MD, PhD, FMedSci, FSB, FRCP, FRCPEd

homeopathy

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The FDA just made the following significant announcement:

The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

Date

April 20-21, 2015

Time

9:00 am to 4:00 pm

Location

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Great Room)
Silver Spring, Maryland 20993

Attendance, Registration, and Oral Presentations

Registration is free and available on a first-come, first-served basis. If you wish to attend or make an oral presentation, please reference section III of the forthcoming Federal Register Notice (Attendance and/or Participation in the Public Hearing) for information on how to register and the deadline for registration.

Webcast Information

If you cannot attend in person, information about how you can access a live Webcast will be located at Homeopathic Product Regulation

Agenda

The agenda will be posted soon

And this is what Reuters reported about the planned event:

The hearing, scheduled for April 20-21, will discuss prescription drugs, biological products, and over-the-counter drugs labeled homeopathic, a market that has expanded to become a multimillion dollar industry in the United States. The agency is set to evaluate its regulatory framework for homeopathic products after a quarter century. (http://1.usa.gov/1Hxwup3) An Australian government study released this month concluded that homeopathy does not work. (http://bit.ly/1BheAmR) The FDA issued a warning earlier this month asking consumers not to rely on asthma products labeled homeopathic that are sold over the counter. (http://1.usa.gov/1EEuKrC) Homeopathic medicines include pellets placed under the tongue, tablets, liquids, ointments, sprays and creams. The basic principles of homeopathy, formulated by German physician Samuel Hahnemann in the late 18th century, are based on a theory that a disease can be treated using small doses of natural substances that in a healthy person would produce symptoms of the disease. The agenda for the hearing will be posted soon, the FDA said on Tuesday.

In my view, this is an important occasion for experts believing in evidence to make their position regarding homeopathy heard. I therefore encourage all my readers who have an evidence-based opinion on homeopathy to submit it to the hearing.

Homeopathy has a long history in Canada.  In 1842, James Lilli was probably the first Canadian homeopath to begin practicing in Toronto. Joseph J. Lancaster, who had studied in New York, began practicing sometime in the 1840s in Ontario. The ‘Homeopathic Medical Society of Canada’ was established in 1854 in Hamilton, Ontario.

Since these early days much has changed. At present, all health care professions in Ontario are governed by the ‘Regulated Health Professions Act’ which allows all health-care professions the same right to practice. This law upholds the belief that the public has the right to choose what health care it wishes, and that the government should only intervene to regulate where a profession poses a significant risk of harm to the public. Only allopathic professions are currently regulated, and, in Ontario, doctors are censured if they practice homeopathy.

All schools of homeopathy in Canada offer ‘diplomate status’ and all offer three-year, part-time courses (one or two weekends per month plus perhaps one or two evenings per week). There are no legal doctorate or university degree programs for homeopathy in Canada. A doctorate in any field other than allopathic medicine cannot legally be used while practicing homeopathy.

I have been reliably informed that the regulation of homeopathy in Ontario is about to change. A transitional council of the ‘College of Homeopaths of Ontario’ had already been appointed in September 2009. The next step in the regulatory process is now imminent. On April 1 this year,  Ontario will proclaim the ‘Homeopathy Act’. The bill will further empower the ‘College of Homeopaths of Ontario’. This regulatory body will hence forth have control over who gets to call themselves a homeopath. In addition, it will also have a complaint tracking system.

This moves comes only days after the ‘Australian National Health and Medical Research Council’ has published the most thorough and independent assessment of homeopathy in the history of this form of alternative therapy. It concluded that homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness.

In view of the fact that homeopathy has been disproven as a treatment that fails to have a positive risk/benefit balance, the move of the regulators in Ontario seems pure madness to me. It sends the wrong signal to consumers and gives credibility to a form of quackery.

In a nutshell: EVEN THE BEST REGULATION OF NONSENSE WILL RESULT IN NONSENSE!

The other day, I received a request from THE GUARDIAN: could I write a piece on homeopathy in relation to the Australian report which had just come out; they gave me ~700 words and all of 3 hours to do it. I had an extremely busy day, but accepted the challenge nevertheless.

My article was published the next day and the ‘headliner’ at THE GUARDIAN had elected to call it There is no scientific case for homeopathy: the debate is over.

What followed was a flurry of debate – well over 2200 comments – which was more than a little ironic, considering the headline.

