The Times on 4th April 08 featured an ad for "PainSolv", which is a "therapy based on more than 30 years of worldwide research carried out by renowned scientists." Hmmmm.....See the full ad here.
Apparently it works by "pulsed electromagnetic wave forms into the body, passing through all body tissue including bone without any impairment of wave strength".
Which is amazing because you'd expect that, if this thing has any effect, the wave strength might just be impaired.
But apparently it does work, it's been "clinically proven to have vigorous biological effects, influencing cell behaviour by inducing electrical charges around and within the cell wall membrane, the starting point for a strong immune system." and "The resulting natural reactions within the body helps to activate and regenerate cell function that can be beneficial for a wide range of conditions."
Where is the evidence please?
For the amount of money it costs to place an ad of this size in a national newspaper, they are going to have to rip a hell of a lot of people off before making a profit. Even at £129.95 + £5.95 p&p.
I've submitted a complaint to the Advertising Standards Authority this morning:
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05 April 2008
New Complaints
Advertising Standards Authority
Mid
71 High Holborn
WC1V 6QT
To Whom It May Concern:
I have enclosed a misleading advertisement in The Times on April 4th 2008.
My complaints about this advert breaching your standards are as follows:
3.1 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove all claims, whether direct or implied, that are capable of objective substantiation.
Relevant evidence should be sent without delay if requested by the ASA or CAP. The adequacy of evidence will be judged on whether it supports both the detailed claims and the overall impression created by the marketing communication. The full name and geographical business address of marketers should be provided without delay if requested by the ASA or CAP.
50.1 Medical and scientific claims made about beauty and health-related products should be backed by evidence, where appropriate consisting of trials conducted on people. Where relevant, the rules will also relate to claims for products for animals. Substantiation will be assessed by the ASA on the basis of the available scientific knowledge.
“PainSolv encourages your body to enhance the efficiency of cell functions which in turn increases oxygen content in your blood as well as many other beneficial processes.”
(a) This claim breeches 3.1 and 50.1 as there is no credible evidence to suggest that the product enhances efficiency of cell functions.
(b) This claim breeches 3.1 and 50.1 as there is no credible evidence to suggest that the product increases oxygen content in the blood.
“PainSolv can help relieve the pain associated with the following conditions and many more – Arthritis, Back Pain, Migraine, Whilash, Joint Pain, Muscle Spasm, Stress, Leg Ulcers, Gout, Tendinitis.”
(c) This claim breeches 3.1 and 50.1 as there is no credible evidence to suggest that the product works better than placebo for any form of pain relief.
“PainSolv works directly on the cause rather than just the symptoms!”
(d) When combined with the claim that the product relieves pain from arthritis, the advertisement is making the claim that the product can repair damage to joints or remove infection of joints. As there is no credible evidence for this, this claim breeches both 3.1 and 50.1.
By charging £129.95 + £5.95 P&P, this company is extorting money from vulnerable people in pain, who are easily fooled. This in itself is a breech of 6.1.
Yours sincerely,
Simon.
Posts
46 comments:
These people are cowboys and should be locked up. They claim to treat leg ulcers, meningitis, angina, etc.?
I would encourage anyone to undertake some research into the background of the people behind this gadget - colourful is not the word!!
I see the ASA have done their work. Well done!
You people need to get a life quickly!!!!
Its very sad trying to put down someones Brilliantly exellent Product which is proven to work..
I am a PainSolv veteran and have had one for 3 years. its the best product i have use.
Your lack to understand that it is a comprehensive THERAPY SYSTEM.
It DOES work and you should try it for yourself and pipe down!!!
You seem to have your breeches in a twist. (I think you mean _breaches_...)
Here is a review paper on pulsed signal therapy. You need to do a literature search before you state that there are no data backing it up. This device per se is about to be tested in clinical trials, but the principle of pulsed signal therapy has some actual scientific backing. E.g., http://www.ncbi.nlm.nih.gov/pubmed/20329696
Phyllis
@Phyllis
I prefer it if people link to the article rather than just the abstract. The full article you refer to is here: http://nopr.niscair.res.in/bitstream/123456789/6722/1/IJEB%2047(12)%20939-948.pdf
The article doesn't mention the PainSolv device.
It doesn't seem to relate to trials of devices that operate on remotely similar frequencies, so I'm not sure how they're relevant - even if they are properly conducted (which I haven't checked).
