An Open Letter to Alliance Boots
The Boots brand is synonymous with health care in the United Kingdom. Your website speaks proudly about your role as a health care provider and your commitment to deliver exceptional patient care. For many people, you are their first resource for medical advice; and their chosen dispensary for prescription and non-prescription medicines. The British public trusts Boots.
However, in evidence given recently to the Commons Science and Technology Committee, you admitted that you do not believe homeopathy to be efficacious. Despite this, homeopathic products are offered for sale in Boots pharmacies – many of them bearing the trusted Boots brand.
Not only is this two-hundred-year-old pseudo-therapy implausible, it is scientifically absurd. The purported mechanisms of action fly in the face of our understanding of chemistry, physics, pharmacology and physiology. As you are aware, the best and most rigorous scientific research concludes that homeopathy offers no therapeutic effect beyond placebo, but you continue to sell these products regardless because “customers believe they work”. Is this the standard you set for yourselves?
The majority of people do not have the time or inclination to check whether the scientific literature supports the claims of efficacy made by products such as homeopathy. We trust brands such as Boots to check the facts for us, to provide sound medical advice that is in our interest and supply only those products with a demonstrable medical benefit.
We don’t expect to find products on the shelf at our local pharmacy which do not work.
Not only are these products ineffective, they can also be dangerous. Patients may delay seeking proper medical assistance because they believe homeopathy can treat their condition. Until recently, the Boots website even went so far as to tell patients that “after taking a homeopathic medicine your symptoms may become slightly worse,” and that this is “a sign that the body’s natural energies have started to counteract the illness”. Advice such as this directly encourages patients to wait before seeking real medical attention, even when their condition deteriorates.
We call upon Boots to withdraw all homeopathic products from your shelves. You should not be involved in the sale of ineffective products, because your customers trust you to do what is right for their health. Surely you agree that your commitment to excellent patient care is better served by supplying only those products whose claims can be substantiated by rigorous scientific research? Or do you really believe that Boots should be in the business of selling placebos to the sick and the injured?
The support lent by Boots to this quack therapy contributes directly to its acceptance as a valid medical treatment by the British public, acceptance it does not warrant and support it does not deserve. Please do the right thing, and remove this bogus therapy from your shelves.
Yours sincerely,
Merseyside Skeptics Society
Thursday 26 November 2009
Tuesday 25 August 2009
Busy Skeptical Times
Sadly I have been spending far too much time preparing my talk for the British Tinnitus Association's conference and far too little time blogging. Hopefully all the work won't be in vain. I'm planning posts on Tinnitus Retraining Therapy, Acupuncture and food supplements.
As an interesting side note I purchased a pair of Biosun Hopi ear candles to demonstrate during my talk. I tried one out at home, not in an ear but a jar of spare change. I have to say it gave off a pleasant scent while burning but the 'filter' inside it was a surprise. It was a plastic tube with a simple cross of plastic on the centre which seemed completely insufficient to block a ball of burning wax.
In preparation for my talk I've also been feverishly reading some excellent books I'd like to bring to your attention:
Bad Science - Ben Goldacre
Healing, Hype or Harm? - Ed. Edzard Ernst
Snake Oil Science - R. Barker Bausell
Suckers - Rose Shapiro
Trick or Treatment - Simon Singh & Edzard Ernst
You may also be interested in this worrying piece of nonsense from the Kings Fund which appears to be arguing for different (lower) standards of scientific proof and research methodology for CAM modalities of treatment. A letter to your MP may be in order expressing your dismay with regard to this dangerous and irresponsible form of special pleading...
As an interesting side note I purchased a pair of Biosun Hopi ear candles to demonstrate during my talk. I tried one out at home, not in an ear but a jar of spare change. I have to say it gave off a pleasant scent while burning but the 'filter' inside it was a surprise. It was a plastic tube with a simple cross of plastic on the centre which seemed completely insufficient to block a ball of burning wax.
In preparation for my talk I've also been feverishly reading some excellent books I'd like to bring to your attention:
Bad Science - Ben Goldacre
Healing, Hype or Harm? - Ed. Edzard Ernst
Snake Oil Science - R. Barker Bausell
Suckers - Rose Shapiro
Trick or Treatment - Simon Singh & Edzard Ernst
You may also be interested in this worrying piece of nonsense from the Kings Fund which appears to be arguing for different (lower) standards of scientific proof and research methodology for CAM modalities of treatment. A letter to your MP may be in order expressing your dismay with regard to this dangerous and irresponsible form of special pleading...
Tuesday 11 August 2009
Simon Singh's Original Article on Chiropracty
NB. This article has had the offending section removed so please don't come sniffing around my door BCA, you'll find the coffers are already empty
Some practitioners claim it is a cure-all, but the research suggests chiropractic therapy has mixed results – and can even be lethal, says Simon Singh.
You might be surprised to know that the founder of chiropractic therapy, Daniel David Palmer, wrote that “99% of all diseases are caused by displaced vertebrae”. In the 1860s, Palmer began to develop his theory that the spine was involved in almost every illness because the spinal cord connects the brain to the rest of the body. Therefore any misalignment could cause a problem in distant parts of the body.
In fact, Palmer’s first chiropractic intervention supposedly cured a man who had been profoundly deaf for 17 years. His second treatment was equally strange, because he claimed that he treated a patient with heart trouble by correcting a displaced vertebra.
You might think that modern chiropractors restrict themselves to treating back problems, but in fact some still possess quite wacky ideas. The fundamentalists argue that they can cure anything, including helping treat children with colic, sleeping and feeding problems, frequent ear infections, asthma and prolonged crying – even though there is not a jot of evidence.
I can confidently label these assertions as utter nonsense because I have co-authored a book about alternative medicine with the world’s first professor of complementary medicine, Edzard Ernst. He learned chiropractic techniques himself and used them as a doctor. This is when he began to see the need for some critical evaluation. Among other projects, he examined the evidence from 70 trials exploring the benefits of chiropractic therapy in conditions unrelated to the back. He found no evidence to suggest that chiropractors could treat any such conditions.
