Generally speaking, Cochrane reviews provide the best (most rigorous, transparent and independent) evidence on the effectiveness of medical or surgical interventions. It is therefore important to ask what they tell us about homeopathy. In 2010, I did exactly that and published it as an overview of the current best evidence. At the time, there were 6 relevant Cochrane reviews. They covered the following conditions: cancer, attention-deficit hyperactivity disorder, asthma, dementia, influenza and induction of labour. And their results were clear: they did not show that homeopathic medicines have effects beyond placebo.
Now a further Cochrane review has been published.
Does it change this situation?
This systematic review assessed the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat acute respiratory tract infections (ARTIs) in children. The researchers conducted extensive literature searches, checked references, and contacted study authors to identify additional studies. They included all double-blind, randomised controlled trials (RCTs) or double-blind cluster-RCTs comparing oral homeopathy medicinal products with identical placebo or self selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years.
Eight RCTs of 1562 children receiving oral homeopathic medicinal products or a control treatment (placebo or conventional treatment) for upper respiratory tract infections (URTIs). Four treatment studies examined the effect on recovery from URTIs, and four studies investigated the effect on preventing URTIs after one to three months of treatment and followed up for the remainder of the year. Two treatment and two prevention studies involved homeopaths individualising treatment for children. The other studies used predetermined, non-individualised treatments. All studies involved highly diluted homeopathic medicinal products.
Several key limitations to the included studies were identified, in particular methodological inconsistencies and high attrition rates, failure to conduct intention-to-treat analysis, selective reporting, and apparent protocol deviations. The authors deemed three studies to be at high risk of bias in at least one domain, and many had additional domains with unclear risk of bias. Three studies received funding from homeopathy manufacturers; one reported support from a non-government organisation; two received government support; one was co-sponsored by a university; and one did not report funding support.
Methodological inconsistencies and significant clinical and statistical heterogeneity precluded robust quantitative meta-analysis. Only four outcomes were common to more than one study and could be combined for analysis. Odds ratios (OR) were generally small with wide confidence intervals (CI), and the contributing studies found conflicting effects, so there was little certainty that the efficacy of the intervention could be ascertained.
All studies assessed as at low risk of bias showed no benefit from oral homeopathic medicinal products; trials at uncertain and high risk of bias reported beneficial effects. The authors found low-quality evidence that non-individualised homeopathic medicinal products confer little preventive effect on ARTIs (OR 1.14, 95% CI 0.83 to 1.57). They also found low-quality evidence from two individualised prevention studies that homeopathy has little impact on the need for antibiotic usage (N = 369) (OR 0.79, 95% CI 0.35 to 1.76).
The authors also assessed adverse events, hospitalisation rates and length of stay, days off school (or work for parents), and quality of life, but were not able to pool data from any of these secondary outcomes. There is insufficient evidence from two pooled individualised treatment studies (N = 155) to determine the effect of homeopathy on short-term cure (OR 1.31, 95% CI 0.09 to 19.54; very low-quality evidence) and long-term cure rates (OR 1.01, 95% CI 0.10 to 9.96; very low-quality evidence). Adverse events were reported inconsistently; however, serious events were not reported. One study found an increase in the occurrence of non-severe adverse events in the treatment group.
The authors concluded that pooling of two prevention and two treatment studies did not show any benefit of homeopathic medicinal products compared to placebo on recurrence of ARTI or cure rates in children. We found no evidence to support the efficacy of homeopathic medicinal products for ARTIs in children. Adverse events were poorly reported, so conclusions about safety could not be drawn.
In their paper, the authors state that “there are no established explanatory models for how highly diluted homeopathic medicinal products might work. For this reason, homeopathy remains highly controversial because the key concepts governing this form of medicine are not consistent with the established laws of conventional therapeutics.” In other words, there is no reason why highly diluted homeopathic remedies should work. Yet, remarkably, when asked what conditions responds best to homeopathy, most homeopaths would probably include ARTI of children.
The authors also point out that “The results of this review are consistent with all previous systematic reviews on homeopathy. Funders and study investigators contemplating any further research in this area need to consider whether further research will advance our knowledge, given the uncertain mechanism of action and debate about how the lack of a measurable dose can make them effective. The studies we identified did not use a uniform approach to choosing and measuring outcomes or assigning appropriate time points for outcome measurement. The use of validated symptom scales would facilitate future meta-analyses. It is unclear if there is any benefit from individualised (classical) homeopathy over the use of commercially available products.”
