I have reported previously about the tragic death of John Lawler. Now after the inquest into the events leading to it has concluded, I have the permission to publish the statement of Mr Lawler’s family:
We were devastated to lose John in such tragic and unforeseen circumstances two years ago. A much-loved husband, father and grandfather, he continues to be greatly missed by all of us. Having to re-live the circumstances of his death has been particularly difficult for us but we are grateful to have a clearer picture of the events that led to John’s death. We would like to take this opportunity to thank the coroner’s team, our legal representatives and our wider family and friends for their guidance, empathy and sensitivity throughout this process.
There were several events that went very wrong with John’s chiropractic treatment, before, during, and after the actual manipulation that broke his neck.
Firstly, John thought he was being treated by a medically qualified doctor, when he was not. Furthermore, he had not given informed consent to this treatment.
The chiropractor diagnosed so-called ‘vertebral subluxation complex’ which she aimed to treat by manipulating his neck. We heard this week from medical experts that John had ossified ligaments in his spine, where previously flexible ligaments had turned to bone and become rigid. This condition is not uncommon, and is present in about 10% of those over 50. It would have showed on an X-ray or other imaging technique. The chiropractor did not ask for any images before commencing treatment and was seemingly unaware of the risks of doing a manual manipulation on an elderly patient.
It has become clear that the chiropractor did the manipulation incorrectly, and broke these rigid ligaments during a so-called ‘drop table’ manipulation, causing discs in the cervical spine to rupture and the spinal cord to become crushed. Although these manipulations are done frequently by chiropractors, we have heard that the force applied to his neck by the chiropractor would have had to have been “significant”.
Immediately John reported loss of sensation and paralysis in his arms. At this stage the only safe and appropriate response was to leave him on the treatment bed and await the arrival of the paramedics, and provide an accurate history to the ambulance controller and paramedics. The chiropractor, in fact, manhandled John from the treatment bed into a chair; then tipped his head backwards and gave “mouth to mouth” breaths. She provided an inaccurate and misleading history to the paramedic and ambulance controller, causing the paramedic to treat the incident as “medical” not “traumatic” and to transport John downstairs to the ambulance without stabilising his neck. If the paramedics had been given the full and accurate story, they would have stabilised his neck in situ and transported him on a scoop stretcher – and he would have subsequently survived.
The General Chiropractic Council decided not to suspend the chiropractor from practicing in September 2017. They heard evidence from the chiropractor that she had “not touched the neck during the appointment” and from an expert chiropractor that it would be “physically impossible” for the treatment provided to cause the injury which followed. We have heard this week that this is incorrect. The family was not allowed to attend or give evidence at that hearing, and we are waiting – now 2 years further on – for the GCC to complete their investigations.
We hope that the publicity surrounding this event will highlight the dangers of chiropractic, especially in the elderly and those with already compromised spines. We would again urge the regulator to take immediate measures to ensure that the profession is properly controlled: that chiropractors are prevented from styling themselves as medical professionals; that patients are fully informed and consent to the risks involved; that imaging is done before certain procedures and on high risk clients; and that the limits of the benefits chiropractic can provide are fully explored.
Before someone comments pointing out that this is merely a single case which does not amount to evidence, let me remind you of the review of cervical manipulation prepared for the Manitoba Health Professions Advisory Council. Here is the abstract:
Neck manipulation or adjustment is a manual treatment where a vertebral joint in the cervical spine—comprised of the 7 vertebrae C1 to C7—is moved by using high-velocity, low-amplitude (HVLA) thrusts that cannot be resisted by the patient. These HVLA thrusts are applied over an individual, restricted joint beyond its physiological limit of motion but within its anatomical limit. The goal of neck manipulation, referred to throughout this report as cervical spine manipulation (CSM), is to restore optimal motion, function, and/or reduce pain. CSM is occasionally utilized by physiotherapists, massage therapists, naturopaths, osteopaths, and physicians, and is the hallmark treatment of chiropractors; however the use of CSM is controversial. This paper aims to thoroughly synthesize evidence from the academic literature regarding the potential risks and benefits of cervical spine manipulation utilizing a rapid literature review method.
METHODS Individual peer-reviewed articles published between January 1990 and November 2016 concerning the safety and efficacy of cervical spine manipulation were identified through MEDLINE (PubMed), EMBASE, and the Cochrane Library.
- A total of 159 references were identified and cited in this review: 86 case reports/ case series, 37 reviews of the literature, 9 randomized controlled trials, 6 surveys/qualitative studies, 5 case-control studies, 2 retrospective studies, 2 prospective studies and 12 others.
