test of time
I have to admit, I only read the DAILY MAIL, if I have to (and certainly not today). This is probably why I missed this article announcing the 1st traditional Chinese medicine to be licensed in the UK.
The plant Sigesbeckia, which has an unpleasant smell, is renowned for its ability to treat aches and pains – including those caused by arthritis. It is the active ingredient in Phynova Joint and Muscle Relief Tablets, which have just been licensed by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency.
The directive also made it more difficult for medicines to get a licence as it demanded they had to have been in use for 30 years, of which at least 15 years had to be in the EU. Some Western herbal medicines have managed to gain licences in a process costing thousands of pounds to verify their ingredients. But the Phynova tablets are the first traditional Chinese medicine to be approved.
Robert Miller, chief executive of Oxford-based Phynova, said he was ‘extremely proud’, adding: ‘This has come from years of working with our Chinese colleagues. ‘Britain can now benefit from having access to high quality, regulated Chinese medicines.’ He also said that the company is planning to apply for a licence for a second traditional Chinese medicine, a cold and flu remedy.
Dr Chris Etheridge, a medical herbalist and adviser to Potter’s Herbals, celebrated the ‘good news’, adding that Sigesbeckia, which is not commonly used in the West, ‘offers an alternative to those who prefer not to take non-steroidal anti-inflammatory drugs for muscle and joint pain’.
But Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, warned that the new product demonstrates the difficulties the EU rules created for supplying herbal products safely to the public. He said it is ‘almost impossible to satisfy the licensing conditions’. He added that some people have therefore turned to the internet to buy unlicensed products, but this means they have ‘no idea whether they are safe or effective’.
Exciting enough to do a quick search for the evidence. Are there any clinical trials to show or suggest that this herbal remedy does anything other than filling the bank account of the manufacturer? Sadly, the answer seems to be NO! At least, I could not find a single such study (if anyone knows more, I’d be pleased to stand corrected).
Frustrated I looked at the website of the manufacturer. Here I found this:
Exclusively containing Sigesbeckia extract, Phynova Joint and Muscle Relief Tablets is a traditional herbal medicinal product used for the relief of backache, rheumatic, joint and muscle pain as well as minor sports injuries. Sigesbeckia has been used for thousands of years around the world to relieve painful joints and muscles.
– Relief from joint & muscle pain
– Gentle on the stomach
– No known side effects
– No known drug indications or contraindications
– Can be taken with or without food
What can Sigesbeckia be used to treat?
Traditionally used for arthritic pain, rheumatic pain, back pain and sciatica. Today, Sigesbeckia can be used for;
Back pain can occur through a sprain or strain, spasms, nerve compression, herniated discs and other problems in your lower, middle and upper back.
Poor posture, lifting and stretching, sudden movements placing strain on your lower back and sports injuries, are amongst the main culprits for causing back pain.
Minor sports injuries
Minor sports injuries can be caused by an accident such as a fall or blow, not warming up properly before exercise, pushing yourself too hard and not using the appropriate equipment or perhaps poor technique.
Rheumatic and muscular pain
Common causes of rheumatic and muscle pain can be due to; tension and stress, lack of minerals, certain medication, dehydration, sprains and strains, sleep deficiency, too much physical activity and sometimes other underlying health conditions and diseases.
General aches and pains in muscles and joints
Overexertion due to a new exercise routine or from a sprain or strain can cause general aches and pains in muscles and joints. But so too can modern day busy life. The impact on our bodies can trigger aches and pains in your muscles and joints and lower your resistance to illness and disease.
The Benefit of Sigesbeckia extract
One of the benefits of Sigesbeckia extract, as used in approved licensed products, is that it has no known side effects or interactions with other medications according to the Summary of Product Characteristics (SmPC). Always check that the product you purchase is an approved Traditional Herbal Medicine Product in the UK.
In summary: Look after your joints and muscles with Sigesbeckia
Our bodies are all different, and our approach and tolerances will vary. Used for over a thousand years and known for its anti-inflammatory and mobility benefits alongside being used for joint and muscle pain; Sigesbeckia is a herbal medicine that works best when used over time.
Looking for a traditional remedy for joint and muscle relief? Why not try Sigesbeckia?