Even though I agree with the authors on most of their views and comment their excellent work, I would be more outspoken regarding the need of further research. In my view, it would be a foolish, wasteful and therefore unethical activity to fund, plan or conduct further research in this area.
I have written about the use of homeopathy in France before (as I now live half of my time in France, this is a subject of considerable interest to me). After decades of deafening silence and uncritical acceptance by the French public, it seems that finally some change to the better might be on its way. Recently, a sizable number of prominent doctors protested publicly against the fact that, despite its implausibility and the lack of proof of efficacy, homeopathy continues to be reimbursed in France and scarce funds are being wasted on it. This action seems to have put pressure on officials to respond.
Yesterday (just in time for the ‘HOMEOPATHIC AWARENESS WEEK’) the French minister of health was quoted making a statement on homeopathy. Here is my translation of what Agnès Buzyn was quoted saying:
“There is a continuous evaluation of the medicines we call complementary. A working group* at the head office of my department checks that all these practices are not dangerous. If a therapy continues to be beneficial without being harmful, it continues to be reimbursed… The French are very attached [to homeopathy]; it’s probably a placebo effect. If it can prevent the use of toxic medicine, I think that we all win. I does not hurt.”
- I would like to know who they are, how they can be contacted, and whether they would consider recruiting my assistance in evaluating alternative therapies.
So, if I understand her correctly, Agnès Buzyn believes that:
- the French people are fond of homeopathy;
- homeopathy is a placebo-therapy;
- homeopathy does no harm;
- homeopathy can even prevent harm from conventional medicine;
- on balance, therefore, homeopathy should continue to be reimbursed in France.
My views of this type of reasoning have been expressed repeatedly. Nevertheless, I will briefly state them again:
- true but not relevant; healthcare is not a popularity contest; and the current popularity is essentially the result of decades of systematic misinformation of consumers;
- wrong: we have, on this blog, discussed ad nauseam how homeopathy can cause serious harm; for instance, whenever it replaces effective treatments, it can cause serious harm and might even kill patients;
- if doctors harm patients by needlessly prescribing harmful treatments, we need to re-train them and stop this abuse; using homeopathy is not the solution to bad medicine;
- wrong: the reimbursement of homeopathy is a waste of money and undermines evidence-based medicine.
So, what’s the conclusion?
Politicians are usually not good at understanding science or scientific evidence. They (have to?) think in time spans from one election to the next. And they are, of course, keenly aware that, in order to stay in power, they rely on the vote of the people. Therefore, the popularity of homeopathy (even though it is scientifically irrelevant) is a very real factor for them. This means that, on a political level, homeopathy is sadly much more secure than it should be. In turn, this means we need to:
- use different arguments when arguing with politicians (for instance, the economic impact of wasting money on placebo-therapies, or the fact that systematically misinforming the public is highly unethical and counter-productive),
- and make politicians understand science better than they do at present, perhaps even insist that ministers are experts in their respective areas (i. e. a minister of health fully understands the fundamental issues of healthcare).
Does that mean the new developments in the realm of French homeopathy are all doomed to failure?
No, I don’t think so – at least (and at last) we have a vocal group of doctors protesting against wasteful nonsense, and a fairly sound and accurate statement from a French minister of health:
HOMEOPATHY, IT’S PROBABLY A PLACEBO EFFECT!
It’s still ‘HOMEOPATHIC AWARENESS WEEK’. What better time for introducing you to one of the most bewildering aspect of this bizarre therapy?
Homeopathy is not just being promoted as a treatment for humans and animals, it is also advocated for plants. There are plenty of websites about this that give concrete advice such as this one: “Try the key symptom of a remedy that you would normally give to a person, on plants. For example, in cases of freezing where the leaves turn to a light or silvery colour, use Aconite 200 CH. When the leaves are more of a reddish colour use Belladonna 200 CH. Just like with a feverish child. If the child is pale then you know it is an Aconite fever. If is extremely red on the other hand, like a hot tomato, then the remedy is Belladonna. And you see this on the leaves too. You simply convert it one to one.”
Given this school of thought within homeopathy (not even Hahnemann would have dreamt this up), it seems only logical to use plants also for attempts to prove that highly diluted homeopathic remedies are more than pure placebos.
