The main complaint from homeopaths regarding the DBRCT is that it interferes in the all important relationship between the practitioner and the patient. This protocol, as a number one priority, attempts to avoid interfering at all in this relationship. If there are sufficient numbers of patients and the allocation of patients to the remedy and placebo groups is genuinely random, the differences should even out, shouldn't they?
If not, then it is just as likely to favour the placebo as the remedy group, so we would have to run the test maybe 20 times (perhaps with twenty different homeopaths) and statistically work out what a significant difference would be.

The ethics of clinical placebo controlled studies have been and are intensively examined from both sides.

It would be extremely unethical to control a study on childhood leukaemia with a placebo when we know that no treament is far worse than the best treatment that is available. In these cases, a new treatment will be compared against an existing successful treatment. It is important to notice that not just any new treatment is tested this way. The new treatment must be shown to have relevant activity in terms of the mechanism of action and have proven activity at the molecular, cellular and whole organism level.

These thought modes did not just spring up overnight, they are the result of many mistakes which were made in the early history of medicine.

The other side of the problem is the question: is it ethical to treat people when you cannot prove if the treatment is successful?

And here we should keep in mind that "successful" in holistic medicine (not only homeopathy) is defined/understood in a very different way than in so-called conventional medicine - so I'm not sure that everyone would be able to agree that the swan is black unless people start to think (I'm sorry to repeat myself) about people in the first place, and the oath of Hippocrates which states "no harm" first.

And what about ethics re the details of homeopathic treatment that I've mentioned?

Also do you suggest that "successful" treatment exists in every possible condition? I have often read re cancer treatments, for example, that "the operation was successful, but the cancer spread to other organs and patient succumbed to this shortly afterwards". Now, what should "successful operation" mean here in the first place? Clearly the span of trials and assessment of treatments should be extended - and the quality of life somehow included in the aspects to be assessed (in allopathy) - then it will become clear which treatment regime is (I will not say successful) beneficial to the patient. Homeopathy, for one, always thinks in terms of the whole time-line of the person's life-long existence... And I have also read about complete recovery from (adult) leukemia - only on a Russian homeopathic site

You have to define success before any trial. It may be survival after a period of time, elimination of an infectious organism by an accepted test or relief of symptoms.

You are quite right about agreement on the black swan. There were three people travelling on a train to a conference in Scotland when they saw a black sheep in a field. 'Ah', said the first, a biologist, 'there are black sheep in Scotland'. The second, a physicist replied, 'We can say there is at least one black sheep in Scotland'. The last was a mathematician and shaking his head, said 'All that can be said is that there is a sheep in one field in Scotland, of which at least one side is black'.

I thought I had responded to your point, my apologies if I haven't and could you point to the unobeserved section.

Modern science and indeed medicine does not talk about absolutes. The wonderful universe we are in doesn't allow us that luxury, we can only talk about probabilities.

Surgery, at one time, was the only option for cancer tumours, and as you point out, if it had metastased, it would appear elsewhere in the body. Once this was recognised, a combination of chemotherapy, radiotherapy and surgery have improved outcomes.

As mentioned above, the success of a trial has to be defined before the trial starts. Quality of life is obviously an important ingredient in any outcome, blood pressure can easily be reduced by amputating all the limbs but nobody would ever advocate that as a treatment. At the extremes, it is easy to examine quality of life, it is much more difficult to assess this in the middle. For example, is someone's quality of life reduced by expending wealth on a useless 'cure' for the common cold? The mere act of expenditure for one person may just make them feel good, for another it may mean them having to buy less nutritious food.

Have you a reference to the adult leukaemia case? The clear demonstration of a complete recovery of a non-self limiting disease would go a long way to showing that homeopathy can work.

BTW The word allopathy is used by many homeopaths as a derogatory term (cf Hahnemann). It doesn't worry me, but in the interests of open discussion it may be better to leave it out.

"What do you think?
Could it work and, if not, why not?"

Solid.

Similar thread over at laughingmysocksoff - though verbose.

The problems with clinical trials of CAM: a case of wholly holey socks? Laughing my socks off …

Acleron,

Well, I'm a mathematician by education and I must say I agree about what one can say about the black sheep, one has to have all their definitions right before talking about things. And yes, before the trials - if one still thinks that they should indeed be indispensable and should replace clinical evidence.
I will reread your post, I just have no time now, it's very late here in Japan, re ethics in trials of homeopathy, sorry, I cannot comment right now.

