MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

experience

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My friend Gustav Born FRS died on 16 April 2018.

Gustav was born into a Jewish family that emigrated from 1930s Goettingen (Germany) to the UK. His father Max, a friend of Einstein, was a physicist who received a Nobel Prize for his work in quantum mechanics. Gustav  served in the British forces as a doctor during WW2. After the war, he became a pharmacologist in London and Cambridge who had many achievements to his name. For instance, he discovered the mechanisms through which the body stops bleeding and initiates blood clotting. He also invented the platelet aggregometer that is still used universally to quantify platelet activity and which he never patented so that not he but mankind would benefit from it. Gustav was indefatigable and continued his research for many years after his retirement. His work was crowned with uncounted scientific awards.

There have been numerous, much more detailed obituaries honouring Gustav e. g.:

https://www.theguardian.com/science/2018/apr/26/gustav-born-obituary

https://www.thetimes.co.uk/article/gustav-born-obituary-gt5k9r8jc

Mine is merely a personal tribute. I met Gustav in the early 1990s while working in Vienna. We became close friends, and he took me under his wings, encouraged me to come to the UK, wrote a glowing reference when I applied for the Exeter post, and gave me moral support whenever I needed it.

After I had moved to the UK, we regularly met, and he even came to my 50th birthday party insisting to make a speech. About 15 years ago, he once attended one of my public lectures on alternative medicine; afterwards his comment was: “you know, your work is going to save lives.” Since my retirement, he kept phoning me at home (apparently Gustav had an irresistible attraction to the telephone) and urged me, usually speaking in German, to arrange a meeting. We always concluded that this must be soon; sadly, however, this did not happen.

Gustav was a great story-teller. One of his preferred anecdotes related to homeopathy. He recounted (interrupting himself giggling) that, when Einstein and his father once were talking, someone mentioned homeopathy and asked them what they thought of it. Einstein reflected for a little while and then said: “If one were to lock up 10 very clever people in a room and told them they were only allowed out once they had come up with the most stupid idea conceivable, they would soon come up with homeopathy.”

It is therefore not surprising that, when I invited Gustav to contribute a chapter to my book ‘HEALING, HYPE OR HARM?‘, he agreed to write an essay entitled ‘HOMEOPATHY IN CONTEXT’. Here is a short extract from it: What can be done to counteract the persistence of homeopathy? Its unwarranted claims must be continuously exposed. The diversion of public money from the proper purposed of the NHS must be stopped.

I shall miss Gustav for his clear thinking, his wry humour, his unfailing support and fatherly friendship.

Today, enthusiasts of homeopathy celebrate the start of the HOMEOPATHY AWARENESS WEEK. Let’s join them by re-addressing one of their favourite themes: their personal experience with homeopathy.

Most homeopathy-fans argue that the negative scientific evidence must be wrong because they have had positive experiences. Whenever I give a lecture, for instance, there will be at least one person in the audience who presents such an experience (and I too could contribute a few such stories from my own past). Such ‘case reports’ can, of course, be interesting, illuminating or leading to further research, but they can never be conclusive.

This concept is often profoundly confusing for patients and consumers. They tend to feel that I am doubting their words, but nothing could be further from the truth. Their experience is certainly true – what might be false is their interpretation of it. I think, I better explain this in more detail using a concrete, published example.

After the publication of our 2003 RCT of homeopathic Arnica which showed that two different potencies have effects that do not differ from those of placebo, I received lots of angry responses from people who told me that they had the opposite experience or observed positive outcomes on their pets. In my subsequent publication in the journal ‘Homeopathy‘ entitled ‘The benefits of Arnica: 16 case reports‘, I have tried my best to explain their experiences in the light of our finding that highly diluted homeopathic Arnica is a placebo:

Sixteen case reports of the apparent benefits of Arnica … raise several relevant points. Firstly, topical Arnica preparations are often wrongly equated with homeopathic Arnica, the subject of our trial. The former are herbal preparations (ie not homeopathically diluted), which have undisputed pharmacological activity. Taken orally they would even be toxic. Thus all Arnica for oral administration must be highly diluted and has therefore no pharmacological effects. The case reports show that many lay people seem to be unclear about the difference between herbal and homeopathic Arnica.

Secondly, if animals seem to respond to homeopathic Arnica, as claimed in several of the case reports, this is not necessarily a proof of its effectiveness. Animals are not immune to placebo effects. Think of Pavlov’s experiments and the fact that conditioning is clearly an element in the placebo response.

Thirdly, the natural history of the condition can mimic clinical improvement caused by therapy. Many of the 16 cases summarized can be explained through a placebo response or the natural history of disease or the combination of both phenomena…

Many of the letters I received were outspoken to say the least. The authors stated that they were ‘appalled’, ‘saddened and angry’ by our research. Others implied that I was paid by the pharmaceutical industry to abolish homeopathy in the UK. One person felt that ‘it is highly irresponsible to dismiss a natural healing remedy with no evidence at all’. I believe the case reports … convey an important message about the power of belief, anecdotes, placebos and expectation.

END OF QUOTE

The thing about case reports and personal experiences is quite simply this: they may seem almost overwhelmingly convincing, but they can NEVER serve as a proof that the treatment in question was effective. The reason for this fact could not be more simple. Any therapeutic response is due to a complex combination of factors: placebo effects, natural history of the condition, regression to the mean, etc.

