Acupuncture is often recommended for relieving symptoms of fibromyalgia syndrome (FMS). The aim of this systematic review was to ascertain whether verum acupuncture is more effective than sham acupuncture in FMS.
Ten RCTs with a total of 690 participants were eligible, and 8 RCTs were eventually included in the meta-analysis. Its results showed a sizable effect of verum acupuncture compared with sham acupuncture on pain relief, improving sleep quality and reforming general status. Its effect on fatigue was insignificant. When compared with a combination of simulation and improper location of needling, the effect of verum acupuncture for pain relief was the most obvious.
The authors concluded that verum acupuncture is more effective than sham acupuncture for pain relief, improving sleep quality, and reforming general status in FMS posttreatment. However, evidence that it reduces fatigue was not found.
I have a much more plausible conclusion for these findings: in (de-randomised) trials comparing real and sham acupuncture, patients are regularly de-blinded and therapists are invariably not blind. The resulting bias and not the alleged effectiveness of acupuncture explains the outcome.
And why do I think that this conclusion is much more plausible?
Firstly, because of Occam’s Razor.
Secondly, because this is roughly what my own systematic review of the subject found (The notion that acupuncture is an effective symptomatic treatment for fibromyaligia is not supported by the results from rigorous clinical trials. On the basis of this evidence, acupuncture cannot be recommended for fibromyalgia). This view is also shared by other critical reviews of the evidence (Current literature does not support the routine use of acupuncture for improving pain or quality of life in FM). Perhaps more crucially, the current Cochrane review seems to concur: There is low to moderate-level evidence that compared with no treatment and standard therapy, acupuncture improves pain and stiffness in people with fibromyalgia. There is moderate-level evidence that the effect of acupuncture does not differ from sham acupuncture in reducing pain or fatigue, or improving sleep or global well-being. EA is probably better than MA for pain and stiffness reduction and improvement of global well-being, sleep and fatigue. The effect lasts up to one month, but is not maintained at six months follow-up. MA probably does not improve pain or physical functioning. Acupuncture appears safe. People with fibromyalgia may consider using EA alone or with exercise and medication. The small sample size, scarcity of studies for each comparison, lack of an ideal sham acupuncture weaken the level of evidence and its clinical implications. Larger studies are warranted.
I have met many acupuncturists who think that homeopathy is bunk. Similarly, I have met many homeopaths who are convinced that acupuncture is a placebo therapy. And, I have met some (not many) practitioners of so-called alternative medicine (SCAM) who think so highly of both SCAMs that they combine the two into one handy treatment: HOMEOPUNCTURE.
I had almost forgotten (or is supressed the correct verb?) but, to be entirely truthful, a long time ago (in the mid 1970s), I even experimented with this odd therapy myself. When I worked as a junior doctor in a homeopathic hospital, several of my collegues practised homeopuncture and taught me how to do it. Essentially, you inject homeopathic remedies into acupuncture points. My colleagues told me that this approach is more powerful than each method alone. I tried it several times but remained unconvinced.
Recently, a German Heilpraktiker (Andreas Maier), reminded me of all this. Here is what he states on his website about homeopuncture:
In traditional Chinese medicine, acupuncture in addition to the herb medicine as well as certain movement therapies (eg. B. Gong Qi) constituting an important element in the treatment of diseases.
By stimulating energy points with the help of fine needles will then attempts to harmonize the flow of vital energy. a disruption of vital energy because (also called Qi), is considered in Chinese medicine as a cause of any disease.
Only when the energy flows freely through all the tissues and organs of the body, the organism can develop normally and is healthy. A similar approach is also the Homeopathy, which originated at the other end of the world, namely in Germany.
Samuel Hahnemann (1755 – 1843), the discoverer of this method of healing, also saw a failure of the life force as a pathogenic factor.
By smallest stimuli the homeopath tries to eliminate these disease-causing disorder and bring about healing. Unlike in the acupuncture reduced drug doses to be used strictly in accordance with the principle of similarity are selected.
Mid-19th century was the German physician Dr. August consecration firmly (1840- 1896) that disease with painful spots may accompany the body.
These pain points are often far from the actual disease process. The phenomenon was known to the Chinese for thousands of years in Europe, however, no one had yet busy. Dr. Weihe, himself a keen homeopath, was in the treatment of his patients finally see that by the suitably chosen homeopathic healed not only the disease, but also disappeared the painfulness of the points.
It was surprising that certain homeopathic remedies appear to be well-defined points had a direct bearing on the body.
A few years later, the Chinese medicine and acupuncture also reached the European continent, they took Weihe discoveries closer look. A comparison of the so-called consecration points with acupuncture points showed significant matches.
