There is no such thing as “bloodless” surgery – let’s make that clear. There is, however, blood loss that is insignificant, like when you cut yourself shaving, and then there’s significant blood loss such happens after major trauma cases with multiple fractures. As surgeons, often responsible for that blood loss, we try as much as we can to minimise blood loss, and hence the need for transfusion. And before you ask, if you’ve lost red cells, then there is nothing available yet that can replace the oxygen carrying capabilities of those red cells like, you guessed it, red cells.
Placing a patient on a well padded and designed operating table is often the first step in minimising blood loss. The “Jackson table” is, in my opinion, currently the best table for large posterior spinal cases. It allows the abdomen to hang free and the pads are soft and well positioned. Other positions, such as on the side, can also be used for different approaches which minimise blood loss simply due to their anatomy. An ALIF, for example, can be an operation that involves very small amounts of blood loss just by it’s approach.
Many of us practice “minimally invasive surgery”. This is poorly defined as everyone has a different opinion of what it means, but in principle it is about doing an operation through a smaller incision than how it was done before. Whilst it may appear like these techniques lose less blood, often the blood loss is kept hidden. Muscles are still being retracted and dissected, and bones are being cut, both of which lead to blood loss, but because the skin incisions are so small, often that blood is kept inside the skin. In the long term the body with resorb that blood, but in the short term effectively that blood is out of your circulation and so it still lost to you.
It’s important to tell your surgeon what medications and supplements you’re taking. Many of these can increase blood loss, and cause postoperative epidural haematomas that may press on the spinal cord. We also often use a medication called tranexamic acid, which has been proven to reduce blood loss during your operation.
Like many other surgeons I use a machine during my large operations called a “cell saver”. This takes the blood that you have lost, washes it, and allows us to give you back your red cells. It doesn’t give you back all your blood, like platelets and clotting factors, but it does give you back your oxygen carrying red cells.
When it’s needed
Of course, despite our best efforts, a blood transfusion is sometimes necessary after elective procedures. In trauma cases where we’re often dealing with multiple fractures and abdominal bleeding, transfusions save lives. Fortunately in Australia we have a very safe and efficient blood donor system run through the Red Cross. Yesterday I gave my 98th donation, and if you’re able to, I recommend you consider donating as well. Every time you give blood, you can just about guarantee that your blood is going to someone who may die without it. I’ve even learnt something about my own blood. My platelets are a very rare type (HLA 1bb 2bb), with less that one percent of the population having the same, and they can be used to treat Neonatal Alloimmune Thrombocytopenia, a rare but often catastrophic bleeding disorder of newborns.
So why don’t you consider giving blood? You’ll be saving someone’s life, and one day you might need the gift that a donor made for you.
The “take home” message from my post about the YODA studies was that Infuse was as effective as autologous bone graft at establishing a fusion. There were concerns raised though about the number of people who were reported as having being diagnosed with a cancer, and on the surface of it there was good reason to be suspicious. BMP’s stimulate cells to grow, and that’s what cancers do – they grow uncontrollably. Suspicions though are one thing – research was required.
Take any group of people and you can expect a certain proportion to be diagnosed with cancer over a period of time. Therefore, to see if a drug “causes” (increases the risk of) cancer, you need to compare a treated group to an untreated group and look at how many get diagnosed with cancer over several years.
First out of the blocks with a study was, once again, Eugene J. Carragee, who you may remember was the instigator of the first paper that focussed on the possible risks of using Infuse, that triggered off the YODA studies. His paper, published here, looked at the data from a study that was used to trial a combination of a new non-compressible matrix with a high dose of Infuse. In the trial, they compared two groups of people having spinal fusions. One group received the high-dose infuse, and the other used their own autologous bone graft. As part of the study they were tracked for several years, so Carragee, et al, looked at the number of people who were diagnosed with a cancer in both groups. What did they find?
“The incidence rate of cancers was 6.8-fold greater in the rhBMP-2/ CRM group compared with the control group (p = 0.0026).”
WHAT? The people receiving Infuse had an almost 7 times risk of getting cancer than those that didn’t! “Infuse causes cancer!”
