Updated Edition!
We have repeatedly discussed the risks of chiropractic spinal manipulation (see, for instance here, here and here). Some chiropractors seem to believe that using a hand-held manipulator, called ‘activator’, better controls the forces used on the spine and therefore is safer. This recent paper raises doubts on this hypothesis.
A neurosurgeon from Florida published the case-report of a 75-year-old active woman who presented to a local hospital emergency room with a 3-day history of the acute onset of severe left temporal headache, initially self-treated with non-steroidals, to which they were resistant. Additional complaints included some vague right eye blurring of vision and a mild speech disturbance. Her primary-care physician had ordered an outpatient MRI, which was interpreted as showing a small sub-acute left posterior temporal lobe haemorrhage. He then referred her to the emergency room where she was categorized as a “stroke alert” and evaluated according to the hospital “stroke-alert” protocol.
There was no prior history of migraine, but some mild treated hypertension. The patient subsequently gave a history of chronic neck and back pain, but no headache, for which she had intermittently received chiropractic adjustments. Her current problem started after an activator treatment to the base of the left side at the junction of the skull with the upper cervical spine. She became concerned enough a few days later, because of the persistence of unremitting headache, to contact her primary-care physician. The patient was not taking any anticoagulants or antiplatelet agents and had a relatively unremarkable past medical and surgical history. Although she did not have a formal visual field examination or an ophthalmology consultation, she was found to have an incomplete right homonymous hemi-anopsia on clinical exam by the neurologist.
Based on MRI characteristics, the haemorrhage was determined to be primarily subarachnoid and displacing but not involving any brain parenchyma, and without any extra-axial component. After a 4-day hospitalization for evaluation and observation, the patient was discharged, neurologically improved in terms of visual and speech symptoms as well as headache complaints, to outpatient follow-up. She has remained well with resolution of imaging abnormalities and no reoccurrence of symptoms.
The authors explain how difficult it is to prove specific causation in such cases. It is frequently inferred by epidemiological reasoning or evidence. While there are other potential causes of the haemorrhage that occurred in this case, none is as or more likely than the activator stimulus. In support of the activator as the cause of the haemorrhage, the symptoms began almost immediately after the activator treatment (a temporal relationship), the area to which the activator was applied is almost directly superficial to the area of haemorrhage (a spatial relationship), the anatomic location of this haemorrhage is statistically unusual for any underlying and/or preexisting conditions, including stroke. The MRI confirmed that there was no infarction underlying the area of haemorrhage. The MRA disclosed no dissections or vascular lesions present. The only mechanisms left are trauma or cryptic vascular lesion that ruptured, obliterated itself, and occurred coincident to the activator stimulus. Although Activator stimulus is not high energy, it nonetheless was targeted to the cervico-occipital junction, an area where neural tissue is among the most vulnerable and least protected and closest to the skin (as opposed to the lower cervical or any of the thoracic or lumbar spine). There are many articles that make reference to minor or trivial head injury as a likely cause of intracranial haemorrhage.
The author concluded that he was unable to find a single documented case in which a brain hemorrhage in any location was reported from activator treatment. As such, this case appears to represent the first well-documented and reported brain hemorrhage plausibly a consequence of activator treatment. In the absence of any relevant information in the chiropractic or medical literature regarding cerebral hemorrhage as a consequence of activator treatment, this case should be instructive to the clinician who is faced with a diagnostic dilemma and should not forget to inquire about activator treatment as a potential cause of this complication. Our case had a benign course, but we do not rule out a more serious or potentially dangerous clinical course or adverse outcome. This is of heightened concern in the elderly and/or those with treatment-induced coagulopathy or platelet inhibition.
In light of all of the difficulties inherent in linking chiropractic treatments, including activator treatments, with serious neurological events, it is very possible that intracranial hemorrhage is far more frequent than reported. Several articles comment on the likelihood that complications of this type are almost certainly underreported. Most of the incidents mentioned in case series or surveys had never been previously reported. Neurologists, neurosurgeons, and chiropractors should be more vigilant both in the application and evaluation of these methods in all patients who report new neurologic-type symptoms following a manipulation (including an activator application) to the occiput or the cranio-cervical junction.
I think that case-report speaks for itself.
Chiropractors will, of course, argue (yet again) that:
- conventional treatments cause much more harm,
- spinal manipulation is highly effective,
- such complications are extreme rarities,
- the risk/benefit profile of spinal manipulation is positive,
- some studies have failed to show a risk of spinal manipulation,
- case-reports cannot establish causality.