The more than 300 known Weihe points are also used therapeutically since both diagnosis. Because they can provide information on the pathological processes in the body and on the displayed homeopathic. thus the Homöopunktur brings together the findings from Chinese medicine and homeopathy. The treatment can be done differently.
On the one hand the consecration points can be traditionally stimulated with fine needles, concomitant administration of homeopathic medicine. With the help of injection preparations, means may also be injected directly to the point.
(sorry about my friend’s poor English; I hope you could make sense of it)
I don’t think I need to tell you what the evidence tells us about homeopuncture. Yes, you guessed it: nothing! But the idea of combining SCAMs is fascinating nevertheless. So, let me suggest a few further SCAM combinations that might be attractive:
- acupuncture + massage (sorry, that already exists under the name of shiatsu)
- colonic irrigation + coffea (that to is already taken by the Gerson guys)
- art therapy + homeopathy (too late: this one too already exists; painting homeopathy on the body surface)
- detox + meditation (no, the health retreat/wellness entrepreneurs might get upset)
I am clearly not very successful at finding viable SCAM combinations. Let’s look for something innovative, something that nobody has yet thought of. How about:
- homeo-laugh (homeopathy followed by an explanation what homeopathy is resulting in laughter; not sure that this would sell all that well)
- kinesiology colour taping (instead of using random colours for kinesiology tape, this approach uses the wisdom of coulourtherapists to match the patient’s individual colour requirements; this means the therapists needs dual qualifications and can thus charge double – I think that might be attractive!)
- autologous slapping therapy (this combination of slapping and autologous blood therapy (ABT) means the therapist has to hit so hard that the patient develops sizable haematomas which are the ABT part of the intervention; perhaps a bit risky, as some patients might call the police)
- effective reverse energy transfer counselling, ERETC (the patients is counselled that his money can, with the help of the therapist, be converted into pure healing energy; to make it work, the patient needs to transfer it to the account of the therapist – the more the better)
I think I like ERECT best; in fact, I will start work on it straight away. It still needs to be perfected, but once it’s up and running, it will be just great and, as the name already makes clear, effective – not for the patient, but for the therapist!
I live (most of my time) in the UK, a country where the media interest in so-called alternative medicine (SCAM) is considerable. Years ago, the UK press used to be very much in favour of SCAM. In 2000, we showed that the level of interest was huge and the reporting was biased. Here is our short BMJ paper on the subject:
The media strongly influences the public’s view of medical matters.1 Thus, we sought to determine the frequency and tone of reporting on medical topics in daily newspapers in the United Kingdom and Germany. The following eight newspapers were scanned for medical articles on eight randomly chosen working days in the summer of 1999: the Times, the Independent, the Daily Telegraph, and the Guardian in the United Kingdom, and Frankfurter Allgemeine Zeitung, Süddeutsche Zeitung, Frankfurter Rundschau, and Die Welt in Germany. All articles relating to medical topics were extracted and categorised according to subject, length, and tone of article (critical, positive, or neutral).
A total of 256 newspaper articles were evaluated. The results of our analysis are summarised in the table. We identified 80 articles in the German newspapers and 176 in the British; thus, British newspapers seem to report on medical topics more than twice as often as German broadsheets. Articles in German papers are on average considerably longer and take a positive attitude more often than British ones. Drug treatment was the medical topic most frequently discussed in both countries (51 articles (64%) in German newspapers and 97 (55%) in British). Surgery was the second most commonly discussed medical topic in the UK newspapers (32 articles; 18%). In Germany professional politics was the second most commonly discussed topic (11 articles; 14%); this category included articles about the standing of the medical profession, health care, and social and economic systems—that is, issues not strictly about treating patients.
Because our particular interest is in complementary medicine, we also calculated the number of articles on this subject. We identified four articles in the German newspapers and 26 in the UK newspapers. In the United Kingdom the tone of these articles was unanimously positive (100%) whereas most (3; 75%) of the German articles on complementary medicine were critical.
This analysis is, of course, limited by its small sample size, the short observation period, and the subjectivity of some of the end points. Yet it does suggest that, compared with German newspapers, British newspapers report more frequently on medical matters and generally have a more critical attitude (table). German newspapers frequently discuss medical professional politics, a subject that is almost totally absent from newspapers in the United Kingdom.
The proportion of articles about complementary medicine seems to be considerably larger in the United Kingdom (15% v 5%), and, in contrast to articles on medical matters in general, reporting on complementary medicine in the United Kingdom is overwhelmingly positive. In view of the fact that both healthcare professionals and the general public gain their knowledge of complementary medicine predominantly from the media, these findings may be important.2,3
Reporting on medical topics by daily newspapers in the United Kingdom and Germany, 1999
|United Kingdom (n=176)||Germany (n=80)|
|Mean No articles/day||5.5||2.5|
|Mean (SD) No words/article||130 (26)||325 (41)|
|Ratio of positive articles to critical articles*||1.0||3.2|
Even though I have no new data on this, my impression is that things have since changed. It seems that the UK press has become more objective and are now reporting more critical comments on SCAM. While this is most welcome, of course, one feature is still deplorable, in my view: journalists’ obsession with ‘balance’.