See it this way: you wake up one morning with an enormous hangover. You try to identify the cause of it. Was it the beer you had in the pub? The wine you drank before you went out? Or the whiskey you consumed before you went to bed? Perhaps you think it was the Cognac you enjoyed at a friend’s house? Only one thing is for sure: it was not the glass of shaken water you drank during the night.

 

Lock 10 bright people into a room and tell them they will not be let out until they come up with the silliest idea in healthcare. It is not unlikely, I think, that they might come up with the concept of visceral osteopathy.

In case you wonder what visceral osteopathy (or visceral manipulation) is, one ‘expert’ explains it neatly: Visceral Osteopathy is an expansion of the general principles of osteopathy which includes a special understanding of the organs, blood vessels and nerves of the body (the viscera). Visceral Osteopathy relieves imbalances and restrictions in the interconnections between the motions of all the organs and structures of the body. Jean-Piere Barral RPT, DO built on the principles of Andrew Taylor Still DO and William Garner Sutherland DO, to create this method of detailed assessment and highly specific manipulation. Those who wish to practice Visceral Osteopathy train intensively through a series of post-graduate studies.  The ability to address the specific visceral causes of somatic dysfunction allows the practitioner to address such conditions as gastroesophageal reflux disease (GERD), irritable bowel (IBS), and even infertility caused by mechanical restriction.

But, as I have pointed out many times before, the fact that a treatment is based on erroneous assumptions does not necessarily mean that it does not work. What we need to decide is evidence. And here we are lucky; a recent paper provides just that.

The purpose of this systematic review was to identify and critically appraise the scientific literature concerning the reliability of diagnosis and the clinical efficacy of techniques used in visceral osteopathy.

Only inter-rater reliability studies including at least two raters or the intra-rater reliability studies including at least two assessments by the same rater were included. For efficacy studies, only randomized-controlled-trials (RCT) or crossover studies on unhealthy subjects (any condition, duration and outcome) were included. Risk of bias was determined using a modified version of the quality appraisal tool for studies of diagnostic reliability (QAREL) in reliability studies. For the efficacy studies, the Cochrane risk of bias tool was used to assess their methodological design. Two authors performed data extraction and analysis.

Extensive searches located 8 reliability studies and 6 efficacy trials that could be included in this review. The analysis of reliability studies showed that the diagnostic techniques used in visceral osteopathy are unreliable. Regarding efficacy studies, the least biased study showed no significant difference for the main outcome. The main risks of bias found in the included studies were due to the absence of blinding of the examiners, an unsuitable statistical method or an absence of primary study outcome.

The authors (who by the way declared no conflicts of interest) concluded that the results of the systematic review lead us to conclude that well-conducted and sound evidence on the reliability and the efficacy of techniques in visceral osteopathy is absent.

It is hard not to appreciate the scientific rigor of this review or to agree with the conclusions drawn by the French authors.

But what consequences should we draw from all this?

The authors of this paper state that more and better research is needed. Somehow, I doubt this. Visceral osteopathy is not plausible and the best evidence available to date does not show it works. In my view, this means that we should declare it an obsolete aberration of medical history.

To this, the proponents of visceral osteopathy will probably say that they have tons of experience and have witnessed wonderful cures etc. This I do not doubt; however, the things they saw were not due to the effects of visceral osteopathy, they were due to chance, placebo, regression towards the mean, the natural history of the diseases treated etc., etc. And sometimes, experience is nothing more that the ability to repeat a mistake over and over again.

  • If it looks like a placebo,
  • if it behaves like a placebo,
  • if it tests like a placebo,

IT MOST LIKELY IS A PLACEBO!!!

And what is wrong with a placebo, if it helps patients?

GIVE ME A BREAK!

WE HAVE ALREADY DISCUSSED THIS AD NAUSEAM. JUST READ SOME OF THE PREVIOUS POSTS ON THIS SUBJECT.

An article in the medical magazine ‘GP’ caught my eye. In it, a GP from Southampton argues that it is counter-productive for the NHS to ban ineffective treatments. Here are a few excerpts (my comments are inserted in brackets and are in bold print):

START OF QUOTES

NHS England’s recent decision requiring GPs stop prescribing a list of 18 medicines will reinforce the fears of many doctors that healthcare rationing is being introduced by the back door (all finite NHS resources need to be and always have been rationed). I would also argue that it is an illogical and ill-informed decision that will not achieve the professed aim of saving NHS resources (perhaps the decision is not purely based on the need to save money but also on a matter of principle and an attempt to make the NHS evidence-based?).

The decision to impose a blanket ban on these items will disproportionately affect those patients who currently receive free prescriptions: the young, the poor and the elderly (where is the evidence for this statement?). The conditions these patients are suffering from will persist (treating them with ineffective medications would also make them persist).

If in future these vulnerable patients want to continue with their medicines, they will be forced to pay for them. While wealthier patients will have the option to pay for their medications, those unable to do so will return to their GP for an alternative medication or procedure that has not been prohibited by NHS England’s recommendations. GPs will then find themselves prescribing other more costly medications. How this is helping NHS England to reduce prescribing costs is difficult to see (really? I don’t find it difficult to see that spending money on effective treatments is a better investment than wasting it on ineffective stuff)…

… ‘evidence-informed practice’… not only includes scientific research, but also evidence from clinical practice acquired over many years and endorsed by numerous clinicians. Yet this type of evidence, from the front line of medicine, is being dismissed as ‘unscientific’ or ‘anecdotal’ (no, it has never been considered to be evidence; remember: the plural of anecdote is anecdotes, not evidence)…

We all want the NHS to operate cost effectively… (as long as the NHS continues to pay for homeopathy?). Of course, treatments that have no good evidence of benefit to patients should be questioned (as long as the NHS continues to pay for homeopathy?)…

NHS England needs to conduct a review of how it evaluates treatments and take far more notice of the experiences of doctors and patients. Then perhaps we will see a more financially efficient health service, healthier patients and an end to the injustice of healthcare rationing (the author forgot to tell her readers that she is a homeopath – in fact, she did not even once use the word ‘homeopathy’ in her diatribe. Because of her extreme views, she has featured on this blog before. [“homeopathy can be helpful for pretty much any condition”] Dr Day also forgot to declare conflicts of interest in her most recent vituperation [easy mistake to make; I know I am being petty).

