In the latest issue of ‘Simile’ (the Faculty of Homeopathy‘s newsletter), the following short article with the above title has been published. I took the liberty of copying it for you:
Members of the Faculty of Homeopathy practising in the UK have the opportunity to take part in a trial of a new homeopathic remedy for treating infant colic. An American manufacturer of homeopathic remedies has made a registration application for the new remedy to the MHRA (Medicines and Healthcare products Regulatory Agency) under the UK “National Rules” scheme. As part of its application the manufacturer is seeking at least two homeopathic doctors who would be willing to trial the product for about a year, then write a short report about using the remedy and its clinical results. If you would like to take part in the trial, further details can be obtained from …
END OF QUOTE
A homeopathic remedy for infant colic?
Yes, indeed!
The British Homeopathic Association and many similar ‘professional’ organisations recommend homeopathy for infant colic: Infantile colic is a common problem in babies, especially up to around sixteen weeks of age. It is characterised by incessant crying, often inconsolable, usually in the evenings and often through the night. Having excluded underlying pathology, the standard advice given by GPs and health visitors is winding technique, Infacol or Gripe Water. These measures are often ineffective but fortunately there are a number of homeopathic medicines that may be effective. In my experience Colocynth is the most successful; alternatives are Carbo Veg, Chamomilla and Nux vomica.
SO, IT MUST BE GOOD!
But hold on, I cannot find a single clinical trial to suggest that homeopathy is effective for infant colic.
Ahhhhhhhhhhhhhhhhhhh, I see, that’s why they now want to conduct a trial!
They want to do the right thing and do some science to see whether their claims are supported by evidence.
How very laudable!
After all, the members of the Faculty of Homeopathy are doctors; they have certain ethical standards!
After all, the Faculty of Homeopathy aims to provide a high level of service to members and members of the public at all times.
Judging from the short text about the ‘homeopathy for infant colic trial’, it will involve a few (at least two) homeopaths prescribing the homeopathic remedy to patients and then writing a report. These reports will unanimously state that, after the remedy had been administered, the symptoms improved considerably. (I know this because they always do improve – with or without treatment.)
These reports will then be put together – perhaps we should call this a meta-analysis? – and the overall finding will be nice, positive and helpful for the American company.
And now, we all understand what homeopaths, more precisely the Faculty of Homeopathy, consider to be evidence.
24 Responses to Homeopathy: ‘Doctors sought for new infant colic remedy trial’
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Prof. Ernst,
I don´t think that it necessarily is a problem that only a few doctors (or even only a single one) conduct the trial, but only if the study design is suitable to generate reliable data that are of scientific value.
This would imply e.g. prior calculation of the number of patients necessary for the study (depending on data variance and statistical test type I and type II errors, etc. pp.) and of course implies including proper control arms for the study. Independent replication should then be done to increase reliability of the findings. You are of course well aware of how a proper study design should look like.
But can it be true that such a „clinical trial“ like the one you refer to (in this case initiated by an American company that obviously is trying to sell their products and therefore clearly has a conflict of interest), can simply be conducted with UK citizens (even infants), without any prior critical evaluation of the study design and approval from some official authority? How can it be possible that the doctors can simply try some new company product on their patients without any official approval?
If this is true, would you have suggestions for policies that could be established to prevent such pointless, potentially harmful and clearly unethical pseudo-trials?
I don’t think you understand.
the ‘trial’ they are hinting at has none of the features a real trial must have. it is just a vague description to what happened to a few selected patients after they took the remedy. no control group, no nothing!
Oh yes, I am very aware that the „trial“ intended by the company most likely will have nothing in common with a properly designed medical study.
But as you mention in your post, this “trial” will be part of an application to the Medicines and Healthcare products Regulatory Agency. This indicates that product registration in the UK must include some sort of “trial” for the remedy, before it gets registered by the MHRA.
The part that surprises me is that apparently, anecdotal surveys are accepted by an official governmental regulatory agency of the UK as some form of evidence.
If this is true, then policies should be established to prevent admission of results from studies that fail to pass a certain minimal standard and therefore obviously are of no value whatsoever.
yes, homeopathics do not need a proper proof of efficacy in the UK/EU
Not sure why the company wants to do a “study” for the MHRA then. Probably just for PR.
Would be nice if doctors would be prevented (e.g. by an ethics committee) to take part in such kind of „studies“ that have more in common with medieval rituals that with modern medical trials.
Spain?
Correct. It is not science. Period.