But again no sign of a clinical trial to back up this plethora of therapeutic claims. How can this be? The answer lies in the directive mentioned in the Mail article. To obtain a licence that enables the manufacturer to make therapeutic claims, a herbal remedy merely needs to demonstrate that it has been in use for 30 years, of which at least 15 years had to be in the EU.
I think I understand the intention of the directive. But I would nevertheless have thought that, 4 years after obtaining a license, the manufacturer could have conducted a study to test whether the product works. In my view this should be a moral and ethical, if not legal obligation. The ‘test of time’ is woefully insufficient and unreliable and no basis for generating progress or securing the best interests of patients.
Considering the total lack of efficacy and safety data, do you agree that the above comment by Michael McIntyre are ironic to the extreme? And do you agree that manufacturers who manage to obtain such a license should be obliged to deliver a proof of efficacy within a reasonable period of time?
Realgar, α-As4S4, is an arsenic sulfide mineral, also known as “ruby sulphur” or “ruby of arsenic”. It is a soft, sectile mineral occurring in monoclinic crystals, or in granular, compact, or powdery form, often in association with the related mineral, orpiment (As2S3).
In Traditional Chinese Medicine (TCM), realgar is often used in combination with herbs. An investigation found a total of 191 different, realgar-containing traditional Chinese patent medicines, and about 87% of them were for oral application. Realgar is said to:
counteract toxic pathogen both externally and internally. For abscess swelling and sores, it can be used singly or in compound prescription for external application mostly. When taken internally, it is combined with blood-activating and abscess-curing herbs to obtain the action of activating blood to relieve swelling, removing toxicity to cure sores. For example, it is combined with Ru Xiang, Mo Yao and She Xiang in Xing Xiao Wan from Wai Ke Quan Sheng Ji. For itching of skin due to scabies and ringworm, it is often combined with dampness-astringing and itching-relieving herbs to obtain actions of killing parasites and curing ringworm, astringing dampness and relieving itching. For instance, it is combined with the same dose of Bai Fan in powder mixed with clear tea for external application in Er Wei Ba Du San from Yi Zong Jin Jian. For poisonous insect bite, it is mixed with sesame oil and then applied on the afflicted sites.
This herb can kill parasites so it is indicated for intestine track parasites. For roundworm induced abdominal pain, it is often combined with other roundworm-killing herbs to reinforce action. For instance, it is combined with Qian Niu Zi and Bing Lang, etc. in Qian Niu Wan from Shen Shi Zun Sheng Shu. For anus pruritus caused by pinworm, it can be made into gauze strip by mixing with vaseline, and then inserted into the anus.
In addition, according to some ancient formulas, this herb can dispel phlegm and check malaria for internal application, so it can also be indicated for epilepsy, asthma and malaria.
Longtime topical over-dose or oral intake of realgar can cause chronic arsenic poisoning and even death. Chinese authors recently published the case of a 35-year-old Chinese man, who was diagnosed with severe psoriasis and died of fatal acute arsenic poisoning after he applied a local folk prescription ointment containing mainly realgar to the affected skin for about 4 days. The autopsy showed multiple punctate haemorrhages over the limbs, pleural effusion, oedematous lungs with consolidation, mild myocardial hypertrophy and normal-looking kidneys. The histopathological examination of renal tissue showed severe degeneration, necrosis and desquamation of renal tubular epithelial cells, presence of protein cast and a widened oedematous interstitium with interstitial fibrosis. The presence of arsenic in large amount in the ointment (about 6%), in blood (1.76 μg/mL), and in skin (4.71 μg/g), were confirmed analytically. The authors also review 7 similar cases in literature.
My advice is that, when you see recommendations by TCM practitioners like this one
the typical internal dose of realgar is between 0.2 and 0.4 grams, decocted in water and taken up to two times per day. Some practitioners may recommend slightly higher doses (0.3-0.9 grams). Larger doses of realgar may be used if it is being applied topically
you think again and consider that TCM really is not a form of healthcare that can be trusted to be safe.
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.
Pertussis (whooping-cough) is a serious condition. Today, we have vaccinations and antibiotics against it and therefore it is rarely a fatal disease. A century or so, the situation was different. Then all sorts of quacks claimed to be able to treat pertussis and many patients, particularly children, died.