A recent example might explain this best. The ‘i’ newspaper published an article about homeopathy which was well-written and thoroughly researched. It explained the current best evidence on the subject and made it quite clear why homeopathy is not a reasonable therapy for any condition. But then, towards the end of the article, the journalist added this section:
Dr Lise Hansen, a veterinary homeopath based in London and author of a forthcoming book, The Complete Book of Cat and Dog Health, argues that scientists have shown how homeopathy works. She cites a paper by Luc Montagnier, the French virologist who won a Nobel Prize in 2008 for his role in discovering HIV. The following year, he published evidence of his discovery of “electromagnet signals that are produced by nanostructures derived from bacterial DNA at high aqueous dilutions”. “Mainstream medicine is about chemistry, homeopathy is physics and scientists have only recently begun to study these nanostructures,” Hansen says.
Basically, the reader is left with the impression that homeopathy might be fine after all, and that science will soon be able to catch up with it. In the interest of balance, the journalist thus confused her readers and misled the public.
Journalists are obviously taught to always cover ‘both sides’ of their stories, and they adhere to this dogma no matter what. In most instances, this works out well, because in most cases there are two sides.
But not always!
When there is a strong consensus supported by facts, science and reproducible findings, the other side ceases to have a reasonable point. There simply is no reasonable ‘other side’ when we consider global warming, evolution, the Holocaust, and many other subjects. Of course, one can always find some loon who claims the earth is flat, or that cancer is a Jewish plot against public health. But these arguments lack reason and integrity – to dish them out without anything remotely resembling a ‘fact check’ is not just annoying but harmful.
Journalists should, in my view, be more responsible, check the facts, and avoid false balance. I know this will often entail much more work, but they owe it to their readers and to the reputation of their profession.
I am not usually a vulgar person, and I do apologise for the title of this post. But, in view of todays’ subject, some vulgarity seems almost unavoidable. This post is about homeopathic provings. In my book, I explain them in some detail:
The term ‘proving’ is a mis-translation of Hahnemann’s term ‘Pruefung’ which means ‘a test’. The English term wrongly implies that some fact is being proven. According to the International Dictionary of Homeopathy, provings (also known as ‘homeopathic pathogenetic trials’ or ‘Arzneimittelpruefung’ as Hahnemann called them), are defined as the process of determining the medicinal properties of a substance; testing in material dose, mother tincture or potency, by administration to healthy volunteers, to elicit effects from which the therapeutic potential, or material medica of the substance may be derived.
In order to individualise their treatment according to the ‘like cures like’ principle, homeopaths need to know what symptoms, or ‘artificial disease’, can be caused by the substances they prescribe. If they treat a patient who suffers from running eyes and nose, for instance, they would be looking for a substance that causes runny eyes and nose in healthy individuals. This is why remedies based on onion might be used to treat conditions like the common cold or hay fever.
But most patients’ complaints are usually a lot more complex. For instance, a person might suffer from frequently runny eyes and nose together with a whole host of other symptoms, many of which might seem trivial or irrelevant to conventional doctors but, for a homeopath, all complaints and patient characteristics are potentially important.
The first proving in the history of homeopathy was Hahnemann’s quinine experiment, which convinced him that he had discovered that this malaria cure causes the symptoms of malaria when taken by a healthy individual. From this observation he deduced that any substance causing symptoms in a healthy person could be used to cure these same symptoms when they occur in a patient.
Provings are normally conducted by administering a mother tincture or a low potency to healthy volunteers who subsequently note in minute detail all sensations, symptoms, emotions and thoughts that occur to them while taking it. These are then carefully registered and eventually form the ‘drug picture’ of that substance.
As a day goes by, we all experience, of course, all sorts of sensations without apparent reason, whether we have taken a medicine or not. Therefore, simple provings are not reliable and might not describe the specific symptoms caused by the substance in question. Realising this problem, most homeopaths now advocate conducting provings in a placebo-controlled manner hoping that this method might generate only symptoms which are specific to the tested substance.
Today thousands of provings have been carried out; most of them are of very low methodological quality. Their results have been published in reference books called ‘repertories’. Homeopaths, once they have noted the full range of characteristics of a patient, can look up the optimal remedy for each individual case. To ease this process even further, sophisticated computer programs are available.
