in 2004 found that the available studies are limited by poor design, that rubefacients are pretty rubbish in acute pain, but they might work for 1 in 6 patients above those that respond due to placebo effect with chronic pain. The same review reveals that topical NSAIDs might benefit 1 in 3 patients with chronic pain.

Part of the reason these topical preparations work for some people actually has little to do with the drug content of them and a lot to do with application technique: rubbing the product into the area itself can increase blood flow and soothe the area. These patches eliminate that effect, which I think is a really problem in justifying their use. The side effects look pretty innocuous for Salonpas, but I would postulate that having irritants in constant contact with the skin for 8-12 hours, rather than acutely rubbing a small amount of cream into the area, would lead to more local skin irritation.

I have emailed the manufacturers to see if they have any more evidence in their favour. I guess we'll have to wait and see what they come back with, but in the meantime: Will I be recommending this product to patients? Definitely not. There's limited evidence that they work, and no evidence to suggest they are better than the existing (cheaper) products on the market. In short, its yet another gimmick to fill up the shelves in a pharmacy and yet another way to get people to part with their money with little justification. Would you agree?

Hxxx

Salonpas in the firing line

I feel like I've recently been bombarded with slightly cringe-worthy adverts for pharmaceutical products. And no adverts annoy me more than those for painkillers which claim to be delivered "direct to the source of pain" or similar. 

When I was a wee bairn, I remember being interminably confused by how one particular glug of Calpol will know that this time I have a headache, so it has to go to my head, whilst the next dose knows that it is required to report for painkilling duties in my ear because I have an earache at that particular time. Now of course, I have a more thorough understanding of pharmacokinetics (or at least I should have, but most of it has probably been pushed out of my brain by less useful, but inordinately more entertaining things), and I know that this is all total nonsense. A drug is distributed around the body depending on its properties, and whether it needs to go "direct to the site of action" depends on how it works, and whether it acts centrally or not.

I now spend a percentage of my time on locum shifts advising people that topical painkillers like Ibuleve and Voltarol are probably no better than taking tablets, and attempting to steer them towards the more effective-and cheaper- option of ibuprofen tablets, with advice to just rub the area if that makes it feel better, as that's what makes topical preparations work. So I'm already set to default to cynical mode with topical pain preparations. 

Enter the newest shiny painkilling gimmick onto our screens: Salonpas, a patch which, according to the US website allows absorption of the active ingredients through the skin to "go directly to the pain site"

So my skeptical ears are already pricked up. A quick glance at the website offers me a video to tell me how it works, which also makes me suspicious. I also can't find any particularly robust evidence on the website with a cursory look. 

The other thing that's worrying me is that these patches are rather expensive. they appear to retail at £4.99 for 3 plasters, with the maximum dose being 1 patch twice daily. That would be a whopping £23.29 per week.

So I'm going to start having a bit of a dig about to see what evidence there is on this new product and i shall, of course, let you know the results. It could well be that these patches are worth every penny, and are the holy grail in pain relief. However I suspect they're just another way to get money from people who are pretty desperate. But, I will remain open minded in my quest for evidence-based information.

Salonpas, be warned. I'm after your evidence.

Lets have some honesty, shall we?

Stigmas. They're stubborn things aren't they?

I've seen a few folk tweeting this article: Hooked on Happy Pills? in The Independent this week about the sort of language used to describe medication for mental illness, and this has started me thinking a bit about one of the seemingly most stubborn stigmas: mental health. When you've worked as a community pharmacist for a while, you sort of start to see the sort of numbers of people who are taking mental health drugs, and you start not really thinking twice about them, so its interesting to see how pervasive the stigmatisation of mental health issues even in this day and age.

Now I'm a pretty normal person, to be honest. I'm not particularly exciting in any way shape or form, I have a stable, loving family background, and a truly wonderful circle of friends. I'm not rich, nor am I completely destitute. I work a 9-5, five days a week job which I rather enjoy. I function pretty well in daily life, to be honest, despite living up to my nickname of Simple Dog. I've been subjected to few major traumas in life, and whilst I've been certainly affected by my divorce, even that went pretty smoothly to be honest.

So what am I doing writing about mental health then, eh? Well, like pretty much everyone else in the world, I'm affected by it. And I'm tired of this stigma, and I think its becoming time to just start talking. I know that my contribution to the party is going to be very, very tiny, but I'm also naive enough to think that very, very tiny bits all add up to a change. Lately, I've just started being honest about myself with other people. It started imperceptively, but seems to have grown to the point where I'm merrily discussing my anxiety issues with colleagues that I would never have dreamed talking to about such things with.

I'm generally of a pretty anxious constitution, and I think I always have been. When I was much younger, maybe 12-13-ish I started having panic attacks which led to a period of bulimia, which had nothing to do with my weight but was to do with a fear of vomiting in public. It seemed logical at the time (and to be entirely honest, I still think its a bit logical now). Anyway, I overcame all that, and am left with a sort of residual anxiety which raises its head now and then, but most of the time is fairly easily kept in check. In recent months its resurfaced a fair bit, and its not being helped by my increasingly monstrous appearance of late as my guttate psoriasis continues. What helps? telling people about it. If I'm getting palpitations, I'll tell people that I'm getting them, and that in itself makes me feel a bit better. If I wake up early in the morning filled with vague, formless fears, I'll tweet about it, and there's an instant bit of relief, and usually someone there to say something practical or funny about it.