We have rehearsed these arguments ad nauseam on this blog. The bottom line is well-expressed in the above conclusions: it is very possible that intracranial hemorrhage is far more frequent than reported. And that obviously applies to all other types of complications after chiropractic treatments.
Mike Cummings recently stated on this blog “I’m not into blog banter.” Is he perhaps referring to some ‘alternative facts’? The truth seems to be that he blogs happily, regularly and – I am sad to say – disgracefully. This is a quote from his new post about the discussions regarding an acupuncture trial which was in the press a few days ago, (and also has been discussed on this blog):
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So there has been a big response to this paper press released by BMJ on behalf of the journal Acupuncture in Medicine. The response has been influenced by the usual characters – retired professors who are professional bloggers and vocal critics of anything in the realm of complementary medicine. They thrive on oiling up and flexing their EBM muscles for a baying mob of fellow sceptics (see my ‘stereotypical mental image’ here). Their target in this instant is a relatively small trial on acupuncture for infantile colic.[1] Deserving of being press released by virtue of being the largest to date in the field, but by no means because it gave a definitive answer to the question of the efficacy of acupuncture in the condition. We need to wait for an SR where the data from the 4 trials to date can be combined. On this occasion I had the pleasure of joining a short segment on the Today programme on BBC Radio 4 led by John Humphreys. My protagonist was the ever-amusing David Colquhoun (DC), who spent his short air-time complaining that the journal was even allowed to be published in the first place. You can learn all about DC care of Wikipedia – he seems to have a surprisingly long write up for someone whose profession career was devoted to single ion channels, perhaps because a significant section of the page is devoted to his activities as a quack-busting blogger. So why would BBC Radio 4 invite a retired basic scientist and professional sceptic blogger to be interviewed alongside one of the journal editors – a clinician with expertise in acupuncture (WMA)? At no point was it made manifest that only one of the two had ever been in a position to try to help parents with a baby that they think cries excessively. Of course there are a lot of potential causes of excessive crying, but I am sure DC would agree that it is unlikely to be attributable to a single ion channel…
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I encourage everyone to read Cummings post in full; it’s full of surprises. Here I just want to comment very briefly why I find his post disgraceful (the Cummings quotes are in bold followed by my comments):
….usual characters….. Disrespectful to the point of being derogatory, in my view
….retired professors….. Not true, non-retired professionals commented as well
….professional bloggers…. Meaning people who earn their income by blogging? Certainly not true!
….vocal critics of anything in the realm of complementary medicine…. Critic not of ‘anything’ but merely of things that are false or misleading like the trial in question
….a baying mob of fellow sceptics…. Unquestionably meant to be insulting and arguably libelous
….Deserving of being press released by virtue of being the largest to date in the field…. Large is not necessarily a virtue that merits a press-release, particularly, if it is not matched with quality
….We need to wait for an SR where the data from the 4 trials to date can be combined…. More than doubtful that we ‘need to wait’. The 4 trials in question are all very weak and therefore cannot provide a firm answer via a systematic review
….the ever-amusing David Colquhoun…. Derogatory to the extreme
….why would BBC Radio 4 invite a retired basic scientist and professional sceptic blogger…. The answer could be because he understands science and has vast experience exposing false claims
….only one of the two had ever been in a position to try to help parents with a baby that they think cries excessively…. This does not necessarily mean that such a person understands science, and Cummings might even be an example for this
….is unlikely to be attributable to a single ion channel…. Even Cummings’ attempts at humour are quite appalling.
The comments of Dr Mike Cummings MB ChB Dip Med Ac, I am afraid, befit an ill-educated acupuncturist who feels personally hurt because his views have been challenged and who is not quite bright enough to have a rational discussion about his favourite subject, particularly with someone who has a superior grasp of the issues at hand (which are clearly not ‘how to stick a needle in a baby’). However, Cummings is not a simple acupuncturist; he happens to be a member of the medical profession, a medical director of the British Medical Acupuncture Society and (as he seems keen to point out) a journal editor. With these credentials, he should, in my view, be able to argue a bit more intelligently, truthfully and a lot more gracefully.
Sad, really!
One could almost think he wants to give acupuncture a bad name!!!
Acupuncture is often recommended as a treatment for shoulder pain, but its effectiveness is far from proven. A new study has just been published; but does it change this uncertainty?
A total of 227 patients with subacromial pain syndrome were recruited to this RCT. The patients were allocated to three groups who received either A) group exercise, B) group exercise plus acupuncture or C) group exercise plus electro-acupuncture. The primary outcome measure was the Oxford Shoulder Score. Follow-up was post treatment, and at 6 and 12 months. Data were analysed on intention-to-treat principles with imputation of missing values.