So, essentially, homeopathic provings are experiments where homeopaths give a (often highly diluted/potentised) substance to healthy volunteers and ask them to monitor all sensations that follow. These symptoms are then recorded and eventually form the ‘drug picture’ of a homeopathic remedy. When prescribing a remedy, homeopaths essentially try to match the patient’s symptoms with the drug picture. This is why provings and drug pictures are so very important to classical homeopaths.
Now, imagine that you have just swallowed a substance and start paying attention to all the sensations you feel. As I am writing these lines, I would note all of the following:
- mild mental irritation,
- neck pain,
- back pain,
- heavy feet,
- hot feet,
- slight ringing in right ear,
- pressure on abdomen,
- tickling nose,
- sweaty hands,
- acid taste in mouth,
- need to pass urine,
- feeling of need to wash hands,
- itchy scalp,
- acidity in stomach,
- itch over right eyebrow.
These are just some of the sensations that come and go with everyday life; they are devoid of any medical meaning or importance. In homeopathy, however, they are elevated to something of fundamental relevance. As I have just had a cup of coffee, the above list could even be seen as a proving of coffea and a contribution to its drug picture. In turn, this would then determine how homeopaths prescribe homeopathic coffea. If others generated similar symptoms after coffee, some of the symptoms listed above might become the part of the accepted drug picture of coffea.
Many of the homeopathic provings are indeed based on little more than that. Modern provings are often conducted a little more rigorously, but there are tens of thousands of different remedies and the drug pictures of many are hardly different from my above-described proving of coffea. If you find this hard to believe, see what two homeopaths noted during a homeopathic proving of another remedy:
Domination and abuse are so intense that they lead to total suppression of oneself. The person develops intense hatred towards the dominant person, as though they are being tortured. The intensity of the suppressed emotions produces other emotional, mental and physical symptoms: suicidal thoughts, aversion to company, panic attacks with lot of anxiety, low self confidence, arrested mental development, heart palpitations with anxiety, indisposed to talk, aversion to work, compulsive disorder of work, etc.
Low self-esteem and low self-confidence are associated with dependency and fear of failure.There is intense fear of failure and inadequacy, which leads to complete helplessness. This remedy also has aversion to self and a low self image. In this remedy, there are dreams/ thoughts of toilets.
Other symptoms include:
- Ailments from sexual abuse and rape
- Mind; colors; charmed by; golden/ colors; desires; golden
- Delusion or image that body parts/ arms/ legs are smaller, and shortened
- Dreams lascivious/ seduction/ necked people/ prostitution/ violent sex; Dreams; lascivious, voluptuous; partner, frequent change of/ voluptuous; perverse; girls, about little)
- Dreams of dogs/ cats, felines
- Fastidious; appearance, about; personal
- Music; desires; drums
Believe it or not, the above text is taken from a published proving of excrementum canium – yes: dog shit!
This leads me to conclude that homeopathic provings (and, as provings are the basis for all homeopathy, with it the entire field of homeopathy) are BS.
Controlled clinical trials are methods for testing whether a treatment works better than whatever the control group is treated with (placebo, a standard therapy, or nothing at all). In order to minimise bias, they ought to be randomised. This means that the allocation of patients to the experimental and the control group must not be by choice but by chance. In the simplest case, a coin might be thrown – heads would signal one, tails the other group.
In so-called alternative medicine (SCAM) where preferences and expectations tend to be powerful, randomisation is particularly important. Without randomisation, the preference of patients for one or the other group would have considerable influence on the result. An ineffective therapy might thus appear to be effective in a biased study. The randomised clinical trial (RCT) is therefore seen as a ‘gold standard’ test of effectiveness, and most researchers of SCAM have realised that they ought to produce such evidence, if they want to be taken seriously.
But, knowingly or not, they often fool the system. There are many ways to conduct RCTs that are only seemingly rigorous but, in fact, are mere tricks to make an ineffective SCAM look effective. On this blog, I have often mentioned the A+B versus B study design which can achieve exactly that. Today, I want to discuss another way in which SCAM researchers can fool us (and even themselves) with seemingly rigorous studies: the de-randomised clinical trial (dRCT).
The trick is to use random allocation to the two study groups as described above; this means the researcher can proudly and honestly present his study as an RCT with all the kudos these three letters seem to afford. And subsequent to this randomisation process, the SCAM researcher simply de-randomises the two groups.
To understand how this is done, we need first to be clear about the purpose of randomisation. If done well, it generates two groups of patients that are similar in all factors that might impact on the results of the study. Perhaps the most obvious factor is disease severity; one could easily use other methods to make sure that both groups of an RCT are equally severely ill. But there are many other factors which we cannot always quantify or even know about. By using randomisation, we make sure that there is an similar distribution of ALL of them in the two study groups, even those factors we are not even aware of.