This article starts with this amazing introduction: Osteopathic physicians may want to consider using osteopathic manipulative treatment (OMT) as an adjunctive treatment modality for pertussis; however, suitable OMT techniques are not specified in the research literature.
For the paper, the author then searched the historical osteopathic literature to identify OMT techniques that were used in the management of pertussis in the pre-antibiotic era. The 24 identified sources included 8 articles and 16 book contributions from the years 1886 to 1958. Most sources were published within the first quarter of the 20th century. Commonly identified OMT techniques included mobilization techniques, lymphatic pump techniques, and other manipulative techniques predominantly in the cervical and thoracic regions.
The author concluded that the wealth of OMT techniques for patients with pertussis that were identified suggests that pertussis was commonly treated by early osteopaths. Further research is necessary to identify or establish the evidence base for these techniques so that in case of favorable outcomes, their use by osteopathic physicians is justified as adjunctive modalities when encountering a patient with pertussis.
I found it hard to decide whether to laugh or to cry after reading this. One could easily have a good giggle about the silliness of the idea to revive obsolete techniques for treating a potentially serious infection. One the other hand, I cannot help but ask myself:
- Is there any suggestion at all that OMT was successful in treating pertussis?
- If the answer is negative (and I fear it is), why would anyone spend considerable resources to establish the evidence base for these techniques?
- Do osteopaths believe in progress at all?
- Do they really think that there is even a remote chance that mobilization techniques, lymphatic pump techniques, and other manipulative techniques will, one day, come back as adjunctive therapies for pertussis?
- Do they not believe in a rational approach to prioritising medical research such that scarce resources are spent ethically and wisely?
You may think that none of this really matters. The author of this paper is just a lone loon! That may well be so, but even lone loons can do a lot of harm, if they convince consumers of their bizarre ideas.
But surely, the profession of osteopathy would not tolerate this, you say. I am not convinced. The article was published in the Journal of the American Osteopathic Association. This seems significant to me. It is comparable to the JAMA or the BMJ publishing an article calling for a programme of research into the possible benefits of blood-letting as a treatment of pneumonia!
We all know Epsom salt, don’t we? This paper provides an interesting history of it: The purgative effect of the waters of Epsom, in southern England, was first discovered in the early seventeenth century. Epsom subsequently developed as one of the great English spas where high society flocked to take the medicinal waters. The extraction of the Epsom Salts from the spa waters and their chemical analysis, the essential feature of which was magnesium sulphate, were first successfully carried out by Doctor Nehemiah Grew, distinguished as a physician, botanist and an early Fellow of the Royal Society. His attempt to patent the production and sale of the Epsom Salts precipitated a dispute with two unscrupulous apothecaries, the Moult brothers. This controversy must be set against the backcloth of the long-standing struggle over the monopoly of dispensing of medicines between the Royal College of Physicians and the Worshipful Society of Apothecaries of London.
Epsom salt has the reputation of being very safe. But unfortunately, even something as seemingly harmless as Epsom salt can become dangerous in the hand of people who have little understanding of physiology and medicine. Indian doctors have just published a paper in (‘BMJ Case Reports’) with the details of a 38-year-old non-alcoholic, non-diabetic man suffering from gallstones. The patient was prescribed three tablespoons of Epsom salt to be taken with lukewarm water for 15 days for ‘stone dissolution’ by a ‘naturopathy practitioner’. He subsequently developed loss of appetite and darkening of urine from the 12th day of treatment and jaundice from the second day after treatment completion. The patient denied fevers, skin rash, joint pains, myalgia, abdominal pain, abdominal distension and cholestatic symptoms.
Examination revealed a deeply icteric patient oriented to time, place and person without an enlarged liver or stigmata of chronic liver disease. Liver function tests were abnormal, and a liver biopsy revealed sub-massive necrosis with dense portal-based fibrosis, mixed portal inflammation, extensive peri-venular canalicular and hepatocellular cholestasis with macro-vesicular steatosis and peri-sinusoidal fibrosis (suggestive of steato-hepatitis) without evidence of granulomas, inclusion bodies or vascular changes suggestive of acute drug-induced liver injury.