Well, settle down for a minute. There’s a couple of things to look at here. Firstly, the total number of patients in the study was 463, which whittled down to 292 by the five year mark. The number of patients with a cancer across that whole group was 17, which means that the risk of cancer for the whole group was only 5.8% over five years. There is also some dispute about how to even measure cancer incidence; if one person gets two cancers, is that one cancer “event”, or two?
This leads to the second point. Looking at table 1, one patient was diagnosed with a basal cell carcinoma, squamous cell carcinoma of the skin, and chronic myelogenous leukaemia. That one patient accounted for 7 of the cancer events in the Infuse group. Another 3 events was one patient who had multiple SCC’s. As an Australian it’s easy to see that if someone presents with a BCC or an SCC, they are then more closely followed to recurrences of those tumours. BCCs and SCCs are also very common, so it could be that, given the small number of people in the study, the Infuse group were “unlucky” to have two patients with multiple tumours. Or it could be the other way around…
Lastly, the dose of Infuse was extremely high. Usually when we use Infuse, the dose is either 8.4mg or 12mg. The dose in the study was 40mg – three to five times the usual dose. Clearly, even if it does have some mild carcinogenic effect at 40mg, that may not apply at the lower doses used in Australia.
So that brings us to the other study, “Risk of Cancer After Lumbar Fusion Surgery With Recombinant Human Bone Morphogenic Protein-2 (rh-BMP-2).” written by a gastroenterologist and oncologist – in other words, people least likely to have a conflict of interest. This paper looked at all lumbar fusions performed in the USA over a five year period where the Medicare record were complete and who didn’t already have a cancer diagnosis: that left them with only 146,278 patients to analyse! They then looked at any patients who later developed one of the 26 most common cancers, and compared them to the use of a rhBMP, either -2 or -7. Generally it is thought that the bulk of the use was for rhBMP-2. So what did they find?
Overall, there was no association of rhBMP admin- istration with cancer incidence (hazard ratio: 0.98, 95% confidence interval [CI]: 0.95–1.02). Similarly, when individual cancer sites were considered, there were no significant differences between the 2 groups.
In simple terms, they found there was no association between use of a rhBMP and cancer.
So we have two studies to look at. One looked at high dose rhBMP and only 292 patients. The other was retrospective, but it looked at 146,278 patients and included all types of lumbar fusion surgery, all doses, all techniques. Which do I put more credence to? The latter study.
As you probably realise now, I’m not very good at limericks, but to be fair, “virus” isn’t the easiest word to rhyme. “Name the Virus” is a funding opportunity you have to help the Florey Institute raise funds to complete some of their projects. For the first time, YOU can donate money and be rewarded by the scientists of the Institute. Apparently cookies are offered, and if you donate enough, you can also decide the name of one of their virus vectors! For only $2,500…
You get to “Name the Virus”!
As each viral vector is created it will be named. The Name must be 10 letters or less and be socially acceptable. E.g. If the name “noodles” was chosen the viral vector would be called “pNoodles” and this name will appear in any publications or presentations in which it is used. Each rewardee will be sent a copy of the “map” of the viral vector they named.
Of course, there’s rewards for smaller amounts to, all the way down to $20.
Surely some of you reading this could spare a few bob to help Dave take over the world… oops! I mean Name the Virus.
Before I go on, please do not read this as a criticism of all chiropractors. You need to understand that there are two bodies that represent chiropractors within Australia. There is the Chiropractic and Osteopathic College of Australasia (COCA), and the Chiropractors’ Association of Australia (CAA). I believe that anybody practicing in the health professions should always employ evidence-based techniques and treatment regimes, myself included. If you want a chiropractor who practices based on evidence, you’ll be more likely to find one within the ranks of the COCA than you will in the ranks of the CAA though. For example, of the fifty chiropractors openly expressing anti-vaccination lies on their websites documented here, most of them are members of the CAA. None are members of COCA.
A recent article in The Age, by Julia Medew and Amy Corderoy, has outraged chiropractors, or more specifically, the CAA. If you want to know how much it has outraged them, you only need to read this press release by the CAA, and see the report on their outrage here. The Age hasn’t even acknowledged their outrage, which must add disappointment to their already overflowing cup of emotion.