De-randomisation is thus a process whereby the two previously similar groups are made to differ in terms of any factor that impacts on the results of the trial. In SCAM, this is often surprisingly simple.
Let’s use a concrete example. For our study of spiritual healing, the 5 healers had opted during the planning period of the study to treat both the experimental group and the control group. In the experimental group, they wanted to use their full healing power, while in the control group they would not employ it (switch it off, so to speak). It was clear to me that this was likely to lead to de-randomisation: the healers would have (inadvertently or deliberately) behaved differently towards the two groups of patients. Before and during the therapy, they would have raised the expectation of the verum group (via verbal and non-verbal communication), while sending out the opposite signals to the control group. Thus the two previously equal groups would have become unequal in terms of their expectation. And who can deny that expectation is a major determinant of the outcome? Or who can deny that experienced clinicians can manipulate their patients’ expectation?
For our healing study, we therefore chose a different design and did all we could to keep the two groups comparable. Its findings thus turned out to show that healing is not more effective than placebo (It was concluded that a specific effect of face-to-face or distant healing on chronic pain could not be demonstrated over eight treatment sessions in these patients.). Had we not taken these precautions, I am sure the results would have been very different.
In RCTs of some SCAMs, this de-randomisation is difficult to avoid. Think of acupuncture, for instance. Even when using sham needles that do not penetrate the skin, the therapist is aware of the group allocation. Hoping to prove that his beloved acupuncture can be proven to work, acupuncturists will almost automatically de-randomise their patients before and during the therapy in the way described above. This is, I think, the main reason why some of the acupuncture RCTs using non-penetrating sham devices or similar sham-acupuncture methods suggest that acupuncture is more than a placebo therapy. Similar arguments also apply to many other SCAMs, including for instance chiropractic.
There are several ways of minimising this de-randomisation phenomenon. But the only sure way to avoid this de-randomisation is to blind not just the patient but also the therapists (and to check whether both remained blind throughout the study). And that is often not possible or exceedingly difficult in trials of SCAM. Therefore, I suggest we should always keep de-randomisation in mind. Whenever we are confronted with an RCT that suggest a result that is less than plausible, de-randomisation might be a possible explanation.
Autologous whole blood (AWB) therapy is a treatment where a patients blood is first drawn from a vein and then (unmodified or treated in various bizarre ways) reinjected intra-muscularly. This sounds barmy, not least because there is no remotely plausible mode of action. Nonetheless, the therapy is popular in some countries (like Germany, where it is practised by many doctors and Heilpraktikers) and recommended for all sorts of illnesses, particularly for strengthening the immune system and fend off infections.
I have personally used it quite a bit and even conducted the first but very small double-blind, placebo-controlled RCT of AWB therapy which showed promising results. Now two systematic reviews of AWB therapy have become available almost simultaneously.
The first systematic review included our plus 7 more clinical studies. The authors included all prospective controlled trials concerning intra-muscular AWB therapy with the exception of trials using oxygenated, UV radiated or heated blood. Information was extracted on the indication, design, additions to AWB and outcome. Full texts were screened for information about the effector mechanisms.
Eight trials met their inclusion criteria. In three controlled trials with patients suffering from atopic dermatitis and urticaria, AWB therapy showed beneficial effects. In five randomized controlled trials (RCTs), two of which concerned respiratory tract infections, two urticaria and one ankylosing spondylitis, no efficacy could be found. A quantitative assessment was not possible due to the heterogeneity of the included studies. The authors found only 4 controlled trials with sample sizes bigger than 37 individuals per group. Only one study investigated the effector mechanisms of AWB.
The German authors concluded that there is some evidence for efficacy of AWB therapy in urticaria patients and patients with atopic eczema. Firm conclusions can, however, not be drawn. We see a great need for further RCTs with adequate sample sizes and for investigation of the effector mechanisms of AWB therapy.
The second systematic review had a slightly different focus in that it assessed AWB therapy as well as autologous serum therapy (AST) for patients suffering from chronic spontaneous urticaria (CSU). Its authors managed to include 8 clinical trials. AST was not more effective than the placebo treatment in alleviating CSU symptoms at the end of treatment (p = .161), and AWB injection was also not more effective in response rates than the placebo at the end of follow-up (p = .099). Furthermore, the efficacy of AST or AWB injection for CSU and the ASST status were not significantly related. No remarkable adverse events were recorded during therapy.
The Taiwanese authors concluded that their meta-analysis suggested that AWB therapy and AST are not significantly more effective in alleviating CSU symptoms than the placebo treatment.
These somewhat contradictory conclusions will confuse most readers. Personally, I think that caution is well-justified. The trials are mostly flawed, and even our positive study (which received the highest possible quality marks by the authors of the first review) can in no way be definitive, because it was far too small for allowing firm conclusions.