Essentially, my article had repeated the well-rehearsed arguments which have so often been made on this blog and elsewhere:

Our trials failed to show that homeopathy is more than a placebo.

Our reviews demonstrated that the most reliable of the 230 or so trials of homeopathy ever published are also not positive.

Studies with animals confirmed the results obtained on humans.

Surveys and case reports suggested that homeopathy can be dangerous.

The claims made by homeopaths to cure conditions like cancer, asthma or even Ebola were bogus.

The promotion of homeopathy is not ethical.

The comments that followed were mixed, of course; those that disagreed with me used a range of counter-arguments; in no specific order, these were the following:

  1. For several reasons, I cannot be trusted.
  2. I even once stated that I have treated my wife homeopathically.
  3. The Australian report was neither thorough nor reliable.
  4. The Australian expert panel were bought by Big Pharma.
  5. Homeopathic treatment must be individualised and can therefore not be tested in RCTs.
  6. Just because we don’t understand how homeopathy works, we should not conclude that it is ineffective.
  7. 200 years of positive experience with homeopathy clearly prove that it works.
  8. The huge popularity of homeopathy worldwide demonstrated its effectiveness.
  9. The fact that some very clever people support homeopathy shows that it works.
  10. Homeopathy works in animals and little children, therefore it cannot be just a placebo.
  11. The Queen and my aunt Doris use homeopathy.
  12. Placebos work.
  13. Patients must be able to choose; patient choice is an important principle in all health care.
  14. There’s more to evidence than just RCTs.
  15. Homeopathy works like vaccines.

With such an abundance of counter-arguments, the debate is clearly NOT over! Or is it? Let’s see how solid the arguments really are.

1) I cannot be trusted

Ad hominem attacks are no arguments at all; they are merely a sign that the person using them has no real arguments left.

2) I treated my wife homeopathically

This is true. At one stage in my life, I treated anyone who couldn’t run fast enough to escape me with homeopathy. What does that show? It simply shows that I can make mistakes too.

3) The Australian report was flawed

Perhaps it was not entirely faultless (no report ever is), but it certainly was rigorous – more so than any previous document in the entire history of homeopathy. If it excluded certain types of evidence, like the observational studies (which are so much loved by homeopaths), it did so because such data are wide open to bias.

4) The panel was not independent

Yes, it was! It even included a homeopath. The Australian National Health and Medical Research Council is internationally highly respected, and to defame it without evidence is, in a way, just another ad hominem attack.

5) Homeopathy must be individualised

This is a half-truth: classical homeopathy is mostly individualised, but lots of homeopathic prescribing is not individualised. And in any case, we have recently seen how totally unconvincing the results of strictly individualised trials of homeopathy are. This argument turns out to be a red herring.

6) We currently don’t understand how homeopathy works

What we do understand perfectly well, however, is the fact that no explanation exists which would not require throwing over board big chunks of the laws of nature. But even if we accepted that the mode of action is unknown, this would not change the lack of homeopathy’s clinical effectiveness. Lots of treatments work without us understanding how.

7) Experience shows it works

Experience is a very unreliable indicator of effectiveness; there are simply far too many confounders such as placebo effects, regression towards the mean or natural history of the disease. This is why we need evidence to be sure, and historically medicine finally started making progress when this lesson had been learnt.

8) The amazing popularity of homeopathy is proof of its effectiveness

This is the ‘argumentum ad populum’ fallacy. Think of the popularity of blood-letting to see how wrong this argument can be.

9) Homeopathy is backed by some very clever people

So what? Clever people are not always correct – look at me (just joking!)

10) Homeopathy works in animals and little children which proves that it is more than a placebo

First, animals and children do also show placebo-responses.

Second, the animal owner/parent might respond to placebo and thus mimic a placebo-response in the patient.

Third, the evidence for homeopathy is not positive neither in animals nor in children.

11) The Queen swears by homeopathy

Yes, so much so that, as soon as she is really ill, she makes use of what the very best of conventional medicine has to offer.

12) Placebos work

For sure! But that does not mean that we should prescribe placebos. If an effective treatment is given with compassion and empathy, the patient will also profit from a placebo effect – in addition to the effect of the treatment. Merely administering placebos means withholding the latter and is thus not in the best interest of the patient.