The article was startling for several reasons. Firstly, it described the case of a four-month old baby treated by a chiropractor with a fractured neck. Yep – a fractured neck. Did the chiropractor cause it? We don’t know, but suffice to say that it appears from the information available, that the parents took the baby to a hospital ED after an “adjustment” by a chiropractor, and the baby was found to have a fracture in his or her cervical spine. I was not and am not part of the treating team. Maybe the fracture occurred before the adjustment. In that case the chiropractor possibly missed the signs and symptoms of a fractured neck – disappointing for someone who’s had “five years of university training” as we keep hearing. The other option is that the chiropractor caused the fracture. Either way, it’s not a shining endorsement.
The other startling aspect of the story was the claim that chiropractors visit hospitals and provide adjustments without the hospital’s permission. More can be read on those allegations here.
So what is the reaction of the CAA? Outrage. Take a read of the media release. They appear to know in great detail the results of the investigation of the case by AHPRA, despite those results being confidential. Yet, they know. And they tell us that The Age article “smeared the Chiropractor” – despite the name of the chiropractor not being mentioned. Kinda hard to smear someone when you don’t name them. This sort of confusion occurs when you are outraged.
Then we get to,
“National President of the CAA, Dr Laurie Tassell said, “It remains the case that not a single serious adverse event has been recorded in the medical literature (world-wide) involving a qualified Chiropractor treating a child since 1992.”
This Claim is obviously part of the gift pack you receive when you join the CAA, as it’s the same Claim made by Tony Croke on Catalyst. The CAA lodged a complaint against Catalyst for criticising this Claim, and the complaint was only today dismissed by an independent investigator. More outrage. Lots of it.
So what of the Claim? I contacted Bevan Lisle, Communications Director of the CAA today about the claim, and his response was, well, less than satisfactory in my opinion. You see, The Claim, as we shall refer to it as, has several weak points. Firstly, a health practitioner who claims to have no adverse events is someone who does not practice. Secondly, as they have no systematic method of compiling adverse events, they simply aren’t looking for them. It’s like claiming there’s no stars out while you’re down a mine shaft. Thirdly, by Claiming that there has never been even a single adverse event, the documentation of just one is enough to falsify the Claim. Lastly, the word “involving”, or as Bevan put it, “associated with”, doesn’t mean they caused the event – it just means the chiropractic treatment was “connected” with the event. So how does the Claim stand up?
As defined by the FDA, a Serious Adverse Event (SAE) can be of several types. One is
Disability or Permanent Damage: Report if the adverse event resulted in a substantial disruption of a person’s ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities and/or quality of life.
I had to help Bevan today with his definition of SAE, so let’s be clear in case anyone else doesn’t know it.
A slipped capital femoral epiphysis is a serious event, and a delayed diagnosis meets the criteria of a SAE. The paper here describes 12 delayed diagnoses because of attendance at either a physiotherapist or a chiropractor. Remember, we only need one case “associated” with chiropractic care after 1992 to disprove the Claim. Hence, the Claim is apparently false.
This paper also describes fractured ribs associated with chiropractic care. Published after 1992, associated with chiropractic care. The Claim is therefore false. Surely?
This paper also describes a litany of SAE’s associated with chiropractic care. The events were all in 1992 or before, so technically lie outside the Claim, but still make for shocking reading.
The CAA, when asked for comment, stands by the Claim. It’s like a mantra. Even in the face of the investigation of the four-month old baby, they still repeat the Claim. It happened after 1992, was associated with chiropractic care, and is a SAE. Time to retract the Claim?
Instead of expressing outrage at one of their members, the CAA prefers to express outrage at journalists, and probably now myself, at what they see as a smear against an unnamed chiropractor. In fact, in a brilliant example of double talk…
CAA president Dr Laurie Tassell (Chiro) said there was no doubt the baby had a hangman’s fracture. “The official report made it quite clear that the chiropractor did not cause the injury but unless AHPRA releases the report we can’t use those findings,” he told Medical Observer.
See what he did there? He can’t use the findings, but here they are anyway. But he can’t use them, OK?
And we’re meant to believe him. We’re meant to trust the CAA to have the public’s interest in mind. We’re meant to see them as a peak representative body whilst they repeat the apparently false Claim, talk in double talk, and rather than express sympathy or even a whim of accountability, prefer to express their own outrage.