Yet, despite all this, I do think that AWB therapy merits further study.
On Twitter, I recently found this remarkable advertisement:
Naturally, it interested me. The implication seemed to be that we can boost our immune system and thus protect ourselves from colds, the flu and other infections by using this supplement. With the flu season approaching, this might be important. On the other hand, the supplement might be unsafe for many other patients. As I had done a bit of research in this area, I needed to know more.
According to the manufacturer’s information sheet, Viracid
- Provides Support for Immune Challenges
- Strengthens Immune Function
- Maintains Normal Inflammatory Balance
The manufacurer furthermore states the following:
Our body’s immune system is a complex and dynamic defense system that comes to our rescue at the first sign of exposure to an outside invader. The dynamic nature of the immune system means that all factors that affect health need to be addressed in order for it to function at peak performance. The immune system is very sensitive to nutrient deficiencies. While vitamin deficiencies can compromise the immune system, consuming immune enhancing nutrients and botanicals can support and strengthen your body’s immune response. Viracid’s synergistic formula significantly boosts immune cell function including antibody response, natural killer (NK) cell activity, thymus hormone secretions, and T-cell activation. Viracid also helps soothe throat irritations and nasal secretions, and maintains normal inflammatory balance by increasing antioxidant levels throughout the body.
This sounds impressive. Viracid could thus play an important role in keeping us healthy. It could also be contra-indicated to lots of patients who suffer from autoimmune and other conditions. In any case, it is worth having a closer look at this dietary supplement. The ingredients of the product include:
- Vitamin A,
- Vitamin C,
- Vitamin B12,
- Pantothenic Acid,
- L-Lysine Hydrochloride,
- Echinacea purpurea Extract,
- Acerola Fruit,
- Andrographis paniculata,
- European Elder,
- Berry Extract,
- Astragalus membranaceus Root Extract
Next, I conducted several literature searches. Here is what I did NOT find:
- any clinical trial of Viracid,
- any indication that its ingredients work synergistically,
- any proof of Viracid inducing an antibody response,
- or enhancing natural killer (NK) cell activity,
- or thymus hormone secretions,
- or T-cell activation,
- or soothing throat irritations,
- or controlling nasal secretions,
- or maintaining normal inflammatory balance,
- any mention of contra-indications,
- any reliable information about the risks of taking Viracid.
There are, of course, two explanations for this void of information. Either I did not search well enough, or the claims that are being made for Viracid by the manufacturer are unsubstantiated and therefore bogus.
Which of the two explanations apply?
Please, someone – preferably the manufacturer – tell me.
I recently saw a tweet by a German homeopath stating that ‘homeopathy is 100% experienced based medicine’. It made me think and realise that there is not just one EBM, there are, in fact, at least three EBMs!
- Experience based medicine
- Eminence based medicine
- Evidence based medicine
I will start with the type which I encountered first when studying medicine all those years ago.
EMINENCE BASED MEDICINE
German healthcare was at the time – 1970s – deeply steeped in this variety of EBM. What the professor said was right, and there was no discussion about it. I don’t even know how my teachers would have reacted, if we had challenged their wisdom, because nobody ever did; it just did not occur to us.
Personally, I never got along too well with this type of EBM. I found it stifling, and this feeling might have contributed to my first ‘escape’ to England in 1979. In the UK, I felt, things were refreshingly different (see also my recent obituary of my former boss).
EXPERIENCE BASED MEDICINE
So-called alternative medicine (SCAM) is almost entirely based on this type of EBM. Practitioners of SCAM pride themselves of their experience and are convinced that it outweighs evidence any time. They rarely miss an occasion to stress that their treatment as stood the test of time. And as such it does not require evidence; if SCAM did not work, it would not have survived all these years.
Little do they know that the appeal to tradition is a logical fallacy. And little do they care that the long tradition of their SCAMs might just signal how obsolete their treatments truly are. Hundreds (homeopathy) or thousands (acupuncture) of years ago, we had little knowledge about physiology, pathology, etc., and clinicians had to make do with the little that got. Seen in this light, experience based medicine is a negative label that indicates the fact that the treatments are likely to be obsolete and out-dated.
EVIDENCE BASED MEDICINE
Providers of SCAM have a deeply rooted dislike for the word evidence. The reason is simple: their SCAMs are usually very shy on evidence; little wonder that they like to focus on experience instead. Yet, try to explain the concept of evidence to someone neutral like a barman, for instance – whenever I made this attempt, I was interrupted by him saying: ‘Hold on, are you saying that before EBM you did not depend on evidence? This is frightening! What on earth did you rely on then?’