But what about chiropractic in the context of treating back problems? Manipulating the spine can cure some problems, but results are mixed. To be fair, conventional approaches, such as physiotherapy, also struggle to treat back problems with any consistency. Nevertheless, conventional therapy is still preferable because of the serious dangers associated with chiropractic.
In 2001, a systematic review of five studies revealed that roughly half of all chiropractic patients experience temporary adverse effects, such as pain, numbness, stiffness, dizziness and headaches. These are relatively minor effects, but the frequency is very high, and this has to be weighed against the limited benefit offered by chiropractors.
More worryingly, the hallmark technique of the chiropractor, known as high-velocity, low-amplitude thrust, carries much more significant risks. This involves pushing joints beyond their natural range of motion by applying a short, sharp force. Although this is a safe procedure for most patients, others can suffer dislocations and fractures.
Worse still, manipulation of the neck can damage the vertebral arteries, which supply blood to the brain. So-called vertebral dissection can ultimately cut off the blood supply, which in turn can lead to a stroke and even death. Because there is usually a delay between the vertebral dissection and the blockage of blood to the brain, the link between chiropractic and strokes went unnoticed for many years. Recently, however, it has been possible to identify cases where spinal manipulation has certainly been the cause of vertebral dissection.
Laurie Mathiason was a 20-year-old Canadian waitress who visited a chiropractor 21 times between 1997 and 1998 to relieve her low-back pain. On her penultimate visit she complained of stiffness in her neck. That evening she began dropping plates at the restaurant, so she returned to the chiropractor. As the chiropractor manipulated her neck, Mathiason began to cry, her eyes started to roll, she foamed at the mouth and her body began to convulse. She was rushed to hospital, slipped into a coma and died three days later. At the inquest, the coroner declared: “Laurie died of a ruptured vertebral artery, which occurred in association with a chiropractic manipulation of the neck.”
This case is not unique. In Canada alone there have been several other women who have died after receiving chiropractic therapy, and Edzard Ernst has identified about 700 cases of serious complications among the medical literature. This should be a major concern for health officials, particularly as under-reporting will mean that the actual number of cases is much higher.
If spinal manipulation were a drug with such serious adverse effects and so little demonstrable benefit, then it would almost certainly have been taken off the market.
Simon Singh is a science writer in London and the co-author, with Edzard Ernst, of Trick or Treatment? Alternative Medicine on Trial. This is an edited version of an article published in The Guardian for which Singh is being personally sued for libel by the British Chiropractic Association.
You can also read this article at the Sense About Science website which contains further details of the Singh Case, a petition to sign and links to wider coverage.
Some practitioners claim it is a cure-all, but the research suggests chiropractic therapy has mixed results – and can even be lethal, says Simon Singh.
You might be surprised to know that the founder of chiropractic therapy, Daniel David Palmer, wrote that “99% of all diseases are caused by displaced vertebrae”. In the 1860s, Palmer began to develop his theory that the spine was involved in almost every illness because the spinal cord connects the brain to the rest of the body. Therefore any misalignment could cause a problem in distant parts of the body.
In fact, Palmer’s first chiropractic intervention supposedly cured a man who had been profoundly deaf for 17 years. His second treatment was equally strange, because he claimed that he treated a patient with heart trouble by correcting a displaced vertebra.
You might think that modern chiropractors restrict themselves to treating back problems, but in fact some still possess quite wacky ideas. The fundamentalists argue that they can cure anything, including helping treat children with colic, sleeping and feeding problems, frequent ear infections, asthma and prolonged crying – even though there is not a jot of evidence.
I can confidently label these assertions as utter nonsense because I have co-authored a book about alternative medicine with the world’s first professor of complementary medicine, Edzard Ernst. He learned chiropractic techniques himself and used them as a doctor. This is when he began to see the need for some critical evaluation. Among other projects, he examined the evidence from 70 trials exploring the benefits of chiropractic therapy in conditions unrelated to the back. He found no evidence to suggest that chiropractors could treat any such conditions.
But what about chiropractic in the context of treating back problems? Manipulating the spine can cure some problems, but results are mixed. To be fair, conventional approaches, such as physiotherapy, also struggle to treat back problems with any consistency. Nevertheless, conventional therapy is still preferable because of the serious dangers associated with chiropractic.
In 2001, a systematic review of five studies revealed that roughly half of all chiropractic patients experience temporary adverse effects, such as pain, numbness, stiffness, dizziness and headaches. These are relatively minor effects, but the frequency is very high, and this has to be weighed against the limited benefit offered by chiropractors.
More worryingly, the hallmark technique of the chiropractor, known as high-velocity, low-amplitude thrust, carries much more significant risks. This involves pushing joints beyond their natural range of motion by applying a short, sharp force. Although this is a safe procedure for most patients, others can suffer dislocations and fractures.
Worse still, manipulation of the neck can damage the vertebral arteries, which supply blood to the brain. So-called vertebral dissection can ultimately cut off the blood supply, which in turn can lead to a stroke and even death. Because there is usually a delay between the vertebral dissection and the blockage of blood to the brain, the link between chiropractic and strokes went unnoticed for many years. Recently, however, it has been possible to identify cases where spinal manipulation has certainly been the cause of vertebral dissection.
Laurie Mathiason was a 20-year-old Canadian waitress who visited a chiropractor 21 times between 1997 and 1998 to relieve her low-back pain. On her penultimate visit she complained of stiffness in her neck. That evening she began dropping plates at the restaurant, so she returned to the chiropractor. As the chiropractor manipulated her neck, Mathiason began to cry, her eyes started to roll, she foamed at the mouth and her body began to convulse. She was rushed to hospital, slipped into a coma and died three days later. At the inquest, the coroner declared: “Laurie died of a ruptured vertebral artery, which occurred in association with a chiropractic manipulation of the neck.”
This case is not unique. In Canada alone there have been several other women who have died after receiving chiropractic therapy, and Edzard Ernst has identified about 700 cases of serious complications among the medical literature. This should be a major concern for health officials, particularly as under-reporting will mean that the actual number of cases is much higher.
If spinal manipulation were a drug with such serious adverse effects and so little demonstrable benefit, then it would almost certainly have been taken off the market.
