Homeopathy and Randomized Clinical Trials

Posted on March 1, 2008. Filed under: Homeopathy and Randomized Clinical Trials | Tags: , , , , , , |

A very good friend of mine is an editor for an online homeopathic journal. He wrote a very interesting editorial this month and I wanted to replicate it here; I think it speaks to the frustrations homeopaths have in dealing with material science and “Evidence Based Medicine”.

In homeopathy we discuss our science to a great extent with cases. This is in contrast with mainstream medicine, where journals are filled with double blind studies, more recently called “Randomized Clinical Trials”, or abbreviated RCT’s. The double blind studies are seen as the ultimate in science, the holy grail to prove if something works or not. Many homeopaths have the feeling that they are not effective for homeopathy, or even further that they cannot be used in homeopathy. But double blind studies can also be done in homeopathy as for instance; David Riley has done in 2 studies with hay-fever. He proved homeopathy did work, but the point is that homeopaths didn’t learn anything from it. It was just a nice proof of homeopathy, but it did not give any insight that might help the homeopath in his daily practice.
That is indeed the central point, the insight. Double blind studies are a kind of black box idea, one symptom is evaluated when one impulse is given (mostly a medicine), but there is no idea what is going on inside the black box. Sometimes the researcher does not even want to know what is going on. Researching one facet is often done out of reasons of simplification; the living organism is too complex to take everything into account, but that is just the pitfall. Reduction of complex problems into simple ones can be revealing, but especially in living systems it can also lead to distorted conclusions. That is what we can see in practice: promising treatment leads, after a while, to disappointments as the benefits turn out to be not that great and the side-effects are growing. It was more complex than originally thought.
The main problem lies in the black box. It is typical that in the past double blind studies were called “double blind studies”, it expresses that nothing is understood. What is the black box? It is the energy field, the soul or psyche or whatever one wants to call it, which is denied by mainstream medicine, by the materialism paradigm. That leads to strange and counter intuitive notions; like that intelligence does not exist, but is defined as the results of a test. The test then is not the result of intelligence, but intelligence is a result of the test. What other option does one have when there is no mind or soul? Behaviorism is a very striking example of this direction. [Homeopathic] case studies can show the in depth structure of disease, the origin in the mind and that gives understanding of health and disease. Statistics are then not necessary anymore. One can even say that statistics are only needed when understanding is lacking.  

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26 Responses to “Homeopathy and Randomized Clinical Trials”

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As a sceptic of homeopathy there is actually some elements of this editorial that I would very much agree with. I have recently aired similar themes in my own recent blog entry “Should Cochrane Call for More Reseach into Homeopathy”, and I would agree that there is little point of using RCTs on homeopathy, but maybe or subtly different reasons.

Firstly, yes, RCTs are a black box. They are incapable of telling us anything about how a medical intervention works. But the author appears to fail to realise that this is not the point of RCTs. Such trials are done to see if the intervention works at all. If it does, then we might start to look for reasons why.

Where I would disagree is that RCTs are not about ‘evaluating one symptom’ and not the ‘whole person’. And they need not be about testing one ‘impulse’. Take the hayfever example. It is perfectly reasonable to assume that should homeopathy help hayfever sufferers then they can expect to have fewer attacks and/or the episodes to be less severe. Why can we not asks a group of sufferers to record ‘holistically’ how severe they have felt their homeopathy to be and how many times they had attacks. Let them keep a diary and ask them to score their days from very bad to very good. Its not rocket science. Let each hayfever sufferer have an individualised remedy but allow the pharmacist to randomly swap the individualised remedy for a placebo in half the group so that neither the homeopath or the patient know whether they are taking an individualised remedy.

Such a test would surely tell us whether homeopathy can improve the lives of hay fever sufferers, can it not? It might not tell us why, but we would have real evidence?