Here’s my message to the CAA: instead of expressing outrage, why don’t you start behaving like professionals, start regulating yourselves, start looking for adverse events and start reporting them openly like other medical professionals do, stop tolerating anti-vaccination garbage, encourage evidence based care, and for once, take responsibility.
Many of you may have seen the episode of Catalyst that aired on 11 July, 2013, which discussed the chiropractic profession. It can also be seen here.
I’ve been pleasantly surprised by the positive reaction of many members of the public and indeed chiropractors to the show. It confirms what I pointed out in my previous post – that the chiropractic profession here in Australia is currently divided between those who cling to the concept of the subluxation as a cause of extra-spinal disease like colic, asthma, diabetes and even cancer (the “straights”) and those who are struggling to establish an evidence based chiropractic scope of practice. To the latter, as I’ve said before, I say go forth and publish!
I’m fairly critical of research papers I study, and that includes my own. For example, one of my own studies that was published recently lacks randomisation, is a single surgeon series, and has quite a wide range of followup periods. That indicates that one must be careful about what conclusions we draw from it. That’s me criticising my own work, as a short example.
In response to the programme, several papers have been presented to me as evidence that chiropractic can cure deafness, ala William Harvey Lillard. One study is a hypothetical discussion of a complex neurological pathway involving the spine and the middle ear causing Ménière’s disease. See the word hypothetical there? It’s not evidence.
Another is this paper from 1995, on the association of late whiplash injury syndrome (LWIS) and tinnitus. It was in the second ever issue of a biannual journal, and the author was the journal’s founding editor. Hmmmm. It may be the case that people with LWIS get tinnitus, but LWIS is clearly not a simple diagnosis. In fact, when you remove the medicolegal implications of having a chronic injury, it’s found that “Expectation of disability, a family history, and attribution of pre-existing symptoms to the trauma may be more important determinants for the evolution of the late whiplash syndrome.” Neither is the cause of the tinnitus clear – it’s could very well be the temporomandibular joint!
With respect to hearing and balance problems due to whiplash, the exact nature of the lesion is not known but the following have been put forward as possible explanations: Transient ischaemia or haemorrhage in the labyrinth as a result of transient compression of the vertebral artery, direct labyrinthine concussion, brain stem concussion, the noise of the collision causing acoustic trauma or psychological triggering of a pre-existing hearing disorder. With so many suggestions it is a cynical truism to say we do not know the exact cause and site of the lesion.
We do not know. We just don’t know.
Another paper that was sent to me was on a case series of people with hearing improvement after chiropractic treatment. Without a control group, it does little to provide evidence of efficacy. As the authors themselves said,
Further research in this area is required, in the form of a well designed randomised controlled trial.
So that was in 2006. It’s been seven years, and still no followup study. Why not? If I wanted to do a research project, this would be my first one – interesting topic, straight forward design, short time period. Why hasn’t it been done? Why?
Yet another paper, in German, discusses a condition “vertebragenic hearing disorder”. The author himself admits that the condition’s very existence is disputed. The hearing testing is poor and so is the description of the intervention. No control group, once again, means that it is not to be regarded with any sense of gravity.
Protecting their turf
As predicted, several chiropractors wrote to me attempting to denigrate my profession. Claims of high morbidity and mortality rates of conventional medicine abound, yet what these people fail to appreciate is the logical fallacy they had fallen into: tu quoque. Criticising my profession doesn’t validate yours.
The other irony is that, at least in my practice, I rarely treat patients with back pain alone, or, for that matter, asthma, autism, deafness or colic. I treat patients who have pathological conditions that are demonstrable on imaging studies, and therefore, I have no vested interest in the chiropractic subluxation. I have no turf to protect.
The chiropractic profession in Australia, as far as I know, does not have a systematic way of collecting adverse events. Conventional medicine doctors are subject to regular peer review of our practice, as part of our registration. I attend monthly review meetings of both hospitals I practice at. The RACS runs the Australian and New Zealand Audit of Surgical Mortality. We’re open, transparent, and provide reliable data.