I'm not sure how your statement "the device per se is about to be tested in clinical trials" is relevant. Are you assuming that the results will come out positive? Is there a commitment to publish in these trials? Could you provide us with further information on them?
Thanks for your reply. The concept of pulsed magnetic therapy has been tested with positive results. I actually did speak with someone from the company and they are investing in clinical trials. It is really the only way to show that something works, but the tone of your original statement seemed dismissive of the possibility that pulsed magnetic therapy would do anything. I am a clinical investigator and review many manuscripts per year, so I am really tough on claims. The studies are not that well-done, but the do support the possibility of real benefit.
@Phyllis
I hadn't looked into the the trials quoted, but if you say that they were "not that well-done" then I suppose you must be in agreement.
You didn't respond to my points on the irrelevance of the trials to the PainSolv device however. The frequencies seem to be out by a factor of 1,000 - or do I have that wrong?
Not exactly. Not well done means that they did not prove their point beyond a shadow of a doubt. For example there is a Brazilian Trial showing that 70% of patients improved with PST, but a lot of patients were lost to follow up and we don't know about them. So we do know that 70% of the patients that they managed to follow up had significant improvements in their pain scores by self report and 30% did not. There are a lot of badly done trials in every area of medicine. Training in doing research and training in clinical medicine do not necessarily overlap and a lot of good interventions are never written up for publication. However, I plan to try this device for myself. I will let you know if it does anything. They do provide a money-back guarantee trial period. Do you have any chronic pain you want to try it on? :-) I do appreciate your skepticism. You have really looked into the details! There are certainly enough untested false claims out there.
@Phyllis
If you mention a trial, could you link to it please?
1. Do you have a link to the Brazilian trial you mentioned in your last comment?
2. You state that the trials do not prove the efficacy. Do you then agree that marketing PainSolv as "Proven Technology" is misleading?
3. You have not responded to my original question: isn't the previous article you mentioned irrelevant seeing as the frequencies are out by a factor of 1,000?
Hi
Try this link:
http://www.certifiedpst.com/
It is the Vancouver CA Pulsed Signal Therapy link and there are links on it to publications.
@Phyllis
I presented 4 clear questions. Wherever you have asked questions, I have answered them. There isn't much point in continuing the debate if you are not interested in providing honest answers.
In your next comment, could you please answer the questions I presented?
Thanks, Simon
@Phyllis Ooops. I meant 3 questions :-)
Okay Brian, your questions which I am quoting:
Are you assuming that the results will come out positive?
You never do a clinical trial without the hope that the results will be positive, otherwise, why bother. But you don't know until you do it.
Is there a commitment to publish in these trials?
You do understand that most negative trial are not published. They are not usually even accepted for publication if submitted and it would be insane for a manufacturer to publish such a trial. So you are right, we wait for a positive trial. If we don't see one in the next couple of years, I would assume there were no results. However, the link I sent you for PST had some positive, published studies.
Could you provide us with further information on them?
The person I spoke to at Painsolv said that they were currently funding three clinical trials. I did not ask him for the details. In addition, he was very interested in talking with me about possibly doing additional trials here. He was definitely EAGER to do clinical trials. As you know there is anecdotal evidence and there is clinical trial evidence. His personal experience with using the device on people was very positive, including the report that his 90-year old mother had begun to walk after being wheel-chair bound due to bone-on-bone osteoarthritis that could not be operated on because of other clinical comorbidities. It took a few months, but it happened.
Here is my take on pulsed magnetic therapy. I think it works somewhat like cardiac bypass surgery in the sense that when you restore blood flow in that surgery, you wake up "stunned myocardium." That is, if you have cells that are acting dead but are really alive, you get results. If the cardiac cells are really dead, bypass does nothing. I think that PST may do the same thing, that it wakes up a healing response but only if there is something to wake up which is not always the case.
@Phyllis
Those weren't the questions. It's not too difficult Phyllis, I even numbered the questions for your convenience. Here they are again:
1. Do you have a link to the Brazilian trial you mentioned in your last comment?
2. You state that the trials do not prove the efficacy. Do you then agree that marketing PainSolv as "Proven Technology" is misleading?
3. You have not responded to my original question: isn't the previous article you mentioned irrelevant seeing as the frequencies are out by a factor of 1,000?