After discontinuation of Epsom salt and adequate hydration, the patient had an uneventful recovery with normalisation of liver function tests after 38 days. The Roussel Uclaf Causality Assessment score was strongly suggestive of Epsom salt-induced liver injury.
I was invited to provide a comment and stated that, in my view, this case reminds us:
1) that naturopaths prescribe a lot of nonsense,
2) that not everything which is promoted as natural is safe,
3) that treatments which apparently have ‘stood the test of time’ can still be rubbish, and
4) that even a relatively harmless remedy can become life-threatening, if one takes it at a high dose for a prolonged period of time.
Naturopaths have advocated Epsom salt for gall-bladder problems since centuries, yet there is no good evidence that it works. It is time that alternative practitioners abide by the rules of evidence-based medicine.
A quick Medline search reveals that there is only one further report of a serious adverse effect after Epsom salt intake: a case of fatal hypermagnesemia caused by an Epsom salt enema. A 7-year-old male presented with cardiac arrest and was found to have a serum magnesium level of 41.2 mg/dL (33.9 mEq/L) after having received an Epsom salt enema earlier that day. The medical history of Epsom salt, the common causes and symptoms of hypermagnesemia, and the treatment of hypermagnesemia are reviewed. The easy availability of magnesium, the subtle initial symptoms of hypermagnesemia, and the need for education about the toxicity of magnesium should be of interest to physicians.
… and to alternative practitioners, I hasten to add.
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.
In their now famous 1998 NEJM editorial about alternative medicine, Angell and Kassirer concluded that “It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine — conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Once a treatment has been tested rigorously, it no longer matters whether it was considered alternative at the outset. If it is found to be reasonably safe and effective, it will be accepted. But assertions, speculation, and testimonials do not substitute for evidence. Alternative treatments should be subjected to scientific testing no less rigorous than that required for conventional treatments.”
Then and today, I entirely agree(d) with these sentiments. Years later, the comedian Tim Minchin brought it to the point: “You know what they call alternative medicine that’s been proved to work? – Medicine.” So, comedians have solved the terminology problem, but we, the experts, have not managed to get rid of the notion that there is another type of medicine. Almost 20 years after the above editorial, we still struggle to find the ideal name.
Despite their desperate demand ‘THERE CANNOT BE TWO KINDS OF MEDICINE’, Angell and Kassirer still used the word ALTERNATIVE MEDICINE. On this blog, I usually do the same. But there are many terms, and it is only fair to ask: which one is the most suitable?
- ALTERNATIVE MEDICINE is strictly speaking an umbrella term for modalities (therapy or diagnostic technique) employed as a replacement of conventional medicine; more commonly the term is used for all heterodox modalities.
- CHARLATANERY treatment by someone who professes to have expertise that he does not have.
- COMPLEMENTATY MEDICINE is an umbrella term for modalities usually employed as an adjunct to conventional healthcare.
- COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) an umbrella term for both 1 and 3 often used because the same alternative modality can be employed either as a replacement of or an add-on to conventional medicine.
- COMPLEMENTARY AND INTEGRATIVE MEDICINE (CIM) a nonsensical term recently created by authors of an equally nonsensical BMJ review.
- DISPROVEN MEDICINE is an umbrella term for treatments that have been shown not to work (as proving a negative is usually impossible, there are not many such therapies).
- FRINGE MEDICINE is the term formerly used for alternative medicine.
- HETERODOX MEDICINE is the linguistically correct term for unorthodox medicine (this could be the most correct term but has the disadvantage that consumers are not familiar with it).
- HOLISTIC MEDICINE is healthcare that emphasises whole patient care (as all good medicine is by definition holistic, the term seems problematic).
- INTEGRATED MEDICINE describes the use of treatments that allegedly incorporate ‘the best of both worlds’, i.e. the best of alternative and conventional healthcare (integrated medicine can be shown to be little more than a smokescreen for adopting bogus treatments in conventional medicine).
- INTEGRATIVE MEDICINE is the same as 10 (10 is more common in the UK, 11 is more common in the US).
- NATURAL MEDICINE is healthcare exclusively employing the means provided by nature for treating disease.
- QUACKERY is the deliberate misinterpretation of the ability of a treatment or diagnostic technique to treat or diagnose disease (quackery exists in all types of healthcare).