- Serious adverse events following CSM seem to be rare, whereas minor adverse events occur frequently.
- Minor adverse events can include transient neurological symptoms, increased neck pain or stiffness, headache, tiredness and fatigue, dizziness or imbalance, extremity weakness, ringing in the ears, depression or anxiety, nausea or vomiting, blurred or impaired vision, and confusion or disorientation.
- Serious adverse events following CSM can include the following: cerebrovascular injury such as cervical artery dissection, ischemic stroke, or transient ischemic attacks; neurological injury such as damage to nerves or spinal cord (including the dura mater); and musculoskeletal injury including injury to cervical vertebral discs (including herniation, protrusion, or prolapse), vertebrae fracture or subluxation (dislocation), spinal edema, or issues with the paravertebral muscles.
- Rates of incidence of all serious adverse events following CSM range from 1 in 10,000 to 1 in several million cervical spine manipulations, however the literature generally agrees that serious adverse events are likely underreported.
- The best available estimate of incidence of vertebral artery dissection of occlusion attributable to CSM is approximately 1.3 cases for every 100,000 persons <45 years of age receiving CSM within 1 week of manipulative therapy. The current best incidence estimate for vertebral dissection-caused stroke associated with CSM is 0.97 residents per 100,000.
- While CSM is used by manual therapists for a large variety of indications including neck, upper back, and shoulder/arm pain, as well as headaches, the evidence seems to support CSM as a treatment of headache and neck pain only. However, whether CSM provides more benefit than spinal mobilization is still contentious.
- A number of factors may make certain types of patients at higher risk for experiencing an adverse cerebrovascular event after CSM, including vertebral artery abnormalities or insufficiency, atherosclerotic or other vascular disease, hypertension, connective tissue disorders, receiving multiple manipulations in the last 4 weeks, receiving a first CSM treatment, visiting a primary care physician, and younger age. Patients whom have experience prior cervical trauma or neck pain may be at particularly higher risk of experiencing an adverse cerebrovascular event after CSM.
CONCLUSION The current debate around CSM is notably polarized. Many authors stated that the risk of CSM does not outweigh the benefit, while others maintained that CSM is safe—especially in comparison to conventional treatments—and effective for treating certain conditions, particularly neck pain and headache. Because the current state of the literature may not yet be robust enough to inform definitive prohibitory or permissive policies around the application of CSM, an interim approach that balances both perspectives may involve the implementation of a harm-reduction strategy to mitigate potential harms of CSM until the evidence is more concrete. As noted by authors in the literature, approaches might include ensuring manual therapists are providing informed consent before treatment; that patients are provided with resources to aid in early recognition of a serious adverse event; and that regulatory bodies ensure the establishment of consistent definitions of adverse events for effective reporting and surveillance, institute rigorous protocol for identifying high-risk patients, and create detailed guidelines for appropriate application and contraindications of CSM. Most authors indicated that manipulation of the upper cervical spine should be reserved for carefully selected musculoskeletal conditions and that CSM should not be utilized in circumstances where there has not yet been sufficient evidence to establish benefit.
Just three points which, in my view, sand out most in relation to Mr Lawler’s death:
- Mr Lawler had no proven indication (and at least one very important contra-indication) for neck manipulation.
- He did not give infromed consent.
- The neck manipulation was not within the limits of the physiological range of motion.
“Maybe it is as simple as: I enjoyed that treatment, it was worth the amount I spent on it and I feel better.”
This argument between the fans and the critics of so-called alternative medicine (SCAM) might be the key to understanding the two opposing positions. It applies across the board to all the SCAMs that lack solid evidence (which, of course, is most).
- The sceptic asks for evidence of effectiveness and finds none that is convincing. He concludes that the SCAM is not evidence-based.
- The SCAM enthusiast cannot argue with the evident lack of evidence, but says (as Angela did in a recent comment): “Maybe it is as simple as: I enjoyed that treatment, it was worth the amount I spent on it and I feel better.”
Both positions may well be correct. And both are held with total conviction. Thus, many consumers who are not deeply into SCAM are confused or even bewildered.
So, how can we make sense of this situation?
Let me start with the argument of the SCAM enthusiast. She is, of course, right to sate that she enjoyed reflexology, or aromatherapy, or crystal therapy. She might also enjoy having her hair done, or soaking in a bath, or drinking a glass of champagne. There is nothing wrong with that, and we should all be happy for her.
Enjoying something is often good for you – often but not always. Enjoying a fag isn’t. Enjoying a bottle of whiskey per evening isn’t. Enjoying a drive at neck-breaking speed on a public motorway isn’t. Enjoying sending out hate-mail isn’t. But innocent treats like a foot massage by an aromatherapist probably is!