Treatment groups were similar at baseline. All treatment groups demonstrated improvements over time. Between-group estimates were, however, small and non-significant.
The authors concluded that neither acupuncture nor electro-acupuncture were found to be more beneficial than exercise alone in the treatment of subacromial pain syndrome.
Well, that was to be expected!… I hear the rationalists amongst us exclaim.
Actually, I am not so sure.
One could easily have expected that the acupuncture groups (B and C) show a significant advantage over group A.
Why?
Because acupuncture is a ‘theatrical placebo’, a ritual that impresses patients and thus impacts on results, particularly on subjective outcomes like pain. If the results had shown a benefit for acupuncture + exercise (groups B and C) versus exercise alone (group A), what would we have made of it? Acupuncture fans would surely have claimed that it is evidence confirming acupuncture’s effectiveness. Sceptics, on the other hand, would have rightly insisted that it demonstrates nothing of the sort – it merely confirms that placebo effects can affect clinical outcomes such as pain.
As it turned out, however, this trial results happened to indicate that these placebo-effects can be so small that they fail to reach the level of statistical significance.
I think there is one noteworthy message here: RCTs with such a design (no adequate control for placebo effects) can easily generate false-positive results (in this case, this did not happen, but it was nevertheless a possible outcome). Such studies are popular but utterly useless: they don’t advance our knowledge one single iota. If that is so, we should not waste our resources on them because, in the final analysis, this is not ethical. In other words, we must stop funding research that has little or no chance of advancing our knowledge.
First she promoted vaginal steam baths and now Gwyneth Paltrow claims that putting a ball of jade (which you can order from her online-business, if you happen to have the cash) in their vaginas is good for women.
Yes, I kid you not; this is what she states on her website:
The strictly guarded secret of Chinese royalty in antiquity—queens and concubines used them to stay in shape for emperors—jade eggs harness the power of energy work, crystal healing, and a Kegel-like physical practice. Fans say regular use increases chi, orgasms, vaginal muscle tone, hormonal balance, and feminine energy in general. Shiva Rose has been practicing with them for about seven years, and raves about the results; we tried them, too, and were so convinced we put them into the goop shop. Jade eggs’ power to cleanse and clear make them ideal for detox…
But if you think that Gwyneth is somehow fixated on her feminine parts, you are probably mistaken. She is much more versatile than that and seems to employ her vagina merely for drumming up publicity for her business. If you browse her site, you find no end of baffling, vagina-unrelated wonders and purchasable products from the world of alternative medicine.
Here are just two further examples.
Flower remedies
A flower essence is a bioenergetic preparation. Through the use of sunlight and water, we are able to capture the energy of a flower and use it for healing purposes: A freshly harvested flower is placed on the surface of water for a specific length of time and exposed to sunlight, resulting in the vibrational imprint of the flower in water. The flower essence is then used as an energetic remedy, with each flower having its own range of unique therapeutic benefits.
Vibrational imprint?
Unique therapeutic benefit?
Pull the other one! The truth about (Bach) flower remedies is much simpler: they are expensive placebos.
A method for getting rid of the parasites we allegedly all suffer from
…an eight-day, mono-diet goat-milk cleanse—accompanied by a specific vermifuge made of anti-parasitic herbs—is the most successful treatment. Parasites primarily live in the mucus lining of the gut system, where they feed on nutrients before they enter the body. Think of the goat milk as bait—parasites come out of the gut lining to drink the milk, which they love, but they also consume the vermifuge, which will eventually eradicate them. On top of being highly effective, this method is a much more gentle medicine than bombarding them—and your body—with a harsh drug.
Are they for real?
This is pure and potentially very dangerous, unethical nonsense!
Oh sorry – I forgot: we now must call it differently now: we are obviously dealing with Gwyeneth’s ‘alternative facts’.
Why has homeopathy such a bad name?
Why have the most ardent defenders of homeopathy become the laughing stock of the science community?
Why is there, after >200 years., still no proof of homeopathy’s efficacy?
Why is there not more research into homeopathy?
Why is there not more money in homeopathy?
Why is there so much opposition to homeopathy?
Nothing to do, of course, with the fact that highly diluted homeopathic remedies are pure placebos. No, no, no! It is because BIG PHARMA is doing everything they can to supress homeopathy!!! They have no choice: if the good news about homeopathy would go any further, they would go bankrupt.
On this blog, we have heard such ludicrous notions regularly. Homeopaths seem to believe that, according homeopathy’s ‘like cures like’ principle, their ‘alternative facts’ can be converted into real facts.