The big difference between homeopathy and medicine is though that scientific medicine recognises the limits of RCTs and carries on massive research efforts into understanding why treatments may work. Basic science. That gives us greater insight that has lead to a deeper understanding of the causes of diseases. Homeopathy gives us no such insights and appears to desire not to. For this reason, I argue, that RCTs for homeopathy are a complete waste of time as all it allows us to do is to argue about whether a trial has been properly conducted, was not just a random fluke or was even fraudulent, and gives us no insight into how homeopathy can really improve peoples lives. Homeopaths should stop messing around with poor RCTs and instead concentrate on providing evidence as to why we should take their theories seriously and not just stick with the perfectly reasonable explanation that it is a placebo therapy.

I agree with Andy Lewis — there’s some sense in that. This bit was interesting, though:

He proved homeopathy did work, but the point is that homeopaths didn’t learn anything from it. It was just a nice proof of homeopathy, but it did not give any insight that might help the homeopath in his daily practice.

(I doubt that he did prove that, but that’s a separate discussion.)

Individual case studies are a fair enough way to get “insight”, to work out new treatments and so forth, yes, but you still have to do the RCTs, because that’s the only good way to prove that your new treatment actually does anything. You can have all the insight in the world, but if you haven’t proven that it works it’s just ritual and mythology.

Homeopaths seem to have got the first bit down but struggle with the second — most notably because (as your post notes) when an RCT comes up negative, they ask what was wrong with the RCT. There’s an almost religious assumption that homeopathy works and proof is considered pointless (see first sentence of quote above).

If you’ve decided what the result will be before you do the trial, then why even bother?

There are plenty of more exotic methods of running experiments to examine what is going on with your patients without using RCTs. They would not necessarily silence your critics, like me, but would give you some insight, if your assumptions are valid.

You could, for example, use multivariate statistics:

Work out a set of characteristics of wellness to map out a “Wellness” space and ask patients to rate them selves on those scales before you start treatment, then regularly throughout treatment. Use some dimensional reduction technique to look at how these patients move through the multivariate “Wellness” space over time. If lots of your patients move towards the “Healthy” region of the “Wellness” but a few don’t then this will help you identify which patients you didn’t help. This will provide you with some insight into where you are going wrong so you can improve your practice. You can go back over case reports and look for things you missed etc.

Why are things like this never published in the homeopathic literature? Looking through it, all I can find are poorly conducted or analysed RCT’s, reviews, speculation about mechanism and case reports.

Could it be that when ever anybody does anything to try to get an insight to help them in their homeopathic practise the insight they find is its complete absence of effect?

” And they need not be about testing one ‘impulse’. Take the hayfever example. It is perfectly reasonable to assume that should homeopathy help hayfever sufferers then they can expect to have fewer attacks and/or the episodes to be less severe. Why can we not asks a group of sufferers to record ‘holistically’ how severe they have felt their homeopathy to be and how many times they had attacks. Let them keep a diary and ask them to score their days from very bad to very good. Its not rocket science.”

These type of studies have already been successfully done by Iris Bell MD. Some published- check it out yourself!

She is actually an expert on medical studies, has published many and so it isn’t just spouting amateur objection theories like some.

Hello Derik, what you suggest is brilliant! AND it is exactly how homeopaths determine weather or not the remedy they have chosen is correct. The homeopath chooses the remedy based on the totality of symptoms, mental, emotional and physical; so you can see the “multivariate” is a wide spectrum. I am not sure if you have heard of “Hering’s Law”, but it is similar to what you suggest, determining whether or not an individual is moving toward “Wellness”. You do not read of this in homeopathic studies because it is known that the success of the case was based on homeopathic principles, therefore was measured very much in the manner you suggest. There is no need to explain how you measured it because all homeopaths measure it in the same way. The case study is to teach the depth and characteristics of the medicine.

Do not confuse “double blind” with “randomised controlled”. Both are independant – and randomisation of participants to intervention and control intervention without allocation bias are far more important than blinding.

The black-box idea is quite important – even sound physiological theories (homeopathy is not one of these) have been proven false empirically (like treating arrhythmias after infarction/CAST-study).

That’s interesting; so homeopaths have an absolutely standard method to measure the mental, emotional and physical symptoms? Please tell me more about that. What are the scales like? Are they continuous or categorical, or a mix of the two?