13) Patient choice

Yes, patient choice is important. However, it only applies to the choice between treatments that are demonstrably effective – if not choice becomes arbitrariness.

14) Evidence is more than just RCTs

True, there are many study designs other than RCTs. They all have their place in research – but when the research question is to test whether a treatment is effective beyond placebo, they are all open to different types of bias. The one that minimises bias best and thus produces more reliable findings than any other study design is the placebo-controlled, double-blind RCT.

15) Homeopathy works like vaccines

No! The ‘like cures like principle’ appears to be similar to the principles of vaccination, but this appearance is misleading. Vaccines contain small amounts of active material, while the typical homeopathic remedy doesn’t. Vaccines use the substance that causes the illness, e. g. (parts of) a virus, while homeopathy doesn’t.

So, is there still a debate? Obviously there is – the Guardian headliner was wrong – but it is a debate without reasonable arguments. And in the public domain, the debate is dominated by enthusiasts who endlessly repeat nonsensical notions which have been shown to be wrong over and over again.

In a nutshell:

Yes, there continues to be a debate.

No, there is no reasonable debate.

 

I have argued since many years that pharmacists should not be selling or promoting homeopathic and other remedies for which there is no proof of efficacy – the last time I published my view on this matter is even less than a week ago: Personally, I would go another step further and remind pharmacists who sell homeopathic remedies to the unsuspecting public that it is unethical to pretend they are more than placebos.

Despite my insistence and despite the fact that many agree with me (at least privately), there are precious few pharmacists who actually do something meaningful about the current situation. And there is very little visible change: in the UK, it is currently hard to find a pharmacy where homeopathic remedies are not on the shelves, and certainly all the major chains seem to put money before health care ethics.

I am, of course, speaking about the situation in the UK, France, Germany and some other European countries. Perhaps elsewhere things are different?

A NZ website seems to indicate that ‘down under’ the pharmacists are getting more active. Some strongly argue against unproven or disproven remedies in pharmacies:

Firstly, …it’s not a case that “pharmacists ‘should’ only be selling health products for which there is credible evidence of efficacy” (alterations mine, emboldened) but that they are obliged to—but choose not to. Their ethical guidelines state -

[PHARMACISTS] MUST:… Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.

…Secondly, the argument that ‘other businesses sell junk remedies therefore we shall’ is unsound. One of the key points about the ethical regulations for pharmacies is that customers should be able to walk into a store and have an expectation that the remedies within the store are basically sound. If other businesses elect to be unsound, that’s poor health practice, but no justification to do likewise. On the face of it, it would seem that the profit motive is ruling over sound and ethical practice.

Thirdly, that some GPs subscribe placebos should have no standing in this. There is some arguments for GPs to prescribe placebo remedies in some cases; others would argue that education is a better response in most cases. Either way—and just my opinion—it seems to me that GPs prescribing homeopathic remedies encourages people to think these have real remedial effects. I don’t work within the industry, but I am sure are ways of offering placebos that avoid using off-the-shelf commercial products. One might be that patients only get placebo ‘treatments’ via prescription.

…Fourthly, Pharmacy Today encourages that “pharmacies need to reconsider their stance in the light of this report”***. While this is an excellent idea, and one I thoroughly support, I suspect the underlying driver isn’t the report, but media presence on the topic. There is a long trail of evidence over many years showing that homeopathic remedies are not effective for anything.

The Australian study*** that prompted the latest round of interest drew this statement,

Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective.

Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner.* Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.

The National Health and Medical Research Council expects that the Australian public will be offered treatments and therapies based on the best available evidence.

…Why were the relevant professional bodies not onto this evidence sooner?…

GOOD QUESTION!

I might add another one: why are the European professional bodies of pharmacy doing so little about this ongoing breach of their own ethical codes?

(*** the report that the author refers to is the one by the Australian National Health and Medical Research Council we discussed on this blog a few days ago.)

My memoir ‘A SCIENTIST IN WONDERLAND’ continues to get rather splendid reviews. On 23 March, it will be published also in a German edition. Probably a good time to post another short excerpt from it.