Simon Singh is a science writer in London and the co-author, with Edzard Ernst, of Trick or Treatment? Alternative Medicine on Trial. This is an edited version of an article published in The Guardian for which Singh is being personally sued for libel by the British Chiropractic Association.
You can also read this article at the Sense About Science website which contains further details of the Singh Case, a petition to sign and links to wider coverage.
Tuesday 7 July 2009
Critical Thinking in Healthcare - Why Does it Matter?
There are a wide variety of treatments for every condition known to humanity. Some treatments have a solid research evidence base which demonstrates their safety and effectiveness, others do not. Very often personal anecdotes and testimonies are also used to demonstrate the worth of a given intervention. Does it matter whether you choose to buy into a rigorous scientific methodology or prefer to believe in a more natural approach, and if so why?
At the risk of stating the obvious, when we fall victim to a disease our first and primary interest is: 'How quickly can I get rid of this and return to normal?'. It can obviously be difficult to maintain a detached analytical thought process whilst in the midst of extreme suffering. Before proceeding further and to avoid the charge of simply being a sententious egotist I have to admit I am also human and no different to any other person in pain.
Several years ago a good friend of mine upon hearing of my plans to get engaged gave me a hug. Unfortunately my friend is a very large, strong man and his judgement was impaired by alcohol. His hug broke a bone in my lower back which has intermittently given me quite a large amount of pain. I have in the past seen both a Chiropractor and a Doctor of Traditional Chinese medicine, on both occasions it was during a period of extreme discomfort.
The Chiropractor was very convinced of her own efficacy. She took quite a detailed history of the injury, my ongoing symptoms, my emotional state and my work/home life. She then showed me where my pain was by drawing it in red felt tip on a medical looking picture of the back and spine. Strangely enough I was already quite familiar with this information. When she discovered I was an Audiologist she proudly told me of the ‘origin story’ of Chiropractic in which D.D. Palmer ‘cured’ the Deafness of a friend by manipulating his spine.
D.D. Palmer
http://maximizedhealth.blogspot.com/2008/04/can-chiropractic-cure-deaf-man.html
In my defence at the time I was unaware of the background of Chiropractic and believed I was seeing a legitimate scientific practitioner. My B.S. sensor did go into the red when she told me this story but I was in pain and if she could sort it out I wasn’t going to argue, I think I said something like ‘That seems unlikely’ to which she just smiled. Besides, I had just paid over £200 for a course of treatment, I was committed.
The following treatment sessions were remarkable in a number of ways. Firstly I discovered that I was only one of three or four people being treated at the same time in the same room, confidentiality be damned! Secondly having laid down face first on the very comfy massage bench she proceeded to do almost nothing at all. Sometimes she would touch a point just above my buttocks, sometimes a point at the top of the spine but that was it. Probably this was a good thing in the long run. But perhaps the most incredible aspect of the treatment was her positively Jesuitical ability to change literally any statement I made into a positive sign. If the pain was just as intense but in a different spot she would say ‘oh good, something’s moving’. If the pain was worse she would say ‘that’s a sign that something’s happening’, and of course any reduction in my symptoms were her doing. This is a clear example of a logical fallacy known as confirmation bias, i.e. the ‘tendency to search for or interpret new information in a way that confirms one's preconceptions’.
Despite my increasing frustration and the derision of a Physiotherapist friend of mine I stayed out the course. The point at which I really began to understand just what bunkum this was came when I walked into her office and saw a sign in neat calligraphy on the desk stating ‘All healing is magical and spontaneous’. I felt sufficiently moved to ask why, if this was so had I just spent a small fortune on her in order to get better? I didn’t return for any further treatments.
Attending the Doctor of Traditional Chinese medicine was a more opportunistic occasion during an acute period of pain after a long drive. My partner had been seeing this chap for back pain throughout her pregnancy and assured me that she had really benefited from his ministrations. Unfortunately her usual Doctor was not available. The Doctor who saw me prescribed a massage, acupuncture and two different pots of tiny black pills along with some horse lineament. The massage really seemed wonderful. The acupuncture seemed to do little but bring back my symptoms due to the length of time I was required to lie in one position waiting for them to take effect. I've no idea what was in the pills, but the horse lineament gave some relief. Sadly, despite the excellent massage I walked away 110 pounds lighter and still in pain.
By telling you all this I hope to make several points. We tend to seek out help for illness only when it's at its worst. Some conditions such as lower back pain and to a degree Tinnitus are self-limiting, i.e. they can only remain as bad as they are for so long before there is some degree of easing, with or without treatment. This easing is sometimes termed regression to the mean and it is easy to see how a naive and yet sincere alternative therapist can fall foul of both a confirmation bias and this regression fallacy and persuade themselves that their particular intervention is unusually successful. When my partner was overdue with our baby she went to see a reflexologist who said she specialised in inducing labour. At the consultation she told us with absolute sincerity that she had a 100% success rate. She said this with no evidence of humour or self-deprecation, and yet given enough time that statement was ALWAYS going to be true, whether the treatment was reflexology or vanilla ice-cream.
Still, does it really matter? We know that roughly 30% of the population are susceptible to the placebo effect, and that the more dramatic an intervention is the stronger the effect becomes. So if your therapist believes it and you believe it, and you feel better afterwards where's the harm? Ben Goldacre in his excellent book Bad Science sites the economic theory of 'opportunity cost', i.e. irrespective of any financial outlay involved how much extra time do you spend experiencing your symptoms when they could have been more effectively be treated elsewhere, and what impact does this have on your ability to enjoy life, earn a living etc. I believe there is also a more serious repercussion of treating all claims of benefit, whatever their source as equal. That is the potential for someone who is experiencing a symptom such as Tinnitus to become locked into 'health seeking behaviour' and to identify themselves as a "Tinnitus Sufferer" long-term, going from treatment to treatment in search of the miracle cure with thoughts about Tinnitus taking up a disproportionate amount of their time, rather than learning to manage their condition effectively. This is often seen in people who naturally have a very external, rather than internal locus of control, i.e they feel change must be done to them rather than come from themselves.