 

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If I were a fan of homeopathy and a believer in the magical healing power of shaken water, I would be very worried. While homeopaths put forward such embarrassingly daft arguments, the future of homeopathy looks bleak indeed.

 

 

A cognitive bias known as the Dunning-Kruger Effect has, I think, considerable relevance in alternative medicine. The effect means that, the less you know, the less able you are to recognize how little you know, and the less likely you are to recognize your limitations. Consequently, your confidence in yourself is inflated and you believe you are more competent than your opponent. Expressed differently:

  • Incompetence prevents the recognition of incompetence.
  • Too stupid to doubt.

Even though the phenomenon of illusory superiority is today attributed to David Dunning and Justin Kruger, many others before them have alluded to the phenomenon:

Image result for dunning kruger effect

The relevance of the Dunning Kruger Effect to alternative medicine seems obvious, I think. Here we are confronted with all sorts of practitioners who believe they know it all, can treat any condition, alleviate the ‘root cause’ of all ills, etc., etc. Many of my previous posts on this blog have dealt with aspects of this problem. And with unfailing regularity, the discussions brought some individuals badly affected by the Dunning-Kruger Effect to the fore. Typically, they go on and on and on… consumed by their inflated confidence and trapped by their incompetence to realise their incompetence. And typically, they find an audience who is gullible enough to applaud them.

They often remind me of a cartoon I once saw:

The little graph below explains it all quite neatly:

Image result for dunning kruger effect

The novice lacks knowledge but, as he acquires a modicum of (pseudo-)knowledge, he gets a boost of confidence. An experienced person has enough knowledge to know that he knows very little; therefore his confidence is relatively low. When experience and knowledge combine to become wisdom, confidence grows and we might be talking to a real expert. Oddly, in terms of confidence, the novice can score higher than even the wisest expert.

To some extent, this simple graph even explains the popularity of many forms of quackery: they are being promoted by people who know very little but are bursting with confidence. And it is this high level of confidence that tends to impress the gullible public who then eagerly adopt the quackery.

Where the graph is somewhat misleading, I think, is where it might give the impression that there is an automatic and necessary transition from novice to expert (from left to right on the X-axis). In many individuals, this development does occur but, sadly, in many others it does not. The evangelical believers in alternative medicine, I fear, usually belong to the latter, sad category.

If I am correct, the Dunning Kruger Effect can therefore partly explain 1) the inflated confidence of proponents of alternative medicine, as well as 2) the current popularity of quackery.

This is a fascinating new review of upper neck manipulation. It raises many concerns that we, on this blog, have been struggling with for years. I take the liberty of quoting a few passages which I feel are important and encourage everyone to study the report in full:

The Minister of Health, Seniors and Active Living gave direction to the Health Professions Advisory Council (“the Council”) to undertake a review related to high neck manipulation.

Specifically, the Minister directed the Council to undertake:

1) A review of the status of the reserved act in other Canadian jurisdictions,

2) A literature review related to the benefits to patients and risks to patient safety associated with the procedure, and

3) A jurisprudence review or a review into the legal issues that have arisen in Canada with respect to the performance of the procedure that touch upon the risk of harm to a patient.

In addition, the Minister requested the Council to seek written input on the issue from:

  • Manitoba Chiropractic Stroke Survivors
  • Manitoba Chiropractic Association
  • College of Physiotherapists of Manitoba
  • Manitoba Naturopathic Association
  • College of Physicians and Surgeons of Manitoba
  • other relevant interested parties as determined by the Council

… The review indicated that further research is required to:

  • strengthen evidence for the efficacy of cervical spinal manipulations (CSM) as a treatment for neck pain and headache, “as well as for other indications where evidence currently does not exist (i.e., upper back and should/arm pain, high blood pressure, etc.)”
  • establish safety and efficacy of CSM in infants and children
  • assess the risk versus benefit in consideration of using HVLA cervical spine manipulation, which also involve cost-benefit analyses that compare CSM to other standard treatments.

… the performance of “high neck manipulation” or cervical spine manipulation does present a risk of harm to patients. This risk of harm must be understood by both the patient and the practitioner.

Both the jurisprudence review and the research literature review point to the need for the following actions to mitigate the risk of harm associated with the performance of cervical spine manipulation:

  • Action One: Ensure that the patient provides written informed consent prior to initiating treatment which includes a discussion about the risk associated with cervical spine manipulation.
  • Action Two: Provide patients with information to assist in the early recognition of a serious adverse event.

During Voltaire’s time, this famous quote was largely correct. But today, things are very different, and I often think this ‘bon mot’ ought to be re-phrased into ‘The art of alternative medicine consists in amusing the patient, while medics cure the disease’.

To illustrate this point, I shall schematically outline the story of a patient seeking care from a range of clinicians. The story is invented but nevertheless based on many real experiences of a similar nature.