The following episode gives just one of many examples of attempts by my Exeter peers to sabotage my scientific, moral and ethical standards. The players in this scene are:

By the year 2000, I began to experience unnecessary unpleasantness at Exeter on a more and more regular basis. This passage from my book describes the key moment when it became clear to me that something profoundly wrong was going on:

The watershed came in 2003, when I saw an announcement published in the newsletter of the Prince of Wales’ Foundation for Integrated Health:

“The Peninsula Medical School aims to become the UK’s first medical school to include integrated medicine at postgraduate level. The school also plans to extend the current range and depth of programmes offered by including healthcare ethics and legislation. Professor John Tooke, dean of the Peninsula Medical School, said: “The inclusion of integrated medicine is a patient driven development. Increasingly the public is turning to the medical profession for information about complementary medicines. This programme will play an important role in developing critical understanding of a wide range of therapies”.

When I stumbled on this announcement, I was truly puzzled. Tooke is obviously planning a new course for me, I thought, but why has he not told me about it? When I enquired, Tooke informed me that the medical school was indeed preparing to offer a postgraduate “Pathway in Integrated Health”; this exciting new innovation had been initiated by Dr Michael Dixon, a general practitioner who, after working in collabora-tion with my unit for several years, had become one of the UK’s most outspoken proponents of spiritual healing and other similarly dubious forms of alternative medicine. For this reason, Dixon was apparently very well regarded by Prince Charles.

A few days after I had received this amazing news, Dixon arrived at my office and explained, with visible embarrassment, that Prince Charles had expressed his desire to him personally to establish such a course at Exeter. His Royal Highness had already facilitated its funding which, in fact, came from “Nelsons”, one of the UK’s largest manufacturers of homeopathic remedies. The day-to-day running of the course was to be put into the hands of the ex-director of the Centre for Complementary Health Studies (CCHS), the very unit that, almost a decade earlier, I had struggled—and eventually even paid—to be separated from because of its overtly anti-scientific agenda. The whole thing had been in the planning for many months. I was, it seemed, the last to know—but now that I had learnt about it, Dixon and Tooke leaned on me with all their might to persuade me to contribute to this course by giving a few lectures.

I could no more comply with this request than fly. Apart from anything else, anyone who had read my papers would have known that I was opposed in principle to the concept of “Integrated Health”. As I saw it, “integrating” quackery with genuine, science-based medicine was nothing less than a profound betrayal of the ethical basis of medical practice. By putting its imprimatur on this course, and by offering it under the auspices of a mainstream medical school, my institution would be encouraging the dangerously erroneous idea of equivalence—i.e. the notion that alternative and mainstream medicine were merely two parallel but equally valid and effective methods of treating illness.

To add insult to injury, the course was to be run by someone who I had good reason to reject and sponsored by a major manufacturer of homeopathic remedies. In all conscience, the latter circumstance seemed to me to be the last straw. Study after study carried out by my unit had found homeopathy to be not only conceptually absurd but also therapeutically worthless. To all intents and purposes, the discussion about the value of homeopathy was closed. Even a former director of the Royal London Homeopathic Hospital had concluded in his book that “homeopathy has not been proved to work… the great majority… of the improvement that patients experience is due to non-specific causes”. If we did not take a stand on this issue, we might as well give up and go home. Consequently, I politely but firmly declined the offer of participating in this course.
By now numerous other incidents of a similar nature had poisoned the atmosphere at my own medical school and university so much that both my work and my health were suffering. How had it come to this? Why was even the most obvious and demonstrable truth being turned upside down so that it could be used against me? Why were my peers seemingly bent on constraining me and making life increasingly difficult for me?

I reported previously on this blog that the Australian National Health and Medical Research Council (NH&MRC) has made the most thorough and independent assessment of homeopathy in the history of this form of alternative therapy. The report published at the time was preliminary, and further evidence from parties that were critical of it needed to be taken into account.

Today (11/3/2015), the NH&MRC has released its final report on homeopathy. In essence, it concluded that there is no scientific basis for homeopathy and no quality evidence of its efficacy.

The report is similar in its conclusions to the UK Government Science and Technology 2010 Report on Homeopathy.

The summary of the report sates the following:

Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.

Professor Warwick Anderson, CEO of the Council, commented: “All medical treatments and interventions should be underpinned by reliable evidence. NH&MRC’s review shows that there is no good quality evidence to support the claim that homeopathy works better than a placebo.”
The report confirms what many scientific and public health experts have maintained since about 200 years, that not only does homeopathy not work, if it did, chemistry, physics and physiology could not.