Not to homeopaths!
Not even to some academic researchers within the realm of homeopathy.
The authors of this systematic review evaluated publications on plant-based test systems. A literature search was conducted in online databases and specific journals, including publications from 2008 to 2017 dealing with plant-based test systems in homeopathic basic research. To be included, they had to contain statistical analysis and fulfil quality criteria according to a pre-defined manuscript information score (MIS). Publications scoring at least 5 points (maximum 10 points) were assumed to be adequate. They were analysed for the use of adequate controls, outcome and reproducibility.
Seventy-four publications on plant-based test systems were found. Thirty-nine publications were either abstracts or proceedings of conferences and were excluded. From the remaining 35 publications, 26 reached a score of 5 or higher in the MIS. Adequate controls were used in 13 of these publications. All of them described specific effects of homeopathic preparations. The publication quality still varied: a substantial number of publications (23%) did not adequately document the methods used. Four reported on replication trials. One replication trial found effects of homeopathic preparations comparable to the original study. Three replication trials failed to confirm the original study but identified possible external influencing factors. Five publications described novel plant-based test systems. Eight trials used systematic negative control experiments to document test system stability.
The authors concluded that, regarding research design, future trials should implement adequate controls to identify specific effects of homeopathic preparations and include systematic negative control experiments. Further external and internal replication trials, and control of influencing factors, are needed to verify results. Standardised test systems should be developed.
Really, just one (!) replication trial found effects of homeopathic preparations comparable to the original study? And yet the authors do not arrive at the only possible conclusion that is based on the actual data presented?
THE AVAILABLE EVIDENCE FAILS TO SHOW THAT PLANT-BASED TEST SYSTEMS PROVIDE SOUND EVIDENCE TO SUGGEST THAT THEY ARE USEFUL OR THAT HIGHLY DILUTED HOMEOPATHICS ARE DIFFERENT FROM PLACEBOS.
But there are other things which seem odd here. The very first two sentences of the abstract of the above article read as follows: Plant-based test systems have been described as a useful tool for investigating possible effects of homeopathic preparations. The last reviews of this research field were published in 2009/2011.
This is odd because there is a very similar review dated 2015 (what is more, it is by some of the authors who also did the new review); it concluded: Plant models appear to be a useful approach for investigating basic research questions relating to homeopathic preparations, but more independent replication trials are needed in order to verify the results found in single experiments. Adequate controls and SNC experiments should be implemented on a routine basis to exclude false-positive results.
Why do the authors mislead us so badly?
Ahh, I see! They are affiliated to the following institutions:
- Centre for Complementary Medicine, Faculty of Medicine, Institute for Infection Prevention and Hospital Epidemiology, University of Freiburg, Germany
- Institute of Integrative Medicine, University of Witten/Herdecke, Witten, Germany
- Institute of Complementary Medicine, University of Bern, Switzerland.
- Hiscia Institute, Arlesheim, Switzerland
- Crystal Lab, Landgoed Roepaen, Ottersum, Netherlands.
Could they have an interest in perpetuating the notion of homeopathy (for plants)?
Could it be that these researchers are less than objective?
No reason to make a fuss, because no harm done!
Not entirely true: some might choke laughing about the idea of treating plants with highly diluted, shaken water.
Samuel Hahnemann published a lot, but his main ideas about homeopathy are summarised in his ‘Organon‘ which has thus become ‘the bible’ for all homeopaths. They regularly refer to this book, yet I sometimes get the impression that many of them have even read it.
I did! Most recently, I re-studied it when writing my own book ‘HOMEOPATHY, THE UNDILUTED FACTS‘. And I have to say, it is rather boring, full of contradictions and obsolete nonsense.
To mark Samuel’s birthday – he was born on 10 April 1755 in Meissen – I take the liberty of quoting directly from Dudgeon’s translation of the 1st edition of the Organon:
- In no way whatever can [a] disease itself be recognized.
- This eternal, universal law of nature [the like cures like assumption]…
- …only one disease can exist in the body at any one time…
- …if an acute infection attacks an organism already suffering from a similar acute disease, then the stronger infection uproots the weaker entirely and removes it homoeopathically.
- …diseases are only destroyed by similar diseases.