I have the link to the case of leukemia, but it's in Russian, I doubt you'll be able to read it, but still I'll post it, so that you could affirm that the site that talks about this exists in reality.
Îñòðûé ëåéêîç. Ïðèìåíåíèå íà ïðàêòèêå Ãàíåìàííîâñêîé äîêòðèíû â ëå÷åíèè õðîíè÷åñêèõ çàáîëåâàíèé - Öåíòð êëàññè÷åñêîé ãîìåîïàòèè ÎËËÎ

(I thought they had an English version of this somewhere, but could not find it this time)

I've got the ENglish link now, here it is (although I did not read it to check the adequacy of the translation, I hope it is close enough)
ACUTE LEUKEMIA. PRACTICAL APPLICATION OF THE HAHNEMANNIC DOCTRINE TO THE TREATMENT OF A CHRONIC DISEASE - Öåíòð êëàññè÷åñêîé ãîìåîïàòèè ÎËËÎ

It contains most of the blood tests readings, and I should also add to some people that say that clinical evidence might be unreliable because of people's memories, that usually homeopaths have everything on file, and every time the patients come the clinically important things that they said are always noted and added to the file, so the cases tend to be well documented, if you'd care to examine them and forget about the trials for the moment.

I personally have helped in treating people with thyroid disorders (would you consider them self-limiting? I have not heard much about spontaneous recovery of such cases - i.e. without ANY treatment, at what rate do they get better?), and all 3 cases do the regular follow ups at the hospital for tests - one had Hashimoto's disorder completely improved, the tests are back to normal and stay so for 5 years now, improved within 3 months after beginning of treatment, the other had Basedow's completely recovered (although it took almost a year, the initial complaint, though, was endometriosis, which also showed considerable improvement, she is almost pain free now) and tests stay normal for 3 years now, the third one is a very difficult case, she had cancer of thyroid, half of it was removed, but since she started homeo/treatment her tests show steady increase in hormone production, and as she takes regular follow ups there is a chance that her thyroxine supplement will be decreased if the values go too high... I don't have the full records, because I was only helping as I'm only a student, but I have seen the tests from the lab with my own eyes. And needless to say, the tests were not used as an indication of success or otherwise of the treatment.

I will also - if my family with 2 small children will let me to write more or less regularly - refrain from using this word "allopathy", I just meant to distinguish the treatment non-homeopathic in this case, not really derogatory, just meaning what it means "treatment not by likes" - "allos"=different.

THanks for reading, by the way, hope my posts will clarify something for some people.

Elena Zagrebelnaya

Thank you for your link, especially the English translation.

The patient was receiving chemotherapy at the same time. It would be impossible to dissociate which treatment affected the progress of the disease.

It shows an example where practitioners of non-evidence based medicine (and others :)) can make mistakes of cause and effect.

Chemotherapy is a very aggressive treatment. It has immediate effects of severe nausea and weight and hair loss. One can imagine that in sheer desperation a patient may seek alternative methods even when told the effects are temporary. After seeking an alternative and the symptoms receding the alternative practitioner may claim success but the symptom relief would have happened anyway.

I couldn't comment on your thyroid cases as there is no detailed history. When I mentioned that an example of a successful treatment of a non self-limiting disease would be useful, I should have said that a full clinical/biochemical diagnosis before and complete clinical/biochemical examination afterwards would be necessary. Otherwise the examples could be considered as anecdotes.

It is possible that the treatment was eventually successful. It is also possible that the treatment was ineffective and that the underlying conditions resolved spontaneously over that period of time. We would need to know what conditions were being treated and what the natural history (ie without treatment) of these conditions are.

Perhaps we need to trial only one remedy and treat only acute illnesses which would be expected to resolve within a short time frame. However, remember the first proirity is no interference in the practitioner/patient relationship.

Certain conditions would not matter in this respect. Consider the common cold or flu, headaches or migraines. There must be lots of conditions which are just a nuisance left untreated rather than life threatening. That would be a good place to start.

It is impossible to make a proper assessment in these three cases on what you have toled us here. It is what we would describe as anecdotal evidence which is extremely unreliable. Also, as Acleron said, we don't even have the full histories. For example, were the diagnoses confirmed histologically? Was there any doubt about the diagnosis? Were they also receiving conventional medical treatment? And what is the natural history of these conditions (left untreated)?

Interesting.

The aim of that protocol seems to be similar to mine: no interference in the homoeopath/patient interaction by letting the homoeopath do exactly what he normally does in his homoeopathic treatment of the patient. And he achieves this in the same way by introducing randomisation and blinding only at the point of the dispensary. And the endpoints are chosen by the homoeopath just as in my protocol. The main difference is that he has the patient answer a questionaire to assess effectiveness, whereas I am happy to let the homoeopath do this.

Here is an interesting and relevant quote from someone called "Andy" where he answers questions posed by the homoeopath.
(Unfortunately, he tends to be a little agressive in his attitude)