“In short, the continued promotion of homeopathy would represent a commercial scam preying on the gullible,” said Professor John Dwyer AO, President of Friends of Science in Medicine (FSM), a non-industry aligned advocacy group for quality evidence in health. “Worse still, as a placebo therapy, harm may occur when it replaces effective therapies, as those given homeopathic treatments may wrongly think that they and their children are protected from serious infections,” he added.

The report emphasises that ‘People who choose homeopathy may put their health at risk, if they reject or delay treatments for which there is good evidence for safety and effectiveness’.

“With so many pressures on the Australian health dollar the Government must stop subsidising unproven alternative therapies such as homeopathy through student loans for homeopathy and similar courses,” said Professor Rob Morrison OAM, Co-Vice President of FSM, “The government should also not subsidise health funds offering cover for pseudoscientific electives of this kind,” said Professor Morrison. “The government should at least mandate that health funds offer a cheaper option that does not include ‘belief based’ therapies,” he said.

“It is completely unprofessional and unethical now for pharmacies to sell homeopathic products,” said Emeritus Professor Alastair MacLennan AO, Co-Vice President of FSM, “These products should now be removed from pharmacies and retail outlets”.

Highly diluted homeopathic remedies are pure placebos; at least this is what sceptics have been saying for about 200 years. This assumption is based on the fact that homeopathy’s plausibility is close to zero and that the totality of the reliable evidence fails to demonstrate that it works beyond placebo for any condition.

But, if this is true,  why do so many patients swear by homeopathy and experience benefit from it? This question has been answered many times: THE BENEFIT IS NOT DUE TO THE REMEDY BUT TO NON-SPECIFIC EFFECTS OF THE CONSULTATION.

More confirmation for this conclusion comes from an unexpected source.

Indian homeopaths recently published a trial of individualized homeopathy in osteoarthritis. To be more precise, it was a prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study which was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30). All patients were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India.

The results show statistically significant reduction in 3 visual analogue scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05). However, group differences were not significant (P > .05).

The authors conclude that, overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future.

Considering what I wrote above, I would alter these conclusion to something much more reasonable: further studies of homeopathy are certainly feasible. However, they are neither necessary nor desirable.

TO PUT IT DIFFERENTLY: HOMEOPATHY BELONGS IN THE BOOKS OF MEDICAL HISTORY.

I would have never thought that someone would be able to identify the author of the text I quoted in the previous post:

It is known that not just novel therapies but also traditional ones, such as homeopathy, suffer opposition and rejection by some doctors without having ever been subjected to serious tests. The doctor is in charge of medical treatment; he is thus responsible foremost for making sure all knowledge and all methods are employed for the benefit of public health…I ask the medical profession to consider even previously excluded therapies with an open mind. It is necessary that an unbiased evaluation takes place, not just of the theories but also of the clinical effectiveness of alternative medicine.

More often than once has science, when it relied on theory alone, arrived at verdicts which later had to be overturned – frequently this occurred only after long periods of time, after progress had been hindered and most acclaimed pioneers had suffered serious injustice. I do not need to remind you of the doctor who, more than 100 years ago, in fighting puerperal fever, discovered sepsis and asepsis but was laughed at and ousted by his colleagues throughout his lifetime. Yet nobody would today deny that this knowledge is most relevant to medicine and that it belongs to the basis of medicine. Insightful doctors, some of whom famous, have, during the recent years, spoken openly about the crisis in medicine and the dead end that health care has maneuvered itself into. It seems obvious that the solution is going in directions which embrace nature. Hardly any other form of science is so tightly bound to nature as is the science occupied with healing living creatures. The demand for holism is getting stronger and stronger, a general demand which has already been fruitful on the political level. For medicine, the challenge is to treat more than previously by influencing the whole organism when we aim to heal a diseased organ.

It is from the opening speech by Rudolf Hess on the occasion of the WORLD CONFERENCE ON HOMEOPATHY 1937, in Berlin. Hess, at the time Hitler’s deputy, was not the only Nazi-leader. I knew of the opening speech because, a few years ago, DER SPIEGEL published a theme issue on homeopathy, and they published a photo of the opening ceremony of this meeting. It shows many men in SS-uniform and, in the first row of the auditorium, we see Hess (as well as Himmler) ready to spring into action.