- …it is certain that a suitably selected homoeopathic remedy gently destroys and removes disease…
- …aggravation during the first hours… is, in fact, a very good prognostic sign…
- …even the smallest dose of a homoeopathic remedy always causes a small homoeopathic aggravation…
- …we should always choose the very smallest doses…
- …hardly any dose of the homoeopathically selected remedy can be so small as not to be stronger than the natural disease…
- If dilution is also employed… an excessive effect is easily produced.
- …a single drop of a tincture to a pound of water and shaking vigorously… will produce more effect than a single dose of eight drops of the tincture.
- …this action must be called spirit-like.
For homeopaths, these quotes (should) depict some of the central assumptions of homeopathy. For non-homeopaths, they are just gibberish that makes no sense whatsoever. Time has moved on, and most of us have moved with it. Yet homeopaths still live by (and from) the errors of 200 years ago.
Hahnemann died on 2 July 1843 in Paris. I don’t want to be disrespectful, but perhaps we should, in future, rather celebrate this date? It could be a celebration of the progress we made since (and because) we have recognised Hahnemann’s errors.
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.
In the current issue of the Faculty of Homeopathy‘s Simile publication, Dr Peter Fisher, the Queen’s homeopath, re-visits the old story of the ‘Smallwood Report’. To my big surprise, I found the following two paragraphs in his editorial:
A prepublication draft [of the Smallwood report] was circulated for comment with prominent warnings that it was confidential and not to be shared more widely (I can personally vouch for this, since I was one of those asked to comment). Regrettably, Prof Ernst did precisely this, leaking it to The Times who used it as the basis of their lead story. The editor of The Lancet, Richard Horton, certainly no friend of homeopathy, promptly denounced Ernst for having “broken every professional code of scientific behaviour”.
Sir Michael Peat, the Prince of Wales’ Principal Private Secretary, wrote to the vice chancellor of Exeter University protesting at the leak, and the university conducted an investigation. Ernst’s position became untenable, funding for his department dried up and he took early retirement. Thirteen years later he remains sore; in his latest book More Harm than Good? he attacks the Prince of Wales as “foolish and immoral”.
END OF QUOTE
Sadly it is true that Horton wrote these defaming words. Subsequently, I asked him to justify them explaining that they were being used by my university against me. He ignored several of my emails, but eventually he sent a reply. In it, he said that, since the university was investigating the issue, the truth would doubtlessly be disclosed. I remember that I was livid at the arrogance and ignorance of this reply. However, being in the middle of my university’s investigation against me, never did anything about it. Looking back at this part of the episode, I feel that Horton behaved abominably.
But back to Dr Fisher.
Why did his defamatory and false accusation in his new editorial come as a ‘big surprise’ to me?
Should I not have gotten used to the often odd way in which some homeopaths handle the truth?
Yes, I did get used to this phenomenon; but I am nevertheless surprised because I have tried to correct Fisher’s ‘error’ before.
This is from a post about Fisher which I published in 2015:
In this article [available here in archive,org – Admin] which he published as Dr. Peter Fisher, Homeopath to Her Majesty, the Queen, he wrote: There is a serious threat to the future of the Royal London Homoeopathic Hospital (RLHH), and we need your help…Lurking behind all this is an orchestrated campaign, including the ’13 doctors letter’, the front page lead in The Times of 23 May 2006, Ernst’s leak of the Smallwood report (also front page lead in The Times, August 2005), and the deeply flawed, but much publicised Lancet meta-analysis of Shang et al…
If you have read my memoir, you will know that even the hostile 13-months investigation my own university did not find me guilty of the ‘leak’. The Times journalist who interviewed me about the Smallwood report already had the document on his desk when we spoke, and I did not disclose any contents of the report to him…
END OF QUOTE
So, assuming that Dr Peter Fisher has seen my 2015 post, he is knowingly perpetuating a slanderous untruth. However, giving him the benefit of the doubt, he might not have read the post nor my memoir and could be unaware of the truth. Error or lie? I am determined to find out and will send him today’s post with an offer to clarify the situation.
I will keep you posted.
Some commentators on this blog and elsewhere keep on claiming that conventional medicine is dangerous, certainly more dangerous than homeopathy (or other alternative therapies). To test the validity of this assumption, I invite you to a little thought experiment:
Imagine 100 patients suffering from each of the conditions listed below.