The homeopathic industry tries very hard to keep the image of the poor little victim, while, in fact, it is not really much different from the pharmaceutical industry. This is, of course, what we have been pointing out repeatedly on this blog; yet somehow the message does not seem to get across to many homeopaths. Perhaps this excellent comment by Thomas Mohr (I don’t know who he is) might be more successful:
“…homeopathic companies work exactly like any other pharmaceutical company to the point that homeopathic companies can patent homeopathic drugs and do that. The reason why this is not extensively used in the field of homeopathy is not the impossibility, but the necessity to provide at least feasible examples of efficacy with the patent application – which fails in most cases.
If one looks at the balance of Boiron, one of the largest manufacturers of homeopathic drugs one notes that the profit is comparable, if not higher than any pharmaceutical company (e.g. Pfitzer, etc.) but research costs are one tenth. That means that homeopathic companies have a far lower risk to benefit ratio while yielding the same profit. The same time pharmaceutical companies have a high failure rate (e.g. substances screened to drugs marketable) whereas the failure rate of homeopathic companies is almost zero. I.o.W. investing into homeopathic companies is far safer than into pharmaceutical companies. No company would try to destroy a low risk : benefit concurrent. A company would try to purchase it. Why is that not done with homeopathic companies ? Because the market is very limited due to the ineffectiveness of the drugs.
The comment was prompted by an article of Dana Ullman entitled “Extreme Bias in FTC’s Ruling on Homeopathic Medicine” where he, yet again, displays his well-known biases and ignorance. There you can, if you want, read all the misconceptions and stupidities about homeopathy you ever need to know about. They include the firm anti-vaccination stance of deluded homeopaths, and the fact that Dana can never resist claiming that ‘the Swiss government’s “Health Technology Assessment” on homeopathic medicine is much more comprehensive than any previous governmental report written on this subject to date’ and – how could it be otherwise? – is sufficient proof that homeopathy works.
Personally, I also find certain temptations too difficult to resist – like citing the intriguing evidence on Ullman being called as an expert witness in a class action against a homeopathy vendor for misleading marketing claims. On this occasion, the judge stated:
The Defendant presented the testimony of Gregory Dana Ullman who is a homeopathic practitioner. He outlined the theory of homeopathic treatment and presented his opinion as to the value and effectiveness of homeopathic remedies. The Court found Mr. Ullman’s testimony to be not credible. Mr. Ullman’s bias in favor of homeopathy and against conventional medicine was readily apparent from his testimony. He admitted that he was not an impartial expert but rather is a passionate advocate of homeopathy. He posted on Twitter that he views conventional medicine as witchcraft. He opined that conventional medical science cannot be trusted.
[…]
Mr. Ullman’s testimony was unhelpful in understanding the purported efficacy of the ingredients of SnoreStop to reduce the symptoms of snoring. Although he is familiar with the theory of homeopathic treatment, his opinions regarding its effectiveness was unsupported and biased. The Court gave no weight to his testimony.(Rosendez v. Green Pharmaceuticals)
Ullman is a rich source of ‘alternative facts’. For the ral facts about homeopathy, however, I should direct you elsewhere (for instance, here) and, if I may, to my latest book.
*** another thing I cannot not resist is to use this new term (recently coined by the Trump team) to describe outright lies.
We all know that alternative medicine is currently popular, and much of the evidence suggested that this is mostly because mostly people in the midst of their lives are using it. This may be so, but it is about to change; it stands to reason that these ‘baby boomers’ are getting older, and therefore the typical user of alternative medicine is or will soon be an elderly person. In addition, the ‘oldies’ (I am one of them) are likely to be multi-morbid and therefore have more reason to try everything that is on offer.
Not convinced? But that is roughly is what this website seems to suggest:
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Geriatric population is more susceptible to chronic diseases such as heart problems, joint disorders and others. Therefore, this population group needs regular use of the medicines to prevent the disease conditions. The use of complementary and alternative medicines is increasing among the geriatric population globally due to the fact that CAMs decreases the risk of adverse reactions and drug interactions.
Complementary and alternative medicines include products such as dietary medicine and herbal medicine products. These medicines can be used for the management of both communicable (i.e. tuberculosis, hantavirus and others) and non communicable diseases (i.e. chronic kidney disease, cardiovascular and others) in geriatric population. These medicines (i.e. CAM) treat the patients by healing therapies which is not based on principles of conventional medicine.
Geographically, North America is considered as the largest market of geriatric complementary and alternative medicines owing to high use of CAMs in this region. For example, Health and Retirement Study conducted one survey which concluded that around 85% of the geriatric population in North America reported the use of complementary and alternative medicines. Thus, high use of CAM modalities will establish healthy platform to develop the growth of geriatric complementary and alternative medicines market.