But none of these things can be considered to be a THERAPY. Feeling better is not necessarily a therapeutic aim.
So, the situation might not be so confusing after all: enjoyments are enjoyments. They are usually fine, and they are often very personal. Some people enjoy being massaged, others don’t. But enjoyments are not therapies. This means that all would be fine, if we stopped calling aromatherapy, reflexology, crystal therapy THERAPIES, and if we stopped calling aromatherapists, etc. THERAPISTS.
Therapies are medical interventions, and as such they need evidence to back them up, evidence that they do something positive to our health. Therapists are healthcare professionals who make therapeutic claims that need evidence to back them up. If that is missing, sceptics are entirely correct to criticise them. In fact, they fulfil a public service when criticising bogus therapies or claims.
So, the confusion mentioned above mainly arises from mislabelling enjoyments as therapies. Lets call aromatherapists, etc. by different names, and the confusion disappears. Let’s stop aromatherapists, etc. making therapeutic claims, and there is no more reason for sceptics to criticise.
Burning mouth syndrome (BMS) is a rare but potentially debilitating condition. So far, individualised homeopathy (iHOM) has not been evaluated or reported in any peer-reviewed journal as a treatment option. Here is a recently published case-report of iHOM for BMS.
At the Centre of Complementary Medicine in Bern, Switzerland, a 38-year-old patient with BMS and various co-morbidities was treated with iHOM between July 2014 and August 2018. The treatment involved prescription of individually selected homeopathic single remedies. During follow-up visits, outcome was assessed with two validated questionnaires concerning patient-reported outcomes. To assess whether the documented changes were likely to be associated with the homeopathic intervention, an assessment using the modified Naranjo criteria was performed.
Over an observation period of 4 years, an increasingly beneficial result from iHOM was noted for oral dysaesthesia and pains as well as for the concomitant symptoms.
The authors concluded that considering the multi-factorial aetiology of BMS, a therapeutic approach such as iHOM that integrates the totality of symptoms and complaints of a patient might be of value in cases where an association of psychological factors and the neuralgic complaints is likely.
BMS can have many causes. Some of the possible underlying conditions that can cause BMS include:
- hormonal imbalances
- acid reflux
- infections in the mouth
- various medications
- nutritional deficiencies in iron or zinc
Threatemnt of BMS consists of identifying and eliminating the underlying cause. If no cause of BMS can be found, we speak of primary BMS. This condition can be difficult to treat; the following approaches to reduce the severity of the symptoms are being recommended:
- avoiding acidic or spicy foods
- reducing stress
- avoiding any other known food triggers
- exercising regularly
- changing toothpaste
- avoiding mouthwashes containing alcohol
- sucking on ice chips
- avoiding alcohol if it triggers symptoms
- drinking cool liquids throughout the day
- smoking cessation
- eating a balanced diet
- checking medications for potential triggers
The authors of the above case-report state that no efficient treatment of BMS is known. This does not seem to be entirely true. They also seem to think that iHOM benefitted their patient (the post hoc ergo propter hoc fallacy!). This too is more than doubtful. The natural history of BMS is such that, even if no effective therapy can be found, the condition often disappears after weeks or months.
The authors of the above case-report treated their patient for about 4 years. The devil’s advocate might assume that not only did iHOM contribute nothing to the patient’s improvement, but that it had a detrimental effect on BMS. The data provided are in full agreement with the notion that, without iHOM, the patient would have been symptom-free much quicker.
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.
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.
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.
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.
It is hard to deny that many practitioners of so-called alternative medicine (SCAM) advise their patients to avoid ‘dangerous chemicals’. By this they usually mean prescription drugs. If you doubt how strong this sentiment often is, you have not followed the recent posts and the comments that regularly followed. Frequently, SCAM practitioners will suggest to their patients to not take this or that drug and predict that patients would then see for themselves how much better they feel (usually, they also administer their SCAM at this point).
Lo and behold, many patients do indeed feel better after discontinuing their ‘chemical’ medicines. Of course, this experience is subsequently interpreted as a proof that the drugs were dangerous: “I told you so, you are much better off not taking synthetic medicines; best to use the natural treatments I am offering.”
But is this always interpretation correct?
I seriously doubt it.
Let’s look at a common scenario: a middle-aged man on several medications for reducing his cardiovascular risk (no, it’s not me). He has been diagnosed to have multiple cardiovascular risk factors. Initially, his GP told him to change his life-style, nutrition and physical activity – to which he was only moderately compliant. Despite the patient feeling perfectly healthy, his blood pressure and lipids remained elevated. His doctor now strongly recommends drug treatment and our chap soon finds himself on statins, beta-blockers plus ACE-inhibitors.