If you don’t look for something, you can’t claim it’s not there. Before we looked for exoplanets (planets outside our solar system), there was discussion based upon poor quality data about how many are out there. Since we’ve been looking, we’ve found over 900. How many adverse events are there from chiropractic therapy? Let’s start looking. Maybe there’s none, maybe there’s lots, but until you look systematically, I can’t see how you can make any claims. But that’s just me.
As I’ve said before, unless you base your practice upon good evidence, then you’re not necessarily practicing evidence based medicine.
Many of my patients have either been to a chiropractor, or ask me if they should go and see one. Some of them are aware that there is some discrepancy between mainstream medicine and chiropractic theory, but aren’t sure of the specifics. Here’s why I have problems giving an opinion on the matter.
Firstly, there’s two broad categories of chiropractors. There are those who tend to be younger, who are struggling to define their art form in terms of evidence and reproducibility. They tend to encourage sensible evidence based principles, concentrate on strengthening the spine, and treat spine-related symptoms. They are to be encouraged, because it is through them that chiropractors may gain some credibility in the medical community.
Now let’s talk about the others – the “straights”; the vitalistic, intuitive, metaphysical practitioners who remain separate from the mainstream community, and who are determined to remain that way. The irony is that they are also the one’s wanting to introduce chiropractors to primary health care roles. I’m reminded of the desire to simultaneously have and eat cake.
A short history lesson… A gent by the name of DD Palmer apparently cured a man’s deafness in 1895 by performing a manipulation on his neck, and this is the miracle upon which DD made his mark, and from which chiropractic began. A connection was made, in the minds of some, that diseases come from malalignments within the spine. Not just some, but all. They figured that by fixing these malalignments, or “subluxations”, a person could be cured of all sorts of ailments. Sounds simple, huh? Sounds like a concept that’s plausible and attractive, especially for those seeking “natural” therapies.
So here’s the kicker. There are simply no nerves, no pathways at all, that link the cervical spine to the parts of the ear to do with hearing. There is a cervical (neck) nerve branch that supplies sensation to the skin near the outer part of the ear, but no neck nerve at all within the middle or inner ear. So how does a manipulation of the neck affect hearing? Well, it can’t. No way. It’s just not plausible. No matter how hard you want to believe it, it just not possible.
When the Wright brothers built the first successful powered aeroplane, they formed the basis for the development of aircraft we see today, and people can still build replicas of the plane and fly it. The scientific principles haven’t changed – techniques and understandings have deepened, but the Wright Flyer can still fly today.
Likewise, if DD Palmer was able to cure deafness in 1895, then modern chiropractors should be able to do this as well – they should be able to fly the first plane. According to my checks, there is little evidence that this trick hasn’t been performed since. Why not? DD Palmer did it, so why aren’t chiropractors curing deaf people world wide? Surely that should be the first therapy taught to young chiropractors!
If you want another reason to doubt the concept, then what about high quadriplegics, like Christopher Reeve, who had perfect hearing, but a non-functioning spinal cord. Not malaligned or subluxed – not functioning at all. So when you hear someone tell you this story, just remember that you’re hearing it without using your spinal cord.
Some chiropractors insist that adjusting the spine can, indeed, fix your hearing, your diabetes, your child’s autism and asthma, and “enhance” your immune system. They invented the concept of “innate intelligence” to explain it, which is some sort of life force that cannot be seen, does not follow nerve pathways, yet can somehow be manipulated and adjusted by cracking a person’s neck or back. How is it that something, that cannot be seen or touched or imaged, be “adjusted”? How can you know that the supposed “adjustment” is being performed correctly, healing the “innate”, when it cannot even be measured? You’ll need to ask a chiropractor that. It’s a convenient and intuitive concept, but completely without evidence. None. And much evidence to the contrary. It’s a fairy tale, designed to make people believe.
Many chiropractors claim that they can help with middle ear infections in children, but once again, there are simply no nerves that come from the neck and go to the drainage tube (Eustachian tube) of the middle ear. They are simply not connected. No nerves in the cervical spine goes to or comes from the Eustachian tube. Is it the “innate” again? It must be, because it’s not anatomy.