I think you’re saying this is used in individual case studies. Have you considered studying groups of patients and looking at your data graphically? That can give you greater insight than a single case and a description of the data.

Suppose you were to collect data from your hay fever sufferers one year (you can treat them individually just group them by hay fever like symptoms). If you were to look at that data with some multivariate tool you might find some interesting things. Perhaps you find there are distinct groups that have different trajectories to “Wellness”, possibly members of those groups have something in common like they’re going through divorce or they’re adolescent etc. That might help prescription practices.

I predict a short spurt towards wellness shortly after starting treatment, moving back to ill over time then rushing back to wellness at the end of the summer as the pollen disappears.

“There is no need to explain how you measured it because all homeopaths measure it in the same way.”

Such a statement is indefensible. While you could posit that “most” homeopaths operate in the “same way” you cannot factually assert that they **all** do without surveying each and everyone on the planet, living or dead. The fact that you would blithely make a factually unsupportable absolute statement does not speak well of your critical thinking–or writing–faculties.

Derick, yes we could do all of the above, but the point is it does not teach homeopaths anything. The only reason to do it would be to satisfy EBM and frankly, for most homeopaths, a waste of time.
Scote,………..yes, yes I should have said “most” homeopaths. WOW you got me there!! Feel better now??

No.

My point is that if the theory of homeopathy is broadly correct, such experiments would teach you something. You would be able to look at your data and work out how to improve your practice, which remedies were not working as previously described etc.

My idea is a mere example, it might be useless in practice and I don’t really think it would in itself satisfy a serious skeptic. If homeopathy is a science however, I would expect you to be actively seeking new ways of obtaining and analysing data so that you can make finer distinctions in your theory and hence as a healing art, treat your patients better. Even if homeopathy is broadly correct there must be some mistakes in the pharmacopeia, you are only human. Are you not anxious to find those errors so you can improve your practice?

Hey Derik, why do you assume that homeopaths do not have studies and standards that prove to them that a remedy is correct and the patient IS moving toward wellness? I doubt if many homeopaths would be satisfied if a patient was better for a time and then reverted to the same pathology they walked through the door with. A movement toward wellness is not temporary and is not restricted to one expression of the pathology, i.e. hay fever. Most (suit you Scote?) homeopaths are only satisfied when the totality (mentally, emotionally and physically) is moving toward a healthy state. As opposed to EBM where they are measuring wellness based on only one small part of the whole. There are no mistakes in the pharmacopeia, there is only the misunderstanding of the practioner applying the remedy. That is why case studies are more important to homeopaths than the studies you suggest.

There are NO mistakes in the pharmacopeia? That’s a claim of infallibility of almost papal proportions. I can see why you would be disdainful of modern science with its arcane caveats, stated assumptions and error bars when you already have access to absolute truth. I would be concerned that, as the information in the pharmacopeia was collected by practitioners, it might embody the misunderstanding of the practioner that entered it.

I’d like you to ask about the misunderstandings of homeopathic practitioners. What is the great controversy of the age? What is the argument for which there is much to be said on both sides but which, when finally resolved, is likely to deepen understanding and open up new vistas of treatment for your patients?

It does sound like a sweeping statement, and maybe not completely accurate because of the humane element. I am sorry. What I meant was that the pharmacopeia is a collection of information gathered from provings where the substance is revealing its healing properties. The substance has everything to do with what it can cure, there are no mistakes. Understanding the totality and applying the correct simillimum is where the difficulty lies. It is not black and white; you have an infection take an antibiotic. A human being is complex and so is figuring out the correct remedy. If 100% of the homeopathic practitioners understood exactly where the problem lies in each individual 100% of the time and could always apply the correct simillimum – homeopathy would be effective 100% of the time. The failure is not with the remedy, the failure is in the perception of the homeopath.

I must admit that I have found this rather puzzling to. ‘The failure is not in the remedy’, but surely the remedy picture is obtained through an all too fallible human process – the proving. Surely, there are proving errors too? I am sure you aware that many people, including academic homeopath George Lewith, believe that the proving methodology is horribly flawed and so undermines vast swathes of the pharmacopeia.