Europe is the second largest market of geriatric complementary and alternative medicines. The growth is mainly attributed to the increasing aging population coupled with rising use of complementary and alternative medicines in Europe. According to European Commission (Eurostat) report published in 2013, around 17.8% of the European population were aged 65 years and above. The organization has also stated that aging population is expected to increase at high rate in coming year in Europe. In addition, Asia-Pacific is the emerging market for geriatric complementary and alternative medicines market because of rising interest of key companies to expand their presence in Asia Pacific.
Key companies operating in the market for geriatric complementary and alternative medicines include Geriatric & Medical Companies, Inc., Merck Sharp & Dohme Corporation. Geri-Care pharmaceuticals, UAS Laboratories.
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I know, this text includes several glaring errors. But the main claim that alternative medicine is fast becoming a thing for the elderly might well be true. This, of course, has implications for marketing, research, etc. For us on this blog it means that we need to find better ways to get through to people who are no spring chickens any longer.
The elderly have special needs and can be vulnerable in several ways. When they are ill, they need efficacious treatments. By and large, this excludes alternative therapies. The elderly may also be more susceptible to the risks of alternative medicine. Moreover, they are often not that affluent and might need to watch their expenses. Making them spend large amounts of cash on treatments that are ineffective is therefore a particularly unethical.
I think that messages like these might convince some elderly people to stop putting unreasonable hope in, and wasting their time/money on bogus therapies. But I am very keen to hear from my readers about further ideas how to curb the boom of alternative medicine in this age group.
Currently, we witness an unprecedented hype about the ALKALINE DIET. It seems to be everywhere: on TV, radio, in the dailies, magazines, books and the Internet. The diet is being promoted for an amazing array of conditions by a dazzling list of VIPs. To me this merely indicates that very important people have paid very little attention when it was explained to them how the body controls its pH. It seems that VIPs tend listen to stuff that is not only factually incorrect but potentially dangerous. (Perhaps ‘VIP’ stands for ‘very ignorant person’?) This website (one of millions on the subject) is as good an example as any for the level of misinformation that is currently out there:
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When a food is ingested, digested, and absorbed, each component of that food will present itself to the kidneys as either an acid-forming compound or a base-forming one. And when the sum total of all the acid-producing and the base-producing micro and macronutrients are tabulated, we’re left with a calculated acid-base load.
One common problem with most industrialized societies is that our diets produce what’s called a “low grade chronic metabolic acidosis.” This means we’re in a chronic state of high acidity. Since the body must, at all costs, operate at a stable pH, any dietary acid load ha to be neutralized by one of a number of homeostatic base-producing mechanisms. Although the pH of the body is maintained, many cells of the body will suffer.
A cancerous cell is acidic. If your body is in a constant state of over-acidification, it becomes impossible for healthy cells to regenerate. Cancer cells thrive in an overly acidic environment. By taking action to become more alkaline, you can make it more difficult for cancer cells to regenerate.
Eating an acid/alkaline balanced diet is the key to staying healthy. Understanding the pH of the foods that you eat is relative to the state of your body’s health.
The goal of the acid alkaline balance diet, also known as the alkaline diet and the alkaline ash diet, is to achieve an optimal balance between acid-forming and alkaline-forming foods. The anti cancer diet greatly reduces the strain on the body’s acid-detoxification systems.
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Personally, I don’t care a hoot whether VIPs eat this or any other diet. When it comes to claiming that the ALKALINE DIET can treat or prevent cancer (or other serious conditions) I do, however, get concerned. Such claims will almost inevitably prompt patients to give up their treatments in the hope that the diet will do the trick. In other words, such claims endanger the lives of patients, and I find this intolerable. Tragically, a recent case seems to demonstrate how real this danger is.
So, allow me to put the record straight: there is no evidence that the Alkaline Diet is effective for the prevention or treatment of any disease, particularly not cancer. For those who find this hard to believe (vis a vis the current hype, this would hardly be surprising), here is the evidence.
One systematic review concluded that despite the promotion of the alkaline diet and alkaline water by the media and salespeople, there is almost no actual research to either support or disprove these ideas. This systematic review of the literature revealed a lack of evidence for or against diet acid load and/or alkaline water for the initiation or treatment of cancer. Promotion of alkaline diet and alkaline water to the public for cancer prevention or treatment is not justified.