Hess in particular was besotted with alternative medicine which the Nazis elected to call NEUE DEUTSCHE HEILKUNDE. Somewhat to the dismay of today’s alternative medicine enthusiasts, I have repeatedly published on this aspect of alternative medicine’s past, and it also is an important part of my new book A SCIENTIST IN WONDERLAND which the lucky winner (my congratulations!) of my little competition to identify the author has won. The abstract of an 2001 article explains this history succinctly:

The aim of this article is to discuss complementary/alternative medicine (CAM) in the Third Reich. Based on a general movement towards all things natural, a powerful trend towards natural ways of healing had developed in the 19(th)century. By 1930 this had led to a situation where roughly as many lay practitioners of CAM existed in Germany as doctors. To re-unify German medicine under the banner of ‘Neue Deutsche Heilkunde’, the Nazi officials created the ‘Heilpraktiker’ – a profession which was meant to become extinct within one generation. The ‘flag ship’ of the ‘Neue Deutsche Heilkunde’ was the ‘Rudolf Hess Krankenhaus’ in Dresden. It represented a full integration of CAM and orthodox medicine. An example of systematic research into CAM is the Nazi government’s project to validate homoeopathy. Even though the data are now lost, the results of this research seem to have been negative. Even though there are some striking similarities between today’s CAM and yesterday’s ‘Neue Deutsche Heilkunde’ there are important differences. Most importantly, perhaps, today’s CAM is concerned with the welfare of the individual, whereas the ‘Neue Deutsche Heilkunde’ was aimed at ensuring the dominance of the Aryan race.

One fascinating aspect of this past is the fact that the NEUE DEUTSCHE HEILKUNDE was de facto the invention of what we today call ‘integrated medicine’. Then it was more like a ‘shot-gun marriage’, while today it seems to be driven more by political correctness and sloppy thinking. It did not work 70 years ago for the same reason that it will fail today: the integration of bogus (non-evidence based) treatments into conventional medicine must inevitably render health care not better but worse!

One does not need to be a rocket scientist to understand that, and Hess as well as other proponents of alternative medicine of his time had certainly got the idea. So they initiated the largest ever series of scientific tests of homeopathy. This research program was not just left to the homeopaths, who never had a reputation of being either rigorous or unbiased, but some of the best scientists of the era were recruited for it. The results vanished in the hands of the homeopaths during the turmoil of the war. But one eye-witness report of a homeopaths, Fritz Donner, makes it very clear: as it turned out, there was not a jot of evidence in favour of homeopathy.

And this, I think, is the other fascinating aspect of the story: homeopaths did not give up their plight to popularise homeopathy. On the contrary, they re-doubled their efforts to fool us all and to convince us with dodgy results (see recent posts on this blog) that homeopathy somehow does defy the laws of nature and is, in effect, very effective for all sorts of diseases.

My readers suggested all sorts of potential authors for the Hess speech; and they are right! It could have been written by any proponent of alternative medicine. This fact is amusing and depressing at the same time. Amusing because it discloses the lack of new ideas and arguments (even the same fallacies are being used). Depressing because it suggests that progress in alternative medicine is almost totally absent.

Recently I came across an interesting speech on alternative medicine which impressed me for a number of reasons. It made me think of a little game: the first person who correctly guesses who its author is, and posts the right answer as a comment on this blog, will receive a free copy of my new book A SCIENTIST IN WONDERLAND.

Here are 2 paragraphs from the speech in question:

It is known that not just novel therapies but also traditional ones, such as homeopathy, suffer opposition and rejection by some doctors without having ever been subjected to serious tests. The doctor is in charge of medical treatment; he is thus responsible foremost for making sure all knowledge and all methods are employed for the benefit of public health…I ask the medical profession to consider even previously excluded therapies with an open mind. It is necessary that an unbiased evaluation takes place, not just of the theories but also of the clinical effectiveness of alternative medicine.

More often than once has science, when it relied on theory alone, arrived at verdicts which later had to be overturned – frequently this occurred only after long periods of time, after progress had been hindered and most acclaimed pioneers had suffered serious injustice. I do not need to remind you of the doctor who, more than 100 years ago, in fighting puerperal fever, discovered sepsis and asepsis but was laughed at and ousted by his colleagues throughout his lifetime.  Yet nobody would today deny that this knowledge is most relevant to medicine and that it belongs to the basis of medicine. Insightful doctors, some of whom famous, have, during the recent years, spoken openly about the crisis in medicine and the dead end that health care has maneuvered itself into. It seems obvious that the solution is going in directions which embrace nature. Hardly any other form of science is so tightly bound to nature as is the science occupied with healing living creatures. The demand for holism is getting stronger and stronger, a general demand which has already been fruitful on the political level. For medicine, the challenge is to treat more than previously by influencing the whole organism when we aim to heal a diseased organ.