- TRADITIONAL MEDICINE is healthcare that has been in use before the scientific era (the assumption is that such treatments have stood the test of time).
- UNCONVENTIONAL MEDICINE is healthcare not normally used in conventional medicine (this would include off-label use of drugs, for instance, and therefore does not differentiate well).
- UNORTHODOX MEDICINE the linguistically incorrect but often used term for healthcare that is not normally used in orthodox medicine.
- UNPROVEN MEDICINE is healthcare that lacks scientific proof (many conventional therapies fall in this category too).
These terms and explanations (mostly my own) are meant to bring out clearly that:
- none of them is perfect,
- none has ever been clearly defined,
- none describes the area completely,
- none is without considerable overlap to other terms,
- none is really useful.
My conclusion, after pondering about these terms for many years (it can be an intensely boring issue!), is that the best solution would be to abandon all umbrella terms (see Angell and Kassirer above). Alas, that hardly seems practical when running a blog on the subject. I think therefore that I will continue to (mostly) use the term ALTERNATIVE MEDICINE (consumers understand it best, in my experience) … unless, of course, someone has a better idea.
Traditional and folk remedies have been repeatedly been reported to contain toxic amounts of lead. I discussed this problem before; see here, here, and here. Recently, two further papers were published which are relevant in this context.
In the first article, Indian researchers presented a large series of patients with lead poisoning due to intake of Ayurvedic medicines, all of whom presented with unexplained abdominal pain.
In a retrospective, observational case series from a tertiary care center in India, the charts of patients who underwent blood lead level (BLL) testing as a part of workup for unexplained abdominal pain between 2005 and 2013 were reviewed. The patients with lead intoxication (BLLs >25 μg/dl) were identified and demographics, history, possible risk factors, clinical presentation and investigations were reviewed. Treatment details, duration, time to symptomatic recovery, laboratory follow-up and adverse events during therapy were recorded.
BLLs were tested in 786 patients with unexplained abdominal pain, and high levels were identified in 75 (9.5%) patients of which a majority (73 patients, 9.3%) had history of Ayurvedic medication intake and only two had occupational exposure. Five randomly chosen Ayurvedic medications were analyzed and lead levels were impermissibly high (14-34,950 ppm) in all of them. Besides pain in abdomen, other presenting complaints were constipation, hypertension, neurological symptoms and acute kidney injury. Anemia and abnormal liver biochemical tests were observed in all the 73 patients. Discontinuing the Ayurvedic medicines and chelation with d-penicillamine led to improvement in symptoms and reduction in BLLs in all patients within 3-4 months.
The authors of this paper concluded that the patients presenting with severe recurrent abdominal pain, anemia and history of use of Ayurvedic medicines should be evaluated for lead toxicity. Early diagnosis in such cases can prevent unnecessary investigations and interventions, and permits early commencement of the treatment.
The second article German researchers analysed 20 such ‘natural health products’ (NHPs) from patients with intoxication symptoms. Their findings revealed alarming high concentrations of mercury and/or lead (the first one in “therapeutic” doses). 82 % of the studied NHPs contained lead concentrations above the EU limit for dietary supplements. 62 % of the samples exceeded the limit values for mercury. Elevated blood lead and mercury levels in patients along with clinical intoxication symptoms corroborate the causal assumption of intoxication (s).
The authors concluded that, for NHPs there is evidence on a distinct toxicological risk with alarming low awareness for a possible intoxication which prevents potentially life-saving diagnostic steps in affected cases. In many cases patients do not communicate the events to their physicians or the local health authority so that case reports (e.g. the BfR-DocCentre) are missing. Thus, there is an urgent need to raise awareness and to initiate more suitable monitory systems (e.g. National Monitoring of Poisonings) and control practice protecting the public.