Tom is in his mid 50s, happily married, mildly over-weight and under plenty of stress. In addition to holding a demanding job, he has recently moved home and, as a consequence of lots of heavy lifting, his whole body aches. He had previous episodes of back trouble and re-starts the exercises a physio once taught him. A few days later, the back-pain has improved and most other pains have subsided as well. Yet a dull and nagging pain around his left shoulder and arm persists.

He is tempted to see his GP, but his wife is fiercely alternative. She was also the one who dissuaded  Tom from taking Statins for his high cholesterol and put him on Garlic pills instead. Now she gives Tom a bottle of her Rescue Remedy, but after a week of taking it Tom’s condition is unchanged. His wife therefore persuades him to consult alternative practitioners for his ‘shoulder problem’. Thus he sees a succession of her favourite clinicians.

THE CHIROPRACTOR examines Tom’s spine and diagnoses subluxations to be the root cause of his problem. Tom thus receives a series of spinal manipulations and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.

THE ENERGY HEALER diagnoses a problem with Tom’s vital energy as the root cause of his persistent pain. Tom thus receives a series of healing sessions and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.

THE REFLEXOLOGIST examines Tom’s foot and diagnoses knots on the sole of his foot to cause energy blockages which are the root cause of his problem. Tom thus receives a series of most agreeable foot massages and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.

THE ACUPUNCTURIST examines Tom’s pulse and tongue and diagnoses a chi deficiency to be the root cause of his problem. Tom thus receives a series of acupuncture treatments and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.

THE NATUROPATH examines Tom and diagnoses some form of auto-intoxication as the root cause of his problem. Tom thus receives a full program of detox and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.

THE HOMEOPATH takes a long and detailed history and diagnoses a problem with Tom’s vital force to be the root cause of his pain. Tom thus receives a homeopathic remedy tailor-made for his needs and feels a little improved after taking it for a few days. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore tries to make another appointment for him.

But this time, Tom had enough. His pain has not really improved and he is increasingly feeling unwell.

At the risk of a marital dispute, he consults his GP. The doctor looks up Tom’s history, asks a few questions, conducts a brief physical examination, and arranges for Tom to see a specialist. A cardiologist diagnoses Tom to suffer from coronary heart disease due to a stenosis in one of his coronary arteries. She explains that Tom’s dull pain in the left shoulder and arm is a rather typical symptom of this condition.

Tom has to have a stent put into the affected coronary artery, receives several medications to lower his cholesterol and blood pressure, and is told to take up regular exercise, lose weight and make several other changes to his stressful life-style. Tom’s wife is told in no uncertain terms to stop dissuading her husband from taking his prescribed medicines, and the couple are both sent to see a dietician who offers advice and recommends a course on healthy cooking. Nobody leaves any doubt that not following this complex (holistic!) package of treatments and advice would be a serious risk to Tom’s life.

It has taken a while, but finally Tom is pain-free. More importantly, his prognosis has dramatically improved. The team who now look after him have no doubt that a major heart attack had been imminent, and Tom could easily have died had he continued to listen to the advice of multiple non-medically trained clinicians.

The root cause of his condition was misdiagnosed by all of them. In fact, the root cause was the atherosclerotic degeneration in his arteries. This may not be fully reversible, but even if the atherosclerotic process cannot be halted completely, it can be significantly slowed down such that he can live a full life.

My advice based on this invented and many real stories of a very similar nature is this:

  • alternative practitioners are often good at pampering their patients;
  • this may contribute to some perceived clinical improvements;
  • in turn, this perceived benefit can motivate patients to continue their treatment despite residual symptoms;
  • alternative practitioner’s claims about ‘root causes’ and holistic care are usually pure nonsense;
  • their pampering may be agreeable, but it can undoubtedly cost lives.

George Vithoulkas * (GV) is one of today’s most influential lay-homeopaths, a real ‘super guru’. He has many bizarre ideas; one of the most peculiar one was recently outlined in his article entitled ‘An innovative proposal for scientific alternative medical journals’. Here are a few excerpts from it:

…the only evidence that homeopathy can present to the scientific world at this moment are these thousands of cured cases. It is a waste of time, money, and energy to attempt to demonstrate the effectiveness of homeopathy through double blind trials.

… the international “scientific” community, which has neither direct perception nor personal experience of the beneficial effects of homeopathy, is forced to repeat the same old mantra: “Where is the evidence? Show us the evidence!” … the successes of homeopathy have remained hidden in the offices of hardworking homeopaths – and thus go largely ignored by the world’s medical authorities, governments, and the whole international scientific community…

… simple questions that are usually asked by the “gnorant”, for example, “Can homeopathy cure cancer, multiple sclerosis, ulcerative colitis, etc.?” are invalid and cannot elicit a direct answer because the reality is that many such cases can be ameliorated significantly, and a number can be cured…

A journal could invite a selected number of good prescribers from all over the world as a start to this project and let them contribute to their honest experience and results, as well as their failures. The possibilities and limitations would soon be revealed…

I admit that an argument against accepting cases is that it is possible that false or unreliable information could be provided. This risk could be minimized by preselecting a well-known group of good prescribers, who could be asked to submit their cases, at least in the first phase of such a radical change in the policy of the journals…

This way, instead of rejecting important homeopathic case studies, in the name of a dry intellectualism and conservatism, homeopathy journals (including alternative and complementary journals) could become lively and interesting: initiating debates and discussions on real issues of therapeutics in medicine…

Our own “Evidence Based Medicine” lies in the multitude of chronic cases treated with homeopathy that we can present to the world and on the better quality of life that such cures offer.