- coronary heart disease
- peripheral vascular disease
(this list could be extended ad libitum)
Now imagine all of these patients would receive alternative treatment in the form of homeopathy.
Next ask yourself in how many of these patients would hasten death (i. e. contribute to a fatal outcome earlier than necessary).
Here are my estimates (based on the best available evidence):
- cancer: 100
- AIDS: 100
- Ebola: 100
- sepsis: 100
- TB: 100
- MS: 100
- dementia: 100
- coronary heart disease: 100
- stroke: 100
- diabetes: 100
- peripheral vascular disease: 100
(Please don’t tell me that homeopaths do not regularly claim to be able to treat those conditions; and please don’t say that they do not advocate homeopathy as a truly alternative therapy, because they do – if you don’t believe me, do a simple google search yourself.)
And now imagine these patients are being treated by conventional medicine. It seems obvious that not all lives would be saved and that some would die of their condition. But that was not my question. It was, in how many of these patients would conventional medicine hasten death?
Here are my estimates (based on the best available evidence):
- cancer: 0
- AIDS: 0
- Ebola: 0
- sepsis: 0
- TB: 0
- MS: 0
- dementia: o
- coronary heart disease: 0
- stroke: 0
- diabetes: 0
- peripheral vascular disease: 0
I know this is a bit simplistic (as well as provocative). But I was merely trying to make a point: Homeopathy (and many other alternative treatments) are by no means as safe as its proponents seem to think.
An announcement (it’s in German, I’m afraid) proudly declaring that ‘homeopathy fulfils the criteria of evidence-based medicine‘ caught my attention.
Here is the story:
In 2016, Dr. Melanie Wölk, did a ‘Master of Science’* at the ‘Donau University’ in Krems, Austria investigating the question whether homeopathy follows the rules of evidence-based medicine (EBM). She arrived at the conclusion that YES, IT DOES! This pleased the leading Austrian manufacturer of homeopathics (Dr Peithner) so much and so durably that, on 23 March 2018, he gave her a ‘scientific’ award (the annual Peithner award) for her ‘research’.
So far so good.
Her paper is unpublished, or at least not available on Medline; therefore, I am unable to evaluate it directly. All I know about it from the announcement is that she did her ‘research at the ‘Zentrum für Traditionelle Chinesische Medizin und Komplementärmedizin‘ of the said university. A quick Medline search revealed that this unit has never published anything, not a single paper, it seems! Disappointed I search for Dr. Christine Schauhuber, the leader of the unit; and again I find no Medline-listed publications in her name. My interim conclusion is thus that this institution might not be at the cutting edge of science.
But what do we know about Dr. Melanie Wölk’s award-winning master thesis *?
The announcement tells us that she investigated all RCTs published between 2010 and 2016. In addition, she evaluated:
- the ‘Swiss report’,
- the NHMRC report,
- Shang 2005,
- Ernst 2002,
- the Frass sepsis trial of 2005,
- Linde 1997 (why not Linde 1999? I ask myself; perhaps because this re-analysis of the same material came to a largly negative conclusion?)
On that basis, she arrived at her positive verdict – not just tentatively, but without doubt (“Das Ergebnis steht fest”).
Dr Peithner, the owner of the company and awarder of the prize, was quoted stating that this is a very important piece of work for homeopathy; it shows yet again what we see in our daily routine, namely that homeopathics are effective. Wölk’s investigation demonstrates furthermore that high-quality trials of homeopathy do exist, and that it is time to end the witch-hunt aimed at discrediting an effective therapy. Conventional medicine and homeopathy ought to finally work hand in hand – for the benefit of our patients. (“Für die Homöopathie ist das eine sehr wichtige Arbeit, die wieder zeigt, was wir in der ärztlichen Praxis täglich erleben, nämlich dass homöopathische Arzneimittel wirken. Wölks Untersuchung zeigt weiters deutlich, dass es sehr wohl hochqualitative Homöopathie-Studien gibt und es an der Zeit ist, die Hexenjagd zu beenden, mit der eine wirksame medizinische Therapie diskreditiert werden soll. Konventionelle Medizin und Homöopathie sollten endlich Hand in Hand arbeiten – zum Wohle der Patientinnen und Patienten.”)