Our previously healthy man has thus been turned into a patient with all sorts of symptoms. His persistent cough prompts his GP to change the ACE-inhibitor to a Ca-channel blocker. Now the patients cough is gone, but he notices ankle oedema and does not feel in top form. His GP said that this is nothing to worry about and asks him to grin and bear it. But the fact is that a previously healthy man has been turned into a patient with reduced quality of life (QoL).
This fact takes our man to a homeopath in the hope to restore his QoL (you see, it certainly isn’t me). The homeopath proceeds as outlined above: he explains that drugs are dangerous chemicals and should therefore best be dropped. The homeopath also prescribes homeopathics and is confident that they will control the blood pressure adequately. Our man complies. After just a few days, he feels miles better, his QoL is back, and even his sex-life improves. The homeopath is triumphant: “I told you so, homeopathy works and those drugs were really nasty stuff.”
When I was a junior doctor working in a homeopathic hospital, my boss explained to me that much of the often considerable success of our treatments was to get rid of most, if not all prescription drugs that our patients were taking (the full story can be found here). At the time, and for many years to come, this made a profound impression on me and my clinical practice. As a scientist, however, I have to critically evaluate this strategy and ask: is it the correct one?
The answer is YES and NO.
YES, many (bad) doctors over-prescribe. And there is not a shadow of a doubt that unnecessary drugs must be scrapped. But what is unnecessary? Is it every drug that makes a patient less well than he was before?
NO, treatments that are needed should not be scrapped, even if this would make the patient feel better. Where possible, they might be altered such that side-effects disappear or become minimal. Patients’ QoL is important, but it is not the only factor of importance. I am sure this must sound ridiculous to lay people who, at this stage of the discussion, would often quote the ethical imperative of FIRST DO NO HARM.
So, let me use an extreme example to explain this a bit better. Imagine a cancer patient on chemo. She is quite ill with it and QoL is a thing of the past. Her homeopath tells her to scrap the chemo and promises she will almost instantly feel fine again. With some side-effect-free homeopathy see will beat the cancer just as well (please, don’t tell me they don’t do that, because they do!). She follows the advice, feels much improved for several months. Alas, her condition then deteriorates, and a year later she is dead.
I know, this is an extreme example; therefore, let’s return to our cardiovascular patient from above. He too followed the advice of his homeopath and is happy like a lark for several years … until, 5 years after discontinuing the ‘nasty chemicals’, he drops dead with a massive myocardial infarction at the age of 62.
I hope I made my message clear: those SCAM providers who advise discontinuing prescribed drugs are often impressively successful in improving QoL and their patients love them for it. But many of these practitioners haven’t got a clue about real medicine, and are merely playing dirty tricks on their patients. The advise to stop a prescribed drug can be a very wise move. But frequently, it improves the quality, while reducing the quantity of life!
The lesson is simple: find a rational doctor who knows the difference between over-prescribing and evidence-based medicine. And make sure you start running when a SCAM provider tries to meddle with necessary prescribed drugs.
Dr Alice Hodkinson is a GP in Cambridge, England. She says of herself that she is interested in supporting people to make informed choices about their own health, reduce the burden of illness and lighten the load of medication on patients and the country’s National Health Service. She is studying medical ethics and law at King’s College London.
Even though we live in the same town, I don’t know Dr Hodkinson personally and never met her. My only contact with her is the one depicted here: on Twitter I had posted my recent article entitled ‘A new, comprehensive review: HOMEOPATHY = PLACEBO THERAPY‘. This prompted the following exchange:
At the very least homeopathy and placebos don’t cause harm that medicines do.
Edzard Ernst @EdzardErnst
have you heard of something called ‘risk/benefit balance’?
Which is precisely where homeopathy wins over toxins I prescribe as medication.
Edzard Ernst @EdzardErnst
oh really? I do worry about the students you teach
I worry about the over-use of toxins that harm. Lots of ppl get much better when meds are stopped. They come back from the dead and live much happier. Lots of evidence for this.
Edzard Ernst @EdzardErnst
” Lots of ppl get much better when meds are stopped.” surely this is a sign that they never needed them; in other words, it is the mistake of the GP who did the prescription
It’s a sign meds’ aren’t reviewed and they do harm. Water doesn’t harm, unless in excess. Promoting water as a cure might be harmful, yet there are sooooo many conditions where medicine has no answers, and for these, homeopathy comes up trumps.