At best, it is anecdotal evidence collected by a person who is already being deceptive by calling himself a doctor. What else is he lying about? I mean, let’s face it. These practitioners have a history of self-delusion and seeing what they want to see. This “evidence” will be used for only thing: to further an already seriously flawed argument in favour of woo woo.
But except for that, it sounds fantastic!
Uh oh:
“In my experience …”
OK, children, please repeat after me:
A “new product” for colic.
So that’ll be non-individualised, then? So not homeopathy..
And homeopaths don’t treat conditions, do they? They always tell us that they treat the totality of symptoms.
Self-contradiction from the homeoquacks?
Surely not. I mean, some might be forced to conclude that it’s all aload of ineffectual made-up cobblers.
First the manufacturer has to set up a presence in the UK so that it can register with the MHRA. This is quite an onerous and expensive process. Given that there isn’t a product already on the market, it begs the question as to whether there is enough of a market to justify the expenditure. There is in the UK is gripe water.
There is now a mutual agreement between US and EU to mutually recognise GMP (Good Manufacturing Practice) inspections (GMP compliance is a requirement to register as a manufacturer in the EU). At the moment, the US only accepts inspections from certain EU member states (curiously not Germany). In theory, this makes it easier for manufacturers based in one market to enter the other.
Of course, because of differences in how homeopathic medicines are regulated, some products legally available in the US are prohibited in the EU and vice versa. Labelling requirements, claims permitted etc are different. It is also the case that registration of homeopathic medicines is at Member State level rather than pan-EU.
The National Rules scheme requires evidence of efficacy – although the bar is set very low. Provings are acceptable, so are scientific literature searches and “study reports”. Presumably, the latter is what the manufacturer is attempting.
The US market seems to have a high proportion of combination products. For example, homeopathic cold/flu remedies contain a large number of ingredients that notionally have an effect on one or more symptoms. EU products need to be single remedies only. How member state regulators would react to such products is unknown and would likely vary. Because of the power of the French and German manufacturers, it is not difficult to imagine them lobbying against these foreign products. It’s known that some EU member states limit the languages in which dossiers can be submitted. Technical translation is not cheap.
The idea of doctors handing out an OTC homeopathic remedy tends to go against individuised prescribing. Most medical homeopaths are either in private practice or homeopathy is a private side line. Are parents really going to pay to take their children to see a private quack for colic?
they might already be in the UK
https://www.coliccalm.co.uk/
not sure though
Ketomi Distribution
15 Waterfield Way
Sketchley Meadows Industrial Estate
Hinckley, Leicestershire
LE10 3ER
It might be worth asking the MHRA…
Hinckley is part of the constituency held by the famous David Tredinnick, MP. ‘Nuff said.
Does it? The “Register a homeopathic medicine or remedy” on the gov.uk says that they “must submit data that demonstrates quality, safety and use within the UK homeopathic tradition”: https://www.gov.uk/guidance/register-a-homeopathic-medicine-or-remedy
Actually, would use by “at least two homeopathic doctors” practising in the UK “for about a year” be enough to demonstrate “use within the UK homeopathic tradition?
If any GMC registered doctor attempts to treat a patient without getting fully informed consent from the patient (in this case – parent or guardian) they have acted unethically and should be reported to the GMC.
Consent should include no only the fact that there is no plausible reproducible evidence that homeopathic remedies have any beneficial effect on any condition, but also that the child/parent would be part of a trial which, having no placebo arm, is useless and also unethical.
Given babies with colic invariably recover, the clinical results are already in:
“Babies cease to have colic in all but the most pathological of conditions.”
Where do I collect my fee for providing this result?
Based on the supposed concern about physician’s making judgments based on their “experience,” then, we must all agree that surgeons are quacks because they do not base their procedures efficacy on randomized double-blind AND placebo controlled trials. Wow. Do surgeons really know that you consider them QUACKS? This should be fun to watch…
may I be so bold as to suggest that you search on Medline ‘surgery, clinical trial’ before you repeat such idiocy again?
Mere facts and evidence hasn’t stopped Dana repeating idiocy before. You’re surely not more hopeful this time, are you?
I am an optimist, but have to admit that this case is rather desperate.
Not to mention that surgeons look at objective and/or blinded tests, everything from grip strength or five year survival rates.
Ok…I’ve taken you up on your challenge, and you’ve proven again that you’re a bullshiter. No surprise.
Where are the PLACEBO controlled trials? You commonly complain that CAM trials don’t have a placebo control, even though it is difficult to have a “placebo” for many CAM treatments. This problem NEVER stops you from ignoring the evidence for CAM treatments.
Can you ever give an honest answer?
Oh you are amusing, Dana!