END OF QUOTES

So, GV wants homeopathy to thrive by means of publishing lots of case reports of patients who benefitted from homeopathy. And he believes that this suggestion is ‘innovative’? It is not! Case reports were all the rage 150 years ago before medicine started to become a little more scientific. And today, there are several journals specialising in the publication of case-reports, hundreds of journals that like accepting them, as well as dozens of websites that do little else but publishing case reports of homeopathy.

But case reports essentially are anecdotes. Medicine finally managed to progress from its dark ages when we realised how unreliable case reports truly are. To state it yet again (especially for GV who seems to be a bit slow on the uptake): THE PLURAL OF ANECDOTE IS ANECDOTES, NOT EVIDENCE!

In the above article, GV claims that ‘it is a waste of time, money, and energy to attempt to demonstrate the effectiveness of homeopathy through double blind trials.’ That is most puzzling because, only a few years ago, he did publish this:

Alternative therapies in general, and homeopathy in particular, lack clear scientific evaluation of efficacy. Controlled clinical trials are urgently needed, especially for conditions that are not helped by conventional methods. The objective of this work was to assess the efficacy of homeopathic treatment in relieving symptoms associated with premenstrual syndrome (PMS). It was a randomised controlled double-blind clinical trial. Two months baseline assessment with post-intervention follow-up for 3 months was conducted at Hadassah Hospital outpatient gynaecology clinic in Jerusalem in Israel 1992-1994. The subjects were 20 women, aged 20-48, suffering from PMS. Homeopathic intervention was chosen individually for each patient, according to a model of symptom clusters. Recruited volunteers with PMS were treated randomly with one oral dose of a homeopathic medication or placebo. The main outcome measure was scores of a daily menstrual distress questionnaire (MDQ) before and after treatment. Psychological tests for suggestibility were used to examine the possible effects of suggestion. Mean MDQ scores fell from 0.44 to 0.13 (P<0.05) with active treatment, and from 0.38 to 0.34 with placebo (NS). (Between group P=0.057). Improvement >30% was observed in 90% of patients receiving active treatment and 37.5% receiving placebo (P=0.048). Homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo. The use of symptom clusters in this trial may offer a novel approach that will facilitate clinical trials in homeopathy. Further research is in progress.

I find this intriguing, particularly because the ‘further research’ mentioned prominently in the conclusions never did surface! Perhaps its results turned out to be unfavourable to homeopathy? Perhaps this is why GV dislikes RCTs these days? Perhaps this is why he prefers case reports such as this one which he recently published:

START OF QUOTE

An 81-year-old female patient was admitted in July 2015 to the Cardiovascular Surgery Department of a hospital in Bucharest for an aortic valve replacement surgery.

The patient had a history of mild hypertension, insulin-dependent type 2 diabetes, coronary artery disease, congestive heart failure NYHA 2, severe aortic stenosis, moderate mitral regurgitation, mild pulmonary hypertension, bilateral carotid atheromatosis with a 50% stenosis of the left internal carotid artery, complete right mastectomy for breast cancer (at that moment in remission).

After a preoperative evaluation and preparation, the surgery was completed with the replacement of the aortic valve with a bioprosthesis (Medtronic Hancock II Ultra no. 23) and myocardial revascularization by using a double aortic-coronary bypass.

The post-operatory evolution was a good one in terms of the heart disease. However, the patient did not regain consciousness after the anaesthesia, maintaining a deep comatose state (GCS 7 points – E1V2M4).

A brain CT was performed the third day postoperatively, showing no recent ischemic or haemorrhagic cerebral lesions, moderate diffuse cerebral atrophy and carotid atheromatosis.

After the surgery, the patient was admitted to the Intensive Care Unit and was treated by using a multidisciplinary approach. The patient was treated with inotropic, antiarrhythmic, and diuretic drugs, insulin and antidiabetic drugs were used in order to keep the blood sugar levels under control. The patient was kept hydrated and the electrolytes balanced by using an i.v. line, prophylaxis for deep vein thrombosis, and pulmonary thromboembolism was performed by using low molecular weight heparin. Prophylaxis for bedsores was also performed by using a pressure relieve air mattress.

The patient went into acute respiratory distress, needing mechanical ventilation in order to maintain oxygenation.

Despite these complex and correctly performed therapeutic efforts, the patient did not regain consciousness and was still in a deep coma in the fourteenth day post-operatory (GCS 7 points – E1V2M4), without having a confirmed medical explanation.

At that point, the patient’s family requested a consult from a homeopathic specialist.

The homeopathic examination, which was performed in the fourteenth day postoperatively, revealed the following: old, comatose, tranquil patient, with pale and cold skin, with the need to uncover herself (the few movements that she made with her hands were to remove her blanket and clothes, as if she wanted more air – “thirst for air”), abdominal distension, and bloating.

The thorough evaluation of the patient and the analysis of her symptoms led us to the remedy most appropriate for this critical situation – Carbo Vegetabilis.

Homeopathic treatment was initiated the same day, by using Carbo Vegetabilis 200CH 7 granules twice a day, administered diluted in 20ml of water by using a nasogastric tube.

The patient’s evolution was spectacular. The next day after the initiation of the treatment (fifteenth day postoperatively) the patient was in a superficial coma (GCS 11 points – E2V4M5), and the following day she regained consciousness. Carbo Vegetabilis was administered in the same dose for a total of five days (including the nineteenth day postoperatively).