I do hope that Dr Wölk uses the prize money (by no means a fortune; see photo) to buy some time for publishing her work (one of my teachers, all those years ago, used to say ‘unpublished research is no research’) so that we can all benefit from it. Until it becomes available, I should perhaps mention that the description of her methodology (publications between 2010 and 2016 [plus a few other papers that nicely fitted the arguments?]; including one Linde review and not his more recent re-analysis [see above]) does not inspire me to think that Dr Wölk’s research was anywhere near rigorous, systematic or complete. In the same vein, I am tempted to point out that the Swiss report is probably the very last document I would select, if I wanted to generate an objective picture about the value of homeopathy.
Taking all this into account, I conclude that we seem to be dealing here with a
- pseudo-prize (given by a commercial firm to further its business) for a piece of
- pseudo-research (the project seems to have been aimed to white-wash homeopathy) into
- pseudo-medicine (a treatment that has been tested extensively but has not been shown to work beyond placebo).
*Wölk, Melanie: Eminenz oder Evidenz: Die Homöopathie auf dem Prüfstand der Evidence based Medicine. Masterarbeit zur Erlangung des akademischen Abschlusses Master of Science im Universitätslehrgang Natural Medicine. Donau-Universität Krems, Department für Gesundheitswissenschaften und Biomedizin. Krems, Mai 2016.
An article in yesterday’ Times makes the surprising claim that ‘doctors turn to herbal cures when the drugs don’t work’. As the subject is undoubtedly relevant to this blog and as the Times is a highly respected newspaper, I think this might be important and will therefore comment (in normal print) on the full text of the article (in bold print):
GPs are increasingly dissatisfied with doling out pills that do not work for illnesses with social and emotional roots, and a surprising number of them end up turning to alternative medicine.
What a sentence! I would have thought that GPs have always been ‘dissatisfied’ with treatments that are ineffective. But who says they turn to alternative medicine in ‘surprising numbers’ (our own survey does not confirm the notion)? And what is a ‘surprising number’ anyway (zero would be surprising, in my view)?
Charlotte Mendes da Costa is unusual in being both an NHS GP and a registered homeopath. Her frustration with the conventional approach of matching a medicine to a symptom is growing as doctors increasingly see the limits, and the risks, of such a tactic.
Do we get the impression that THE TIMES does not know that homeopathy is not herbal medicine? Do they know that ‘matching a medicine to a symptom’ is what homeopaths believe they are doing? Real doctors try to find the cause of a symptom and, whenever possible, treat it.
She asks patients with sore throats questions that few other GPs pose: “What side is it? Is it easier to swallow solids or liquids? What time of day is it worst?” Dr Mendes da Costa is trying to find out which homeopathic remedy to prescribe. But when NHS guidance for sore throats aims mainly to convince patients that they will get better on their own, her questions are just as important as her prescription.
This section makes no sense. Sore throats do get better on their own, that’s a fact. And empathy is not a monopoly of homeopaths. But Dr Mendes Da Costa might be somewhat detached from reality; she once promoted the nonsensical notion that “up to the end of 2010, 156 randomised controlled trials (RCTs) in homeopathy had been carried out with 41% reporting positive effects, whereas only 7% have been negative. The remainder were non-conclusive.” (see more on this particular issue here)
“It’s very difficult to disentangle the effect of listening to someone properly, in a non-judgmental way, and taking a real rather than a superficial interest,” she says. “With a sore throat [I was trained] really only to be interested in, ‘Do they need antibiotics or not?’ ”
In this case, she should ask her money back; her medical school seems to have been rubbish in training her adequately.
This week a Lancet series on back pain said that millions of patients were getting treatments that did them no good. A government review is looking into how one in 11 people has come to be on potentially addictive drugs such as tranquillisers, opioid painkillers and antidepressants.
Yes, and how is that an argument for homeopathy? It isn’t! It seems to come from the textbook of fallacies.
And this week a BMJ Open study found that GPs with alternative training prescribed a fifth fewer antibiotics.
That study was akin to showing that butchers sell less vegetables than green-grocers. It provided no argument at all for implying that homeopathy is a valuable therapy.
Doctors seem receptive to alternative approaches: in a poll on its website 70 per cent agreed that doctors should recommend acupuncture to patients in pain. The Faculty of Homeopathy now counts 400 doctors among its 700 healthcare professional members.