If Mr Ullman is incapable of differentiating between surgery and ‘medicine’, I’ll be happy to enlighten him.
Most certainly surgeons do all they can to audit and better understand the results of their manual work. ( Chiron, Greek: a hand. Geddit? The clue is in the name).
We certainly use control groups (usually, patients who have no surgery).
E.g., that method proved ligation of the internal mammary artery for angina was of no benefit – so it was abandoned.
Placebo controls in homeopathic research are a piece of cake.
Use whatever ‘remedy’ seems appropriate and determined as being indicated, but have the homeopathic pharmacist use plain pillules in 50% of the trial patients – in a bottle falsely labelled as whatever remedy was decided.
Neither the prescribing homeopath, nor the patient, nor the homeopath making the outcome assessment to be aware of the remedy’s nature until un-blinded at the end of the trial.
Simple.
As an oncologist with 30 years’ experience in clinical practice I am well aware of how misleading experience can be.
When patients come for cancer treatment, they place a lot of hope and trust in the team treating them, and will almost always report that their treatment is making them feel better, regardless of what is really going on (often even if they were asymptomatic to begin with). They will try to make a good impression when they come for their appointments, with nice clothes, makeup or whatever, and will do whatever they can to please the people looking after them. Of course we never see them when they are at home, too ill to get out of a chair, and it is surprising how quickly people forget their symptoms (patients will tell you how their pain is now, but they won’t remember how it was an hour ago). Meanwhile, the doctors (nurses, radiographers and everyone else) also strongly want to believe that the patient is getting better.
With the recipe for mass delusion, we constantly have to be aware of how easily it can happen, and to look for objective measures. What is happening to the weight? How much have they gone out in the past couple of weeks? What level of activity have they been able to achieve, and how does this compare to a month ago? What do the scans show? The tumour markers? The blood count? The physiotherapist’s report? What do they really look like when you get them to strip off so that you can examine them properly? What do your callipers or ruler tell you about the size of tumours near the surface?
During my specialist training I learnt a lot about the dangers of relying on experience, and how easily that could be skewed. Apart from what was taught (including having to pass an exam in statistics), I had the opportunity to observe for myself how easy it was to be fooled. I remember one colleague giving the example of all the patients coming regularly to the clinic who had survived for two years with chemotherapy for pancreatic cancer, when the “official” median survival was known to be two months. Of course the patients who were doing well were the ones returning for more chemotherapy (which clearly was benefitting them), and the ones who died early were quickly forgotten, assuming that they had survived long enough to see an oncologist in the first place. But this sort of thing gives the practitioner the false impression that their treatment is more effective than it really is.
I remember another patient with bowel cancer which was sufficiently extensive to have blocked his intestines completely. When he came for the first time he was a wreck, but he was strongly motivated to try anything, and my colleague felt that chemotherapy was worth a shot (in this case flurouracil, which is not particularly toxic). Since he was already so malnourished, he was also started on total parenteral nutrition (i.e. exclusively intravenous feeding), which is not standard management at all for this kind of situation, and quite tricky to manage out of hospital (though as it happened he managed it well). Withing a couple of weeks he was visibly improving, and over the nine months he remained on this management he put on weight, felt much better, and resumed his normal activities (I remember he was a keen birdwatcher). There is no doubt that he had an enormous boost to his quality of life, and to his survival. However, his blood tests showed a steady rise in CEA (the marker that his tumour was secreting), and his three-monthly CT scans showed a steady progression of the cancer. His oncologist was congratulating themselves on the effectiveness of the chemotherapy, and as far as the patient was concerned they were a god. But it was clear to me that his improvement was entirely due to being properly nourished, and had very little to do with the chemotherapy.
The practice of medicine is a skill which cannot be acquired without experience, but it is essential to be aware of the limitations of the experience of a single individual. When evaluating a treatment personal experience has to be combined with that of colleagues and particularly with evidence from properly-conducted clinical trials (though experience of treating the disease in question is also usually necessary for understanding the results of a trial, along with specific training in statistics and in reading scientific papers).
And when assessing an individual patient it is essential for the doctor to look at themselves as well and to avoid all the pitfalls that can so easily lead to self-deception. Proper training, evidence-based medicine, audit and working within a multidisciplinary team are important tools here.
Coming back to your comment about surgeons, I think to some extent, due to the historical way that surgery has evolved, and also due to the personality traits which are helpful for the practice of surgery, surgeons have not always been as self-critical as other medical practitioners, but this is changing, and at least in the UK they work within the same systems and frameworks as their non-surgical colleagues.