After these five days, the case was reassessed from a homeopathically point of view and the second evaluation revealed the following: severely dyspnoeic patient (even talking caused exhaustion) with pale skin, severe fatigue aggravated by the slightest movements, a weakness sensation located in the chest area, extreme lack of energy, the wish “to be left alone”.

Considering the state of general exhaustion the patient was in at that moment and her lack of energy, the homeopathic treatment was changed to a new remedy: Stanum metallicum 30CH 7 granules administered sublingually twice a day for a week.

After the administration of the second remedy, the patient’s general condition improved dramatically: she started eating, she was able to get up in a sitting position with only little help, her fatigue diminished significantly.

The patient was then transferred to a recovery clinic in Cluj-Napoca in order to continue the cardiovascular recovery treatment. During her three-week admission in the clinic, she followed an individualized cardiovascular recovery program, which led to her ability to walk short distances with minimal support and has was released from the hospital in September 2015.

The following weeks after release, the patient recovered almost entirely, both physically and mentally. She was able to retake her place in her family and in society in general.

END OF QUOTE

One has to be a homeopath (one who is ignorant of the ‘post hoc propter hoc fallacy’) to believe in a causal link between the intake of the homeopathic remedy and the recovery of this patient. Thankfully, comatose patients do re-gain consciousness all the time! Even without homeopathy! But GV seems to not know that. In the discussion of this paper, he even states this: “ even after a well-conducted therapy, this condition leads to the death of the patient.” Is it ethical to publish such falsehoods, I wonder?

As far as the case report goes, the homeopathic remedy might even have delayed the process – perhaps the patient would have re-gained consciousness quicker and more completely without it! My hypothesis (homeopathy cased harm) is exactly as strong and silly as the one (homeopathy cased benefit) of GV. Anecdotes will never be able to answer the question as to who is correct.

One has to be a homeopath (and a daft one at that) to believe that this sort of evidence will lead to the acceptance of homeopathy by the scientific community. No journal will take GV seriously. No editor can be that stupid!

Oooops! Hold on, I might be wrong here.

Dr Peter Fisher, editor of the journal ‘Homeopathy’ just published an editorial ( Fisher P, Homeopathy and intellectual honesty, Homeopathy (2017), see also my previous post) stating that, in future, ‘we will increase publication of well-documented case-reports’.

Did I just claim that no editor can be that stupid?

 

 

 

  • I should declare a conflict of interest: when he got his ‘Right Livelihood Award’, GV sent me (and other prominent homeopathy-researchers) some of the prize money (I think it was around £ 1000) to support my research in homeopathy. I used it for exactly that purpose.

 

Shinrin-yoku means “taking in the forest atmosphere” or “forest bathing.” It was developed in Japan during the 1980s and has, according to its proponents, become a cornerstone of preventive health care and healing in Japanese medicine. Researchers primarily in Japan and South Korea have established a robust body of scientific literature on the health benefits of spending time under the canopy of a living forest… there have been many scientific studies that are demonstrating the mechanisms behind the healing effects of simply being in wild and natural areas. (some of this research is available here). For example, many trees give off organic compounds that support our “NK” (natural killer) cells that are part of our immune system’s way of fighting cancer.

The claimed benefits of Shinrin-yoku are remarkable:

  • Boosted immune system functioning, with an increase in the count of the body’s Natural Killer (NK) cells.
  • Reduced blood pressure
  • Reduced stress
  • Improved mood
  • Increased ability to focus, even in children with ADHD
  • Accelerated recovery from surgery or illness
  • Increased energy level
  • Improved sleep
  • Deeper and clearer intuition
  • Increased flow of energy
  • Increased capacity to communicate with the land and its species
  • Increased flow of eros/life force
  • Deepening of friendships
  • Overall increase in sense of happiness

But is any of this really true?

The aim of this state-of-the-art review was to summarise empirical research conducted on the physiological and psychological effects of Shinrin-Yoku. Research published from 2007 to 2017 was considered. A total of 64 studies met the inclusion criteria. According to the authors, they show that health benefits associated with the immersion in nature continue to be currently researched. Longitudinal research, conducted worldwide, is needed to produce new evidence of the relationships associated with Shinrin-Yoku and clinical therapeutic effects. Nature therapy as a health-promotion method and potential universal health model is implicated for the reduction of reported modern-day “stress-state” and “technostress.”

Odd?

Yes!

A look at the primary studies reveals that they are usually small and of poor quality.

Perhaps a brand new  review aimed more specifically at evaluating preventive or therapeutic effects of Shinrin-Yoku on blood pressure can tell us more. The authors considered all published, randomized, controlled trials, cohort studies, and comparative studies that evaluated the effects of the forest environment on changes in systolic blood pressure. Twenty trials involving 732 participants were reviewed. Systolic and diastolic blood pressure of patients submitted to the forest environment was significantly lower than that of controls. The authors concluded that this systematic review shows a significant effect of Shinrin-yoku on reduction of blood pressure.

I find this paper odd as well:

  • it lacks important methodological detail;
  • the authors included not just controlled clinical trials but all sorts of ‘studies’;
  • there is no assessment of the methodological rigor of the primary trials (from what I could see, they were mostly too poor to draw any conclusions from them).

What does all of this mean?

I have no problems in assuming that relaxation in a forest is beneficial in many ways and a nice experience.

But why call this a therapy?

It is relaxation!

Why make so many unsubstantiated claims?

And why study it in such obviously flawed ways?

All this does, I fear, is giving science a bad name.