As promised, I will try with this post to explain my reservations regarding the new meta-analysis suggesting that individualised homeopathic remedies are superior to placebos. Before I start, however, I want to thank all those who have commented on various issues; it is well worth reading the numerous and diverse comments.

To remind us of the actual meta-analysis, it might be useful to re-publish its abstract (the full article is also available online):

BACKGROUND:

A rigorous and focused systematic review and meta-analysis of randomised controlled trials (RCTs) of individualised homeopathic treatment has not previously been undertaken. We tested the hypothesis that the outcome of an individualised homeopathic treatment approach using homeopathic medicines is distinguishable from that of placebos.

METHODS:

The review’s methods, including literature search strategy, data extraction, assessment of risk of bias and statistical analysis, were strictly protocol-based. Judgment in seven assessment domains enabled a trial’s risk of bias to be designated as low, unclear or high. A trial was judged to comprise ‘reliable evidence’ if its risk of bias was low or was unclear in one specified domain. ‘Effect size’ was reported as odds ratio (OR), with arithmetic transformation for continuous data carried out as required; OR > 1 signified an effect favouring homeopathy.

RESULTS:

Thirty-two eligible RCTs studied 24 different medical conditions in total. Twelve trials were classed ‘uncertain risk of bias’, three of which displayed relatively minor uncertainty and were designated reliable evidence; 20 trials were classed ‘high risk of bias’. Twenty-two trials had extractable data and were subjected to meta-analysis; OR = 1.53 (95% confidence interval (CI) 1.22 to 1.91). For the three trials with reliable evidence, sensitivity analysis revealed OR = 1.98 (95% CI 1.16 to 3.38).

CONCLUSIONS:

Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

Since my team had published an RCTs of individualised homeopathy, it seems only natural that my interest focussed on why the study (even though identified by Mathie et al) had not been included in the meta-analysis. Our study had provided no evidence that adjunctive homeopathic remedies, as prescribed by experienced homeopathic practitioners, are superior to placebo in improving the quality of life of children with mild to moderate asthma in addition to conventional treatment in primary care.

I was convinced that this trial had been rigorous and thus puzzled why, despite receiving ‘full marks’ from the reviewers, they had not included it in their meta-analysis. I thus wrote to Mathie, the lead author of the meta-analysis, and he explained: For your trial (White et al. 2003), under domain V of assessment, we were unable to extract data for meta-analysis, and so it was attributed high risk of bias, as specified by the Cochrane judgmental criteria. Our designated main outcome was the CAQ, for which we needed to know (or could at least estimate) a mean and SD for both the baseline and the end-point of the study. Since your paper reported only the change from baseline in Table 3 or in the main text, it is not possible to derive the necessary end-point for analysis.

It took a while and several further emails until I understood: our study did report both the primary (Table 2 quality of life) and secondary outcome measure (Table 3 severity of symptoms). The primary outcome measure was reported in full detail such that a meta-analysis would have been possible. The secondary outcome measure was also reported but not in full detail, and the data provided by us would not lend themselves to meta-analyses. By electing not our primary but our secondary outcome measure for their meta-analysis, Mathie et al were able to claim that they were unable to use our study and reject it for their meta-analysis.

Why did they do that?

The answer is simple: in their methods section, they specify that they used outcome measures “based on a pre-specified hierarchical list in order of greatest to least importance, recommended by the WHO“. This, I would argue is deeply flawed: the most important outcome measure of a study is usually the one for which the study was designed, not the one that some guys at the WHO feel might be important (incidentally, the WHO list was never meant to be applied to meta-analyses in that way).

By following rigidly their published protocol, the authors of the meta-analysis managed to exclude our negative trial. Thus they did everything right – or did they?

Well, I think they committed several serious mistakes.