Another group of researchers evaluated the following diets: raw vegetables and fruits, alkaline diet, macrobiotics, Gerson’s regime, Budwig’s and low carbohydrate or ketogenic diet. They did not find clinical evidence supporting any of the diets. Furthermore, case reports and pre-clinical data point to the potential harm of some of these diets. The authors concluded that considering the lack of evidence of benefits from cancer diets and potential harm by malnutrition, oncologists should engage more in counselling cancer patients on such diets. Our recommendations could be helpful in this process.
So, yet again we are confronted with the fact that the media create attention, hype and misinformation with no real substance whatsoever. It is high time, I think, that journalists are reminded of their duty to report truthfully and responsibly!!!
Health journalists must be reminded of the undeniable fact that misinformation kills people.
The Committees of Advertising Practice (CAP) write and maintain the UK Advertising Codes, which are administered by the Advertising Standards Authority. On their website, the CAP recently published an updated advertising code for naturopathy. As we have regularly discussed the fact that the public is being frequently misled in this area, I consider the code important in the context of this blog. I therefore take the liberty of repeating it here – not least in the hope that this helps preventing misinformation in the future [the numbers in square brackets refer to me footnotes below].
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What is Naturopathy?
Naturopathy is a holistic [1] approach to healthcare that uses a combination of one or more different disciplines (for example herbal medicine or hydrotherapy) and a healthy lifestyle [2] in order to gain and maintain a healthy body [3].
What claims are likely to be acceptable?
The promotion of a healthy [4] lifestyle is likely to acceptable as are claims that go no further than those commonly accepted for healthy [4] eating, sleeping well, taking exercise and the like.
What claims are likely to be problematic?
The ASA and CAP have not yet been provided with evidence which demonstrates that Naturopathy can be used to treat medical conditions (Rule 12.1). Therefore, any claims that go beyond accepted claims for a healthy [4] lifestyle are likely to be problematic [5] unless they are supported by a robust body of evidence. In 2013, the ASA ruled against claims on a marketer’s website which said that Naturopathy could be used to treat acute and chronic illness and disease because the marketer had not provided any evidence in support of their claims (CNM The College of Naturopathic Medicine Ltd, 13 March 2013).
What about serious medical conditions?
Claims to offer treatment on conditions for which medical supervision should be sought [6] are likely to be considered to discourage essential treatment unless that treatment is carried out under the supervision of a suitably qualified health professional (Rule 12.2).
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Naturopathy has been the subject of my posts before – see for instance here, here, here, here and here. Naturopathy can be dangerous to the point where it can kill the patient – see for instance here and here. Therefore it is important that advertising gets regulated. To make it very clear: the above statement by the CAP is, in my view, a step in the right direction, and I encourage alternative practitioners to look up the equivalent CAP documents for their specific therapy.
Having said that, I still feel the need to make a few comments:
- It is misleading to call naturopathy ‘holistic’. This is often factually incorrect and also gives the impression that conventional medicine is not holistic – see also here.
- Are we sure that all lifestyles promoted by naturopaths are, in fact, healthy?
- Maintaining a healthy body is naturopathy speak for DISEASE PREVENTION. Who decides what is effective prevention? On what evidence? How come many naturopaths are against the most effective means of prevention of all times – vaccination?
- Who decides what is ‘healthy’? On what evidence?
- Why ‘problematic’? Are they not wrong or bogus or false or fraudulent or criminal?
- Are there conditions for which medical supervision should not be sought? Which are they?
Whenever a level-headed person discloses that a specific alternative therapy is not based on good evidence, you can bet your last shirt that a proponent of the said treatment responds by claiming that conventional medicine is not much better.
There are several variations to this theme. Today I want to focus on just one of them, namely the counter-claim that, only a short while ago, conventional medicine was not much better than the said alternative therapy (the implication is that it must be unfair to demand evidence from alternative medicine, while accepting a similar state of affairs in conventional medicine). The argument has recently been formulated by one commentator on this blog as follows:
“Trepanation, leeches for UTI’s, and bloodletting are all historical treatments of medical doctors…It’s hypocritical… to impute mainstream chiropractice to the profession’s beginnings and yet not admit that medicine’s founding and evolution was inbued with consistently scientific rigor.”
Sadly, some people seem to be convinced by such words, and this is why they are being repeated ad nauseam by interested parties. Yet the argument is fallacious for a range of reasons.
- Firstly, it is based on the classical ‘tu quoque’ fallacy (appeal to hypocrisy).
- Secondly – unless we happen to be historians – it is not the healthcare of the past that is relevant to our discussions. The question cannot be what this or that group of clinicians used to do; the question is HOW DO THEY TREAT THEIR PATIENTS TODAY?