This is where we get back to your original post, where you reject double DBRCTs because they don’t provide insight that might help the homeopath in his daily practice. You don’t seem to be willing to acknowledge that any study of any type, even one making use of modern statistical methods capable of handling the multi-dimensional data sets a holistic medicine might produce. You say that the pharmacopeia is, as near as makes no difference, totally accurate so that the only area a homeopath might need to improve insight into is the nature of a specific patients symptoms. I think at this point your talk of souls and intelligence is a red herring. Homeopaths are pattern matching patient symptoms with the simillimum. The underlying cause of those symptoms has no impact on this process.

So all that’s left is how complete and accurate a list of symptoms a homeopath can obtain from a patient. This is what your case studies tell you is it; some questions you must not forget to ask patients.

Interestingly, in a letter to the Chest Journal, complaining about the inclusion of a successful study showing homeopathy works in serious chest conditions, the great magician and skeptic Coquilini, actually complains and debunks double blind studies using a homeopathic remedy and not the outcome of the study. It prompted a working medical Professor (unlike Coquilini) and one of the authors of the study to say:

“We are also concerned that Dr. Colquhoun questions the value of randomized controlled trials. This opinion appears to be inconsistent with the current position of conventional science.”

It will always be a lose lose situation for homeopaths and homeopathic supporters and those doing studies when it comes to radical skeptics who hold the prejudices that homeopathy doesn’t work.

Even worse, Coquilini, the successor to Randini, treats homeopaths and any supporter of homeopathy with megalomanic gall such as in the letter calling it magic, (something he knows alot about) and dictating what these working Professors of Medicine should do and not do.

I have read the Frass paper and Colquhoun’s response. I was also disappointed with Colquhoun’s letter as he didn’t engage with the method or results of the original paper. You are wrong, however, to say that he cast doubt on the value of randomized controlled trials. What he did was to recount the extreme implausibility of homeopathy because:

1. There is no molecule left in the pill, as was entirely true of the 30C remedy used in this study

And

2. The proposed “memory of water” mechanism that would get round this problem is also implausible given the very short time this memory could persist (50 femto seconds).

The Frass paper its self is interesting. I have posted the abstract below, which I think is permitted. Looking at the paper itself the placebo group look to be a lower weight, have a lower body mass index and have more advanced COPD than the treated group. This is no criticism of their randomisation procedure but with group sizes of 25 that sort of thing will happen by chance alone. Crucially a single a-typical patient could have distorted the whole analysis. So is this a one of fluke or compelling proof of the efficacy of homeopathy? You would have to repeat the experiment to find that out, and with p-values of <0.0001 you would think that was the authors top priority.

The paper was first received by the Journal Chest 4 years ago, today, on 17 March 2004. Since then not a single paper in the mainstream or alternative literature, searchable by web of science, has referenced the paper. Was more work done that returned negative findings? Did the authors simply go off to do other things? Has a body of positive results been suppressed by the evil pharma industry?

We will never know.

Letter: Chest, Feb 2007; 131: 635 – 636.

Paper: Frass et al Chest 2005;127;936-941

Abstract:

Background: Stringy, tenacious tracheal secretions may prevent extubation in patients weaned from the respirator. This prospective, randomized, double-blind, placebo-controlled study with parallel assignment was performed to assess the influence of sublingually administered potassium dichromate C30 on the amount of tenacious, stringy tracheal secretions in critically ill patients with a history of tobacco use and COPD.
Methods: In this study, 50 patients breathing spontaneously with continuous positive airway pressure were receiving either potassium dichromate C30 globules (group 1) [Deutsche Homoopathie-Union, Pharmaceutical Company; Karlsruhe, Germany] or placebo (group 2). Five globules were administered twice daily at intervals of 12 h. The amount of tracheal secretions on day 2 after the start of the study as well as the time for successful extubation and length of stay in the ICU were recorded.
Results: The amount of tracheal secretions was reduced significantly in group 1 (p < 0.0001). Extubation could be performed significantly earlier in group 1 (p < 0.0001). Similarly, length of stay was significantly shorter in group 1 (4.20 +/- 1.61 days vs 7.68 +/- 3.60 days, p < 0.0001 [mean +/- SD]).
Conclusion: These data suggest that potentized (diluted and vigorously shaken) potassium dichromate may help to decrease the amount of stringy tracheal secretions in COPD patients.