  • Firstly, they wrote the protocol, which forced them to exclude our study. Following a protocol is not a virtue in itself; if the protocol is nonsensical it even is the opposite. Had they proceeded as is normal in such cases and used our primary outcome measure in their meta-analyses, it is most likely that their overall results would not have been in favour of homeopathy.
  • Secondly, they awarded our study a malus point for the criterium ‘selective outcome reporting’. This is clearly a wrong decision: we did report the severity-outcome, albeit not in sufficient detail for their meta-analysis. Had they not committed this misjudgment, our RCT would have been the only one with an ‘A’ rating. This would have very clearly highlighted the nonsense of excluding the best-rated trial from meta-analysis.

There are several other oddities as well. For instance, Mathie et al judge our study to be NOT free of vested interest. I asked Mathie why they had done this and was told it is because we accepted free trial medication from a homeopathic pharmacy. I would argue that my team was far less plagued by vested interest than the authors of their three best (and of course positive) trials who, as I happen to know, are consultants for homeopathic manufacturers.

And all of this is just in relation to our own study. Norbert Aust has uncovered similar irregularities with other trials and I take the liberty of quoting his comments posted previously again here:

I have reason to believe that this review and metaanalysis in biased in favor of homeopathy. To check this, I compared two studies (1) Jacobs 1994 about the treatment of childhood diarrhea in Nicaragua, (2) Walach 1997 about homeopathic threatment of headaches. The Jacobs study is one of the three that provided ‘reliable evidence’, Walach’s study earned a poor C2.2 rating and was not included in the meta-analyses. Jacobs’ results were in favour of homeopathy, Walach’s not.

For the domains where the rating of Walach’s study was less than that of the Jacobs study, please find citations from the original studies or my short summaries for the point in question.

Domain I: Sequence generation:
Walach:
“The remedy selected was then mailed to a notary public who held a stock of placebos. The notary threw a dice and mailed either the homeopathic remedy or an appropriate placebo. The notary was provided with a blank randomisation list.”
Rating: UNCLEAR (Medium risk of bias)

Jacobs:
“For each of these medications, there was a box of tubes in sequentially numbered order which had been previously randomized into treatment or control medication using a random numbers table in blocks of four”
Rating: YES (Low risk of bias)

Domain IIIb: Blinding of outcome assessor
Walach:
“The notary was provided with a blank randomization list which was an absolutely unique document. It was only handed out after the biometrician (WG) had deposited all coded original data as a printout at the notary’s office. (…) Data entry was performed blindly by personnel not involved in the study. ”
Rating: UNCLEAR (Medium risk of bias)

Jacobs:
“All statistical analyses were done before breaking the randomisation code, using the program …”
Rating: YES (Low risk of bias)

Domain V: Selective outcome reporting

Walach:
Study protocol was published in 1991 prior to enrollment of participants, all primary outcome variables were reported with respect to all participants and the endpoints.
Rating: NO (high risk of bias)

Jacobs:
No prior publication of protocol, but a pilot study exists. However this was published in 1993 only after the trial was performed in 1991. Primary outcome defined (duration of diarrhea), reported but table and graph do not match, secondary outcome (number of unformed stools on day 3) seems defined post hoc, for this is the only one point in time, this outcome yielded a significant result.
Rating: YES (low risk of bias)

Domain VI: Other sources of bias:

Walach:
Rating: NO (high risk of bias), no details given

Jacobs:
Imbalance of group properties (size, weight and age of children), that might have some impact on course of disease, high impact of parallel therapy (rehydration) by far exceeding effect size of homeopathic treatment
Rating: YES (low risk of bias), no details given

In a nutshell: I fail to see the basis for the different ratings in the studies themselves. I assume bias of the authors of the review.

Conclusion

So, what about the question posed in the title of this article? The meta-analysis is clearly not a ‘proof of concept’. But is it proof for misconduct? I asked Mathie and he answered as follows: No, your statement does not reflect the situation at all. As for each and every paper, we selected the main outcome measure for your trial using the objective WHO classification approach (in which quality of life is clearly of lower rank than severity). This is all clearly described in our prospective protocol. Under no circumstances did we approach this matter retrospectively, in the way you are implying. 

Some nasty sceptics might have assumed that the handful of rigorous studies with negative results were well-known to most researchers of homeopathy. In this situation, it would have been hugely tempting to write the protocol such that these studies must be excluded. I am thrilled to be told that the authors of the current new meta-analysis (who declared all sorts of vested interests at the end of the article) resisted this temptation.

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