By the application of critical appraisal and critical thinking skills we can begin to learn that all claims are not made equal and should not be given equal weight. This can make us less anxious that we are somehow missing out by not trying Ear Candles or laser therapy etc. and gradually empower us to become more confident in the decisions we make about our own healthcare.
At the risk of stating the obvious, when we fall victim to a disease our first and primary interest is: 'How quickly can I get rid of this and return to normal?'. It can obviously be difficult to maintain a detached analytical thought process whilst in the midst of extreme suffering. Before proceeding further and to avoid the charge of simply being a sententious egotist I have to admit I am also human and no different to any other person in pain.
Several years ago a good friend of mine upon hearing of my plans to get engaged gave me a hug. Unfortunately my friend is a very large, strong man and his judgement was impaired by alcohol. His hug broke a bone in my lower back which has intermittently given me quite a large amount of pain. I have in the past seen both a Chiropractor and a Doctor of Traditional Chinese medicine, on both occasions it was during a period of extreme discomfort.
The Chiropractor was very convinced of her own efficacy. She took quite a detailed history of the injury, my ongoing symptoms, my emotional state and my work/home life. She then showed me where my pain was by drawing it in red felt tip on a medical looking picture of the back and spine. Strangely enough I was already quite familiar with this information. When she discovered I was an Audiologist she proudly told me of the ‘origin story’ of Chiropractic in which D.D. Palmer ‘cured’ the Deafness of a friend by manipulating his spine.
D.D. Palmer
http://maximizedhealth.blogspot.com/2008/04/can-chiropractic-cure-deaf-man.html
In my defence at the time I was unaware of the background of Chiropractic and believed I was seeing a legitimate scientific practitioner. My B.S. sensor did go into the red when she told me this story but I was in pain and if she could sort it out I wasn’t going to argue, I think I said something like ‘That seems unlikely’ to which she just smiled. Besides, I had just paid over £200 for a course of treatment, I was committed.
The following treatment sessions were remarkable in a number of ways. Firstly I discovered that I was only one of three or four people being treated at the same time in the same room, confidentiality be damned! Secondly having laid down face first on the very comfy massage bench she proceeded to do almost nothing at all. Sometimes she would touch a point just above my buttocks, sometimes a point at the top of the spine but that was it. Probably this was a good thing in the long run. But perhaps the most incredible aspect of the treatment was her positively Jesuitical ability to change literally any statement I made into a positive sign. If the pain was just as intense but in a different spot she would say ‘oh good, something’s moving’. If the pain was worse she would say ‘that’s a sign that something’s happening’, and of course any reduction in my symptoms were her doing. This is a clear example of a logical fallacy known as confirmation bias, i.e. the ‘tendency to search for or interpret new information in a way that confirms one's preconceptions’.
Despite my increasing frustration and the derision of a Physiotherapist friend of mine I stayed out the course. The point at which I really began to understand just what bunkum this was came when I walked into her office and saw a sign in neat calligraphy on the desk stating ‘All healing is magical and spontaneous’. I felt sufficiently moved to ask why, if this was so had I just spent a small fortune on her in order to get better? I didn’t return for any further treatments.
Attending the Doctor of Traditional Chinese medicine was a more opportunistic occasion during an acute period of pain after a long drive. My partner had been seeing this chap for back pain throughout her pregnancy and assured me that she had really benefited from his ministrations. Unfortunately her usual Doctor was not available. The Doctor who saw me prescribed a massage, acupuncture and two different pots of tiny black pills along with some horse lineament. The massage really seemed wonderful. The acupuncture seemed to do little but bring back my symptoms due to the length of time I was required to lie in one position waiting for them to take effect. I've no idea what was in the pills, but the horse lineament gave some relief. Sadly, despite the excellent massage I walked away 110 pounds lighter and still in pain.
By telling you all this I hope to make several points. We tend to seek out help for illness only when it's at its worst. Some conditions such as lower back pain and to a degree Tinnitus are self-limiting, i.e. they can only remain as bad as they are for so long before there is some degree of easing, with or without treatment. This easing is sometimes termed regression to the mean and it is easy to see how a naive and yet sincere alternative therapist can fall foul of both a confirmation bias and this regression fallacy and persuade themselves that their particular intervention is unusually successful. When my partner was overdue with our baby she went to see a reflexologist who said she specialised in inducing labour. At the consultation she told us with absolute sincerity that she had a 100% success rate. She said this with no evidence of humour or self-deprecation, and yet given enough time that statement was ALWAYS going to be true, whether the treatment was reflexology or vanilla ice-cream.
Still, does it really matter? We know that roughly 30% of the population are susceptible to the placebo effect, and that the more dramatic an intervention is the stronger the effect becomes. So if your therapist believes it and you believe it, and you feel better afterwards where's the harm? Ben Goldacre in his excellent book Bad Science sites the economic theory of 'opportunity cost', i.e. irrespective of any financial outlay involved how much extra time do you spend experiencing your symptoms when they could have been more effectively be treated elsewhere, and what impact does this have on your ability to enjoy life, earn a living etc. I believe there is also a more serious repercussion of treating all claims of benefit, whatever their source as equal. That is the potential for someone who is experiencing a symptom such as Tinnitus to become locked into 'health seeking behaviour' and to identify themselves as a "Tinnitus Sufferer" long-term, going from treatment to treatment in search of the miracle cure with thoughts about Tinnitus taking up a disproportionate amount of their time, rather than learning to manage their condition effectively. This is often seen in people who naturally have a very external, rather than internal locus of control, i.e they feel change must be done to them rather than come from themselves.
By the application of critical appraisal and critical thinking skills we can begin to learn that all claims are not made equal and should not be given equal weight. This can make us less anxious that we are somehow missing out by not trying Ear Candles or laser therapy etc. and gradually empower us to become more confident in the decisions we make about our own healthcare.
Monday 15 June 2009
Low Level Laser Therapy
A useful guideline to bear in mind when looking at possible treatments might go something like - The relationship between likely benefit of a given treatment is inversely proportional to the number of illnesses it purports to treat. To put it another way if snake oil can cure anything then why do we take Aspirin?