I'm surrounded by people who also have mental health issues of varying degrees, from some of my nearest, dearly loved and oldest friends to momentary acquaintances. There are people I have never met, but who have been some of the greatest pillars of support to me in less than 140 characters. There are people who I hope I've helped a bit, and some I wish I could help more. And guess what, everyone else is surrounded too. The more open I've been, the more open people have been with me, and I think this is a privilege and a right that everyone should have. There's been some  who haven't handled these things as sensitively as they could have done, but I figure the more I bleat on about things, the more normalised it becomes.

At our Skeptics In The Pub talk the other night, there was one lone voice in the crowd that believed and spoke up for homeopathy. I'm reminded of him when writing this because he was getting a pretty thorough grilling from myself and other folk who were there, and was being asked about his particular experience with homeopaths and he had little hesitation in talking openly about his depression, and how he felt it was helped by having a homeopath with whom he felt he could talk to. His bravery is quite staggering really, given he was in a room full of people who disagreed heartily with him, and yet he still told us all.

I know this has been said already in bigger and better ways, but this is my tiny contribution. I guess what I'm trying to say is lets be rational about this whole thing, accept that these issues are everywhere and everyone has them to some degree or another, and just be honest about it. The more matter of fact we are, every day, even in the tiniest of ways, the more difference we can make to everyone. I sort of feel like its the people like myself, the "normal, functioning" folk who can maybe make the most amount of difference here. I'm guessing people with milder mental health issues may be more able to mask it, and more reluctant to be open about it lest something terrible happens. But they key thing here is that we have to be open, so that the something-terrible-that-might-happen-if-we-do-let-on doesn't exist anymore.

Hope this makes sense,

Hxxx

Red wine as painkiller... In babies?!

A couple of years ago, I was working a locum shift in a supermarket pharmacy. It was quite late at night, and a man came up to the counter to ask me if I did circumcisions. I assumed I had heard incorrectly, but no. "I thought you would be able to do circumcisions, since you can do healthcare services and you have a private room" he said, pointing at the extremely small and flimsy consulting "room" and the end of the counter. I couldn't help but notice the small boy cowering behind him as I politely explained that no, circumcision certainly wasn't a pharmacy service.

At the time, I remember being amazed that it would occur to someone to take their child to a supermarket for what is a surgical procedure. Whilst it may be considered minor surgery, I'm sure to the young boy himself it didn't seem all that minor, and I'm pretty sure he wouldn't be wanting a pharmacist to do it in the middle of a supermarket with only some thin plastic walls between him and the vegetable aisle.

Anyway, I shall leave aside the ethics of circumcision for now, and consider a tweet I saw this morning by Andy Lewis. One particular Doctor, on his website, is advising pain relief options for babies who are about to be circumcised. He advises loading the child up on red wine as a preferred option. Now hold on here, this is a GMC registered Dr advising on giving babies alcohol. Whilst he doesn't give any information about how much wine to give, i'm assuming it would have to be enough to get the child at least slightly intoxicated to have any painkilling effect. A quick google search suggests the 8th day after birth is a usual time for the circumcision to take place.

"1. To give the baby sweet, red wine prior to the procedure. (Kiddush wine is ideal). This is very effective in calming the baby. Ideally it is given about 15 minutes before the circumcision and I will give it on arrival if you wish. You will need to provide the wine."

At this point, let us consult TOXbase.org, the database of the National Poisons Information Service (NPIS). They advise that any children under the age of 10 who are symptomatic due to an alcohol ingestion (i.e. intoxicated) are taken into hospital for medical assessment.

Why is it dangerous to advise wine as a painkiller in a child of this age? Well, alcohol in children can be very nasty. It can cause hypoglycaemia, particularly in children, and a seemingly well child can sometimes suddenly and quickly go downhill fast- that's why NPIS recommend that they are observed in hospital.

Such advice, coming from a trusted Doctor, is very concerning indeed. It appears from the website that he expects the baby to be "prepared" prior to his arrival, so he is expecting the parents to administer and provide the wine (whilst he says he can give it "if they wish", to me this implies that its more usual for the parents to give it). He also recommends Emla cream, which he says the parents can buy from a pharmacy. This is an off-label use that he is openly promoting.

I have emailled the GMC to ask what their stance on such advice is:

"To whom it may concern,

I have happened upon the following website, which promotes the work of a GMC registered doctor, Dr Howard Cohen GMC number 3057256, and wish to clarify with yourselves whether I would be able to make a complaint against the advice he gives on his website:
www.mohel-circumcision.co.uk

I am particularly concerned about the advice regarding pain relief that Dr Cohen is giving. He recommends giving babies "sweet red wine prior to the procedure". It is my understanding that children should not be given alcohol, particularly on the advice of a healthcare professional. I regularly use Toxbase in my daily work and note that children who have ingested notable amounts of alcohol should be observed in hospital due to the risk of hypoglycaemia and other issues. A Dr recommending that a child is given presumably enough wine to be intoxicated as pain relief is highly dangerous advice.

He also advises purchasing Emla cream from a pharmacy for use prior to circumcision. It is my understanding that, although Emla cream is licensed in children, its use on the skin of male genital organs is only licensed in adults. Dr Cohen is therefore promoting off-label use of a drug on his website, without giving sufficient dosing advice or guidance.

I look forward to hearing from yourselves if this would be grounds for a complaint, or if promoting such advice is reasonable from your point of view.

Kind regards,"

Let's hope I get a decisive reply back. 

Hxxx

Update: As of 25th Feb I still haven't heard back from the GMC.