Wow! Does the Times journalist know that the ‘Faculty of Homeopathy’ is primarily an organisation for doctor homeopaths? If so, why are these figures anything to write home about? And does the author appreciate that the pole was open not just to doctors but to to anyone (particularly those who were motivated, like acupuncturists)?
This horrifies many academics, who say that there is almost no evidence that complementary therapies work.
It horrifies nobody, I’d say. It puzzles some people, and not just academics. And their claim of a lack of sound evidence is evidence-based.
“It’s a false battle”, says Michael Dixon, a GP who chairs the College of Medicine, which is trying to broaden the focus on treatment to patients’ whole lives. “GPs are practical. If a patient gets better that’s all that matters.”
Dr Dixon says there are enormous areas of illness ranging from chronic pain to irritable bowels where few conventional treatments have been shown to be particularly effective, so why not try alternatives with fewer side effects?
Unable to diagnose and treat adequately, let’s all do the next worst thing and apply some outright quackery?!? Logic does not seem to be Dixon’s strong point, does it?
He recommends herbal remedies such as pelargonium — “like a geranium, quite a pretty little flower” — acupressure, and techniques such as self-hypnosis. To those who say these are placebos he replies: so what?
So what indeed! There are over 200 species of pelargonium; only 2 or 3 of them are used in herbal medicine. I don’t suppose Dr Dixon wants to poison us?
“Aromatherapy does work, but only if you believe in it, that’s the way you have to look at it, like a mother kissing knees better.” He continues: “We are healers. That’s what we do as doctors. You can call it theatrical or you can call it a relationship. A lot of patients come in with a metaphor — a headache is actually unhappiness — and the treatment is symbolic.”
It frightens me to know that there are doctors out there who think like this!
What if a patient is seriously ill?
A cancer is a metaphor for what exactly?
As doctors, we have the ethical duty to apply BOTH the science and the art of medicine, BOTH efficacious, evidence-based therapies AND compassion. Can I be so bold as to recommend our book about the ethics of alternative medicine to Dixon?
Such talk makes conventional doctors very nervous. Yet acupuncture illustrates their dilemma. It used to be recommended by the NHS for back pain because patients did improve. Now it is not, after further evidence suggested that patients given placebo “sham acupuncture” did just as well.
No, acupuncture used to be recommended by NICE because there was some evidence; when subsequently more rigorous trials emerged showing that it does NOT work, NICE stopped recommending it. Real medicine develops – it’s only alternative medicine and its proponents that seem to be stuck in the past and resist progress.
Martin Underwood, of the University of Warwick, asks: “So are you going to say, ‘Well, patients get better than they would do otherwise’? Or say it’s all theatrical placebo because it shows no benefit over sham treatment? That’s the question for society.”
Society has long answered it! The answer is called evidence-based medicine. We are not content using quackery for its placebo response; we know that effective treatments do that too, and we want to make progress and improve healthcare of tomorrow.
Although many doctors agree that they need to look at patients more broadly, they insist they do not need to turn to unproven treatments. The magic ingredient, they say, is not an alternative remedy, but time. Helen Stokes-Lampard, chairwoman of the Royal College of GPs, said: “Practices which offer alternative therapies tend to spend longer with patients . . . allowing for more in-depth conversations.”
I am sorry, if this post turned into a bit of a lengthy rant. But it was needed, I think: if there ever was a poorly written, ill focussed, badly researched and badly argued article on alternative medicine, it must be this one.
Did I call the Times a highly respected paper?
I take it back.
At least this is what the authors of this new study want us to believe.
But are they right?
This RCT is entitled ‘Efficacy and tolerability of a complex homeopathic drug in children suffering from dry cough-A double-blind, placebo- controlled, clinical trial’. It recruited children suffering from acute dry cough to assess the efficacy and tolerability of a complex homeopathic remedy in liquid form (Drosera, Coccus cacti, Cuprum Sulfuricum, Ipecacuanha = Monapax syrup, short: verum).
The authors stated that “preparations of Drosera, Coccus cacti, Cuprum sulfuricum, and Ipecacuanha are well-known antitussives in homeopathic medicine. Each of them is connected with special subtypes of cough. Drosera is intended for inflammations of the respiratory tract, especially for whooping cough. Coccus cacti is intended for inflammations of the nasopharyngeal space and the respiratory tract. Cuprum sulfuricum is intended for spasmodic coughing at night. Ipecacuanha is intended for bronchitis, bronchial asthma, and whooping cough. The complex homeopathic drug explored in this trial consists of all four of these active substances.”