Guest post by Richard Rawlins MB BS MBA FRCS

Doctors who are registered medical practitioners (RMPs) must comply with the standards of practice set down by the General Medical Council. ‘Homeopathy’ is a specific system of medical care, devised by Dr Samuel Hahnemann in the nineteenth century, and comprises two distinct dimensions: (i) the establishment of a constructive therapeutic relationship between an empathic homeopath and a patient. This may provide benefit due to the non-specific effects of condolence, counselling, and care – and should be a component of the practice of all doctors in any event; (ii) the homeopathically prepared (HP) remedies that are generally prescribed. To avoid confusion, these two dimensions should not be conflated.

HP remedies may be obtained over the counter, prescribed by lay homeopaths and even given out by dentists and nurses on the grounds that “30C homeopathic arnica helps bruising”. The US Federal Trades Commission has stated that “The Commission will carefully scrutinize the net impression of OTC homeopathic advertising or other marketing employing disclosures to ensure that it adequately conveys the extremely limited nature of the health claim being asserted…accordingly, unqualified disease claims made for homeopathic drugs must be substantiated by competent and reliable scientific evidence.” (FTC Policy statement 2017).

Special focus should be brought to bear on the ethical, intellectual and professional obligations of those doctors registered as medical practitioners by the GMC and practicing homeopathy in the UK. Some homeopaths may intend taking advantage of gullible and vulnerable patients. Here I take it that those practitioners who prescribe homeopathic remedies sincerely do believe they have worthwhile effects, but I contend such practice generally fails to comply with ethical and professional standards as set down by the GMC. That is to be deprecated.

Systems to regulate medical practice in the British Isles have been devised since the middle ages. In 1518, Thomas Linacre founded the College of Physicians – based on systems he had seen in Europe. From 1704, the Society of Apothecaries licensed its members to prescribe and dispense medicines, and developed the profession of general practice. In order to protect the public from charlatans, quacks and fraudsters more effectively, the Medical Act of 1858 established formal statutory regulation of doctors by the General Medical Council. Registrants who are not deemed fit to practice may be struck off the register. They can still practice, but not as registered medical practitioners. They can still use the title ‘doctor’ (as can anyone), but not for fraudulent purposes.

Dr Samuel Hahnemann qualified in Saxony in 1781 and was a good doctor, but he became disillusioned with many of the practices and practitioners of his day. He wrote about his fellow doctors: “Precious and fragile human life, so easily destroyed, was frequently placed in jeopardy at the hands of these perverted people, especially since bleedings, emetics, purges, blistering plaster, fontanels, setons, caustics and cauterisations were used.” In 1796 he wrote to a friend, “I renounced the practice of medicine that I might no longer incur the risk of doing injury, and I engaged in chemistry exclusively and in literary occupations.”

Hahnemann went on to develop his own alternative system of health care, which he styled ‘Homoeopathy’. Published as the Organon of the Healing Arts in 1810, Hahnemann set out an idiosyncratic medical system based on identifying ‘remedies’ which in large doses, could produce symptoms comparable to those suffered by the patient. The remedies he prescribed were prepared with serial dilutions so that no active principle remained. Today’s homeopaths hold that a remedy’s ‘vital force’, ‘healing energy’ or ‘memory’ provides therapeutic benefit. That may be the case, but the consensus of informed scientific and medical opinion is that any effects of ‘homeopathy’ are as a result of contextual placebo effects. The remedies themselves cannot and do not have any effect. England’s Chief Medical Officer has described homeopathy’s principles as ‘rubbish’. The government’s Chief Scientific Adviser, Sir Mark Walport has said he would tell ministers, “My view, scientifically, is absolutely clear: homeopathy is nonsense. The most it can have is a placebo effect.” Simon Stevens, CEO of the NHS, when interviewed on Radio 4 said he agrees with Sir Mark – yet failed to explain why he had not included homeopathic remedies in the 2017 list of NHS proscribed medicines. That stance is being reviewed.

The GMC states, “Patients must be able to trust doctors with their lives and health. To justify that trust you must show respect for human life and make sure your practice meets the standards expected.” Those standards are set down in the GMC’s Good Medical Practice which advises, “Serious or persistent failure to follow this guidance will put your registration at risk.” The GMC standards are coherent with those of the American Medical Association’s Principles of Medical Ethics (2016).

In précis, the most relevant and important GMC standards are:

  • Make the care of your patient your first concern.
  • Give patients the information they want or need in a way they can understand.
  • Be honest and open and act with integrity.
  • Never abuse your patients’ trust in you or the public’s trust in the profession.
  • You are personally accountable for your professional practice and must always be prepared to justify your decisions and actions.
  • You must  prescribe drugs or treatment only when you are satisfied that the drugs or treatment serve the patient’s needs.                                                                                                                                             
  • You must provide effective treatments based on the best available evidence.
  • You must be satisfied that you have consent or other valid authority before you carry out any examination, investigation or provide treatment.
  • You must make good use of the resources available to you.

I contend that medical practitioners who prescribe homeopathic remedies regularly fail to meet these standards. They know perfectly well that the best available evidence indicates no support for the assertion that homeopathic remedies ‘serve the patient’s needs’, except as placebos; that the treatments have no specific effects; that the remedies are placebos; and that resources are wasted by expenditure on these ineffective remedies. Medical homeopaths invariably do not give patients this information; they fail to obtain properly informed consent; they do not justify their decisions and actions rationally; and they may be obtaining financial advantage by misrepresentation to insurance companies or the NHS. This is an abuse of the public’s trust in the medical profession.