There are many reasons why anecdotes are useless in assessing if medical devices work, especially for self-limiting conditions. See this article on the subject http://beta.thisisleicestershire.co.uk/news/alternative-way-thinking/article-1796519-detail/article.html
Okay Brian:
1. Do you have a link to the Brazilian trial you mentioned in your last comment?
Yes, I actually said that there was a link in the Vancouver PST site that I sent you. Here is another paper:
Indian J Exp Biol. 2009 Dec;47(12):939-48.
Low frequency pulsed electromagnetic field--a viable alternative therapy for arthritis.
Ganesan K, Gengadharan AC, Balachandran C, Manohar BM, Puvanakrishnan R.
Do a search for Pulsed Signal Therapy on PubMed http://www.ncbi.nlm.nih.gov/pubmed/
2. You state that the trials do not prove the efficacy. Do you then agree that marketing PainSolv as "Proven Technology" is misleading?
Yes and no. It is marketing yes. It PST proven technology, yes. In medicine we have multiple levels of proof. Does this meet the highest level, no? Have there been published trials that say it works? Yes. Has the device itself been shown to work in published trials, no. Are they planning clinical trials? Yes.
3. You have not responded to my original question: isn't the previous article you mentioned irrelevant seeing as the frequencies are out by a factor of 1,000?
No, I am not tracking the frequency at all. I have been in a PST coil and I could feel the magnetic pulses. The painsolv seems to be at a similar, feelable frequency. Has anyone done enough trials to figure out the best frequency? No.
There is a context here. When they test a medication, say beta blockers, they give it to half the people and not to the other half (placebo, blinded, all that). Then if the treated half does better by some arbitrary rule (and keeping in mind all of the selection criteria for the trial) the drug company excitedly concludes that it works and everyone starts prescribing it. Years later, they figure out that it only work with people who have certain genetic and could be harmful on others. So proven efficacy is a very amorphous concept.
Again, I do appreciate your detailed attention to these things, but jumping to conclusions can happen on either end of this.
@Phyllis
I'm not sure how many times I've asked now, but you've still failed to link to this Brazilian trial. Linking to a site that markets a clinic and that happens to have a link to a trial somewhere hidden in it isn't the same as linking to the trial.
All the trials I've found to date from the PainSolv "research" page have been seen to research drastically different devices. Your avoidance of linking to this Brazilian trial is perhaps caused by your knowledge that this trial is also irrelevant.
It's interesting that could still count the technology as "proven" when you admit that it hasn't been tested and the trials linked to have frequencies that appear to be out by a factor of 1,000.
You seem to think that I'm jumping to conclusions about the efficacy of this device. My position is simply that PainSolv have decided to simply claim that their device works without testing it first. I haven't reached the conclusion that it is ineffective, I've only reached the conclusion that the claims made about the device are clearly bullshit. By bullshit, I mean that the claims have simply been stated without concern for first checking if they were true.
@Phyllis
Are you interested in doing a proper, open-minded test of the device?
If so, comment your email address so we can arrange. I won't publish your email-address comment.
What do you have in mind? I actually discussed doing research with a representative of the company, but that person had not thought through what question they actually wanted to answer. He was not really their research person. I am a research scientist. I design trial. I do this stuff for a living. I don't do pain research but I do perform outcomes research in cardiology. I left the possibility of studying the device open, to be revisited after my 60-day trial to see how I felt about it. If you have an idea, let me know. Doing good research is not as simple as it seems.
@Phyllis
Is there any way to tell if the device is actually on, other than the LED? Does it make any noise? If not, it should be fairly easy to blind and a test to see if, for instance, it reduces pain with 4 minutes use, should be relatively simple.
Yes, it kind of buzzes too. If the manufacturer wanted to create a dummy device they could. However, if you are using a placebo, the people in the study have to know it and actually, expecting something to work have a powerful (and real) effect on people and that is not to be discounted, so doing a placebo trial is different from doing a crossover trial where people wait for treatment and keep doing whatever they have been doing. Crossover is more lifelike actually.
[Customer testimonial removed from post].
@Phyllis
I'm confused. Why can't you do a crossover trial comparing PainSolv against placebo?
I figured that with your testimonial that you felt pain reduction within 4 minutes, this would be ideal for a crossover trial. 4 mins with device, 4 mins with device containing disabled cell. It would be extremely easy if it didn't buzz.