According to the authors of the paper, “the primary objective of the trial was to demonstrate the superiority of verum compared to the placebo”.
A total of 89 children, enrolled in the Ukraine between 15/04/2008 and 26/05/2008 in 9 trial centres, received verum and 91 received placebo daily for 7 days (age groups 0.5–3, 4–7 and 8–12 years). The trial was conducted using an adaptive 3-stage group sequential design with possible sample size adjustments after the two planned interim analyses. The inverse normal method of combining the p-values from all three stages was used for confirmatory hypothesis testing at the interim analyses as well as at the final analysis. The primary efficacy variable was the improvement of the Cough Assessment Score. Tolerability and compliance were also assessed. A confirmatory statistical analysis was performed for the primary efficacy variable and a descriptive analysis for the secondary parameters.
A total of 180 patients (89 in the verum and 91 in the placebo group) evaluable according to the intention-to-treat principle were included in the trial. The Cough Assessment Score showed an improvement of 5.2 ± 2.6 points for children treated with verum and 3.2 ± 2.6 points in the placebo group (p < 0.0001). The difference of the least square means of the improvements was 1.9 ± 0.4. The effect size of Cohen´s d was d = 0.77. In all secondary parameters the patients in the verum group showed higher rates of improvement and remission than those in the placebo group. In 15 patients (verum: n = 6; placebo: n = 9) 18 adverse drug reactions of mild or moderate intensity were observed.
The authors concluded that the administering verum resulted in a statistically significantly greater improvement of the Cough Assessment Score than the placebo. The tolerability was good and not inferior to that of the placebo.
This study seems fairly rigorous. What is more, it has been published in a mainstream journal of reasonably high standing. So, how can its results be positive? We all know that homeopathy does not work, don’t we?
Are we perhaps mistaken?
Are highly diluted homeopathic remedies effective after all?
I don’t think so.
Let me explain to you a few points that raise my suspicions about this study:
- It was conducted 10 years ago; why did it take that long to get it published?
- I don’t think highly of a study with “the primary objective … to demonstrate the superiority” of the experimental interventions. Scientists use RCTs for testing efficacy and pseudo-scientist use it for demonstrating it, I think.
- The study was conducted in the Ukraine in 9 centres, yet no Ukrainian is an author of the paper, and there is not even an acknowledgement of these primary investigators.
- The ‘adaptive 3-stage group sequential design with possible sample size adjustments’ sounds very odd to me, but I may be wrong; I am not a statistician.
- We learn that 180 patients were evaluated, but not how many were entered into the trial?
- The Cough Assessment Score is not a validated outcome measure.
- Was the verum distinguishable from the placebo? It would be easy to test whether the patients/parents were truly blinded. Yet no such results were included.
- The trial was funded by the manufacturer of the homeopathic remedy.
- The paper has three authors 1)Hans W. Voß has no conflict of interest to declare. 2) Rainer Brünjes is employed at Cassella-med, the marketing authorisation holder of the study product. 3) Andreas Michalsen has consulted for Cassella-med and participated in advisory boards.
I know, homeopathy fans will think I am nit-picking; and perhaps they are correct. So, let me tell you why I really do strongly reject the notion that this study shows or even suggests that highly diluted homeopathic remedies are more than placebos.
The remedy used in this study is composed of Drosera 0,02 g, Hedera helix Ø 0,04 g, China D1 0,02 g, Coccus cacti D1 0,04 g, Cuprum sulfuricum D4 2,0 g, Ipecacuanha D4 2,0 g, Hyoscyamus D4 2,0 g.
In case you don’t know what ‘Ø’ stands for (I don’t blame you, hardly anyone outside the world of homeopathy does), it signifies a ‘mother tincture’, i. e. an undiluted herbal extract; and ‘D1’ signifies diluted 1:10. This means that the remedy may be homeopathic from a regulatory point of view, but for all intents and purposes it is a herbal medicine. It contains an uncounted amount of active compounds, and it is therefore hardly surprising that it might have pharmacological effects. In turn, this means that this trial does by no means overturn the fact that highly diluted homeopathic remedies are pure placebos.
It’s a pity, I find, that the authors of the paper fail to explain this simple fact in full detail – might one think that they intentionally aimed at misleading us?