Derek said: 1. There is no molecule left in the pill, as was entirely true of the 30C remedy used in this study

And

2. The proposed “memory of water” mechanism that would get round this problem is also implausible given the very short time this memory could persist (50 femto seconds).

What you are saying here is all opinion and conjecture coming from your own narrow framework and world view which dismissing anything homeopathically potentized.

It is the problem with skeptics like yourself where you state opinion as if it is scientific fact where it is only a narrow view that finds energetic activity as implausible.

Homeopathic remedies are ACTIVE and that is why millions of people have used them for 200 + years. Get over it already. And that is why in the Chest Journal study, no matter how much you attempt to shred and dispute it what is left is still very obvious action from the homeopathic remedy. That is why it was published in the first place.

I am not saying this myself, I am reporting what Colquhoun said in a letter to Chest because I want to clarify that he did not question the validity of DBRCTs as you said, but the plausibility of homeopathy itself. This is an important distinction because if you were correct that he was casting doubt on DBRCTs, only because a homeopathy study had a positive result, it would show him to be a hypocrite. The actually content of the letter shows this not to be the case, though as I said I was disappointed that he didn’t engage with the science in the paper.

I have been thinking about the Chest paper some more, its unfortunate that all the results were presented in tabular form, it’s so hard to get a grip of what is actually going on. There are many graphical techniques for displaying data like boxplots, histograms, percentile box plots, density plots etc. If the authers had put some of those in instead of summary statistics it would be much easier to see what was going on. If it was truly a positive study it should have been repeated, first by them, then by another hospital, with ever increasing sample sizes. Why wasn’t it?

You say:

“it is only a narrow view that finds energetic activity as implausible”

I have no idea what this might mean. I have experienced what I consider “energetic activity” in the gym. Let us not, however, have a pointless definitional argument. Define your terms in a way intelligible to a smart 16 year old and I will tell you if I find it plausible or not.

Derik said: “Why wasn’t it?” You are referring to replication of a study utilizing a homeopathic remedy. This is frequent question about studies using homeopathic remedies.

Considering the way you have STARTED from the opinion that it is “implausable” and nitpicked this one apart and considering that there are individuals like Coqulini who START with the assumption and scream loudly that it is “magic” and “dangerous” why would you want to be the person or institute to replicate a study using a homeopathic remedy ?

When dealing with bigots many people prefer to stay indoors for fear of being hung or burned.

I don’t like the accusations of bigotry that come out of the CAM lobby. The history of science is replete with examples of dominant theories being over turned by new data. My experience of doing science is that I very often make false assumptions and that the only way to avoid wasting huge amounts of time it to be as open and relaxed as possible about the results of an experiment. I am only talking to you because I’m fascinated by the problem of homeopathy; How do you really test if its real or not? My attitude is one of interested playfulness rather than hostile stamping.

I’m not singling out the Chest paper for unwarranted pedantic nitpicking. This is just what you do with a paper, even and especially if it returns results you expect with. Every experiment has limitations, every result admits of alternative explanations. Picking a paper to pieces is fun; it is why they are there! It is only when you accrue a body of evidence from diverse sources that you can begin to have any confidence in a theory, which is why you need more than a few random RCTs to make the case for homeopathy.

However I think what you are saying, in more temperate language is:

This work threatens to overturn the scientific orthodoxy and whilst scientific institutions and ethics comities were prepared to cooperate whilst it looked like the result would be negative they no longer want to cooperate if the result might be positive.

That’s not the attitude I’m familiar with in science most of us are working to find out new stuff after all. Who cares about the old stuff!

I’d rather talk about this “energetic activity” of yours: What do you mean?