At some point you’ll probably come across the term subluxation. This is a chiropractic subluxation which implies an abnormal movement of the facet joint. It is not visible on X-ray or MRI studies. This is opposed to the subluxations that I treat, which are demonstrable with imaging. If the chiropractic subluxation was the cause of disease, then why aren’t people with adolescent idiopathic scoliosis riddled with disease? After all, their spines are abnormally curved in all sorts of directions and have abnormal and unbalanced movements. Long term studies of these patients however show no difference in their health compared to the general population (unless the curvature impacts on their breathing, but this is only for people with very large curves). In the UK, the General Chiropractic Council stated that the chiropractic vertebral subluxation complex “is an historical concept” and “is not supported by any clinical research evidence that would allow claims to be made that it is the cause of disease or health concerns.” So throw that out as well. If you want to respect your chiropractor, ask them to never speak of subluxation.
Some chiropractors go so far as to claim that by adjusting the spine they can “boost” the immune system, to the point that you do not need vaccination. This is a very attractive sounding claim, but again, seriously flawed. There is simply no proof for the claim. Nada. And what if by “boosting” the immune system, it brings about auto-immune disease like rheumatoid arthritis? Do you want someone doing that to you? The only proven way to reduce the risk of many deadly infectious diseases is – you guessed it – vaccination.
The vitalistic chiropractors claim to address the body as a whole (vitalism), and that conventional doctors only see the body as a sum of parts. Doctors are fully aware of the entire body functioning as a whole, and any claim to the contrary is just nonsense. I’ve seen chiropractors claim that the SF-36 score (a whole-body health score) is only used by holistic or vitalistic practitioners like themselves, but even a quick browse of the literature shows that scores like this are used all the time by all branches of medicine. Contrary to their claim, conventional doctors receive an education that covers all aspects of the human body. To become a highly specialised spinal surgeon I’ve had to pass exams in fields as diverse as immunology, renal physiology, biomechanics, radiology, epidemiology, anatomy, pharmacology and pathology. Who is “holistic” now?
Let’s be honest, if your chiropractor mentions the words innate or subluxation, or attempts to provide you treatment that isn’t directly related to spinal complaints, then you’re dealing with a non-evidence based practitioner. That may be fine for you, if that’s what you’re looking for. Enjoy it. But please don’t expect it to produce anything more than the placebo effect. If that’s what you’re willing to spend money on, then that’s your choice.
As you may appreciate, there are many chiropractors actively seeking to establish themselves as evidence based practitioners. They are to be encouraged, and if they can produce good evidence, then I’ll be the first to applaud them.
Only once a treatment modality, no matter what it is (chiropractic, physiotherapy, homeopathy, and conventional medicine) can describe it’s mechanism of action, its effectiveness and its safety profile, will it, can it, should it, be accepted. Life is too short, and dare I say, the health dollar is too limited. Show me the evidence, and I will embrace.
Yesterday I was interviewed by a journalist from The Age, and it really shouldn’t have come as a surprise to learn that the article hasn’t reflected the message I thought I was quite clearly giving her.
Here’s the background: Medtronic, a large medical device company, brought to the market Infuse, which is a Bone Morphogenic Protein (rhBMP-2 to be precise). This is soaked into collagen sponge and placed around fusion sites, and it works on the cellular level to transform cells to make bone. Simple enough. It has been used widely, by myself and most other spinal surgeons, to help the body fuse a spinal level.
Eugene Carragee, a prominent Stanford surgeon, raised concerns about Infuse in 2011. In response to those concerns, Medtronic sponsored a large project in order to address these concerns. In doing so, they set a new standard in “in the emerging era of open science“. In fact, they exceeded expectations – not one but two independent groups of researchers were granted access to every last morsel of data that the company had regarding Infuse. Completely independently, the two groups analysed the data and published their findings recently here and here.
It gives a surgeon and any researcher interested in Infuse confidence knowing that two independent groups produced such similar results, and yet at the same time, each group emphasised different aspects of their results.
it’s as good as bone graft to create fusion – that’s the key message to take home people. When a patient’s own bone can’t be used, then we now know that without a doubt Infuse will do as good a job.