It's interesting that it buzzes. Do you think that was added in to make it feel like it was doing anything? It doesn't seem necessary.
BTW, you may have noticed I'm removing product promotional testimonials from comments. As a designer of trials, you'll know that customers can be wrongly convinced by them.
You could do that too, but the most efficient preliminary trial would be Painsolv against wait list. If that is positive, then you could do a trial with a crossover of Painsolv vs. placebo Painsolv except I think people who were getting pain relief and were crossed over to placebo might not be happy and might not stay in the trial. It depends on what you are testing. If you are testing whether using the Painsolv devices reduces pain you can do it without a placebo. If you are testing the mechanism by which it does, i.e., the light and the buzzer or the actual magnetic field, you could use a placebo device. Another possibility, in an acute setting, is to use a blinded placebo or active device on one side (e.g., right side) vs. the other and have neither the therapist nor the patient know which is the active treatment. There are two effects you are testing though-the acute pain-relieving effect and whether chronic use results, as they say it does, in sustained improvements. I don't know that yet, but I am convinced that it does something acutely.
I'm not sure what you're trying to demonstrate by suggesting a test vs wait list. You can't measure if it works against pain or not in any other way than asking people's opinion. At best, this would be a collection of customer testimonials rather than a trial.
Not only do you not know if the measured effect is real or placebo, you wouldn't know if it exists at all. It could just be that people like to be polite and will rate the device higher to please the person administering the test.
Brian, self-report is a valid method. You could have people rate their pain at baseline and say every two weeks for 6 weeks (anything, I am just making this up) and have the control group do the same thing. Then you cross over and give the control group the device and have them do the same thing. That at least tests whether the pain would go away on its own. If you are worried that people will report that their pain is better without it being better, I suspect you will never be happy with self-report measures, but that is what is done in pain research.
Sorry I missed this one. Yes, a placebo device, should they make one, would be very useful for a trial. I will suggest it. I actually HATE the buzz. It is really annoying. I think there might be some moving part that generates the field but that is just a guess. It should be easy to disable the field.
I don't have an issue with self-report itself. It is obviously hugely subjective and unreliable yes, but you can get around this problem by properly blinding the test.
If you don't blind the test, then any positive outcome will not be accepted as evidence by the ASA, so it won't help PainSolv make the claims.
What happened about your complaint to the ASA?
The only reference I can see is:
http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2008/10/MediConcepts-Ltd/TF_ADJ_45101.aspx
and this is not your claim is it?
@chris sivewright
Here it is:
http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2008/10/Aromatheutics-Ltd/TF_ADJ_45102.aspx
Simon, I know you are campaigning for truth and all that, but really, this thing DOES actually work. I don't know why. I dropped mine and had to go 8 days without it and that was BAD. I have tried it on many friends (since people are often in pain) and they have generally been amazed that the pain was relieved. Your suggestion to make a placebo device has been accepted and a trial will go ahead with a placebo device. Also the new model will likely not have that annoying buzz. I would suggest you simply TRY one. Surely you have some pain in your body that you would like to lose.
@Phyllis
Not sure what to make of your last comment. Firstly say that you know it works. Or even more certainly, that you KNOW it works. Then, you seem to accept that a trial is needed. The positions are mutually exclusive.
Thanks for the ASA link.
I don't think ASA covers the net does it?
http://www.amazon.co.uk/Physio-Supplies-Ltd-PAINSOLV/dp/B001ANQF1Y
http://www.naturesnaturals.co.uk/PainSolvInfo.pdf
Anyone know if the 60 day trial is watertight i.e. if I do buy it (I have a bad back) and there's no result then i definitely do get my money back?
I have seen one site selling it 'plus VAT' and one saying 'no VAT' - very odd
Contact them. They are varying between a 60 and a 30 day policy but if you say that you saw it advertised as 60, I am sure they will give it to you. This is what happened to me. This is a small enough company so you deal with actual individuals.
@chris sivewright
Website claims aren't in the ASA's remit I'm afraid - unless there is a promotion. So if you find it 10% off or with a free Q-Link pendant, report it.
I've just heard of painsolv and looked it up only to find this discussion from 2010, has there been any further proof that it works?
Ad
I just looked it up on PubMed again, and I still can't find any references. It's unlikely that the manufacturer would fund any proper research seeing as the outcome would likely be negative.
I'm about to buy one for my wife who is suffering from severe headaches.