That is a slightly unfair comparison to use with Low Level Laser Therapy (Cold Laser Therapy, Photobiomodulation, Transmeatal Cochlear Laser or Laser Biostimulation), however the claims that are often very strongly made for the use of LLLT in Tinnitus are probably in need of some of the 'Cold light of reality' shining upon them. Whilst a treatment for one illness may be very effective, it is unsafe to assume that the same treatment will be equally effective in a completely different illness. And yet that is what is suggested in the case of LLLT, a treatment whose main indicators are in soft tissue injury, chronic pain and wound care is now being suggested as a 'cure' for Tinnitus.
Proposed Mechanism of Action
Taken from the article by Barry Keate on the Arches Formula Site
'LLLT was first developed for inner ear diseases by Uwe Witt, MD of Hamburg, Germany in the 1980’s. Lutz Wilden, MD, of the Center for Low Level Laser Therapy in Bad Fussing, Germany developed it further and brought it to a wide range of patients. Dr. Wilden’s central thesis is that laser energy in the red and near infrared light spectrum is capable of penetrating tissue. It stimulates mitochondria in the cells to produce energy through the production of ATP (adenosine triphosphate). Mitochondria are the power supplies of all cells; they metabolize (burn) fuel and produce energy for the cell in the form of ATP. In stimulating the mitochondria, laser therapy can repair damaged tissue and return cells to a healthy state, reversing many degenerative conditions.'
Controversies
Although there is evidence for the use of Photobiomodulation in surface injuries and possibly deeper sources of chronic pain there is no evidence that this translates to the sort of neural regeneration that would be required to cause the effects claimed by Dr Wildens and other proponents. Of interest is that Dr Wildens et al are yet to publish a peer-reviewed academic paper demonstrating their findings, they have been presented papers at conference but this carries nowhere near the same weight. It is also doubtful that laser energy is capable of penetrating to the depth of the inner ear or of doing anything when it gets there. The inner ear or Cochlear is embedded in the Petrous (stone-like) portion of temporal bone which as the name suggests is extremely dense.
As you can see, whether applied directly to the mastoid process (pointy bone behind the external ear) or directed straight down the ear canal the cold laser has quite a journey ahead of it, the likelyhood of the energy being absorbed or dissipated would appear to be very high.
Some practitioners and researchers argue that a great deal of the research that has been done has been of insufficient repetition or laser strength or wavelength to achieve the desired and claimed effects, however they also seem to be perfectly happy to sell home laser systems direct to the public with the same limited power levels. (I've been informed by a customer of Dr Wildens that the laser he sells is stronger than average at around 30mW, although I could find no evidence of this on the site).
The Evidence
Taken in order of publication;
Partheniadis-Stumpf et al used a combined approach using Tebonin (a form of Ginko-Biloba supplement) and laser treatment and failed to find any evidence of benefit although their sample size was quite small, abstract available here
With a slightly higher number of participants Shiomi et al appeared to show some degree of benefit, however their study suffered from a lack of a control group, abstract available here
Mirz et al with a similar number to Shiomi but using a well structured randomized double blind placebo-control trial were unable to find any statistically significant evidence of benefit using the active laser and concluded that previous reports of benefit were simply placebo effect, abstract available here
Once again using a combination of Ginko (this time in the form of EGb 761) and laser Hahn et al. with 120 study participants reported an improvement in just over 50%, however this study was once again marred by the lack of any control group, abstract available here
Despite again failing to supply a control group and with a small study size than Hahn, Nakashima et al found no benefit whatsoever from the use of 60mW laser irradiation, abstract available here
Tauber et al looked at whether any effect of the laser was dose-dependant in terms of wavelength and strength of laser, again without a control group. They report 15/35 experiencing significant improvement, with two subjects reporting no Tinnitus after six months. They acknowledge the need for large double-blind placebo-controlled studies to confirm and support their findings, abstract available here
Siedentopf et al conducted an interesting study which appears to show central changes occurring in regions of the brain that have been associated with Tinnitus generation only when an active rather than placebo laser is used. Unfortunately the size of the study and detailed methodology are not available in the abstract. It is also worthy of note that fMRI measures are only indicative of activity and may not relate to the stimulus presented, abstract available here
In 2008 Hahn et al again revisited soft-laser therapy in comparison with a number of drug and physical therapies. By dividing the 150 participants into seven treatments arms they substantially weakened the power of each separate arm, however their conclusion was that 'The most effective treatment was defined as a combination of Cavinton and physiotherapy', the outcome for soft laser is not mentioned in the abstract, which is available here
Gungor et al. found using a laser strength, wavelength and duration of treatment that is often suggested by LLLT proponents to be insufficient (5mW, 650nM, 15 mins 1/day for 1 week) that in all three of their measures subjects exposed to active laser rather than placebo improved by approximately 50%. The abstract does not mention the size of the control group used. Abstract available here
In a recent study with very small active and control arms Cudia et al again using a 5mW laser but over a much longer treatment period (three months) found that the treatment group experienced 26% more improvement than the control group. It should be noted that no reason is given for the greater size of the treatment arm of the study (26 compared to 20 in the control) and that the difference in daily intervention was not controlled for. 26% would correspond well with a placebo effect, abstract available here
For completeness and background I've included the full search results from the NHS Library for Health and information on the proposed mechanism for Photobiomodulation here. Dr Wilden's take on this is available here, although it is important to note that although it looks like an academic paper it has NOT been peer reviewed or published in a journal of note. Also, given the prevalence of Ginko-Biloba in these studies used alongside laser therapy (and the willingness of online companies such as Arches to sell you the supplement) it may be useful to reflect on the evidence from this very well designed and large scale study, funded by the British Tinnitus Association.
Conclusions
There appears to be a very limited evidence base for the use of LLLT in Tinnitus, and where it does exist there are often significant methodological flaws which act to weaken the evidence. Despite concerns from the proponents of LLLT that sufficient exposure time, strength or correct wavelength have not been used in negative studies this does not alter the apparent fact that there is an absence of peer reviewed evidence using the criteria they propose.
The mechanism of action proposed for LLLT has a degree of surface validity, although it remains controversial even in the areas where it is normally employed. In the ear it is claimed that the laser is capable of both penetrating to the neuronal tissue of the Cochlea and facilitating regeneration of damaged nerve tissue, thus improving hearing and reducing Tinnitus. Two extraordinary claims, both in need of extraordinary evidence which currently does not appear to exist.