Derek, I appreciate your light attitude and you will have to excuse me if I am a bit suspicious. The orthodoxy you talk about is very anti- homeopathy to the point of great intensity and virulence. I agree that this orthodoxy which is partially at work in the anti-homeopathy movement is very detrimental to open scientific inquiry in general.

Randini successfully destroyed Benveniste’s career and I see on many anti-homeopathy blogs that they still spit on Benveniste in very nasty terms, ignoring his accomplishments and dedication to his scientific inquiry and research.

And now we have a current situation which I believe started with Golddigger bringing up Egger’s Lancet meta-analysis to continually call for the end of homeopathy and to claim homeopathy is “dangerous”. It seems, and maybe you can answer as to why, that homeopathy brings out the worst in scientific openness and inquiry.

Michel Aiken (statistician, University of Arizona) said of the Lancet article:
“There are, therefore, five areas in which the Lancet article does not meet
the minimum, conventional criteria for publication in biomedicine. This is, however, not the
most serious problem with the article. … Somehow
this precise and useful form [meta-analysis] has degraded into an unrecognizable hash, in which any papers
on any topic can be bundled together in an investigation of questions of unlimited
ambiguity. ”

…”To return to Thomas Kuhn, we certainly have many biomedical puzzles that are worth
working on, and which have not been addressed by normal biomedical science. Some of us
are engaged in an experiment to see whether we can fashion research tools that will help us
to understand more, by extending existing methods when feasible, and developing new ones
when appropriate. For us, it is particularly discouraging to see normal biomedical scientists
perverting their own tools for the evident purpose of attacking unconventional therapies. “

So to try to have a friendly banter with you about homeopathy or even scientific methodology of CAM is just not reasonable under these circumstances. You already in your comments show much bias even though you are being “nice” prior to discussion. On these blogs, to try to state anything about “energy” in the same sentence as medicine meets with a barrage of humiliation, condemnation and downright nastiness but not a discussion.

The nature of the anti-homeopathy movement is MORE than just light hearted scientific bantering, and much different than contesting opinion or striving for truth. It is much more nasty and I will repeat, bigoted than that.

So replicating studies, discussing “energy medicine” etc. for me, at least, is best left to more friendly ground than on these blogs.

Of course I don’t think homeopathy has any validity what so ever. This, however, makes me bias in the same sense that your are. You must regard the entire body of chemistry, physics and biology and fundamentally flawed given the utterly incompatible nature of homeopathy and modern science. Never the less tell me what you mean by energy medicine. It sounds to me like it might be a theoretical, non-physical, explanation for disease but Hahnemann said right at the beginning of the Organon:

“His [the physicians] mission is not, however, to construct so-called systems, by interweaving empty speculations and hypotheses concerning the internal essential nature of the vital processes and the mode in which diseases originate in the interior of the organism”

So what can it be, this Energy Medicine, that uses the word energy in some way I am not familiar with and contradicts the instruction of the master?

Go on, I’ll be vorsiferouse in argument but fair and reasonable and I genuinely want someone to actually explain what they actually mean by Energy Medicine. I’m beginning to think it might be nothing more than a shibboleth, friends purport to believe in it, enemies can’t say it for smiling.

“Of course I don’t think homeopathy has any validity what so ever.
-I hear you Derik. The rigid belief system longs for emancipation.

So I have an “energetic” and “spiritual” prayer for you:

I bless your mighty intellect and also that your soul that knows the value and wonderful miracle of homeopathy joins to dissipate all that is skeptical and that you embrace the healing power of homeopathy and you come forward as one of its main proponents bridging the gap between intellect and soul knowing. Bless you.

What a nice thing to say.

I usually like people I disagree with more than those I agree with, so its possible I could fall in love with you.

I’m afraid however that my critical faculties are unlikely to dissolve to homeopathic concentrations just yet.

I wonder about your response. Is this an issue of faith for you? Impossible poetic paradoxes are a good basis for religion, and are the seed from which great cultural achievements across the world have grown. Homeopathy is, however, a matter of medicine. Relief of flu like symptoms is hardly a transcendental religious experience. Do you not think you would get more fulfilment in this regard from a fully fledged mystic religion?


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