It is indeed not logical to rely on eminence or on experience, in my view. And therefore, I have stopped explaining EBM to people who have common sense, like my barman. Let’s try something else instead: imagine you are seriously ill and are able to chose between three clinician who are each the leading head in their type of EMB.
THE EMINENCE IS A PROFESSOR MANY TIMES OVER AND SIMPLY KNOWS THAT HE IS ALWAYS RIGHT
Personally, I would run a mile. I have seen too many of those blundering through the wards of university hospitals. He never makes a mistake, except that things do go wrong quite often; and when they do, it is the fault of some underling, of course.
THE EXPERIENCED CLINICIAN WITH YEARS OF PRACTICE WHO HAS SEEN IT ALL AND HAS ALL THE ANSWERS
With a bit of bad luck, he might be a homeopath. He will tell you endlessly of cases that were similar to yours. Occasionally, there was an aggravation (which, of course, is a good sign in his view), but in the end he cured them all with his treatments that had stood the test of time. He has excellent bedside manners, a lot of charisma, and is a good listener. Who was it that said: “the three most dangerous words in medicine are IN MY EXPERIENCE”?
Yes, you guessed it: run and don’t turn back!
THE CLINICIAN WHO KNOWS WHAT THE CURRENT BEST EVIDENCE HAS TO OFFER
He might not be all that charismatic, perhaps he even is a bit abrupt. But he will know the latest developments and weigh the risks of all therapeutic options against their benefits.
But hold on, my barman would interrupt at this point, this is not either or. One can have both experience and evidence!
I told you my barman was clever. The definition of evidence based medicine is not healthcare based on up-to date knowledge, it is the integration of best research evidence with clinical expertise and patient values. It thus rests on three pillars: external evidence, ideally from systematic reviews, the clinician’s experience, and the patient’s preferences.
Therefore, my barman and I agree that eminence based medicine is highly questionable, experience based medicine can be outright dangerous, and evidence based medicine is the only EBM version that does make sense.
Myelopathy is defined as any neurologic deficit related to the spinal cord. When due to trauma, it is known as (acute) spinal cord injury. When caused by inflammatory, it is known as myelitis. Disease that is vascular in nature is known as vascular myelopathy.
The symptoms of myelopathy include:
- Pain in the neck, arm, leg or lower back
- Muscle weakness
- Difficulty with fine motor skills, such as writing or buttoning a shirt
- Difficulty walking
- Loss of urinary or bowel control
- Issues with balance and coordination
The causes of myelopathy include:
- Tumours that put pressure on the spinal cord
- Bone spurs
- A dislocation fracture
- Autoimmune diseases like multiple sclerosis
- Congenital abnormality
- A traumatic injury
This review presents a series of cases with cervical spine injury and myelopathy following therapeutic manipulation of the neck, and examines their clinical course and neurological outcome.
Its authors conducted a search for patients who developed neurological symptoms due to cervical spinal cord injury following neck SMT in the database of a spinal unit in a tertiary hospital between the years 2008 and 2018. Patients with vertebral artery dissections were excluded. Patients were assessed for the clinical course and deterioration, type of manipulation used and subsequent management.
A total of four patients were identified, two men and two women, aged between 32 and 66 years. In three patients neurological deterioration appeared after chiropractic adjustment and in one patient after tuina therapy. The patients had experienced symptoms within one day to one week after neck manipulation. The four patients had signs of:
- central cord syndrome,
- spastic quadriparesis,
- spastic quadriparesis,
- radiculopathy and myelomalacia.
Three patients were managed with anterior cervical discectomy and fusion while one patient declined surgical treatment.
The authors note that their data cannot determine whether the spinal cord dysfunction was caused my the spinal manipulations or were pre-existing problems which were aggravated by the treatments. They recommend that assessment for subjective and objective evidence of cervical myelopathy should be performed prior to cervical manipulation, and suspected myelopathic patients should be sent for further workup by a specialist familiar with cervical myelopathy, such as a neurologist, a neurosurgeon or orthopaedic surgeon who specializes in spinal surgery. They also state that manipulation therapy remains an important and generally safe treatment modality for a variety of cervical complaints. Their review, the authors stress, does not intend to discard the role of spinal manipulation as a significant part in the management of patients with neck related symptoms, rather it is meant to draw attention to the need for careful clinical and imaging investigation before treatment. This recommendation might be medically justified, yet one could argue that it is less than practical.
This paper from Israel is interesting in that it discloses possible complications of cervical manipulation. It confirms that chiropractors are most frequently implicated and that – as in our survey – under-reporting is exactly 100% (none of the cases identified by the retrospective chart review had been previously reported).