I should emphasise, particularly in light of the current court case between the British Chiropractic Association and Simon Singh that I am not in any way suggesting that major practitioners of LLLT are being disingenuous in offering it as a treatment for Tinnitus. I suspect that most of them are entirely persuaded by the science and their own experience. However in all likelihood their sincerity is a product of a number of logical and methodological fallacies. Selection bias, in that only the very motivated and well-heeled can afford the high fees often charged (3000 euro's is not uncommon). Regression to the mean, i.e. people tend to seek out radical treatments when in extremis, however most chronic conditions can only remain at their peak severity for a short time then regress to their background level, particularly true with Tinnitus (Hallam, 1970). And finally confirmation bias, i.e. the tendency we all have to only remember the positive feedback, and forget those who are dissatisfied or simply don't return for further treatment.
Further Reading
http://www.tinnitusformula.com/infocenter/articles/treatments/LLLT.aspx
http://www.dr-wilden.de/en/
http://www.laser.nu/tlc/tinnitusEnglish.htm
http://www.laserpartner.org/lasp/web/en/2000/0004.htm
http://www.rnid.org.uk/community/forums/tinnitus/dr_wilden/?pn=1
That is a slightly unfair comparison to use with Low Level Laser Therapy (Cold Laser Therapy, Photobiomodulation, Transmeatal Cochlear Laser or Laser Biostimulation), however the claims that are often very strongly made for the use of LLLT in Tinnitus are probably in need of some of the 'Cold light of reality' shining upon them. Whilst a treatment for one illness may be very effective, it is unsafe to assume that the same treatment will be equally effective in a completely different illness. And yet that is what is suggested in the case of LLLT, a treatment whose main indicators are in soft tissue injury, chronic pain and wound care is now being suggested as a 'cure' for Tinnitus.
Proposed Mechanism of Action
Taken from the article by Barry Keate on the Arches Formula Site
'LLLT was first developed for inner ear diseases by Uwe Witt, MD of Hamburg, Germany in the 1980’s. Lutz Wilden, MD, of the Center for Low Level Laser Therapy in Bad Fussing, Germany developed it further and brought it to a wide range of patients. Dr. Wilden’s central thesis is that laser energy in the red and near infrared light spectrum is capable of penetrating tissue. It stimulates mitochondria in the cells to produce energy through the production of ATP (adenosine triphosphate). Mitochondria are the power supplies of all cells; they metabolize (burn) fuel and produce energy for the cell in the form of ATP. In stimulating the mitochondria, laser therapy can repair damaged tissue and return cells to a healthy state, reversing many degenerative conditions.'
Controversies
Although there is evidence for the use of Photobiomodulation in surface injuries and possibly deeper sources of chronic pain there is no evidence that this translates to the sort of neural regeneration that would be required to cause the effects claimed by Dr Wildens and other proponents. Of interest is that Dr Wildens et al are yet to publish a peer-reviewed academic paper demonstrating their findings, they have been presented papers at conference but this carries nowhere near the same weight. It is also doubtful that laser energy is capable of penetrating to the depth of the inner ear or of doing anything when it gets there. The inner ear or Cochlear is embedded in the Petrous (stone-like) portion of temporal bone which as the name suggests is extremely dense.
As you can see, whether applied directly to the mastoid process (pointy bone behind the external ear) or directed straight down the ear canal the cold laser has quite a journey ahead of it, the likelyhood of the energy being absorbed or dissipated would appear to be very high.
Some practitioners and researchers argue that a great deal of the research that has been done has been of insufficient repetition or laser strength or wavelength to achieve the desired and claimed effects, however they also seem to be perfectly happy to sell home laser systems direct to the public with the same limited power levels. (I've been informed by a customer of Dr Wildens that the laser he sells is stronger than average at around 30mW, although I could find no evidence of this on the site).
The Evidence
Taken in order of publication;
Partheniadis-Stumpf et al used a combined approach using Tebonin (a form of Ginko-Biloba supplement) and laser treatment and failed to find any evidence of benefit although their sample size was quite small, abstract available here
With a slightly higher number of participants Shiomi et al appeared to show some degree of benefit, however their study suffered from a lack of a control group, abstract available here
Mirz et al with a similar number to Shiomi but using a well structured randomized double blind placebo-control trial were unable to find any statistically significant evidence of benefit using the active laser and concluded that previous reports of benefit were simply placebo effect, abstract available here
Once again using a combination of Ginko (this time in the form of EGb 761) and laser Hahn et al. with 120 study participants reported an improvement in just over 50%, however this study was once again marred by the lack of any control group, abstract available here
Despite again failing to supply a control group and with a small study size than Hahn, Nakashima et al found no benefit whatsoever from the use of 60mW laser irradiation, abstract available here
Tauber et al looked at whether any effect of the laser was dose-dependant in terms of wavelength and strength of laser, again without a control group. They report 15/35 experiencing significant improvement, with two subjects reporting no Tinnitus after six months. They acknowledge the need for large double-blind placebo-controlled studies to confirm and support their findings, abstract available here
Siedentopf et al conducted an interesting study which appears to show central changes occurring in regions of the brain that have been associated with Tinnitus generation only when an active rather than placebo laser is used. Unfortunately the size of the study and detailed methodology are not available in the abstract. It is also worthy of note that fMRI measures are only indicative of activity and may not relate to the stimulus presented, abstract available here
In 2008 Hahn et al again revisited soft-laser therapy in comparison with a number of drug and physical therapies. By dividing the 150 participants into seven treatments arms they substantially weakened the power of each separate arm, however their conclusion was that 'The most effective treatment was defined as a combination of Cavinton and physiotherapy', the outcome for soft laser is not mentioned in the abstract, which is available here
Gungor et al. found using a laser strength, wavelength and duration of treatment that is often suggested by LLLT proponents to be insufficient (5mW, 650nM, 15 mins 1/day for 1 week) that in all three of their measures subjects exposed to active laser rather than placebo improved by approximately 50%. The abstract does not mention the size of the control group used. Abstract available here
In a recent study with very small active and control arms Cudia et al again using a 5mW laser but over a much longer treatment period (three months) found that the treatment group experienced 26% more improvement than the control group. It should be noted that no reason is given for the greater size of the treatment arm of the study (26 compared to 20 in the control) and that the difference in daily intervention was not controlled for. 26% would correspond well with a placebo effect, abstract available here
For completeness and background I've included the full search results from the NHS Library for Health and information on the proposed mechanism for Photobiomodulation here. Dr Wilden's take on this is available here, although it is important to note that although it looks like an academic paper it has NOT been peer reviewed or published in a journal of note. Also, given the prevalence of Ginko-Biloba in these studies used alongside laser therapy (and the willingness of online companies such as Arches to sell you the supplement) it may be useful to reflect on the evidence from this very well designed and large scale study, funded by the British Tinnitus Association.