Edzard Ernst @EdzardErnst
I am sooooooo pleased you are not my GP!
I’m bored. Go poison yourself on prescribed medication!
END OF EXCHANGE
I don’t know why this shocks me more than any of the often much more disagreeable disputes I have with other proponents of homeopathy on Twitter or on this blog. Perhaps it is because it occurred with a person who is a doctor like myself, or because it happened with a complete stranger, or because it was with someone who is, for all I know, an entirely reasonable clinician in other medical matters, or because Dr Hodkinson is studying medical ethics? I really don’t know.
Or perhaps nobody have ever told me to poison myself?
The journal NATURE has just published an excellent article by Andrew D. Oxman and an alliance of 24 leading scientists outlining the importance and key concepts of critical thinking in healthcare and beyond. The authors state that the Key Concepts for Informed Choices is not a checklist. It is a starting point. Although we have organized the ideas into three groups (claims, comparisons and choices), they can be used to develop learning resources that include any combination of these, presented in any order. We hope that the concepts will prove useful to people who help others to think critically about what evidence to trust and what to do, including those who teach critical thinking and those responsible for communicating research findings.
Here I take the liberty of citing a short excerpt from this paper:
Claims about effects should be supported by evidence from fair comparisons. Other claims are not necessarily wrong, but there is an insufficient basis for believing them.
Claims should not assume that interventions are safe, effective or certain.
- Interventions can cause harm as well as benefits.
- Large, dramatic effects are rare.
- We can rarely, if ever, be certain about the effects of interventions.
Seemingly logical assumptions are not a sufficient basis for claims.
- Beliefs alone about how interventions work are not reliable predictors of the presence or size of effects.
- An outcome may be associated with an intervention but not caused by it.
- More data are not necessarily better data.
- The results of one study considered in isolation can be misleading.
- Widely used interventions or those that have been used for decades are not necessarily beneficial or safe.
- Interventions that are new or technologically impressive might not be better than available alternatives.
- Increasing the amount of an intervention does not necessarily increase its benefits and might cause harm.
Trust in a source alone is not a sufficient basis for believing a claim.
- Competing interests can result in misleading claims.
- Personal experiences or anecdotes alone are an unreliable basis for most claims.
- Opinions of experts, authorities, celebrities or other respected individuals are not solely a reliable basis for claims.
- Peer review and publication by a journal do not guarantee that comparisons have been fair.
Studies should make fair comparisons, designed to minimize the risk of systematic errors (biases) and random errors (the play of chance).
Comparisons of interventions should be fair.
- Comparison groups and conditions should be as similar as possible.
- Indirect comparisons of interventions across different studies can be misleading.
- The people, groups or conditions being compared should be treated similarly, apart from the interventions being studied.
- Outcomes should be assessed in the same way in the groups or conditions being compared.
- Outcomes should be assessed using methods that have been shown to be reliable.
- It is important to assess outcomes in all (or nearly all) the people or subjects in a study.
- When random allocation is used, people’s or subjects’ outcomes should be counted in the group to which they were allocated.
Syntheses of studies should be reliable.
- Reviews of studies comparing interventions should use systematic methods.
- Failure to consider unpublished results of fair comparisons can bias estimates of effects.
- Comparisons of interventions might be sensitive to underlying assumptions.
Descriptions should reflect the size of effects and the risk of being misled by chance.
- Verbal descriptions of the size of effects alone can be misleading.
- Small studies might be misleading.
- Confidence intervals should be reported for estimates of effects.
- Deeming results to be ‘statistically significant’ or ‘non-significant’ can be misleading.
- Lack of evidence for a difference is not the same as evidence of no difference.
What to do depends on judgements about the problem, the relevance (applicability or transferability) of evidence available and the balance of expected benefits, harm and costs.
Problems, goals and options should be defined.
- The problem should be diagnosed or described correctly.
- The goals and options should be acceptable and feasible.
Available evidence should be relevant.
- Attention should focus on important, not surrogate, outcomes of interventions.
- There should not be important differences between the people in studies and those to whom the study results will be applied.
- The interventions compared should be similar to those of interest.
- The circumstances in which the interventions were compared should be similar to those of interest.
Expected pros should outweigh cons.
- Weigh the benefits and savings against the harm and costs of acting or not.
- Consider how these are valued, their certainty and how they are distributed.
- Important uncertainties about the effects of interventions should be reduced by further fair comparisons.
END OF QUOTE
I have nothing to add to this, except perhaps to point out how very relevant all of this, of course, is for SCAM and to warmly recommend you study the full text of this brilliant paper.