The authors of the 2nd paper also reported a detailed case report:
Patient, male, 31 with BMI slightly below normal, non-smoker, was referred to the neurological department of the university clinic with severe peripheral poly neuropathy and sensory motor symptoms with neuropathic pain. The patient was in good general state of health until approximately 3 weeks before hospital admission; he spent his holiday in Himalaya region and came back with headaches and fatigue. He was taking pain medication without any relieve; his routine blood values were normal. He claimed to take no further medications. Since poly neuropathy and fatigue could be caused by pesticides or other poisoning, i.e. heavy metals, we have been consulted for taking a detailed exposure history. While in the clinic, 3 different NHPs were found in form of globules, (a, b, c for morning, lunch time and evening respectively), which he imported from his trip to Asia and ingested 3 times a day against stress. We have analyzed these 3 NHPs and found: 45 μg/g, 53,000 μg/g and 28 μg/g lead (for morning, midday and evening globules, respectively) and additionally 15.72 μg/g mercury in the “evening globules”. Since, his blood metal levels were: 340 μg/L Pb and 15 μg/L Hg a diagnosis of heavy metal intoxication was made. Slowly occurring clinical recovery after starting chelation therapy corroborated with the causal assumption proposed. He was released for further consultancy to his family physician. The administrated treatment and the improvement of his status corroborate lead and mercury intoxication.
The researchers finish their paper with this stark warning: In many countries, even in Germany, no comprehensive nutria vigilance- or poisoning monitoring system exists, from which the application of natural health products and the consequent intoxication can be estimated. There is also an urgent need for comprehensive scientifically evaluated studies based on efficient national monitoring to protect the consumer from heavy metal intoxications. There are no comparable surveillance systems like the US ABLES program for lead- and no surveillance systems for mercury exposures allowing any comparisons. Exposure to lead and mercury from environmental sources remains an overlooked and serious public health risk.
The ‘Deutsche Apotheker Zeitung’, a paper for German pharmacists, rarely is the most humorous of publications. However, recently they reported on a battle between the EU and the European producers of homeopathic remedies – a battle over mercury which has, I think, hints of Monty Python and the Flying Circus.
The EU already has strict regulations on the use of mercury, for obvious reasons, they apply particularly to medicines. The law in this area is now 8 years old and is about to be replaced by a new one which is even stricter. A draft has been recently published here.
The new law would prohibit all mercury in medicinal products, except for some used in dentistry. For the homeopathic and anthroposophic manufacturers, this is not good news because they have many remedies on the market that have the word ‘mercury’ on the label. Consequently, they fear that the sale of these products might be impeded or even become impossible in the EU.
„Quecksilber und Quecksilberverbindungen stellen für manche homöopathische und andere traditionelle Arzneimittel einen unverzichtbaren Bestandteil dar“ (Mercury and mercury compounds are an essential ingredient of some homeopathic and other traditional medicines) .. “Es steht keine Quecksilber-freie Alternative zur Verfügung, die als aktiver Bestandteil in der Therapie mit homöopathischen oder anderen traditionellen Arzneimitteln verwendet werden könnte“ (There is no mercury-free alternative that could be used in these medications”) wrote the Dachverband der Arzneimittelhersteller im Bereich der Selbstmedikation (AESGP) (a lobby group of the homeopathic manufacturers) in a comment adding that „Diese Produkte sind seit Dekaden auf dem europäischen Markt und gehören zum Arzneimittel-Werkzeugkoffer” (these products are on the market since decades and belong to the medical tool-kit)… and that these products contain merely tiny amounts of mercury – even the largest manufacturers of these remedies only require a few milligrams for their production.
The plea of the manufacturers therefore is for an exemption from the new law which would allow the trade of mercury-containing remedies in future. They even have the support of some health politicians; for instance Peter Liese CDU favours an exemption for homeopathic medicines. The next meeting of the EU committee on public health will vote on the matter.
Personally, I can imagine the following dialogue between the EU officials (EU) and the lobbyists of the homeopathic industry (LOHI):
EU: We are very sorry but, because of the toxicity of mercury, we will not allow any of it in medicines.
LOHI: But we have always used it and nobody has come to harm.
EU: We don’t know that, and we have to be strict.
LOHI: We appreciate your concern, but we use only very, very tiny amounts; they cannot cause harm.
EU: The law is the law!
LOHI: Actually, the vast majority of our products are so dilute that they do not contain a single molecule of the ingredient on the bottle.
EU: That’s interesting! In this case, they are not medicines and we will have to ban them.
LOHI: NO, no, no – you don’t understand. We potentise our medicines; this means that the ingredient that they no longer contain gets more and more powerful.
EU: Are you sure?