Conclusions
There appears to be a very limited evidence base for the use of LLLT in Tinnitus, and where it does exist there are often significant methodological flaws which act to weaken the evidence. Despite concerns from the proponents of LLLT that sufficient exposure time, strength or correct wavelength have not been used in negative studies this does not alter the apparent fact that there is an absence of peer reviewed evidence using the criteria they propose.
The mechanism of action proposed for LLLT has a degree of surface validity, although it remains controversial even in the areas where it is normally employed. In the ear it is claimed that the laser is capable of both penetrating to the neuronal tissue of the Cochlea and facilitating regeneration of damaged nerve tissue, thus improving hearing and reducing Tinnitus. Two extraordinary claims, both in need of extraordinary evidence which currently does not appear to exist.
I should emphasise, particularly in light of the current court case between the British Chiropractic Association and Simon Singh that I am not in any way suggesting that major practitioners of LLLT are being disingenuous in offering it as a treatment for Tinnitus. I suspect that most of them are entirely persuaded by the science and their own experience. However in all likelihood their sincerity is a product of a number of logical and methodological fallacies. Selection bias, in that only the very motivated and well-heeled can afford the high fees often charged (3000 euro's is not uncommon). Regression to the mean, i.e. people tend to seek out radical treatments when in extremis, however most chronic conditions can only remain at their peak severity for a short time then regress to their background level, particularly true with Tinnitus (Hallam, 1970). And finally confirmation bias, i.e. the tendency we all have to only remember the positive feedback, and forget those who are dissatisfied or simply don't return for further treatment.
Further Reading
http://www.tinnitusformula.com/infocenter/articles/treatments/LLLT.aspx
http://www.dr-wilden.de/en/
http://www.laser.nu/tlc/tinnitusEnglish.htm
http://www.laserpartner.org/lasp/web/en/2000/0004.htm
http://www.rnid.org.uk/community/forums/tinnitus/dr_wilden/?pn=1
Monday 25 May 2009
'Hopi' Ear Candles
The claims made for ‘Hopi’ ear candles are as varied, if not more so than the names for the treatment itself. It is often somewhat oddly described as Thermo-Auricular Therapy (TAT), which implies an application of heat to the ear, strangely this is one of the few mechanisms of action that is seldom if ever claimed. ‘Ear Candling’ and ‘Ear Coning’ are two other commonly used terms for this intervention. The candles themselves are usually made of muslin cloth or linen soaked in a mixture of paraffin and beeswax, often with a mixture of herbs and aromatic oils.
Link to the Hopi Indians
Despite their name there is no evidence that the Hopi Indians ever used Ear Candles. Indeed there is a quote cited by several sources including Wikipedia and a more detailed quote on Quackometer which suggests that representatives of the tribe have respectfully requested that manufacturers of ear candles stop using their name to sell these items.
Proposed Mechanism of Action
Here is a suggested mechanism of action from one of the main manufacturers, Biosun:
‘Earcandles have a purely physical function. A light suction action (chimney effect) and the movement of the flame create a vibration of air in the Earcandle, generating a massage-like effect on the eardrum. This induces a pleasant feeling of warmth and a balance of pressure in the ears, forehead and sinuses.’
Suggested Ailments Treatable by Ear Candling
Here is a list presented on this site (1):
Excessive or compacted wax in the ears
Pressure regulation in cases of headache/migraine
Irritations in the ears or sinuses
Sinusitis, "glue ear" and Rhinitis
Noises in the ear e.g. Tinnitus
Energetic revitalisation in cases of hearing impairment
Relaxation and stress relief
Local activation of the lymph and metabolic process
And a further list of possible benefits from this site (2):
Excessive or compacted wax in the ears (see patients comments)
Irritation in ears and sinuses
Pressure regulation in cases of : sinusitis / rhinitis / glue ear / colds / flu / headaches / migraine
Stimulation of local and reflex energy flow
Energetic revitalisation in cases of hearing impairment
Relaxing and calming effect in cases of stress
Noises in the ears, ringing, tinnitus
Available Peer-Reviewed Papers
The first paper to review the claims made for ear candling was Seely et al in 1996, abstract available here
Professor Edzard Ernst then wrote a critical paper called ‘Ear Candles - A Triumph of Ignorance over Science’, abstract available here
Rafferty J. et al wrote a review of the evidence for the Canadian Family Physician, whole paper available here
There is also a case study paper by Kutz J et al which sites Seely et al, whole paper available here
Conclusions
The overwhelming evidence appears to suggest that the mechanism of action for ear candling is totally implausible. Should there be sufficient vacuum to draw sticky or hard wax from the ear canal the ear drum would likely rupture before any wax is removed. Seely clearly shows that there is no such vacuum. Edzard Ernst concludes very firmly that the sale and use of ear candles should be banned, and Refferty et al suggest that they demonstrate more harm than good and therefore GP’s should discourage their use.
Part of the candling ‘ceremony’ is to demonstrate to the client the wax that has been drawn from the canal and into the candle or cone by slicing it open. It has been shown conclusively that this is not human wax, rather it is the burned wax that has fallen down inside the cone. For this very reason some manufacturers insert a wax barrier within the cone itself to prevent molten wax falling into the ear canal, or burning a hole in the ear drum. Many do not have this safety device.