As soon as we focus on this issue, it is impossible to deny that conventional medicine has made lots of progress and moved light years away from treatments such as trepanation, leeches, bloodletting and many others.
Why?
Why did we make such huge progress?
Because research showed that many of the traditional treatments were ineffective, unsafe and/or implausible (thus demonstrating that hundreds of years of experience – which alternative therapists rate so very highly – is of more than dubious value), and because we consequently developed and tested new therapies and subsequently used those treatments that passed these tests and were proven to do more good than harm.
By contrast, in the last decades, centuries and millennia, homeopathy, chiropractic, acupuncture, paranormal healing etc. did make no (or very little) progress. So much so that Hahnemann, for instance, would pass any exam for homeopathy today. (If you disagree with this statement, please post a list of those treatments that have been given up by alternative therapists in the last 100 years or so.) Come to think of it, it is a hallmark of alternative medicine that it does not progress in the way conventional medicine does. It is almost completely static, a fact, that renders it akin to a dogma or a cult.
But why? Why is there no real progress in alternative medicine?
Don’t tell me that there is no research, research funding, etc. There are now hundreds of studies of homeopathy or chiropractic, thousands of acupuncture, and dozens of paranormal healing, for instance. The trouble is not the paucity of such research but its findings! The totality of the evidence in each of these areas fails to show that the therapy in question is efficacious.
And there we have, I think, another hallmark of alternative medicine: it is an area where research is only acted upon, if its findings are in line with the preconceptions and aspirations of its proponents.
I find this interesting!
It means, amongst other things, that research into alternative medicine tends not to be used for finding the truth or establishing new knowledge; it is mainly employed for the promotion of the therapy in question, regardless of what the truth about it might be (this would disqualify this exercise from being research and qualify it as PSEUDO-RESEARCH). If the research findings are such that they cannot be used for promotion, they are simply ignored or defamed as inadequate.
This new RCT was embargoed until today; so, I had to wait until I was able to publish my comments. Here are the essentials of the study:
The Swedish investigators compared the effect of two types of acupuncture versus no acupuncture in infants with colic in public child health centres (CHCs). The study was designed as a multicentre, randomised controlled, single-blind, three-armed trial (ACU-COL) comparing two styles of acupuncture with no acupuncture, as an adjunct to standard care. Among 426 infants whose parents sought help for colic and registered their child’s fussing/crying in a diary, 157 fulfilled the criteria for colic and 147 started the intervention.
Parallel to usual care, study participants visited the study CHC twice a week for 2 weeks. Thus, all infants received usual care plus 4 extra visits to a CHC, during which parents met a nurse for 20–30 min and were able to discuss their infant’s symptoms. Together these were considered to represent gold standard care. The nurse listened, and gave evidence-based advice and calming reassurance. Breastfeeding mothers were encouraged to continue breastfeeding. At each visit, the study nurse carried the infant to a separate treatment room where they were left alone with the acupuncturist for 5 min.
The acupuncturist treated the baby according to group allocation and recorded the treatment procedures and any adverse events. Disposable stainless steel 0.20×13 mm Vinco needles (Helio, Jiangsu Province, China) were used. Infants allocated to group A received standardised MA at LI4. One needle was inserted to a depth of approximately 3 mm unilaterally for 2–5 s and then withdrawn without stimulation. Infants allocated to group B received semi-standardised individualised acupuncture, mimicking clinical TCM practice. Following a manual, the acupuncturists were able to choose one point, or any combination of Sifeng, LI4 and ST36, depending on the infant’s symptoms, as reported in the diary. A maximum of five insertions were allowed per treatment. Needling at Sifeng consisted of 4 insertions, each to a depth of approximately 1 mm for 1 s. At LI4 and ST36, needles were inserted to a depth of approximately 3 mm, uni- or bilaterally. Needles could be retained for 30 seconds. De qi was not sought, therefore stimulation was similarly minimal in groups A and B. Infants in group C spent 5 min alone with the acupuncturist without receiving acupuncture.
The effect of the two types of acupuncture was similar and both were superior to gold standard care alone. Relative to baseline, there was a greater relative reduction in time spent crying and colicky crying by the second intervention week (p=0.050) and follow-up period (p=0.031), respectively, in infants receiving either type of acupuncture. More infants receiving acupuncture cried <3 hours/day, and thereby no longer fulfilled criteria for colic, in the first (p=0.040) and second (p=0.006) intervention weeks. No serious adverse events were reported.
The authors concluded that acupuncture appears to reduce crying in infants with colic safely.