In light of this, some of the affirmations of the authors are bizarre. In particular, I ask myself how they can claim that cervical manipulation is a ‘generally safe’ treatment. With under-reporting at such high levels, the only thing one can say with certainty is that serious complications do happen and nobody can be sure how frequently they occur.
I have often discussed the fact that many proponents of so-called alternative medicine (SCAM) have in recent years adopted the following argument: even if our SCAM were just a placebo, it would still be useful. After all, placebo effects are real and increasingly backed by sound science. The argument is deeply flawed, yet it convinces many lay people.
A recent article by Fabrizio Benedetti, the leading researcher in the area of placebo, is addressing exactly this issue. I feel that it is sufficiently important to quote it extensively here:
… a number of biochemical pathways, such as endogenous opioids and cannabinoids,5,6 and brain regions, like the prefrontal cortex, have been found to be involved in placebo analgesia. Likewise, dopamine and the basal ganglia circuitry have been found to mediate placebo responses in Parkinson’s disease. Although this is wonderful news for science, this may not be the case for society. The number of nonmedical organizations and healers that rely on this hard science, and actually justify their odd and bizarre procedures, has increased over the past few years. The main claim is that any procedure boosting patients’ expectations, which represent the main mediator of placebo effects, is acceptable because it can activate the same biochemical pathways and neural networks that have been made credible by hard science…
The crucial point here is that when hard science started investigating placebo effects, it unconsciously produced a shift in quackery thinking. In fact, charlatans are becoming more and more aware that their bizarre interventions could work through a placebo effect. Indeed, whereas hard science has so far denied any scientific basis for nonconventional therapies, now the very same hard science certifies that the placebo effect has scientific grounds. Therefore, quacks are no longer interested in showing that their pseudo-interventions work; rather, they justify their use on the basis of the possibility that these bizarre interventions may induce strong placebo effects…
… A first point that should be emphasized is that placebos do not cure, but rather, they may sometimes improve quality of life. There is plenty of confusion on this point, and unfortunately, many claim that they can cure virtually all illnesses with placebos. Hard science tells us that placebos can reduce symptoms such as pain and muscle rigidity in Parkinson’s disease, yet the progression of the disease is not affected; for example, in Parkinson’s disease, neurons keep degenerating even though some symptoms can be reduced for a short time.4 The second point is related to the first. The type of disease is crucial, and we need to make people understand that pain is different from cancer and that anxiety differs from infectious diseases. The psychological component of some illnesses can indeed be modulated by placebos, but placebos cannot stop cancer growth, nor can they kill the bacteria of pneumonia. The third point is related to the difference between real placebo effects and spontaneous remissions. So far, hard science has studied the placebo effect within a time span of hours/days, thereby limiting our knowledge to short-lasting effects. Consequently, long-lasting effects can be often attributed to spontaneous remissions.
In addition to these three important points, we should also make patients understand that a diagnosis is required before any sort of therapy. An apparently trivial pain may conceal a danger; thus, it must never be treated unless a diagnosis has been made before, and this can be made only by physicians. Moreover, not only should we discuss and consider the positive effects of placebos and the impact they may have in clinical trials and medical practice, but we should also pay much of our attention to the negative counterpart, that is, the misuse and abuse by quacks, charlatans, shamans, and nonmedical organizations. Thus, we need to inform the whole society that the benefits following a nonconventional healing procedure are attributable to a placebo effect in most of the cases. Last but not least, we need to be more honest on the real efficacy of many pharmacological and nonpharmacological treatments, acknowledging that some of them are useful whereas some others are not: This will boost patients’ trust and confidence in medicine further, which I believe are the best foes of quackery…
…Unfortunately, quackery has today one more weapon on its side, which is paradoxically represented by the hard science–supported placebo mechanisms. This new “scientific quackery” can do a lot of damage; thus, we must be very cautious and vigilant as to how the findings of hard science are exploited. The study of the biology of these vulnerable aspects of mankind may unravel new mechanisms of how our brain works, but it may have a profound negative impact on our society as well. We cannot accept a world where expectations can be enhanced with any means and by anybody. This is a perspective that would surely be worrisome and dangerous. I believe that some reflections are necessary in order to avoid a regression of medicine to past times, in which quackery and shamanism were dominant. Unfortunately, the new knowledge about placebos by hard science is now backfiring on it. What we need to do is to stop for a while and reflect on what we are doing and how we want to move forward. A crucial question to answer is, Does placebo research boost pseudoscience?
I am immensely thankful to Prof Benedetti to make such clear and long-overdue statements. They will be most helpful in refuting the myth that homeopathy, para-normal healing, reflexology, acupuncture, chiropractic, etc., etc. are legitimate and uselful therapies, even if they are not better than a placebo. Using placebo therapies in routine care is not in the best interest of either the patient or progress.