Further Reading
http://www.randi.org/jr/02-02-2001.html
http://www.quackometer.net/blog/2008/03/hopi-ear-candling-removing-grey-goo.html
http://www.quackwatch.org/01QuackeryRelatedTopics/candling.html
http://en.wikipedia.org/wiki/Ear_candling
http://skepticzone.wordpress.com/?s=Ear+Candling
Link to the Hopi Indians
Despite their name there is no evidence that the Hopi Indians ever used Ear Candles. Indeed there is a quote cited by several sources including Wikipedia and a more detailed quote on Quackometer which suggests that representatives of the tribe have respectfully requested that manufacturers of ear candles stop using their name to sell these items.
Proposed Mechanism of Action
Here is a suggested mechanism of action from one of the main manufacturers, Biosun:
‘Earcandles have a purely physical function. A light suction action (chimney effect) and the movement of the flame create a vibration of air in the Earcandle, generating a massage-like effect on the eardrum. This induces a pleasant feeling of warmth and a balance of pressure in the ears, forehead and sinuses.’
Suggested Ailments Treatable by Ear Candling
Here is a list presented on this site (1):
Excessive or compacted wax in the ears
Pressure regulation in cases of headache/migraine
Irritations in the ears or sinuses
Sinusitis, "glue ear" and Rhinitis
Noises in the ear e.g. Tinnitus
Energetic revitalisation in cases of hearing impairment
Relaxation and stress relief
Local activation of the lymph and metabolic process
And a further list of possible benefits from this site (2):
Excessive or compacted wax in the ears (see patients comments)
Irritation in ears and sinuses
Pressure regulation in cases of : sinusitis / rhinitis / glue ear / colds / flu / headaches / migraine
Stimulation of local and reflex energy flow
Energetic revitalisation in cases of hearing impairment
Relaxing and calming effect in cases of stress
Noises in the ears, ringing, tinnitus
Available Peer-Reviewed Papers
The first paper to review the claims made for ear candling was Seely et al in 1996, abstract available here
Professor Edzard Ernst then wrote a critical paper called ‘Ear Candles - A Triumph of Ignorance over Science’, abstract available here
Rafferty J. et al wrote a review of the evidence for the Canadian Family Physician, whole paper available here
There is also a case study paper by Kutz J et al which sites Seely et al, whole paper available here
Conclusions
The overwhelming evidence appears to suggest that the mechanism of action for ear candling is totally implausible. Should there be sufficient vacuum to draw sticky or hard wax from the ear canal the ear drum would likely rupture before any wax is removed. Seely clearly shows that there is no such vacuum. Edzard Ernst concludes very firmly that the sale and use of ear candles should be banned, and Refferty et al suggest that they demonstrate more harm than good and therefore GP’s should discourage their use.
Part of the candling ‘ceremony’ is to demonstrate to the client the wax that has been drawn from the canal and into the candle or cone by slicing it open. It has been shown conclusively that this is not human wax, rather it is the burned wax that has fallen down inside the cone. For this very reason some manufacturers insert a wax barrier within the cone itself to prevent molten wax falling into the ear canal, or burning a hole in the ear drum. Many do not have this safety device.
Further Reading
http://www.randi.org/jr/02-02-2001.html
http://www.quackometer.net/blog/2008/03/hopi-ear-candling-removing-grey-goo.html
http://www.quackwatch.org/01QuackeryRelatedTopics/candling.html
http://en.wikipedia.org/wiki/Ear_candling
http://skepticzone.wordpress.com/?s=Ear+Candling
Wednesday 20 May 2009
Why BadTinnitus.net?
I am an NHS Chief Audiologist and Hearing Therapist who has a special interest in Tinnitus as a condition, and how to best manage it with and for my patients. I have been working in the NHS from January 1993 as an Audiologist and dual qualified as a Hearing Therapist in 2004. A few months ago I was asked to speak at this years British Tinnitus Association Conference. I couldn't think of anything I wished to discuss more than the degree to which people with Tinnitus are persuaded to part with significant amounts of their time and money by people offering unlikely, implausible and miracle 'secret cures'. I feel it's very important that interventions ought to have a plausible mechanism supported by a strong and developing evidence base, and that people who feel they are suffering from Tinnitus should not have that suffering unnecessarily prolonged by ill-evidenced and exploitative 'cures'.
The purpose then of this blog is to lay out clearly the available evidence base for each and every putative treatment for Tinnitus. My intention is not to over-editorialise, but to simply present the evidence in peer reviewed journals and allow you the reader to arrive at your own informed conclusions. If you then choose to engage in a treatment with no proof, or with evidence of active harm such as 'Hopi' ear candles then best of luck to you. If along the way we get into discussions about the positive effects of the 'Placebo Effect' and how this is used, consciously or otherwise by 'Complementary and Alternative Medicine' practitioners then that's great, I'd love to hear your views.
For the purpose of both self-interest and full disclosure let me say that alongside my NHS practice I have a private practice based in Sheffield at http://www.hearingtherapy.net, and more information can be found about me at http://www.timhusband.info.
As a warm up at a truly fat and feeble target I shall be placing my sites firmly on 'Hopi' and other ear candles,
I hope you come along for the ride and enjoy,
Tim
The purpose then of this blog is to lay out clearly the available evidence base for each and every putative treatment for Tinnitus. My intention is not to over-editorialise, but to simply present the evidence in peer reviewed journals and allow you the reader to arrive at your own informed conclusions. If you then choose to engage in a treatment with no proof, or with evidence of active harm such as 'Hopi' ear candles then best of luck to you. If along the way we get into discussions about the positive effects of the 'Placebo Effect' and how this is used, consciously or otherwise by 'Complementary and Alternative Medicine' practitioners then that's great, I'd love to hear your views.
For the purpose of both self-interest and full disclosure let me say that alongside my NHS practice I have a private practice based in Sheffield at http://www.hearingtherapy.net, and more information can be found about me at http://www.timhusband.info.
As a warm up at a truly fat and feeble target I shall be placing my sites firmly on 'Hopi' and other ear candles,
I hope you come along for the ride and enjoy,
Tim
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