Notice that the investigators are cautious and state in the abstract that “acupuncture appears to reduce crying…” Their conclusions from the actual article are, however, quite different; here they state the following:
Among those initially experiencing excessive infant crying, the majority of parents reported normal values once the infant’s crying had been evaluated in a diary and a diet free of cow’s milk had been introduced. Therefore, objective measurement of crying and exclusion of cow’s milk protein are recommended as first steps, to avoid unnecessary treatment. For those infants that continue to cry >3 hours/day, acupuncture may be an effective treatment option. The two styles of MA tested in ACU-COL had similar effects; both reduced crying in infants with colic and had no serious side effects. However, there is a need for further research to find the optimal needling locations, stimulation and treatment intervals.
Such phraseology is much more assertive and seems to assume acupuncture caused specific therapeutic effects. Yet, I think, this assumption is not warranted.
In fact, I believe, the study shows almost the opposite of what the authors conclude. Both minimal and TCM acupuncture seemed to reduce the symptoms of colic compared to no acupuncture at all. I think, this confirms previous research showing that acupuncture is a ‘theatrical placebo’. The study was designed without an adequate placebo group. It would have been easy to use some form of sham acupuncture in the control group. Why did the authors not do that? Heaven knows, but one might speculate that they were aiming for a positive result – and what better way to ensure it than with a ‘no treatment’ control group?
There are, of course, numerous other flaws. For instance, Prof David Colquhoun FRS, Professor of Pharmacology at University College London, criticised the study because of its lousy statistics:
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“It is truly astonishing that, in the 21st century, the BMJ still publishes a journal devoted to a form of pre-scientific medicine which after more than 3000 trials has still not been able to produce convincing evidence of efficacy1. Like most forms of alternative medicine, acupuncture has been advocated for a vast range of problems, and there is little evidence that it works for any of them. Colic has not been prominent in these claims. What parent would think that sticking needles into their baby would stop it crying? The idea sounds bizarre. It is. This paper certainly doesn’t show that it works.
“The statistical analysis in the paper is incompetent. This should have been detected by the referees, but wasn’t. For a start, the opening statement, ‘A two-sided P value ≤0.05 was considered statistically significant’ is simply unacceptable in the light of all recent work about reproducibility. Still worse, Table 1 uses the description ‘statistical tendency towards significance (p=0.051–0.1)’.
“Worst of all, Table 1 reports 24 different P values, of which three are (just) below 0.05. Yet no correction has been used for multiple comparisons. This is very bad practice. It’s highly unlikely that, if the proper correction had been done, any of the results would have given a type 1 error rate below 5%.
“Even were it not for this, most of the ‘significant’ P values are marginal (only slightly less than 0.05). It is now well known that the type 1 error rate gives an optimistic view. What matters is the false positive rate – the chance that a ‘significant’ result is a false positive. A p-value close to 0.05 implies that there is at least a 30% chance that they are false positives. If one thought, a priori, that the chance of colic being cured by sticking needles into a baby was less than 50%, the false positive rate could easily be greater than 80%2. It is now recognised that this misinterpretation of p-values is a major contributor to the crisis of reproducibility.
“Other problems concern the power calculation. A priori calculations of power are well-known to be overoptimistic, because small trials usually overestimate the effect size. In this case the initial estimated sample size was not attained, and a rather mysterious recalculation of power was used.
“Another small problem: the discussion points out that ‘the majority of infants in this cohort did not have colic’.
“The nature of the control group is not very clear. An appropriate control might have been to cuddle the baby – this was used in a study in which another implausible treatment, chiropractic, was shown not to work. This appears not to have been done.
“Lastly, p-values are reported in the text without mention of effect sizes. This is contrary to all statistical advice.
“In conclusion, the design of the trial is reasonable (apart from the control group) but the statistical analysis is appalling. It’s very likely that there aren’t any real effects of acupuncture at all. This paper serves more to muddy the waters than to add useful information. It’s a model for the sort of mistakes that have led to the crisis in reproducibility. The BMJ should not be publishing this sort of stuff, and the referees seem to have no understanding of statistics.”
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Despite these rather obvious – some would say fatal – flaws, the editor of ACUPUNCTURE IN MEDICINE (AIM) thought this trial to be so impressively rigorous that he issued a press-release about it. This, I think, is particularly telling, perhaps even humorous: it shows what kind of a journal AIM is, and also provides an insight into the state of acupuncture research in general.
The long and short of it is that conclusions about specific therapeutic effects of acupuncture are not permissible. We know that colicky babies respond even to minimal attention, and this trial confirms that even a little additional TLC in the form of acupuncture will generate an effect. The observed outcome is most likely unrelated to acupuncture.