EU: In this case, we will ban not just your mercury products but all your phony remedies. Because either science is right and they are fraudulent, or you are correct and they are dangerous.
Dengue is a viral infection spread by mosquitoes; it is common in many parts of the world. The symptoms include fever, headache, muscle/joint pain and a red rash. The infection is usually mild and lasts about a week. In rare cases it can be more serious and even life threatening. There’s no specific treatment – except for homeopathy; at least this is what many homeopaths want us to believe.
And, of course, we don’t want to listen to just any odd homeopath, we want true experts to tell us the truth – for instance, experts like Dr. R.K. Manchanda, Deputy Director(Homoeopathy), Directorate of ISM & Homoeopathy, Govt. of NCT of Delhi and Dr. Surinder Verma, Assistant Director (Homoeopathy), Directorate of ISM & Homoeopathy, Govt. of NCT of Delhi. They authored an article which states the following:
There are about 25 homoeopathic drugs available for the treatment of dengue fever. These are Aconite., Arnica, Arsenic-alb., Arum-tri., Baptisia., Belladonna., Bryonia., Cantharis., China officinalis Colocynthis., Eupatorium perfoliatum., Ferrum metallicum., Gelsemium., Hamamelis., Ipecac., Lachesis, Merc-sol, Nux vomica., Podophyllum., Rhus toxicodendron., Rhus-venenata., Sanicula., Secale cornutum and Sul-acidum. These drugs had been successfully used by various homeopaths across the globe for its treatment and management. In 1996 during the epidemic of dengue in Delhi Eupatorium perfoliatum was found most effective.
Sadly, the article does not provide any evidence. A quick Medline search located one (!) single trial on the subject. Here is the abstract:
A double-blind, placebo-controlled randomized trial of a homeopathic combination medication for dengue fever was carried out in municipal health clinics in Honduras. Sixty patients who met the case definition of dengue (fever plus two ancillary symptoms) were randomized to receive the homeopathic medication or placebo for 1 week, along with standard conventional analgesic treatment for dengue. The results showed no difference in outcomes between the two groups, including the number of days of fever and pain as well as analgesic use and complication rates. Only three subjects had laboratory confirmed dengue. An interesting sinusoidal curve in reported pain scores was seen in the verum group that might suggest a homeopathic aggravation or a proving. The small sample size makes conclusions difficult, but the results of this study do not suggest that this combination homeopathic remedy is effective for the symptoms that are characteristic of dengue fever.
This is a 2007 study by a well-known US homeopath. Its results fail to confirm that homeopathy is effective for Dengue. So, surely the homeopathic community has since stopped claiming that homeopathy is an option for this infection!
No, you guessed correctly, they continue claiming that homeopathy works for Dengue. Currently, there are about half a million websites doing exactly that. An example is this article published YESTERDAY (!):
Alopathy is no more the only solution for Dengue these days. Especially in a place like Bengaluru where doctors and medicines are both expensive, residents have now turned to a cheaper and an effective alternative-Homeopathy to combat Dengue.People have been milling Homeopathy clinics and hospitals for an antidote. Dr Sudhir Babu of Javaji Advanced Homeopathy said, “People ask for some cure to keep the disease at bay. We do in fact have medicines to help build immunity against the ailment.”The dosage is for four or five days and is taken daily. Homeopathy has now become a trusted alternative in the field of medicine, especially because of its easy acceptibility among children and adults. According to a survey by IMRB, 100% people know about this form of medicine and 92% perceive it as a reputed form of treatment. The medicines that are administered depending on the symmptoms of Dengue Fever are Aconitum Napellus, Arsenicum Album, Belladonna, Bryonia Alba, Cantharis, Cinchona Officinalis, Eupatorium Perfoliatum, Gelsemium, Ipecacuanha, Nux Vomica, Rhus Toxicodendron and Rhus Venenata.
What I found particularly impressive here is the way popularity has been used to replace evidence. This, I think, begs several questions:
- How long will homeopaths continue treating self-limiting conditions to claim success based no nothing but their natural history?
- How long will they continue to lie to the public?
- How long will they refuse to learn from the evidence?
- How long will they ignore even the most fundamental rules of medical ethics?
- How long will we let them get away with all this?