When used in the anterior neck, it’s associated with increased complications – surgeons have know about this for many years now and it’s no longer used there.
complications such as retrograde ejaculation are about as common with Infuse as with bone graft.
there is no appreciable increase in the risk of cancer with Infuse – this was a great concern, and although the cancer rates were very slightly higher in the Infuse patients compared to bone graft, it was not higher than the normal population, and after four years there was no difference at all. I suspect this will turn out to be a statistical anomaly. Medtronic are continuing to research this area.
If you’ve had a fusion with Infuse, there is not need for concern. I will continue to use it, as well as similar products, when appropriate, with the patient’s consent. The journalist and the editors clearly have a newspaper to sell, and boring science is always outweighed by sensationalism.
Medtronic should be commended on what they have done with the YODA project. With complete transparency, they have opened up their data for not one but two independent reviews, and the results are difficult to argue with. They have set the standard by which other companies must now live up to – a new era of open science.
Further to my last article “Can back pain be cured with antibiotics?”, remember how I said talk of a Nobel prize might be premature, and that we need to see if these results can be repeated? Well, today I came across this article:
Unfortunately, the authors of the two papers discussed apparently didn’t declare a conflict of interest. No matter how small it may appear to themselves, any conflict should always be declared when authoring a paper. Whilst it doesn’t necessarily mean that we should ignore their results, it does raise a shadow over their results. Many people have unfortunately made this mistake previously, notably Andrew Wakefield, when he failed to declare his financial interest in a mono-valent vaccine that stood to profit by discrediting the MMR vaccine that was in use.
Declaring a conflict of interest does not negate that conflict, but it does, at least, make it public knowledge. The bigger sin is to not declare it. Now, unfortunately, this paper has lost some credibility.
As I said before, let’s wait and see if it can be repeated.
Over the next few months many of you will hear about a paper that has just been published in the European Spine Journal. The study, from the University of Southern Denmark, suggest that back pain can be cured with a 100 day course of antibiotics, and certainly they provide some good evidence for that. Certainly some surgeons are calling for a Nobel prize, but I don’t think it’s that significant yet. Maybe if you operate on a lot of people with back pain it’s significant, but those of you who know me, know that surgery for back pain is a last resort.
So, what about the study?
Well, it looked at people who had Modic type 1 changes on their MRI after having a disc herniation, whether or not they had surgery for the herniation. A prior study from the same team, and others, showed that many disc herniations (about half) are infected with a very low grade bacteria called Proprionibacterium acnes which also causes… yep – acne. It has a peculiar ability to be benign enough not to produce an acute inflammatory reaction, but at the same time it produces propionic acid, which is known to be able to dissolve bone. Wow. What a bug.
Now, modic type 1 changes are only about 10-40% of modic changes, the other types being 2, the most common, and 3, the least common. Modic type 1 changes appear dark on the T1 films, and bright on the T2 films, and represent oedema. One way of remembering this is that type 1 changes appear the same as the CSF. See below.
An example of Modic Type 1 changes
Anyway, back to the study. They randomised the participants into three groups. One group received a placebo, and the other two received the antibiotic (amoxicillin–clavulanate (500 mg/125 mg) tablets three times a day, at 8 h intervals, for 100 days) in two difference doses. They found that the antibiotic subjects improved remarkably well, usually beginning at 6-8 weeks after commencement, after 100 days, and it appears that the improvement lasted out to one year – well after the antibiotics had ceased being taken. Within the placebo group not much changed at all. In addition, the amount of modic change visible on their MRI’s also decreased, which supports the notion that it is due to a chronic low grade infection.
Were there problems with the antibiotics? Mostly gastrointestinal of nature – loose bowel movements and increased flatus. Thanks for asking.
So what does that mean? Well, if I had type 1 modic changes and back pain, I’d be considering this study carefully. However, as a public health measure, we need to realise that this isn’t the cure for ALL back pain – maybe only 10 to 40% of back pain patients. We know that back pain has many causes, but I think it’s just amazing that this subset may have found a cure. Of course, we need to see that these results can be repeated. Hold back on the Nobel prize for now…
There’s information on spinal conditions, prevention, exercises for your back, and descriptions of operations. There’s text pages, videos and brochures. I ask you to have a look and give me some feedback. Too much? Anything else you’d like to see? Can you find things easily, or not?