These headaches occur at irregular times, are extremely painful and knock her out for 2 - 4 hours. None of the doctors we have consulted know what causes them. Scans don't show any irregularities. So I'm lookin at Painsolv as a last resort. If anyone is interested I'll be happy to report the results if any.
Wow this is frustrating. You get an intelligent debate and then you get:
"Or even more certainly, that you KNOW it works. Then, you seem to accept that a trial is needed. The positions are mutually exclusive."
Not true. We "know" evolution works but no trial has proven it. Phyllis apparently knows that it works according to her criteria, but trials are designed to make that same assertion against a wider stricter criteria.
" It's unlikely that the manufacturer would fund any proper research seeing as the outcome would likely be negative."
That's an appalling position for a scientific philosopher to take. The outcome would likely be negative? Where's the evidence for the outcome likely being negative? What trials have been performed so far that indicate it would be negative again? You have a hypothesis and a null hypothesis and a scientific skeptic must assume that until the balance of research sways the view in one direction or another that both are equally true.
I've not done a literature search myself, but from your discussion there is some research that shows some effect. There is no research that shows no effect.
What you're demonstrating is negative bias and if you believe yourself to be in a position of knowledge, power, or influence then you shouldn't be doing that.
@Anonymous
Strongly disagree. The only point of doing a trial is to look for evidence that it works. If we can be 100% sure it works (which would be classed as "knowing it works") then there is no point in doing the trial.
In terms of the probability of the outcome of a trial being negative, I stand by my initial statement.
Currently there is no meaningful evidence that this thing works.
You seem to think that in the absence of evidence it's a 50/50 chance. This is absurd.
If I was to simply make up a medical claim (e.g. that wrapping a towel round my head cured malaria) would you think I would be unlikely to be correct, or do you think it's 50/50?
Most things don't work. Even if you've got a rational basis for believing why something might work before you run a trial, there's still a damn good chance that it won't work.
Yet I have not yet seen even a rational basis for how this might work. The claim has simply been made up in the same way as my towel/malaria example.
With no rational basis and absolutely no reasonable evidence for assuming it might work, the chances of a trial producing a positive outcome are low.
Look up good quality RCTs of medical interventions with no rational basis. You'll find that pretty much all of them turn out to be negative.
@Simon
Totally agree with your point of view. Do you have an opinion in regards to a Digital TENS & EMS Device?
My Mother has severe back issues and has been in pain for many years now, which causes her to throw out her money in her desperation for relief and that's how I found your post since she has purchased this Painsolv device.
Thanks,
Renee
Hi everyone I've just brought one of these painsolv things from my local chemist as my husband has back pain and suffers from anxiety I only paid £3 as it was a discontinuded line and they were selling them off got the last one what I want to know is am I wasting my time in using it or what? Thanks Sarah.
Hi Sarah,
I've had a good look and have seen absolutely no credible evidence that they work. I've contacted the manufacturer too and they have not provided any. The ASA has ruled against their claims.
The mechanism by which it is proposed to work is implausible.
It's highly unlikely that this thing will work, so yes - you're likely wasting your time.
£3 or not, I advise you return it on principle.
Simon
Simon, thank you for producing this blog. I was about to purchase a PainSolv in hopes of doing just that-solve my pain. I've been diagnosed with several ailments not limited to spondylolysis of my lower vertebrae and moderate OA in both hips, I'm only 45. I'm limited in my activity with my children now and with what I can do at work. I'm currently doing physiotherapy which has lasted over several months, out-of-pocket and am waiting for a surgical consult. Companies like Painsolv, I fear, do prey on victims that are looking for some form of salvation for their pain, assuming it is proven to be a scam. As much as I want relief and get back to a normal life of just playing with my children, I have to rely on blogs like yours to uncover the truth and not approach these gadgets and gizmos from an emotional standpoint. So I hope that you uncover many truths in your travels and I don't become a victim. Thank you.
I would like to remain anonymous as I have no clever comments. I would like to ask 1) What happened to the debate with Phyllis? 2)Is there no trial after all? 3) Bearing in mind it's four years later and as the ASA ruled against this companys' claims how are they allowed to continue claiming and selling a 'bogus' product?
Of course as a chronic pain sufferer I woulod dearly like this device to be effective, which is why I am asking what became of this debate and the debators? Kind Regards
Has anyone tried to see what's in it?
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