The issue of informed consent is particularly important. GMC guidance states that, “The doctor uses specialist knowledge and experience and clinical judgement, and the patient’s views and understanding of their condition, to identify which investigations or treatments are likely to result in overall benefit for the patient. The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice. …Before accepting a patient’s consent, you must consider whether they have been given the information they want or need, and how well they understand the details and implications of what is proposed. This is more important than how their consent is expressed or recorded.”

The GMC states that, “in order to have effective discussions with patients about risk, you must identify the adverse outcomes that may result from the proposed options… risks can take a number of forms, but will usually be: side effects; complications; failure of an intervention to achieve the desired aim.” The risk of wasting money on ineffective remedies, whether NHS or private, and of delaying treatment known to be effective should also be discussed.

Homeopaths acknowledge that after ministration of remedies, some patients experience ‘aggravations’ – a worsening of symptoms, but they advise this is evidence that the remedy is ‘working’. Medical consensus is more likely to suggest ‘aggravations’ are evidence of an underlying psychological component to the patient’s condition. Suggestions that remedies themselves have any effect, good or bad, is misrepresentation and may be fraud. Offering patients sugar pills with a claim the pills have therapeutic effects means lying to them, and is an abuse of trust.

Homeopaths’ system of diagnosis and prescription of remedies requires them to have beliefs for which there is no plausible evidence base. The Oxford Dictionary defines ‘belief’ as “assent to a proposition, statement or fact, especially on the grounds of testimony or authority, or in the absence of proof or conclusive evidence.” It might be acceptable to practice ‘homeopathy’ as a counselling modality, providing the practitioner complies with the GMC standard that, “You must not express your personal beliefs to patients in ways that exploit their vulnerability or are likely to cause them distress.”

Homeopaths are invariably non-compliant in obtaining fully informed consent. Such a failing is an abuse of patients’ trust in the medical profession. Doctors might be determined to be unfit to practice unless they clearly justify their prescriptions, and identify the evidence that supports them. All these issues should also be explored during the doctor’s annual appraisal, without which a registered medical practitioner will not be licensed to practice. Even registration without a licence requires compliance with the standards. Appraisal can be carried out by non-homeopaths, as the issue is not the assessment of the standard of ‘homeopathic practice’, but compliance with GMC standards of good medical practice.

If a medical homeopath wishes to be GMC compliant, they must properly inform patients about contentious issues. I suggest that consent should be obtained along the lines: “I propose prescribing you a remedy comprising sugar pills impregnated with a solution which has been diluted to such an extent that a sphere of water the size of the Earth’s average radius to the Sun would probably contain no more than one molecule of the original substance. Nevertheless, my clinical experience suggests to me that this remedy will improve your condition. You need to understand that colleagues who practise conventional evidence-based scientific medicine regard my belief as implausible and the methods I use as ‘alternative.’ I believe the remedy will help you, but I have no evidence accepted by the majority of doctors that the intervention I propose will achieve the desired effects. I do not believe that taking a homeopathic remedy will delay any other treatment which might reasonably help your condition and I invite you to take this remedy with understanding of the issues I have outlined.” A copy of the consent should be placed in the patient’s records.

Those who defend the right of registered medical practitioners to prescribe HP remedies do so with arguments fatally holed by a myriad of logical fallacies. Some arguments are (with fallacies in parenthesis):

  • “Homeopathy has been used for over two hundred years” (appeal to tradition and argument from ignorance);
  • “It has become very popular and is what patients want (appeal to popularity);
  • “Homeopathy has the capacity to help patients” (red herring, because present consideration is about the value of HP remedies, not relationships);
  • “Remedies are cheap” (red herring);
  • “Homeopathy does not do any harm” (irrelevant and a red herring);
  • “Pharmaceuticals have side effects” (tu quoque and red herring);
  • “The Royal Family use it” (appeal to irrelevant authority);
  • “The remedies enhance the doctor/patient relationship (straw man);
  • “Science does not know everything” (red herring and false dichotomy);
  • “Those who oppose us don’t understand homeopathy” (argumentum ad hominem and ‘poisoning the well’);
  • “I have the evidence of patients’ anecdotes and testimonials” (pseudoscience, confirmation bias and cherry picking);
  • “Homeopathic doctors are caring people” (red herring and straw man);
  • “I’ve got much evidence of  patients taking remedies and getting better” (post hoc ergo propter hoc – ‘after this, therefore because of this’ – confusion of coincidence with causation).

The latter most perverse fallacy is the foundation of homeopathic practice, based on identifying a remedy whereby ‘like cures like’ – a principle based on post hoc fallacy for which there is no scientifically credible evidence.

Unless and until medical homeopaths understand the intellectual environment in which they practice, are prepared to properly inform their patients, and obtain consent for treatment having done so, they should not prescribe homeopathic remedies. Fortunately, there is no evidence that patients who are prescribed HP remedies by empathic GMC registered homeopaths have any different outcomes from those prescribed pure sugar pills – even if they are told they are placebos. However, trust in the medical profession can only be maintained if deceptive practices are set aside and full explanations for proposed interventions are offered. Given the scientific consensus, patients have to face up to the fact that to the highest degree of probability, HP remedies have no value. Regrettably, too many patients and even homeopaths are in denial. Medical homeopaths should continue to serve their patients with care, compassion and intellectual honesty, but if they are to comply with the standards required for GMC registration, they should not prescribe homeopathically prepared remedies.

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